chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Ulcer
Clinical narrative: ADR, treatments, outcomes 79yo female with DM on prednisone at home developed a severe rash 24 hours after receiving the moderna vaccine. Patient has extensive skin rash and sloughing superficial venous involving extensive area on the back. Red blanching papules and patches on back, buttocks, legs, arms. Sparing face, hands and feet. Ears with some ulceration. Exfoliation and superficial ulcerations of hte buttocks. Nikolskly sign is negative. Information was shared with local burn center with clinically suspicion for Stevens-Johnson sx or TEN. Patient denies any fever chills. Hemodynamically stable wit no evidence of involvement - improving with prednisone and topicals. Thrush appears to be developing in the mouth today as well. Differential diagnosis: Symmetri, drug related intertriginous and flexural exanthema (previously bad bone syndrome) has been reported with COVID-19 infection but not with the vaccine. DRESS. Dermatomyositis rash flare after covid vaccine. Treated with prednisone 30 mg daily, halobetasol BID x2 weeks. Silver sulfadiazine, mupirocin BID.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Bursal fluid accumulation, Injection site pain, Magnetic resonance imaging, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Patient developed left shoulder/arm pain the evening after injection. Was diagnosed with subdeltoid fascial planes and subcromia/subdeltoid bursa with complex fluid. SIRVA - shoulder injury related to vaccine administration. Tendinopathy of rotator cuff with full thickness tearing of posterior supraspinatus tendon. All occurred in left shoulder.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon disorder, Tendon rupture
Clinical narrative: Patient developed left shoulder/arm pain the evening after injection. Was diagnosed with subdeltoid fascial planes and subcromia/subdeltoid bursa with complex fluid. SIRVA - shoulder injury related to vaccine administration. Tendinopathy of rotator cuff with full thickness tearing of posterior supraspinatus tendon. All occurred in left shoulder.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Lacrimation increased
Clinical narrative: Approximately 15 minutes after 1st moderna vaccine experienced hot, eyes watering, patient started to feel weak. APRN in room. 1340 NS started, Benedryl 12.5mg IVP given, 1355 Benedryl 12.5mg IVP 2nd dose. 1354 epinephrine auto inject done, 1400 Solumedrol 125mg duoneb tx, EMS transported
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitis
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Throat irritation
Clinical narrative: The patient stated that her throat was scratchy & itchy just minutes after receiving the injection.  After a few more minutes her lips started feeling tingly.  Her tongue then also started feeling tingly shortly thereafter. The patient started feeling better and went to MD.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Bradycardia, Dizziness, Tremor
Clinical narrative: This was 2nd dose of this vax. She went to her car and felt dizzy, trembling, weak. Found to be bradycardic, later learned she has had              bradycardia in the past. Patient improved after 1 liter normal saline We observed in ER for several hours & symptoms resolved
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nausea, Swelling face, Vomiting
Clinical narrative: swelling face and red spots on face nausea and vomiting
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness lightheadedness
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Discomfort, Influenza, Lymphadenitis, Lymphadenopathy, Ultrasound lymph nodes
Clinical narrative: 4/15 Swollen Lymph node on R side on neck 4/20/21 ED - U/S Lymphadenitis on R neck - Augmentin 4/21/21 ED - Swollen gland & discomfort - Acetominophen  4/22/21 PCP office - flu - lymph gland softening                      continue Augmentin till complete.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash from "head to toe" upon waking up on Wed. Received shot Mon. Patient went to urgent care and was prescribed Benadryl and Zyrtec.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Breast swelling, Injection site swelling, Injection site warmth, Oedema peripheral, Pain
Clinical narrative: 4/22 Pt. walked in to doctor's office         c/o swelling around outside         harder with Left breast & Left         axillary area with pain. Left upper         arm warm and swollen
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling cold, Headache, Injection site erythema
Clinical narrative: 4/18/2021 - injection site red swollen tender chilly feeling 4/19/2021 chills, H.A. SOB 4/20/2021 redness @ injection site resolving. H.A 4/21/2021 - redness @ injection site
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 4/18/2021 - injection site red swollen tender chilly feeling 4/19/2021 chills, H.A. SOB 4/20/2021 redness @ injection site resolving. H.A 4/21/2021 - redness @ injection site
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Diarrhea, Fatigue
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Grade 1-2 anaphylaxis
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Superficial vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Vaccine 04/05/21 noon time Woke on 04/17/21 with soreness in Right distal upper arm. Soreness got worse over 2 days. Was seen in Urgent Care 04/19/21. US upper extremity shows right superficial venous thrombosis of right basilic vein with near occlusion
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: VERTIGO IN AM ON 03/16, 17, 18, AND EXTREME VERTIGO ON 03/19 ALL DAY..  TAKEN TO DOCTOR ON 03/19/2021
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test, Pain in extremity, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Pt states "foot pain" started 3/30/21. He went to get it checked on 4-1-21, and was diagnosed with a "blood clot".   Started on Eliquis for 6 months.  A second dr's appt is scheduled in 3 months.  The blood clot is in the L leg.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Pt states "foot pain" started 3/30/21. He went to get it checked on 4-1-21, and was diagnosed with a "blood clot".   Started on Eliquis for 6 months.  A second dr's appt is scheduled in 3 months.  The blood clot is in the L leg.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Muscle tightness, Tension headache
Clinical narrative: Headache, Arthralgia,   HA occurs with head flexion 7/10. Starts at base of his neck and is a tightness sensation that moves to the top of his head. Motrin helping.   Narrative:    Other Relevant History:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Hyperhidrosis, Hypertension
Clinical narrative: Developed headache + diaphoresis. Found to have severe hypertension which resolved in 10 minutes. No local or system allergic reaction noted.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache Fatigue, chills, injection site pain and tenderness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Injection site pain
Clinical narrative: Headache  First headache around 4am, pain at injection site, loss of apettite  Narrative:   Other Relevant History:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain Narrative:  Other Relevant History:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia
Clinical narrative: Headache, Myalgia & Diarrhea Narrative:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Headache, Myalgia & Arthralgia Narrative: Other Relevant History:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Pyrexia
Clinical narrative: Fever Headache,fever,and fatigue after 2nd Pfizer COVID vaccine causing loss of work. Narrative: Headache,fever,and fatigue after 2nd Pfizer COVID vaccine causing loss of work.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Headache, Myalgia, UrticariaPruritus, NauseaVomiting, prickling sensation off/on throughtout body, swollen lymph nodes, fatigue Narrative:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Urticaria, Vomiting
Clinical narrative: Headache, Myalgia, UrticariaPruritus, NauseaVomiting, prickling sensation off/on throughtout body, swollen lymph nodes, fatigue Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia
Clinical narrative: Dizziness, Headache, Myalgia, chills Narrative
Age: 0.17
Sex: F
Vaccine: COVID19
Symptoms: Erythema multiforme, Nausea, Vomiting
Clinical narrative: ErythemaMultiform & NauseaVomiting Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, numbness right hip/toes intermittent; fatigue Narrative:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Hypertension, Hypertensive emergency, Nausea
Clinical narrative: Headache, NauseaVomiting, HYPERtension, lupus flare up with hypertensive emergency  Narrative:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus, Vomiting
Clinical narrative: Headache, NauseaVomiting, HYPERtension, lupus flare up with hypertensive emergency  Narrative:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Pain in extremity
Clinical narrative: Fatigue and arm soreness causing work absence Narrative:  Fatigue and arm soreness causing work absence
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: red, itchy spots under the breast and now it is radiating to the neck and belly button Narrative:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgia & Fever Narrative:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgia & Fever Narrative:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache & Fever Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache & NauseaVomiting Narrative:
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES Narrative:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Headache Narrative:  c/o headache/migraine starting one day post vaccination spanning to 4 days post vaccination. migraine resolved on day 5.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Myalgia, Arthralgia, Fever, chills, swollen glands-symptoms lasted 5 days Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Myalgia, Fever, NauseaVomiting, Pain at injection site Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Heavy menstrual bleeding, Myalgia, Pain
Clinical narrative: Local symptoms- Pain-discomfort, swelling. Genera symptoms- muscle pains ,fatigue, heavier than usual periods. Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Local symptoms- Pain-discomfort, swelling. Genera symptoms- muscle pains ,fatigue, heavier than usual periods. Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Headache, Arthralgia, NauseaVomiting, Palpitations, Fatigue, sore throat Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vomiting
Clinical narrative: Headache, Arthralgia, NauseaVomiting, Palpitations, Fatigue, sore throat Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Dizziness, Headache, NauseaVomiting, sore arm Narrative:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Myalgia severe arm pain and immobility to appendage that had the injection Narrative:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, Fever & NauseaVomiting Narrative:
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Myalgia Narrative:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Side effects Narrative:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lethargy
Clinical narrative: reports lethargy and injection site pain and swelling lasted 36 hours Narrative:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive covid test before procedure Narrative: positive covid test, asymptomatic as of 4-19-2021 RN check in
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Tonsillar hypertrophy
Clinical narrative: Swollen Tonsils Narrative: Patient is a 61 year old male who received Moderna Vaccine on 3/15/21. Patient contacted Facility on 3/25/21 reporting swelling/tenderness of right tonsil which started several days following vaccine. He reports symptoms are improving and denies any shortness of breath or difficulty swallowing. Patient denies need for any urgent care visit for further evaluation. No reported history of allergic reactions to vaccines in the past.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea
Clinical narrative: nausea, L sided HA, and generalized weakness Narrative:
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Burning sensation, Feeling abnormal, Hyperventilation, Urticaria
Clinical narrative: Per ED notes from Dr. on 12/20/20: Patient is a 35-year-old female that presents the emergency department because of hives.  She was getting her COVID-19 vaccination and it was administered at 815.  She went back to work and she started to develop hives around 30 minutes after the vaccine.  She had a burning feeling in her arms and was feeling very anxious and noted she was hyperventilating.  She was not wheezing did not have any shortness of breath.  She is given epinephrine at 846.  She calmed down at 849 and the burning feeling went away.  She feels back to her normal self. She has a history of getting hives to the purple Sani wipes.  Otherwise no history of anaphylaxis or other allergic reaction.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Hyperventilation, Skin burning sensation, Urticaria
Clinical narrative: Per ED notes from Dr. on 12/20/20: Patient is a 35-year-old female that presents the emergency department because of hives.  She was getting her COVID-19 vaccination and it was administered at 815.  She went back to work and she started to develop hives around 30 minutes after the vaccine.  She had a burning feeling in her arms and was feeling very anxious and noted she was hyperventilating.  She was not wheezing did not have any shortness of breath.  She is given epinephrine at 846.  She calmed down at 849 and the burning feeling went away.  She feels back to her normal self. She has a history of getting hives to the purple Sani wipes.  Otherwise no history of anaphylaxis or other allergic reaction.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Chills, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Patient received first dose of Moderna COVID-19 vaccine on 12/23/20. Received second dose on 1/20/21. Patient is an employee/physician at the institution. Patient reports symptoms of congestion/ runny nose to institution's COVID call center on 4/5. Pt's husband had tested positive the day prior. Nasopharyngeal swab obtained 4/5 at 1218 Coronavirus PCR test resulted positive a few hours later.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Patient received first dose of Moderna COVID-19 vaccine on 12/23/20. Received second dose on 1/20/21. Patient is an employee/physician at the institution. Patient reports symptoms of congestion/ runny nose to institution's COVID call center on 4/5. Pt's husband had tested positive the day prior. Nasopharyngeal swab obtained 4/5 at 1218 Coronavirus PCR test resulted positive a few hours later.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Patient received first dose of Moderna COVID-19 vaccine on 12/23/20. Received second dose on 1/20/21. Patient is an employee/physician at the institution. Patient reports symptoms of congestion/ runny nose to institution's COVID call center on 4/5. Pt's husband had tested positive the day prior. Nasopharyngeal swab obtained 4/5 at 1218 Coronavirus PCR test resulted positive a few hours later.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Swollen tongue, Throat irritation
Clinical narrative: Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a contactable pharmacist. A 41-year-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN3518), via intramuscular route of administration in left arm on 02Feb2021 at 11:45 AM at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El1283), via intramuscular route of administration in left arm on 01Jan2021 at single dose for COVID-19 immunization and had no problem post 1st dose. Medical history and concomitant medications were not reported. The patient was allergic to shellfish anaphylaxis. On 02Feb2021 at 12:15 PM, the patient experienced tongue felt like it was swelling, tickle in her throat and itching. During observation period post second dose patient began itching and felt like she had a tickle in her throat. Patient began clearing her throat and asked for some water. RN noted she was rubbing throat and gave her water and benadryl 25 mg PO for itching. Patient noted that her throat was starting to feel funny like it might be closing up and her tongue felt like it was swelling. Epinephrine 0.3mg IM administered immediately after identifying these symptoms and patient wheeled down to ER for evaluation. Patient received IV benadryl in ER and famotidine. Observed for a couple of hours and then released. The outcome of the events was unknown.; Sender's Comments: A causal relationship between  BNT162B2 and the reported events swollen tongue, pruritus and throat irritation cannot be excluded based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Swollen tongue, Throat irritation
Clinical narrative: Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a contactable pharmacist. A 41-year-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN3518), via intramuscular route of administration in left arm on 02Feb2021 at 11:45 AM at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El1283), via intramuscular route of administration in left arm on 01Jan2021 at single dose for COVID-19 immunization and had no problem post 1st dose. Medical history and concomitant medications were not reported. The patient was allergic to shellfish anaphylaxis. On 02Feb2021 at 12:15 PM, the patient experienced tongue felt like it was swelling, tickle in her throat and itching. During observation period post second dose patient began itching and felt like she had a tickle in her throat. Patient began clearing her throat and asked for some water. RN noted she was rubbing throat and gave her water and benadryl 25 mg PO for itching. Patient noted that her throat was starting to feel funny like it might be closing up and her tongue felt like it was swelling. Epinephrine 0.3mg IM administered immediately after identifying these symptoms and patient wheeled down to ER for evaluation. Patient received IV benadryl in ER and famotidine. Observed for a couple of hours and then released. The outcome of the events was unknown.; Sender's Comments: A causal relationship between  BNT162B2 and the reported events swollen tongue, pruritus and throat irritation cannot be excluded based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma
Clinical narrative: asthma attack (Difficulty to breathe); This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthma attack (Difficulty to breathe)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date, Diabetes since an unknown date, High cholesterol since an unknown date and Asthma since an unknown date.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ASTHMA (asthma attack (Difficulty to breathe)) (seriousness criterion death). The reported cause of death was Asthma. It is unknown if an autopsy was performed.        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.   Treatment medications of the patient included Inhaler. Concomitant medications of the patient included high blood pressure medication ,cholesterol medication and diabetes medication not otherwise specified.  Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. However, the patient's comorbidities are risk factors and confounds causality assessment. Further information has been requested.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: It was provided that patient passed away.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. However, the patient's comorbidities are risk factors and confounds causality assessment. Further information has been requested.; Reported Cause(s) of Death: asthma
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Death
Clinical narrative: Approximately 2-3 hour after vaccination patient was witnessed to become unresponsive.  EMS was summoned and life support guidelines was performed for approximately 35-45 minutes to no avail. Pronounced dead in emergency department.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Death, Hypersensitivity
Clinical narrative: Approximately 2-3 hour after vaccination patient was witnessed to become unresponsive.  EMS was summoned and life support guidelines was performed for approximately 35-45 minutes to no avail. Pronounced dead in emergency department.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Blood electrolytes normal, Blood immunoglobulin E increased, Death, Resuscitation
Clinical narrative: Approximately 2-3 hour after vaccination patient was witnessed to become unresponsive.  EMS was summoned and life support guidelines was performed for approximately 35-45 minutes to no avail. Pronounced dead in emergency department.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Tryptase increased, Unresponsive to stimuli
Clinical narrative: Approximately 2-3 hour after vaccination patient was witnessed to become unresponsive.  EMS was summoned and life support guidelines was performed for approximately 35-45 minutes to no avail. Pronounced dead in emergency department.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Dizziness, Feeling abnormal, Heart rate irregular
Clinical narrative: she was having a feeling like she was in shock; woke up last night not feeling right and this morning; irregular heart beat/Pulse 112/Pulse 108/went to 112; checked her blood pressure on 25Jan2021, the lower number was high, upper number lower than what it usually was, it was exactly: 130/96; then 110/78; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number EL3247 and expiry date not reported) via an unspecified route of administration on 21Jan2021 10:00 am at 71 years of age as single dose in left arm for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included atenolol, amlodipine, lisinopril; all ongoing for high blood pressure. The patient received the Pfizer COVID-19 vaccine at 10 am yesterday, her symptoms started last night and came on suddenly. She went and checked her blood pressure on 25Jan2021, the lower number was high, upper number lower than what it usually was, it was exactly: 130/96, pulse 112, then 110/78, pulse 108, after taking her medication. Her pulse went to 112, it does that when it gets irregular, it did get better after blood pressure medication atenolol. She woke up last night not feeling right and this morning, she was having a feeling like she was in shock. She developed an irregular heart beat last night on 25Jan2021. It was still bothering her. She had her first shot on Thursday of this past week. She was unsure if this was a side effect. Received the vaccine on 21Jan2021. She says it felt like it was right before you pass out. No treatment received. She was supposed to take blood pressure medication but she was being cautious right now. Her blood pressure medications were: atenolol, amlodipine, lisinopril. She did not take them this morning; all have taken for years. At the time of this report, the outcome of the event irregular heart beat/pulse 112/pulse 108/went to 112 was not recovered, while unknown for the rest of the events.  Follow-up (25Mar2021): Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Feeling abnormal, Heart rate irregular, Shock symptom
Clinical narrative: she was having a feeling like she was in shock; woke up last night not feeling right and this morning; irregular heart beat/Pulse 112/Pulse 108/went to 112; checked her blood pressure on 25Jan2021, the lower number was high, upper number lower than what it usually was, it was exactly: 130/96; then 110/78; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number EL3247 and expiry date not reported) via an unspecified route of administration on 21Jan2021 10:00 am at 71 years of age as single dose in left arm for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included atenolol, amlodipine, lisinopril; all ongoing for high blood pressure. The patient received the Pfizer COVID-19 vaccine at 10 am yesterday, her symptoms started last night and came on suddenly. She went and checked her blood pressure on 25Jan2021, the lower number was high, upper number lower than what it usually was, it was exactly: 130/96, pulse 112, then 110/78, pulse 108, after taking her medication. Her pulse went to 112, it does that when it gets irregular, it did get better after blood pressure medication atenolol. She woke up last night not feeling right and this morning, she was having a feeling like she was in shock. She developed an irregular heart beat last night on 25Jan2021. It was still bothering her. She had her first shot on Thursday of this past week. She was unsure if this was a side effect. Received the vaccine on 21Jan2021. She says it felt like it was right before you pass out. No treatment received. She was supposed to take blood pressure medication but she was being cautious right now. Her blood pressure medications were: atenolol, amlodipine, lisinopril. She did not take them this morning; all have taken for years. At the time of this report, the outcome of the event irregular heart beat/pulse 112/pulse 108/went to 112 was not recovered, while unknown for the rest of the events.  Follow-up (25Mar2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lip swelling
Clinical narrative: After receiving Moderna dose 2, pt initially with progressive swelling and erythema of the left lateral upper arm overlying the site of injection.  On 1/30/21, appox 3 days later, presents to ED with progressive swelling of her left lower lip.  No tongue swelling.  Denies difficulty breathing/swallowing.  No other rashes.  VS T 98.4F, P 52, RR 19, BP 109/81, SpO2 97% RA, Weight 176 lb 5.9 oz; CBC & CMP WNL. Administered in ED: Benadryl 50mg IVP, Solu-MEDROL 125mg IVP D/C with new Rx for: Benadryl 25mg - take 1 capsule PO every 6 hours PRN for itching for up to 7 days; Pepcid 20mg - take 1 tablet PO BID x4 days; prednisone 20mg - take 2 tablets PO daily x4 days.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Injection site erythema, Injection site swelling, Lip swelling, Metabolic function test
Clinical narrative: After receiving Moderna dose 2, pt initially with progressive swelling and erythema of the left lateral upper arm overlying the site of injection.  On 1/30/21, appox 3 days later, presents to ED with progressive swelling of her left lower lip.  No tongue swelling.  Denies difficulty breathing/swallowing.  No other rashes.  VS T 98.4F, P 52, RR 19, BP 109/81, SpO2 97% RA, Weight 176 lb 5.9 oz; CBC & CMP WNL. Administered in ED: Benadryl 50mg IVP, Solu-MEDROL 125mg IVP D/C with new Rx for: Benadryl 25mg - take 1 capsule PO every 6 hours PRN for itching for up to 7 days; Pepcid 20mg - take 1 tablet PO BID x4 days; prednisone 20mg - take 2 tablets PO daily x4 days.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache
Clinical narrative: patient received the first COVID dose on 1/26/21 a week later reports headache, fatigue took 5 weeks to recover. Got the second vaccine for COVID, reports again of headache and not feeling well. Patient came to the office and got diagnosed with Temporal arteritis
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Giant cell arteritis, Headache, Magnetic resonance imaging, Malaise
Clinical narrative: patient received the first COVID dose on 1/26/21 a week later reports headache, fatigue took 5 weeks to recover. Got the second vaccine for COVID, reports again of headache and not feeling well. Patient came to the office and got diagnosed with Temporal arteritis
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: patient received the first COVID dose on 1/26/21 a week later reports headache, fatigue took 5 weeks to recover. Got the second vaccine for COVID, reports again of headache and not feeling well. Patient came to the office and got diagnosed with Temporal arteritis
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergy and illicit drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and expiry: 08-MAR-2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-Serious.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergy and illicit drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and expiry: 08-MAR-2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-Serious.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: developed acute neck and arm pain with decreased ability to use subjective after, continued swelling, on 2/8/2021 wnl, patient went on to develop COVID after son had covid and has had brain fog after.  completed series for vaccine on 1/23/2021, covid diagnosis on 3/13/2021
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Feeling abnormal, Mobility decreased, Neck pain
Clinical narrative: developed acute neck and arm pain with decreased ability to use subjective after, continued swelling, on 2/8/2021 wnl, patient went on to develop COVID after son had covid and has had brain fog after.  completed series for vaccine on 1/23/2021, covid diagnosis on 3/13/2021
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Swelling, Ultrasound scan normal
Clinical narrative: developed acute neck and arm pain with decreased ability to use subjective after, continued swelling, on 2/8/2021 wnl, patient went on to develop COVID after son had covid and has had brain fog after.  completed series for vaccine on 1/23/2021, covid diagnosis on 3/13/2021
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: developed acute neck and arm pain with decreased ability to use subjective after, continued swelling, on 2/8/2021 wnl, patient went on to develop COVID after son had covid and has had brain fog after.  completed series for vaccine on 1/23/2021, covid diagnosis on 3/13/2021
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed acute neck and arm pain with decreased ability to use subjective after, continued swelling, on 2/8/2021 wnl, patient went on to develop COVID after son had covid and has had brain fog after.  completed series for vaccine on 1/23/2021, covid diagnosis on 3/13/2021
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: FLU LIKE SYMPTOMS; SORENESS OF THE ARM; SEVER CHILLS/CHATTERING TEETH; KNEE ACHES; MUSCLE ACHES; SEVERE HEADACHE; FEVER; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced soreness of the arm. On 08-MAR-2021, the subject experienced sever chills/chattering teeth. On 08-MAR-2021, the subject experienced knee aches. On 08-MAR-2021, the subject experienced muscle aches. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 100.6, 100.3-101. On 09-MAR-2021 02:00, Laboratory data included: Body temperature (NR: not provided) 102.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever chills/chattering teeth, was recovering from soreness of the arm, had not recovered from fever, dizziness, severe headache, knee aches, muscle aches, and nausea, and the outcome of flu like symptoms was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Immediate post-injection reaction, Influenza like illness, Injection site pain, Ocular hyperaemia
Clinical narrative: FLU LIKE SYMPTOMS; SORENESS OF THE ARM; SEVER CHILLS/CHATTERING TEETH; KNEE ACHES; MUSCLE ACHES; SEVERE HEADACHE; FEVER; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced soreness of the arm. On 08-MAR-2021, the subject experienced sever chills/chattering teeth. On 08-MAR-2021, the subject experienced knee aches. On 08-MAR-2021, the subject experienced muscle aches. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 100.6, 100.3-101. On 09-MAR-2021 02:00, Laboratory data included: Body temperature (NR: not provided) 102.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever chills/chattering teeth, was recovering from soreness of the arm, had not recovered from fever, dizziness, severe headache, knee aches, muscle aches, and nausea, and the outcome of flu like symptoms was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, Tinnitus, Tremor
Clinical narrative: FLU LIKE SYMPTOMS; SORENESS OF THE ARM; SEVER CHILLS/CHATTERING TEETH; KNEE ACHES; MUSCLE ACHES; SEVERE HEADACHE; FEVER; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced soreness of the arm. On 08-MAR-2021, the subject experienced sever chills/chattering teeth. On 08-MAR-2021, the subject experienced knee aches. On 08-MAR-2021, the subject experienced muscle aches. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 100.6, 100.3-101. On 09-MAR-2021 02:00, Laboratory data included: Body temperature (NR: not provided) 102.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever chills/chattering teeth, was recovering from soreness of the arm, had not recovered from fever, dizziness, severe headache, knee aches, muscle aches, and nausea, and the outcome of flu like symptoms was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: FLU LIKE SYMPTOMS; SORENESS OF THE ARM; SEVER CHILLS/CHATTERING TEETH; KNEE ACHES; MUSCLE ACHES; SEVERE HEADACHE; FEVER; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced soreness of the arm. On 08-MAR-2021, the subject experienced sever chills/chattering teeth. On 08-MAR-2021, the subject experienced knee aches. On 08-MAR-2021, the subject experienced muscle aches. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 100.6, 100.3-101. On 09-MAR-2021 02:00, Laboratory data included: Body temperature (NR: not provided) 102.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever chills/chattering teeth, was recovering from soreness of the arm, had not recovered from fever, dizziness, severe headache, knee aches, muscle aches, and nausea, and the outcome of flu like symptoms was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS; SORENESS OF THE ARM; SEVER CHILLS/CHATTERING TEETH; KNEE ACHES; MUSCLE ACHES; SEVERE HEADACHE; FEVER; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced soreness of the arm. On 08-MAR-2021, the subject experienced sever chills/chattering teeth. On 08-MAR-2021, the subject experienced knee aches. On 08-MAR-2021, the subject experienced muscle aches. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 100.6, 100.3-101. On 09-MAR-2021 02:00, Laboratory data included: Body temperature (NR: not provided) 102.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever chills/chattering teeth, was recovering from soreness of the arm, had not recovered from fever, dizziness, severe headache, knee aches, muscle aches, and nausea, and the outcome of flu like symptoms was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Headache, Malaise, Ocular hyperaemia, Pain
Clinical narrative: FLU LIKE SYMPTOMS; SORENESS OF THE ARM; SEVER CHILLS/CHATTERING TEETH; KNEE ACHES; MUSCLE ACHES; SEVERE HEADACHE; FEVER; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced soreness of the arm. On 08-MAR-2021, the subject experienced sever chills/chattering teeth. On 08-MAR-2021, the subject experienced knee aches. On 08-MAR-2021, the subject experienced muscle aches. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 100.6, 100.3-101. On 09-MAR-2021 02:00, Laboratory data included: Body temperature (NR: not provided) 102.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever chills/chattering teeth, was recovering from soreness of the arm, had not recovered from fever, dizziness, severe headache, knee aches, muscle aches, and nausea, and the outcome of flu like symptoms was not reported. This report was non-serious.