chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, HIV test, Headache, Malaise, Pain in extremity
Clinical narrative: Arm pain the next day followed by fatigue and malaise; Arm pain the next day followed by fatigue and malaise; Arm pain the next day followed by fatigue and malaise; headaches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Jan2021 (Lot number: EL 0142) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Jan2021, outcome "unknown", FATIGUE (non-serious), MALAISE (non-serious) all with onset 13Jan2021, outcome "recovered" (18Jan2021) and all described as "Arm pain the next day followed by fatigue and malaise"; HEADACHE (non-serious) with onset Jan2021, outcome "unknown", described as "headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:Description of Event: Following dose 1 of Pfizer Lot # EL 0142. On 12Jan2021 Patient reported experiencing arm pain the next day followed by fatigue and malaise x 5 days. Patient also reported periodic severe headaches lasting several hours during this time. Patient subsequently received Does to Pfizer lot # EL3247 on 02Feb2021. No reaction. On 08Aug2021 patient received booster dose of Pfizer lot # FC 3180. Next day patient experienced a sore arm followed by five days of general malaise. On day 2 post vaccination patient experienced a fever spike of 100.5F which lasted about six hours per report.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eyelid ptosis, Fatigue, Headache, Pain
Clinical narrative: tired; eyes felt droopy and hard to keep open; chills and was shivering; Headache; achy; arm pain; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 29Aug2021 (Lot number: FC3184) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: FA7485), administration date: 09Aug2021, when the patient was 18 years old, for COVID-19 immunization; Hpv (Adverse Event: Eczema Flare after second HPV vaccine, Onset Age: 11), when the patient was 11 years old, reaction(s): "Eczema Flare". The following information was reported: CHILLS (non-serious) with onset 30Aug2021 09:30, outcome "unknown", described as "chills and was shivering"; HEADACHE (non-serious) with onset 30Aug2021 09:30, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset 30Aug2021, outcome "unknown", described as "achy"; PAIN IN EXTREMITY (non-serious) with onset 29Aug2021, outcome "unknown", described as "arm pain"; FATIGUE (non-serious), outcome "unknown", described as "tired"; EYELID PTOSIS (non-serious), outcome "unknown", described as "eyes felt droopy and hard to keep open".  Additional information: The mother of the patient reported that the patient slept under a blanket for chills and shivering. The patient did not had any prior vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: tired; eyes felt droopy and hard to keep open; chills and was shivering; Headache; achy; arm pain; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 29Aug2021 (Lot number: FC3184) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: FA7485), administration date: 09Aug2021, when the patient was 18 years old, for COVID-19 immunization; Hpv (Adverse Event: Eczema Flare after second HPV vaccine, Onset Age: 11), when the patient was 11 years old, reaction(s): "Eczema Flare". The following information was reported: CHILLS (non-serious) with onset 30Aug2021 09:30, outcome "unknown", described as "chills and was shivering"; HEADACHE (non-serious) with onset 30Aug2021 09:30, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset 30Aug2021, outcome "unknown", described as "achy"; PAIN IN EXTREMITY (non-serious) with onset 29Aug2021, outcome "unknown", described as "arm pain"; FATIGUE (non-serious), outcome "unknown", described as "tired"; EYELID PTOSIS (non-serious), outcome "unknown", described as "eyes felt droopy and hard to keep open".  Additional information: The mother of the patient reported that the patient slept under a blanket for chills and shivering. The patient did not had any prior vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Pain in extremity
Clinical narrative: pain in the arm/ Sore arm; Blood sugar was extremely high; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 11:30 (Lot number: FC3180) at the age of 72 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing), notes: Diagnosed about 15 years ago.; "Sciatica" (unspecified if ongoing), notes: Diagnosed about 5 years ago. The caller goes to the chiropractor. Concomitant medication(s) included: TRULICITY; PRADAXA; LISINOPRIL; DULOXETINE; CARVEDILOL; DIGOXIN; TRAMADOL taken for back pain; TYLENOL taken for headache. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Aug2021, outcome "unknown", described as "pain in the arm/ Sore arm"; BLOOD GLUCOSE INCREASED (non-serious) with onset 09Aug2021, outcome "unknown", described as "Blood sugar was extremely high". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Additional information: The caller had pain in the arm, like she was punched in the arm, like she did with the first one. The caller has type 2 diabetes and she gets her blood test every Monday and her blood sugar was 178. The caller's blood glucose was usually 122 and never over 125. Event: The sore arms lasted about a day. The caller later clarified and confirmed that she took her blood sugar this morning and she was always checking it on Wednesdays and took her Trulicity shot after it. The caller took Trulicity 1.5 mini open once a week and her blood sugar is always 122-133. Lot D389795, unknown, expiration date 12Jan2023. No AE(s) required a visit to emergency room or physician Office. Prior Vaccinations (within 4 weeks): No. AE(s) following prior vaccinations: None.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: She is not feeling really well; She is feeling like dizzy from last three days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "She is not feeling really well"; DIZZINESS (non-serious) with onset 28Aug2021, outcome "unknown", described as "She is feeling like dizzy from last three days".  Additional information: The patient got the vaccine and she was not feeling really well. She was feeling like dizzy from last three days and she said about the Pfizer vaccine was approved and licensed. Is that true?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pruritus
Clinical narrative: My eyes are very itchy and dry; My eyes are very itchy and dry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 15:00 (Lot number: F51620) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 2, Solution for injection, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 23Mar2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Solution for injection, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 02Mar2021, when the patient was 39 years old, for COVID-19 immunization.  The following information was reported: DRY EYE (non-serious), EYE PRURITUS (non-serious) all with onset 18Nov2021 09:00, outcome "recovering" and all described as "My eyes are very itchy and dry". Therapeutic measures were taken as a result of dry eye, eye pruritus.  Additional information: Despite putting on eye drops the irritation does not go away. She could not work on computer screens for too long and being in the dark alleviate the. The patient did not have any other vaccine in four weeks. Other medications in two weeks was Synthroid. Ae resulted in None of the above. Patient did not have Covid prior vaccination. Covid was not tested post vaccination. There was No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: minor issues of fever and chills; minor issues of fever and chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: In February he was diagnosed with COVID-19; "Breathing issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), PYREXIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "minor issues of fever and chills".  Additional information: I have a consumer on the line that is calling to report an adverse event and in Feb he was diagnosed with COVID-19 and he was having breathing issues with having the COVID and in Apr he received the Pfizer COVID -19 vaccine and he had minor issues of fever and chills he said it didn't last very long but he said that having the vaccine alleviated the breathing issue that he was having from having COVID and then two nights ago he received the booster dose and he said that he has the swollen lymph node that is about the size half a lemon."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Lip swelling, Oral disorder
Clinical narrative: swollen lips; Oral Lesions; I developed 5 canker sore; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Oct2021 (Lot number: FF2593) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MULTIVITAMIN & MINERAL. Past drug history included: Penicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF8839, Location of injection: Arm Left), administration date: 29Sep2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: LIP SWELLING (non-serious) with onset 11Nov2021, outcome "not recovered", described as "swollen lips"; ORAL DISORDER (non-serious) with onset 11Nov2021, outcome "not recovered", described as "Oral Lesions"; APHTHOUS ULCER (non-serious) with onset 11Nov2021, outcome "recovering", described as "I developed 5 canker sore". Therapeutic measures were taken as a result of lip swelling, oral disorder, aphthous ulcer. No follow-up attempts are possible. No further information is expected.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The treatment received for the adverse event was  Lidocaine mouth rinse, Prednisone. Prior to vaccination, the patient was diagnosed with COVID-19.Since the vaccination, has the patient not been tested for COVID-19.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: slight fatigue; injection site sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Apr2021 (Lot number: FF8839) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Back injuries", start date: 27Feb1995 (ongoing), notes: No surgical procedures.; "Endometriosis", start date: 1984 (ongoing), notes: Diagnostic laproscopies.; "Internal adhesions", start date: 1998 (ongoing), notes: Diagnostic laproscopies. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1, Time: 19:00, Anatomical site of injection: Upper left arm, Lot#: FF8839), administration date: 10Feb2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Extreme fatigue", "Burning at injection site", "expected sore feeling like bruise", "side effects were awful". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "slight fatigue"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovering", described as "injection site sore". Additional information: Prior Vaccinations (within 4 weeks): None. Concomitant Drugs: None. Specific Relevant test for thromboembolic events with thrombocytopenia: None. 2nd vaccine was much better, slight fatigue went to work without a problem. Injection site sore, no burning at injection site. She was not sure if the side effects with the 1st vaccine are due to her blood type o negative. No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Axillary pain, Headache, Lymphadenopathy
Clinical narrative: Complaining of under arm pain/unable to lift arm without pain; golf ball size swelling of lymph node; Also complained of headache; bellyache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), (tirs),  intramuscular, administered in arm, administration date 30Nov2021 16:30 (Lot number: FK5127) at the age of 10 years as dose 2 , single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MULTIVITAMIN [VITAMINS NOS]. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, lot No.- FK5127, Time: 16:30, Anatomical location: Arm, Route of administration: Intramuscular), administration date: 09Nov2021, when the patient was 10 years old, for COVID-19 immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 01Dec2021, outcome "recovered" (Dec2021), described as "Complaining of under arm pain/unable to lift arm without pain"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021, outcome "recovered" (Dec2021), described as "golf ball size swelling of lymph node"; HEADACHE (non-serious) with onset 01Dec2021, outcome "recovered" (Dec2021), described as "Also complained of headache"; ABDOMINAL PAIN (non-serious) with onset 01Dec2021, outcome "recovered" (02Dec2021), described as "bellyache". Therapeutic measures were taken as a result of axillary pain, lymphadenopathy, headache. Therapeutic measures were not taken as a result of abdominal pain.  Additional Information: Twin sister received the same dose at same time and is also experiencing under arm pain but very little swelling, no headache, and no bellyache. No information reported on Specific relevant test for thromboembolic events with thrombocytopenia. No further details on patient was reported.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Joint lock, Muscle spasms
Clinical narrative: had baby on 02Dec2021; knees locked when her water broke (was leaning over bed) and legs cramped (such as thigh); knees locked when her water broke (was leaning over bed) and legs cramped (such as thigh); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 30's (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "TBI from car accident in 20s" (unspecified if ongoing), notes: TBI from car accident in 20s; "Knee surgery" (unspecified if ongoing), notes: Knee surgery; "Drug allergy" (unspecified if ongoing), notes: Reaction: Allergy, Drug: Unsure. The patient took concomitant medications. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "had baby on 02Dec2021"; MUSCLE SPASMS (non-serious), JOINT LOCK (non-serious), outcome "unknown" and all described as "knees locked when her water broke (was leaning over bed) and legs cramped (such as thigh)".  Additional information: Patient had baby said was a whirlwind delivery but haven't gotten other details. List of any other medications the patient received within 2 weeks of vaccination: likely blood thinner shots but unsure if that was during vaccination period. Baby went to pediatrics appointment today and reporter described baby as totally perfect, which means he is healthy. Unsure of medical history of both parents. Patient had TBI in 20s and is on blood thinners (has continued to use following pregnancy). Patient is relatively healthy. Other ailments unknown. Baby came two days before set induction date. He originally was not growing as quickly, but started feeding more, and now he is wearing 23-month-old colthes. Had around a pound of water weight that he lost after initial birth. They feed him breastmilk. Patient told me birth story, and I don't think there were any AEs but two things stuck out. Contractions started the day before or estimated 12 hours before labor. Patient knees locked when her water broke (was leaning over bed) and legs cramped (such as thigh) to where doctors had to roll her onto the bed. Patient is estimated 36 years old. She definitely has received first shot of vaccine, but cannot remember whether got second. Her husband, early to mid 40s is also vaccinated and may have been vaccinated 2 dose during pregnancy or conception, unsure timeline (separate AE submitted for this previously). Cannot confirm, but spouses may have gotten Moderna. Patient was in mid-30s. Dad was in 40s, if pertinent. Reporter believe mother and baby are doing well.  Follow-up attempts completed. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Magnetic resonance imaging, Muscle tightness, Pain in extremity
Clinical narrative: Tightening in her right calf; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6202) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 26Feb2021, outcome "recovered" (2021), described as "Tightening in her right calf"; PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "sore arm". The event "tightening in her right calf" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (2021) heart palpitations; electrocardiogram: (2021) abnormal; magnetic resonance imaging: (2021) heart palpitations; pulmonary function test: (2021) unknown results; x-ray: (Oct2021) unknown results, notes: pulmonary. Therapeutic measures were not taken as a result of muscle tightness, pain in extremity. Therapeutic measures were not taken as a result of muscle tightness, pain in extremity. No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test, X-ray
Clinical narrative: Tightening in her right calf; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6202) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 26Feb2021, outcome "recovered" (2021), described as "Tightening in her right calf"; PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "sore arm". The event "tightening in her right calf" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (2021) heart palpitations; electrocardiogram: (2021) abnormal; magnetic resonance imaging: (2021) heart palpitations; pulmonary function test: (2021) unknown results; x-ray: (Oct2021) unknown results, notes: pulmonary. Therapeutic measures were not taken as a result of muscle tightness, pain in extremity. Therapeutic measures were not taken as a result of muscle tightness, pain in extremity. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Caller also noted that she had "a terrible response to the initial vaccine; This is a spontaneous report received from a contactable reporter (Nurse) from medical information team. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Caller also noted that she had "a terrible response to the initial vaccine". Additional information: Report no related to a study or program.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Systemic: she had a period start 2 days after and last for 1 week not supposed to get her period for 2 more weeks and she is normally regular-Mild, Additional Details: she started abnormal period bled for 1 week was 2 weeks early for period she will monitor since she got her second dose today
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: pt said her arm tingled from elbow to hand then spread to shoulder-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Vasculitis
Clinical narrative: Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: VASCULITIS-Mild
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure fluctuation, Dizziness, Hypertension
Clinical narrative: Since July of 2021, second vaccine date in May, my blood pressure has been hypertension stage 1, or elevated, or normal.  I was looking at my blood pressure history on my phone and the first case of hypertension was 133/69 on July 23rd. A value as high as 149/87 on February the 6th. I am continuing to monitor. I reported this to my doctor in December they advised I come in however I lost my job and benefits.  I did not become worried about my circulation until December when I felt lightheaded after a meal in the evening. I did contact my doctor however I did not make an appointment because I had lost my health insurance.  Presently I'm monitoring my blood pressure daily and it fluctuates.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient is complaining of arm bicep pain that can extend into his shoulder and down to his forearm.  It has been happening since he got his second dose. Patient did not receive his second dose at our facility and did not have his CDC card with him.  But he said that it switched from pain in his left arm after the second dose to pain in his right arm after his booster dose.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Insomnia, Otorrhoea, Tinnitus
Clinical narrative: On same day of vaccination, I experienced severe and almost unbearable ringing in both ears.  On same night, I experienced a watery discharge from my right ear which fortunately, alleviated the symptoms after several hours. The closest ENT appointment was given for March 8. Currently, I am still experiencing the noise from my left ear which is traumatizing. Difficulty sleeping and concentrating.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Arthralgia, Atrial fibrillation, Blood creatinine increased, COVID-19
Clinical narrative: Patient is fully vaccinated. COVID + 2/2/2022 on admission to hospital. Patient admitted with neck pain ans shoulder pain.  The patient also described left-sided vague chest pain, while still in emergency room patient developed severe tachycardia. Labs: cr 2.12, Hg 8.7, Plts 119, Troponin elevated. CXR: Mild nonspecific prominence of the interstitium may be related to pulmonary vascular congestion or less likely infiltrates. assessment:  CHF, afib iwth RVR, chronic kidney disease. Medications:  heparin, antibiotics, insulin, linezolid. Pt went into shock, ventilator, patient expired.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Chest X-ray abnormal, Chest pain, Chronic kidney disease, Death
Clinical narrative: Patient is fully vaccinated. COVID + 2/2/2022 on admission to hospital. Patient admitted with neck pain ans shoulder pain.  The patient also described left-sided vague chest pain, while still in emergency room patient developed severe tachycardia. Labs: cr 2.12, Hg 8.7, Plts 119, Troponin elevated. CXR: Mild nonspecific prominence of the interstitium may be related to pulmonary vascular congestion or less likely infiltrates. assessment:  CHF, afib iwth RVR, chronic kidney disease. Medications:  heparin, antibiotics, insulin, linezolid. Pt went into shock, ventilator, patient expired.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Interstitial lung disease, Mechanical ventilation, Neck pain, Platelet count decreased
Clinical narrative: Patient is fully vaccinated. COVID + 2/2/2022 on admission to hospital. Patient admitted with neck pain ans shoulder pain.  The patient also described left-sided vague chest pain, while still in emergency room patient developed severe tachycardia. Labs: cr 2.12, Hg 8.7, Plts 119, Troponin elevated. CXR: Mild nonspecific prominence of the interstitium may be related to pulmonary vascular congestion or less likely infiltrates. assessment:  CHF, afib iwth RVR, chronic kidney disease. Medications:  heparin, antibiotics, insulin, linezolid. Pt went into shock, ventilator, patient expired.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Shock, Tachycardia, Troponin increased
Clinical narrative: Patient is fully vaccinated. COVID + 2/2/2022 on admission to hospital. Patient admitted with neck pain ans shoulder pain.  The patient also described left-sided vague chest pain, while still in emergency room patient developed severe tachycardia. Labs: cr 2.12, Hg 8.7, Plts 119, Troponin elevated. CXR: Mild nonspecific prominence of the interstitium may be related to pulmonary vascular congestion or less likely infiltrates. assessment:  CHF, afib iwth RVR, chronic kidney disease. Medications:  heparin, antibiotics, insulin, linezolid. Pt went into shock, ventilator, patient expired.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram abdomen abnormal, Lung opacity, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: COVID-19 breakthrough. 83-year-old with PMHx dementia, HTN, HLD, alcohol abuse and urinary incontinence s/p nerve stimulator presents to ED via EMS. Symptoms worsening per patient's husband. CT abdomen/pelvis with patchy bibasilar ground glass opacities. Patient afebrile. Room air SAT 96%.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: COVID-19 breakthrough. 83-year-old with PMHx dementia, HTN, HLD, alcohol abuse and urinary incontinence s/p nerve stimulator presents to ED via EMS. Symptoms worsening per patient's husband. CT abdomen/pelvis with patchy bibasilar ground glass opacities. Patient afebrile. Room air SAT 96%.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Memory impairment, Neuralgia, Ovarian vein thrombosis, Pulmonary embolism
Clinical narrative: Memory loss, memory lapses, all over nerve pain, ovarian vein thrombosis, pulmonary embolism
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Decreased appetite, Dyspnoea
Clinical narrative: 81 year old female history of arthritis, renal CA, diverticulitis,GERD, hyperlipidemia, HTN presents to ED complaining of cough, HA, sore throat, fatigue, reduced appetite x2 days. This morning she states she had some SOB and CP. She is on 3L of O2 at home at night. Patient is vaccinated and boosted for COVID. Admission dx:  SOB, elevated troponin, hypoxemia requiring oxygen, COVID, pneumonia due to COVID. Treatment: oxygen, remdesivir, antibiotics, decadron.  Discharged home.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoxia, Oropharyngeal pain, Troponin increased
Clinical narrative: 81 year old female history of arthritis, renal CA, diverticulitis,GERD, hyperlipidemia, HTN presents to ED complaining of cough, HA, sore throat, fatigue, reduced appetite x2 days. This morning she states she had some SOB and CP. She is on 3L of O2 at home at night. Patient is vaccinated and boosted for COVID. Admission dx:  SOB, elevated troponin, hypoxemia requiring oxygen, COVID, pneumonia due to COVID. Treatment: oxygen, remdesivir, antibiotics, decadron.  Discharged home.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Itchy and mild redness on face and neck. I gave 1 Benadryl 25mg and observed for 30 min after itching. She left with advice to keep taking Benadryl-Mild, Additional Details: Itching on face and neck. She felt better and she left.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Muscle spasms, Neuralgia, Pulmonary embolism
Clinical narrative: Pulmonary embolism, joint pain, all over nerve pain, chest pain, muscle spasms
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Muscle fatigue, Muscular weakness, Pain in extremity
Clinical narrative: Got booster on 12/20/2021. 12/26/2021: cut trees down; cleaned barn all day long. Right arm got tired so started using left arm. 12/27/2021: woke up both arms so sore could hardly move. 12/28/2021: right arm was fine. Left arm weakness persisted and never got better. Bicep is weak He used to put all medicine in left hand and put it in mouth. Now he cannot lift left hand to the mouth (doing a bicep curl). No numbness/tingling in left arm. Left shoulder occasionally feels numbness. 2/28/2022 symptoms of bicep weakness still present along with posterior shoulder numbness.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, Brain natriuretic peptide normal, COVID-19, COVID-19 pneumonia
Clinical narrative: Patient is full vaccinated and boosted.  COVID + on 2/3/2022 on admission to the hospital. Presented to the ED with complaint of shortness of breath/chest pain.She was also having productive cough. Pt was hypoxic requiring oxygen. Workup initially showed acute kidney injury with creatinine of 1.99 above from baseline with normal BNP level; however, positive repeat echo and a chest x-ray concerning for vascular congestion. DX: acute renal failure, COVID pneumonia, CHF, HTN, transient ischemic attack, Treatment:  antibiotics, steriod, nebulizer, metoprolol.  Pt discharged home.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Chest X-ray abnormal, Chest pain, Dyspnoea, Echocardiogram abnormal
Clinical narrative: Patient is full vaccinated and boosted.  COVID + on 2/3/2022 on admission to the hospital. Presented to the ED with complaint of shortness of breath/chest pain.She was also having productive cough. Pt was hypoxic requiring oxygen. Workup initially showed acute kidney injury with creatinine of 1.99 above from baseline with normal BNP level; however, positive repeat echo and a chest x-ray concerning for vascular congestion. DX: acute renal failure, COVID pneumonia, CHF, HTN, transient ischemic attack, Treatment:  antibiotics, steriod, nebulizer, metoprolol.  Pt discharged home.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoxia, Productive cough, SARS-CoV-2 test positive, Transient ischaemic attack
Clinical narrative: Patient is full vaccinated and boosted.  COVID + on 2/3/2022 on admission to the hospital. Presented to the ED with complaint of shortness of breath/chest pain.She was also having productive cough. Pt was hypoxic requiring oxygen. Workup initially showed acute kidney injury with creatinine of 1.99 above from baseline with normal BNP level; however, positive repeat echo and a chest x-ray concerning for vascular congestion. DX: acute renal failure, COVID pneumonia, CHF, HTN, transient ischemic attack, Treatment:  antibiotics, steriod, nebulizer, metoprolol.  Pt discharged home.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Parent stated that the child was between the ages of 5 - 11 years old.   After the 12 year old child received the Pediatric Pfizer 5 -11 year old vaccine and the error was identified, the parent stated that she did not want her child of small stature to receive the full dose required for her age.   The child did not experience any adverse events.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Temperature intolerance, Urticaria
Clinical narrative: Client complaining of urticaria.  However, the urticaria only occurs when exposed to cold.  Started 10 days after vaccine.  Benadryl has helped.  Avoiding cold and has not had any further symptoms.  No other complaints.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Colitis, Haemoglobin decreased, Hypotension
Clinical narrative: Patient is fully vaccinated. COVID + on admission to hospital on 2/3/2022. 58-year-old significant known history for diverticulitis, who presented to the emergency department secondary to abdominal pain with associated nausea/emesis.  Acute septic shock/hypotension, requiring pressor support. Colitis, leukocytosis, Treatment:  rocephin, flagyl, not a cadidate for remdesivir, on RA. HG 8.6; required 1 unit PRBC. Discharged home.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Leukocytosis, Nausea, Packed red blood cell transfusion, SARS-CoV-2 test positive, Septic shock
Clinical narrative: Patient is fully vaccinated. COVID + on admission to hospital on 2/3/2022. 58-year-old significant known history for diverticulitis, who presented to the emergency department secondary to abdominal pain with associated nausea/emesis.  Acute septic shock/hypotension, requiring pressor support. Colitis, leukocytosis, Treatment:  rocephin, flagyl, not a cadidate for remdesivir, on RA. HG 8.6; required 1 unit PRBC. Discharged home.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient is fully vaccinated. COVID + on admission to hospital on 2/3/2022. 58-year-old significant known history for diverticulitis, who presented to the emergency department secondary to abdominal pain with associated nausea/emesis.  Acute septic shock/hypotension, requiring pressor support. Colitis, leukocytosis, Treatment:  rocephin, flagyl, not a cadidate for remdesivir, on RA. HG 8.6; required 1 unit PRBC. Discharged home.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asphyxia, Blood pressure increased, Fatigue, Flushing, Headache
Clinical narrative: Flushing of the face, increased blood pressure, suffocation, frequent headache, tiredness.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody increased, Arthralgia, Blood test normal, C-reactive protein increased, Inflammation
Clinical narrative: It started off with finger pain in my ring finger of my left hand. Finger and hand pain. It progressed to kind of a migrating pain from my hand and my other joints. My elbows, knees, shoulders, neck, and back. A different joint was in pain on each different day. It was every day and it was intense pain. From a scale from 1-10 it was between an 8 and a 10. I went to the doctor on 04/13/2021 and they took some blood work and rheumatoid factor and everything came back normal. She put me on some prednisone. I did have the blood work repeated in May with another doctor and it did show inflammation increased member on the C reactive protein and the ANA. He prescribed hydroxychloroquine and I have been in that since August. My doctor said I have rheumatoid arthritis.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rheumatoid arthritis, Rheumatoid factor negative
Clinical narrative: It started off with finger pain in my ring finger of my left hand. Finger and hand pain. It progressed to kind of a migrating pain from my hand and my other joints. My elbows, knees, shoulders, neck, and back. A different joint was in pain on each different day. It was every day and it was intense pain. From a scale from 1-10 it was between an 8 and a 10. I went to the doctor on 04/13/2021 and they took some blood work and rheumatoid factor and everything came back normal. She put me on some prednisone. I did have the blood work repeated in May with another doctor and it did show inflammation increased member on the C reactive protein and the ANA. He prescribed hydroxychloroquine and I have been in that since August. My doctor said I have rheumatoid arthritis.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The mother doubted about the patient's age when both reaffirmed that she was only 12 years old, the adult PFIZER vaccine is administered and then we realized that the young women was only 11 years old when we checked with the system. There was a poor administration of the vaccine when it was the patients turn to the PFIZER vaccine but for children between 5 and 11 years of age. Is Your.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Joint swelling
Clinical narrative: Red swollen knuckles, bilaterally
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Dyspnoea, Fatigue, Headache
Clinical narrative: Approximately around 2-3 minutes after patient's vaccination she experienced the following symptoms - Sore arm, Tingling in the finger (right side), shortness of breath, Fatigue that last about  11 days, neck pain, headache and stomach ache - all these symptoms lasted about 10 - 11 days. She has lost her appetite for about 4 days. The symptoms went away after the 12th day and came back right away after 2 days (All symptoms mentioned).  For treatment I gave her Motrin (4x per 24 hours) and gave her nebulize treatment but nothing worked. We had a televisit with the doctor and  was advised that if the headache was happening too long we should go to the ER.  As of today some of the symptoms subsided except for the headache and some slight stomach ache.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Approximately around 2-3 minutes after patient's vaccination she experienced the following symptoms - Sore arm, Tingling in the finger (right side), shortness of breath, Fatigue that last about  11 days, neck pain, headache and stomach ache - all these symptoms lasted about 10 - 11 days. She has lost her appetite for about 4 days. The symptoms went away after the 12th day and came back right away after 2 days (All symptoms mentioned).  For treatment I gave her Motrin (4x per 24 hours) and gave her nebulize treatment but nothing worked. We had a televisit with the doctor and  was advised that if the headache was happening too long we should go to the ER.  As of today some of the symptoms subsided except for the headache and some slight stomach ache.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient has first dose of Pfizer and when he returns to his second Vaccination appointment, he is placed the Moderna, patient was kept under observation for 30 minutes and did not present any signs for symptoms. The nursing staff was In contact with the patient for several weeks to know if there were side effects from the vaccines.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Irritability
Clinical narrative: 3 hours of inconsolable fussiness the night of vaccination, self resolved without lasting effect
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute sinusitis, Autopsy, Blood urine present, Cardiac arrest, Chest X-ray normal
Clinical narrative: (Privacy) stated that her son had been complaining of the following symptoms since he received the second dose in September 2021: 1. Tingling in both feet daily 2.  Both heels hurting daily 3. Around beginning of October 2021 hands and fingers started going numb and he started having difficulty grasping and holding onto objects.  4. Blood in his sperm and urine past couple of weeks (Not sexually active) 5. Sinus pressure, sinus drip, Diagnosed with Acute maxillary sinusitis on 10/13/2021 6. Severe cough 7. Past week developed sensitivity to light.  Wanted to remain in the dark as any light source was causing him severe pain to his eyes. 8. 10/27/2021-Started coughing up blood prior to going unresponsive and went into cardiac arrest at home. The patient presented to the ER on October 12, 2021 with multiple complaints, sinus congestion and sore throat, and a cough.  There was a reported lump on the left side of his neck for the past two weeks.  The patient reported that for the past two weeks he noted blood in his sperm.  The patient denied STD's, no testicle pain, no penis pain or lesions (Reportedly not sexually active). The patient denied any recent fevers, chills, chest pain, or shortness of breath, nausea or vomiting, abdominal pain, dysuria or hematuria, diarrhea, melena, hematochezia, rashes or wounds, or new leg pain or swelling. The patient stated there was no recent travel or trauma.   XR Chest 2 Views PA and Lateral (Standard) were said to be completed.  The report stated that lungs were clear without findings of a focal consolidation, pneumothorax, or pleural effusion.  The cardio mediastinal silhouette is within normal limits for age.   The patient returned to the ER on October 19, 2021 for concern his cough is getting worse and his health has not improved after a week of antibiotic (Augmentin). The patient was previously diagnosed with sinusitis. The patient vomited while coughing last night, October 18, 2021. The patient denied recent fever, chills chest pain, shortness of breath, nausea, abdominal pain, dysuria, diarrhea, melena, hematochezia, rashes or wounds, or new leg pain or swelling.   XR 2 View PA and Lateral (Standard)  Two view chest comparison studies.  No definite evidence of an acute infiltrate or pneumothorax.  No significant pleural effusion.  Heart size is within normal limits with no evidence of cardiac failure.  No acute osseous abnormalities are seen. There were no definite acute cardiopulmonary findings seen radiographically.   The patient died on October 27, 2021 at the Hospital, in the Emergency Room.  Postmortem autopsy  completed at (Privacy) Hospital, on October 28, 2021 by (Privacy), MD/Pathologist.  Autopsy Results: (Privacy), Pathologist-MD reported that based on consideration of the autopsy examination, review of available records, and toxicologic analysis, the death of the patient to a reasonable degree of medical certainty, is ascribed to COVID-19 vaccine-related myocarditis.  The death is ruled natural.