chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: severe pains in his stomach; nausea; vomiting; This is a spontaneous report from a contactable consumer or other non health care professional. This reporter was a caregiver reported for a 70-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 04Mar2021 (at the age of 70-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Mar2021, the patient experienced severe pains in his stomach, nausea and vomiting. Consumer reported about his partner who had a Pfizer shot on past Thursday, he stated on tonight he was experiencing nausea, vomiting, and some severe pain on the side and middle of his stomach. The outcome of all events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 17:30 (at the age of 28 years old) as 1st dose, single for COVID-19 immunization. Medical history included asthma, transient ischemic attack (at 16), Heart murmur, anxiety, depression, Penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Concomitant medication(s) included bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), fluoxetine (FLUOXETINE), Multivitamins taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 06:00, the patient experienced arm pain, mild constant headache (dull throbbing), fatigue, the skin on her back, neck, and arm where she received the injection was sensitive, and sore back. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included Nasal swab test: negative on an unspecified date. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 17:30 (at the age of 28 years old) as 1st dose, single for COVID-19 immunization. Medical history included asthma, transient ischemic attack (at 16), Heart murmur, anxiety, depression, Penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Concomitant medication(s) included bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), fluoxetine (FLUOXETINE), Multivitamins taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 06:00, the patient experienced arm pain, mild constant headache (dull throbbing), fatigue, the skin on her back, neck, and arm where she received the injection was sensitive, and sore back. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included Nasal swab test: negative on an unspecified date. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes:1) Axillary (mild/moderate) 2)Supraclavicular (severe); This is a spontaneous report from a contactable other health care professional (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200), via an unspecified route of administration, administered in arm left on 24Feb2021 at 16:45 as 1st dose, single dose for COVID-19 immunization. The patient's medical history included thoracic outlet syndrome and Lyme disease. The patient's concomitant medications were not reported. The patient did not had COVID-19 prior to vaccination. The patient did not test for COVID post vaccination. On 01Mar2021, the patient experienced swollen lymph nodes: axillary (mild/moderate) and supraclavicular (severe). No treatment was received with regards to the events. The outcome for the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Vomiting; abdominal pain; This is a spontaneous report received from a non-contactable consumer (patient). A 22-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, in Arm left, on 06Mar2021 at 11.30, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. Prior vaccination, the patient had experienced covid. Post vaccination, the patient was not tested for covid. Other medications in two weeks was reported as Lexapro and birth control. On 07Mar2021 at 03:30, the patient had experienced vomiting and abdominal pain. There was no treatment received for the adverse events. Outcome of the event was reported as recovering  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Headache, Speech disorder
Clinical narrative: mental confusion; difficulty speaking; severe headache; This is a spontaneous report from a contactable other hcp.   A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 11:00 hr (at the age of 64-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included Rheumatoid arthritis, gastro-oesophageal reflux disease (GERD) and drug hypersensitivity to penicillin (allergies with PCN) from an unknown date and unknown if ongoing. Concomitant medication included methotrexate (METHOTREXATE), hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); omeprazole (OMEPRAZOLE); pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced mental confusion, difficulty speaking, severe headache on 04Mar2021 23:00 hr. Lingering feeling of not being completely back to normal after another additional day. No treatment received. The outcome of the events was recovering at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Thirst, Vaccination site pain
Clinical narrative: excessive thirst; pain at injection site; tired; This is a spontaneous report from a contactable Other HCP (patient). A 62-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL6198) via an unspecified route of administration in left arm on 03Mar2021 at 11:00 (at the age of 62-year-old) in left arm for COVID-19 immunisation. Patient had no known allergies and had no medical history. Cncomitant medication was not reported. Patient did not receive any other medication in two weeks and did not receive any other vaccination in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 05Mar2021, at 12:00, two days and one hour after receiving vaccination, patient experienced excessive thirst, pain at injection site and was tired. Patient was not treated for the reported adverse events. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness
Clinical narrative: Within five mins of receiving the shot, my insides felt like they were burning up.; I felt a bit lightheaded.; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: En 6206), via an unknown route on 06Mar2021 at 15:00 (at the age of 34-years) as 1ST dose, single dose in the left arm for covid-19 immunisation. The patient medical history included asthma, hypothyroidism, anemia, polycystic ovarian, gastric bypass, obesity. The patient had known allergies had reactions to ct contrast dye before. However, this is a different reaction and had throat closing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Synthroid for an unknown indication from an unknown date and unknown if ongoing. On 06Mar2021 at 15:00, the patient experienced felt liked they was burning up and felt a bit lightheaded. However, it mostly subsided within the first 10 minutes. Patient received intermittent recurrences but they were fleeting. It was unknown that patient received treatment for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Ventricular extrasystoles
Clinical narrative: premature ventricular contractions; Within 5 minutes of receiving the vaccines I begin to have heart palpitations; This is a spontaneous report from contactable consumer (patient). A 36-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in right arm on 25Feb2021 at 10:00 AM (at the age of 36 years old) as single dose for COVID-19 immunisation. The patient medical history included hypertension, atrial fibrillation (2 events in 10 years non-sustained) and the patient has a history of known allergies of Tree-nuts. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). The patient has not received any other vaccines in four weeks. There was no Covid prior vaccination and has not been tested for Covid post vaccination. Within 5 minutes of receiving the vaccines on 25Feb2021 at 10:15 AM the patient began to have heart palpitations that were later confirmed to be premature ventricular contractions. This lasted for about 1.5 hours before going away. Paramedic were called but not transported to hospital. Adverse event was resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glossodynia, Tongue discomfort
Clinical narrative: Vaccine exposure during pregnancy; Burning sensation on tongue; appearance of tongue sores; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route of administration in right arm on 06Mar2021 at 13:30 (at the age of 37-year-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history included hypothyroidism and PCOS (Polycystic ovary syndrome). The patient had allergy to Minute Maid Fruit Punch. The patient last menstrual period was 02Dec2020 and expected date of delivery was 05Sep2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included Levothyroxine (MANUFACTURER UNKNOWN), Prenatal vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; En9266) via an unspecified route of administration in right arm on 06Mar2021 at 15:00 as a single dose for COVID-19 immunisation. On 07Mar2021 at 02:00 am, the patient experienced burning sensation on tongue, followed by the appearance of tongue sores. It was reported that this happened frequently when the patient gets sick. Since, the patient was pregnant at the time of vaccination. Hence, vaccine exposure during pregnancy was captured as separate event. The patient did not receive any treatment for the events.The outcome of events burning sensation on tongue, followed by the appearance of tongue sores was recovering and other events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: Severe headache; fever; chills; nausea; fatigue; swollen injection site & pain; swollen injection site & pain; This is a spontaneous report from a contactable Consumer (patient). A 68-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN9581) via unspecified route of administration in left arm on 13Feb2021 at 7:30 (at the age of 68-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Hypothyroidism. Patient received other medications (concomitant) in two weeks (unspecified). Patient did not receive any other vaccination within four weeks of COVID vaccination. No covid prior vaccination and no covid tested post vaccination. Patient previously took erythromycin for an unspecified indication and had allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL3249) in left arm on 23Jan2021 at 11:00 as single dose for COVID-19 immunization. On 14Feb2021, at 08:30 AM, patient experienced severe headache, fever, chills, nausea, fatigue, swollen injection site & pain. Patient did not receive any treatment for the events. Outcome of the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Severe headache; fever; chills; nausea; fatigue; swollen injection site & pain; swollen injection site & pain; This is a spontaneous report from a contactable Consumer (patient). A 68-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN9581) via unspecified route of administration in left arm on 13Feb2021 at 7:30 (at the age of 68-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Hypothyroidism. Patient received other medications (concomitant) in two weeks (unspecified). Patient did not receive any other vaccination within four weeks of COVID vaccination. No covid prior vaccination and no covid tested post vaccination. Patient previously took erythromycin for an unspecified indication and had allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL3249) in left arm on 23Jan2021 at 11:00 as single dose for COVID-19 immunization. On 14Feb2021, at 08:30 AM, patient experienced severe headache, fever, chills, nausea, fatigue, swollen injection site & pain. Patient did not receive any treatment for the events. Outcome of the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: back itching; This is a spontaneous report from a contactable consumer (patient).   A 71-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 18262), via an unspecified route of administration in Right arm on 12Feb2021 at 11:15 am (at the age of 71-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergy to sulfa. Concomitant medications included digoxin (DIGOXIN), lisinopril (LISINOPRIL), montelukast (MONTELUKAST) and dicyclomine (DICYCLOMINE) taken for an unspecified indication on an unspecified date received in two weeks of vaccination. The patient previously took microbid and experienced drug allergy. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 26Feb2021 at 07:00, the patient experienced back itching and resulted in Doctor or other healthcare professional office/clinic visit. Treatment for adverse event included Hydroxyzine HCL 50mg and hydrocortison-E 2.5%. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little pain where we got the shot; This is a spontaneous report from a contactable consumer (Patient). This consumer reported similar events for 2 patients (Himself and His Wife) This is 1st of 2 reports. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 21Feb2021 as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing prostate cancer. The patient's concomitant medications were not reported. The patient experienced little pain where we got the shot on an unspecified date. It was reported that, the patient got an appointment reminder for the second dose on 26Mar2021 which was beyond the 3 week period. It should be 14Mar2021. The patient inquired about how to change the appointment. The patient did not have any adverse events to report. The patient reported that he will try to get it change to the 14Mar2021 but if not then maybe he will have to keep it for the 26Mar2021. The outcome of the event little pain where we got the shot was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021262751 same reporter, drug, event/different patients
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Developed large area of SEVERE bruising on the inside of my left forearm, almost from my wrist to elbow, and on the OUTSIDE of my left elbow; This is a spontaneous report received from a contactable consumer (patient).   A 65-year-old female patient (Non-pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205), via an unspecified route of administration on Left arm on 28Feb2021 at 01:15 PM, (at the age of 65-years-old) as a 1st dose single for COVID-19 immunization at Store. The patient had medical history included chronic bronchitis (COPD), previous stroke in 2016, brain aneurism and patient had "bumped" her left elbow "funny bone" on the day before the vaccine, and it was sore. Patient had concomitant medication included clopidogrel bisulfate  (Plavix ), fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy), amlodipine besilate (Norvasc), enalapril maleate (Vasotec), atenolol (Tenormin), tramadol hydrochloride (Trama) in two weeks, all were started on unspecified dates and unknown if ongoing. Patient had no known allergies and also she did not have Allergies to medications, food, or other products. She did not have covid prior vaccination. The patient did not receive vaccine within 4 weeks prior to the next dose of vaccine. On 01Mar2021 at 08:00 AM, Day after vaccine, Patient developed large area of severe bruising on the inside of his left forearm, almost from her wrist to elbow, and on the outside of her left elbow. Bruising showed up day after vaccine. She was very prone to surface bruising due to being on a blood thinner and also using Trelegy inhaler which she had been told can contribute to easy skin bruising. Patient did not receive any treatment for the events. She has not been tested for covid post vaccination. Outcome of all the event was Recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (friend). A female (age 66, unit unknown) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Mar2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) for COVID-19 immunization. It was reported that patient received her dose 3 or 4 days ago and now reported chills and a fever of 101F on an unspecified date in Mar2021. Reporter asked if patient should seek medical intervention or what they could do. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on Mar2021. The outcome of event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Chills
Clinical narrative: I felt chills and temperature after 18 hours and after 28 hours of the vaccination; I felt chills and temperature after 18 hours and after 28 hours of the vaccination; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202) via an unspecified route of administration, in right arm on 06Mar2021 at 10:15 (at the age of 59-years-old) as single dose for covid-19 immunization. Medical history included rheumatoid arthritis. The patient had no known allergies. The patient did not receive any vaccines within four weeks prior to the vaccination. Concomitant medications included: rheumatoid arthritis medication. The patient previously received first dose of bnt162b2 (Lot Number: EM9809) via an unspecified route of administration, in right arm on 13Feb2021 at 17:00 as single dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 07Mar2021 at 04:00, the patient felt chills and temperature after 18 hours and after 28 hours of the vaccination. The patient did not receive any treatment for the events. Since the vaccination the patient had not been tested for COVID-19. Outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Inappropriate schedule of product administration
Clinical narrative: Both the dose of the drug was taken on the same date that is 24Feb2021; Higher blood pressure. Hypertension; This is a spontaneous report from a contactable consumer (patient). A 67-year-old elderly non-pregnat female patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6203), via unspecified route of administration in the Left arm, on 24Feb2021 at 01:00 PM, as a single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. On 24Feb2021 at 01:15 PM, the patient experienced higher blood pressure. The patient did not received treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Ear pain, Lymphadenopathy, Neck pain
Clinical narrative: swollen lymph node in RT side of the neck; extreme discomfort; producing an earache; sore neck/shoulder x 3 days which began the day after the injection; sore neck/shoulder x 3 days which began the day after the injection; This is a spontaneous report from a contactable other hcp (patient). A 51-years-old (non-pregnant) female patient received BNT162B2 (BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), dose 1 intramuscularly, administered in Arm Left on 04Mar2021 11:30 (at the age of 51-years-old) as SINGLE DOSE for covid-19 immunization at School or Student Health Clinic. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, migraine, attention deficit hyperactivity disorder, drug hypersensitivity (sulfa allergy) with supplementation therapy from an unknown date. Concomitant medications included pregabalin (LYRICA), naproxen (NAPROXEN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), cetirizine hydrochloride (CETRIZINE), vitamin b complex (VIT B COMPLEX), calcium (CALCIUM) tizanidine (TIZANIDINE); quetiapine fumarate (SEROQUEL) was taken for an unknown indication from an unknown start date at an unknown dose and magnesium (MAGNESIUM) taken for supplementation therapy, from unknown start date. The patient had not covid prior vaccination. The patient did not have any other vaccine in the past four weeks. On 05Mar2021 08:00AM, the patient experienced swollen lymph node in RT side of the neck, extreme discomfort, producing an earache and sore neck/shoulder for 3 days which began the day after the injection. The patient did not receive any treatment for events. The patient was not tested for covid post vaccination. The outcome of the events was reported as recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Still have 2 inch oval redness at injection site after two weeks.Is not painful.; This is a spontaneous report received from a contactable consumer (patient herself). A 73-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9267), via an unspecified route of administration on 20Feb2021 15:30 (age at vaccination: 73 years) as SINGLE DOSE for covid-19 immunisation. The patient's medical history included pre-diabetic, high cholesterol and Hashimoto's disease. Concomitant medication(s) included levothyroxine, metformin and simvastatin. The patient did not have any known allergies. On 21Feb2021, the patient experienced still have 2-inch oval redness at injection site after two weeks was not painful. The patient did not receive any treatment for adverse events. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior to vaccination nor was tested for covid post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: headache; tiredness; chill; fever; nausea; dizziness; weakness; This is spontaneous report from a contactable consumer. A 71-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: en6202), via an unspecified route of administration, administered in left arm on 06Mar2021 12:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies was reported. Patient did not other vaccine in four weeks. The patient experienced headache, tiredness, chill, fever, nausea, dizziness and weakness on 06Mar2021 21:00. Treatment was received by the patient. No covid prior vaccination. Patient did not covid tested post vaccination. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: headache; tiredness; chill; fever; nausea; dizziness; weakness; This is spontaneous report from a contactable consumer. A 71-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: en6202), via an unspecified route of administration, administered in left arm on 06Mar2021 12:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies was reported. Patient did not other vaccine in four weeks. The patient experienced headache, tiredness, chill, fever, nausea, dizziness and weakness on 06Mar2021 21:00. Treatment was received by the patient. No covid prior vaccination. Patient did not covid tested post vaccination. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysgeusia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Pt reports he has had symptoms of nausea, fatigue, headache, weakness, fuzziness , sinus burn and metallic teste for about 6-7 days after he had 1st Moderna shot (021C21A). Other than that, everything is fine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal discomfort, Nausea
Clinical narrative: Pt reports he has had symptoms of nausea, fatigue, headache, weakness, fuzziness , sinus burn and metallic teste for about 6-7 days after he had 1st Moderna shot (021C21A). Other than that, everything is fine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Peripheral swelling
Clinical narrative: light chest pain - swelling to l arm no SOB no sweating  pain subsides after few minutes  BP: 155/95  pulse 72 second reading BP: 179/130 pulse 77  CODE CAMPUS ACTIVATED  patient sent to the ER via 911 for further evaluation
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Swelling
Clinical narrative: Redness, swelling, and itching in right arm and axilla.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Product storage error
Clinical narrative: vaccine was administered outside of storage recommendations. patient returned on 6/4/21 to re-vaccinate
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was inadvertently administered a Pfizer covid-19 dose that was beyond 6 hours from first puncture of vial.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Hypertension, Pain
Clinical narrative: Markedly elevated blood pressure, anxiety, severe body aches, chills
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody positive, Blood thyroid stimulating hormone, Chest pain, Chills
Clinical narrative: Reports nausea, myalgias, lightheadedness, headaches, chills, diaphoresis, fatigue, chest pain, cough, dyspnea on exertion and shortness of breath at rest, most symptoms are chronic but reports worsening with second Covid vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Dyspnoea exertional, Electrocardiogram
Clinical narrative: Reports nausea, myalgias, lightheadedness, headaches, chills, diaphoresis, fatigue, chest pain, cough, dyspnea on exertion and shortness of breath at rest, most symptoms are chronic but reports worsening with second Covid vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Full blood count normal, Headache, Hyperhidrosis, Metabolic function test normal
Clinical narrative: Reports nausea, myalgias, lightheadedness, headaches, chills, diaphoresis, fatigue, chest pain, cough, dyspnea on exertion and shortness of breath at rest, most symptoms are chronic but reports worsening with second Covid vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Rheumatoid factor negative
Clinical narrative: Reports nausea, myalgias, lightheadedness, headaches, chills, diaphoresis, fatigue, chest pain, cough, dyspnea on exertion and shortness of breath at rest, most symptoms are chronic but reports worsening with second Covid vaccine.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Cardiac discomfort, Fatigue, Peripheral swelling
Clinical narrative: Fatigue, minor swelling feet and hands occurred a week or two after second doses of vaccine. Hands and feet symptoms seem get a bit relieved in motion. Occasional heart pressure.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, C-reactive protein, C-reactive protein normal, Chest pain, Electrocardiogram
Clinical narrative: After second dose of Pfizer Covid-19 vaccine he received two days ago on Wednesday June 2nd around 5pm. Felt tired that night and into the next day with some local swelling and pain to the right arm at site of injection, and also into right armpit. Thursday evening, he was resting sitting on the couch and developed some mild chest pain. Can't really describe the location or severity very well. Did seem to be worse with inspiration. Hasn't reoccurred since that time. Still feels somewhat tired today with mildly sore right arm. No fevers. No chest pain today.    IR showed second dose of Pfizer Covid-19 vaccine was given to the left arm but confirmed with CVS that it was given to the right arm.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Fatigue, Full blood count, Full blood count normal, Injection site pain
Clinical narrative: After second dose of Pfizer Covid-19 vaccine he received two days ago on Wednesday June 2nd around 5pm. Felt tired that night and into the next day with some local swelling and pain to the right arm at site of injection, and also into right armpit. Thursday evening, he was resting sitting on the couch and developed some mild chest pain. Can't really describe the location or severity very well. Did seem to be worse with inspiration. Hasn't reoccurred since that time. Still feels somewhat tired today with mildly sore right arm. No fevers. No chest pain today.    IR showed second dose of Pfizer Covid-19 vaccine was given to the left arm but confirmed with CVS that it was given to the right arm.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Troponin, Troponin normal
Clinical narrative: After second dose of Pfizer Covid-19 vaccine he received two days ago on Wednesday June 2nd around 5pm. Felt tired that night and into the next day with some local swelling and pain to the right arm at site of injection, and also into right armpit. Thursday evening, he was resting sitting on the couch and developed some mild chest pain. Can't really describe the location or severity very well. Did seem to be worse with inspiration. Hasn't reoccurred since that time. Still feels somewhat tired today with mildly sore right arm. No fevers. No chest pain today.    IR showed second dose of Pfizer Covid-19 vaccine was given to the left arm but confirmed with CVS that it was given to the right arm.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Patient developed pruritic rash 10 min after vaccine administration. She was given antihistamine with improvement in her rash, and symptoms. She was discharged home from the vaccination site in improved condition.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash and hives after first week, got worse after second shot.  two days after second shot, rash and bumps under breast, about  50 of them.  since then rashes and welts on arms, breast, stomach, back, buttocks, neck, head, legs. tried local over counter creams, stop itch for a few hours,  finally went to doctor on 5/21/21 doctor subscribed Famotidine 40 mg, take one tablet twice a day, allergy relief tablet once a day.  rash went away for about a week.  it is coming back, but not as bad
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Skin induration, Skin warm
Clinical narrative: Annular redness and swelling of upper arm, 5.5 cm in diameter (increasing in size since 6/1/21), no streaking, positive warmth, no tenderness, slight hardening /induration under skin
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a third dose of the vaccine.  Patient was asked whether it was the first or second dose to which they replied 2nd dose.  Upon attempting to enter into the LINKS database, it was discovered that this was in fact the patient's 3rd dose.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising on both inner arms (not outer arm where vaccine was given),  about 3 inches from armpits, looking like a series of several dots in a cluster about 2 inches long.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Condition aggravated, Pemphigus, Wound secretion
Clinical narrative: As a result of the Covid vaccine activating my immune system against the Covid virus, my immune system was also activated to create a bad flare up of my autoimmune disease, Pemphigus Vulgaris. I developed very bad oozing blisters on my scalp. I also had a couple of blisters on my shoulder, chest, and back. In order to quiet down my immune system, my dermatologist put me on Prednisone for 10 days (6 days of 40 MG and 4 days of 20 MG). My skin  has improved but is not entirely healed. I will also need to see a rheumatologist in July.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Low- grade fever 99.3, body aches, chills, headache
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 1415 Patient experienced dizziness post vaccination. Provided juice. VS HR 100 regular rate. B/P 110/60 RR 20 even and non labored. Pulse ox rate of 96%. Asked patient to stay an additional 15 minutes for observation. Spoke with patient's father who was present on site. Advised of current situation and the need to stay an additional 15 minutes. 1430 no further complaints voiced. Followed up with patient and father, provided education on after care and to contact MD for any additional issues. Voiced understanding. 1445 no complaints at this time and allowed to leave vaccination site at this time. RN.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Injection site redness and swelling,  fever, myalgias, arthralgia
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patients wife stated he was found  dead on floor the morning of 6/1/21 and exact time of death was unknown.  It sounded like cause was unknown.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: patient received first dose of Pfizer vaccine on 05/15/2021, noticed lump on clavicle 05/24/2021
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal growth restriction, Maternal exposure before pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: First dose moderna: 3/18/21 Second dose moderna: 4/15/21 Conceived: 4/14/21 Miscarriage at 7.5 weeks pregnant. Baby stopped growing at size 6 weeks pregnant.  Due date: January 17 2022 Pregnancy confirmed 5/24/21. gestation age: 8 weeks 1 day based on LMP.  Baby only measured 6 weeks 0 days on this date.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Slow speech, Tension
Clinical narrative: On Thursday, 6/3/2021 received her second dose of Pfizer Covid-19 vaccine (LOT #: EW0187, exp.: on 8/2021) at 9:28 am on her left deltoid. During assessment questions, client states her underlying medical condition includes hypertension and currently takes Atenolol and Losartan. Client denied any other heart or respiratory diseases. Client also states she experiences "severe allergic reaction" to Bactrim and Sulfa and exhibits "anxiety and confusion" and requires a place to sit if standing for long period. At 10:00 am, while waiting in Observation Area, client stated to EMTs, "I'm feeling very tired." EMT's responded immediately and provided a quiet environment and helped client in anti gravity chair. Vital signs were taken every 5 minutes. At 10:00 am: BP: 181/115 sitting, O2 sat: 99% with no respiratory distress noted, skin was warm to touch bilaterally, no skin rashes or swelling noted. Patient was alert, oriented X4 with clear, slow speech. At 10:07am, client was responsive to stimuli but was not verbally responsive with noted body guard; BP: 177/104 lying, HR: 56, O2sat: 99%. Upon further assessment, client complained of "the same 7/10 lower back pain that happened 3 weeks ago" and "feeling nauseous and fatigue". Client also stated she took her BP medications at 8:30 am. Client told the EMTs she did not follow up with her primary care provider after her first Pfizer dose. Client was also offered an ice pack to apply on her neck and encouraged to take deep breaths by EMT. At 10:15 am, BP: 201/121 lying, O2 sat: 99%, RR: 14, HR 59. Client was encouraged to drink water. At 10:17 am, client reported she felt "tension in the back of head and headache. Vitals: BP: 189/114 lying, HR: 67 bpm. Staff encouraged client to change positions in gravity chair for comfort however client reported "no improvement of the symptoms." EMT offered EMS service to which the client requested. At 10:22 am, EMS was activated by Lead RN. Client was educated by EMT and RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe and importance of following up with her primary care physician. At 10:26 am, care was turned over to paramedics. At 10:30 am, client was verbally responsive, alert, oriented X4. Vitals: BP: 181/115 lying, HR: 80, O2 sat: 99%, Temp: 98.1. Client was transferred to a gurney with assistance from 4 AMR staff. At 10:36 am, client left facility to be transported to hospital for further assessment.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: He asked if he could get 2nd shot here even though he got 1st dose at the hospital. I told him yes, processed and administered the shot. I forgot to ask which kind he received for 1st dose and only noticed it once I went to complete his CDC card. He was not concerned. we consulted the CDC website and it said not administer any other doses.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Night sweats, Pyrexia
Clinical narrative: high fever that continued to escalate from Friday night until the Following Wednesday. Intense night sweats, intense chills. So weak I couldn't even walk my own dog. Very frightening.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: During the 15 minute post immunization observation period, the patient complained of difficulty breathing. The pharmacy called 911 immediately. EMS arrived and assessed the patient and determined that she didn't need an Epipen to be administered. The patient's lungs and breathing were determined to be good and clear upon further assessment by EMS. The patient refused to leave with EMS. Her breathing returned to normal before leaving the pharmacy.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder
Clinical narrative: Haven't had a period for 3 years and then almost 3 weeks after first dose, I had a full period. And now 29 days later, I am having another period.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EFFECTS REPORTED BY PATIENT. ON 05/28/2021 , PATIENT CAME IN TO GET 1ST DOSE OF COVID VACCINE. SHE PREFFERED TO GET THE PFIZER VACCINE, BUT WAS ADMINISTERED THE MODERNA VACCINE.  PATIENT WAS FOLLOWED UP WITH AND INFORMED TO GET THE 2ND DOSE OF MODERNA IN 28 DAYS TO COMPLETE THE SERIES.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: 101.3 degree fever, chills, sweating, nausea, vomiting, diarrhea, swollen lymph nodes, axillary lymph node pain, migraine, photophobia, lack of appetite, fatigue, malaise
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lymph node pain, Lymphadenopathy, Malaise, Migraine
Clinical narrative: 101.3 degree fever, chills, sweating, nausea, vomiting, diarrhea, swollen lymph nodes, axillary lymph node pain, migraine, photophobia, lack of appetite, fatigue, malaise
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Photophobia, Pyrexia, Vomiting
Clinical narrative: 101.3 degree fever, chills, sweating, nausea, vomiting, diarrhea, swollen lymph nodes, axillary lymph node pain, migraine, photophobia, lack of appetite, fatigue, malaise
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received a third dose of the vaccine.  Patient was asked whether it was the first or second dose to which they replied 2nd dose.  Upon attempting to enter into the  database, it was discovered that this was in fact the patient's 3rd dose.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash broke out on abdomen.  I treated with apple cider vinegar for itch.  After a week the rash went away.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Client immediately fainted upon receiving the vaccination in his right deltoid.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Dizziness, Heart rate increased, Palpitations
Clinical narrative: At about 1050, After receiving 2 nd dose of pfizer, patient reported feeling slightly dizzy, and feeling of fast heart rate. Brought patient back to observation gurney. Vitals taken BP 180/106, P 88, o2 sat 99% RA. 02 applied and advised patient to rest.  Patient  stated, she did not take her BP meds this morning, has hx of high BP. After few minutes of rest patient felt better, BP came down to 195/93. Within few minutes she reported feeling of heart racing again and upper back pain. Called 911, supervisor was notified. After 911 call patient reported having chest pressure, called 911 again to notify change in patient's condition.  At about 1135 paramedics arrived, BP 191/86, patient stable, husband at bedside. At about 1150 patient transferred to emergency room by paramedics, belongings given to husband.