chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder, Tachycardia
Clinical narrative: had a rough night as she was tossing and turning; On and OFF headaches; completely unconscious; sweaty; collapsed on the floor; heart beats really fast when she wakes up from sleep; ended up with a concussion; arm started aching; A spontaneous report was received from a consumer, concerning herself a 73-years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced her arm started aching/ pain in extremity, she had a rough night as she was tossing and turning/ sleep disorder, she was all sweaty/hyperhidrosis, collapsed on the floor/fall, completely unconscious/loss of consciousness, headaches, ended up with a concussion/concussion and her heart beats really fast when she wakes up from sleep/tachycardia.  The patient's medical history included hight blood pressure and AFib. Concomitant medications reported included diltiazem hydrochloride, apixaban, levothyroxine, montelukast, dicyclomine, alprazolam, nortriptyline.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection. On 24 Feb 2021, on same day prior to onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 0016MOA (?)) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 24 Feb 2021, after taking mRNA-1273, patient experienced arm started Aching, Tossing and Turning at night. Next morning on 25 Feb 2021, she went to the bathroom, she was all sweaty, collapsed on the Floor, completely unconscious, ended up with a concussion.  After a week CT scan done which said everything was alright. Currently she has On and off headaches and her heart beats was fast when she wakes up from sleep. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events Aching, Tossing and Turning at night, sweaty, collapsed on the Floor, completely unconscious, ended up with a concussion, headache was not reported.; Reporter's Comments: This case concerns a 73 Y/O F with serious unexpected loss of consciousness and nonserious unexpected fall, concussion, tachycardia, pain in extremity, sleep disorder, hyperhidrosis, and expected headache. Event onset on Day 2 after the first dose of mRNA-1273. Event outcome sunknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eye pain, Headache, Ocular discomfort, Rectal haemorrhage
Clinical narrative: Rectal bleeding; Severe stomach pain; Nerve pain in his eyes; Feel like something is crawling inside his eyes; Headaches; A spontaneous report from was received from a Healthcare professional, concerning a male patient of  unknown age , who received Moderna's COVID-19 vaccine and experienced Rectal haemorrhage/rectal bleeding, Abdominal pain upper/ severe stomach pain, Headache, Eye pain/nerve pain in his eyes, Ocular discomfort/feel like something is crawling inside his eyes.  History of the patient was not provided. Concomitant product use was not provided by the reporter.  On 21-Mar-2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot no. unknown) via unknown route on his arm for COVID-19 infection prophylaxis.  8 weeks after first dose of vaccine, the patient suffered rectal bleeding, severe stomach pain, headaches, nerve pain in his eyes that feel like something is crawling inside his eyes. He is now afraid to get the second dose.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event Rectal haemorrhage was considered to be medically significant. The outcome of the event  Abdominal pain upper, Headache, Eye pain, Ocular discomfort was considered to be unknown at the time of this report.  No treatment medication was reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Renal failure, Rhabdomyolysis
Clinical narrative: muscle breakdown; kidney failure; A Spontaneous report was recieved from a consumer concerning her mother a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced muscle breakdown, kidney failure and hospitalized for 2 days.  The patient's medical history was not provided by the reporter.  On 12FEB2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1237(Batch number: Unknown) route of administration( unknown) for prophylaxis of Covid-19 infection.  On 15FEB2021, three days after administration of vaccine the consumer stated that her mother developed muscle breakdown and kidney failure, and it resulted in hospitalization for 2 days.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event muscle breakdown, kidney failure were considered to be not recovered or not resolved,; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypertensive crisis, Vomiting
Clinical narrative: patient had a Blood pressure of 195/115; vomited; Chills; A spontaneous report was received from a consumer concerning her 31-year-old, husband, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a blood pressure of 195/115( hypertensive crisis)and nonserious events like vomiting and chills.  The patient's medical history was not reported. Concomitant medications were not reported.  On 19-03-2021, Approximately 1 day prior event patient received their second of two planned doses of mRNA-1273(Batch Number 003B21A) for prophylaxis of COVID-19 infection.  On 20 Mar 2021, after receiving mRNA-1273 dose, patient had a Blood pressure of 195/115 where previous ones only ranges from 150/97-161/100. Patient also vomited and had chills. The patient did not had these reaction with the first dose. Treatment were not reported. The patient received both scheduled doses of mRNA-1273 prior to the events: therefore, action taken with the drug in response to the events is not applicable. The outcome of the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.; Reporter's Comments: This case concerns a male of unknown who had serious unexpected events of hypertensive crisis along with nonserious expected vomiting, chills.  Event onset occurred Day 2 after the second dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Mass excision, Skin swelling, Thrombophlebitis superficial
Clinical narrative: blood clot in her leg/clots in upper thigh on inside of thigh which were very sore; more lumps in crease of leg/knee/lump red and raised/ones behind the knee in the crease are still there and hard as a rock; lump was red and raised; Patient reports it was really sore up toward groin; A spontaneous report was received  from a consumer concerning herself, who is 68-years old  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombosis, mass excision, groin pain, skin swelling, developed more clots in upper thigh on inside of thigh which were very sore.  No medical history was reported. No concomitant medications were reported.  On 04-Feb-2021, the patient received their first of first planned doses of mRNA-1273  (Lot number: 031120A)was administered intramuscularly with unknown site  for prophylaxis of COVID-19 infection.   On an unknown date, an unspecified amount of time, the patient developed a blood clot in her leg, her lump was red and raised. She went to the doctor and they told her to put a warm compress and keep her leg up. The lumps did not start to go down. She started to develop more lumps in crease of leg/knee. Patient went to vascular doctor who did an ultrasound and diagnosed superficial thrombophlebitis. Patient then went to get second Moderna vaccine on 10MAR2021(lot#036021A). She developed more clots in upper thigh on inside of thigh which were very sore. Patient reports it was really sore up toward groin. She went to doctor again and they put her on Xarelto, and Aleve as directed on box. Symptoms are ongoing. Original lumps were no longer sore to the touch, ones behind the knee in the crease are still  hard as a rock. New lumps after second dose are tender.   Action taken with mRNA-1273 in response to the events was not applicable .  The outcome of the events were not recovered.  The reporter did not provide an assessment for the events; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia aspiration
Clinical narrative: Aspiration pneumonia; A spontaneous report  was received from a consumer concerning 79-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Aspiration pneumonia (Pneumonia aspiration).    The patient's medical history included 3 episodes of aspiration pneumonia before vaccination. Concomitant product use was not provided by the reporter.       On 15 Feb 2021, approximately 4 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number-Unknown ) via unknown route in the right arm for prophylaxis of COVID-19 infection.   On 19 Feb 2021, the patient was diagnosed with aspiration pneumonia. The event Pneumonia aspiration was medically significant.   Treatment for the event included antibiotics.      Action taken with mRNA-1273 in response to the event was not reported.  On an unknown date, the event aspiration pneumonia, was considered resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Loss of consciousness, Nasopharyngitis, Pyrexia
Clinical narrative: passed out on the floor; heaving all day; really cold; headache; fever; chills; A spontaneous report  was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out on the floor, really cold, heaving all day, headache, fever and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot: 007M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 21 Feb 2021, patient experienced sore arm and it recovered on 22 Feb 2021.  On 18 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch:032M20A) through unknown route of administration in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced really cold, headache, fever and chills. On 19 Mar 2021, the patient experienced passed out on the floor and heaving all day. The event passed out was medically significant.  No laboratory data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable as it was second dose of vaccine.  Th events really cold, fever and chills were recovered on 19 Mar 2021.  On 19 Mar 2021 the outcome of cold, fever and chills.  On 20 Mar 2021 the outcome of event(s), headache, passed out on the floor, heaving all day was resolved..; Reporter's Comments: This case concerns a 65 Y/O F with serious unexpected loss of consciousness and nonserious unexpected retching and  nasopharyngitis, and expected pyrexia, chills, and headache. Event onset the same day as the second dose of mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: passed out on the floor; heaving all day; really cold; headache; fever; chills; A spontaneous report  was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out on the floor, really cold, heaving all day, headache, fever and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot: 007M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 21 Feb 2021, patient experienced sore arm and it recovered on 22 Feb 2021.  On 18 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch:032M20A) through unknown route of administration in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced really cold, headache, fever and chills. On 19 Mar 2021, the patient experienced passed out on the floor and heaving all day. The event passed out was medically significant.  No laboratory data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable as it was second dose of vaccine.  Th events really cold, fever and chills were recovered on 19 Mar 2021.  On 19 Mar 2021 the outcome of cold, fever and chills.  On 20 Mar 2021 the outcome of event(s), headache, passed out on the floor, heaving all day was resolved..; Reporter's Comments: This case concerns a 65 Y/O F with serious unexpected loss of consciousness and nonserious unexpected retching and  nasopharyngitis, and expected pyrexia, chills, and headache. Event onset the same day as the second dose of mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Insomnia
Clinical narrative: Inability to experience an erection; Inability to sleep; A spontaneous report was received from a male patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inability to sleep/ insomnia and inability to experience an erection/ erectile dysfunction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Mar 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 037A21A) through intramuscular route (deltoid) in left non-dominant arm for prophylaxis of COVID-19 infection.  On 17 Mar 2021, after receiving the first dose, patient had an inability to sleep or experience an erection. The event inability to experience an erection was considered as medically significant. The patient did not receive any treatments for the events.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events, inability to sleep and inability to experience an erection was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eye disorder, Pain, Retinal detachment, Vaccination site rash
Clinical narrative: Major outpatient eye surgery which called for a bubble in eye; Detached retina; Arm was hard and rashy; Felt weak; Achy; A spontaneous report was received from a consumer concerning herself a 49 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness/asthenia, achy/pain, arm was hard and rashy/vaccination site rash, detached retina, major outpatient eye surgery which called for a bubble in eye/eye abnormality NOS.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28Feb2021, prior to the onset of events the patient received first dose of the two planned doses of mRNA-1273 (Batch/Lot No: 014M20A) for prophylaxis of COVID-19 infection.  On 02Mar2021, patient experienced felt weak and achy. On 05Mar2021 she reported that her arm was hard and rashy. On 8Mar2021, she had a detached retina and on 09Mar2021, the patient had major outpatient eye surgery which called for a bubble in eye which was still there. The event Retinal Detachment was considered as medically significant. Treatment information included Prednisone and Atrione for events Detached retina and Major outpatient eye surgery which called for a bubble in eye.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, Felt weak, achy, arm was hard and rashy was unknown at the time of this report. The outcome of the events Arm was hard and rashy was recovered on an unknown date, Major outpatient eye surgery which called for a bubble in eye and Detached retina were recovered on 09Mar2021 at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased
Clinical narrative: Hemoglobin dropped to 6.2; A spontaneous report was received from a consumer concerning a 86-year-old, elderly male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and his hemoglobin dropped  to 6.2/hemoglobin decreased.   The patient's medical history, as provided by the reporter, included cancer. Concomitant medications were not provided.  On 16 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the patient's hemoglobin dropped to 6.2 due to which he was hospitalized. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of event hemoglobin dropped to 6.2 was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Cerebrovascular accident, Hypertension
Clinical narrative: Stroke; Anaphylactic shock; High blood pressure; A spontaneous report was received from a pharmacist concerning a 50-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, stroke/cerebrovascular accident and high blood pressure/hypertension.  The patient's medical history was not reported. The relevant concomitant medications were not reported.  On 18 Mar 2021, approximately five minutes prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 032M20A) via unknown route for prophylaxis of COVID-19 infection.   On 18 Mar 2021,five minutes after vaccination the patient experienced anaphylactic shock, stroke and was subsequently hospitalised. The patient also had high blood pressure. The events anaphylactic shock and stroke was life threatening. Treatment for the  events included steroids, diphenhydramine and epinephrine.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events anaphylactic shock, stroke and high blood pressure was not reported.; Reporter's Comments: This is a case of Anaphylaxis and Stroke in a 50-years-old female patient with no medical hx provided who was hospitalized  immediately after receiving first dose of vaccine. Very limited information has been provided at this time. Further information is expected
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Haematinuria
Clinical narrative: Blood clots in urine; Chills; A spontaneous report was received from a consumer concerning an 83-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clots in urine/haemorrhage urinary tract and chills.  The patient's medical history was not provided. Concomitant product use provided by reporter included baby aspirin.     On 18 Mar 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch number: 030A210) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced blood clots in urine and chills. The event blood clots in urine was medically significant. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events blood clots in urine and chills was resolved on an unspecified date.; Reporter's Comments: Although a temporal association exist, there is not enough information to assess the events of blood clots in urine as the patient's medical history is lacking.  However, chills is consistent with the known safety profile of the vaccine. Further information has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: Hospitalized; Has been 49 days since the first dose; A spontaneous report was received from a consumer concerning a 81-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized during the scheduled second dose and has been 49 days since the first dose/ product dose omission issue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 05 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch no: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient was hospitalized during the scheduled second dose and has been 49 days since the first dose. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was hospitalized during the scheduled second dose was not provided. The outcome of the event has been 49 days since the first dose was considered resolved.; Reporter's Comments: This report refers to a case of hospitalization and. product dose omission issue for mRNA-1273 (Batch no: 011M20A) with no other AEs reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cellulitis, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Possible cellulitis; Arm was red and swelled up, when she touched it, I had heat in it; Arm was Red and swelled up, when she touched it, I had heat in it; Arm was red and swelled up, when she touched it, I had heat in it; Arm was sore to shoulder; Sore in her arm; A spontaneous report was received from a Consumer herself concerning a 58-Year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in her arm, her arm was red and swelled up when she touched it I had heat in it, possible cellulitis, arm was sore to shoulder.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 MAR 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 036A21A) via unknown route for prophylaxis of COVID-19 infection.  On 11 MAR 2021, patient experienced sore in arm and went away after two days. On 20 MAR 2021, the patient experienced arm was red and swelled up, when touched it was hot. Nurse practitioner suggested patient to apply damp warm moisture to it. They think it could be a possible cellulitis which was a serious condition as medically significant. The arm was sore to shoulder. Treatment information was provided as damp warm moisture to red and swelled up arm. Cephalexin for the possible cellulitis.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event sore in arm was resolved on 13 MAR 2021. The outcome of the events possible cellulitis, arm was red and swelled up when touched it felt hot, arm is sore to shoulder was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Possible cellulitis; Arm was red and swelled up, when she touched it, I had heat in it; Arm was Red and swelled up, when she touched it, I had heat in it; Arm was red and swelled up, when she touched it, I had heat in it; Arm was sore to shoulder; Sore in her arm; A spontaneous report was received from a Consumer herself concerning a 58-Year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in her arm, her arm was red and swelled up when she touched it I had heat in it, possible cellulitis, arm was sore to shoulder.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 MAR 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 036A21A) via unknown route for prophylaxis of COVID-19 infection.  On 11 MAR 2021, patient experienced sore in arm and went away after two days. On 20 MAR 2021, the patient experienced arm was red and swelled up, when touched it was hot. Nurse practitioner suggested patient to apply damp warm moisture to it. They think it could be a possible cellulitis which was a serious condition as medically significant. The arm was sore to shoulder. Treatment information was provided as damp warm moisture to red and swelled up arm. Cephalexin for the possible cellulitis.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event sore in arm was resolved on 13 MAR 2021. The outcome of the events possible cellulitis, arm was red and swelled up when touched it felt hot, arm is sore to shoulder was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis in left arm; A spontaneous report was received from a consumer who is a female patient of unknown age that received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis in left arm/cellulitis after the first dose.  Medical history or concomitant product use were not reported.  On an unknown date, the patient received her first of the two planned doses of mRNA-1273 (batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed cellulitis in left arm. Treatment information was not provided. The event cellulitis in left arm was considered to be medically significant.  No action was taken with mRNA-1273 in response to the event.  The outcome of the event cellulitis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the 1st dose of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Nausea; Dizziness; Extreme tiredness; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. On 26Jan2021 16:00, the patient experienced nausea, dizziness, extreme tiredness. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Pyrexia, Vaccination site rash
Clinical narrative: Fever over 100; Injection site rash and swelling; Injection site rash and swelling; Severe headache; Lower body jont pain; This is a spontaneous report from a contactable Other Health Professional, the patient. A 52-year-old non-pregnant female patient, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL 3248), via an unspecified route of administration in the left arm on 26Jan2021 at 02:00 PM (at the age of 52-years-old) as a single dose for covid-19 immunisation. Medical history included gadolinium contrast (allergies to medications, food, or other products). 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's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On 27Jan2021 at 05:30 AM the patient exepreienced fever over 100, severe headache, lower body joint pain, injection site rash and swelling. The event were assessed as non-serious by the reporter. No treatment was received for the events. Outcome of the events were recovering.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Fever over 100; Injection site rash and swelling; Injection site rash and swelling; Severe headache; Lower body jont pain; This is a spontaneous report from a contactable Other Health Professional, the patient. A 52-year-old non-pregnant female patient, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL 3248), via an unspecified route of administration in the left arm on 26Jan2021 at 02:00 PM (at the age of 52-years-old) as a single dose for covid-19 immunisation. Medical history included gadolinium contrast (allergies to medications, food, or other products). 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's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On 27Jan2021 at 05:30 AM the patient exepreienced fever over 100, severe headache, lower body joint pain, injection site rash and swelling. The event were assessed as non-serious by the reporter. No treatment was received for the events. Outcome of the events were recovering.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: experience scratchy throat/itchy throat; This is a spontaneous report from a non-contactable other healthcare professional. A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular, administered in right arm on 26Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, during her 30 minute waiting period after the injection, the patient began to experience scratchy throat/itchy throat. She denied difficulty breathing, difficulty swallowing and throat tightness. No treatment was received. Patient was observed for 65 minutes s/p injection. She states symptom of itchy throat improved. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Malaise
Clinical narrative: low fever; chills; headache; week muscles; joint pain; sinus pain; feeling unwell; He has flu-like symptoms; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for Covid-19 Immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low fever, chills, headache, week muscles, joint pain, sinus pain, feeling unwell and he has flu-like symptoms. The patient took Advil, Flonase and pseudoephedrine, this morning he woke up feeling much better and many of his symptoms resolved, however under his armpit he has a very pronounced and tender swollen area that was not there before, he assumes it is a lymph node. On Tuesday, he had a good number of the possible side effects. He was feverish, and had chills, pounding headache, sinus pain, painful joints and generally felt pretty bad. He took Sudafed last night, Flonase and Advil and woke up this morning feeling much better. He also noticed a really swollen area near armpit, which he assumes is a lymph node, and is very tender and swollen. He doesn't want to say it is a baseball size. It is not small either. It is unusual and was not there before. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of low fever, chills, headache, week muscles, joint pain, sinus pain, feeling unwell and he has flu-like symptoms. the outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pyrexia, Sinus pain
Clinical narrative: low fever; chills; headache; week muscles; joint pain; sinus pain; feeling unwell; He has flu-like symptoms; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for Covid-19 Immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low fever, chills, headache, week muscles, joint pain, sinus pain, feeling unwell and he has flu-like symptoms. The patient took Advil, Flonase and pseudoephedrine, this morning he woke up feeling much better and many of his symptoms resolved, however under his armpit he has a very pronounced and tender swollen area that was not there before, he assumes it is a lymph node. On Tuesday, he had a good number of the possible side effects. He was feverish, and had chills, pounding headache, sinus pain, painful joints and generally felt pretty bad. He took Sudafed last night, Flonase and Advil and woke up this morning feeling much better. He also noticed a really swollen area near armpit, which he assumes is a lymph node, and is very tender and swollen. He doesn't want to say it is a baseball size. It is not small either. It is unusual and was not there before. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of low fever, chills, headache, week muscles, joint pain, sinus pain, feeling unwell and he has flu-like symptoms. the outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Back pain; leg pain; general rib pain; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 24Jan2021 as single dose for COVID-19 immunization in an public health department. The patient's medical history was not reported. The patient has no concomitant medications. No other vaccine was given within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced back pain, leg pain and general rib pain for the last 3 days on 24Jan2021 12:00. No treatment was received. The events were considered non-serious since it did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. The outcome of the event was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Dyspepsia
Clinical narrative: Moderate indigestion; constipation; This is a spontaneous report from a contactable consumer(patient herself). A 60-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; batch/lot number and expiry date were not reported), via an unspecified route of administration on 24Jan2021, 12:00pm (at the age of 60-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took acetaminophen and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. At 4:00pm (16:00) of 25Jan2021, the patient experienced moderate indigestion and constipation. Treatment was not received for the events. The outcome of  these events was recovering. The events were reported as non-serious by the reporter.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Sore arm; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, batch and expiration date not reported), via an unspecified route of administration, administered on the left arm on 26Jan2021 07:00 (at the age of 51-years-old) at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Workplace Clinic. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19.  The patient experienced sore arm and diarrhea on 26Jan2021. Events were assessed as non-serious. Treatment was not received for the events. The outcome of the events reported was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; chills; This is a spontaneous report from a contactable Other Health Professional. A male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as single dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that he reports a fever that started Tuesday night, 26Jan2021, and persisted for the next day, along with chills. He reports he is feeling much better, today. He also went for a PCR rapid-Covid test, that was negative. To take the 2nd dose- it says 21 days. The place that we got the shot it says 17 to 21 days-CDC site says do not take before 21 days. The outcome of the events was reported as recovered on an unspecified date in Jan2021.  Information about Lot/Batch has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache; fatigue; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient himself). A 75-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Lot Number: EN 5318; Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 24Jan2021, 12:00pm (at the age of 75-years-old) at a single dose for covid-19 immunization. Patient's medical history included type 2 diabetes mellitus, lymphoma and arteriosclerosis, all of which started from an unknown date and unknown if ongoing. Concomitant medications included metformin, sitagliptin (JANUVIA), enalapril, glyburide and clopidogrel bisulfate (PLAVIX). The start and stop dates and indications of patient's concomitant medications were not reported. The patient previously took losartan and amoxicillin and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 24Jan2021 at 2:30pm (14:30), the patient experienced headache, fatigue and soreness at the injection site which lasted for 3 days. No treatment was received for the adverse events. The events were reported as non-serious. The outcome of these events was recovered on 27Jan2021 14:30.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: shortness of breath; aching on the left side of the chest; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 21Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath, aching on the left side of the chest for a week in Jan2021 with outcome of not recovered. The patient was wondering whether it was okay to get the second dose as scheduled on 11Feb2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Slight fever on same day of vaccine.; This is a spontaneous report from a non-contactable consumer. An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on Jan2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. 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. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient experienced slight fever on same day of vaccine on 28Jan2021. Outcome of the event was unknown. The reporter considered the events as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Influenza like illness, Pain, Pain in extremity
Clinical narrative: the pain is going up higher and higher.; I feel flush; Flu like symptoms; Arm pain; This is a spontaneous report from a contactable consume. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249) via an unspecified route of administration in Arm left on 21Jan2021 11:00 (Age at time of Vaccination: 78-years-old) as single dose for covid-19 immunisation.Medical history included ongoing blood pressure abnormal, arthritis, gastrooesophageal reflux disease. She also takes a medication for reflux, but does not know the name of it. The patient's concomitant medications were not reported. On 23Jan2021 the patient experienced flu like symptoms, arm pain. On an unknown date the patient stated the pain is going up higher and higher and I feel flush. She got the vaccine last thursday, on 21Jan2021. She stated she was fine the day after, but then the next day she started to get flu like symptoms. She is also having arm pain and the pain is going up higher and higher. The pain is going up behind her head, it is hurting there too. She wants to know why she has not stopped hurting. She stated she kept taking Ibuprofen thinking that was a good thing to do. However, she would only take half of it.Therapeutic measures were taken as a result of flu like symptoms, arm pain , the pain is going up higher and higher. It was reported that she is scheduled for the second dose on 11Feb2021. No prior vaccinations was given to patient within 4 weeks. The outcome of the event flu like symptoms and arm pain was not recovered and outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness after getting the COVID vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: reported having chills; muscle soreness; headache; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (solution for injection; batch/lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021, 08:30am at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, at approximately 7:30pm of 28Jan2021, the patient experienced having chills, muscle soreness and headache. The outcome of these events was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Small fever blister on bottom lip; This is a spontaneous report from a contactable pharmacist (patient). A 38-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 25Jan2021 12:00 as single dose for COVID-19 immunization in an nursing home. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EL0142) on 04Jan2021 in the left arm for COVID-19 immunization. The patient previously took naproxen and experienced drug allergy. No other vaccine administered in four weeks. Patient has not been tested for COVID-19 post vaccination. The patient experienced small fever blister on bottom lip on 27Jan2021 06:00 with outcome of recovered. No treatment was received.