chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test negative
Clinical narrative: not getting any Covid nothing, always negative; " I got 2 shot I feel like I have Covid "; This is a spontaneous report from a contactable nurse  (patient).  A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration in Dec2020 as single dose for COVID -19 immunization. The patient had  already received two doses.   The patient's medical history and concomitant medications were not reported.  The patient reported not getting any COVID nothing, always negative; " I got 2 shot I feel like I have COVID " on an unspecified date.  The patient underwent lab tests and procedures which included negative COVID; the patient indicated that it was always negative.  The outcome of not getting any COVID nothing, always negative; " I got 2 shot I feel like I have COVID " was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye inflammation, Eye swelling, Fatigue, Tenderness
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine  Swollen & inflamed (right) eye, right (axilla) tenderness, & fatigue.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Eye inflammation, Eye swelling
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine  Swollen & inflamed (right) eye, right (axilla) tenderness, & fatigue.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Electrocardiogram, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Tachycardia, body aches, chills, headache.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia, body aches, chills, headache.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: Tachycardia, body aches, chills, headache.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Limited ROM; Cannot move arm; Severe arm pain; sharp pain while at rest; This is a spontaneous report from a non-contactable consumer.   A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in the left arm, on 17Dec2020 at 11:00 (at the age of 26-years-old) at a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced limited range of motion (ROM), cannot move arm, severe arm pain, and sharp pain while at rest on 17Dec2020 at 11:45. No therapeutic measures were taken as a result of the events. The clinical outcome of limited ROM, cannot move arm, severe arm pain, and sharp pain while at rest was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Headache, Initial insomnia, Injection site pain
Clinical narrative: AT 12:30AM MIDNIGHT I BEGAN WITH A LIGHT HEADACHE AND STARTED MY BODY FEELING ACHY. I TRIED TO GO TO SLEEP, BUT I COULD'NT, IN FACT IT TOOK ME A LONG TIME TO BE ABLE TO FALL ASLEEP. I DID NOT HAVR TACHYCARDIA, BUT I DID FEEL ANXIOUS-LIKE. I WOKE UP AT AROUNF 5 AM WITH A FEVER OF 101.1 F, CHILLS, LIGHT BODY ACHES AND MY INJECTION SITE FELT AS IF I HAD BEEN PUNCHED OR HIT REALLY BADLY. I THEN TOOK TWO TYLENOL, EACH 250MG, AND I BEGAN FEELING NORMAL AGAIN.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: AT 12:30AM MIDNIGHT I BEGAN WITH A LIGHT HEADACHE AND STARTED MY BODY FEELING ACHY. I TRIED TO GO TO SLEEP, BUT I COULD'NT, IN FACT IT TOOK ME A LONG TIME TO BE ABLE TO FALL ASLEEP. I DID NOT HAVR TACHYCARDIA, BUT I DID FEEL ANXIOUS-LIKE. I WOKE UP AT AROUNF 5 AM WITH A FEVER OF 101.1 F, CHILLS, LIGHT BODY ACHES AND MY INJECTION SITE FELT AS IF I HAD BEEN PUNCHED OR HIT REALLY BADLY. I THEN TOOK TWO TYLENOL, EACH 250MG, AND I BEGAN FEELING NORMAL AGAIN.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Moderna COVID-19 Vaccine- Fever, Chills, Muscle and joint aches, headache, fatigue.  Self limiting, went to bed and woke feeling better.  Only fatigue now.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine- Fever, Chills, Muscle and joint aches, headache, fatigue.  Self limiting, went to bed and woke feeling better.  Only fatigue now.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, chills, headache
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Menorrhagia
Clinical narrative: My period  bleeding  more than usual
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extrasystoles, Fatigue, Headache, Myalgia
Clinical narrative: Extreme Fatigue (started 3 days after vaccine), 'skipped heart beats' at least 4 times during the date of report (6 days post injection), daily morning headaches (started 2 days after vaccine) with runny nose and sneezing (started 4 days after vaccine) and myalgias with chills  intermittently,
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Extreme Fatigue (started 3 days after vaccine), 'skipped heart beats' at least 4 times during the date of report (6 days post injection), daily morning headaches (started 2 days after vaccine) with runny nose and sneezing (started 4 days after vaccine) and myalgias with chills  intermittently,
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Respiratory distress
Clinical narrative: tiredness/body ache/fever/respiratory distress
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: arm pain at the injection site; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), via an unspecified route of administration on 17Dec2020 as single dose for COVID-19 immunization.  The patient's medical history and/ concomitant medications were not reported.  The patient experienced arm pain at the injection site in Dec2020, reported as non-serious.  Therapeutic measures were taken as a result of the event; patient took ibuprofen (ADVIL) 200 mg. The outcome of arm pain at the injection site was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: About 15 minutes after injection, patient began experiencing itching on her head which progressed downward over the rest of her body.  after about 20 minutes, she developed hives on her arms and legs.  Reaction resolved within 24 hours without intervention.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pain in jaw
Clinical narrative: Starting at 9am, had jaw pain, that subsided, nausea at dinner, severe chills when I went to bed, generalized fatigue and body aches throughout the day and night and continue to still have both
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: Tingling throat; This is a spontaneous report from a contactable physician. This physician reported the same event for two patients. This is the first of two reports. A patient of unspecified age and gender received the first dose of the bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; unknown lot number, NDC number and expiration date), 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. It was also reported that it was unknown if other products were received or if an investigation assessment was performed. On 16Dec2020, the patient experienced: tingling throat (non-serious).  The physician called regarding the COVID-19 vaccine since they had two events that happened on 16Dec2020; however, the physician stated she needed to ask a question before speaking with Pfizer's Drug Safety Unit (DSU) and reporting the events. The physician stated that two patients reported tingling in their throats during the observation period after the vaccine was administered. The physician thought "they just panicked and overreacted " and she did not think they had a reaction. The patients did go the ER (emergency room) and were discharged the same day. The physician wanted to be able to give the second dose. The physician wanted to ask about the side effects of the vaccine. The outcome of the event was unknown.   The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.   ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504906 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fevers, headache, fatigue, myalgia about 12 hours after vaccine.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever/mild side effect of fever; This is a spontaneous report from a contactable other healthcare professional (HCP, patient himself) via Medical information team. A 24-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; NDC/batch/lot number and expiration date were unknown), via an unspecified route of administration on the left shoulder on 17Dec2020 at 13:30 at a  single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient previously received a flu shot [influenza vaccine (INFLUENZA)] for immunization when he was a kid (a long time ago) and experienced the same reaction, fever. The patient was having a fever/mild side effect of fever on 18Dec2020. He said he just called the number on the packet they gave him at the site, where he got the vaccine and he was wondering if it was okay to take ibuprofen. He did not think they provided him with an NDC, lot, and expiration as it was not on the packet he got; he said they might have put the information on the little card they gave him, but he did not have it with him at the time of the report. He did not know the dose that he was administered.  This was the first injection with this COVID 19 vaccine. He further stated that fever started on 18Dec2020; when he woke up, it was like that, but he woke up at 9AM. The event did not require a visit to an emergency room or physician office. The patient had no prior vaccinations (within 4 weeks). The patient had no investigation assessment. Therapeutic measures were taken as a result of fever/mild side effect of fever. The patient was not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: headache, fatigue, fever
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Immediate post-injection reaction, Neck pain
Clinical narrative: Symptoms include light headedness that was immediate; 30 minutes later had a headache and neck pain; 30 minutes later had a headache and neck pain; Diarrhea started 2 hours after the shot and now symptoms are improving.; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had symptoms that include light headedness that was immediate, 30 minutes later patient had a headache and neck pain, and then diarrhea started 2 hours after the shot and now symptoms were improving. Clinical outcome of headache was not recovered while for the other events was recovering.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Fatigue and severe headache x 2 days. Moderate arm pain x 4 days. Slept for 2 days straight
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Mild headache; injection site soreness; This is a spontaneous report from a contactable consumer.   A 48-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EH9899) at single dose at left arm on 17Dec2020 for an immunization, at Doctor's office/urgent care.  The patient medical history and concomitant medications were not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced mild headache and injection site soreness on 17Dec2020. The patient received no treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Dec2020. The events were assessed as non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Low grade temperature of 100.6 Friday at 1:30am; This is a spontaneous report from a contactable nurse reporting for herself. This 28-year-old female patient received on 16Dec2020 08:00 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18Dec2020 01:30 am, the patient had low grade temperature of 100.6 F. The patient recovered in Dec2020 without treatment. Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseated; This is a spontaneous report from a contactable nurse (patient).   A 54-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EK5730, Exp date Mar2021) at single dose  at right deltoid on 17Dec2020 08:15 for immunization, administered at hospital.  Medical history was none. There were no concomitant medications. No additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. No adverse events followed prior vaccinations. The patient was really nauseated last night on 17Dec2020 from 21:00 and has been slightly nauseated 18Dec2020. The outcome of event was recovering. The event was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mildly sore arm where injection; This is a spontaneous report from a contactable physician (patient) through a Pfizer sales representative.   A patient of an unspecified age and gender received BNT162B2 (Pfizer-Biontech covid-19 vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, one day after the vaccination, the patient experienced mildly sore arm where injection of vaccine was given. Clinical outcome of the event was unknown at time of this report.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache; This is a spontaneous report from a contactable consumer (patient) through a Pfizer sales representative.   A 32-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech covid-19 vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced mild headache within 45 minutes of first Covid vaccine. Clinical outcome of the event was unknown at time of this report.   Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable pharmacist. A male patient (physician) of an unspecified age received the bnt162b2 (BNT162B2; also reported as Pfizer-BioNTech COVID-19 VACCINE), 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 sore arm (non-serious).  The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling hot, Flatulence, Gastrointestinal disorder
Clinical narrative: headache and feeling overheated; headache and feeling overheated; fatigue; GI symptoms; loose stool; gas; mild tightness but not so much like a cramp; This is a spontaneous report from non-contactable physician via a Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache and feeling overheated, fatigue, gastrointestinal (GI) symptoms, loose stool, gas, mild tightness but not so much like a cramp in Dec2020. The clinical course was reported as follows: The patient was symptom free for the first 20 hours after vaccination, had mild symptoms from the 20-28 hour mark, and felt fine since then. The patient woke up at 3:30 in the morning one day (day of reporting) with a headache and feeling overheated. The temperature was checked several times on an unspecified date, with no fever. For the next 3-4 hours, there were a wave of symptoms; mostly a headache, fatigue, and GI symptoms. The symptoms responded pretty well to increasing water intake, taking an electrolyte supplement (MANUFACTURER UNKNOWN), and breakfast. The patient also had gas, loose stool, and mild tightness but not so much like a cramp. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of headache and feeling overheated, fatigue, GI symptoms, loose stool, gas, mild tightness but not so much like a cramp was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache and feeling overheated; headache and feeling overheated; fatigue; GI symptoms; loose stool; gas; mild tightness but not so much like a cramp; This is a spontaneous report from non-contactable physician via a Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache and feeling overheated, fatigue, gastrointestinal (GI) symptoms, loose stool, gas, mild tightness but not so much like a cramp in Dec2020. The clinical course was reported as follows: The patient was symptom free for the first 20 hours after vaccination, had mild symptoms from the 20-28 hour mark, and felt fine since then. The patient woke up at 3:30 in the morning one day (day of reporting) with a headache and feeling overheated. The temperature was checked several times on an unspecified date, with no fever. For the next 3-4 hours, there were a wave of symptoms; mostly a headache, fatigue, and GI symptoms. The symptoms responded pretty well to increasing water intake, taking an electrolyte supplement (MANUFACTURER UNKNOWN), and breakfast. The patient also had gas, loose stool, and mild tightness but not so much like a cramp. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of headache and feeling overheated, fatigue, GI symptoms, loose stool, gas, mild tightness but not so much like a cramp was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large amount of swelling, redness and heat at the injection site; Large amount of swelling at the injection site; Large amount of redness at the injection site, heat; Large amount of heat at the injection site; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a six year old patient who experienced large amount of swelling, redness and heat at the injection site (vaccination site inflammation), (vaccination site swelling), (vaccination site erythema) and (vaccination site warmth), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious large amount of swelling, redness and heat at the injection site (vaccination site inflammation), (vaccination site swelling), (vaccination site erythema) and (vaccination site warmth), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.    Corrective treatment was recommended to ice the site, motrin, benedryl.   At the time of reporting, the outcome of events were reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: After severe reactions from the last two shots patient will never get a flu shot again; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who had severe reactions from the last two shots patient will never get a flu shot again (vaccination complication), while patient was treated with influenza vaccine.  Vaccination(s) included influenza vaccine.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, it was reported that after severe reactions from the last two shots patient will never get a flu shot again (vaccination complication) and that certainly goes for a new, relatively untested vaccine for covid.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got a flu shot which has 40% effective rate and paient still get the flu; got a flu shot which has 40% effective rate and paient still get the flu; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got a flu shot which has 40% effective rate and patient still get the flu (influenza due to therapeutic product effect incomplete), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got a flu shot which has 40% effective rate and patient still get the flu (influenza due to therapeutic product effect incomplete).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: patient felt quite sick with definite flu symptoms within 2 days; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional via social media.  This case was linked with 2020SA353040 (same reporter)  This case involves a female patient with an unknown age who felt quite sick with definite flu symptoms within 2 days (illness), while being received vaccine influenza vaccine.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient felt quite sick with definite flu symptoms within 2 days (illness).   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who got the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient was required to take it for 10 years at the job and got the flu every year and starting the year after retirement (20) years ago and never had the flu shot nor the flu.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who had the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient got flu 3 times and each time it was after flu shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got sick as a dog when patient took it; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient with an unknown age who got sick as a dog when patient took it (illness), while being received vaccine influenza vaccine.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got sick as a dog when patient took it (illness). However patient don't get sick when patient don't get that. Think patient will stick with what had been working no flu shot for patient.   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis, Malaise, Sinusitis
Clinical narrative: patient was sick with sinus infection and Bronchitis; patient was sick with sinus infection and Bronchitis; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient was sick with sinus infection and bronchitis (sinusitis) and (bronchitis), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick with sinus infection and bronchitis (sinusitis) and (bronchitis) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown for all events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient was sicker; Initial information was received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (Patient).  This case involves patient (unknown demography) who was sicker (illness), while the patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sicker (illness) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Patient got sick; Initial information was received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (Patient).   This case involves patient (unknown demography) who got sick (illness), while the patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, haven't had a flu shot in 6 years and haven't been sick.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the patient had intended to administer Pentacel, since Quadracel is not approved for patients under 4 years of age with no AE; Initial information regarding an unsolicited valid non-serious case was received from a Other Health Care Professional via Regulatory Authority (Reference number- 00382011) and transmitted to Sanofi on 04-Dec -2020 via call-center.  This case involves a 2-years-old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] on an unknown date (lot number: C5763AA and expiry date was unknown) via intramuscular route in the right thigh (3rd) dose in the series, when they had intended to administer Pentacel, since Quadracel was not approved for patients under 4 years of age  (Product administered to patient of inappropriate age) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and and family history were not provided. Concomitant medication included HEPATITIS A VACCINE.   It was an actual medication error case due to vaccine administered to patient of inappropriate age (latency: unknown).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 21.0
Sex: M
Vaccine: FLUC3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This spontaneous case was received on 14-Dec-2020 with an additional information received on 15-Dec-2020 (being processed together) from other non-health professional via Med Communications (reference number: SEQW20-05768) and concerned a 21-year-old, male patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 13-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prevention. The batch number was 279831 and expiration date was 30-Jun-2021.  On an unknown date in 2020, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced Guillain Barre syndrome. It was the first time that the patient got an adverse event.  The outcome of the event of Guillain Barre syndrome was not reported.  The reporter did not provide a causality assessment.  The event of Guillain Barre syndrome  was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: The patient developed Guillain-Barre syndrome after receiving the suspect product, Flucelvax Quadrivalent. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. Based presented findings, causal relationship between the suspect product and the event is assessed as possibly related (defaults to "related" in the safety database for reporting purposes). Brighton collaboration criteria for Guillain-Barre syndrome could not be assessed due to insufficient information provided.; Sender's Comments: The patient developed Guillain-Barre syndrome after receiving the suspect product, Flucelvax Quadrivalent. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. Based presented findings, causal relationship between the suspect product and the event is assessed as possibly related (defaults to "related" in the safety database for reporting purposes). Brighton collaboration criteria for Guillain-Barre syndrome could not be assessed due to insufficient information provided.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Intractable nausea and vomiting with excruciating stomach pain for 4 hours - only relieved by Zofran.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Condition aggravated, Headache, Injection site pain
Clinical narrative: Intractable nausea and vomiting with excruciating stomach pain for 4 hours - only relieved by Zofran.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Intractable nausea and vomiting with excruciating stomach pain for 4 hours - only relieved by Zofran.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: patient complained of burning when vaccine was being injected. no swelling or redness noted.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: Woke up from a dead sleep in extreme joint pain at 1:20 am.  (Almost went to the er as I have never had pain like this) Finally went back to sleep woke up at 7:30 am.  No pain.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Nausea, Throat tightness
Clinical narrative: "Patient was given their first COVID-19 vaccine dose. Patient was given VIS sheet and informed of all potential side effects and when to seek emergent care.  Patient was given a follow-up plan and scheduled for administration of second dose.  Patient tolerated procedure well. At 15 minutes post vaccine 1147 patient reports that she had just experienced chest pain sharp on left side of chest followed by nausea and slight sensation of tightness in her throat. She reports this lasted about 30 seconds and then subsided and went away. Vitals taken BP 118/76 HR 66 R 16 pulse ox 100% on room air. Patient denies any cardiac history and no history of allergic reaction in past to any medications or injections. Vaccine was given in right deltoid. She was monitored an additional 15 minutes with during which time she was asymptomatic. I consulted with ARNP provider across the hall in care clinic prior to letting patient leave clinic and she was agreeable with plan of care. Patient was advised is symptoms chest pain, tightness in chest, any shortness of breath she needs to seek emergent care by calling 911. She communicated understanding. Patient discharged to home."
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Injection site pain; tiredness; headache; muscle pain; chills; joint pain; nausea;
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Injection site pain; tiredness; headache; muscle pain; chills; joint pain; nausea;
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Patient complained of burning on injection. No redness or swelling noted.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, Tachycardia
Clinical narrative: Employee received covid19 vaccine without issue. At discharge became diaphoretic and tachycardia. Medical proceed out called and ED team arrived. On arrival vital signs patient was hypertensive, A&O x3, able to answer questions. ED offered to transport employee to ED for observation. Employee chose to stay at the Administration Clinic to be monitored. After 30", vital signs were within normal range, employee stated he felt fine, no tachycardia, no diaphoresis. Ambulated out of department with out issue.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Blood pressure increased, Bradykinesia
Clinical narrative: I didnt notice but evidently my eyes changed because the CNO looked at me and asked if I was ok.  Im not sure of what they looked like to make her cue in on I wasnt feeling well but she came over and began to monitor me at that time.  I felt light and fluffy and when I got up to get juice I felt  like I was disassociated from my body, my movements were awkward, I was severely weak and was not steady on my feel.  I felt as if my mind was moving but my body couldnt keep up.  I was very laggy and felt as if I was intoxicated.  The head of the ER made me drink alot of cold water about 24oz of water and 4 oz of juice which then caused me to get super cold and shivery.  Vitals were stable the whole time but my BP shot up to 170/90 a few moments after the water.  I was transferred to a monitoring room where I was covered with alot of blankets and allowed to lay down until I warmed up until my BP lowered and I was released.  My arm didnt begin to hurt until about 6-8 hours after and I have a red mark and the top layer of skin just do not want to heal.  I am still today having to put bandages on the spot because its red and the skin on top keeps coming off. I had joint pain and aches into the next day after causing me to take an Aleve gelcap for the pain.  Nausea here and there also.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dissociation, Dyskinesia, Erythema, Feeling abnormal
Clinical narrative: I didnt notice but evidently my eyes changed because the CNO looked at me and asked if I was ok.  Im not sure of what they looked like to make her cue in on I wasnt feeling well but she came over and began to monitor me at that time.  I felt light and fluffy and when I got up to get juice I felt  like I was disassociated from my body, my movements were awkward, I was severely weak and was not steady on my feel.  I felt as if my mind was moving but my body couldnt keep up.  I was very laggy and felt as if I was intoxicated.  The head of the ER made me drink alot of cold water about 24oz of water and 4 oz of juice which then caused me to get super cold and shivery.  Vitals were stable the whole time but my BP shot up to 170/90 a few moments after the water.  I was transferred to a monitoring room where I was covered with alot of blankets and allowed to lay down until I warmed up until my BP lowered and I was released.  My arm didnt begin to hurt until about 6-8 hours after and I have a red mark and the top layer of skin just do not want to heal.  I am still today having to put bandages on the spot because its red and the skin on top keeps coming off. I had joint pain and aches into the next day after causing me to take an Aleve gelcap for the pain.  Nausea here and there also.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling drunk, Malaise, Nausea, Pain
Clinical narrative: I didnt notice but evidently my eyes changed because the CNO looked at me and asked if I was ok.  Im not sure of what they looked like to make her cue in on I wasnt feeling well but she came over and began to monitor me at that time.  I felt light and fluffy and when I got up to get juice I felt  like I was disassociated from my body, my movements were awkward, I was severely weak and was not steady on my feel.  I felt as if my mind was moving but my body couldnt keep up.  I was very laggy and felt as if I was intoxicated.  The head of the ER made me drink alot of cold water about 24oz of water and 4 oz of juice which then caused me to get super cold and shivery.  Vitals were stable the whole time but my BP shot up to 170/90 a few moments after the water.  I was transferred to a monitoring room where I was covered with alot of blankets and allowed to lay down until I warmed up until my BP lowered and I was released.  My arm didnt begin to hurt until about 6-8 hours after and I have a red mark and the top layer of skin just do not want to heal.  I am still today having to put bandages on the spot because its red and the skin on top keeps coming off. I had joint pain and aches into the next day after causing me to take an Aleve gelcap for the pain.  Nausea here and there also.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin exfoliation
Clinical narrative: I didnt notice but evidently my eyes changed because the CNO looked at me and asked if I was ok.  Im not sure of what they looked like to make her cue in on I wasnt feeling well but she came over and began to monitor me at that time.  I felt light and fluffy and when I got up to get juice I felt  like I was disassociated from my body, my movements were awkward, I was severely weak and was not steady on my feel.  I felt as if my mind was moving but my body couldnt keep up.  I was very laggy and felt as if I was intoxicated.  The head of the ER made me drink alot of cold water about 24oz of water and 4 oz of juice which then caused me to get super cold and shivery.  Vitals were stable the whole time but my BP shot up to 170/90 a few moments after the water.  I was transferred to a monitoring room where I was covered with alot of blankets and allowed to lay down until I warmed up until my BP lowered and I was released.  My arm didnt begin to hurt until about 6-8 hours after and I have a red mark and the top layer of skin just do not want to heal.  I am still today having to put bandages on the spot because its red and the skin on top keeps coming off. I had joint pain and aches into the next day after causing me to take an Aleve gelcap for the pain.  Nausea here and there also.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Throat irritation
Clinical narrative: Sore/Itchy throat - 25mg Benadryl IM. Relief 8 minutes post Benadryl
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypoaesthesia oral, Vital functions abnormal
Clinical narrative: Sore/Itchy throat - 25mg Benadryl IM. Relief 8 minutes post Benadryl
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Palpitations, Throat tightness
Clinical narrative: Patient received Pfizer -BioNTech COVID-19 vaccine in the  clinic. At check out, patient reported 'heart racing, dizziness, and feeling flushed" ED Proceed Out called. Patient evaluated by ED team. Patient transported to ED for further monitoring.  In ED, patient complained of  mild throat tightness which was resolved by Benadryl. patient was monitored for 4 hours and was discharged home on benadryl
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Injection site pain, Nausea, Pallor
Clinical narrative: Employee administered vaccine at 0725.  At about 0740 he began to feel lightheaded, dizzy, and nauseous.  He also became pale and diaphoretic.  Gave some water and monitored for several more minutes.  He stood up at 0747 as he stated that he was feeling much better.  When he stood up, he became dizzy and lightheaded again.  Had him sit down, cool down, had a few sips of water.  BP 148/95, HR 83, O2 sat was 99%.  He did state that the vaccine burned for about 2-3 minutes when administered.  Had him sit for 10 more minutes and he stated that he was feeling much better.  He stood up and was feeling much better.  He was offered to go to the emergency room and refused.  He was escorted to his department by an RN observer.  At this time, he has no symptoms and states he is feeling good.