chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Palpitations, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 12-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 12, left arm, on Sep 21, 2021, single dose, for COVID-19 immunisation. No medical history reported. The patient did not take any concomitant medications. Vaccination history included the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 12, left arm, on Aug 31, 2021, single dose, for COVID-19 immunisation. The patient reported palpitations/heart palpitations, and chest discomfort/pressure in chest multiple times a day starting 3 days after receiving 2nd vaccine shot, onset Sep 24, 2021, with outcome of recovered (unknown date in 2021). The events were evaluated at a physician office visit. Laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of palpitations and chest discomfort. Additional information: The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient tested negative for COVID-19. It was reported that the events continued for 4 days. On the 4th day the patient saw his primary doctor who had him take Aleve for 3 days. This reduced the frequency to once a day, but  lasted for 2 months. The patient also went to a specialist, but by the time the patient could get in to see them his episodes had pretty much stopped. This costed patient's mom $1,000. The lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Mar2021 12:00 (Lot number: EN6206) at the age of 66 years as dose 2, single and intramuscular, administered in arm left, administration date 01Mar2021 12:00 (Lot number: EN6200) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN", start date: 2000 (ongoing), notes: Patient Medical History (including any illness at time of vaccination): None, Illness/AE: HTN, Onset date: 2000, stop date: Ongoing checked, Pertinent details: take Procardia; "Hyperthyroid", start date: 06Jun2018 (ongoing), notes: Illness/AE: Hyperthyroid, Onset date: 06Jun2018, stop date: Ongoing checked, Pertinent details: take thyroxine; "High cholesterol", start date: 02Feb2019 (ongoing), notes: Illness/AE: High cholesterol, Onset Date: 02Feb2019, stop date: Ongoing checked, Pertinent details: take Crestor; "contracted covid", start date: Sep2021 (unspecified if ongoing), notes: i contracted covid back in Sep2021. Concomitant medication(s) included: PROCARDIA [NIFEDIPINE] taken for hypertension; THYROXINE taken for hyperthyroidism; CRESTOR taken for blood cholesterol increased. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 19Sep2021, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Sep2021) negative; (13Sep2021) negative; (19Sep2021) positive, notes: Comments: Treated with Regeneron+ Steroid; (15Oct2021) negative. Therapeutic measures were taken as a result of covid-19. Clinical Information: 9Sep2021 patient had treated with Regeneron+ Steroid. Prior vaccination (within 4 weeks): None. Specific Relevant Test for thromboembolic events with thrombocytopenia: None After receiving booster on 27Nov2021, Patient ill with covid symptoms-cough, severe headache, Temp of 101 degree F. Nausea, Chills, severe pain down spine + pain to all extremities. All symptoms subsided by 29Nov2021 except for the persistent cough. Also patient had the expected sore arm at injection site.Patient did not have the covid type symptoms with mu 1st or 2nd vaccination. The reaction to the booster did feel as i did when i contracted covid back in Sep2021. If symptoms had not subsided I was going to get tested for Covid again, but luckily it resolved 2 days after booster.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Immunisation, Pyrexia
Clinical narrative: At approx. 48 hours after dose, experienced sweating lasting approx. 4 hours with return to normal, no treatment was given; At approx. 30 hours after dose, experienced chills also lasting ~2 hours with return to normal, no treatmentwas given.; At approximately 18 hours after dose, experienced fever lasting ~2 hours with return to normal, no treatment had been given.; Dose number: 3; This is a spontaneous report from a contactable reporter (nurse).  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 at 10:30 (Lot number: FF8839) at the age of 63 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3247; Route of administration: Intramuscular), administration date: 25Feb2021, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EN6203; Route of administration: Intramuscular), administration date: 18Mar2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 10:30, outcome "unknown", described as " Dose number: 3"; PYREXIA (non-serious) with onset 16Dec2021 at 04:30, outcome "recovered" (16Dec2021 at 06:30), described as "At approximately 18 hours after dose, experienced fever lasting ~2 hours with return to normal, no treatment had been given"; CHILLS (non-serious) with onset 16Dec2021 at 16:30, outcome "recovered" (16Dec2021 at 18:30), described as "At approx. 30 hours after dose, experienced chills also lasting ~2 hours with return to normal, no treatment was given"; HYPERHIDROSIS (non-serious) with onset 17Dec2021 at 10:30, outcome "recovered" (17Dec2021 at 14:30), described as "At approx. 48 hours after dose, experienced sweating lasting approx. 4 hours with return to normal, no treatment was given". Therapeutic measures were not taken as a result of pyrexia, chills and hyperhidrosis.  Additional Information: Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Headache, Immunisation
Clinical narrative: Headache; Coughing; Chest pain; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 at 14:15 (Lot number: PH8030) at the age of 17 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Pulmonary stenosis" (unspecified if ongoing) and "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE Lot number: ER8737 Anatomical location : Arm Left Vaccine Administration Time: 12:45), administration date: 09Apr2021, when the patient was 16 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE Lot number: EN6207 Anatomical location : Arm Left Vaccine Administration Time: 12:45), administration date: 19Mar2021, when the patient was 16 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021 at 14:15, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 19Dec2021 at 19:30, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "Headache"; COUGH (non-serious) with onset 19Dec2021 at 19:30, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "Coughing"; CHEST PAIN (non-serious) with onset 19Dec2021 at 19:30, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "Chest pain". Therapeutic measures were not taken as a result of headache, cough and chest pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events were recovered with lasting effects. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: This is a spontaneous report from a consumer or other non-HCP (patient's parent). The reporter is the parent. A 15-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# FJ8757),  at the age of 15, in left arm, on Dec 14, 2021, single dose, for COVID-19 immunisation. No medical history reported. Concomitant medications included: Zyrtec and Xyzal. Vaccination history included the 1st dose of BNT162B2 (Comirnaty, batch/lot# FH8028), at the age of 15, left arm, on Nov 23, 2021, single dose, for COVID-19 immunisation. The patient reported constipation, onset Dec 17, 2021, with outcome of recovering. Therapeutic measures were taken as a result of constipation. Additional Information: The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, patient has not tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment for constipation included laxative.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Immunisation, Interchange of vaccine products, Malaise
Clinical narrative: About 1 week later I devoloped a dry cough; Felt sick everyday; Patient received initial dose of J&J vaccines and booster dose of BNT162b2; The patient received third\booster dose of BNT162b2; This is a spontaneous report from a contactable reporter(consumer). The reporter is the patient.   A 59-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 at 09:00 (Lot number: FF8841) at the age of 59 years as dose 2 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing). Vaccination history included: Covid-19 vaccine J&J (DOSE NUMBER UNKNOWN, SINGLE Lot number: UNKNOWN Route of administration: Unspecified), administration date: an unknown date in 2021, for COVID-19 immunisation, reaction(s): "Cough" and Covid-19 vaccine J&J (DOSE NUMBER UNKNOWN, SINGLE Lot number: UNKNOWN Route of administration: Unspecified), administration date: an unknown date in 2021, for COVID-19 immunisation, reaction(s): "Sore throat". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 04Nov2021 at 09:00, outcome "unknown", described as "Patient received initial dose of J&J vaccines and booster dose of BNT162b2"; IMMUNISATION (non-serious) with onset 04Nov2021 at 09:00, outcome "unknown", described as "The patient received third\booster dose of BNT162b2"; COUGH (non-serious) with onset 11Nov2021 at 13:00, outcome "recovered" (an unknown date in 2021), described as "About 1 week later I devoloped a dry cough"; MALAISE (non-serious) with onset 11Nov2021 at 13:00, outcome "recovered" (an unknown date in 2021), described as "felt sick everyday". Therapeutic measures were taken as a result of cough and malaise.  Additional Information: Concomitant medications included high blood pressure medicine (unspecified medicine). Therapeutic measures were taken as a result of cough and malaise which included treatment with Omeprazole and the patient got relived from cough. The patient had a J and J shot about 6 months before. The patient coughed about every minute for 6 weeks straight and had a sore throat. Took Omeprazole for Acid Reflux to finally get rid of cough. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Immunisation, Migraine
Clinical narrative: Migraine; joint pain; chills; sweating; nausea; Dose number:3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Dec2021 at 11:45 (Lot number: FH8027) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing) and "Migraine" (unspecified if ongoing), notes: migraines. Concomitant medication(s) included: MESALAMINE; FLUTICASONE and MIRENA IUD. Past drug history included: Cecloretta, reaction(s): "Drug allergy", notes: known allergies: ceclore. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: EP6955; Anatomical location: Arm Right ; Vaccine Administration Time: 15:00), administration date: 06Apr2021, when the patient was 42 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot number: EP6955; Anatomical location: Arm Right; Vaccine Administration Time: 13:00), administration date: 16Mar2021, when the patient was 42 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 11:45, outcome "unknown", described as "dose number: 3"; MIGRAINE (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "migraine"; ARTHRALGIA (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "joint pain"; CHILLS (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "sweating"; NAUSEA (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "nausea". Therapeutic measures taken as a result of migraine, joint pain, chills, sweating, nausea was unknown.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Migraine; joint pain; chills; sweating; nausea; Dose number:3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Dec2021 at 11:45 (Lot number: FH8027) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing) and "Migraine" (unspecified if ongoing), notes: migraines. Concomitant medication(s) included: MESALAMINE; FLUTICASONE and MIRENA IUD. Past drug history included: Cecloretta, reaction(s): "Drug allergy", notes: known allergies: ceclore. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: EP6955; Anatomical location: Arm Right ; Vaccine Administration Time: 15:00), administration date: 06Apr2021, when the patient was 42 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot number: EP6955; Anatomical location: Arm Right; Vaccine Administration Time: 13:00), administration date: 16Mar2021, when the patient was 42 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 11:45, outcome "unknown", described as "dose number: 3"; MIGRAINE (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "migraine"; ARTHRALGIA (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "joint pain"; CHILLS (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "sweating"; NAUSEA (non-serious) with onset 09Dec2021 at 21:00, outcome "recovered" (an unknown date in Dec2021), described as "nausea". Therapeutic measures taken as a result of migraine, joint pain, chills, sweating, nausea was unknown.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Immunisation
Clinical narrative: My appetite has been suppressed, since receiving the booster; Dose number: 3; This is a spontaneous report from a contactable reporter (pharmacist). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 11Dec2021 at 12:00 (Lot number: unknown) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: LEXAPRO. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown; Anatomical location: Right Arm, Administration Time: 09:00), administration date: 07Feb2021, when the patient was 42 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Anatomical location: Right Arm, Administration Time: 09:00), administration date: 27Feb2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 at 12:00, outcome "unknown", described as "Dose number: 3"; DECREASED APPETITE (non-serious) with onset 13Dec2021 at 00:00, outcome "recovering", described as "My appetite has been suppressed, since receiving the booster". Therapeutic measures were not taken as a result of decreased appetite.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Head discomfort, Heart rate increased
Clinical narrative: Heart was rapidly beating; Felt tightness in the chest; Tiredness; Chills; Head stuffed up; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 08Sep2021 (Lot number: 30130BA) at the age of 39 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Immune thrombocytopenic purpura" (unspecified if ongoing), notes: Immune Thrombocytopenic purpura (ITP) and "Psoriasis" (unspecified if ongoing). Concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 09Sep2021 at 08:00, outcome "recovering", described as "Heart was rapidly beating"; CHEST DISCOMFORT (non-serious) with onset 09Sep2021 at 08:00, outcome "recovering", described as "Felt tightness in the chest"; FATIGUE (non-serious) with onset 09Sep2021, outcome "unknown", described as "Tiredness"; CHILLS (non-serious) with onset 09Sep2021, outcome "unknown", described as "Chills"; HEAD DISCOMFORT (non-serious) with onset 09Sep2021, outcome "unknown", described as "Head stuffed up". Therapeutic measures were not taken as a result of heart rate increased, chest discomfort, fatigue, chills and head discomfort.  Additional Information: The patient had no known allergies to his awareness. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that the patient's heart was rapidly beating and felt tightness in the chest during the morning (09Sep2021). By the afternoon, the symptoms lessened but continued to have typical symptoms (tiredness, chills, head stuffed up). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Immunisation, Pyrexia
Clinical narrative: Shivering/ Chills; High Fever (100 deg. F); Slight pain in joints due to the shivering; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP).  A 66-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 20Dec2021 (Lot number: FL3197) at the age of 66 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing) and "Graves' disease" (unspecified if ongoing), notes: Graves disease. Concomitant medication included: METHIMAZOLE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021, outcome "unknown", described as "Dose received: 3"; CHILLS (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Shivering/ Chills"; PYREXIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "High Fever (100 deg. F)"; ARTHRALGIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Slight pain in joints due to the shivering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia and arthralgia.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blepharospasm, Headache, Immunisation, Pyrexia
Clinical narrative: Joint pain; Eyelid twitching; Fever; Headache; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 (Lot number: 33130BA) at the age of 29 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: none; Known allergies: none. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8732; Anatomical location: left arm), administration date: 27Mar2021, when the patient was 29 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EU0161; Anatomical location: left arm), administration date: 17Apr2021, when the patient was 29 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "Dose number 3"; ARTHRALGIA (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Joint pain"; BLEPHAROSPASM (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Eyelid twitching"; PYREXIA (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Fever"; HEADACHE (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Headache". Therapeutic measures were not taken as a result of arthralgia, blepharospasm, pyrexia and headache.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable other HCP (patient). A 32-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# EH9899), at the age of 32, intramuscularly, in left deltoid, administration date Dec 22, 2021, at 19:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The following information patient reported vaccination site pain/injection site soreness, onset Dec 23, 2021, with outcome of recovered (Dec 24, 2021). No therapeutic measures taken as a result of vaccination site pain. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient, of unknown age, received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), for COVID-19 immunization; and had a reaction(s): some confusion, speaking in a different language than which she normally spoke/speaking a different language, did not feel well for a few days, did not want to get out of bed for a few days and frequent urination 2-3 weeks. The patient reported back pain; pain in extremity/severe pain in her back and her leg, with outcome of unknown. Additional information: Other products was noted as not provided. The patient had severe pain in her back and her leg following her 2nd vaccine dose. Investigation assessment was noted as not provided. Reporter (daughter of the patient) stated she called the pharmacist to review the Pfizer vaccine ingredients. She was looking specifically for beef and anything that comes from a cow. Patient has anaphylactic reactions to anything that has beef. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: FLUX
Symptoms: Burning sensation, Hypoaesthesia, Nerve injury
Clinical narrative: nerve damage; Leg went numb; burning sensation; Initial information was received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult patient (unknown gender) who experienced nerve damage (nerve injury), leg went numb (hypoaesthesia) and burning sensation, after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications 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 a non-serious nerve damage (nerve injury), leg went numb (hypoaesthesia) and burning sensation(unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported "enabled me to walk properly."  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Ill-defined disorder
Clinical narrative: almost died; Initial information was received on 14-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves an unknown age female patient who had almost died (ill-defined disorder) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious almost died (ill-defined disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "my sister in law almost die after that"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.   It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 15-Dec-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional (under reference number: US-SA-SAC20211222000185).  This case involves Adult and unknown gender patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.   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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There was be no information on the batch number for this case.
Sex: M
Vaccine: DTAP
Symptoms: Generalised oedema
Clinical narrative: Blew up like an elephant and he was all swollen up; Initial information was received on 17-Dec-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 3 year old male patient who had blew up like an elephant and all swollen up (Generalised oedema) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry not reported, Suspension for injection) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious blew up like an elephant and all swollen up (Generalised oedema) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "The caller's brother got a diphtheria, tetanus, and pertussis (DTP) shot and blew up like an elephant. The patient was 3 years old when this happened, he was all swollen up."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 20-Dec-2021 regarding an unsolicited valid  serious case received from a consumer non health care professional under reference number: US-SA-SAC20211222000641.  This case involves an unknown age and unknown gender patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications 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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There was be no information on the batch number for this case; Sender's Comments: This case concerns an unknown age and unknown gender patient who experienced influenza (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Headache, Malaise, Sinusitis
Clinical narrative: headache; sinus infection; being sick; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from a non-healthcare professional (under reference: US-SA-SAC20211222000712).  This case involves a 77 years old female patient who experienced headache, sinus infection and being sick when received vaccine INFLUENZA VACCINE.  The patient's medical history included pulmonary arterial hypertension.  The patient's past vaccination and family history were not provided.  Concomitant medications included AMBRISENTAN (LETAIRIS), TADALAFIL (ADCIRCA) and WARFARIN.  In October 2021, 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.  In 2021 the patient developed a non-serious headache, sinus infection (sinusitis), being sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "On an unreported date, the patient experienced event of was off Tyvaso for a little while but has since restarted (therapy interrupted)."  Laboratory details were not reported.   The patient was treated with TREPROSTINIL SODIUM (TYVASO) for pulmonary arterial hypertension.  At the time of reporting, the outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves a patient (unknown demographics) who had flu (influenza), after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(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 not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported I got my flu shot two weeks ago and now I'm at home with full blown flu, never again. Details of laboratory were not reported. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm still sensitive; Initial information received on 19-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) patient who had arm still sensitive (pain in extremity), after receiving INFLUENZA VACCINE.  The patient's 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 developed a non-serious arm still sensitive (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: nurse is about to administer a dose of IMOVAX RABIES 14 day shot on day 16 to her mother/ No AE; Initial information received on 13-Dec-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves an unknown age female patient who was about to receive a dose of RABIES (HDC) VACCINE [IMOVAX RABIES] 14 day shot on day 16 by a nurse (inappropriate schedule of product administration).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient would receive a dose of suspect RABIES (HDC) VACCINE lot number and expiry date not reported via an unknown route in unknown administration site for post exposure immunization.  It was a potential medication error due to inappropriate schedule of vaccine administered (latency: same day).   It was reported "Nurse travels for work, and their mother is looking to get the rabies vaccination (nurse is fairly sure it is IMOVAX). Nurse is looking to administer the vaccination himself and says since they cannot store the vaccine on the road, if it would be possible to administer her 14 day shot on day 16 instead. The caller states that he will administer a dose today on the 13th and then on the 20th. He states that she is receiving IMOVAX for post exposure even though her test was negative just to be safe. He states that he will be giving her 14 day shot on day 16th because otherwise he would be unable to keep the vaccination at the correct temperature."  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 the 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.  There will be no information on the batch number of the suspect drug.
Sex: U
Vaccine: DTAP, DTAPIPVHIB, FLU4, HIBV, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: The products were exposed to highest temperature of 54.9 degrees Fahrenheit (12.72 degrees Celsius) and lowest temperature of 40.5 degrees Fahrenheit (4.72 degrees Celsius) with no AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves unknown gender patient for whom it was reported the products were exposed to highest temperature of 54.9 degrees Fahrenheit (12.72 degrees Celsius) and lowest temperature of 40.5 degrees Fahrenheit (4.72 degrees Celsius) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], HIB (PRP/T) VACCINE [ActHIB], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Product storage error).  The patient medical history, medical treatment(s), vaccination(s),concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot U7328AA, expiry date: 30-Jun-2022] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ496AAA, expiry date:09-Jul-2022] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot UJ426AAA and expiry date:07-Mar-20222] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6828AB, expiry date: 09-Jan-2022] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5765BA and expiry date: 28-Aug-2022] via an unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to product storage error [Latency: on the same day].   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 the 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: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 17 years old patient received a dose of Flublok vaccine/ No AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case from a pharmacist via Medical Information (MI) number: 00898092.  This case involves a 17 years old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included a booster dose of Coronavirus disease 2019 (COVID-19) VACCINE in arm for prophylactic vaccination.  On 12-Dec-2021, the patient received a 0.5 ml total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE Pre-filled syringe, strength: standard, frequency: once, lot number: QFAA2116, expiry date: 30-Jun-2022 via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "The pharmacist states that one of the associates received Flublok and he is 17 going to be 18 and she would like to know if there are any studies for using Flublok in a person younger than 18 years of age."  Product used: Used, Still using product: No and Was Device Used: Yes.  At the time of reporting, 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 the 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.