chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: couldn't sleep; had severe paresthesia of the right side of my scalp down my neck on the right side; I couldn't sleep nor function normally; pain; pulling and tingling sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 06:15 (Lot number: EW0169) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "pencillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Dose administration time:3.30am, dose vaccine location: left arm, Lot number:EW0150, Dose brand: Pfizer, Dose product: COVID-19), administration date: 01Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "couldn't sleep"; PARAESTHESIA (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "had severe paresthesia of the right side of my scalp down my neck on the right side"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "I couldn't sleep nor function normally"; PAIN (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "pain"; PARAESTHESIA (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "pulling and tingling sensation". The events "couldn't sleep", "had severe paresthesia of the right side of my scalp down my neck on the right side", "i couldn't sleep nor function normally" and "pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of insomnia, paraesthesia, loss of personal independence in daily activities, pain, paraesthesia.  Additional information: No other vaccine in four weeks and no Other medications in two weeks. Patient had severe paresthesia of the right side of her scalp down my neck on the right side starting at about 2 weeks after the 2nd shot. she couldn't sleep nor  function normally due to the pain, pulling and tingling sensation, it has since subsided considerably but has not gone away. This lasted several weeks and went to the dr and insisted on an MRI as she couldn't tell if this was her scalp or inside my head. It was reported that patient did not have covid prior to vaccination nor tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: couldn't sleep; had severe paresthesia of the right side of my scalp down my neck on the right side; I couldn't sleep nor function normally; pain; pulling and tingling sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 06:15 (Lot number: EW0169) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "pencillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Dose administration time:3.30am, dose vaccine location: left arm, Lot number:EW0150, Dose brand: Pfizer, Dose product: COVID-19), administration date: 01Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "couldn't sleep"; PARAESTHESIA (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "had severe paresthesia of the right side of my scalp down my neck on the right side"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "I couldn't sleep nor function normally"; PAIN (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "pain"; PARAESTHESIA (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "pulling and tingling sensation". The events "couldn't sleep", "had severe paresthesia of the right side of my scalp down my neck on the right side", "i couldn't sleep nor function normally" and "pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of insomnia, paraesthesia, loss of personal independence in daily activities, pain, paraesthesia.  Additional information: No other vaccine in four weeks and no Other medications in two weeks. Patient had severe paresthesia of the right side of her scalp down my neck on the right side starting at about 2 weeks after the 2nd shot. she couldn't sleep nor  function normally due to the pain, pulling and tingling sensation, it has since subsided considerably but has not gone away. This lasted several weeks and went to the dr and insisted on an MRI as she couldn't tell if this was her scalp or inside my head. It was reported that patient did not have covid prior to vaccination nor tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain in legs/Leg pain; pain was also in his joints; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing), notes: Had shingles once when he was in his twenties from chicken pox or wherever it comes from. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Jul2021, outcome "not recovered", described as "Pain in legs/Leg pain"; ARTHRALGIA (non-serious) with onset 10Jul2021, outcome "not recovered", described as "pain was also in his joints". The events "pain in legs/leg pain" and "pain was also in his joints" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: The patient had an unusual reaction to the Pfizer COVID Vaccine. About 3 days after the 1st dose, the patient developed pain in legs like someone beat his legs with a baseball bat from hips down to feet that pain was also in his joints. He had really bad pain in his leg and joint from his hips down to his feet that lasted for 10 days and went away. Was taking a lot of Advil to get rid of it. The patient was taking Advil and Tylenol and all kinds of stuff trying to keep pain under control. The patient was advised to take Gabapentin 100mg at night and 100mg in morning because it needs to turn the pain off so the sensory nerves would die. The patient stated that the Gabapentin was helping. Took Fish Oil to relive inflammation. Took Vitamin C. He stated that this had been going on for 15 weeks and it was getting worse. Everything went good for about a week before he was going for the second shot. The patient had his 2nd shot on 28Jul2021. Doctor and ER did not know what was going on either. Had been going on 15 weeks now. He was seeking a solution and treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy arm post booster shot of Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Manufacturer unknown), for Covid-19 Immunization; Bnt162b2 (Second Dose, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itchy arm post booster shot of Covid"  Additional information: Event took place after use of product. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Mass, Pain in extremity
Clinical narrative: swollen lymph; lump and it is painful; lump and it is painful; pain in arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 08Nov2021 (Lot number: FH8028) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: FF2590, Route, Anatomical Location: left arm), administration date: 16Oct2021, when the patient was 47 years old, for COVID-19 Immunisation. The following information was reported: AXILLARY PAIN (non-serious) with onset 08Nov2021, outcome "not recovered", described as "pain in arm pit"; LYMPHADENOPATHY (non-serious) with onset 09Nov2021, outcome "not recovered", described as "swollen lymph"; MASS (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 09Nov2021, outcome "not recovered" and all described as "lump and it is painful". No follow-up attempts are possible. No further information is expected.  Follow-Up (15Nov2021): Follow-up attempts are completed. No further information is expected.  Additional information: Time the Vaccination Was Given: between 2PM and 3PM.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Expired product administered, Poor quality product administered, Soft tissue disorder
Clinical narrative: there is a lump underneath my left arm, in my armpit area/it just puffy is like a lump like it is full of some kind of fluid; puffy is like a lump like it is full of some kind of fluid; When probed for expiration date, consumer stated 10Nov2021; When probed for expiration date, consumer stated 10Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date Nov2021 (Lot number: FF2593, Expiration Date: 10Nov2021) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis; "Bronchitis" (unspecified if ongoing), notes: Verbatim: Bronchitis. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), administration date: 2021, for COVID-19 Immunisation; Bnt162b2 (Dose:2), administration date: 2021, for COVID-19 Immunisation.  The following information was reported: MASS (non-serious) with onset 12Nov2021, outcome "unknown", described as "there is a lump underneath my left arm, in my armpit area/it just puffy is like a lump like it is full of some kind of fluid"; EXPIRED PRODUCT ADMINISTERED (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset Nov2021, outcome "unknown" and all described as "When probed for expiration date, consumer stated 10Nov2021". Therapeutic measures were not taken as a result of mass, expired product administered, poor quality product administered.  Additional information: Patient stated that to have got Pfizer booster last Friday and now there is a lump underneath patient's left arm, in armpit area. It does not hurt but it just puffy is like a lump like it is full of some kind of fluid or something. Vaccination Facility: Consumer stated, Withheld, it's a pharmacy.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Full blood count, Urinary tract infection, Urine analysis
Clinical narrative: I had a UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 22Sep2021 (Lot number: EW0162) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Chronic Pain disorder" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing), notes: I take Blood Pressure medication. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, LOT# EW0175), administration date: 30Aug2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset 12Nov2021, outcome "not recovered", described as "I had a UTI". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urinary tract infection.   Additional information: The patient had the Pfizer vaccine on 23Sep2021 and on 04Oct2021, the patient had a UTI, it's first UTI the patient ever had in 49 years they treated it and then the patient got a secondary UTI yesterday 12Nov which is just you know very short period time away from the first one so the doctor and the patient discussed that it could be a side effect of the Pfizer vaccine since there is some literature out there and some reporting that it is some length neurology issue in women 44 to 65 and also men but, the patient don't have age range for them. So, the patient would like to know is this going to go away or am the patient going to have to live life getting a UTI every single month having a beyond antibiotic which will ultimately lead me to be antibiotic resistance and also the patient is supposed to get a booster in Mar and the patient doesn't think the patient is going to get it if this is you know what's going to happen to the patient is side effect. The patient has chronic Pain disorder and the patient take pain medication (Further not clarified) for that the patient has bit of hypertension. the patient takes Blood Pressure medication (Further Not clarified) for that other than that the patient takes a natural vitamin. Vitamin B12, Vitamin C, Vitamin D and little bit of zinc the patient wouldn't be taking Vitamin C you know what the patient mean that's all the medications. The patient had not diagnosed with covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Vaccination site swelling
Clinical narrative: Swelling/on the same arm where he got the shot is 'like swollen'; his underarm, underneath, on the same arm where he got the shot is 'like swollen'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "Swelling/on the same arm where he got the shot is 'like swollen'"; AXILLARY MASS (non-serious) with onset Nov2021, outcome "unknown", described as "his underarm, underneath, on the same arm where he got the shot is 'like swollen'".  Additional information: Reason for no lot number: of COVID-19 Vaccine: Reporter unwilling to complete the report. Expiry Date of COVID-19 Vaccine: Unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Investigation, Malaise, Nasal congestion
Clinical narrative: repeated respiratory viral infections; generally not feeling well; fever; congested; feeling chills and cold; feeling chills and cold; This is a spontaneous report received from a contactable Other HCP. The reporter is the parent.  A 16-year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Mar2021, for COVID-19 immunization. The following information was reported: RESPIRATORY TRACT INFECTION VIRAL (non-serious) with onset 15Oct2021, outcome "unknown", described as "repeated respiratory viral infections"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "generally not feeling well"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "congested"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 2021, outcome "unknown" and all described as "feeling chills and cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of respiratory tract infection viral, malaise, pyrexia, nasal congestion, chills, feeling cold.  Additional information: The patient Other Products and Patient History has been Not Provided. The patient was taking Motrin and Tylenol.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract infection viral
Clinical narrative: repeated respiratory viral infections; generally not feeling well; fever; congested; feeling chills and cold; feeling chills and cold; This is a spontaneous report received from a contactable Other HCP. The reporter is the parent.  A 16-year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Mar2021, for COVID-19 immunization. The following information was reported: RESPIRATORY TRACT INFECTION VIRAL (non-serious) with onset 15Oct2021, outcome "unknown", described as "repeated respiratory viral infections"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "generally not feeling well"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "congested"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 2021, outcome "unknown" and all described as "feeling chills and cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of respiratory tract infection viral, malaise, pyrexia, nasal congestion, chills, feeling cold.  Additional information: The patient Other Products and Patient History has been Not Provided. The patient was taking Motrin and Tylenol.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Investigation, Malaise, Nasal congestion
Clinical narrative: viral infection; repeated respiratory viral infections; feel like they have a fever and are both congested; feel like they have a fever and are both congested; cough is terrible; feeling chills and cold; feeling chills and cold; generally not feeling well; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Lot number: ED6201) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: EL9126 (reporter was guessing on the LP or it could be EL9126)), administration date: 27Jan2021, for COVID-19 Immunisation. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "generally not feeling well"; VIRAL INFECTION (non-serious) with onset 22Oct2021, outcome "unknown", described as "viral infection "; RESPIRATORY TRACT INFECTION VIRAL (non-serious) with onset 2021, outcome "unknown", described as "repeated respiratory viral infections"; PYREXIA (non-serious), NASAL CONGESTION (non-serious) all with onset 2021, outcome "unknown" and all described as "feel like they have a fever and are both congested"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "cough is terrible"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset 2021, outcome "unknown" and all described as "feeling chills and cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, pyrexia, nasal congestion.  Additional information: Reporter is Wife of the Patient. Reporter stated that her husband and son should go again to be tested, since they are both having symptoms again, they both are generally not feeling well. Other Products and Patient History: Not Provided. Reporter stated that between the 5 of them, they have tested about 5 times in the last 12 days. Patient's cough was terrible, last episode lasted 10 days. Patient got tested when the symptoms ran. Now her husband (patient) is experiencing symptoms again since the 11th.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia, Respiratory tract infection viral, Viral infection
Clinical narrative: viral infection; repeated respiratory viral infections; feel like they have a fever and are both congested; feel like they have a fever and are both congested; cough is terrible; feeling chills and cold; feeling chills and cold; generally not feeling well; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Lot number: ED6201) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: EL9126 (reporter was guessing on the LP or it could be EL9126)), administration date: 27Jan2021, for COVID-19 Immunisation. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "generally not feeling well"; VIRAL INFECTION (non-serious) with onset 22Oct2021, outcome "unknown", described as "viral infection "; RESPIRATORY TRACT INFECTION VIRAL (non-serious) with onset 2021, outcome "unknown", described as "repeated respiratory viral infections"; PYREXIA (non-serious), NASAL CONGESTION (non-serious) all with onset 2021, outcome "unknown" and all described as "feel like they have a fever and are both congested"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "cough is terrible"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset 2021, outcome "unknown" and all described as "feeling chills and cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, pyrexia, nasal congestion.  Additional information: Reporter is Wife of the Patient. Reporter stated that her husband and son should go again to be tested, since they are both having symptoms again, they both are generally not feeling well. Other Products and Patient History: Not Provided. Reporter stated that between the 5 of them, they have tested about 5 times in the last 12 days. Patient's cough was terrible, last episode lasted 10 days. Patient got tested when the symptoms ran. Now her husband (patient) is experiencing symptoms again since the 11th.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "urinary tract infection". Therapeutic measures were taken as a result of urinary tract infection.  Additional information: The patient taking Meloxicam and Tramadol for spasms in neck. The patient started taking both medication after 2nd dose of covid vaccine also said after 1st Pfizer covid vaccine she had a urinary tract infection and had to take an antibiotic.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101593834 Same patient, same drug, different dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: urinary tract infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "urinary tract infection". Therapeutic measures were taken as a result of urinary tract infection.  Additional information: The patient taking Meloxicam and Tramadol for spasms in neck. The patient started taking both medication after 2nd dose of covid vaccine also said after 1st Pfizer covid vaccine she had a urinary tract infection and had to take an antibiotic.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101593834 Same patient, same drug, different dose
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Chills, Cough, Lymphadenopathy, Malaise
Clinical narrative: a little bit cough now; lump under the armpit and it hurts; it hurts; Swollen Lymph node between the armpit and breast; chills; The anatomical location where she got the vaccine, its sore there too on the arm; Fever; feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: 30135BA) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Diabetes Type 2" (unspecified if ongoing); "sinus" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY taken for hypersensitivity; DAYQUIL taken for sinus disorder. Vaccination history included: Bnt162b2 (Dose Number :1, Batch/lot No: EL9269, Location of injection: Arm left), administration date: 03Feb2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Dose Number :2, Batch/lot No: EN6202, Location of injection: Arm left), administration date: 26Feb2021, when the patient was 50 years old, for Covid-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Nov2021, outcome "not recovered", described as "The anatomical location where she got the vaccine, its sore there too on the arm"; PYREXIA (non-serious) with onset 13Nov2021, outcome "recovered" (14Nov2021), described as "Fever"; LYMPHADENOPATHY (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Swollen Lymph node between the armpit and breast"; CHILLS (non-serious) with onset 13Nov2021, outcome "recovered" (13Nov2021), described as "chills"; AXILLARY MASS (non-serious) with onset 15Nov2021, outcome "unknown", described as "lump under the armpit and it hurts"; PAIN (non-serious) with onset 15Nov2021, outcome "unknown", described as "it hurts"; MALAISE (non-serious) with onset 13Nov2021, outcome "unknown", described as "feeling sick"; COUGH (non-serious), outcome "unknown", described as "a little bit cough now".  Additional information: The chills stopped on the 13Nov2021, when she got under the heating blanket. She got over heated and then got off, that was her body telling her that she is warm. Expiry Date of Covid Vaccine: Unknown. Reporter states that she is a caregiver, and takes care of a disabled person. Reporter stated that she was feeling sick for 2 days, on the 13Nov2021 and 14Nov2021. If she touches where she got the vaccination, its still sore.  Follow-Up (22Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: a little bit cough now; lump under the armpit and it hurts; it hurts; Swollen Lymph node between the armpit and breast; chills; The anatomical location where she got the vaccine, its sore there too on the arm; Fever; feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: 30135BA) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Diabetes Type 2" (unspecified if ongoing); "sinus" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY taken for hypersensitivity; DAYQUIL taken for sinus disorder. Vaccination history included: Bnt162b2 (Dose Number :1, Batch/lot No: EL9269, Location of injection: Arm left), administration date: 03Feb2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Dose Number :2, Batch/lot No: EN6202, Location of injection: Arm left), administration date: 26Feb2021, when the patient was 50 years old, for Covid-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Nov2021, outcome "not recovered", described as "The anatomical location where she got the vaccine, its sore there too on the arm"; PYREXIA (non-serious) with onset 13Nov2021, outcome "recovered" (14Nov2021), described as "Fever"; LYMPHADENOPATHY (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Swollen Lymph node between the armpit and breast"; CHILLS (non-serious) with onset 13Nov2021, outcome "recovered" (13Nov2021), described as "chills"; AXILLARY MASS (non-serious) with onset 15Nov2021, outcome "unknown", described as "lump under the armpit and it hurts"; PAIN (non-serious) with onset 15Nov2021, outcome "unknown", described as "it hurts"; MALAISE (non-serious) with onset 13Nov2021, outcome "unknown", described as "feeling sick"; COUGH (non-serious), outcome "unknown", described as "a little bit cough now".  Additional information: The chills stopped on the 13Nov2021, when she got under the heating blanket. She got over heated and then got off, that was her body telling her that she is warm. Expiry Date of Covid Vaccine: Unknown. Reporter states that she is a caregiver, and takes care of a disabled person. Reporter stated that she was feeling sick for 2 days, on the 13Nov2021 and 14Nov2021. If she touches where she got the vaccination, its still sore.  Follow-Up (22Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: Booster dose; arm sore; chills; feverish; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 35 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Nov2021 12:00 (Lot number: FF2589) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021 12:00, outcome "unknown", described as "Booster dose"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "arm sore"; CHILLS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "chills"; PYREXIA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "feverish". It was unknown if therapeutic measures were taken as a result of pain in extremity, chills, pyrexia.  Additional information: Facility where most recent vaccine administered was Workplace clinic. The treatment received for the adverse event was reported as unknown. Covid prior vaccination and covid tested post vaccination was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1: suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died due to unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211222777-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myalgia, Vaccination complication, Vaccination site pain
Clinical narrative: Feeling very worn out after second dose; Body aches after second dose; Received the second dose of  Moderna COVID-19 vaccine while pregnant; Sore arm after second dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling very worn out after second dose), VACCINATION SITE PAIN (Sore arm after second dose), MYALGIA (Body aches after second dose) and MATERNAL EXPOSURE DURING PREGNANCY (Received the second dose of  Moderna COVID-19 vaccine while pregnant) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 19-Dec-2020 and the estimated date of delivery was 05-Oct-2021. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm after second dose) and MATERNAL EXPOSURE DURING PREGNANCY (Received the second dose of  Moderna COVID-19 vaccine while pregnant). On 05-Apr-2021, the patient experienced VACCINATION COMPLICATION (Feeling very worn out after second dose) and MYALGIA (Body aches after second dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy. The delivery occurred  on 01-Oct-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth NOS. On 02-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received the second dose of  Moderna COVID-19 vaccine while pregnant) had resolved. At the time of the report, VACCINATION COMPLICATION (Feeling very worn out after second dose), VACCINATION SITE PAIN (Sore arm after second dose) and MYALGIA (Body aches after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-407358, MOD-2021-407515 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A nurse called in to report an adverse event for 7 patients who received an expired dose of the Moderna COVID-19 vaccine/ Expiration: 06DEC2021 and administered on 08DEC2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse called in to report an adverse event for 7 patients who received an expired dose of the Moderna COVID-19 vaccine/ Expiration: 06DEC2021 and administered on 08DEC2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A, 033621A and 044B21A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE), IBUPROFEN and OMEPRAZOLE for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse called in to report an adverse event for 7 patients who received an expired dose of the Moderna COVID-19 vaccine/ Expiration: 06DEC2021 and administered on 08DEC2021). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (A nurse called in to report an adverse event for 7 patients who received an expired dose of the Moderna COVID-19 vaccine/ Expiration: 06DEC2021 and administered on 08DEC2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.  The vial was initially stored in the refrigerator on 08-Dec-2021, later taken out of freezer and placed into the fridge again. The vial did not undergo any temperature excursions.   This case was linked to MOD-2021-408598 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-408707, MOD-2021-409000 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test
Clinical narrative: coughing a lot while talking; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing a lot while talking) and COVID-19 (tested positive for COVID-19) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced COUGH (coughing a lot while talking) and COVID-19 (tested positive for COVID-19). At the time of the report, COUGH (coughing a lot while talking) and COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. Treatment information was unknown.  Company comment: This case concerns a 58-year-old male patient, with no medical history reported who experienced non serious unexpected AESI of COVID-19 after third dose of mRNA-1273. The patient reported having received a primary series scheme with mRNA-1273 vaccine (first dose date not provided) and two days after third dose he test positive for COVID-19. The re-challenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 58-year-old male patient, with no medical history reported who experienced non serious unexpected AESI of COVID-19 after third dose of mRNA-1273. The patient reported having received a primary series scheme with mRNA-1273 vaccine (first dose date not provided) and two days after third dose he test positive for COVID-19. The re-challenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Nausea, Pain in extremity
Clinical narrative: sleeping a lot after dose 1; sore arm after dose 1; nauseas after dose 1; headache after dose 1; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping a lot after dose 1), PAIN IN EXTREMITY (sore arm after dose 1), NAUSEA (nauseas after dose 1) and HEADACHE (headache after dose 1) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (sleeping a lot after dose 1), PAIN IN EXTREMITY (sore arm after dose 1), NAUSEA (nauseas after dose 1) and HEADACHE (headache after dose 1). At the time of the report, HYPERSOMNIA (sleeping a lot after dose 1), PAIN IN EXTREMITY (sore arm after dose 1), NAUSEA (nauseas after dose 1) and HEADACHE (headache after dose 1) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included are taken for high blood pressure and diabetes. No treatment drug details was reported.  This case concerns a 55-year-old, male patient with no medical history, who experienced non serious AESI events of   Hypersomnia, Pain in extremity, and expected events of Nausea and Headache. The event occurred on an unknown date after the first dose of mRNA-1273 vaccine. The re challenge was not applicable, since the patient did receive other two doses, but the outcome of the event hypersomnia was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-404786 (Patient Link).; Sender's Comments: This case concerns a 55-year-old, male patient with no medical history, who experienced Non serious AESI events of   Hypersomnia, Pain in extremity, and expected events of Nausea and Headache. The event occurred on an unknown date after the first dose of mRNA-1273 vaccine. The Re challenge was not applicable, since the patient did receive other two doses, but the outcome of the event hypersomnia was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Myalgia, Vaccination site pain
Clinical narrative: Sore on injection site as well as all over the body; feeling tired; Sore on injection site; Sore on injection site as well as all over the body; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired), INJECTION SITE PAIN (Sore on injection site), MYALGIA (Sore on injection site as well as all over the body) and VACCINATION SITE PAIN (Sore on injection site as well as all over the body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced FATIGUE (feeling tired), INJECTION SITE PAIN (Sore on injection site) and MYALGIA (Sore on injection site as well as all over the body). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore on injection site as well as all over the body). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of UNK UNK, qd and IBUPROFEN for Adverse event, at a dose of UNK, qd. At the time of the report, FATIGUE (feeling tired), INJECTION SITE PAIN (Sore on injection site), MYALGIA (Sore on injection site as well as all over the body) and VACCINATION SITE PAIN (Sore on injection site as well as all over the body) had not resolved.            The patents wife stated that there were no such symptoms for first two shots No concomitant medications were reported