chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination site inflammation
Clinical narrative: Fever of 100.8 day after vaccination; Dose number:3; Extreme fatigue; Headache; Eye ache; Right arm (entire side of body) very sore; Right arm (entire side of body) very sore; Local inflammation at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 16:30 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Prediabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Monistat, reaction(s): "Drug allergy", notes: Known allergies: Monistat. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown Route of administration: unspecified Administration time: 04:45 Anatomical site: right arm), administration date: 18Jan2021, when the patient was 61 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown Route of administration: unspecified Administration time:16:00 Anatomical site: left arm), administration date: 03Feb2021, when the patient was 61 years old, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 16:30, outcome "unknown", described as "Dose number:3"; FATIGUE (non-serious) with onset Dec2021, outcome "recovering", described as "Extreme fatigue"; PYREXIA (non-serious) with onset 02Dec2021, outcome "recovering", described as "Fever of 100.8 day after vaccination"; HEADACHE (non-serious) with onset Dec2021, outcome "recovering", described as "Headache"; EYE PAIN (non-serious) with onset Dec2021, outcome "recovering", described as "Eye ache"; PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset Dec2021, outcome "recovering" and all described as "Right arm (entire side of body) very sore"; VACCINATION SITE INFLAMMATION (non-serious) with onset Dec2021, outcome "recovering", described as "Local inflammation at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, headache, eye pain, pain in extremity, pain, vaccination site inflammation.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. 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. The events onset date was also reported as 30Nov2021 at 20:00   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity, Somnolence
Clinical narrative: it's making me tired; I also have a sore arm; Just slept like I've never slept before; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 34 years 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), administration date: 05Apr2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1), administration date: 05Mar2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 02Dec2021, outcome "unknown", described as "it's making me tired"; PAIN IN EXTREMITY (non-serious) with onset 02Dec2021, outcome "unknown", described as "I also have a sore arm"; SOMNOLENCE (non-serious) with onset 02Dec2021, outcome "unknown", described as "Just slept like I've never slept before". Therapeutic measures were not taken as a result of fatigue, pain in extremity, somnolence.  Additional information: Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Fatigue, Feeling of body temperature change, Immunisation
Clinical narrative: Body aches for two full days; Can't get comfortable because I'm hot then I'm cold.; Can't get comfortable because I'm hot then I'm cold.; Can't sleep well; Feeling better on 3rd day but still very tired.; Soreness in my chest from movement not from breathing; Soreness in my left arm of course.; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 13:30 (Lot number: 330308D) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, very minor symptoms that lasted about a half a day from dose2), administration date: 31Mar2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "very minor symptoms"; Bnt162b2 (Dose Number: 1, Batch/Lot No: FN6207, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM,  I had no symptoms from dose1), administration date: 10Mar2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Body aches for two full days"; DISCOMFORT (non-serious), FEELING OF BODY TEMPERATURE CHANGE (non-serious) all with onset 30Nov2021 22:00, outcome "not recovered" and all described as "Can't get comfortable because I'm hot then I'm cold."; INSOMNIA (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Can't sleep well"; FATIGUE (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Feeling better on 3rd day but still very tired."; CHEST PAIN (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Soreness in my chest from movement not from breathing"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Soreness in my left arm of course.". Therapeutic measures were not taken as a result of pain, discomfort, feeling of body temperature change, insomnia, fatigue, chest pain, vaccination site pain.  Additional information: It was reported that, no other vaccine in four weeks and no other medications in two weeks prior to dose 3 Bnt162b2. The patient not had covid prior to vaccination and no covid test post vaccination. No Known allergies were reported. Reported as very healthy. Clinical course: The patient had no symptoms from dose1, very minor symptoms that lasted about a half a day from dose2, and dose3 has really kicked my butt. I haven't been that sick in years.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, Vaccination site pain
Clinical narrative: Body aches for two full days; Can't get comfortable because I'm hot then I'm cold.; Can't get comfortable because I'm hot then I'm cold.; Can't sleep well; Feeling better on 3rd day but still very tired.; Soreness in my chest from movement not from breathing; Soreness in my left arm of course.; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 13:30 (Lot number: 330308D) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, very minor symptoms that lasted about a half a day from dose2), administration date: 31Mar2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "very minor symptoms"; Bnt162b2 (Dose Number: 1, Batch/Lot No: FN6207, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM,  I had no symptoms from dose1), administration date: 10Mar2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Body aches for two full days"; DISCOMFORT (non-serious), FEELING OF BODY TEMPERATURE CHANGE (non-serious) all with onset 30Nov2021 22:00, outcome "not recovered" and all described as "Can't get comfortable because I'm hot then I'm cold."; INSOMNIA (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Can't sleep well"; FATIGUE (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Feeling better on 3rd day but still very tired."; CHEST PAIN (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Soreness in my chest from movement not from breathing"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Soreness in my left arm of course.". Therapeutic measures were not taken as a result of pain, discomfort, feeling of body temperature change, insomnia, fatigue, chest pain, vaccination site pain.  Additional information: It was reported that, no other vaccine in four weeks and no other medications in two weeks prior to dose 3 Bnt162b2. The patient not had covid prior to vaccination and no covid test post vaccination. No Known allergies were reported. Reported as very healthy. Clinical course: The patient had no symptoms from dose1, very minor symptoms that lasted about a half a day from dose2, and dose3 has really kicked my butt. I haven't been that sick in years.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Myalgia
Clinical narrative: Tiredness; muscle aches; chills; Booster; 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 male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 13:45 (Lot number: FH8027) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN; VITAMIN C; VITAMIN B12. Vaccination history included: Bnt162b2 (Dose 2, Lot No: EL3247, Route of Administration: Intramuscular), administration date: 11Feb2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Lot No: EL3247, Route of Administration: Intramuscular), administration date: 21Jan2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 13:45, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 02Dec2021, outcome "recovered" (Dec2021), described as "Tiredness"; MYALGIA (non-serious) with onset 02Dec2021, outcome "recovered" (Dec2021), described as "muscle aches"; CHILLS (non-serious) with onset 02Dec2021, outcome "recovered" (Dec2021), described as "chills". Therapeutic measures were not taken as a result of fatigue, myalgia, chills.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. The patient did not get covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity
Clinical narrative: booster; sore arm; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old female patient 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 (Dose 01), when the patient was 53 years old, for Covid-19 immunization, reaction(s) sore arm, tenderness; Bnt162b2 (Dose 02), when the patient was 53 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), outcome unknown; FATIGUE (non-serious), outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypoaesthesia oral, Immunisation, Lethargy
Clinical narrative: lethargy 6 days later; she started with swelling in the clavicular lymph nodes then it progressed under her arm and to the clavicular area; swollen lymph nodes/swelling in clavicular lymph node; received the pfizer covid vaccine booster; really bad headache which is worsening; pressure in both eyes; her lips feel numb; scalp sensitivity; Mild fever 100 F; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 27Nov2021 (Batch/Lot number: unknown) at the age of 54 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Manufacture), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "received the pfizer covid vaccine booster"; LYMPHADENOPATHY (non-serious) with onset 28Nov2021, outcome "unknown", described as "swollen lymph nodes/swelling in clavicular lymph node"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "really bad headache which is worsening"; OCULAR DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "pressure in both eyes"; HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "unknown", described as "her lips feel numb"; PAIN OF SKIN (non-serious) with onset 2021, outcome "unknown", described as "scalp sensitivity"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Mild fever 100 F"; PERIPHERAL SWELLING (non-serious) with onset 28Nov2021, outcome "unknown", described as "she started with swelling in the clavicular lymph nodes then it progressed under her arm and to the clavicular area"; LETHARGY (non-serious) with onset 03Dec2021, outcome "unknown", described as "lethargy 6 days later". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter states her daughter feels like she has puffy lips but her lips don't look puffy. she started with swelling in the clavicular lymph nodes then it progressed under her arm and to the clavicular area; it is very sensitive. She understands that this side effect can happen and is par the course but what she is concerned about is the headache. She has had the headache since getting the vaccine and it is getting worse. This she does not think is normal; she would think that her daughter would get a side effects and then it would get better, not worse  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ocular discomfort, Pain of skin, Peripheral swelling, Pyrexia
Clinical narrative: lethargy 6 days later; she started with swelling in the clavicular lymph nodes then it progressed under her arm and to the clavicular area; swollen lymph nodes/swelling in clavicular lymph node; received the pfizer covid vaccine booster; really bad headache which is worsening; pressure in both eyes; her lips feel numb; scalp sensitivity; Mild fever 100 F; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 27Nov2021 (Batch/Lot number: unknown) at the age of 54 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Manufacture), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "received the pfizer covid vaccine booster"; LYMPHADENOPATHY (non-serious) with onset 28Nov2021, outcome "unknown", described as "swollen lymph nodes/swelling in clavicular lymph node"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "really bad headache which is worsening"; OCULAR DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "pressure in both eyes"; HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "unknown", described as "her lips feel numb"; PAIN OF SKIN (non-serious) with onset 2021, outcome "unknown", described as "scalp sensitivity"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Mild fever 100 F"; PERIPHERAL SWELLING (non-serious) with onset 28Nov2021, outcome "unknown", described as "she started with swelling in the clavicular lymph nodes then it progressed under her arm and to the clavicular area"; LETHARGY (non-serious) with onset 03Dec2021, outcome "unknown", described as "lethargy 6 days later". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter states her daughter feels like she has puffy lips but her lips don't look puffy. she started with swelling in the clavicular lymph nodes then it progressed under her arm and to the clavicular area; it is very sensitive. She understands that this side effect can happen and is par the course but what she is concerned about is the headache. She has had the headache since getting the vaccine and it is getting worse. This she does not think is normal; she would think that her daughter would get a side effects and then it would get better, not worse  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Bedridden, Fatigue, Headache, Off label use, Pain
Clinical narrative: severe hives; Headache; fatigue; Aches all over body; Was bedridden for 6 days; off label use; Product use for unapproved combination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 13:00 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 12Nov2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious) with onset 12Nov2021, outcome "unknown", described as "off label use"; PRODUCT USE ISSUE (non-serious) with onset 12Nov2021, outcome "unknown", described as "Product use for unapproved combination"; URTICARIA (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "severe hives"; HEADACHE (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "fatigue"; PAIN (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "Aches all over body"; BEDRIDDEN (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "Was bedridden for 6 days". The events "severe hives", "headache", "fatigue", "aches all over body" and "was bedridden for 6 days" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, headache, fatigue, pain, bedridden. Additional information: The events were not serious.They did not meet any seriousness criteria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reported event took place 2 days after injection withheld the patient developed severe hives. Headache and fatigue. Aches all over body. Dr prescribed prednisone and an antihistimine which she took for one week. The patient was bedridden for 6 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. There were no known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Product use issue, Urticaria
Clinical narrative: severe hives; Headache; fatigue; Aches all over body; Was bedridden for 6 days; off label use; Product use for unapproved combination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 13:00 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 12Nov2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious) with onset 12Nov2021, outcome "unknown", described as "off label use"; PRODUCT USE ISSUE (non-serious) with onset 12Nov2021, outcome "unknown", described as "Product use for unapproved combination"; URTICARIA (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "severe hives"; HEADACHE (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "fatigue"; PAIN (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "Aches all over body"; BEDRIDDEN (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "Was bedridden for 6 days". The events "severe hives", "headache", "fatigue", "aches all over body" and "was bedridden for 6 days" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, headache, fatigue, pain, bedridden. Additional information: The events were not serious.They did not meet any seriousness criteria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reported event took place 2 days after injection withheld the patient developed severe hives. Headache and fatigue. Aches all over body. Dr prescribed prednisone and an antihistimine which she took for one week. The patient was bedridden for 6 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. There were no known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Immunisation, Menstruation irregular
Clinical narrative: Dose number=3; I was not due for my period and it came heavy that same evening; I was not due for my period and it came heavy that same evening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:15 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: 23Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "Dose number=3"; MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 02Dec2021, outcome "unknown" and all described as "I was not due for my period and it came heavy that same evening". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding.  Additional Information: There was no other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. There were no known allergies to the patient. There were no other relevant history. The reporter assessed the seriousness of the case to be non-serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever; headache; arm soreness; Dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Dec2021 14:00 (Lot number: FF8839) at the age of 46 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Prev dose Lot number: EN6023,, dose number: 2, Prev dose vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (Prev dose Lot number:EL3247, Prev dose dose number: 1, Prev dose vaccine location: Left arm), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 14:00, outcome "unknown", described as "Dose 3"; PYREXIA (non-serious) with onset 02Dec2021 21:00, outcome "recovered" (Dec2021), described as "Low grade fever"; HEADACHE (non-serious) with onset 02Dec2021 21:00, outcome "recovered" (Dec2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 02Dec2021 21:00, outcome "recovered" (Dec2021), described as "arm soreness". Therapeutic measures were taken as a result of pyrexia, headache, pain in extremity.  Additional information: Patient had no receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Ibuprofen treatment for the adverse event. Patient had no diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. Awareness Date was 02Dec2021.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Pain, Pyrexia
Clinical narrative: Aches; Chills; Fever; Headache; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Dec2021 10:00 (Lot number: FF8839) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT, administration date 21Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Mar2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Mar2021, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 10:00, outcome "unknown", described as "Dose number=3"; PAIN (non-serious) with onset 02Dec2021 20:00, outcome "recovered" (03Dec2021), described as "Aches"; CHILLS (non-serious) with onset 02Dec2021 20:00, outcome "recovered" (03Dec2021), described as "Chills"; PYREXIA (non-serious) with onset 02Dec2021 20:00, outcome "recovered" (03Dec2021), described as "Fever"; HEADACHE (non-serious) with onset 02Dec2021 20:00, outcome "recovered" (03Dec2021), described as "Headache". Therapeutic measures were taken as a result of pain, chills, pyrexia, headache.  Additional information: The patient reported aches, chills, fever, headache that lasted all through the night and into the morning until about noon. The patient was treated with Aleve 220 mg / two tabs taken three times. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had received other vaccine in 4 weeks. Patient had no known allergies. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Sluggishness
Clinical narrative: Booster; Sluggish; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; SLUGGISHNESS (non-serious), outcome "unknown", described as "Sluggish"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: 48 hours - lymph node swelling; 48 hours - lymph node swelling and pain in armpit area (left side) same side as injection site. Currently swelling still present and slight pain; chills; fatigue; booster; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 10:00 (Lot number: 33030BD) at the age of 56 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included ATORVASTATIN; VITAMIN D 2000. Vaccination history included Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 27Feb2021, when the patient was 56 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 21Mar2021, when the patient was 56 years old, for COVID-19 immunization, reaction(s) chills; Bnt162b2 (2nd dose), when the patient was 56 years old, for COVID-19 immunization, reaction(s) fatigue. The following information was reported IMMUNISATION (non-serious) with onset 30Nov2021 10:00, outcome unknown; LYMPHADENOPATHY (non-serious) with onset 02Dec2021 09:00, outcome recovering; LYMPH NODE PAIN (non-serious) with onset 02Dec2021 09:00, outcome recovering. Currently swelling still present and slight pain; CHILLS (non-serious) with onset 02Dec2021 09:00, outcome recovering; FATIGUE (non-serious) with onset 02Dec2021 09:00, outcome recovering. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, chills, fatigue.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was neither diagnosed with COVID-19 Prior to vaccination nor been tested for COVID-19 since the vaccination. 48 hours - lymph node swelling and pain in armpit area (left side) same side as injection site. Currently, swelling still present and slight pain. The lymph node adverse event was new, after her 2nd dose & 3rd dose, the patient had chills, and fatigue that lasted less than 24 hours.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Swollen lymph node; Aching body; Sore arm; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Dec2021 16:30 (Lot number: FJ8762) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa medication" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 12Apr2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 16:30, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious) with onset 03Dec2021, outcome "recovering", described as "Swollen lymph node"; PAIN (non-serious) with onset 03Dec2021, outcome "recovering", described as "Aching body"; PAIN IN EXTREMITY (non-serious) with onset 03Dec2021, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of lymphadenopathy, pain, pain in extremity.  Additional information: Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Immunisation, Nausea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 10Nov2021 (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 (Dose Number: 2, Batch/Lot No: Unknown. ), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. ), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Fever"; NAUSEA (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Nausea"; HEADACHE (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Headache"; CHILLS (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Chills"; ARTHRALGIA (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Ache in joints"; PYREXIA (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Spine fever". The events "fever", "nausea", "headache", "chills", "ache in joints" and "spine fever" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pyrexia, nausea, headache, chills, arthralgia, pyrexia.  Additional information included: It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 10Nov2021 (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 (Dose Number: 2, Batch/Lot No: Unknown. ), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. ), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Fever"; NAUSEA (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Nausea"; HEADACHE (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Headache"; CHILLS (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Chills"; ARTHRALGIA (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Ache in joints"; PYREXIA (non-serious) with onset 11Nov2021, outcome "recovered" (13Nov2021), described as "Spine fever". The events "fever", "nausea", "headache", "chills", "ache in joints" and "spine fever" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pyrexia, nausea, headache, chills, arthralgia, pyrexia.  Additional information included: It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Injection site pain, Malaise, Nasal congestion
Clinical narrative: Two days later I woke up with my lungs very sore, having a hard time breathing, nose was stuffy, I felt dizzy - thought it was just a delayed reaction but when it didn't go away after a few days and it worsened - I went to the urgent care clinic to get antibiotics - they didn't work.  They then gave me albuteral and advair - it didn't work - they then gave me steroids.  It took me about three months to get better and my left arm would have sudden pain in the injection site for about 6 months after, now that side of my arm/neck can hurt a little from time to time. When I went to the Urgency clinic the second time my blood pressure was elevate at 130.  The last time I went (last month) it was 140!  I suddenly developed hypertension stage 2. I know I am in the age where such things can happen, but I have 4 older siblings that are a decade or more my senior and none of them developed this - I am the only one to get the J&J shot.  I had NO reaction with the later moderna booster.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Pulmonary pain, Respiratory tract infection
Clinical narrative: Two days later I woke up with my lungs very sore, having a hard time breathing, nose was stuffy, I felt dizzy - thought it was just a delayed reaction but when it didn't go away after a few days and it worsened - I went to the urgent care clinic to get antibiotics - they didn't work.  They then gave me albuteral and advair - it didn't work - they then gave me steroids.  It took me about three months to get better and my left arm would have sudden pain in the injection site for about 6 months after, now that side of my arm/neck can hurt a little from time to time. When I went to the Urgency clinic the second time my blood pressure was elevate at 130.  The last time I went (last month) it was 140!  I suddenly developed hypertension stage 2. I know I am in the age where such things can happen, but I have 4 older siblings that are a decade or more my senior and none of them developed this - I am the only one to get the J&J shot.  I had NO reaction with the later moderna booster.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: headache,fever of 100.7,rapid pulse, pounding heart, feeling unwell, chills, join pain, arm pain,tiredness, muscle pain,dizziness weekness,shaking.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Malaise, Myalgia, Pain in extremity
Clinical narrative: headache,fever of 100.7,rapid pulse, pounding heart, feeling unwell, chills, join pain, arm pain,tiredness, muscle pain,dizziness weekness,shaking.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Tremor
Clinical narrative: headache,fever of 100.7,rapid pulse, pounding heart, feeling unwell, chills, join pain, arm pain,tiredness, muscle pain,dizziness weekness,shaking.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 2 weeks after my booster I started experiencing a rash, that was very itchy and would swell up in welts.  it would come on quickly and be mainly on my core, chest, back stomach hip area.  It would go away quickly when i used benadryl cream.  I have been able to control with a childs benadryl every 36 hours.  and now after 6 weeks it is not as frequent but I do have flare ups that  I can stop with the cream. I did experience headache, body aches, chills, fever and fatigue with my 2nd Moderna dose and my booster dose.  After the first dose i did get a small red rash around the injection site after a week that went away in a day or 2
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: 2 weeks after my booster I started experiencing a rash, that was very itchy and would swell up in welts.  it would come on quickly and be mainly on my core, chest, back stomach hip area.  It would go away quickly when i used benadryl cream.  I have been able to control with a childs benadryl every 36 hours.  and now after 6 weeks it is not as frequent but I do have flare ups that  I can stop with the cream. I did experience headache, body aches, chills, fever and fatigue with my 2nd Moderna dose and my booster dose.  After the first dose i did get a small red rash around the injection site after a week that went away in a day or 2
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: Rash on left arm and legs; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Nov2021 (Lot number: X) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORATADINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: X, Location of injection: Arm Left), administration date: Feb2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "Skin allergy to previous covid vaccines"; Bnt162b2 (Dose Number: 2, Batch/Lot No: X, Location of injection: Arm Left), administration date: Mar2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "Skin allergy to previous covid vaccines". The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Dose number 3"; RASH (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Rash on left arm and legs". Therapeutic measures were taken as a result of rash.  Additional information: Patient received Steroid cream as treatment for event rash. Vaccination facility type was pharmacy/drug store. Patient received Loratadine and Steroid cream within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.