chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Lymphadenopathy, Myalgia
Clinical narrative: sever fatigue; swollen lymph nodes in left arm pit and behind right ear; Myalgia; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 11:30 (Lot number: FH8027) at the age of 33 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: 1, Batch/Lot No: EW0150, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 32 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 32 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 11:30, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 08Dec2021 06:30, outcome "recovered" (Dec2021), described as "sever fatigue"; LYMPHADENOPATHY (non-serious) with onset 08Dec2021 06:30, outcome "recovered" (Dec2021), described as "swollen lymph nodes in left arm pit and behind right ear"; MYALGIA (non-serious) with onset 08Dec2021 06:30, outcome "recovered" (Dec2021), described as "Myalgia". Therapeutic measures were not taken as a result of fatigue, lymphadenopathy, myalgia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior and post to vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Arm is sore; I got the booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (009679). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 82 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 (Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "I got the booster shot"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is sore".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Illness, Immunisation, Lethargy
Clinical narrative: Feeling sick on stomach; Sick all night, sick as a dog; Couldn''t breathe hardly; Throwing up; Miserable; she's just sitting in one spot, that's it, not moving around much; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 12Dec2021 13:30 (Batch/Lot number: unknown) at the age of 82 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:2), administration date: 03Feb2021, when the patient was 81 years old, for COVID-19 immunization; Bnt162b2 (Dose:1), administration date: Jan2021, when the patient was 81 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021 13:30, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 13Dec2021 02:30, outcome "unknown", described as "Feeling sick on stomach"; ILLNESS (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Sick all night, sick as a dog"; DYSPNOEA (non-serious) with onset 13Dec2021, outcome "unknown", described as "Couldn''t breathe hardly"; VOMITING (non-serious) with onset 13Dec2021, outcome "unknown", described as "Throwing up"; FEELING ABNORMAL (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Miserable"; LETHARGY (non-serious) with onset 13Dec2021, outcome "unknown", described as "she's just sitting in one spot, that's it, not moving around much". Therapeutic measures were not taken as a result of nausea, illness, dyspnoea, vomiting, feeling abnormal, lethargy.  Addition information. The reporter considered events as non serious.The patient explained she did not know if her age had anything to do with these events. Causality of all events reported as yes; because she was feeling fine until she got the third dose. She wished she never took the third dose. Patient verified that there has been no testing, treatment or medical interventions performed relative to these events.list all vaccines administered on same date with the Pfizer vaccine considered as suspect was None. The patient not visited emergency room or physician office. The patient did not receive any other vaccines within four weeks prior to the vaccination. Family medical history was none reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Feeling sick on stomach; Sick all night, sick as a dog; Couldn''t breathe hardly; Throwing up; Miserable; she's just sitting in one spot, that's it, not moving around much; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 12Dec2021 13:30 (Batch/Lot number: unknown) at the age of 82 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:2), administration date: 03Feb2021, when the patient was 81 years old, for COVID-19 immunization; Bnt162b2 (Dose:1), administration date: Jan2021, when the patient was 81 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021 13:30, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 13Dec2021 02:30, outcome "unknown", described as "Feeling sick on stomach"; ILLNESS (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Sick all night, sick as a dog"; DYSPNOEA (non-serious) with onset 13Dec2021, outcome "unknown", described as "Couldn''t breathe hardly"; VOMITING (non-serious) with onset 13Dec2021, outcome "unknown", described as "Throwing up"; FEELING ABNORMAL (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Miserable"; LETHARGY (non-serious) with onset 13Dec2021, outcome "unknown", described as "she's just sitting in one spot, that's it, not moving around much". Therapeutic measures were not taken as a result of nausea, illness, dyspnoea, vomiting, feeling abnormal, lethargy.  Addition information. The reporter considered events as non serious.The patient explained she did not know if her age had anything to do with these events. Causality of all events reported as yes; because she was feeling fine until she got the third dose. She wished she never took the third dose. Patient verified that there has been no testing, treatment or medical interventions performed relative to these events.list all vaccines administered on same date with the Pfizer vaccine considered as suspect was None. The patient not visited emergency room or physician office. The patient did not receive any other vaccines within four weeks prior to the vaccination. Family medical history was none reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: had Pfizer covid vaccine (purple cap) thawed and undiluted in the refrigerator. "31 days in the refrigerator was yesterday. I inadvertently administered it today on day 32; booster dose; had Pfizer covid vaccine (purple cap) thawed and undiluted in the refrigerator. "31 days in the refrigerator was yesterday. I inadvertently administered it today on day 32; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 22 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 22 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 (Manufacturer Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "booster dose"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 14Dec2021, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "had Pfizer covid vaccine (purple cap) thawed and undiluted in the refrigerator. "31 days in the refrigerator was yesterday. I inadvertently administered it today on day 32". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101780965 same reporter/product/event, diff patients
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy, Computerised tomogram, Fatigue, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: booster; Resting Heart Rate elevated; headaches; fatigue; exhaustion; elevated D-Dimer level; Ultrasound of my legs to look for clotting; my spleen had enlarged to 20cm; Other vaccine same date vaccine date 11Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Nov2021 11:00 (Lot number: EW0186) at the age of 38 years as dose 3, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose administration date=23Apr2021, Batch/Lot No: EW0164, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 23Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose administration date=02Apr2021,, Batch/Lot No: EW0150, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Resting Heart Rate elevated"; HEADACHE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "headaches"; FATIGUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "fatigue"; FATIGUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "exhaustion"; FIBRIN D DIMER INCREASED (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "elevated D-Dimer level"; COAGULOPATHY (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Ultrasound of my legs to look for clotting"; SPLENOMEGALY (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "my spleen had enlarged to 20cm"; PRODUCT USE ISSUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Other vaccine same date vaccine date 11Nov2021"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". The events "resting heart rate elevated", "headaches", "fatigue", "exhaustion", "elevated d-dimer level", "ultrasound of my legs to look for clotting" and "my spleen had enlarged to 20cm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate increased, fatigue, fibrin d dimer increased, product use issue. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Immunisation, Product use issue
Clinical narrative: booster; Resting Heart Rate elevated; headaches; fatigue; exhaustion; elevated D-Dimer level; Ultrasound of my legs to look for clotting; my spleen had enlarged to 20cm; Other vaccine same date vaccine date 11Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Nov2021 11:00 (Lot number: EW0186) at the age of 38 years as dose 3, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose administration date=23Apr2021, Batch/Lot No: EW0164, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 23Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose administration date=02Apr2021,, Batch/Lot No: EW0150, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Resting Heart Rate elevated"; HEADACHE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "headaches"; FATIGUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "fatigue"; FATIGUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "exhaustion"; FIBRIN D DIMER INCREASED (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "elevated D-Dimer level"; COAGULOPATHY (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Ultrasound of my legs to look for clotting"; SPLENOMEGALY (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "my spleen had enlarged to 20cm"; PRODUCT USE ISSUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Other vaccine same date vaccine date 11Nov2021"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". The events "resting heart rate elevated", "headaches", "fatigue", "exhaustion", "elevated d-dimer level", "ultrasound of my legs to look for clotting" and "my spleen had enlarged to 20cm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate increased, fatigue, fibrin d dimer increased, product use issue. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Spleen disorder, Splenomegaly, Ultrasound scan
Clinical narrative: booster; Resting Heart Rate elevated; headaches; fatigue; exhaustion; elevated D-Dimer level; Ultrasound of my legs to look for clotting; my spleen had enlarged to 20cm; Other vaccine same date vaccine date 11Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Nov2021 11:00 (Lot number: EW0186) at the age of 38 years as dose 3, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose administration date=23Apr2021, Batch/Lot No: EW0164, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 23Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose administration date=02Apr2021,, Batch/Lot No: EW0150, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Resting Heart Rate elevated"; HEADACHE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "headaches"; FATIGUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "fatigue"; FATIGUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "exhaustion"; FIBRIN D DIMER INCREASED (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "elevated D-Dimer level"; COAGULOPATHY (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Ultrasound of my legs to look for clotting"; SPLENOMEGALY (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "my spleen had enlarged to 20cm"; PRODUCT USE ISSUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Other vaccine same date vaccine date 11Nov2021"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". The events "resting heart rate elevated", "headaches", "fatigue", "exhaustion", "elevated d-dimer level", "ultrasound of my legs to look for clotting" and "my spleen had enlarged to 20cm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate increased, fatigue, fibrin d dimer increased, product use issue. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immunisation, Pain in extremity, Paraesthesia
Clinical narrative: booster; Pain in injection arm (from shoulder down); numbness and tingling in hand; numbness and tingling in hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 13:15 (Lot number: 330308P) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Prior IBS diagnoses" (unspecified if ongoing); "sinus" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Allergies: oranges, Tomatoes" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ECHINACEA PURPUREA; TYLENOL SINUS [CHLORPHENAMINE MALEATE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]; ADIPEX [FENOFIBRATE]; BIOTIN. Past drug history included: Erythromycin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er2613, Location of injection: Arm Left), administration date: 26Mar2021, when the patient was 49 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6206, Location of injection: Arm Left), administration date: 05Mar2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 02:00, outcome "not recovered", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 08Dec2021 02:00, outcome "not recovered", described as "Pain in injection arm (from shoulder down)"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 08Dec2021 02:00, outcome "not recovered" and all described as "numbness and tingling in hand". Therapeutic measures were not taken as a result of immunisation, pain in extremity, hypoaesthesia, paraesthesia. Additional information: Adverse event: Pain in injection arm (from shoulder down) with numbness and tingling in hand. Since receiving booster 7 days ago. No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: who received the booster dose of the Pfizer covid vaccine on "09Sep2021 around 5:00pm, within the 24 hours after receiving the vaccine, I started to intense pain under my left arm; who received the booster dose of the Pfizer covid vaccine on "09Sep2021 around 5:00pm, within the 24 hours after receiving the vaccine, I started to intense pain under my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 17:00 (Lot number: 33030BD) 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 1, Single), for COVID-19 Immunization; Bnt162b2 (DOSE 2, Single), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 17:00, outcome "unknown", PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "not recovered" and all described as "who received the booster dose of the Pfizer covid vaccine on "09Sep2021 around 5:00pm, within the 24 hours after receiving the vaccine, I started to intense pain under my left arm".  Additional information: The patient was a 32-year-old patient who received the booster dose of the Pfizer covid vaccine on 09Dec2021 (discrepant information: also reported as 09Sep2021) around 17:00, within the 24 hours after receiving the vaccine, he started to intense pain under his left arm, the same he received the shot. It has mostly resolved, the intensity was not as bad, but he still feel it.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Computerised tomogram, Dehydration, Dizziness
Clinical narrative: booster; dizziness; dehydrated; couldnt speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 14:00 (Lot number: FF2590) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pancreatis", start date: 2015 (ongoing), notes: No symptoms doing good; "Skin Cancer" (ongoing), notes: Onset date: At least 30 years, Doing good; "BP" (ongoing), notes: Onset date: Last 20 years, Normal losartan; "Cholesterol" (ongoing), notes: Onset date: 20 years, Normal, Pravastatin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 06Jan2021, Time (24 hrs): 2 PM, Site and Route of Injection: Right Arm, Batch/Lot Number: EK4176, DOSE 1, SINGLE), administration date: 06Jan2021, when the patient was 63 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 2nd, Date: 21Jan2021, Time (24 hrs): 1-2 PM, Site and Route of Injection: Right Arm, Batch/Lot Number: 8N5318, DOSE 2, SINGLE), administration date: 21Jan2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Oct2021 14:00, outcome "unknown", described as "booster"; DIZZINESS (non-serious) with onset 07Oct2021, outcome "recovering", described as "dizziness"; DEHYDRATION (non-serious) with onset 07Oct2021, outcome "recovering", described as "dehydrated"; SPEECH DISORDER (non-serious) with onset 07Oct2021, outcome "recovering", described as "couldnt speak". The event "dizziness" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No prior Vaccination. On 28Jan2021, the lab tests CT, Blood and BP were normal. It was reported that vaccine in middle of day but work requires. That night dizzy, dehydrated and couldn't speak. Sent home 3 hours later, doing good. Test Normal. Dehydrated, better.   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Investigation, Speech disorder
Clinical narrative: booster; dizziness; dehydrated; couldnt speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 14:00 (Lot number: FF2590) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pancreatis", start date: 2015 (ongoing), notes: No symptoms doing good; "Skin Cancer" (ongoing), notes: Onset date: At least 30 years, Doing good; "BP" (ongoing), notes: Onset date: Last 20 years, Normal losartan; "Cholesterol" (ongoing), notes: Onset date: 20 years, Normal, Pravastatin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 06Jan2021, Time (24 hrs): 2 PM, Site and Route of Injection: Right Arm, Batch/Lot Number: EK4176, DOSE 1, SINGLE), administration date: 06Jan2021, when the patient was 63 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 2nd, Date: 21Jan2021, Time (24 hrs): 1-2 PM, Site and Route of Injection: Right Arm, Batch/Lot Number: 8N5318, DOSE 2, SINGLE), administration date: 21Jan2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Oct2021 14:00, outcome "unknown", described as "booster"; DIZZINESS (non-serious) with onset 07Oct2021, outcome "recovering", described as "dizziness"; DEHYDRATION (non-serious) with onset 07Oct2021, outcome "recovering", described as "dehydrated"; SPEECH DISORDER (non-serious) with onset 07Oct2021, outcome "recovering", described as "couldnt speak". The event "dizziness" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No prior Vaccination. On 28Jan2021, the lab tests CT, Blood and BP were normal. It was reported that vaccine in middle of day but work requires. That night dizzy, dehydrated and couldn't speak. Sent home 3 hours later, doing good. Test Normal. Dehydrated, better.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Inflammation, Pain
Clinical narrative: Inflammation on my right side; Pain; Booster; Shingles; This is a spontaneous report received from contactable reporter(s) (Pharmacist), other case identifier(s) AE-72143_CASE-01230498.  A 63 year-old patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 2021 (Batch/Lot number: unknown) as dose 1, single, and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included Coeliac disease (unspecified if ongoing); arthritis (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Zostavax, administration date: 2012; Shingrix (Two doses of shingrix, Dose 01), administration date: 2017; Shingrix (Two doses of shingrix, Dose 02), administration date: 2017. The following information was reported HERPES ZOSTER (non-serious) with onset 2021, outcome unknown; INFLAMMATION (non-serious), outcome unknown; PAIN (non-serious) with onset 2021, outcome unknown; IMMUNISATION (non-serious) with onset 2021, outcome unknown.  Patient appointment with a rheumatologist to identify arthritis type is in Dec 21, Apr2021, and Nov2021. Patient have had 2 diagnoses of shingles in Apr2021 and Nov2021. Patient was a dispensing pharmacist and immunizer. Would revaccination with Shingrix be recommended for patient based on the medical/ clinical data available.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pyrexia
Clinical narrative: experienced general soreness; Has a fever; Booster; 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), administration date 2021 (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: Covid-19 vaccine (Manufacturer Unknown, Dose 01), for COVID-19 Immunization; Bnt162b2 (Dose 02), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "experienced general soreness"; PYREXIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Has a fever".  Additional information: Product clarified to the Pfizer COVID vaccine, booster dose. Patient stated that she didn't have time for an experience report regarding her side effects, but she should just follow up with her primary care provider, is that right and How long did the report take. Unfortunately, she had a work call coming up and she was unable to complete. Reported side effects after their booster shot. She said she experienced general soreness & fever after the dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Vaccination site pain, Vaccination site swelling
Clinical narrative: Booster vaccine; A swelling and tenderness in the vaccination area; A swelling and tenderness in the vaccination area; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (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 (Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "Booster vaccine"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 14Dec2021, outcome "unknown" and all described as "A swelling and tenderness in the vaccination area"; FATIGUE (non-serious) with onset 14Dec2021, outcome "unknown", described as "Tiredness".  Additional information: She had her booster vaccine today and was experiencing some adverse reaction. The vaccination itself was painless.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Immunisation, Pain in extremity
Clinical narrative: Arm sore; Arm redness; Fatigue; Joints hurt; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (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 NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 10Dec2021, outcome "unknown", described as "Fatigue"; ARTHRALGIA (non-serious) with onset 10Dec2021, outcome "unknown", described as "Joints hurt"; PAIN IN EXTREMITY (non-serious) with onset 13Dec2021, outcome "unknown", described as "Arm sore"; ERYTHEMA (non-serious) with onset 13Dec2021, outcome "unknown", described as "Arm redness". The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The reporter got booster on Thursday, 09Dec2021. On Friday the patient had fatigue and her joints hurt. She was unsure of the exact date. The patient's arm was sore and it hurt to lift her arm and it was red. Patient's medical history was unknown. Family Medical History Relevant to AE was not provided. History of all previous immunization with the Pfizer vaccine considered as suspect was unknown. Additional Vaccines Administered on Same Date of the Pfizer Suspect was unknown. Prior Vaccinations (within 4 weeks) was unknown. Investigation Assessment was unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Full blood count, Immunisation, Therapeutic response unexpected, Tumour marker decreased
Clinical narrative: booster; She has metastatic breast cancer,  each time she takes the shot her tumor markers goes to normal; She has metastatic breast cancer,  each time she takes the shot her tumor markers goes to normal; 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 received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "metastatic breast cancer" (unspecified if ongoing), notes: She has metastatic breast cancer. Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (1st dose LOT#, looks like EN6207), administration date: 13Mar2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "tumor markers goes to normal", "tumor markers goes to normal"; Bnt162b2 (Dose 2), administration date: 2021, for Covid-19 immunization, reaction(s): "tumor markers goes to normal", "tumor markers goes to normal". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; TUMOUR MARKER DECREASED (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious) all with onset 2021, outcome "unknown" and all described as "She has metastatic breast cancer,  each time she takes the shot her tumor markers goes to normal". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tumour marker decreased, therapeutic response unexpected.  Additional Information: Directly after what was in a week, just few week after and then the next month it went back up, my numbers went up but the vaccine obviously is having some kind of effect on  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Tumour marker test
Clinical narrative: booster; She has metastatic breast cancer,  each time she takes the shot her tumor markers goes to normal; She has metastatic breast cancer,  each time she takes the shot her tumor markers goes to normal; 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 received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "metastatic breast cancer" (unspecified if ongoing), notes: She has metastatic breast cancer. Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (1st dose LOT#, looks like EN6207), administration date: 13Mar2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "tumor markers goes to normal", "tumor markers goes to normal"; Bnt162b2 (Dose 2), administration date: 2021, for Covid-19 immunization, reaction(s): "tumor markers goes to normal", "tumor markers goes to normal". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; TUMOUR MARKER DECREASED (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious) all with onset 2021, outcome "unknown" and all described as "She has metastatic breast cancer,  each time she takes the shot her tumor markers goes to normal". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tumour marker decreased, therapeutic response unexpected.  Additional Information: Directly after what was in a week, just few week after and then the next month it went back up, my numbers went up but the vaccine obviously is having some kind of effect on  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Immunisation, Pyrexia
Clinical narrative: booster; "messed up" stomach; she experienced a fever; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (060820).  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 33 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "triple negative breast cancer" (ongoing); "intravenous chemotherapy" (unspecified if ongoing), notes: intravenous chemotherapy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; ABDOMINAL DISCOMFORT (non-serious), outcome "not recovered", described as ""messed up" stomach"; PYREXIA (non-serious), outcome "recovered", described as "she experienced a fever". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Vaccination site pain
Clinical narrative: Body aches; injection site soreness; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Dec2021 17:00 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 14Dec2021 07:00, outcome "not recovered", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 14Dec2021 07:00, outcome "not recovered", described as "injection site soreness". Therapeutic measures were not taken as a result of pain, vaccination site pain.  Additional information: Serious: No. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Other medications the patient received within 2 weeks of vaccination: Nikki birth control. Prior to vaccination, the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Known allergies: N/a.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation
Clinical narrative: talking out of his head; Got the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 84 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Dec2021 10:30 (Lot number: FJ1620) at the age of 84 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "pacemaker" (ongoing), notes: He had medical conditions. He had the pacemaker for several years, maybe 2 to 3 years. There were no concomitant medications. Past drug history included: Timolol maleate, start date: 2021, stop date: 17Nov2021, notes: He took some eye drops and they took him off of those on 17Nov2021. The eye drops were Timolol Maleate. Caller had to put on her glasses to provide product information because it is tiny print on the bottle. Expiration: Nov2022. Lot: O8OL066. Strength: 0.5%. He was using it once a day. She doesn't know why Dr. withheld gave him the eye drops. He used them for maybe two months. Vaccination history included: Bnt162b2 (First dose, Lot number: EL9262, Expiry: May2021, He didn't have anything with the first dose of COVID19 vaccine), administration date: 21Jan2021, when the patient was 83 years old, for COVID-19 Immunization, reaction(s): "He didn't have anything with the first dose of COVID19 vaccine"; Bnt162b2 (Second dose, Lot number:EL9266, Expiry: May2021), administration date: 10Feb2021, when the patient was 83 years old, for COVID-19 Immunization, reaction(s): "fever". The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 10:30, outcome "unknown", described as "Got the booster"; FEELING ABNORMAL (non-serious) with onset 13Dec2021 22:30, outcome "recovering", described as "talking out of his head".   Additional information included The patient got the booster yesterday. Yesterday he was talking out of his head. He had not done anything different besides getting the shot yesterday. The booster was for COVID19. No prior vaccinations (within 4 weeks) and relevant tests. The patients had family medical history relevant to AE included his grandmother had some problems a long time ago, but caller doesn't know much about that because his grandmother died before caller was involved with the family. Product Complaint included caller reporting adverse event with the COVID Vaccine for her husband.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Platelet count decreased, Ultrasound abdomen
Clinical narrative: After dose two, platelet count was much lower than normal on routine lab draw.  I suspected vaccine may be contributing factor.; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101820680 (Pfizer).  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 10:00 (Lot number: FF2593) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; EXCEDRIN PM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 27Mar2021, when the patient was 60 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 17Apr2021,when the patient was 60 years old, for Covid-19 immunization, reaction(s): "much lower than normal".The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021 10:00, outcome "unknown", described as "booster"; PLATELET COUNT DECREASED (non-serious) with onset 10Dec2021 11:00, outcome "not recovered", described as "After dose two, platelet count was much lower than normal on routine lab draw.  I suspected vaccine may be contributing factor.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of platelet count decreased.  No follow-up attempts are possible. No further information is expected.