chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Lymphadenopathy
Clinical narrative: swelling in arm pit/Swollen lymph nodes; noticed irritation and soreness under his arm which he thought it was like the vaccine was radiating under his arm; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Lot number: FH8030) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (first dose , LOT: EL0142, first dose injected in his arm), administration date: 08Jan2021, when the patient was 41 years old, for COVID-19 immunization; Bnt162b2 (second dose , LOT: EL9265), administration date: 28Jan2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 30Dec2021, outcome "not recovered", described as "swelling in arm pit/Swollen lymph nodes"; AXILLARY PAIN (non-serious) with onset 30Dec2021, outcome "unknown", described as "noticed irritation and soreness under his arm which he thought it was like the vaccine was radiating under his arm". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient reported this morning he woke up and showered and noticed pretty significant swelling under his arm pit. He says he had done no treatment other than stretching his arm, it was swollen lymph nodes.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Chills, Headache, Immunisation
Clinical narrative: Booster dose; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Headache; mild chills; Pain and small hematoma in the injection site; Pain and small hematoma in the injection site; Pain when raising arm above shoulder; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer:Unknown), for COVID-19 immunization; Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer:Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; PARAESTHESIA (non-serious), PAIN (non-serious), ABDOMINAL PAIN (non-serious), CHEST PAIN (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Booster dose -Tingling pain all over the body including the abdominal and sternal area."; HEADACHE (non-serious) with onset Dec2021, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "mild chills"; VACCINATION SITE PAIN (non-serious), INJECTION SITE HAEMATOMA (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Pain and small hematoma in the injection site"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "not recovered", described as "Pain when raising arm above shoulder". Therapeutic measures were not taken as a result of paraesthesia, pain, abdominal pain, chest pain, headache, chills, vaccination site pain, injection site haematoma, pain in extremity.  Additional details: Adverse event experienced reported as Booster dose -Tingling pain all over the body including the abdominal and sternal area. Headache and mild chills. Pain and small hematoma in the injection site. Pain when raising arm above shoulder. No covid prior vaccination. Covid not tested post vaccination. Known allergies reported as NKA. Other medical history reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haematoma, Pain, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: Booster dose; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Headache; mild chills; Pain and small hematoma in the injection site; Pain and small hematoma in the injection site; Pain when raising arm above shoulder; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer:Unknown), for COVID-19 immunization; Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer:Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; PARAESTHESIA (non-serious), PAIN (non-serious), ABDOMINAL PAIN (non-serious), CHEST PAIN (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Booster dose -Tingling pain all over the body including the abdominal and sternal area."; HEADACHE (non-serious) with onset Dec2021, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "mild chills"; VACCINATION SITE PAIN (non-serious), INJECTION SITE HAEMATOMA (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Pain and small hematoma in the injection site"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "not recovered", described as "Pain when raising arm above shoulder". Therapeutic measures were not taken as a result of paraesthesia, pain, abdominal pain, chest pain, headache, chills, vaccination site pain, injection site haematoma, pain in extremity.  Additional details: Adverse event experienced reported as Booster dose -Tingling pain all over the body including the abdominal and sternal area. Headache and mild chills. Pain and small hematoma in the injection site. Pain when raising arm above shoulder. No covid prior vaccination. Covid not tested post vaccination. Known allergies reported as NKA. Other medical history reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Emotional disorder, Immunisation
Clinical narrative: I was disappointed after the booster that my coughing did not stop; I was disappointed after the booster that my coughing did not stop; I was disappointed after the booster that my coughing did not stop; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "dry cough" (unspecified if ongoing), notes: I have had a dry cough for about 18 years that no one has been able to find a cure for. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 1), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), EMOTIONAL DISORDER (non-serious), outcome "unknown" and all described as "I was disappointed after the booster that my coughing did not stop"; COUGH (non-serious), outcome "not recovered".  Additional information: When patient had first Pfizer vaccine for COVID-19 within hours, stopped coughing all together. A few months after the 2nd dose the coughing slowly started returning. The patient was disappointed after the booster that coughing did not stop.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Hypoaesthesia, Swelling
Clinical narrative: Swelling; numbness; lump under left  arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 03:45 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot number unknown, administration time=03:15 AM, vaccine location=Left arm), administration date: Sep2021, for Covid-19 immunization. The following information was reported: SWELLING (non-serious) with onset Nov2021, outcome "not recovered", described as "Swelling"; HYPOAESTHESIA (non-serious) with onset Nov2021, outcome "not recovered", described as "numbness"; AXILLARY MASS (non-serious) with onset Nov2021, outcome "not recovered", described as "lump under left  arm". Therapeutic measures were not taken as a result of swelling, hypoaesthesia, axillary mass. Additional information: This report was received via an agency. The patient received BNT162B2 in hospital and she was not pregnant when vaccination. The patient didn't receive other vaccine in 4 weeks, she had no COVID-19 prior vaccination and didn't test Covid-19 post vaccination. It was reported the events started at Nov2021 03:15 pm. The events didn't result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was taken for the AE.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Vaccination site pain
Clinical narrative: She experienced achy-ness in the injection arm; Booster shot on 30Dec2021; Experienced  immediate pain in the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 30Dec2021 (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: 1, did not experience any side effects with her first two Pfizer Covid vaccine shots.), for COVID-19 immunization, reaction(s): "did not experience any side effects"; Bnt162b2 (Dose: 2, did not experience any side effects with her first two Pfizer Covid vaccine shots.), for COVID-19 immunization, reaction(s): "did not experience any side effects". The following information was reported: Immunisation(non-serious) with onset 30Dec2021, outcome "unknown", described as "Booster shot on 30Dec2021"; Vaccination site pain(non-serious) with onset 30Dec2021, outcome "unknown", described as "Experienced  immediate pain in the injection site"; Pain in extremity (non-serious) with onset 31Dec2021, outcome "unknown", described as "She experienced achy-ness in the injection arm".  Additional information: Event took place after use of product. Experienced immediate pain in the injection site.Patient said that the following day, experienced achy-ness in the injection arm. withheld said that did not experience any side effects with her first two Pfizer Covid vaccine shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Overdose, Pyrexia, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: Having respiratory issues; Fever for 2 days; Booster; received 3cc's of Booster Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 20Sep2021 (Lot number: FC3184) at the age of 40 years as dose 3 (booster), 3 ml single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 2021. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: EL1284, NDC and Expiry Date unknown), administration date: 23Dec2020, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, Lot Number:EL3246), administration date: 12Jan2021, when the patient was 40 years old, for COVID-19 Immunization, reaction(s): "Fever for 12 hours". The following information was reported: IMMUNISATION (non-serious) with onset 20Sep2021, outcome "unknown", described as "Booster"; OVERDOSE (non-serious) with onset 20Sep2021, outcome "unknown", described as "received 3cc's of Booster Vaccine"; PYREXIA (non-serious) with onset 21Sep2021, outcome "recovered" (23Sep2021), described as "Fever for 2 days"; RESPIRATORY DISORDER (non-serious) with onset Dec2021, outcome "not recovered", described as "Having respiratory issues". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative, notes: has tested negative for Covid 19 twice; (2021) negative, notes: has tested negative for Covid 19 twice. Additional information: No additional Vaccines Administered on Same Date of the Pfizer Suspect. Caller states that he had a Flu Vaccine a couple of weeks after the booster dose of the Covid 19 Vaccine  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Pfizer Covid-19 Booster shot; Swollen and tender lymph nodes in left armpit; Swollen and tender lymph nodes in left armpit; Nausea; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: 33130819) 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 manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer Covid-19 Booster shot"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "Swollen and tender lymph nodes in left armpit"; NAUSEA (non-serious), outcome "not recovered", described as "Nausea"; HEADACHE (non-serious), outcome "recovered", described as "Headache".  Follow-up attempts are completed. No further information is expected
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; Fever; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose administrator route=Intramuscular,, prev dose administration date=28May2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 28May2021, for Covid-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose administrator route=Intramuscular,, prev dose administration date=07May2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 07May2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 31Dec2021, outcome "recovering", described as "Fever"; VACCINATION SITE PAIN (non-serious) with onset 31Dec2021 04:00, outcome "recovering", described as "Injection site pain". Therapeutic measures were not taken as a result of pyrexia, vaccination site pain.  Additional information: Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. Patient had no known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation
Clinical narrative: mild Shingles outbreak on right leg 1 month following first 2 vaccines and 2 months following the 3rd vaccine; 3rd vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 (Lot number: FE3592) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "cervical disc disease" (unspecified if ongoing); "chronic Muscle spasm" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Ek5730, Location of injection: Arm Left, Route of Administration: Intramuscular, mild Shingles outbreak on right leg 1 month following first 2 vaccines), administration date: 31Dec2020, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "mild Shingles"; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: El8982, Location of injection: Arm Left, Route of Administration: Intramuscular, mild Shingles outbreak on right leg 1 month following first 2 vaccines), administration date: 21Jan2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "mild Shingles". The following information was reported: IMMUNISATION (non-serious) with onset 03Nov2021, outcome "unknown", described as "3rd vaccine"; HERPES ZOSTER (non-serious) with onset Jan2022, outcome "not recovered", described as "mild Shingles outbreak on right leg 1 month following first 2 vaccines and 2 months following the 3rd vaccine". The event "mild shingles outbreak on right leg 1 month following first 2 vaccines and 2 months following the 3rd vaccine" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of herpes zoster.  Additional information: mild Shingles outbreak on right leg 1 month following first 2 vaccines and 2 months following the 3rd vaccine. There is no history of shingles outbreak in the past until receipt of this vaccine. Ae treatment: Acyclovir, than valacyclovir. Ae resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination and not tested post vaccination. Patient did not have any known allergies.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dysphonia, Headache
Clinical narrative: Woke up running low grade fever; achy; chills; joint aches; headache; sore throat; hoarseness; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jan2022 11:45 (Lot number: FD0810) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Psoriatic arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Chronic bronchitis" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Leg Right, Vaccine Administration Time: 11:15), administration date: 09Apr2021, when the patient was 50 years old, for covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Right, Vaccine Administration Time: 11:45), administration date: 19Mar2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Jan2022 11:45, outcome "unknown", described as "booster dose"; PYREXIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "Woke up running low grade fever"; PAIN (non-serious) with onset 03Jan2022, outcome "not recovered", described as "achy"; CHILLS (non-serious) with onset 03Jan2022, outcome "not recovered", described as "chills"; ARTHRALGIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "joint aches"; HEADACHE (non-serious) with onset 03Jan2022, outcome "not recovered", described as "headache"; OROPHARYNGEAL PAIN (non-serious) with onset 03Jan2022, outcome "not recovered", described as "sore throat"; DYSPHONIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "hoarseness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, arthralgia, headache, oropharyngeal pain, dysphonia. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Woke up running low grade fever; achy; chills; joint aches; headache; sore throat; hoarseness; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jan2022 11:45 (Lot number: FD0810) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Psoriatic arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Chronic bronchitis" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Leg Right, Vaccine Administration Time: 11:15), administration date: 09Apr2021, when the patient was 50 years old, for covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Right, Vaccine Administration Time: 11:45), administration date: 19Mar2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Jan2022 11:45, outcome "unknown", described as "booster dose"; PYREXIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "Woke up running low grade fever"; PAIN (non-serious) with onset 03Jan2022, outcome "not recovered", described as "achy"; CHILLS (non-serious) with onset 03Jan2022, outcome "not recovered", described as "chills"; ARTHRALGIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "joint aches"; HEADACHE (non-serious) with onset 03Jan2022, outcome "not recovered", described as "headache"; OROPHARYNGEAL PAIN (non-serious) with onset 03Jan2022, outcome "not recovered", described as "sore throat"; DYSPHONIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "hoarseness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, arthralgia, headache, oropharyngeal pain, dysphonia. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: booster dose; I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 14:15 (Lot number: FL3198) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROBIOTICS; DIGESTIVE ENZYMES. Vaccination history included: Bnt162b2 (Previous dose details: , Previous dose product=COVID 19, Previous dose brand=Pfizer, Previous dose brand unknown=False, Previous dose lot number=ER8729,, Previous dose lot unknown=False,, Previous dose administration date=02Apr2021, Previous dose number=2, Previous dose vaccine location=Left arm), administration date: 02Apr2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen"; Bnt162b2 (Previous dose product=COVID 19, Previous dose brand=Pfizer, Previous dose brand unknown=False, Previous dose lot number=EN6306,, Previous dose lot unknown=False, Previous dose administration date=12Mar2021, Previous dose number=1, Previous dose vaccine location=Left arm), administration date: 12Mar2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen". The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 14:15, outcome "unknown", described as "booster dose"; LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "recovered with sequelae", described as "I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen.". The event "i have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient went to pharmacy or Drug Store for the Facility type vaccine. The patient did not receive other vaccine in four weeks. After each Covid vaccine the patient developed a large lump in her left armpit the size of a baseball, lymph nodes very swollen. Lump took weeks to go down. Got an MRI of the area in Aug2021, no cancer detected. The patient did not have Covid prior vaccination. The patient tested Covid post vaccination. The patient did Nasal swab for Covid test post vaccination. Covid test result was Negative. No Known allergies. No Other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pollakiuria
Clinical narrative: About 16 hours after receiving 3rd shot I developed frequent urination. I was running to the bathroom every 10 -15 mins to empty a full bladder.; 3rd shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Dec2021 12:30 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. IBS; "IBS" (unspecified if ongoing), notes: Other medical history: Asthma. IBS; "known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN, shellfish, bees, pineapple; "known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: PCN, shellfish, bees, pineapple; "known allergies: bees" (unspecified if ongoing), notes: Known allergies: PCN, shellfish, bees, pineapple; "known allergies: pineapple" (unspecified if ongoing), notes: Known allergies: PCN, shellfish, bees, pineapple. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 15Mar2021, when the patient was 44 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 22Feb2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021 12:30, outcome "unknown", described as "3rd shot"; POLLAKIURIA (non-serious) with onset 02Jan2022 04:00, outcome "recovering", described as "About 16 hours after receiving 3rd shot I developed frequent urination. I was running to the bathroom every 10 -15 mins to empty a full bladder.".  Additional information: Patient did not received other vaccines in 4 weeks. Patient did not have Covid prior vaccination. Patient did not tested Covid post vaccination. It was reported that the event Lasted 6 hours. Still not 100% after almost 3 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Condition aggravated, Cough, Ear infection, Ear inflammation, Ear pain
Clinical narrative: Pt. developed fever and URI symptoms 9 days after the MMR vaccine.  The fever persisted for 4 to 5 days associated with bilateral ear pain, cough and congestion.  He was diagnosed with bilateral ear infections at an urgent care center and prescribed Bactrim for 10 days.  Upon recheck at my office, he continued to have inflammation in the left ear.  The infection flared up again necessitating a second round of antibiotics.  Now there is a perforation in the ear drum.  He is homozygous for an MTHFR mutation associated with decreased liver detoxification ability.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Hepatic function abnormal, Methylenetetrahydrofolate reductase gene mutation, Pyrexia, Respiratory tract congestion, Tympanic membrane perforation
Clinical narrative: Pt. developed fever and URI symptoms 9 days after the MMR vaccine.  The fever persisted for 4 to 5 days associated with bilateral ear pain, cough and congestion.  He was diagnosed with bilateral ear infections at an urgent care center and prescribed Bactrim for 10 days.  Upon recheck at my office, he continued to have inflammation in the left ear.  The infection flared up again necessitating a second round of antibiotics.  Now there is a perforation in the ear drum.  He is homozygous for an MTHFR mutation associated with decreased liver detoxification ability.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Upper respiratory tract infection
Clinical narrative: Pt. developed fever and URI symptoms 9 days after the MMR vaccine.  The fever persisted for 4 to 5 days associated with bilateral ear pain, cough and congestion.  He was diagnosed with bilateral ear infections at an urgent care center and prescribed Bactrim for 10 days.  Upon recheck at my office, he continued to have inflammation in the left ear.  The infection flared up again necessitating a second round of antibiotics.  Now there is a perforation in the ear drum.  He is homozygous for an MTHFR mutation associated with decreased liver detoxification ability.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: Covid Arm Large, red,  warm, itchy rash  Swelling  Pain/sensitive injection site  Hard lump at injection site
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Covid Arm Large, red,  warm, itchy rash  Swelling  Pain/sensitive injection site  Hard lump at injection site
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Lethargy, Photopsia, Somnolence
Clinical narrative: Jan 18th I began to notice Long lasting flashes of light on the left corner of my left eye accompanied by slight blurred vision & lightheaded-ness  Jan 19th I noticed the similar but less frequent type of flashes in the right corner of my right eye when I woke up.  Throughout the day my eyes started to slowly register soreness and that soreness slowly increased in the back of my eyes. Also along with the slight blurred vision and lightheaded-ness.  Jan 20 same symptoms just slightly higher sleepiness throughout the day. I also had a hard time staying awake while idle, sitting while trying to pay attention to being spoken to & reading. Jan 21 same continued symptoms, marginally increased pain & new onset of  floaters as well and extreme lethargy. So much that I was asleep most of the day. I kept falling asleep sitting or trying to focus on anything including eating.  Jan 22 1am- 330  I've been able to stay awake while being occupied.  330 to now I've had a hard time thinking as I try to fill out this questionnaire & now getting sleepy again
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Vitreous floaters
Clinical narrative: Jan 18th I began to notice Long lasting flashes of light on the left corner of my left eye accompanied by slight blurred vision & lightheaded-ness  Jan 19th I noticed the similar but less frequent type of flashes in the right corner of my right eye when I woke up.  Throughout the day my eyes started to slowly register soreness and that soreness slowly increased in the back of my eyes. Also along with the slight blurred vision and lightheaded-ness.  Jan 20 same symptoms just slightly higher sleepiness throughout the day. I also had a hard time staying awake while idle, sitting while trying to pay attention to being spoken to & reading. Jan 21 same continued symptoms, marginally increased pain & new onset of  floaters as well and extreme lethargy. So much that I was asleep most of the day. I kept falling asleep sitting or trying to focus on anything including eating.  Jan 22 1am- 330  I've been able to stay awake while being occupied.  330 to now I've had a hard time thinking as I try to fill out this questionnaire & now getting sleepy again
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain
Clinical narrative: Heart and chest pain that persisted for 2 months. I didn?t seek medical treatment. It eventually went away.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dyspnoea, Heart rate increased, Syncope, Vaccine positive rechallenge
Clinical narrative: Severe chills, difficulty breathing, vomiting, rapid heart beat, fainting  The same thing happened with flu vaccine in 2021
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Severe chills, difficulty breathing, vomiting, rapid heart beat, fainting  The same thing happened with flu vaccine in 2021
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: 13 days after moderna booster I became extremely itchy with hives.  It has now been 15 days and have dermatographia.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Decreased appetite, Headache, Myalgia
Clinical narrative: Fever 101 to 102.8, chills, headache, severe muscle ache low back and neck, nausea, loss appetite, prod cough, just started, some twinges of chest pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Productive cough, Pyrexia
Clinical narrative: Fever 101 to 102.8, chills, headache, severe muscle ache low back and neck, nausea, loss appetite, prod cough, just started, some twinges of chest pain.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: (maybe more needle phobia/history with all vaccines than a side effect)  patient has a history of fainting with injections/blood draw and warned immunizer.  today after vaccination patient did feel a little light headed, but did not faint.  patient felt nauseous and did vomit a couple of times, then felt better.  patient was monitored for 30 mins after vaccine and felt fine after.  patient's prescriber was contacted after the incident.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Injection site pain, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: blurry vision-Medium, Systemic: Visual Changes/Disturbances-Medium
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: blurry vision-Medium, Systemic: Visual Changes/Disturbances-Medium
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Approx. 5 min following vaccination, patient became nauseas, closed his eyes to help it pass and lost consciousness. Brought patient to lie on the floor, he immediately regained consciousness. Sweating, loss of color in face, nausea continued. EMS called for follow up. Normal BP and HR, no further concerns
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Approx. 5 min following vaccination, patient became nauseas, closed his eyes to help it pass and lost consciousness. Brought patient to lie on the floor, he immediately regained consciousness. Sweating, loss of color in face, nausea continued. EMS called for follow up. Normal BP and HR, no further concerns
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Decreased appetite, Fatigue, Headache
Clinical narrative: Felt like death; Body aches; Headaches; Fever 100.7; Loss appetite; Fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 12:00 (Lot number: FL3197) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: other medical history: Anxiety MItral valve prolapse; "MItral valve prolapse" (unspecified if ongoing), notes: other medical history: Anxiety MItral valve prolapse. Concomitant medication(s) included: SERTRALINE; INDERAL. Past drug history included: Vancomycin, reaction(s): "known allergies: Vancomycin", notes: known allergies: Vancomycin. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EP6198,, prev dose lot unknown=False,, prev dose administration date= 25Mar2021,, prev dose administration time=01:00 PM, prev dose number=2, prev dose vaccine location=Left arm), administration date: 25Mar2021, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EP8730,, prev dose lot unknown=False,, prev dose administration date= 04Mar2021,, prev dose administration time=01:00 PM, prev dose number=1,, prev dose vaccine location=Left arm), administration date: 04Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 12:00, outcome "unknown", described as "Booster"; ANXIETY (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Felt like death"; PAIN (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Body aches"; HEADACHE (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Headaches"; PYREXIA (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Fever 100.7"; DECREASED APPETITE (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Loss appetite"; FATIGUE (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anxiety, pain, headache, pyrexia, decreased appetite, fatigue. No follow-up attempts are possible. No further information is expected.  Additional information: Patient was not received any treatment for adverse event. Covid prior vaccination was reported as no. Covid tested post vaccination was reported as no.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pyrexia
Clinical narrative: Felt like death; Body aches; Headaches; Fever 100.7; Loss appetite; Fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 12:00 (Lot number: FL3197) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: other medical history: Anxiety MItral valve prolapse; "MItral valve prolapse" (unspecified if ongoing), notes: other medical history: Anxiety MItral valve prolapse. Concomitant medication(s) included: SERTRALINE; INDERAL. Past drug history included: Vancomycin, reaction(s): "known allergies: Vancomycin", notes: known allergies: Vancomycin. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EP6198,, prev dose lot unknown=False,, prev dose administration date= 25Mar2021,, prev dose administration time=01:00 PM, prev dose number=2, prev dose vaccine location=Left arm), administration date: 25Mar2021, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EP8730,, prev dose lot unknown=False,, prev dose administration date= 04Mar2021,, prev dose administration time=01:00 PM, prev dose number=1,, prev dose vaccine location=Left arm), administration date: 04Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 12:00, outcome "unknown", described as "Booster"; ANXIETY (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Felt like death"; PAIN (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Body aches"; HEADACHE (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Headaches"; PYREXIA (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Fever 100.7"; DECREASED APPETITE (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Loss appetite"; FATIGUE (non-serious) with onset 29Dec2021 19:00, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anxiety, pain, headache, pyrexia, decreased appetite, fatigue. No follow-up attempts are possible. No further information is expected.  Additional information: Patient was not received any treatment for adverse event. Covid prior vaccination was reported as no. Covid tested post vaccination was reported as no.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Immunisation, SARS-CoV-2 test
Clinical narrative: Hair loss; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Aug2021 (Batch/Lot number: unknown) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Small cell ovarian cancer" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Latex Adhesive" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZOLOFT; PRAVASTATIN; METOPROLOL; LISINOPRIL. Past drug history included: Effexor, reaction(s): "Known allergies: Effexor"; Lamotrigine, reaction(s): "Known allergies: lamotrigine". Vaccination history included: Bnt162b2 (Brand: Pfizer, Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 22Jan2021, when the patient was 73 years old, for Covid-19 immunization; Bnt162b2 (Brand: Pfizer, Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 23Feb2021, when the patient was 73 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Aug2021, outcome "unknown", described as "Dose number: 3"; ALOPECIA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Hair loss". The event "hair loss" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Additional information: Reported event as per patient dermatologist thinks that patient loss of hair over the last few months is from the booster patient received the end of Aug. The patient had not received AE treatment, other vaccine in fourweeks and covid prior vaccination. The patient was covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.