chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: tender breast tissue; sore muscles in both arms and neck; aches/pain throughout body and limbs; Terrible flu symptoms approximately 12 hours after vaccination.; Swollen lymph nodes in armpits; sore muscles in both arms and neck; Booster; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 (Lot number: FG3527) at the age of 64 years as dose 3 (booster ), single for covid-19 immunisation. Relevant medical history included: "Eczema bouts", start date: 2016 (unspecified if ongoing), notes: Eczema bouts - last serious in 2016; "Carrier of Staph, Non MRSA" (unspecified if ongoing), notes: carrier of staph, non MRSA. The patient took concomitant medications. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=EW0165, previous dose administration date=27Apr2021, previous dose dose number=2, previous dose vaccine location=Left Arm), administration date: 27Apr2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=ER8727, previous dose administration date=25Mar2021, previous dose dose number=1, previous dose vaccine location=Left Arm), administration date: 25Mar2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "Booster"; BREAST DISCOMFORT (non-serious) with onset 27Nov2021 12:00, outcome "recovering", described as "tender breast tissue"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 27Nov2021 12:00, outcome "not recovered" and all described as "sore muscles in both arms and neck"; PAIN (non-serious) with onset 27Nov2021 12:00, outcome "recovering", described as "aches/pain throughout body and limbs"; INFLUENZA LIKE ILLNESS (non-serious) with onset 27Nov2021 12:00, outcome "recovering", described as "Terrible flu symptoms approximately 12 hours after vaccination."; LYMPHADENOPATHY (non-serious) with onset 27Nov2021 12:00, outcome "not recovered", described as "Swollen lymph nodes in armpits". Therapeutic measures were taken as a result of breast discomfort, neck pain, pain, influenza like illness, lymphadenopathy, pain in extremity.  Additional information: The patient did not take any other vaccine in four weeks of COVID vaccine. The patient took vitamin in two weeks of vaccination. The patient could barely walk the morning following vaccine. The patient was treated with 500 mg Tylenol to reduce symptoms. The patient had very sore arm and neck muscles as well as swollen lymph nodes in armpits 48 hours later. The patient did not had COVID prior vaccination and did not tested positive post vaccination. here were no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation
Clinical narrative: received the 3rd shot, the booster shot; headaches; 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 73 year-old female patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Lot number: FF2593) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hip replacement", start date: 28Sep2021, stop date: 28Sep2021, notes: she had a major surgery, she had hip replacement. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:01), administration date: Mar2021, when the patient was 73 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number:02), administration date: Apr2021, when the patient was 73 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Nov2021, outcome "unknown", described as "received the 3rd shot, the booster shot"; HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "headaches".  Additional information: She stated that the first couple of days were kind of the worst. Said it would be 4 weeks on Friday and she was still kind of getting headaches on the top of her head on and off, especially in the evenings, she guessed that she knew headaches were a side effect. Her question was does Pfizer have any information about how long a side effect like this would last?  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation
Clinical narrative: dizziness/dizzy spells; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: 32030BD) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Illness/AE: Diabetic on Metformin and not insulin. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (1st dose ,  Lot EN5318, Expiration unknown. , Injected in right arm in the muscle.), administration date: 13Feb2021, when the patient was 41 years old, for COVID-19 immunization; Bnt162b2 (2nd dose , Lot EN5318, expiration is unknown., injected in left arm in the muscle.), administration date: 08Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "Booster"; DIZZINESS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "dizziness/dizzy spells".  Additional Information: It was reported that, received call from consumer regarding the Pfizer COVID vaccine booster. She got the booster on 15Nov2021, and 3 days later started having dizzy spells.  If she sits down or up or lays down too fast, she gets really, really dizzy. She got vaccinated with booster on 15Nov2021, and about 18Nov2021, is when she started having dizzy spells and lasted until now. Caller also added that she was on a diet pill that she was taking for a month now and she was not sure if this is associated to her reaction that she was experiencing. They was still here.  It seemed like today is worse. She wanted to know if there are others who have reported these symptoms.  She called the pharmacy. and they suggested she call Pfizer. Vaccination Facility Type: Pharmacy. Time the Vaccination was Given: 12:45-13:00. Additional vaccines administered on same date of the Pfizer suspect: None. Dizzy Spells - third night around 12:30-01:00 and noticed she was dizzy when she sat up. The patient did not require visit to Emergency Room/ Physician Office for adverse events. Prior Vaccinations, the patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AE(s) following prior vaccinations: None. Patient's Medical History included: Diabetic on Metformin and not insulin. Onset Date: She was pre-diabetic but diagnosed as being full diabetic for a year or year and a half. Family Medical History Relevant to AE(s): None. Relevant Tests: None   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Lymphadenopathy, Myalgia
Clinical narrative: Experienced pain and swelling at the injection site; Experienced pain and swelling at the injection site; Muscle aches; Headache; fatigue; A swollen lymph node in my left armpit; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 17:00 (Lot number: FJ1620) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D; FISH OIL; VITAMIN B COMPLEX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 17:00, outcome "unknown", described as "Booster dose"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 28Nov2021, outcome "recovering" and all described as "Experienced pain and swelling at the injection site"; MYALGIA (non-serious) with onset 28Nov2021, outcome "recovering", described as "Muscle aches"; HEADACHE (non-serious) with onset 28Nov2021, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 28Nov2021, outcome "recovering", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 28Nov2021, outcome "recovering", described as "A swollen lymph node in my left armpit". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, myalgia, headache, fatigue, lymphadenopathy. No other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Experienced pain and swelling at the injection site; Experienced pain and swelling at the injection site; Muscle aches; Headache; fatigue; A swollen lymph node in my left armpit; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 17:00 (Lot number: FJ1620) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D; FISH OIL; VITAMIN B COMPLEX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 17:00, outcome "unknown", described as "Booster dose"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 28Nov2021, outcome "recovering" and all described as "Experienced pain and swelling at the injection site"; MYALGIA (non-serious) with onset 28Nov2021, outcome "recovering", described as "Muscle aches"; HEADACHE (non-serious) with onset 28Nov2021, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 28Nov2021, outcome "recovering", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 28Nov2021, outcome "recovering", described as "A swollen lymph node in my left armpit". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, myalgia, headache, fatigue, lymphadenopathy. No other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Immunisation, Myalgia, Nausea
Clinical narrative: dose number:3; dizziness; nausea; muscle aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 (Lot number: FH8030) at the age of 40 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: 1, Batch/Lot No: EL3248), administration date: 09Mar2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: 3248, Route of Administration: Intramuscular, Location of injection: Arm Right), administration date: 30Mar2021, when the patient was 40 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "dose number:3"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine No Prior to vaccination, was the patient was not diagnosed with COVID,  Since the vaccination, has patient has not been tested for COVID  Follow-Up (02Dec2021): Follow-up attempts are completed. No further information is expected.  Follow-up (02Dec2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to consumer letter sent via follow-up letter which included that:  Updated information: This follow-up contains no new safety information. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Immunisation, Panic attack
Clinical narrative: booster; anxiety and panic attacks; anxiety and panic attacks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 (Batch/Lot number: unknown, Expiration Date: 28Feb2022) at the age of 67 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "She has had anxiety all her life." (ongoing), notes: She has had anxiety all her life.; "Migraine" (unspecified if ongoing), notes: Took it that night after her vaccine for Migraine. Concomitant medication(s) included: AJOVY [FREMANEZUMAB] taken for migraine (ongoing). Vaccination history included: Bnt162b2 (Dose no:1, First dose 12Mar2021, Lot: EN6199, Expiration: Unknown, She already had her 2 doses of the vaccine without experiencing any side-effects), administration date: 12Mar2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose no:2, Second dose 02Apr2021, Lot: EP6955, Expiration: Unknown, She already had her 2 doses of the vaccine without experiencing any side-effects), administration date: 02Apr2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: ANXIETY (non-serious), PANIC ATTACK (non-serious) all with onset 30Nov2021, outcome "recovered" (01Dec2021) and all described as "anxiety and panic attacks"; IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "booster". Therapeutic measures were taken as a result of anxiety, panic attack, immunisation. Additional information: Reporter had severe anxiety and panic attacks (probably the worst panic attack she has ever had) 3 hours after with booster dose, administered on 30Nov2021. She has had anxiety all her life. Patient was on medications. It was reported that patient took clonazepam in the morning to make sure she was ok and felt a lot better. Reporter added as if she had a hard time reading the booster dose lot number as said it could be FJ8757.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Immunisation, Supraventricular extrasystoles
Clinical narrative: 3rd dose; had 3 (PAC's) show up during a BP test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 09:30 (Lot number: FH8020) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROZAC; CRESTOR; TERAZOSIN. Past drug history included: None, reaction(s): "Allergy", notes: other medical history: No. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 28Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 07Apr2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "3rd dose"; SUPRAVENTRICULAR EXTRASYSTOLES (non-serious) with onset 19Nov2021 04:00, outcome "recovering", described as "had 3 (PAC's) show up during a BP test". The event "had 3 (pac's) show up during a bp test" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of supraventricular extra systoles.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Had P.,A.C's show up at Blood donation, which alerted me to this condition. they only showed occasionally until the day after my . They are getting better, sometimes none. Just felt I should report. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bruxism, Feeling abnormal, Heart rate increased, Hypertension, Immunisation
Clinical narrative: Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses.; Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses.; Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses.; feeling of needing to run or grind her teeth; rapid heart rate; high blood pressure; feeling of needing to run or grind her teeth; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 (Patient received 1st and 2nd dose of Moderna.), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses."; BRUXISM (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "feeling of needing to run or grind her teeth"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart rate"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use
Clinical narrative: Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses.; Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses.; Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses.; feeling of needing to run or grind her teeth; rapid heart rate; high blood pressure; feeling of needing to run or grind her teeth; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 (Patient received 1st and 2nd dose of Moderna.), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses."; BRUXISM (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "feeling of needing to run or grind her teeth"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart rate"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Oligomenorrhoea
Clinical narrative: booster (3rd dose) of the Covid vaccine; 5 days late with her menstrual cycle; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP).  A female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd dose), for COVID-19 Immunization; Bnt162b2 (1st Dose), for COVID-19 Immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "5 days late with her menstrual cycle"; IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster (3rd dose) of the Covid vaccine". Clinical course: Got her booster (3rd dose) of the Covid vaccine. She is 5 days late with her menstrual cycle. Event took place after use of product. Event took place after use of product.  Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain, Pain in extremity
Clinical narrative: booster; sore arm; Mild headache; mild body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization; Bnt162b2 (2nd dose), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), outcome "unknown", described as "Mild headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "mild body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Vaccination site reaction
Clinical narrative: swollen lymph nodes under injection site; swollen lymph nodes under injection site; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 16:00 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR. Past drug history included: Ceftin, reaction(s): "known allergies: Ceftin", notes: known allergies: Ceftin. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Misplaced/discarded, prev dose administration date: 12Apr2021, prev dose administration time: 02:15 PM, prev dose number: 2, prev dose vaccine location: Right arm), administration date: 12Apr2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Misplaced/discarded , prev dose administration date: 22Mar2021, prev dose administration time: 02:30 AM, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 22Mar2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 16:00, outcome "unknown", described as "Booster"; VACCINATION SITE REACTION (non-serious), LYMPHADENOPATHY (non-serious) all with onset 01Dec2021 22:00, outcome "not recovered" and all described as "swollen lymph nodes under injection site". Therapeutic measures were not taken as a result of vaccination site reaction, lymphadenopathy.  Additional information: The patient did not take any other vaccination in four weeks. The patient did not had COVID prior vaccination or tested COVID post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Inappropriate schedule of product administration
Clinical narrative: I gave Booster dose today and it was early date, it should be Dec2022; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Dec2021 (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 (patient that received the first dose of the Pfizer Covid-19 Vaccine on 02Jun2021), administration date: 02Jun2021, for COVID-19 immunization; Bnt162b2 (patient that received the first dose of the Pfizer Covid-19 Vaccine on 02Jun2021 and then received the second dose on 22Jun2021), administration date: 22Jun2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "I gave Booster dose today and it was early date, it should be Dec2022"; IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Booster dose".  Additional Information: Transferring agent stated, "I have a Registered Nurse (reporter) on the line, and she is calling due to a patient that received the first dose of the Pfizer Covid-19 Vaccine on 02Jun2021 and then received the second dose on 22Jun2021. The patient was sent for the Booster dose and the Nurse said that when she went to enter the Booster dose it says that released dose date should be Dec2022, so she is inquiring if she gave it too early. She is inquiring about the Booster (Covid-19 Vaccine) dose being given too early, that's all the information. When paraphrased the concern, Nurse stated, "Today yes, I gave it (Booster dose) today and it was early date, it should be Dec2022." In response to further probing, Nurse stated, "Yes but I am trying to see, does she need to get another dose or is that okay because I gave it today." Nurse was provided with the number of Medical Information # and was requested to select option 3 and timings as 8 am to 8 pm from Monday to Friday as per. In response Nurse stated, "So in other words, you are not the right person that I need to talk." In response Nurse stated, "Ok, so what about the other question, I asked them, the other question for other patient, her first dose was given today, so I am going Pfizer, it says first dose "1222" (Further not clarified) and she is only 27 years old."  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Immunisation, Lymphadenopathy, Musculoskeletal discomfort
Clinical narrative: Booster; Received both pfizer's COVID booster and flu vaccine yesterday; Received both pfizer's COVID booster and flu vaccine yesterday; Left side lymph nodes are swollen; pain in armpit; discomfort in neck; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 14:05 (Lot number: fj8762, Expiration Date: Jun2022) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 01Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Time: 14:25PM, Anatomical Site of injection: Arm, Batch/Lot number: Lot #EL3247), administration date: 23Feb2021, for Covid-19 Immunization; Bnt162b2 (2nd dose, Time: 14:10 PM, Anatomical Site of injection: Arm, Batch/Lot number: Lot #EL3247), administration date: 16Mar2021, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Dec2021, outcome "unknown" and all described as "Received both pfizer's COVID booster and flu vaccine yesterday"; IMMUNISATION (non-serious) with onset 01Dec2021 14:05, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "unknown", described as "Left side lymph nodes are swollen"; AXILLARY PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "pain in armpit"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "discomfort in neck"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "chills". Therapeutic measures were taken as a result of lymphadenopathy, axillary pain, musculoskeletal discomfort.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product use issue
Clinical narrative: Booster; Received both pfizer's COVID booster and flu vaccine yesterday; Received both pfizer's COVID booster and flu vaccine yesterday; Left side lymph nodes are swollen; pain in armpit; discomfort in neck; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 14:05 (Lot number: fj8762, Expiration Date: Jun2022) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 01Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Time: 14:25PM, Anatomical Site of injection: Arm, Batch/Lot number: Lot #EL3247), administration date: 23Feb2021, for Covid-19 Immunization; Bnt162b2 (2nd dose, Time: 14:10 PM, Anatomical Site of injection: Arm, Batch/Lot number: Lot #EL3247), administration date: 16Mar2021, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Dec2021, outcome "unknown" and all described as "Received both pfizer's COVID booster and flu vaccine yesterday"; IMMUNISATION (non-serious) with onset 01Dec2021 14:05, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "unknown", described as "Left side lymph nodes are swollen"; AXILLARY PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "pain in armpit"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "discomfort in neck"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "chills". Therapeutic measures were taken as a result of lymphadenopathy, axillary pain, musculoskeletal discomfort.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Interchange of vaccine products
Clinical narrative: Fever; chills; arm pain; lymph node swelling in arm pit of right arm (injection sight); tiredness; headache; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; Booster; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 10:00 (Lot number: FJ1620) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 03Nov2021. Vaccination history included: Moderna (DOSE 2, SINGLE, Dose brand: Modema, Batch/Lot No: 038B21A, Location of injection: Arm Left, Administration date: 28Apr2021), administration date: 28Apr2021, for Covid-19 immunization; Moderna (DOSE 1, SINGLE, Dose brand: Modema, Batch/Lot No: 016B21A, Location of injection: Arm Left, Administration date: 31Mar2021), administration date: 31Mar2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 10:00, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 01Dec2021 22:00, outcome "not recovered", OFF LABEL USE (non-serious) with onset 01Dec2021 10:00, outcome "unknown" and all described as "Dose 1: Moderna, Dose 2: Moderna"; PYREXIA (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "arm pain"; LYMPHADENOPATHY (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "lymph node swelling in arm pit of right arm (injection sight)"; FATIGUE (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of interchange of vaccine products, pyrexia, chills, pain in extremity, lymphadenopathy, fatigue, headache.  Additional Information: The patient took other vaccine in four weeks. Patient was not diagnosed with Covid-19 prior to vaccination, neither tested positive.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Off label use, Pain in extremity, Pyrexia
Clinical narrative: Fever; chills; arm pain; lymph node swelling in arm pit of right arm (injection sight); tiredness; headache; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; Booster; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 10:00 (Lot number: FJ1620) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 03Nov2021. Vaccination history included: Moderna (DOSE 2, SINGLE, Dose brand: Modema, Batch/Lot No: 038B21A, Location of injection: Arm Left, Administration date: 28Apr2021), administration date: 28Apr2021, for Covid-19 immunization; Moderna (DOSE 1, SINGLE, Dose brand: Modema, Batch/Lot No: 016B21A, Location of injection: Arm Left, Administration date: 31Mar2021), administration date: 31Mar2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 10:00, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 01Dec2021 22:00, outcome "not recovered", OFF LABEL USE (non-serious) with onset 01Dec2021 10:00, outcome "unknown" and all described as "Dose 1: Moderna, Dose 2: Moderna"; PYREXIA (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "arm pain"; LYMPHADENOPATHY (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "lymph node swelling in arm pit of right arm (injection sight)"; FATIGUE (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of interchange of vaccine products, pyrexia, chills, pain in extremity, lymphadenopathy, fatigue, headache.  Additional Information: The patient took other vaccine in four weeks. Patient was not diagnosed with Covid-19 prior to vaccination, neither tested positive.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: Started running fever today; Booster; Arm hurting; We both felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (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 (Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Arm hurting"; PYREXIA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Started running fever today"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "We both felt sick".  Additional information: NDC and UPC number of COVID-19 Vaccine were unknown. Reason for no lot number of COVID-19 Vaccine was complainant hung up abruptly/transfer incomplete. Patient stated "I just want to double check on the side effects of the booster, Pfizer booster. We had on 01Dec, my husband was sick the second and third day and other than the arm hurting I have started running fever today, today is the 4th, so it is third day, is that normal?"  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain
Clinical narrative: dose number=3; painful; Visibly swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "dose number=3"; PAIN (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "painful"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "Visibly swollen lymph nodes". The events "painful" and "visibly swollen lymph nodes" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pain, lymphadenopathy.  Additional information: Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: Dose Number: 03; Soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Dec2021 11:30 (Lot number: FF2589) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 30 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 15:15 PM, Route of Administration: Intramuscular), administration date: 01Mar2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose Number: 03"; PAIN (non-serious) with onset 03Dec2021, outcome "unknown", described as "Soreness".  Additional information: Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient had not been tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity
Clinical narrative: booster dose; fatigue; arm ached; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Amylodosis" (unspecified if ongoing), notes: Patient has amylodosis and had stem cell transplant 6 years ago; "had stem cell transplant" (unspecified if ongoing), notes: Patient has amyloidosis and had stem cell transplant 6 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, fatigue after all three shots), for Covid-19 Immunization, reaction(s): "fatigue"; Bnt162b2 (Dose: 1, her arm ached longer after receiving the booster dose than the first 2 shots.), for Covid-19 Immunization, reaction(s): "arm ached"; Bnt162b2 (Dose: 2, fatigue after all three shots), for Covid-19 Immunization, reaction(s): "fatigue"; Bnt162b2 (Dose: 2, her arm ached longer after receiving the booster dose than the first 2 shots.), for Covid-19 Immunization, reaction(s): "arm ached". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm ached".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Immunisation, Pyrexia, Urticaria
Clinical narrative: COVID Booster; hives; low grade fever; allergic reaction; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 ; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2 ; Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID Booster"; URTICARIA (non-serious), outcome "unknown", described as "hives"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". Additional information: Event took place after use of product. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Vaccination site pain
Clinical narrative: booster; soreness of arm at injection site; some muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of arm at injection site"; MYALGIA (non-serious), outcome "unknown", described as "some muscle ache".  Additional information: Female patient received the Pfizer Covid vaccine as a booster and experienced soreness of arm at injection site and some muscle ache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.