chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: tired; arm was a little sore; achiness; headache; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 08:45 (Lot number: EM9809) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "illness" (unspecified if ongoing), notes: Patient's Medical History (including any illness at time of vaccination). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "arm was a little sore"; PAIN (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "achiness"; HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "headache"; NAUSEA (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "nausea"; FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional information: She was calling about the Covid 19 vaccine. She was upset and concerned because she got the Covid 19 vaccine about 4 days ago on 11MAR2021 and she was scheduled automatically for the second Covid 19 vaccine. She does not realize it until she got home but she was scheduled for the second Covid 19 dose at 28 days instead of 21 days. She was very concerned about that. Is this a mistake? She got the Covid 19 vaccine at her pharmacy. So far she has not had that bad of a reaction. When asking caller to clarify, she states her arm was a little sore but she could lay on it and the first night after the Covid 19 vaccine and up to the next day, she had an achiness and a headache and some nausea. It was not that bad and then the next day in the afternoon she was maybe a little tired. Her experience and the person who gave it was fine. The side effects weren't that bad. She was very alarmed that she was not getting the second Covid 19 vaccine in 21 days. The pharmacy said it was ok but everyone she knows was getting the second Covid 19 vaccine at 21 days. Other Products, Patient history and Investigation Assessment was reported as No. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) reported as none. Additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect reported as no. Prior Vaccinations (within 4 weeks) reported as no  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain
Clinical narrative: My wife has shooting pain from the neck down to the elbow that does not stop; it was shooting is muscle pain; She also have the other things like chills and fatigue; She also have the other things like chills and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Lot number: EN6199) as dose number unknown, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "My wife has shooting pain from the neck down to the elbow that does not stop"; MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "it was shooting is muscle pain"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", CHILLS (non-serious) with onset Mar2021, outcome "recovered" (2021) and all described as "She also have the other things like chills and fatigue".  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site mass
Clinical narrative: red swollen lump the size of a golf ball at the injection site; arm is tender; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 17:10 (Lot number: EN6205) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 1993 (ongoing), notes: Verbatim: Fibromyalgia; "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for arthritis, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 (Vaccine Name: Covid-19 Vaccine, Manufacturer: Pfizer, Lot Number: EL9266 , Anatomical location: right arm), administration date: 20Feb2021, when the patient was 72 years old, for Covid-19 immunisation.  The following information was reported: VACCINATION SITE MASS (non-serious) with onset 14Mar2021, outcome "not recovered", described as "red swollen lump the size of a golf ball at the injection site"; TENDERNESS (non-serious) with onset 13Mar2021, outcome "not recovered", described as "arm is tender".  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the pfizer suspect was reported as none. The patient did not visited to emergency room or physician office.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: He has some concerns about the side effects he has experienced since receiving the vaccine; This is a spontaneous report received from a contactable reporter Consumer or other non Health professional. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "He has some concerns about the side effects he has experienced since receiving the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eyelid pain, Pain in extremity
Clinical narrative: red puffy hot sore eyelids; red puffy hot sore eyelids; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 12:45 (Lot number: EN6204) at the age of 60 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "recovered" (13Mar2021), described as "sore arm"; ERYTHEMA OF EYELID (non-serious), EYELID PAIN (non-serious) all with onset 15Mar2021, outcome "not recovered" and all described as "red puffy hot sore eyelids".  Additional information: Other Products were reported as, No. Clinical course was reported as, Reporter stated she got the Pfizer Covid vaccine on Friday, 12Mar2021 at 12:45 in the afternoon, states she had sore arm for less than 24 hours. States she had no other symptoms until she woke up this morning and eyelids are puffy, red, hot, and sore. Reporter wanted to know if she needs to be concerned or be seen about this. Reporter was encouraged to reach out to her healthcare provider for medical advice.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Pain
Clinical narrative: Headache; aching; felt like she had a ton of bricks on her; 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), administered in arm (Lot number: EL9266) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; PAIN (non-serious), outcome "recovered", described as "aching"; DISCOMFORT (non-serious), outcome "recovered", described as "felt like she had a ton of bricks on her".  Additional information: It was reported that patient had a terrible headache, aching, and that she felt like she had a ton of bricks on her. She says it took two days almost for her to feel back to normal.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: Unable to move shoulder much; Injection site very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 11:45 (Lot number: EL3247) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to cats and rabbits" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN, start date: 2021. Vaccination history included: Bnt162b2 (Batch/lot number: EL3247, Date of start of drug/ time: 22Feb2021 11:00 AM, Anatomical Location: Arm Left, Dose Number: 1), administration date: 22Feb2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "Sore throat", "Cough increased", "Upper respiratory infection".  The following information was reported: MOBILITY DECREASED (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "Unable to move shoulder much"; VACCINATION SITE PAIN (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "Injection site very sore". Therapeutic measures were not taken as a result of mobility decreased, vaccination site pain.  Additional information included: Events started about 4 hours after injection. Peaked at about 12 hours after injection. It was slowly improving at 30 hours post injection and was still unable to raise arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Influenza like illness, Nausea, Pain
Clinical narrative: Flu like symptoms; Sick and pain; Headache; Nausea; Sick and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), the patient's child.  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 13Mar2021, outcome "unknown", described as "Flu like symptoms"; PAIN (non-serious), ILLNESS (non-serious) all with onset 13Mar2021, outcome "unknown" and all described as "Sick and pain"; HEADACHE (non-serious) with onset 13Mar2021, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Nausea".  Additional information: Patient has no fever.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain on the vaccine site but its underneath my arm and going down my arm; Not really constant pain; Tender down inside my arm; This is a spontaneous report received from a non-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 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain on the vaccine site but its underneath my arm and going down my arm; Not really constant pain; Tender down inside my arm".  Additional information: Patient got first COVID vaccine on 11th. patient do not really have any pain but patient did have initially on the vaccine site but its underneath patient arm and going down patient arm. It depends on how patient move it, It was not really constant pain. patient did not know that was something that other people have been experiencing. Patient further reported that it's nothing drastic, no continuous pain it just depending on patient arm. It was tender down inside patient arm. patient hope other people get a better connection because this was just been a terrible experience.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: Chills; Tiredness; Mild soreness at injection site; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 12:00 (Lot number: EN6207) at the age of 60 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Overweight" (ongoing), notes: Verbatim: Overweight, A few years maybe 3 years.; "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing). The following information was reported: CHILLS (non-serious) with onset 14Mar2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 13Mar2021, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 14Mar2021, outcome "not recovered", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 14Mar2021, outcome "recovering", described as "Mild soreness at injection site". Therapeutic measures were taken as a result of headache, vaccination site pain.  Additional information: Concomitant Products Losartan: Been taking for about a year, Patient has overweight A few years maybe 3 years. Patient has mild soreness at injection site is a little but tender to touch.Investigation Assessment was no.Caller reported having adverse events to COVID 19 vaccine. Treatment was  Drank a lot of water, hydrating constantly, and bed rest. History of all previous immunization with the Pfizer vaccine considered as suspect was none.Additional Administered Vaccines was none.The patient did not visited  to Emergency Room.Prior Vaccinations (within 4 weeks) was none.Relevant Tests was none.the patient taking COVID 19 vaccine (Verbatim): Two comorbidities.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Headache, Hyperacusis, Migraine
Clinical narrative: Headache; brain fog; her ears and head feel full- it felt like a migraine; felt sensitive to sound and light and couldn't watch TV; felt sensitive to sound and light and couldn't watch TV; very stuffy in her sinuses; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 20Feb2021 14:00 (Lot number: EN6208) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "brain fog"; MIGRAINE (non-serious), outcome "recovering", described as "her ears and head feel full- it felt like a migraine"; PHOTOPHOBIA (non-serious), HYPERACUSIS (non-serious), outcome "not recovered" and all described as "felt sensitive to sound and light and couldn't watch TV"; NASAL CONGESTION (non-serious), outcome "unknown", described as "very stuffy in her sinuses". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller reports she had a stiffness kind of headache probably from sleeping weird. She felt sensitive to sound and light; described this as a weird feeling, it was otherwise explained as a migraine. Caller clarified with the first dose, this feeling started on the second day after the vaccine. She states she received the first vaccine around 2 in the afternoon and within 6 to 8 hours, she felt sensitive to sound and light and couldn't watch TV. Caller clarified she was also very stuffy in her sinuses and it could be related to that too, but she did not know. Caller reports she still had fullness in her sinuses, her eye still hurts, but she did not have a cold. The events did not required visit to emergency Room, physician Office. Patient did not receive any other vaccine within 4 weeks. The events really bad headache- ears and head feel full; felt like a migraine after 1st dose. Sensitive to sound and light, couldn't watch TV, described as a weird feeling were reported as related to BNT162B2.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Photophobia
Clinical narrative: Headache; brain fog; her ears and head feel full- it felt like a migraine; felt sensitive to sound and light and couldn't watch TV; felt sensitive to sound and light and couldn't watch TV; very stuffy in her sinuses; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 20Feb2021 14:00 (Lot number: EN6208) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "brain fog"; MIGRAINE (non-serious), outcome "recovering", described as "her ears and head feel full- it felt like a migraine"; PHOTOPHOBIA (non-serious), HYPERACUSIS (non-serious), outcome "not recovered" and all described as "felt sensitive to sound and light and couldn't watch TV"; NASAL CONGESTION (non-serious), outcome "unknown", described as "very stuffy in her sinuses". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller reports she had a stiffness kind of headache probably from sleeping weird. She felt sensitive to sound and light; described this as a weird feeling, it was otherwise explained as a migraine. Caller clarified with the first dose, this feeling started on the second day after the vaccine. She states she received the first vaccine around 2 in the afternoon and within 6 to 8 hours, she felt sensitive to sound and light and couldn't watch TV. Caller clarified she was also very stuffy in her sinuses and it could be related to that too, but she did not know. Caller reports she still had fullness in her sinuses, her eye still hurts, but she did not have a cold. The events did not required visit to emergency Room, physician Office. Patient did not receive any other vaccine within 4 weeks. The events really bad headache- ears and head feel full; felt like a migraine after 1st dose. Sensitive to sound and light, couldn't watch TV, described as a weird feeling were reported as related to BNT162B2.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With the first shot he had soreness in his arm but that was basically it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Feb2021 (Lot number: EN6208) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lung blister" (unspecified if ongoing), notes: blister on lung many years ago in his late 20's or early 30's. They stapled it together.; "smoked" (unspecified if ongoing), notes: he was a runner and he smoked. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Feb2021, outcome "unknown", described as "With the first shot he had soreness in his arm but that was basically it". Additional information: No vaccines administered on same date with the Pfizer vaccine. No prior vaccinations within 4 weeks. AE did not required Emergency Room/Physician Office visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: armpit swelling and pain.; armpit swelling and pain.; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "armpit swelling and pain."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Chills; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache
Clinical narrative: headache; back pain; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; BACK PAIN (non-serious), outcome "unknown", described as "back pain".  Additional information: Enrolment form states, " Diagnosis: Adenocarcinoma of the lung T3 with involvement of the pericardium, N3 with involvement of the mediastinum, M1b with distant spread and a malignant pericardial effusion, stage IV. EGFR mutation negative. ALK positive 80% rearranged.; This patient's CEA continues to go up. She's having symptoms. She's having headaches. She has some back pain. However, this could also be related to the fact that she got the COVID vaccine because it all started when she got the COVID vaccine. "Suspect product(s) (provide Name / Indication/Dosage/Start and Stop date where possible): Lorbrena / C34.32 / 100 mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm was real sore after first dose injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 (Lot number: EK9231) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "Left arm was real sore after first dose injection".  Additional information: No other vaccines administered on same date with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. Patient Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was None.  She was getting close to obesity if she would keep eating like that. Family Medical History Relevant to AE(s) was None that reporter was aware of.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at the injection site; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "rash at the injection site".  Additional information: The patient had a rash at the injection site for the last 4 days and would like to know if she needs to seek medical attention.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  An male patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Feb2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild injection site soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 10:15 (Lot number: EL3247) at the age of 59 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Codeine sensitive, reaction(s): "Known allergies". Vaccination history included: Covid-19 vaccine (product: COVID 19, brand: Pfizer,, lot number: EL3247,, lot unknown: False,, administration date: 22Feb2021,, administration time: 01:15 PM, vaccine location: Left arm, dose number: 1), administration date: 22Feb2021, when the patient was 59 years old, at workplace clinic for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Mar2021 15:00, outcome "recovering", described as "mild injection site soreness". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient had no COVID prior vaccination. Patient was not tested covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: body pain; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-years-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 09:45 (Lot number: EL3247) at the age of 58 years as DOSE 2, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID19, brand=PFIZER, Lot number=EL3247, Lot unknown=False, Administration date=22Feb2021, Administration time=09:15 AM, Vaccine location=Left arm, Dose number=1), administration date: 22Feb2021, when the patient was 58 years old, for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 15Mar2021 22:00, outcome "recovered" (2021), described as "body pain"; CHILLS (non-serious) with onset 15Mar2021 22:00, outcome "recovered" (2021), described as "chills". Therapeutic measures were not taken as a result of pain, chills.  Additional Information: After the second shot, the patient had body pain and chills all night. The patient had no known allergies and no other medical history. The patient had no other vaccines in 4 weeks. No treatment was received for the adverse events. The patient did not have COVID prior to vaccination and was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pain in extremity
Clinical narrative: extremely tired; arm was sore; didn't eat a lot that evening; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extremely tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore"; DECREASED APPETITE (non-serious), outcome "unknown", described as "didn't eat a lot that evening".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: she developed flu-like symptoms after receiving the first dose of the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "she developed flu-like symptoms after receiving the first dose of the vaccine".  Additional information: The patient and her husband received the first dose of the Pfizer Covid-19 vaccine on 24Feb2021 at (facility name withheld) and were due to receive their second dose on 17Mar2021 but have not received a call of confirmation from the facility yet. She was worried that they may not receive the second dose on time, compared to her neighbours who received their first dose later than they did get a confirmation call to receive their second dose already.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hyperhidrosis, Myalgia
Clinical narrative: her body felt like it was 'on fire' Reports 10 pruney fingers; searing muscle pain; lots of sweat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4253307.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALECENSA. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "her body felt like it was 'on fire' Reports 10 pruney fingers"; MYALGIA (non-serious), outcome "unknown", described as "searing muscle pain"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "lots of sweat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: This is a spontaneous report received from a non-contactable consumer. A 57-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Extreme fatigue"; PAIN (non-serious), outcome "unknown", described as "every movement hurt". Additional Information: The patient and her husband told their friend that they both had side effects from the second dose of the Pfizer COVID-19 vaccine as. The patient and her husband both experienced extreme fatigue the day after getting the vaccine; and every movement hurt is how they described it. They were both tired for the next few days after that, but not enough to interfere with daily activities. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s): US-PFIZER INC-2021300751 Same reporter, product, and event; different patient.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Extreme fatigue; Every movement hurt; This is a spontaneous report received from contactable consumers. The reporter is the patient.  A 59-year-old male patient received BNT162B2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 04Mar2021, outcome "unknown", described as "Extreme fatigue"; PAIN (non-serious) with onset 04Mar2021, outcome "unknown", described as "Every movement hurt".  Additional Information: The patient and his wife told their friend that they both had side effects from the second dose of the Pfizer COVID-19 vaccine. The patient and his wife both experienced extreme fatigue the day after getting the vaccine; and every movement hurt is how they described it. They were both tired for the next few days after that, but not enough to interfere with daily activities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021300722 Same reporter, product, and event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: received both vaccines of Pfizer little to no response only sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "received both vaccines of Pfizer little to no response only sore arm".  Additional information: It was reported that: 16 year old son one year post Heart Transplant received both vaccines of Pfizer little to no response only sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: She also mentioned she experienced extreme fatigue with the 1st dose; she slept a lot after the administration of the 1st dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2021 16:30 (Lot number: EN6200) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "She also mentioned she experienced extreme fatigue with the 1st dose"; SOMNOLENCE (non-serious), outcome "unknown", described as "she slept a lot after the administration of the 1st dose.".  Additional Information: Concomitant drugs: birth control pills. Prior vaccinations: None.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Experienced a little bit dizzy in the morning; 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 female patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "Experienced a little bit dizzy in the morning".  Additional information: Patient reported that her 2nd dose was scheduled on 16Mar2021, however as she was experiencing dizziness for couple of days now so she couldn't come for vaccination. She wanted to know if she could still get the 2nd shot even if it's in a later date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; 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 female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  Additional information: Patient asked to schedule the 2nd dose of the covid-19 vaccine. Patient experienced diarrhea after the 1st dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Nasopharyngitis
Clinical narrative: bad cold; high rise of temperature; 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 male patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "bad cold"; BODY TEMPERATURE INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "high rise of temperature". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter was not Healthcare Professional (HCP). The reporter was not  a prescribing HCP. Occupation/Specialty was unknown. The reporter's contact information available to consumer or a sub-contracted party was Unknown. Suspect product(s) Pfizer Covid-19 Vaccine Start Date was 09Mar2021 and Stop Date was 17Mar2021. Patient 2nd dose was rescheduled to 17Mar. He is asking any documents he needs to bring on that day. No any unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program.  A female patient received BNT162B2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache".  Additional Information: The patient's son-in-law reported that the patient experienced a headache after the first dose and wanted to know if the patient can take ibuprofen (ADVIL) or other medications.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 15Feb2021 (Lot number: EL3244) as dose 2, single for covid-19 immunisation. Relevant medical history included: "mental fatigue" (unspecified if ongoing); "physical fatigue" (unspecified if ongoing); "covid-19", start date: 08Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), administration date: 28Jan2021, for covid-19 immunisation, reaction(s): "chills", "fever", "fatigue". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  Additional information: The consumer reported for a (age: 80, unit: Unknown) male patient (Husband) in response to non hcp letter sent in a cross referenced case that included: He returned the previous evaluation packet 2days after receiving it, following was a brief summary of the information: 1) The patient (husband) and I Wife) were healthy, active seniors, He was almost 80 and his wife was 77. 2) They contracted  covid-19 08Nov2020, it took them about 5 weeks to get over it especially the physical and mental fatigue. 3) The patient experienced fatigue but not too bad. 4)As of today 09Mar2021-I (we) have gotten better.  The patient age was not capture in tab because stated "Almost 80" hence added in narrative. This was male patient (husband) case hence added information of that only. Wife case information already took in cross reference cases.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: After vaccination she felt a little light headed for 5 minutes; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 (Lot number: EL8982) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number-1; Lot number- EJ1686; Time the vaccination was given: 12:18; Vaccine Lot Expire date: 31Mar2021, ), administration date: 21Jan2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "A little bit dizzy". The following information was reported: DIZZINESS (non-serious) with onset 10Feb2021, outcome "unknown", described as "After vaccination she felt a little light headed for 5 minutes"; FATIGUE (non-serious) with onset Feb2021, outcome "unknown", described as "fatigue".  Additional Information: After the vaccination the patient felt a little light-headed for approximately 5 minutes. The second and third days she had fatigue in the afternoon. The AE(s) did not require a visit to emergency room and physician office.  No follow-up attempts are possible. No further information is expected.