chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SOB; lung pain; chest pain; fevers; fatigue; The initial case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on (19Nov2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68-year-old female patient received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in arm, administration date 24Feb2021 (Lot number: EN6202) at the age of 68 years as dose 1, single and intramuscular, administered in arm, administration date 18Mar2021 (Lot number: ED7534) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (life threatening) with onset 2021, outcome "not recovered", described as "SOB"; PULMONARY PAIN (life threatening) with onset 2021, outcome "not recovered", described as "lung pain"; CHEST PAIN (life threatening) with onset 2021, outcome "not recovered", described as "chest pain"; PYREXIA (life threatening) with onset 2021, outcome "not recovered", described as "fevers"; FATIGUE (life threatening) with onset 2021, outcome "not recovered", described as "fatigue". The patient underwent the following laboratory tests and procedures: body temperature: (2021) fevers. Clinical course: Patient age at time of vaccination was 68 Years. SOB (Shortness of breath), lung pain, chest pain, fevers, Fatigues continues. Vaccine administered at  facility was No.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Urticaria
Clinical narrative: Large red hives appeared on upper thighs and buttocks and they slightly burned and itched immensely and hurt. The rash would be present for days and go away.  This went on for two months.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram, Pruritus, Rash, Rash erythematous, Syncope
Clinical narrative: PATIENT VACCINATED AT TIME MENTIONED IN SECTION 4. HE WAS VACCINATED WITH 1mL OF VACCINE INSTEAD OF THE PRESCRIBED 0.5mL. PATIENT WOKE UP AT 0300 AM WITH A RASH AND WAS ITCHY. THE PATIENT EXPERIENCED TWO SYNCOPAL EPISODES WITHIN 15 MINUTES IN HIS LIVING QUARTERS. THE PATIENT'S TORSO FRONT AND BACK WAS COVERED IN A RED RASH. THE PATIENT WAS BROUGHT TO CLINIC FOR CARE.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chills, Fatigue, Joint swelling
Clinical narrative: Morning pain; pain in joints of hands and wrists/ sore arm; pain in joints of hands and wrists/ sore arm; pain in joints of hands and wrists/ sore arm; Finger joint swelled; Fatigue; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Apr2021 (Lot number: ER8736) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Waldenstrom's syndrome", start date: 2006 (ongoing), notes: Additional Information for Other Conditions: diagnosed in 2006, found in routine annual physical. The patient's concomitant medications were not reported. The following information was reported: PAIN (disability, medically significant) with onset 29Apr2021, outcome "recovering", described as "Morning pain"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 29Apr2021, outcome "recovering" and all described as "pain in joints of hands and wrists/sore arm"; FATIGUE (non-serious) with onset 28Apr2021, outcome "unknown", described as "Fatigue"; CHILLS (non-serious) with onset 28Apr2021, outcome "unknown", described as "Chills"; JOINT SWELLING (non-serious) with onset 29Apr2021, outcome "unknown", described as "Finger joint swelled". The events "morning pain", "pain in joints of hands and wrists", "pain in joints of hands and wrists" and "pain in joints of hands and wrists" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: no known core "condition however is stable". No lymphnodes and do not have any signs of condition worsening. Therapeutic measures were taken as a result of pain, arthralgia, pain in extremity, arthralgia (put on prednisone 15mg and within 3 days it started going away).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Morning pain; pain in joints of hands and wrists/ sore arm; pain in joints of hands and wrists/ sore arm; pain in joints of hands and wrists/ sore arm; Finger joint swelled; Fatigue; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Apr2021 (Lot number: ER8736) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Waldenstrom's syndrome", start date: 2006 (ongoing), notes: Additional Information for Other Conditions: diagnosed in 2006, found in routine annual physical. The patient's concomitant medications were not reported. The following information was reported: PAIN (disability, medically significant) with onset 29Apr2021, outcome "recovering", described as "Morning pain"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 29Apr2021, outcome "recovering" and all described as "pain in joints of hands and wrists/sore arm"; FATIGUE (non-serious) with onset 28Apr2021, outcome "unknown", described as "Fatigue"; CHILLS (non-serious) with onset 28Apr2021, outcome "unknown", described as "Chills"; JOINT SWELLING (non-serious) with onset 29Apr2021, outcome "unknown", described as "Finger joint swelled". The events "morning pain", "pain in joints of hands and wrists", "pain in joints of hands and wrists" and "pain in joints of hands and wrists" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: no known core "condition however is stable". No lymphnodes and do not have any signs of condition worsening. Therapeutic measures were taken as a result of pain, arthralgia, pain in extremity, arthralgia (put on prednisone 15mg and within 3 days it started going away).
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: ear ringing" since the 1st day she got the shot; She states that she did not hear any noise until she got "the stupid vaccine."; 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 52 year-old patient received bnt162b2 (COMIRNATY) (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: TINNITUS (non-serious), outcome "unknown", described as "ear ringing" since the 1st day she got the shot"; HYPOACUSIS (non-serious), outcome "unknown", described as "She states that she did not hear any noise until she got "the stupid vaccine.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Felt sick; developed 102 degrees fever; This is a spontaneous report received from based on the information received  from a contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): 2021SA337125.  A 58 -old female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (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), administration date: 01Sep2021, for COVID-19 immunization, reaction(s): "felt sick". The following information was reported: MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "Felt sick"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "developed 102 degrees fever". Relevant laboratory tests and procedures are available in the appropriate section.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: received the Pfizer covid-19 vaccine in Feb2021 and felt lousy after the second shot; This This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's friend).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date Feb2021 (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 Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "recovered", described as "received the Pfizer covid-19 vaccine in Feb2021 and felt lousy after the second shot". It was unknown if therapeutic measures were taken as a result of feeling abnormal.  Additional information: It was unknown if other vaccine in four weeks, covid prior vaccination, if Covid tested post vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Off label use, Pyrexia
Clinical narrative: Recently had his Cominaty booster; Fatigue; Low-grade fever; Joint aches; This is a spontaneous report received from contactable reporter (Physician) via Pfizer sales representative.  A 55-year-old male patient 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 (Dose 1), for Covid-19 immunisation; Bnt162b2 (Dose 2), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Recently had his Cominaty booster"; FATIGUE (non-serious), outcome "recovered" (2021), described as "Fatigue"; PYREXIA (non-serious), outcome "recovered" (2021), described as "Low-grade fever"; ARTHRALGIA (non-serious), outcome "recovered" (2021), described as "Joint aches".  Additional information: Twenty-four hours after the booster patient experienced fatigue, low-grade fever and joint aches. These symptoms went away after 12-16 hours.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Skin burning sensation, Skin exfoliation
Clinical narrative: stated that she had dry skin; stated that she had flaky skin; stated that she had burning skin; 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) (Batch/Lot number: unknown) as dose 2, single and (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: DRY SKIN (non-serious), outcome "unknown", described as "stated that she had dry skin"; SKIN EXFOLIATION (non-serious), outcome "unknown", described as "stated that she had flaky skin"; SKIN BURNING SENSATION (non-serious), outcome "unknown", described as "stated that she had burning skin".  Additional information: Attempted transfer from agent has a consumer who stated after second dose of Pfizer Covid 19 vaccine that she had dry, flaky burning skin. Stated that she missed her booster dose today and was informed to call her site. Wanted to know why she needed a booster shot if she had such a bad reaction. Medical Information (MI): Were any medical questions addressed by this program forwarded/referred to Medical information?: Yes: Customer and/or medical inquiry forwarded or referred to MI.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired and fatigued; This is a spontaneous report received from contactable reporter(s) (Other HCP) (Not available). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Dec2020 (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: FATIGUE (non-serious), outcome "unknown", described as "tired and fatigued".  Additional information: Description of Event: After first dose on 30Dec she was tired and fatigued. After the second dose, 12 hours post dose she had a horrible migraine headache, chills, fever, body aches, fatigue and could not get out of bed. Took Advil and Tylenol-neither helped. This lasted 36 hours. After the booster on Oct. 6 24 hours post dose she developed the same symptoms as after the second dose. This lasted for 24 hours then felt better for 12 hours then felt horrible again for 24 more hours. She reports no other health issues. Optional Information: She says she is otherwise healthy and reports nothing. Event took place after use of product. This is a spontaneous report received from a contactable other HCP and Consumer or other non HCP.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  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 have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101478505 same patient/drug, different event and dose;202101478506 same patient/drug, different event and dose
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Migraine, Pain
Clinical narrative: horrible migraine headache; chills; fever; body aches; fatigue; could not get out of bed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Tired and fatigued), administration date: 30Dec2020, for COVID-19 Immunization, reaction(s): "Tired and fatigued". The following information was reported: MIGRAINE (non-serious), outcome "recovered", described as "horrible migraine headache"; CHILLS (non-serious), outcome "recovered", described as "chills"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; MALAISE (non-serious), outcome "recovered", described as "could not get out of bed". Therapeutic measures were taken as a result of migraine, chills, pyrexia, pain, fatigue, malaise.  Additional Information: Patient took Advil and Tylenol as treatment-neither helped. She says she was otherwise healthy and reports nothing.  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-202101478504 same patient/drug, different event and dose;US-PFIZER_INC-202101478506 same patient/drug, different event and dose
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: horrible migraine headache; chills; fever; body aches; fatigue; could not get out of bed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Tired and fatigued), administration date: 30Dec2020, for COVID-19 Immunization, reaction(s): "Tired and fatigued". The following information was reported: MIGRAINE (non-serious), outcome "recovered", described as "horrible migraine headache"; CHILLS (non-serious), outcome "recovered", described as "chills"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; MALAISE (non-serious), outcome "recovered", described as "could not get out of bed". Therapeutic measures were taken as a result of migraine, chills, pyrexia, pain, fatigue, malaise.  Additional Information: Patient took Advil and Tylenol as treatment-neither helped. She says she was otherwise healthy and reports nothing.  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-202101478504 same patient/drug, different event and dose;US-PFIZER_INC-202101478506 same patient/drug, different event and dose
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstruation irregular
Clinical narrative: booster; patient believed that it made start period 5 days earlier and it lasted longer than usual; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 01, Batch/lot number: Unknown), for Covid-19 immunization; Bnt162b2 (Dose number: 02, Batch/lot number: Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "patient believed that it made start period 5 days earlier and it lasted longer than usual".  Additional information: Patient just received booster shot (work in healthcare) and patient believed that it made start period 5 days earlier and it lasted longer than usual. Patient did not use any birth control methods and periods were very regular. Getting the shots and booster are very important and this has not changed patient's mind about it, patient wanted to report it for information as patient know that others have reported this as well. Patient now waiting for 11 YO to receive her vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Inappropriate schedule of product administration
Clinical narrative: received a booster dose one month earlier than the time line/received the booster 4 months and 10 days after the second dose; booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical in-formation team for a Pfizer sponsored program (159558). A contactable pharmacist reporting same event under the same suspect product for 2 patients. This is one of 2 reports.   A 34 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 28Oct2021 (Lot number: FF2593, Expiration Date: 16Nov2021) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (Dose 2), administration date: 29May2021, for Covid-19 Immunization; Comirnaty (Dose 1), for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Oct2021, outcome "unknown", described as "received a booster dose one month earlier than the time line/received the booster 4 months and 10 days after the second dose"; IMMUNISATION (non-serious) with onset 28Oct2021, outcome "unknown", described as "booster".  Additional information: Pharmacist stated that patients received a booster dose one month earlier than the timeline and asks for any recommendations or side effects from it being early? the first patient is a 34-year-old male that received the booster 4 months and 10 days after the second dose. Pharmacist was informed about the Role of Pfizer Drug Safety. When probed for consumer's height and weight, Pharmacist stated, "I don't have that information." Anatomical Route of administration was Deltoid IM injection. The patient did not receive any vaccinations prior within 4 weeks. When probed for any other medical conditions, Pharmacist stated, "No, as far as I know, they are not immunocompromised." (Further not clarified, hence not captured in the tab). When probed if any laboratory tests, Pharmacist stated, "No, I don't know." QR Comment: AE Filed conservatively.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101484800 same reporter./drug/AE, different patient.
Age: 50.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Pain in extremity, Pyrexia
Clinical narrative: Pain in the left Arm; Fever; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 28Oct2021 16:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 28Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR; TRILIPIX; CABERGOLINE. Past drug history included: Known allergies; codeine, reaction(s): "Known Allergies; Codeine", notes: Known Allergies; Codeine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 13:00, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 16Apr2021, when the patient was 49 years old, for COVID-19 immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Oct2021 22:00, outcome "not recovered", described as "Pain in the left Arm"; PYREXIA (non-serious) with onset 28Oct2021 22:00, outcome "not recovered", described as "Fever". Therapeutic measures were not taken as a result of pain in extremity, pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anaesthesia, SARS-CoV-2 test
Clinical narrative: First dose felt like waking from anesthesia.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Latex Allergy" (unspecified if ongoing), notes: known allergies:  Latex. Eye drops; "Eye drops" (unspecified if ongoing), notes: known allergies:  Latex. Eye drops. Concomitant medication(s) included: VIT D [COLECALCIFEROL]. The following information was reported: ANAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "First dose felt like waking from anesthesia.". The event "first dose felt like waking from anesthesia." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anaesthesia.  Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Breast mass, Mammogram
Clinical narrative: might have breast cancer; I had a bad mammogram/showed I have a mass; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (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: BREAST CANCER (medically significant) with onset 2021, outcome "unknown", described as "might have breast cancer"; BREAST MASS (non-serious) with onset 2021, outcome "unknown", described as "I had a bad mammogram/showed I have a mass". The patient underwent the following laboratory tests and procedures: mammogram: she had a mass, notes: She had a bad mammogram.  Clinical course: she was supposed to take the second dose on the 1st. she had a bad mammogram. It showed she have a mass and she need more screenings and they couldn't get me a date until the 18th and I am leaving the country on the 20th. I rescheduled for the 8th. Can she go past that date10/13 was her first dose. In the clinical study, the second dose was allowed to be given 19-23 days after the first dose. The CDC has provided some interim considerations stating individuals who receive the second dose up to 4 days before or at any time after the recommended date can be considered fully vaccinated.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ecthyma, Feeling hot, Immunisation, Pain, Vaccination site erythema
Clinical narrative: the spot of redness is probably about the soft ball size; its hot,  I touch it, its very warm; its itchy; Redness; heat; the ecthyma those symptoms around the injection site; booster; little bit of pain; Swelling; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 05Nov2021 15:30 (Lot number: FF8839, Expiration Date: Dec2021) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "headache" (unspecified if ongoing), notes: Just an occasional Tylenol for headache every once in a while. Concomitant medication(s) included: TYLENOL taken for headache. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 05Nov2021 15:30, outcome "unknown", described as "little bit of pain"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "the spot of redness is probably about the soft ball size"; VACCINATION SITE WARMTH (non-serious), outcome "not recovered", described as "its hot, I touch it, its very warm"; ECTHYMA (non-serious) with onset 06Nov2021, outcome "unknown", described as "the ecthyma those symptoms around the injection site"; IMMUNISATION (non-serious) with onset 05Nov2021 15:30, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Injection site pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 06Nov2021, outcome "not recovered", described as "Redness"; VACCINATION SITE SWELLING (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Swelling"; FEELING HOT (non-serious) with onset 06Nov2021, outcome "not recovered", described as "heat"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "its itchy".  Additional information: it was reported patient having an adverse reaction to my third shot of COVID vaccine. Stated since the vaccination have had injection site pain, and redness and swelling and heat and so she is now here on November 8th at 6pm and still have that. So and beside the redness and its itchy, the size of the spot of redness is probably about the soft ball size. Also reported ecthyma those symptoms around the injection site started on the night on Saturday, so she got the shot she had of course little bit of pain when se got it but the redness and the heat and everything around it started on the night on Saturday. She expected it for a day or 2 but now several day passed and she really shocked by how much, mean its hot, se touch it, its very warm.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: the spot of redness is probably about the soft ball size; its hot,  I touch it, its very warm; its itchy; Redness; heat; the ecthyma those symptoms around the injection site; booster; little bit of pain; Swelling; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 05Nov2021 15:30 (Lot number: FF8839, Expiration Date: Dec2021) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "headache" (unspecified if ongoing), notes: Just an occasional Tylenol for headache every once in a while. Concomitant medication(s) included: TYLENOL taken for headache. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 05Nov2021 15:30, outcome "unknown", described as "little bit of pain"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "the spot of redness is probably about the soft ball size"; VACCINATION SITE WARMTH (non-serious), outcome "not recovered", described as "its hot, I touch it, its very warm"; ECTHYMA (non-serious) with onset 06Nov2021, outcome "unknown", described as "the ecthyma those symptoms around the injection site"; IMMUNISATION (non-serious) with onset 05Nov2021 15:30, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Injection site pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 06Nov2021, outcome "not recovered", described as "Redness"; VACCINATION SITE SWELLING (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Swelling"; FEELING HOT (non-serious) with onset 06Nov2021, outcome "not recovered", described as "heat"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "its itchy".  Additional information: it was reported patient having an adverse reaction to my third shot of COVID vaccine. Stated since the vaccination have had injection site pain, and redness and swelling and heat and so she is now here on November 8th at 6pm and still have that. So and beside the redness and its itchy, the size of the spot of redness is probably about the soft ball size. Also reported ecthyma those symptoms around the injection site started on the night on Saturday, so she got the shot she had of course little bit of pain when se got it but the redness and the heat and everything around it started on the night on Saturday. She expected it for a day or 2 but now several day passed and she really shocked by how much, mean its hot, se touch it, its very warm.  Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: mild fatigue; abdomen pain; loose stool; Adult dose of covid vaccine accidentally given to child at a pharmacy instead of flu shot; Adult dose of covid vaccine accidentally given to child at a pharmacy instead of flu shot; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 6 year-old patient received bnt162b2 (BNT162B2), administration date 24Oct2021 (Batch/Lot number: unknown) at the age of 6 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), WRONG PRODUCT ADMINISTERED (non-serious) all with onset 24Oct2021, outcome "unknown" and all described as "Adult dose of covid vaccine accidentally given to child at a pharmacy instead of flu shot"; FATIGUE (non-serious), outcome "unknown", described as "mild fatigue"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "abdomen pain"; DIARRHOEA (non-serious), outcome "unknown", described as "loose stool". The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up attempts are completed, no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Hypoaesthesia oral, Inappropriate schedule of product administration, Oropharyngeal discomfort, SARS-CoV-2 test
Clinical narrative: My tongue feels slightly numb; my throat feel uncomfortable; lips feel numbness; 1st dose:17Mar2021/ 2nd dose:23Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADD" (unspecified if ongoing); "milk allergy" (unspecified if ongoing); "food allergy" (unspecified if ongoing); "dye allergy" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 01:00 AM), administration date: 17Mar2021, when the patient was 33 years old, for COVID-19 immunisation, reaction(s): "anaphylaxis reaction", "strong intestinal pain", "COVID-19 Positive". The following information was reported: HYPOAESTHESIA ORAL (non-serious) with onset 08Nov2021 15:45, outcome "recovered" (2021), described as "My tongue feels slightly numb"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 08Nov2021 15:45, outcome "recovered" (2021), described as "my throat feel uncomfortable"; HYPOAESTHESIA ORAL (non-serious) with onset 08Nov2021 15:45, outcome "recovered" (2021), described as "lips feel numbness"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Aug2021, outcome "unknown", described as "1st dose:17Mar2021/ 2nd dose:23Aug2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia oral, oropharyngeal discomfort, hypoaesthesia oral.  Additional information: The patient was not pregnant at time of vaccination. The patient did not receive other vaccine in four weeks. The course of events was as follows: Patient normally had a milk allergy when she received her dose she should have had a anaphylaxis reaction days later when she had a interaction with she forgot to ask for special instructions on a food ordered for curbside. Patient normally would as she have. She then started testing my allergy/ sensitivity. Normally it takes several eppi pens to normalize the reaction and following days strong intestinal pain. But absolutely no issues with milk adverse reactions. She had her last dose in August and she can tell that her allergy was now coming back. The patient slowly getting adverse side effects back. Her tongue felt slightly numb and her throat felt uncomfortable lips felt numbness.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: passed away from covid and the doctors did not find any antibodies in his system; passed away from covid and the doctors did not find any antibodies in his system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male 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: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "passed away from covid and the doctors did not find any antibodies in his system". The patient date of death was unknown. The reported cause of death was drug ineffective, covid-19. It was not reported if an autopsy was performed. The reporter asked why did then vaccine fail and wanted to know why this happened and if this had happened to anyone else. The reporter was very angry that believed this vaccine would save lives if ever contracted the virus. Now the reporter's father (patient) was gone. The reporter asked if this was something missed when doing the clinical trials.  The lot number for bnt162b2 was not provided and will be requested during follow up. ; Reported Cause(s) of Death: passed away from covid and the doctors did not find any antibodies in his system; passed away from covid and the doctors did not find any antibodies in his system
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Became positive for COVID; Became positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24May2021 (Lot number: EW0185) at the age of 27 years as dose 2, single and administered in arm right, administration date 03May2021 (Lot number: EW0173) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Nov2021, outcome "recovering" and all described as "Became positive for COVID". Patient had no covid prior vaccination. Became positive for COVID - loss of smell, minor headache, congestion from 14Nov2021. The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Nasal Swab): (16Nov2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective (tested positive for COVID); Tested positive for COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective (tested positive for COVID)"; COVID-19 (medically significant), outcome "unknown", described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Illness, Immunisation, Immunodeficiency
Clinical narrative: received the Pfizer Covid vaccine booster dose.; immunocompromised; feeling weak; fever; and "not feeling herself at all."; fallen ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 84 year-old female patient 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 (medically significant), outcome "unknown", described as "received the Pfizer Covid vaccine booster dose."; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised"; ASTHENIA (non-serious), outcome "unknown", described as "feeling weak"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "and "not feeling herself at all.""; ILLNESS (non-serious), outcome "unknown", described as "fallen ill".  Clinical course: Caller states her 84 y/o aunt recently received the Pfizer Covid vaccine booster dose. She does not know the date but reports that after the booster dose she has been feeling weak, has a fever, and "not feeling herself at all." She wants to know what she can do to make sure she doesn't die. Patient took the third dose, the booster dose. Caller also referred to it as the second booster dose. Patient is immunocompromised. Patient has fallen ill.  Caller just doesn't know and doesn't want the patient to pass. Caller doesn't know if this is something temporary or if there's something she can do. Asking in the clinical trials if there are older people who have had the same symptoms? Asked if these older people passed away? Stated she has been transferred like 10 times now.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: received the Pfizer Covid vaccine booster dose.; immunocompromised; feeling weak; fever; and "not feeling herself at all."; fallen ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 84 year-old female patient 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 (medically significant), outcome "unknown", described as "received the Pfizer Covid vaccine booster dose."; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised"; ASTHENIA (non-serious), outcome "unknown", described as "feeling weak"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "and "not feeling herself at all.""; ILLNESS (non-serious), outcome "unknown", described as "fallen ill".  Clinical course: Caller states her 84 y/o aunt recently received the Pfizer Covid vaccine booster dose. She does not know the date but reports that after the booster dose she has been feeling weak, has a fever, and "not feeling herself at all." She wants to know what she can do to make sure she doesn't die. Patient took the third dose, the booster dose. Caller also referred to it as the second booster dose. Patient is immunocompromised. Patient has fallen ill.  Caller just doesn't know and doesn't want the patient to pass. Caller doesn't know if this is something temporary or if there's something she can do. Asking in the clinical trials if there are older people who have had the same symptoms? Asked if these older people passed away? Stated she has been transferred like 10 times now.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Pain, Pyrexia
Clinical narrative: Fainting in the shower with white out vision; Uncontrollable shaking and convulsions; Fever of 103.3 degrees F.; Uncontrollable shaking and convulsions; Body Aches; Chills/Teeth Chattering; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 11:30 (Lot number: FF2587) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Prior to vaccination, was the patient did not diagnose with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 07:00 AM), administration date: 30Mar2021, when the patient was 33 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 07:00 AM), administration date: 09Mar2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021 11:30, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Fainting in the shower with white out vision"; SEIZURE (medically significant) with onset 18Nov2021 17:00, outcome "recovered" (Nov2021), PYREXIA (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021) and all described as "Fever of 103.3 degrees F."; TREMOR (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Uncontrollable shaking and convulsions"; PAIN (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Body Aches"; CHILLS (non-serious) with onset 18Nov2021 17:00, outcome "recovered" (2021), described as "Chills/Teeth Chattering". The patient underwent the following laboratory tests and procedures: body temperature: (18Nov2021) 103.3 Fahrenheit, notes: 17:00. Since the vaccination, has the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.