chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Lymphadenopathy, Pain
Clinical narrative: Mental fog; Extreme body ache; Fever; Chills; Fatigue; Swollen Lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 11:45 (Lot number: ff8841) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPRINTEC. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: en6199, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 32 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en5318, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 32 years old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Mental fog"; PAIN (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Extreme body ache"; PYREXIA (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Fatigue"; LYMPHADENOPATHY (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Swollen Lymph nodes". Therapeutic measures were taken as a result of feeling abnormal, pain, pyrexia, chills, fatigue, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient took Sprintec within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Patient received treatment of Acetaminophen for the events. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mental fog; Extreme body ache; Fever; Chills; Fatigue; Swollen Lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 11:45 (Lot number: ff8841) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPRINTEC. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: en6199, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 32 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en5318, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 32 years old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Mental fog"; PAIN (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Extreme body ache"; PYREXIA (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Fatigue"; LYMPHADENOPATHY (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Swollen Lymph nodes". Therapeutic measures were taken as a result of feeling abnormal, pain, pyrexia, chills, fatigue, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient took Sprintec within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Patient received treatment of Acetaminophen for the events. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Emotional disorder
Clinical narrative: emotional feelings; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 26Oct2021 (Batch/Lot number: unknown) at the age of 32 years as dose 1 single for covid-19 immunisation. Relevant medical history included: "Lung cancer", start date: 2004 (unspecified if ongoing). There were no concomitant medications. The following information was reported: EMOTIONAL DISORDER (non-serious) with onset 26Oct2021, outcome "not recovered", described as "emotional feelings".  Additional information: He got his first dose of COVID19 vaccine about a week ago. He has been searching online about side effects and thinks he is experiencing something new. It was definitely not there before the vaccine. When asked to explain the side effects that he is experiencing caller stated he is experiencing emotional feelings. It started as soon as the shot entered the body. He got the vaccine on Tuesday, 26Oct2021. The emotional feeling is still happening. Caller confirmed that his emotional feelings are not thoughts of self-harm. No prior vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. No lab test and no additional vaccines administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; was tired for a few hours; 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 66 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm, administration date 26Jan2021 09:00 (Lot number: EL9262) at the age of 66 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "was tired for a few hours".  Additional information: Patient stated that with the first dose of the Pfizer Covid 19 vaccine she had side effects of sore arm and was tired for a few hours that afternoon but states that with the second dose and the booster dose she did not experience any side effects.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Investigation
Clinical narrative: atrial flutter; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 (Lot number: EW0177) at the age of 51 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 (Suspect Product: , First vaccine: , Date: 27Apr2021, Time: unknown, NDC/expiration: unknown, Lot: ER8736, Site: right arm), administration date: 27Apr2021, when the patient was 51 years old, for Covid-19 Immunization. The following information was reported: ATRIAL FLUTTER (non-serious) with onset Aug2021, outcome "not recovered", described as "atrial flutter". The event "atrial flutter" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller states he had the vaccine, both shots, reclarifies as the Pfizer Covid 19 vaccine. Caller states he had atrial flutter after the second vaccine. Caller enquires if anyone reported this event. Caller asked if  it related to the vaccine. Caller states he had seen a cardiologist for his arterial flutter, and it was diagnosed on his Apple watch when he had some discomfort. Caller states he had testing done, and it was confirmed as flutter from 48-165 beats per minute, not fibrillation. Caller stated the flutter was more rhythmic and sequenced then the fibrillation.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on upper body and face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 20:45 (Lot number: FE3590) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pcos" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing); "soy" (unspecified if ongoing); "fish" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing); "Known allergies: peanuts" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC; METOPROLOL. Past drug history included: Erythromycin, reaction(s): "Known allergies: erythromycin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 16:30 PM), administration date: 26Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ENC6202, Location of injection: Arm Left, Vaccine Administration Time: 14:30 PM), administration date: 25Feb2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 05Nov2021 21:00, outcome "not recovered", described as "Itchy rash on upper body and face". Therapeutic measures were not taken as a result of rash pruritic.  Additional information: Patient did not receive any other vaccine within 4 weeks. Patient was not tested to covid-19 prior to vaccine and not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test negative
Clinical narrative: hair lose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 13:00 (Lot number: EL1283) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "shell fish" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; HYDROCHLOROTHIAZIDE; LAMICTAL; BUSPAR. Past drug history included: Phenergan for Phenergan:Allergy. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL5730, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 21Dec2020, when the patient was 26 years old, for Covid-19 Immunisation. The following information was reported: ALOPECIA (non-serious) with onset Jan2021, outcome "unknown", described as "hair lose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information- Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Vyvanse, hydroclothized, lamictal, buspar. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient tested for COVID-19. Device Date : 06Nov2021. The patient had hair lose since January and 2 days after booster the patient menstrual cycle came early and with bleeding heavy.  No follow-up attempts are needed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Sore left arm; lymph node on left side is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 17:00 (Lot number: FK5127) at the age of 11 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: PAIN IN EXTREMITY (non-serious) with onset 06Nov2021 10:00, outcome "unknown", described as "Sore left arm"; LYMPHADENOPATHY (non-serious) with onset 06Nov2021 10:00, outcome "unknown", described as "lymph node on left side is swollen". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: Facility type vaccine other: Vaccination Clinic. No other vaccine taken in four weeks. No other medications taken in two weeks. No Covid prior vaccination. Not tested for Covid post vaccination. No Known allergies  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: mild sore shoulder for me; The injection site is also a little tender (2 out of 10), but nothing like the Pfizer site (7-8 out of 10); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 20:00 (Lot number: EL9265) at the age of 67 years as dose 1, single and administered in arm left, administration date 22Mar2021 20:00 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. Relevant medical history included: " Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LANTUS; METFORMIN; EXFORGE. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "mild sore shoulder for me"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "The injection site is also a little tender (2 out of 10), but nothing like the Pfizer site (7-8 out of 10)". Therapeutic measures were not taken as a result of arthralgia, vaccination site pain.  Additional information: The patient stated both me and my wife were vaccinated at same times and locations for all three doses. The patient stated the first two doses let to a mild sore shoulder for me but not for my wife. The patient stated booster injection for both of us were very painful, and our arms (right rear) continues to be very tender and painful 20 hours later. The patient stated we also received our senior dose Flu shot in the same right (front) arms. The patient stated this injection site is also a little tender (2 out of 10), but nothing like the Pfizer site (7-8 out of 10). The adverse event start date reported as 05Nov2021 at 17:00. The patient received the third dose of BNT162B2, administered in arm right, administration date 05Nov2021 19:00 (Lot number: FH8027) at the age of 68 years as dose 3 (booster), single. On the same day, the patient received Flu vaccine (Lot number: unknown) as dose 1 in arm right. Vaccine was administered at pharmacy or drug store. The patient was not received other vaccines within four weeks prior to the COVID-19 vaccine. Other medications the patient received within 2 weeks of vaccination were Lantus, Metformin, generic ExForge. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye pain, Eye swelling, Ocular hyperaemia
Clinical narrative: Looks a lot like Conjunctivitis; it is red and swollen and oozy; it is red and swollen and oozy; left eye hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. This consumer reported for a 05-year-old female patient (daughter).  A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 10:00 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE].  The following information was reported: CONJUNCTIVITIS (non-serious) with onset 06Nov2021 19:00, outcome "not recovered", described as "Looks a lot like Conjunctivitis"; EYE SWELLING (non-serious), OCULAR HYPERAEMIA (non-serious) all with onset 06Nov2021 19:00, outcome "not recovered" and all described as "it is red and swollen and oozy"; EYE PAIN (non-serious) with onset 06Nov2021 19:00, outcome "not recovered", described as "left eye hurt". The events "looks a lot like conjunctivitis", "it is red and swollen and oozy", "it is red and swollen and oozy" and "left eye hurt" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of conjunctivitis, eye swelling, ocular hyperaemia, eye pain.  Additional Information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. No COVID tested post vaccination. Adverse event: At 7 PM my daughter complained that her left eye hurt, I looked at it and it is red and swollen and oozy. Looks a lot like Conjunctivitis but she didn't have any issues before the vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit.  Follow-Up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia
Clinical narrative: 101.2 degree fever that broke on its own after about 3 hours; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) via Pfizer Colleague.  A 5-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 05Nov2021 15:30 (Lot number: 30155BA) at the age of 5 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: PYREXIA (non-serious) with onset 06Nov2021 16:00, outcome "recovered" (06Nov2021 19:00), described as "101.2-degree fever that broke on its own after about 3 hours"; DIARRHOEA (non-serious) with onset 06Nov2021 16:00, outcome "not recovered", described as "Diarrhoea". The patient underwent the following laboratory tests and procedures: body temperature: (06Nov2021) 101.2. Therapeutic measures were not taken as a result of pyrexia, diarrhoea.  Additional information: Facility type vaccine Other. No other vaccine in four weeks. No other medications in two weeks. Adverse event 101.2-degree fever that broke on its own after about 3 hours. Diarrhoea that continues to persist. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Other medical history None. Awareness date 06Nov2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: I noticed minor digestive problems before the 2nd shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 17Feb2021 13:15 (Lot number: EN6199) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lactose intolerance" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "mild allergy of eggplant & food ingredients" (unspecified if ongoing); "mild allergy of eggplant & food ingredients" (unspecified if ongoing); "normal colonoscopy 2 years Prior" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Augmentin, reaction(s): "Allergic to Augmentin". The following information was reported: DYSPEPSIA (non-serious) with onset 2021, outcome "recovering", described as "I noticed minor digestive problems before the 2nd shot". The event "i noticed minor digestive problems before the 2nd shot" was evaluated at the physician office visit. Therapeutic measures were taken as a result of dyspepsia.  Additional information: The patient had no covid prior to vaccination and was not tested for covid post vaccination. No prior vaccination. The patient did not receive any other vaccine in in four weeks. Other medications in two weeks included OTC multivitamin one per day. The patient received treatment with unspecified medication.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Patient reported on social media that she was very sick after receiving the second dose of Pfizer Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 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: ILLNESS (non-serious), outcome "unknown", described as "Patient reported on social media that she was very sick after receiving the second dose of Pfizer Covid Vaccine".  Additional information: Event took place after use of product  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Condition aggravated, Inflammation, Lymph node pain, Nausea
Clinical narrative: Pain in lymph nodes; nausea; pain in ovary-area; perhaps linked to inflammation and PCOS flare up with vaccination; perhaps linked to inflammation and PCOS flare up with vaccination; perhaps linked to inflammation and PCOS flare up with vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Nov2021 17:30 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE; PAXIL [PIROXICAM]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Card with info not on me at this time), administration date: 15Jan2021, when the patient was 27 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Card not available at this time , Location of injection: Arm Right), administration date: 2021, for COVID-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Pain in lymph nodes"; NAUSEA (non-serious) with onset 05Nov2021, outcome "not recovered", described as "nausea"; ADNEXA UTERI PAIN (non-serious) with onset 05Nov2021, outcome "not recovered", described as "pain in ovary-area"; INFLAMMATION (non-serious), POLYCYSTIC OVARIES (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 05Nov2021, outcome "not recovered" and all described as "perhaps linked to inflammation and PCOS flare up with vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, nausea, adnexa uteri pain, inflammation, polycystic ovaries, condition aggravated.  Additional information- It was reported that Facility where the most recent COVID-19 vaccine was administered: Nursing Home,Senior Living Facility.The patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination,  the patient  was not diagnosed with COVID-19 and Since the vaccination,  the patient had  been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Polycystic ovaries, SARS-CoV-2 test
Clinical narrative: Pain in lymph nodes; nausea; pain in ovary-area; perhaps linked to inflammation and PCOS flare up with vaccination; perhaps linked to inflammation and PCOS flare up with vaccination; perhaps linked to inflammation and PCOS flare up with vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Nov2021 17:30 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE; PAXIL [PIROXICAM]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Card with info not on me at this time), administration date: 15Jan2021, when the patient was 27 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Card not available at this time , Location of injection: Arm Right), administration date: 2021, for COVID-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Pain in lymph nodes"; NAUSEA (non-serious) with onset 05Nov2021, outcome "not recovered", described as "nausea"; ADNEXA UTERI PAIN (non-serious) with onset 05Nov2021, outcome "not recovered", described as "pain in ovary-area"; INFLAMMATION (non-serious), POLYCYSTIC OVARIES (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 05Nov2021, outcome "not recovered" and all described as "perhaps linked to inflammation and PCOS flare up with vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, nausea, adnexa uteri pain, inflammation, polycystic ovaries, condition aggravated.  Additional information- It was reported that Facility where the most recent COVID-19 vaccine was administered: Nursing Home,Senior Living Facility.The patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination,  the patient  was not diagnosed with COVID-19 and Since the vaccination,  the patient had  been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Tremor
Clinical narrative: had crazy shakes later in the evening/her arms just started to shake like she had chills but no fever/couldn't control the shaking in her hands or body; had crazy shakes later in the evening/her arms just started to shake like she had chills but no fever/couldn't control the shaking in her hands or body; had crazy shakes later in the evening/her arms just started to shake like she had chills but no fever/couldn't control the shaking in her hands or body; fell asleep exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: Covid-19 vaccine (1st dose, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (2nd dose, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: TREMOR (non-serious), CHILLS (non-serious), TREMOR (non-serious), outcome "unknown" and all described as "had crazy shakes later in the evening/her arms just started to shake like she had chills but no fever/couldn't control the shaking in her hands or body"; FATIGUE (non-serious), outcome "unknown", described as "fell asleep exhausted". Therapeutic measures were taken as a result of tremor, chills, tremor, fatigue.  Additional Information: Caller calling to report on herself and during report stated her older sister just her booster and she had crazy shakes later in the evening, her husband was in bed and she was cleaning up and her arms just started to shake like she had chills but no fever. Caller states she couldn't control the shaking in her hands or body. States her husband gave her Ibuprofen and she laid in bed and fell asleep exhausted. States she got her booster at the same place. Caller stated she got the Pfizer Covid booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Ultrasound scan
Clinical narrative: I am aching and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 (Lot number: FE3590) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing); "Acid Reflux" (unspecified if ongoing); "Gout" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; DEXILANT; ESCITALOPRAM; ALLOPURINOL; VITAMIN D2. Past drug history included: Prolixin injection. 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 06Nov2021, outcome "unknown", described as "I am aching and pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Consumer stated, I am having a reaction from taking the Pfizer booster shot vaccine, 2 days ago on Friday and I am aching and pain. I was wondering, what could I do for pain. I have taken something for pain. I took some for-pain Ibuprofen (Intent: Treatment) about 4 hours ago and I just took 2 more Ibuprofen just about 30 minutes ago for the pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: I skipped one menstrual cycle following dose 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 26Oct2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Adhd" (unspecified if ongoing), notes: other medical history: Adhd,; "Anxiety Disorder" (unspecified if ongoing), notes: other medical history: Anxiety Disorder, smoker; "smoker" (unspecified if ongoing), notes: other medical history: smoker. Concomitant medication(s) included: ADDERALL; CITALOPRAM; MARIJUANA. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: Unknown. Unable to locate or read the details , Location of injection: Arm Left), for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "I skipped one menstrual cycle following dose 2". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination was Adderral, citalipran, marijuana.Prior to vaccination, was the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, SARS-CoV-2 test
Clinical narrative: Red blood spots on left forearm begin bright red, disappear in a few days and turn brown a few months after 2nd dose.; Shingles on left thigh-mild about 3 months after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 14:00 (Lot number: EW0150) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies: penicillin" (unspecified if ongoing); "Allergies: shellfish" (unspecified if ongoing); "Allergies: dairy intolerance" (unspecified if ongoing); "asthma", start date: Mar2017 (ongoing), notes: current, Illness/AE: Asthma, Pertinent Details: QUAR 80 mcg 2 puffs 2x/day; "ibs" (not ongoing), notes: recovered; "celiac" (unspecified if ongoing); "chronic fatigue" (not ongoing), notes: recovered. Concomitant medication(s) included: QVAR taken for asthma; VIT D3; FOLATE; INFLUENZA VACCIN, administration date 01Oct2021. Past drug history included: Allergies: celiac (gluten), reaction(s): "Allergies: celiac (gluten) allergy"; Macrodentin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3302, Location of injection: Arm Left, Date: 12Mar2021, Time: 2 pm, Route of administration: Intramuscular), administration date: 12Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: ERYTHEMA (non-serious) with onset May2021, outcome "not recovered", described as "Red blood spots on left forearm begin bright red, disappear in a few days and turn brown a few months after 2nd dose."; HERPES ZOSTER (non-serious) with onset 2021, outcome "not recovered", described as "Shingles on left thigh-mild about 3 months after second dose". The events "red blood spots on left forearm begin bright red, disappear in a few days and turn brown a few months after 2nd dose." and "shingles on left thigh-mild about 3 months after second dose" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of erythema, herpes zoster.  Additional information: Red blood spots on left forearm begin bright red, disappear in a few days and turn brown a few months after 2nd dose. Once appeared on right forearm. No pain or itching. Just bright red small spots appear singly and in clusters-ranging between tiny pinpricks to 1/2 inch in diameter Shingles on left thigh-mild about 3 months after second dose. Patient was not covid prior vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Eyelid thickening, Visual impairment
Clinical narrative: Caller states the eye reaction didn't start until after the second shot, it started the next day.; 2 hard bumps under her eye; left eye completely sunken in; can't see that well; 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 49 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Lot number: EW0170) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "she got the filler injections", start date: 02Mar2021 (unspecified if ongoing), notes: she waited from the time she got the filler injections on 02Mar2021, 6 weeks. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose), administration date: 01Apr2021, when the patient was 48 years old, for Covid-19 Immunisation, reaction(s): "one of her eyes looks all messed up and she will need surgery to correct that problem; filler had to be removed; left eye completely sunken in; can't see that well; 2 hard bumps under her eye". The following information was reported: EYE DISORDER (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Caller states the eye reaction didn't start until after the second shot, it started the next day."; EYELID THICKENING (non-serious) with onset 23Apr2021, outcome "not recovered", described as "2 hard bumps under her eye"; VISUAL IMPAIRMENT (non-serious) with onset 23Apr2021, outcome "not recovered", described as "left eye completely sunken in; can't see that well". Additional information;- Caller states she has 2 hard bumps under her eye and she cannot do anything more about them. Caller states she has pictures and documentation, but she is not going to provide any of that yet, she wants to see what Pfizer is willing to do and then proceed forward.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: Severe chills; fever; body ache; diarrhea; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 18:00 (Lot number: CP7534) at the age of 40 years as dose 1, single and administered in arm left, administration date 07Apr2021 15:00 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies: Tree fruits" (unspecified if ongoing); "Allergies: nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Severe chills"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body ache"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional Information: patient experienced severe chills, fever, body ache, diarrhea and fatigue from 14:00 on day 2 which was 27 hrs after the booster shot. Felt worse than the 2nd shot and much worse than first shot. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccinations. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 38-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD0809), at the age of 38, in left arm, Oct 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had  lymphadenopathy (lymph node near left collarbone swelled-up a week after the COVID-19 vaccine), onset Nov 2, 2021, at 14:00, with outcome of not recovered. The event evaluated at a physician office visit. No therapeutic measures taken as a result of lymphadenopathy. Additional information: Prior to vaccination, patient not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, patient has not tested positive for COVID-19. The patient did not receive any treatment for the adverse events. No follow-up attempts possible. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: very painful, and our arms (right rear) continues to be very tender and painful 20 hours later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 19:00 (Lot number: FH8027) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 05Nov2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Diabetis" (unspecified if ongoing). Concomitant medication(s) included: LANTUS; METFORMIN; EXFORGE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 22Mar2021, when the patient was 68 years old, for COVID-19 Immunization, reaction(s): "first two doses to let to a mild sore shoulder for me"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 25Feb2021, when the patient was 67 years old, for COVID-19 Immunization, reaction(s): "first two doses to let to a mild sore shoulder for me". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Nov2021 21:00, outcome "not recovered", described as "very painful, and our arms (right rear) continues to be very tender and painful 20 hours later". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The Booster injection  were very painful, and our arms (right rear) continues to be very tender and painful 20 hours later. Also note that we also received our Senior dose Flu shot in the same right (front) arms. This injection site is also a little tender (2 out of 10), but nothing like the Pfizer site (7-8 out of 10). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. The patient had no known allergy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101531728 Same reporter/ drug/ event for different patients
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain
Clinical narrative: our arms (right rear) continues to be very tender; very painful, and our arms (right rear) continues to be very tender and painful 20 hours later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 19:00 (Lot number: FH8027) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 05Nov2021; LANTUS; METFORMIN; EXFORGE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 25Feb2021, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 22Mar2021, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine".  The following information was reported: TENDERNESS (non-serious) with onset 05Nov2021 21:00, outcome "not recovered", described as "our arms (right rear) continues to be very tender"; VACCINATION SITE PAIN (non-serious) with onset 05Nov2021 21:00, outcome "not recovered", described as "very painful, and our arms (right rear) continues to be very tender and painful 20 hours later". Therapeutic measures were not taken as a result of tenderness, vaccination site pain.  Additional information: The patient was vaccinated at the same times and locations for all three doses. The first two doses to let to a mild sore shoulder for her. The Booster injection for BOTH OF US were very painful, and her arms (right rear) continues to be very tender and painful 20 hours later. Also note that we also received our Senior dose Flu shot in the same right (front) arms. This injection site was also a little tender (2 out of 10), but nothing like the Pfizer site (7-8 out of 10)  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101531727 Same reporter/ drug/ event for different patients