chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: click palpitations; heart skipping a beat; take my breath away; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Sep2021 19:30 (Lot number: FC3180) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, lot number=EW0187,, administration time=01:30 PM,, vaccine location=Left arm), administration date: 07Aug2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: PALPITATIONS (non-serious) with onset Sep2021, outcome "unknown", described as "click palpitations"; EXTRASYSTOLES (non-serious) with onset Sep2021, outcome "unknown", described as "heart skipping a beat"; DYSPNOEA (non-serious) with onset Sep2021, outcome "unknown", described as "take my breath away". The events "click palpitations", "heart skipping a beat" and "take my breath away" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of palpitations, extrasystoles, dyspnoea.  Clinical course: Within a few days of the second vaccine, the patient began to develop around the click palpitations, heart skipping a beat, especially at rest or before going to sleep. It would actually take the breath away. Pulse and blood pressure (BP) were always good though.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, Since the vaccination. No known allergies and other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Myalgia, Vaccination site pain
Clinical narrative: mild headache; muscle and joint aches; muscle and joint aches; general unwell feeling; left arm started to feel sore (site of injection); 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 male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 11:00 (Lot number: EW0217) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Sep2021 18:00, outcome "unknown", described as "left arm started to feel sore (site of injection)"; HEADACHE (non-serious) with onset 30Sep2021, outcome "unknown", described as "mild headache"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 30Sep2021, outcome "unknown" and all described as "muscle and joint aches"; MALAISE (non-serious) with onset 30Sep2021, outcome "unknown", described as "general unwell feeling".  Additional Information: Facility where the most recent COVID-19 vaccine was administered was workplace clinic. known allergies and other medical history were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Clinical course was reported as, about 8h after receiving the booster shot, my left arm started to feel sore (site of injection). This morning I woke up with a mild headache, muscle and joint aches, and a general unwell feeling. Since the vaccination, the patient has not been tested for COVID-19. Case is reported as, non-serious. Device date was reported as, 30Sep2021.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Headache, Myalgia
Clinical narrative: excruciating headache; Fever; Chills; Muscle and joint aches; Muscle and joint aches; Weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Aug2021 (Lot number: FC3183) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: I had previously had COVID. Concomitant medication(s) included: ZYRTEC. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "excruciating headache"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Muscle and joint aches"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Weakness". Therapeutic measures were not taken as a result of headache, pyrexia, chills, myalgia, arthralgia, asthenia.  Additional information: The patient was not pregnant at the time of vaccination. After first dose the patient had excruciating headache, fever, chills, muscle and joint aches, weakness. These lasted about 14 hours. The patient had these symptoms after each dose even though she had previously had COVID. The patient did not received treatment for adverse event. The patient had no prior covid vaccination. The patient had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: excruciating headache; Fever; Chills; Muscle and joint aches; Muscle and joint aches; Weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Aug2021 (Lot number: FC3183) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: I had previously had COVID. Concomitant medication(s) included: ZYRTEC. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "excruciating headache"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Muscle and joint aches"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Weakness". Therapeutic measures were not taken as a result of headache, pyrexia, chills, myalgia, arthralgia, asthenia.  Additional information: The patient was not pregnant at the time of vaccination. After first dose the patient had excruciating headache, fever, chills, muscle and joint aches, weakness. These lasted about 14 hours. The patient had these symptoms after each dose even though she had previously had COVID. The patient did not received treatment for adverse event. The patient had no prior covid vaccination. The patient had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Inappropriate schedule of vaccine administered; Overdose; fever; muscle and joint aches; muscle and joint aches; weakness; nausea; stomach cramps; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: FC3183) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: I had previously had Covid. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: FC3183, Route of administration: Intramuscular, Anatomical Location: Arm Left), administration date: 27Aug2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "excruciating headache", "fever", "chills", "muscle and joint aches", "muscle and joint aches", "weakness". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "muscle and joint aches"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "weakness"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nausea"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered" (2021), described as "stomach cramps"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; OVERDOSE (non-serious) with onset 27Aug2021, outcome "unknown", described as "Overdose". Therapeutic measures were not taken as a result of pyrexia, myalgia, arthralgia, asthenia, nausea, abdominal pain upper.  Additional information: Reporter stated that, patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient was not diagnosed with COVID-19 prior to vaccination and patient had not been tested for COVID-19 since the vaccination. Patient was not hospitalized and no hospitalization prolonged. After second dose: fever, muscle and joint aches, weakness, nausea, stomach cramps. These lasted 48 hours. I had these symptoms after each dose even though I had previously had COVID.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Overdose, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine administered; Overdose; fever; muscle and joint aches; muscle and joint aches; weakness; nausea; stomach cramps; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: FC3183) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: I had previously had Covid. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: FC3183, Route of administration: Intramuscular, Anatomical Location: Arm Left), administration date: 27Aug2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "excruciating headache", "fever", "chills", "muscle and joint aches", "muscle and joint aches", "weakness". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "muscle and joint aches"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "weakness"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nausea"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered" (2021), described as "stomach cramps"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; OVERDOSE (non-serious) with onset 27Aug2021, outcome "unknown", described as "Overdose". Therapeutic measures were not taken as a result of pyrexia, myalgia, arthralgia, asthenia, nausea, abdominal pain upper.  Additional information: Reporter stated that, patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient was not diagnosed with COVID-19 prior to vaccination and patient had not been tested for COVID-19 since the vaccination. Patient was not hospitalized and no hospitalization prolonged. After second dose: fever, muscle and joint aches, weakness, nausea, stomach cramps. These lasted 48 hours. I had these symptoms after each dose even though I had previously had COVID.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives covering her back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2), administration date 30Sep2021 (Lot number: EW0164) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot Number: EW0164), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Hives covering her back".  Additional Context: NDC number, RA Number and expiry date of COVID-19 Vaccine was Unknown Reporter was just wondering if this was going to get worst or she is gonna be okay tonight or if reporter should call anybody else. Reporter was informed if urgent they can visit the Hospital or Emergency room. Further probing could not be initiated as reporter was unwilling to complete the report. Hence, product details, purchase details and other details were unknown and limited information was available over the call.  Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Feeling cold, Flatulence
Clinical narrative: Woke up at 3 am; Night sweats; Stomach pain; Threw up 3 times which made my stomach feel much better; Sat on toilet was only able to pass gas; laid flat on back on floor sweating with not enough energy to get back in bed for 10 minutes; Laid in bed under blankets cold and shivering; Broke out in fever; Laid in bed under blankets cold and shivering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 10:45 (Lot number: EW 0164) at the age of 21 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: prior to the vaccination the patient was diagnosed with Covid-19. Concomitant medication(s) included: VYVANSE. Vaccination history included: Bnt162b2 (Dose 1, lot number: FC 3181,, Administration date 17Aug2021,, Administration time 03:00 PM,, vaccine location: Left Arm), administration date: 17Aug2021, when the patient was 21 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Broke out in fever"; FEELING COLD (non-serious), CHILLS (non-serious) all with onset 29Sep2021 23:00, outcome "recovering" and all described as "Laid in bed under blankets cold and shivering"; TERMINAL INSOMNIA (non-serious) with onset 30Sep2021 03:00, outcome "recovering", described as "Woke up at 3 am"; NIGHT SWEATS (non-serious) with onset 30Sep2021 03:00, outcome "recovering", described as "Night sweats"; ABDOMINAL PAIN UPPER (non-serious) with onset 30Sep2021 03:00, outcome "recovering", described as "Stomach pain"; VOMITING (non-serious) with onset 30Sep2021, outcome "recovering", described as "Threw up 3 times which made my stomach feel much better"; FLATULENCE (non-serious) with onset 30Sep2021, outcome "recovering", described as "Sat on toilet was only able to pass gas"; ASTHENIA (non-serious) with onset 30Sep2021, outcome "recovering", described as "laid flat on back on floor sweating with not enough energy to get back in bed for 10 minutes". Therapeutic measures were taken as a result of pyrexia. Therapeutic measures were not taken as a result of feeling cold, terminal insomnia, chills, night sweats, abdominal pain upper, vomiting, flatulence, asthenia.  Additional Information: Patient took Dayquil to help with fever. Patient further reported that, once he woke up at 3:00 AM he again got back in bed and fell asleep till the fire alarm in his apartment went off at 5am and had to stand outside for 30 minutes.  Felt like a low fever at this point.  Went back to bed until 1:30pm and have had low amount of energy all day. It was sated that hospitalization prolonged as No. It was reported that, the patient was not tested for Covid-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Terminal insomnia, Vomiting
Clinical narrative: Woke up at 3 am; Night sweats; Stomach pain; Threw up 3 times which made my stomach feel much better; Sat on toilet was only able to pass gas; laid flat on back on floor sweating with not enough energy to get back in bed for 10 minutes; Laid in bed under blankets cold and shivering; Broke out in fever; Laid in bed under blankets cold and shivering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 10:45 (Lot number: EW 0164) at the age of 21 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: prior to the vaccination the patient was diagnosed with Covid-19. Concomitant medication(s) included: VYVANSE. Vaccination history included: Bnt162b2 (Dose 1, lot number: FC 3181,, Administration date 17Aug2021,, Administration time 03:00 PM,, vaccine location: Left Arm), administration date: 17Aug2021, when the patient was 21 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Broke out in fever"; FEELING COLD (non-serious), CHILLS (non-serious) all with onset 29Sep2021 23:00, outcome "recovering" and all described as "Laid in bed under blankets cold and shivering"; TERMINAL INSOMNIA (non-serious) with onset 30Sep2021 03:00, outcome "recovering", described as "Woke up at 3 am"; NIGHT SWEATS (non-serious) with onset 30Sep2021 03:00, outcome "recovering", described as "Night sweats"; ABDOMINAL PAIN UPPER (non-serious) with onset 30Sep2021 03:00, outcome "recovering", described as "Stomach pain"; VOMITING (non-serious) with onset 30Sep2021, outcome "recovering", described as "Threw up 3 times which made my stomach feel much better"; FLATULENCE (non-serious) with onset 30Sep2021, outcome "recovering", described as "Sat on toilet was only able to pass gas"; ASTHENIA (non-serious) with onset 30Sep2021, outcome "recovering", described as "laid flat on back on floor sweating with not enough energy to get back in bed for 10 minutes". Therapeutic measures were taken as a result of pyrexia. Therapeutic measures were not taken as a result of feeling cold, terminal insomnia, chills, night sweats, abdominal pain upper, vomiting, flatulence, asthenia.  Additional Information: Patient took Dayquil to help with fever. Patient further reported that, once he woke up at 3:00 AM he again got back in bed and fell asleep till the fire alarm in his apartment went off at 5am and had to stand outside for 30 minutes.  Felt like a low fever at this point.  Went back to bed until 1:30pm and have had low amount of energy all day. It was sated that hospitalization prolonged as No. It was reported that, the patient was not tested for Covid-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Movement disorder, Peripheral swelling, Pyrexia
Clinical narrative: 103 degree fever; feet are swollen; can''t move legs; She is feeling really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 13:00 (Lot number: 30155BA) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic asthmatic", start date: 11Sep2021 (ongoing), notes: Additional Information for Other Conditions: Diagnosed after 11Sep2001; "Nerve disease" (ongoing), notes: Additional Information for Other Conditions: Diagnosed 8 years ago; "Neoplasm malignant" (unspecified if ongoing), notes: Additional Information for Other Conditions: Is in remission. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT Number: EW0186, Route, Anatomical Location: right shoulder), administration date: 08Sep2021, when the patient was 57 years old, for Covid-19 Immunization.  The following information was reported: PYREXIA (non-serious) with onset 30Sep2021, outcome "unknown", described as "103 degree fever"; PERIPHERAL SWELLING (non-serious) with onset 30Sep2021, outcome "unknown", described as "feet are swollen"; MOVEMENT DISORDER (non-serious) with onset 30Sep2021, outcome "unknown", described as "can''t move legs"; FEELING ABNORMAL (non-serious) with onset 30Sep2021, outcome "unknown", described as "She is feeling really bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive Vaccine Administered at (Privacy) Facility. Additional Vaccines Administered on Same Date of the Pfizer Suspect, Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), AE(s) following prior vaccinations and Patient's Medical History (including any illness at time of vaccination)? were None.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: 103 degree fever; feet are swollen; can''t move legs; She is feeling really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 13:00 (Lot number: 30155BA) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic asthmatic", start date: 11Sep2021 (ongoing), notes: Additional Information for Other Conditions: Diagnosed after 11Sep2001; "Nerve disease" (ongoing), notes: Additional Information for Other Conditions: Diagnosed 8 years ago; "Neoplasm malignant" (unspecified if ongoing), notes: Additional Information for Other Conditions: Is in remission. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT Number: EW0186, Route, Anatomical Location: right shoulder), administration date: 08Sep2021, when the patient was 57 years old, for Covid-19 Immunization.  The following information was reported: PYREXIA (non-serious) with onset 30Sep2021, outcome "unknown", described as "103 degree fever"; PERIPHERAL SWELLING (non-serious) with onset 30Sep2021, outcome "unknown", described as "feet are swollen"; MOVEMENT DISORDER (non-serious) with onset 30Sep2021, outcome "unknown", described as "can''t move legs"; FEELING ABNORMAL (non-serious) with onset 30Sep2021, outcome "unknown", described as "She is feeling really bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive Vaccine Administered at (Privacy) Facility. Additional Vaccines Administered on Same Date of the Pfizer Suspect, Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), AE(s) following prior vaccinations and Patient's Medical History (including any illness at time of vaccination)? were None.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Disorientation
Clinical narrative: weakness; diarrhea; bad headaches; woozy; disorriented; fever/fever up to 102; chills; uncontrollable shaking for next 6 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 10:00 (Lot number: EL9267) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "aprox. 4 year remission from Non Hodgkins Lymphoma" (unspecified if ongoing), notes: aprox. 4 year remission from Non Hodgkins Lymphoma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Administration time: 10:00 AM, vaccine location: Left arm, lot number: EL9262,), administration date: 26Jan2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "woozy"; DISORIENTATION (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "disorriented"; PYREXIA (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "fever/fever up to 102"; CHILLS (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "chills"; TREMOR (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "uncontrollable shaking for next 6 hours"; ASTHENIA (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "weakness"; DIARRHOEA (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "diarrhea"; HEADACHE (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "bad headaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, disorientation, pyrexia, chills, tremor, diarrhoea, headache.  Additional information:  Reaction/event as reported by primary source: 1 hour after, woozy & disorriented. 3 hrs after: sudden onset of fever & chills, uncontrollable shaking for next 6 hours. On second day, fever up to 102, weakness and diarrhea, bad headaches. 3rd & 4th day : Headache, weakness & continued diarrhea. On 5th day weak but improved.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Patient did not received any other vaccines within 4 weeks prior to COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: weakness; diarrhea; bad headaches; woozy; disorriented; fever/fever up to 102; chills; uncontrollable shaking for next 6 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 10:00 (Lot number: EL9267) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "aprox. 4 year remission from Non Hodgkins Lymphoma" (unspecified if ongoing), notes: aprox. 4 year remission from Non Hodgkins Lymphoma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Administration time: 10:00 AM, vaccine location: Left arm, lot number: EL9262,), administration date: 26Jan2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "woozy"; DISORIENTATION (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "disorriented"; PYREXIA (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "fever/fever up to 102"; CHILLS (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "chills"; TREMOR (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "uncontrollable shaking for next 6 hours"; ASTHENIA (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "weakness"; DIARRHOEA (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "diarrhea"; HEADACHE (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "bad headaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, disorientation, pyrexia, chills, tremor, diarrhoea, headache.  Additional information:  Reaction/event as reported by primary source: 1 hour after, woozy & disorriented. 3 hrs after: sudden onset of fever & chills, uncontrollable shaking for next 6 hours. On second day, fever up to 102, weakness and diarrhea, bad headaches. 3rd & 4th day : Headache, weakness & continued diarrhea. On 5th day weak but improved.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Patient did not received any other vaccines within 4 weeks prior to COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Joint swelling, Musculoskeletal discomfort
Clinical narrative: Sore Neck; Achy muscles; Fever; Chills; Sweats; Swollen, sore joints; Swollen, sore joints; Has a bad back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 19:00 (Lot number: FA7484) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Feb2021 (unspecified if ongoing), notes: Verbatim: COVID-19. The patient's concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious) with onset 16Sep2021, outcome "recovering", described as "Sore Neck"; MYALGIA (non-serious) with onset 16Sep2021, outcome "recovering", described as "Achy muscles"; PYREXIA (non-serious) with onset 16Sep2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 16Sep2021, outcome "unknown", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 16Sep2021, outcome "unknown", described as "Sweats"; JOINT SWELLING (non-serious), ARTHRALGIA (non-serious) all with onset 16Sep2021, outcome "recovering" and all described as "Swollen, sore joints"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Has a bad back".  Additional Information: Caller states that all of his symptoms began on 16Sep2021. Says the aches and soreness are still bad, but getting better.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pyrexia
Clinical narrative: Sore Neck; Achy muscles; Fever; Chills; Sweats; Swollen, sore joints; Swollen, sore joints; Has a bad back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 19:00 (Lot number: FA7484) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Feb2021 (unspecified if ongoing), notes: Verbatim: COVID-19. The patient's concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious) with onset 16Sep2021, outcome "recovering", described as "Sore Neck"; MYALGIA (non-serious) with onset 16Sep2021, outcome "recovering", described as "Achy muscles"; PYREXIA (non-serious) with onset 16Sep2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 16Sep2021, outcome "unknown", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 16Sep2021, outcome "unknown", described as "Sweats"; JOINT SWELLING (non-serious), ARTHRALGIA (non-serious) all with onset 16Sep2021, outcome "recovering" and all described as "Swollen, sore joints"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Has a bad back".  Additional Information: Caller states that all of his symptoms began on 16Sep2021. Says the aches and soreness are still bad, but getting better.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Pain and swelling in the left axilla.; Pain and swelling in the left axilla.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 09:45 (Lot number: EW0217) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mitral valve replacement", start date: 1982 (unspecified if ongoing); "prophylaxis artificial heart valve" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for prophylaxis, start date: 1982 (ongoing); METOPROLOL taken for prophylaxis, start date: 2019 (ongoing); ASPIRIN taken for prophylaxis, start date: 1990 (ongoing); VITAMINS NOS; MINERALS NOS. Vaccination history included: Bnt162b2 (Dose:1, Anatomical site of injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 03Mar2021, when the patient was 47 years old, for COVID-19 Immunization; Bnt162b2 (Dose:02, Anatomical site of injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 Immunization.  The following information was reported: SWELLING (non-serious) with onset 30Sep2021, outcome "recovered" (03Oct2021), AXILLARY PAIN (non-serious) with onset 30Sep2021, outcome "recovered" (05Oct2021) and all described as "Pain and swelling in the left axilla.". Therapeutic measures were taken as a result of swelling, axillary pain.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No known allegies. Booster dose due to high risk of frequent or occupational exposure to coronavirus (and at risk of serious COVID-19 Complications)  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: FF2588) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, lot number: EL3247,, administration time: 16:00, dose number: 1,, vaccine location: Right arm), administration date: 14Jan2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache".  No follow-up attempts are possible. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Oral discomfort, Swelling face
Clinical narrative: Her mouth didn't feel right; looking now at her upper lip and it has started to swell; Her mouth is starting to swell; Her jaw was swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101301557 (Pfizer). A 92-year-old female patient received bnt162b2 (BNT162B2), administration date 01Oct2021 11:30 (Lot number: EW0186) at the age of 92 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing), notes: Her knees were kind of in pain prior to vaccination. Concomitant medication(s) included: TYLENOL taken for arthritis. Vaccination history included: Bnt162b2 (1st dose) for Covid-19 immunisation, Bnt162b2 (2nd dose) for Covid-19 immunisation. The following information was reported: ORAL DISCOMFORT (non-serious) with onset 01Oct2021, outcome "unknown", described as "Her mouth didn't feel right", LIP SWELLING (non-serious) with onset 01Oct2021, outcome "unknown", described as "looking now at her upper lip and it has started to swell", MOUTH SWELLING (non-serious) with onset 01Oct2021, outcome "unknown", described as "Her mouth is starting to swell", SWELLING FACE (non-serious) with onset 01Oct2021, outcome "unknown", described as "Her jaw was swelling".  Additional information: The patient had her booster or third dose of the Pfizer COVID-19 vaccine today at 11:30 am and was wearing a mask. When removed the mask, her mouth didn't feel right and noticed that her upper lip was swelling and mouth started to swell. Caller stated that she looks like someone hit her in the upper lip and mouth. Caller was looking at her face and on the left side of her face, her jaw was swelling a little and she is in the house by herself. Caller also stated that she took small amount of peanut butter and 2 Tylenol for her arthritis as her knees were kind of in pain prior to vaccination. Caller wanted to know if this had been reported side effect with the Pfizer COVID-19 vaccine and what she should do about it.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Rash pruritic
Clinical narrative: Red itchy bumps on the palms of both hands and on the bottom of both feet was reported as worsened; red itchy bumps on the palms of both hands and on the bottom of both feet; 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 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 (Lot number: 301458A) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date Sep2021. Vaccination history included: Bnt162b2 (First dose, LOT: EJ1686), administration date: 04Jan2021, when the patient was 32 years old, for COVID-19 Immunization, reaction(s): "none of these side effects after his previous 2 doses of the vaccine"; Bnt162b2 (Second dose, LOT: EN5318), administration date: 25Jan2021, when the patient was 32 years old, for COVID-19 Immunization, reaction(s): "none of these side effects after his previous 2 doses of the vaccine". The following information was reported: RASH PRURITIC (non-serious) with onset 29Sep2021, outcome "not recovered", described as "red itchy bumps on the palms of both hands and on the bottom of both feet"; CONDITION AGGRAVATED (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Red itchy bumps on the palms of both hands and on the bottom of both feet was reported as worsened".  Additional information: Patient received his Pfizer BT Covid vaccine booster shot 2 days ago on 29Sep2021. Since the shot he was experiencing "red itchy bumps on the palms of both hands and on the bottom of both feet and red itchy bumps on palms of both hands was reported as worsened." The caller states he had none of these side effects after his previous 2 doses of the vaccine. Vaccination Facility Type was Pharmacy. AE(s) did not require a visit to Emergency Room or Physician Office. Patient had no AE(s) following prior vaccinations. Relevant Tests was none.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: his arm to armpit region swollen, sore and pinkish; his arm to armpit region swollen, sore and pinkish; his arm to armpit region swollen, sore and pinkish/ swollen axillary my armpit area and tenderness and redness; swollen axillary my armpit area and tenderness and redness; He was not particular if it was a swollen lymph node/ swollen axillary my armpit area swollen axillary my armpit area and tenderness and redness; chills and fatigue; chills and fatigue; 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 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Sep2021 (Lot number: FC3183) 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 2, Single), administration date: 07Jan2021, for Covid-19 Immunization, reaction(s): "chills", "fatigue"; Bnt162b2 (Dose 1, Single), for Covid-19 Immunization, reaction(s): "chills", "fatigue". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Oct2021, outcome "not recovered", described as "He was not particular if it was a swollen lymph node/ swollen axillary my armpit area swollen axillary my armpit area and tenderness and redness"; CHILLS (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "not recovered" and all described as "chills and fatigue"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01Oct2021, outcome "not recovered" and all described as "his arm to armpit region swollen, sore and pinkish"; ERYTHEMA (non-serious) with onset 01Oct2021, outcome "not recovered", described as "his arm to armpit region swollen, sore and pinkish/ swollen axillary my armpit area and tenderness and redness"; TENDERNESS (non-serious) with onset 01Oct2021, outcome "not recovered", described as "swollen axillary my armpit area and tenderness and redness".  Additional Information: Reported patient woke up with his arm to armpit region swollen, sore and pinkish. He was not particular if it was a swollen lymph node. Reactogenicity profile within seven days of the booster dose was typically mild to moderate, with frequency of reactions similar to or lower than after the primary vaccination series. Symptoms after the booster shot was just a little bit of fatigue itself and patient did wake up today on third day after with swelling under my armpit and tenderness and redness.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021006181 same patient, events with dose 3/ booster
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: his arm to armpit region swollen, sore and pinkish; his arm to armpit region swollen, sore and pinkish; his arm to armpit region swollen, sore and pinkish/ swollen axillary my armpit area and tenderness and redness; swollen axillary my armpit area and tenderness and redness; He was not particular if it was a swollen lymph node/ swollen axillary my armpit area swollen axillary my armpit area and tenderness and redness; chills and fatigue; chills and fatigue; 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 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Sep2021 (Lot number: FC3183) 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 2, Single), administration date: 07Jan2021, for Covid-19 Immunization, reaction(s): "chills", "fatigue"; Bnt162b2 (Dose 1, Single), for Covid-19 Immunization, reaction(s): "chills", "fatigue". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Oct2021, outcome "not recovered", described as "He was not particular if it was a swollen lymph node/ swollen axillary my armpit area swollen axillary my armpit area and tenderness and redness"; CHILLS (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "not recovered" and all described as "chills and fatigue"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01Oct2021, outcome "not recovered" and all described as "his arm to armpit region swollen, sore and pinkish"; ERYTHEMA (non-serious) with onset 01Oct2021, outcome "not recovered", described as "his arm to armpit region swollen, sore and pinkish/ swollen axillary my armpit area and tenderness and redness"; TENDERNESS (non-serious) with onset 01Oct2021, outcome "not recovered", described as "swollen axillary my armpit area and tenderness and redness".  Additional Information: Reported patient woke up with his arm to armpit region swollen, sore and pinkish. He was not particular if it was a swollen lymph node. Reactogenicity profile within seven days of the booster dose was typically mild to moderate, with frequency of reactions similar to or lower than after the primary vaccination series. Symptoms after the booster shot was just a little bit of fatigue itself and patient did wake up today on third day after with swelling under my armpit and tenderness and redness.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021006181 same patient, events with dose 3/ booster