chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; Muscle aches; Pains throughout my body; Chills; Headache; Dose received: 3; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 38-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm, administration date 29Nov2021 at 11:00 (Batch/Lot number: FH8027) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included: NASAL SPRAY, CLARITIN and METROGEL. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: EP6953, Anatomical site: Left arm, Administration time: 09:15, Route of administration: Intramuscular), administration date: 31Mar2021, and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: EI3247, Anatomical site: Left arm, Administration time: 09:15, Route of administration: Intramuscular), administration date: 10Mar2021, both when the patient was 38 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 11:00, outcome "unknown", described as 'received 3rd dose of BNT162B2 Pfizer vaccine', VACCINATION SITE PAIN (non-serious), MYALGIA (non-serious), PAIN (non-serious), CHILLS (non-serious), HEADACHE (non-serious) all with onset 29Nov2021 at 22:00, outcome "recovering", and described as "soreness at injection site, muscle aches and pains throughout body, chills, headache". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, pain, chills and headache.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Immunisation, Pain
Clinical narrative: 2 days of fever at 102; Body aches; Headache/ lingering headache; Extreme fatigue/ moderate fatigue; Dose received 3/ Dose number=3; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 48-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 27Nov2021 at 10:45 (Batch/Lot number: FJ1620) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications included: GLUCOSAMINE; BIOTIN; ACV; CALCIUM, VIT D and OMEGA-3. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: EJ3247, Route of administration: Unspecified, Anatomical site: left arm, administration time: 12:00), administration date: 09Mar2021, when the patient was 48 years old, for COVID-19 immunisation and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: ER8734, Route of administration: Unspecified, Anatomical site: left arm, administration time: 12:00), administration date: 29Mar2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported:  PYREXIA (non-serious), PAIN (non-serious), HEADACHE (non-serious), FATIGUE (non-serious) all with onset 27Nov2021 at 22:00, outcome "recovering", described as "2 days of fever at 102, body aches, headache, extreme fatigue. 3rd day fever and body aches mostly gone, lingering headache and moderate fatigue". Therapeutic measures were not taken as a result of pyrexia, pain, headache and fatigue. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 2 days of fever at 102; Body aches; Headache/ lingering headache; Extreme fatigue/ moderate fatigue; Dose received 3/ Dose number=3; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 48-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 27Nov2021 at 10:45 (Batch/Lot number: FJ1620) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications included: GLUCOSAMINE; BIOTIN; ACV; CALCIUM, VIT D and OMEGA-3. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: EJ3247, Route of administration: Unspecified, Anatomical site: left arm, administration time: 12:00), administration date: 09Mar2021, when the patient was 48 years old, for COVID-19 immunisation and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: ER8734, Route of administration: Unspecified, Anatomical site: left arm, administration time: 12:00), administration date: 29Mar2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported:  PYREXIA (non-serious), PAIN (non-serious), HEADACHE (non-serious), FATIGUE (non-serious) all with onset 27Nov2021 at 22:00, outcome "recovering", described as "2 days of fever at 102, body aches, headache, extreme fatigue. 3rd day fever and body aches mostly gone, lingering headache and moderate fatigue". Therapeutic measures were not taken as a result of pyrexia, pain, headache and fatigue. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Persistent swollen lymph node: armpit of arm where injection made; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.   A 12-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date unknown (Batch/Lot number: UNKNOWN) as dose 1, single for COVID-19 immunisation and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 11Nov2021 (Batch/Lot number: UNKNOWN) at the age of 12 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "persistent swollen lymph node: armpit of arm where injection made". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Impaired healing, Joint injury, Limb injury
Clinical narrative: Fell down; Hurt knee; Hurt knee and hand; Any injury on body due to falling down etc takes more time to heal compared to how it used to be earlier / fell down and hurt knee and hand and it took almost 2-3 months to recover; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.   A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date unknown (Batch/Lot number: UNKNOWN) at the age of 41 years as dose 1, single for COVID-19 immunisation and also received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date unknown (Batch/Lot number: UNKNOWN) at the age of 41 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Brufen, reaction: "Drug allergy", notes: Known allergies: Brufen. The following information was reported: FALL (non-serious), JOINT INJURY (non-serious), LIMB INJURY (non-serious), IMPAIRED HEALING (non-serious), all with onset 07Aug2021, outcome "recovered with sequelae" (an unknown date in 2021), described as "any injury on body due to falling down etc., takes more time to heal compared to how it used to be earlier / fell down and hurt knee and hand and it took almost 2-3 months to recover". Therapeutic measures were not taken as a result of fall, joint injury, limb injury and impaired healing.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient reported that the same injury would have taken a week to recover before the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not 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: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Pyrexia
Clinical narrative: Dose received: 3/dose number = 3; Fever; Symptoms of rigors; Headache; Fatigue being more severe this time around; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 47 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 28Apr2021 at 18:00 (Batch/Lot number: EW0175) at the age of 46 years as dose 2 and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 28Nov2021 at 09:30 (Batch/Lot number: 33038BD) at the age of 47 years as dose 3 (booster); for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: ER8729, Route of administration: Unspecified, Anatomical site: left arm, administration time: 18:15), administration date: 07Apr2021, when the patient was 46 years old, for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), HEADACHE (non-serious), FATIGUE (non-serious) all with onset on an unknown date in 2021, outcome "recovered" on Nov2021 and all described as ''fever, symptoms of rigors, headache and fatigue being more severe this time around''. Therapeutic measures were not taken as a result of events pyrexia, chills, headache and fatigue.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Fever, rigors, headache and fatigue did not happen with 1st dose. It happened after 2nd dose, but completely resolved in a day. With 3rd booster, completely resolved after day and half. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mobility decreased, Peripheral swelling, Swelling
Clinical narrative: Left axilla swelling and lymph nodes; Left upper arm swelling (injected arm). Left arm noticeably larger than right arm; Left axilla swelling; Difficult raising injected left arm; This is a spontaneous report received from a non-contactable reporter (other healthcare professional). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 30Nov2021 (Batch/Lot number: FF8841) at the age of 28 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: PRENATAL, NORETHINDRONE and IBUPROFEN. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: FF8841, Route of administration: Unspecified, Anatomical site: left arm), administration date: 09Nov2021, when the patient was 28 years old, for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious), SWELLING (non-serious), LYMPHADENOPATHY (non-serious), MOBILITY DECREASED (non-serious) all with onset 30 Nov2021, outcome "not recovered" and all described as "Left upper arm swelling (injected arm). Left arm noticeably larger than right arm"; "Left axilla swelling and lymph nodes"; "Difficult raising injected left arm". Therapeutic measures were not taken as a result of peripheral swelling, swelling, lymphadenopathy and joint range of mobility decreased.  Additional Information: The patient had no known allergies. It was unknown whether the patient received any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Sensory loss, Somnolence
Clinical narrative: Loss of feeling in arm; Random tingling; falling asleep; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 30 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), unspecified route of administration, administered in left arm, administration date 22Nov2021, (Batch/Lot number: unknown) at the age of 30 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: Unknown, Route of administration: Unspecified, Anatomical site: left arm), administration date: Unknown, for COVID-19 immunisation. The following information was reported: SENSORY LOSS (non-serious), PARAESTHESIA (non-serious) and SOMNOLENCE (non-serious), all with onset 2021, outcome "not recovered", described as "Loss of feeling in arm, Random tingling and falling asleep". Therapeutic measures were not taken as a result of sensory loss, paraesthesia and somnolence. Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose increased, COVID-19, Cognitive disorder, Feeling abnormal
Clinical narrative: head to toe pain/Head severe pain; head to toe pain; Cognitive problems; Brain fog; elevated blood sugar/High blood sugar; Joint pain; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right, administration date 22Feb2021 10:00 (Lot number: EN6202) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes", start date: 2000 (ongoing); "Blood pressure" (ongoing); "Hypothyroidism" (ongoing); "Cholesterol" (ongoing); "Insomnia" (unspecified if ongoing); "Fibromyalgia", start date: 2009 (ongoing). Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); SYNTHROID taken for hypothyroidism (ongoing); ROSUVASTATIN taken for blood cholesterol (ongoing); TRAZODONE taken for insomnia (ongoing); DULOXETINE taken for fibromyalgia (ongoing). Vaccination history included: Bnt162b2 (DOSE: 1, Time: 11:00 AM, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch/Lot number: Lot# EL9262), administration date: 24Jan2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "Joint pain", "Head severe pain", "Nausea", "High blood sugar", "Brain fog", "Head to toe pain", "Cognitive problems", "bloody nose", "mild flu like symptoms", "severe pain in her stomach", "tongue was throbbing and hurt", "throat was hoarse", "cough/producing a lot of phlegm", "dyspnea", "slept for several days", "vaginal mucous", "eyes also feels like a film is over them", "gums began to hurt", "weakness", "body felt heavy", "fatigue, total exhaustion". The following information was reported: HEADACHE (disability) with onset 2021, outcome "recovering", described as "head to toe pain/Head severe pain"; PAIN IN EXTREMITY (disability) with onset 2021, outcome "recovering", described as "head to toe pain"; COGNITIVE DISORDER (disability) with onset 2021, outcome "recovering", described as "Cognitive problems"; FEELING ABNORMAL (disability) with onset 2021, outcome "recovering", described as "Brain fog"; BLOOD GLUCOSE INCREASED (medically significant) with onset 2021, outcome "recovered" (2021), described as "elevated blood sugar/High blood sugar"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (Apr2021), described as "Joint pain"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (Mar2021), described as "Nausea". The patient underwent the following laboratory tests and procedures: blood glucose increased: (2021) elevated, notes: elevated blood sugar/High blood sugar; covid-19: (2021) negative; magnetic resonance imaging: (Oct2021) unknown results. Therapeutic measures were not taken as a result of headache, pain in extremity. Therapeutic measures were taken as a result of blood glucose increased.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Nausea, Pain in extremity
Clinical narrative: head to toe pain/Head severe pain; head to toe pain; Cognitive problems; Brain fog; elevated blood sugar/High blood sugar; Joint pain; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right, administration date 22Feb2021 10:00 (Lot number: EN6202) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes", start date: 2000 (ongoing); "Blood pressure" (ongoing); "Hypothyroidism" (ongoing); "Cholesterol" (ongoing); "Insomnia" (unspecified if ongoing); "Fibromyalgia", start date: 2009 (ongoing). Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); SYNTHROID taken for hypothyroidism (ongoing); ROSUVASTATIN taken for blood cholesterol (ongoing); TRAZODONE taken for insomnia (ongoing); DULOXETINE taken for fibromyalgia (ongoing). Vaccination history included: Bnt162b2 (DOSE: 1, Time: 11:00 AM, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch/Lot number: Lot# EL9262), administration date: 24Jan2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "Joint pain", "Head severe pain", "Nausea", "High blood sugar", "Brain fog", "Head to toe pain", "Cognitive problems", "bloody nose", "mild flu like symptoms", "severe pain in her stomach", "tongue was throbbing and hurt", "throat was hoarse", "cough/producing a lot of phlegm", "dyspnea", "slept for several days", "vaginal mucous", "eyes also feels like a film is over them", "gums began to hurt", "weakness", "body felt heavy", "fatigue, total exhaustion". The following information was reported: HEADACHE (disability) with onset 2021, outcome "recovering", described as "head to toe pain/Head severe pain"; PAIN IN EXTREMITY (disability) with onset 2021, outcome "recovering", described as "head to toe pain"; COGNITIVE DISORDER (disability) with onset 2021, outcome "recovering", described as "Cognitive problems"; FEELING ABNORMAL (disability) with onset 2021, outcome "recovering", described as "Brain fog"; BLOOD GLUCOSE INCREASED (medically significant) with onset 2021, outcome "recovered" (2021), described as "elevated blood sugar/High blood sugar"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (Apr2021), described as "Joint pain"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (Mar2021), described as "Nausea". The patient underwent the following laboratory tests and procedures: blood glucose increased: (2021) elevated, notes: elevated blood sugar/High blood sugar; covid-19: (2021) negative; magnetic resonance imaging: (Oct2021) unknown results. Therapeutic measures were not taken as a result of headache, pain in extremity. Therapeutic measures were taken as a result of blood glucose increased.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Tremor
Clinical narrative: Her friend got really really cold; couldn't quit shaking lasted 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "Her friend got really really cold"; TREMOR (non-serious), outcome "unknown", described as "couldn't quit shaking lasted 24 hours ".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021219920 same reporter/drug/AE with different patient
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body mass index, Eye pain, Fatigue, Headache
Clinical narrative: pain over right eye; Armpit pain accompanied by injection site soreness; Armpit pain accompanied by injection site soreness; pain in left side armpit lymph node; tired; headache around back of head accompanied by flashing, slightly electric pains on top back left quadrant of head/ right forehead pain; headache around back of head accompanied by flashing; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 27Feb2021 08:15 (Batch/Lot number: unknown) at the age of 38 years, as dose 1, single for COVID-19 immunisation. Relevant medical history included: "obese/ overweight" (unspecified if ongoing), notes: BMI: 32; "High cholesterol" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "Oral allergy syndrome" (unspecified if ongoing); "severe tree pollen allergy" (unspecified if ongoing); "tree nuts allergy/ wheat sensitive" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA 24 HOUR; VITAMIN D; BIOTIN. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "pain in left side armpit lymph node"; FATIGUE (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "tired"; HEADACHE (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "headache around back of head accompanied by flashing, slightly electric pains on top back left quadrant of head/ right forehead pain"; PHOTOPSIA (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "headache around back of head accompanied by flashing"; EYE PAIN (non-serious) with onset 28Feb2021 08:15, outcome "recovering", described as "pain over right eye"; AXILLARY PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 28Feb2021 08:15, outcome "recovering" and all described as "Armpit pain accompanied by injection site soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, fatigue, headache, photopsia, eye pain, axillary pain, vaccination site pain.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was also concomitantly taking unspecified multivitamin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Photopsia, Vaccination site pain
Clinical narrative: pain over right eye; Armpit pain accompanied by injection site soreness; Armpit pain accompanied by injection site soreness; pain in left side armpit lymph node; tired; headache around back of head accompanied by flashing, slightly electric pains on top back left quadrant of head/ right forehead pain; headache around back of head accompanied by flashing; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 27Feb2021 08:15 (Batch/Lot number: unknown) at the age of 38 years, as dose 1, single for COVID-19 immunisation. Relevant medical history included: "obese/ overweight" (unspecified if ongoing), notes: BMI: 32; "High cholesterol" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "Oral allergy syndrome" (unspecified if ongoing); "severe tree pollen allergy" (unspecified if ongoing); "tree nuts allergy/ wheat sensitive" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA 24 HOUR; VITAMIN D; BIOTIN. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "pain in left side armpit lymph node"; FATIGUE (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "tired"; HEADACHE (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "headache around back of head accompanied by flashing, slightly electric pains on top back left quadrant of head/ right forehead pain"; PHOTOPSIA (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "headache around back of head accompanied by flashing"; EYE PAIN (non-serious) with onset 28Feb2021 08:15, outcome "recovering", described as "pain over right eye"; AXILLARY PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 28Feb2021 08:15, outcome "recovering" and all described as "Armpit pain accompanied by injection site soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, fatigue, headache, photopsia, eye pain, axillary pain, vaccination site pain.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was also concomitantly taking unspecified multivitamin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: this wart is now "drying up and going away"; 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 94-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "wart on her toe that she has had "for ages"" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "this wart is now "drying up and going away"". Additional information: The patient was attributing the effect to the vaccine because she does not take anything for it and her podiatrist has told her in the past that there is nothing that can be done about it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Movement disorder, Peripheral swelling
Clinical narrative: hand swelling; difficulty walking; difficulty turning over in bed; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  An 86 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 19Feb2021 (Batch/Lot number: unknown) at the age of 86 years, as dose 2, single for COVID-19 immunisation. Relevant medical history included: "History of remitting seronegative symmetrical synovitis with pitting edema (RS3PE)", start date: Apr2020 (unspecified if ongoing); "Bicuspid aortic valve" (unspecified if ongoing); "aortic root aneurysm" (unspecified if ongoing); "valve and aortic root replacement" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing); "prostatectomy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Prednisone, start date: Apr2020, for RS3PE. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 21Feb2021, outcome "recovering", described as "hand swelling"; GAIT DISTURBANCE (non-serious) with onset 21Feb2021, outcome "recovering", described as "difficulty walking"; MOVEMENT DISORDER (non-serious) with onset 21Feb2021, outcome "recovering", described as "difficulty turning over in bed". Therapeutic measures were taken as a result of peripheral swelling, gait disturbance, movement disorder. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known food or drug allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was taking unspecified concomitant medications. Two days after the symptoms began, prednisone was restarted at 10 mg. Symptoms were resolving 5 days after restarting prednisone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: Red and itchy arm at site, traveled to shoulder to elbow; Red and itchy arm at site, traveled to shoulder to elbow; flu like; nausea; not eating; Headache; slept all day/ still tired; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 04Feb2021 11:30 (Lot number: EN5318) at the age of 58 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "multiple strokes" (unspecified if ongoing); "seizures" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "known allergies: all stone fruits and tree nuts" (unspecified if ongoing). Concomitant medications included: PLAVIX; LEVOTHYROXIN; LEVETIRACETAM; LIPITOR [ATORVASTATIN CALCIUM]. Vaccination history included: BNT162B2 (dose 1, administered in the right arm, Lot number: EL8982), administration date: 14Jan2021 11:30, when the patient was 58 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 07Feb2021 12:30, outcome "unknown" and all described as "red and itchy arm at site, traveled to shoulder to elbow"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Feb2021 12:30, outcome "unknown", described as "flu like"; NAUSEA (non-serious) with onset 07Feb2021 12:30, outcome "unknown", described as "nausea"; DECREASED APPETITE (non-serious) with onset 07Feb2021 12:30, outcome "unknown", described as "not eating"; HEADACHE (non-serious) with onset 07Feb2021 12:30, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 07Feb2021 12:30, outcome "unknown", described as "slept all day/ still tired". The events "red and itchy arm at site, traveled to shoulder to elbow", "flu like", "nausea", "not eating", "headache" and "slept all day/ still tired" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pruritus, influenza like illness, nausea, decreased appetite, headache, fatigue.  Additional information: Other concomitant medications included "vit." The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and she has not been tested for COVID-19 since the vaccination.  No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red and itchy arm at site, traveled to shoulder to elbow; Red and itchy arm at site, traveled to shoulder to elbow; flu like; nausea; not eating; Headache; slept all day/ still tired; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 04Feb2021 11:30 (Lot number: EN5318) at the age of 58 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "multiple strokes" (unspecified if ongoing); "seizures" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "known allergies: all stone fruits and tree nuts" (unspecified if ongoing). Concomitant medications included: PLAVIX; LEVOTHYROXIN; LEVETIRACETAM; LIPITOR [ATORVASTATIN CALCIUM]. Vaccination history included: BNT162B2 (dose 1, administered in the right arm, Lot number: EL8982), administration date: 14Jan2021 11:30, when the patient was 58 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 07Feb2021 12:30, outcome "unknown" and all described as "red and itchy arm at site, traveled to shoulder to elbow"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Feb2021 12:30, outcome "unknown", described as "flu like"; NAUSEA (non-serious) with onset 07Feb2021 12:30, outcome "unknown", described as "nausea"; DECREASED APPETITE (non-serious) with onset 07Feb2021 12:30, outcome "unknown", described as "not eating"; HEADACHE (non-serious) with onset 07Feb2021 12:30, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 07Feb2021 12:30, outcome "unknown", described as "slept all day/ still tired". The events "red and itchy arm at site, traveled to shoulder to elbow", "flu like", "nausea", "not eating", "headache" and "slept all day/ still tired" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pruritus, influenza like illness, nausea, decreased appetite, headache, fatigue.  Additional information: Other concomitant medications included "vit." The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and she has not been tested for COVID-19 since the vaccination.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: temperature all over the place/temperature is fluctuating a lot from 109 to 99.6 to 99.8 within 20 minutes; sore arm; headache; ache all over; stiff neck; sweats; chill; too tired; 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 female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Advil, reaction(s): "GI issue". Vaccination history included: Bnt162b2 (First dose), for covid-19 immunisation, reaction(s): "pain"; Flu vaccine (4-5 years ago), for immunisation, reaction(s): "very sick". The following information was reported: HYPERPYREXIA (medically significant) with onset Feb2021, outcome "unknown", described as "temperature all over the place/temperature is fluctuating a lot from 109 to 99.6 to 99.8 within 20 minutes"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset Feb2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "ache all over"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Feb2021, outcome "unknown", described as "stiff neck"; HYPERHIDROSIS (non-serious) with onset Feb2021, outcome "unknown", described as "sweats"; CHILLS (non-serious) with onset Feb2021, outcome "unknown", described as "chill"; FATIGUE (non-serious) with onset Feb2021, outcome "unknown", described as "too tired". The patient underwent the following laboratory tests and procedures: body temperature: (Feb2021) fluctuating a lot from 109 to 99.6 to 99.8, notes: within 20 minutes. Therapeutic measures were taken as a result of hyperpyrexia, pain in extremity, headache, pain, musculoskeletal stiffness, hyperhidrosis, chills, fatigue (patient took Tylenol).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperpyrexia, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: temperature all over the place/temperature is fluctuating a lot from 109 to 99.6 to 99.8 within 20 minutes; sore arm; headache; ache all over; stiff neck; sweats; chill; too tired; 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 female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Advil, reaction(s): "GI issue". Vaccination history included: Bnt162b2 (First dose), for covid-19 immunisation, reaction(s): "pain"; Flu vaccine (4-5 years ago), for immunisation, reaction(s): "very sick". The following information was reported: HYPERPYREXIA (medically significant) with onset Feb2021, outcome "unknown", described as "temperature all over the place/temperature is fluctuating a lot from 109 to 99.6 to 99.8 within 20 minutes"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset Feb2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "ache all over"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Feb2021, outcome "unknown", described as "stiff neck"; HYPERHIDROSIS (non-serious) with onset Feb2021, outcome "unknown", described as "sweats"; CHILLS (non-serious) with onset Feb2021, outcome "unknown", described as "chill"; FATIGUE (non-serious) with onset Feb2021, outcome "unknown", described as "too tired". The patient underwent the following laboratory tests and procedures: body temperature: (Feb2021) fluctuating a lot from 109 to 99.6 to 99.8, notes: within 20 minutes. Therapeutic measures were taken as a result of hyperpyrexia, pain in extremity, headache, pain, musculoskeletal stiffness, hyperhidrosis, chills, fatigue (patient took Tylenol).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: My right hand swollen may be after the elbow close to the elbow; My right hand swollen may be after the elbow close to the elbow; My right arm started to hurt; last night the right arm continue hurting more than the vaccine itself; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 14:30 (Lot number: EM9809) at the age of 61 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "the border of diabetes" (unspecified if ongoing), notes: not been treated for it. Concomitant medication(s) included: NORCO; TRAMADOL. The following information was reported: DIZZINESS (non-serious) with onset 26Feb2021, outcome "unknown", described as "Dizzy"; PAIN IN EXTREMITY (non-serious) with onset 26Feb2021 15:45, outcome "unknown", described as "My right arm started to hurt; last night the right arm continue hurting more than the vaccine itself"; PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious) all with onset 27Feb2021, outcome "unknown" and all described as "My right hand swollen may be after the elbow close to the elbow". Therapeutic measures were taken as a result of dizziness, pain in extremity, peripheral swelling, joint swelling.  Additional information: Event onset time for pain arm was reported as 15:45 (also reported as about an hour after/ hour and half later). The patient received Ibuprofen as treatment for the events. Concomitant medications included pain medications.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Tremor
Clinical narrative: got really really cold had to put hat and gloves; couldn't quit shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "got really really cold had to put hat and gloves"; TREMOR (non-serious), outcome "unknown", described as "couldn't quit shaking".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021216477 Same reporter, drug, and events; different patient
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Sleep disorder
Clinical narrative: Persistent night sweats disrupting sleep; Persistent night sweats disrupting sleep; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 26Feb2021 10:30 (Lot number: EN6203) at the age of 64 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "menopause" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "overweight" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "known allergies: mice and rats" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE; VIVELLE DOT; GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]. Past drug history included: KEFLEX, reaction: "known allergies: Keflex". The following information was reported: NIGHT SWEATS (non-serious), SLEEP DISORDER (non-serious) all with onset 28Feb2021 23:00, outcome "recovered" (01Mar2021 01:00) and all described as "persistent night sweats disrupting sleep". Therapeutic measures were not taken as a result of night sweats, sleep disorder.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and she has not been tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: swollen ankles due to her arthritis; This is a spontaneous report received from a contactable reporter (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: REPAGLINIDE taken for diabetes mellitus. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "swollen ankles due to her arthritis". Therapeutic measures were taken as a result of joint swelling.  Additional information: ADVIL was taken as treatment for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.