chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in left leg".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: sick for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "sick for 3 days". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperacusis, Vertigo
Clinical narrative: Vertigo; Loud noises amplified; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Feb2021 17:00 (Lot number: EP6955) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 27Feb2021 08:00, outcome "not recovered", described as "Vertigo"; HYPERACUSIS (non-serious) with onset 2021, outcome "not recovered", described as "Loud noises amplified". The events "vertigo" and "loud noises amplified" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo, hyperacusis.  Additional information: The patient never had an episode of vertigo before. The patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine. 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.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355013 same reporter/drug/AE, different patients
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), on Feb 25, 2021, for COVID-19 immunisation. The patient experienced fatigue (tiredness for one day), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 74-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL9266), in right arm, on Feb 18, 2021, at 11:30, single dose, for COVID-19 immunisation. Medical history included unspecified allergies (unspecified if ongoing). The patient took concomitant medications. The patient had fatigue/very tired, and somnolence (slept for about 10-12 hours each day), onset Feb 18, 2021, with outcome of recovered (Feb 23, 2021). No therapeutic measures taken as a result of fatigue and somnolence. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in right arm, single dose, for COVID-19 immunisation. Medical history included Moyamoya disease (unspecified if ongoing), epilepsy (unspecified if ongoing), and migraines (unspecified if ongoing). Concomitant medication included low-dose Aspirin taken for migraine. The patient had pain in extremity/sore arm (non-serious), with outcome of not recovered. Therapeutic measures were taken as a result of pain in extremity. No follow-up attempts possible. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021366857 same reporter/drug/similar event, different patients.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Insomnia
Clinical narrative: tiredness/ body fatigue; woke up in the middle of the night; was tossing and turning and couldn't sleep; headache; chills; like really really cold; body aches / whole body was achy; lethargic; stuffy nose; muscle pain; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 20:00 (Lot number: ER8730) at the age of 52 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 29Mar2021 21:00, outcome "recovered with sequelae" (31Mar2021), described as "nausea"; FATIGUE (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "tiredness/ body fatigue"; MIDDLE INSOMNIA (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "woke up in the middle of the night"; INSOMNIA (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "was tossing and turning and couldn't sleep"; HEADACHE (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "headache"; MYALGIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "muscle pain"; CHILLS (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "chills"; FEELING COLD (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "like really really cold"; PAIN (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "body aches / whole body was achy"; LETHARGY (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "lethargic"; NASAL CONGESTION (non-serious) with onset 30Mar2021, outcome "not recovered", described as "stuffy nose". Therapeutic measures were taken as a result of nausea, fatigue, headache, myalgia, chills, feeling cold, nasal congestion.  Additional information: It was further reported that nausea started on 29Mar2021 an hour after vaccine and then it stopped and started back up again on 30Mar2021. Patient stated that on 30Mar2021 at 02:00, she woke up in the middle of the night with a bad headache and was tossing and turning and couldn't sleep because the headache was so bad. She was getting the chills, like she was "really really cold". The lethargic part got worse this morning (day of the report). Patient treated the symptoms (nausea, tiredness/body fatigue, headache, and muscle pain) with an allergy pill, fexofenadine (ALLEGRA). For the headache she took Advil, the pain goes away but then comes back.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Middle insomnia, Myalgia, Nasal congestion, Nausea
Clinical narrative: tiredness/ body fatigue; woke up in the middle of the night; was tossing and turning and couldn't sleep; headache; chills; like really really cold; body aches / whole body was achy; lethargic; stuffy nose; muscle pain; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 20:00 (Lot number: ER8730) at the age of 52 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 29Mar2021 21:00, outcome "recovered with sequelae" (31Mar2021), described as "nausea"; FATIGUE (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "tiredness/ body fatigue"; MIDDLE INSOMNIA (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "woke up in the middle of the night"; INSOMNIA (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "was tossing and turning and couldn't sleep"; HEADACHE (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "headache"; MYALGIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "muscle pain"; CHILLS (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "chills"; FEELING COLD (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "like really really cold"; PAIN (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "body aches / whole body was achy"; LETHARGY (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "lethargic"; NASAL CONGESTION (non-serious) with onset 30Mar2021, outcome "not recovered", described as "stuffy nose". Therapeutic measures were taken as a result of nausea, fatigue, headache, myalgia, chills, feeling cold, nasal congestion.  Additional information: It was further reported that nausea started on 29Mar2021 an hour after vaccine and then it stopped and started back up again on 30Mar2021. Patient stated that on 30Mar2021 at 02:00, she woke up in the middle of the night with a bad headache and was tossing and turning and couldn't sleep because the headache was so bad. She was getting the chills, like she was "really really cold". The lethargic part got worse this morning (day of the report). Patient treated the symptoms (nausea, tiredness/body fatigue, headache, and muscle pain) with an allergy pill, fexofenadine (ALLEGRA). For the headache she took Advil, the pain goes away but then comes back.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: tiredness/ body fatigue; woke up in the middle of the night; was tossing and turning and couldn't sleep; headache; chills; like really really cold; body aches / whole body was achy; lethargic; stuffy nose; muscle pain; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 20:00 (Lot number: ER8730) at the age of 52 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 29Mar2021 21:00, outcome "recovered with sequelae" (31Mar2021), described as "nausea"; FATIGUE (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "tiredness/ body fatigue"; MIDDLE INSOMNIA (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "woke up in the middle of the night"; INSOMNIA (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "was tossing and turning and couldn't sleep"; HEADACHE (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "headache"; MYALGIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "muscle pain"; CHILLS (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "chills"; FEELING COLD (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "like really really cold"; PAIN (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "body aches / whole body was achy"; LETHARGY (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "lethargic"; NASAL CONGESTION (non-serious) with onset 30Mar2021, outcome "not recovered", described as "stuffy nose". Therapeutic measures were taken as a result of nausea, fatigue, headache, myalgia, chills, feeling cold, nasal congestion.  Additional information: It was further reported that nausea started on 29Mar2021 an hour after vaccine and then it stopped and started back up again on 30Mar2021. Patient stated that on 30Mar2021 at 02:00, she woke up in the middle of the night with a bad headache and was tossing and turning and couldn't sleep because the headache was so bad. She was getting the chills, like she was "really really cold". The lethargic part got worse this morning (day of the report). Patient treated the symptoms (nausea, tiredness/body fatigue, headache, and muscle pain) with an allergy pill, fexofenadine (ALLEGRA). For the headache she took Advil, the pain goes away but then comes back.   No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness/severe dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent (Mother).  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 15:30 (Lot number: EW0150) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 31Mar2021, outcome "not recovered", described as "dizziness/severe dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional information: There was no PQC present. Caller said that her daughter received the first dose of the Pfizer-BioNtech Covid-19 vaccine yesterday. Her daughter experienced dizziness after receiving the injection. Caller would like to know if that was normal or they should take something or go to the ER and how long it was supposed to last. No treatment done yet. Caller stated that she believes it is EW0150 but had difficulty reading the card writing. Severe dizziness was started ten minutes after leaving the facility. Received at 3:30 pm yesterday 31MAR2021. AE(s) did not require visit to Emergency Room or physician office. None were prior vaccination within 4 weeks. There were no AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling hot, Headache, Malaise
Clinical narrative: Tiredness; Headache; Nauseated; Dizziness; Doesn't feel well; Feels like it is warm in here; 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 24Mar2021 09:15 (Lot number: EP7534, Expiration Date: Jul2021) at the age of 57 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 31Mar2021 01:30, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset 31Mar2021 01:30, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 31Mar2021 01:30, outcome "recovering", described as "Nauseated"; DIZZINESS (non-serious) with onset 31Mar2021 01:30, outcome "recovering", described as "Dizziness"; MALAISE (non-serious) with onset 31Mar2021 01:30, outcome "not recovered", described as "Doesn't feel well"; FEELING HOT (non-serious) with onset 31Mar2021 01:30, outcome "not recovered", described as "Feels like it is warm in here". Therapeutic measures were not taken as a result of fatigue, headache, nausea, dizziness, malaise, feeling hot.  Additional information: The events did not result to ER or Physician office visit. The patient had not received any other vaccines within 4 weeks prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Tiredness; Headache; Nauseated; Dizziness; Doesn't feel well; Feels like it is warm in here; 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 24Mar2021 09:15 (Lot number: EP7534, Expiration Date: Jul2021) at the age of 57 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 31Mar2021 01:30, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset 31Mar2021 01:30, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 31Mar2021 01:30, outcome "recovering", described as "Nauseated"; DIZZINESS (non-serious) with onset 31Mar2021 01:30, outcome "recovering", described as "Dizziness"; MALAISE (non-serious) with onset 31Mar2021 01:30, outcome "not recovered", described as "Doesn't feel well"; FEELING HOT (non-serious) with onset 31Mar2021 01:30, outcome "not recovered", described as "Feels like it is warm in here". Therapeutic measures were not taken as a result of fatigue, headache, nausea, dizziness, malaise, feeling hot.  Additional information: The events did not result to ER or Physician office visit. The patient had not received any other vaccines within 4 weeks prior vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Body temperature, Chills, Fatigue
Clinical narrative: Headache; Tiredness; chills; not feeling well; upset stomach/upset stomach like she had a big rock inside of her stomach; flu like symptoms; stomach ache; Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Lot number: ER8730) 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:EN6199, The first shot gave me tiredness and headache which I have for the while but after half a day both them are fine and I was fine for rest of the time.), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "Tiredness"; Bnt162b2 (First dose, Lot Number:EN6199, The first shot gave me tiredness and headache which I have for the while but after half a day both them are fine and I was fine for rest of the time.), administration date: 03Mar2021, for Covid-19 Immunization, reaction(s): "headache". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; CHILLS (non-serious), outcome "unknown", described as "chills"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "upset stomach/upset stomach like she had a big rock inside of her stomach"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; ABDOMINAL PAIN UPPER (non-serious), outcome "recovered", described as "stomach ache"; INFLUENZA (non-serious), outcome "unknown", described as "Flu". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper.  Additional information: It was reported that on an unknown date the patient acquired all the other symptoms which should not well feels more like Covid of flu to her with unknown outcome and she was wondering if just shot given to her because she wasn't feel this way before she got the shot.She was wondering if this covid going affect the flu shot going to be take on October and she wanted to know how long the events will last. Consumer was informed about the Pfizer Medical Information Department.The patient was unaware of the expiration date of vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Influenza like illness, Malaise
Clinical narrative: Headache; Tiredness; chills; not feeling well; upset stomach/upset stomach like she had a big rock inside of her stomach; flu like symptoms; stomach ache; Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Lot number: ER8730) 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:EN6199, The first shot gave me tiredness and headache which I have for the while but after half a day both them are fine and I was fine for rest of the time.), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "Tiredness"; Bnt162b2 (First dose, Lot Number:EN6199, The first shot gave me tiredness and headache which I have for the while but after half a day both them are fine and I was fine for rest of the time.), administration date: 03Mar2021, for Covid-19 Immunization, reaction(s): "headache". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; CHILLS (non-serious), outcome "unknown", described as "chills"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "upset stomach/upset stomach like she had a big rock inside of her stomach"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; ABDOMINAL PAIN UPPER (non-serious), outcome "recovered", described as "stomach ache"; INFLUENZA (non-serious), outcome "unknown", described as "Flu". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper.  Additional information: It was reported that on an unknown date the patient acquired all the other symptoms which should not well feels more like Covid of flu to her with unknown outcome and she was wondering if just shot given to her because she wasn't feel this way before she got the shot.She was wondering if this covid going affect the flu shot going to be take on October and she wanted to know how long the events will last. Consumer was informed about the Pfizer Medical Information Department.The patient was unaware of the expiration date of vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anger, Hypersomnia, Lymphadenopathy, Tearfulness
Clinical narrative: anger, quick to get angry; adrenaline is really flowing; tearful; lot of sleeping; right gland by clavicle bone swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 (Lot number: EN6198) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing); "acid reflux" (ongoing). Concomitant medication(s) included: CELEXA [CITALOPRAM HYDROBROMIDE] taken for anxiety (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing); VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EL9261, Anatomical location: right arm), administration date: 05Feb2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: ANGER (non-serious), outcome "not recovered", described as "anger, quick to get angry"; AGITATION (non-serious), outcome "unknown", described as "adrenaline is really flowing"; TEARFULNESS (non-serious), outcome "unknown", described as "tearful"; LYMPHADENOPATHY (non-serious) with onset 27Feb2021, outcome "recovering", described as "right gland by clavicle bone swollen"; HYPERSOMNIA (non-serious), outcome "unknown", described as "lot of sleeping".  Additional information: Patient stated she was calling regarding some side effects, not listed as far as emotional aspect, anger, quick to get angry, something that would normally send her into a rage and adrenaline is really flowing and that is not normal for her. She wanted to know if anyone else has reported this and if it could be related to the vaccine. Patient stated she received her second dose on 26Feb2021 and she noticed this symptom a couple of weeks after her second dose, exact date unknown. She stated it happened on Sunday with her son and she has never talked to him the way she did, never spoken to him with rage and anger, and it was not anything of significance that would make her react the way she did, she was tearful. She also experienced the gland by her clavicle bone was very swollen, still a little swollen. She read that it can last 12 weeks and she did a lot of sleeping after that second dose.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Soreness at injection site; Feeling tired; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 28Mar2021 12:15 (Lot number: ER8732) at the age of 57 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6206, Administration time: 12:15 PM, Route of administration: Intramuscular, Vaccine location: Left arm), administration date: 07Mar2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Mar2021 10:00, outcome "recovered" (2021), described as "Soreness at injection site"; FATIGUE (non-serious) with onset 29Mar2021 10:00, outcome "recovered" (2021), described as "Feeling tired". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: The patient had no known allergies to medications, foods, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia, Taste disorder
Clinical narrative: She has a crummy taste in her mouth feels like metallic or metal, it feels weird.; Nothing taste good; On day 3, after the injection she had horrible smell like burnt wood or oranges. Smells it with anything cooked. Anything she eats has that same smell anything that's cooked.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 11Nov2020 (unspecified if ongoing), notes: mild case. On day 10 of having COVID 19 she lost her sense of taste and smell. She gained back 85 percent of her taste came back; "lost her sense of taste and smell", start date: 21Nov2020 (unspecified if ongoing), notes: She gained back 85 percent of her taste came back but, still did not get back smell back at all until just recently; "lost her sense of taste and smell", start date: 21Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAROSMIA (non-serious) with onset 28Mar2021, outcome "unknown", described as "On day 3, after the injection she had horrible smell like burnt wood or oranges. Smells it with anything cooked. Anything she eats has that same smell anything that's cooked."; DYSGEUSIA (non-serious), outcome "unknown", described as "She has a crummy taste in her mouth feels like metallic or metal, it feels weird."; TASTE DISORDER (non-serious), outcome "unknown", described as "Nothing taste good". The action taken for bnt162b2 was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: mild prickly sensations on the back of my hands; soon after the vaccine, the sensations are more intense; It burns to wash my hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 13:30 (Lot number: EP7533) at the age of 52 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 (Lot number=EN6206 , Administration time=10:30 AM , vaccine location=Right arm, dose number=1), administration date: 11Mar2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "mild prickly sensations on the back of my hands". The following information was reported: PARAESTHESIA (non-serious), outcome "not recovered", described as "mild prickly sensations on the back of my hands; soon after the vaccine, the sensations are more intense"; BURNING SENSATION (non-serious), outcome "not recovered", described as "It burns to wash my hands". Therapeutic measures were not taken as a result of paraesthesia, burning sensation.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355060 same patient/vaccine, different dose /event
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Headache, Nausea
Clinical narrative: Chills and hot and cold; Hot and cold; Headache; Waves of nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 16:00 (Lot number: EP7534) at the age of 84 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 (Lot EN6200, Injected into left arm. Unable to confirm if given in the muscle.), administration date: 28Feb2021, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 24Mar2021 03:00, outcome "recovering", described as "Chills and hot and cold"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 24Mar2021 03:00, outcome "recovering", described as "Hot and cold"; HEADACHE (non-serious) with onset 24Mar2021 03:00, outcome "recovered" (25Apr2021 14:00), described as "Headache"; NAUSEA (non-serious) with onset 24Mar2021 03:00, outcome "recovering", described as "Waves of nausea".  Additional information: Reporter's seriousness for all the events were unspecified. Patient reported that she had no side effect from the first Pfizer COVID vaccine shot but with the second shot which she got it on a Tuesday around 16:00pm, and when she got up in the morning at 03:00, she had chills and hot and cold. Patient reported she also had a headache which lasted all of next day, 24Mar2021, and a little bit on 25Mar2021. As the day wore on, it got better by 14:00pm, then it was gone. She also had waves of nausea which came in a wave for a couple of minutes and it would go away. Patient reported it started on 24Mar2021 and she still had it and it was getting less and less. Patient reported no ER or physician's office visit was required for events and patient had no adverse event prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: bowels were loose yesterday; arm sore; 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 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 09:00 (Lot number: EP7534) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "no spleen" (unspecified if ongoing), notes: Verbatim: no spleen; "hocking and spitting up phlegm " (unspecified if ongoing), notes: for the last six months and they are trying to figure out what it is. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovering", described as "arm sore"; DIARRHOEA (non-serious) with onset 30Mar2021, outcome "recovering", described as "bowels were loose yesterday". The event did bot require physician office and emergency visit.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling
Clinical narrative: Swollen gums; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose number unnown,single for covid-19 immunisation. Relevant medical history included: "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: NORVASC; STATIN [ATORVASTATIN CALCIUM]; THYROID. The following information was reported: GINGIVAL SWELLING (non-serious) with onset 14Feb2021, outcome "not recovered", described as "Swollen gums". Therapeutic measures were not taken as a result of gingival swelling. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Diarrhoea, Vomiting
Clinical narrative: Vomiting; Diarrhea; low temperature; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "low temperature". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she had arm soreness but on the second day the soreness was gone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "got the COVID vaccine in her left arm and she had soreness but on the second day the soreness was gone.".  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-2021366695 same reporter/drug/similar event, different patients
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Upon receiving the first dose of the vaccine I seemed to be clear of a chronic condition I have suffered with for 8 years. That condition was Pressure Induced Chronic, Idiopathic Urticaria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pressure Induced Chronic, Idiopathic Urticaria" (unspecified if ongoing), notes: Pressure Induced Chronic, Idiopathic Urticaria; "painful hives" (unspecified if ongoing), notes: unable to wear tight fitting clothing or anything with elastic in it without breaking out into painful hives; "painful rash" (unspecified if ongoing), notes: have not had one instance of hives or a painful rash since my first dose of the Pfizer vaccine; "Hyperlipidemia" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "Benign hypertension" (unspecified if ongoing), notes: Benign hypertension. There were no concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 20Feb2021 12:00, outcome "unknown", described as "Upon receiving the first dose of the vaccine I seemed to be clear of a chronic condition I have suffered with for 8 years. That condition was Pressure Induced Chronic, Idiopathic Urticaria". Therapeutic measures were not taken as a result of therapeutic response unexpected. The patient have been unable to wear tight fitting clothing or anything with elastic in it without breaking out into painful hives. She could not wear a bra as the area most effect was anterior chest, from just below breasts to navel. She have not had one instance of hives or a painful rash since her first dose of the Pfizer vaccine. She was now able to wear a bra. This may seem like a trivial condition, but it greatly effected the quality of her life. Se hope this is a long lasting effect.   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-2021366871
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Mild diarrhea; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. Relevant medical history included: "Benign hypertension" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Chronic idiopathic urticaria" (unspecified if ongoing); "Painful hives" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (DOSE 1), administration date: 2021, for COVID-19 immunization, reaction(s): "Seemed to be clear of a chronic condition she had suffered with for 8 years". The following information was reported: DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Mild diarrhea".  Additional Information: The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. No other vaccine was administered in four weeks.  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-2021366861
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Flatulence, Pain in extremity
Clinical narrative: loose bowels/diarrhea; bloated and gassy; bloated and gassy; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 11:30 (Lot number: EN6207) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "myastenia gravis" (ongoing); "hypothyroid" (unspecified if ongoing); "allergic to aged or fermented things" (unspecified if ongoing); "candida allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL (ongoing); PYRIDOSTIGMINE taken for myasthenia gravis (ongoing); GAMUNEX C (ongoing). Vaccination history included: Polio vaccine, for immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Mar2021, outcome "recovered" (16Mar2021), described as "sore arm"; DIARRHOEA (non-serious) with onset 17Mar2021, outcome "not recovered", described as "loose bowels/diarrhea"; ABDOMINAL DISTENSION (non-serious), FLATULENCE (non-serious) all with onset 17Mar2021, outcome "not recovered" and all described as "bloated and gassy". Additional information: The patient cannot consume alcohol, alcohol related things or even vanilla extract. She can't eat any mushrooms or spores, soft cheeses, there's a whole list of things she can't eat.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Palpitations
Clinical narrative: Slight headache; Heart racing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 (Lot number: EN6208) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: Yes; "Hypothyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing); "Allergic history to medications, food, or other products" (unspecified if ongoing); "Allergic history to medications, food, or other products" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; SPIRONOLACTONE. The following information was reported: HEADACHE (non-serious) with onset 11Mar2021 16:30, outcome "not recovered", described as "Slight headache"; PALPITATIONS (non-serious) with onset 11Mar2021 16:30, outcome "not recovered", described as "Heart racing". Therapeutic measures were not taken as a result of headache, palpitations.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that within fifteen minutes of the receiving the first vaccine ae occurred. Through the month, medical conditions got worse. The adverse events did not result in a visit to the doctors 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.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lethargy
Clinical narrative: Lethargy; Flu-like symptoms; This is a spontaneous report received from a contactable consumer (patient's wife).  A male patient received BNT162B2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LETHARGY (non-serious) with onset 13Mar2021, outcome "recovered" (15Mar2021), described as "Lethargy"; INFLUENZA LIKE ILLNESS (non-serious) with onset 13Mar2021, outcome "recovered" (15Mar2021), described as "Flu-like symptoms".  Additional Information: The patient's symptoms went away in 2 days.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.