chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Head discomfort, Headache, Loss of personal independence in daily activities
Clinical narrative: headache; feeling sick enough; pressure in my head & sinuses; pressure in my head & sinuses; felt very exhausted; my (left) arm is still extremely sore; feeling sick enough to need to lay down & could not continue working/impossible to work or get up; I just felt horrible, & oddly; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 11:30 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included flu (unspecified if ongoing); cold (unspecified if ongoing). There were no concomitant medications. The following information was reported HEADACHE (non-serious) with onset 05Mar2021 13:30, outcome recovering; MALAISE (non-serious) with onset 05Mar2021 13:30, outcome recovering; HEAD DISCOMFORT (non-serious), PARANASAL SINUS DISCOMFORT (non-serious) all with onset 05Mar2021 13:30, outcome recovering; FATIGUE (non-serious) with onset 05Mar2021 13:30, outcome recovering; VACCINATION SITE PAIN (non-serious) with onset 05Mar2021 13:30, outcome not recovered; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 05Mar2021 13:30, outcome recovering; FEELING ABNORMAL (non-serious) with onset 05Mar2021 13:30, outcome recovering. Therapeutic measures were not taken as a result of headache, malaise, head discomfort, paranasal sinus discomfort, fatigue, vaccination site pain, loss of personal independence in daily activities, feeling abnormal.  Facility type vaccine was other. No other vaccine in four weeks. No other medications in two weeks. Beginning about 70-90 minutes after her first injection she started feeling sick enough to need to lay down & could not continue working. She had symptoms like she never had before during flu or cold & they were hard to describe. She felt headache, & pressure in her head & sinuses & felt very exhausted. In general, she just felt horrible, & oddly, laying down did not help her feel better & it was hard to rest through the symptoms, but impossible to work or get up. The symptoms lasted at the same severity for 35-36 hours after which, she felt fine. However, her (left) arm was still extremely sore & not yet improving significantly after 4 days. She was very surprised by her reaction as she had never reacted to any other vaccination. No covid prior vaccination. The patient was not covid tested post vaccination. No known allergies.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Paranasal sinus discomfort, Vaccination site pain
Clinical narrative: headache; feeling sick enough; pressure in my head & sinuses; pressure in my head & sinuses; felt very exhausted; my (left) arm is still extremely sore; feeling sick enough to need to lay down & could not continue working/impossible to work or get up; I just felt horrible, & oddly; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 11:30 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included flu (unspecified if ongoing); cold (unspecified if ongoing). There were no concomitant medications. The following information was reported HEADACHE (non-serious) with onset 05Mar2021 13:30, outcome recovering; MALAISE (non-serious) with onset 05Mar2021 13:30, outcome recovering; HEAD DISCOMFORT (non-serious), PARANASAL SINUS DISCOMFORT (non-serious) all with onset 05Mar2021 13:30, outcome recovering; FATIGUE (non-serious) with onset 05Mar2021 13:30, outcome recovering; VACCINATION SITE PAIN (non-serious) with onset 05Mar2021 13:30, outcome not recovered; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 05Mar2021 13:30, outcome recovering; FEELING ABNORMAL (non-serious) with onset 05Mar2021 13:30, outcome recovering. Therapeutic measures were not taken as a result of headache, malaise, head discomfort, paranasal sinus discomfort, fatigue, vaccination site pain, loss of personal independence in daily activities, feeling abnormal.  Facility type vaccine was other. No other vaccine in four weeks. No other medications in two weeks. Beginning about 70-90 minutes after her first injection she started feeling sick enough to need to lay down & could not continue working. She had symptoms like she never had before during flu or cold & they were hard to describe. She felt headache, & pressure in her head & sinuses & felt very exhausted. In general, she just felt horrible, & oddly, laying down did not help her feel better & it was hard to rest through the symptoms, but impossible to work or get up. The symptoms lasted at the same severity for 35-36 hours after which, she felt fine. However, her (left) arm was still extremely sore & not yet improving significantly after 4 days. She was very surprised by her reaction as she had never reacted to any other vaccination. No covid prior vaccination. The patient was not covid tested post vaccination. No known allergies.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Disorientation, Dizziness, Thinking abnormal, Vaccination site pain
Clinical narrative: First a feeling of light headedness; Then jumbled thoughts not understandable but feeling of urgency; feeling disoriented; no exact memory of the thoughts i was having; Arm was sore at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021275475.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 11:30 (Lot number: EN6198) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Cholesterol" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 27Feb2021 10:00, outcome "recovered" (2021), described as "First a feeling of light headedness"; THINKING ABNORMAL (non-serious) with onset 27Feb2021 10:00, outcome "recovered" (2021), described as "Then jumbled thoughts not understandable but feeling of urgency"; DISORIENTATION (non-serious) with onset 27Feb2021 10:00, outcome "recovered" (2021), described as "feeling disoriented"; AMNESIA (non-serious) with onset 27Feb2021 10:00, outcome "recovered" (2021), described as "no exact memory of the thoughts i was having"; VACCINATION SITE PAIN (non-serious) with onset 27Feb2021, outcome "recovered" (2021), described as "Arm was sore at injection site". Therapeutic measures were not taken as a result of dizziness, thinking abnormal, disorientation, amnesia, vaccination site pain.  Additional information: The patient was not pregnant at time of vaccination. Other vaccine same date product was reported as none. Other vaccine in four weeks was reported as no. Other medications in two weeks included Cholesterol Medication. No COVID prior vaccination and no COVID tested post vaccination. It was reported that, first a feeling of light headedness. Then jumbled thoughts not understandable but feeling of urgency. Then feeling vanishes and left feeling disoriented and no exact memory of the thoughts the patient was having. Stated that, first started approximately on 27Feb2021 at 10:00 am. Stated that, this experience happened 2 to 3 times a day and lasted for about 5 days. Stated that, the last incident was on Saturday, 06Mar2021 at about 10 pm. Enquired, so far, no other occurrences but the patient was concerned about getting the 2nd dose. Would this side effect happen again or worsen.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discharge discolouration
Clinical narrative: Black nasal discharge; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 09:00 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TOPIRAMATE; PAROXETINE; VITAMIN D [VITAMIN D NOS]; XANAX. The following information was reported: NASAL DISCHARGE DISCOLOURATION (non-serious) with onset 07Mar2021 18:30, outcome "not recovered", described as "Black nasal discharge". Therapeutic measures were not taken as a result of nasal discharge discolouration.  Additional information: The patient has no allergies to medications, food, or other products. Additional concomitant medication included multivitamin. The most recent COVID-19 vaccine was administered in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose on 15Mar2021 at 09:45 AM in the left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: whole arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Batch/Lot number: unknown) as dose 2 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 08Jan2021, for COVID-19 Immunisation, reaction(s): "muscle soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "whole arm was sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Moderate soreness at inoculation site (left arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 09:45 (Lot number: EL3248) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; POTASSIUM. Vaccination history included: Bnt162b2 ({product=COVID, 19, brand=Pfizer,, lot number=EL3247,, lot unknown=False,, administration Date=17Feb2021,, administration time=02:00 PM,, vaccine location=Left arm,, dose number=1}]), administration date: 17Feb2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Mar2021 16:00, outcome "recovering", described as "Moderate soreness at inoculation site (left arm)". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: There was no other  vaccine in four weeks. Other medications in two weeks:  Losartan Potassium 50 mg Tabs. Moderate soreness at inoculation site (left arm) about 8 hours after administration. Covid was not given prior to vaccination. The Covid had not been tested post vaccination. There are no Known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority. The reporter is the patient. A 63-year-old male patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (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: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "soreness right where the shot was in the arm". Additional information: Patient stated that he was scheduled for his second dose on 03Apr2021; however, he was also scheduled on 18Mar2021 to have dental work done (had a dental appointment) and believed they may prescribe an antibiotic for him to take beforehand, although he's not certain if they really will or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), via a Pfizer-sponsored program (159558). A 69-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 69, single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient developed chills/felt chills after 1st dose, with outcome of unknown. Additional information: 2nd dose scheduled on Friday, Mar 12, 2021. She felt chills after 1st dose. She stated she went to the doctor and needs an echocardiogram. She will be getting this done today. She stated they don't inject anything and are only scanning her heart. She is also getting a stress test done next week, after the second dose of the vaccine. She asked if it is a problem to get the echocardiogram and get the vaccine on Friday. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP) from Regulatory Authority for a Pfizer sponsored program (159558). The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sinus infection" (unspecified if ongoing), notes: have sinus infection which is been chronic from last 25 years. The patient's concomitant medications were not reported. The following information was reported: SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". Additional information: He had received his first dose of Covid Vaccine and then after getting a first dose he was prescribed amoxycillin for sinus infection. So, he was wondering about his second dose of vaccine coming up on Tuesday. The patient was due to take his second Covid vaccine on Tuesday. He had sinus infection which was been chronic from last 25 years. So, his doctor had prescribed a pill that contain amoxycillin and the other drug spelled Clavulanate Potassium tablet with 75 and 125 respectively (further clarification unknown). He just needs to know can he take this drug still he got his second dose that was all h need to know. When probed if the consumer has taken Pfizer Covid vaccine, Consumer stated, "I have taken first dose and I need to take second dose. I need to find out if there is drug interaction." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Disturbance in attention, Dizziness, Feeling abnormal, Malaise
Clinical narrative: brain fog/fogginess in my head; dizziness; inability to want to do everything; lack of concentration; Waking up at 2-3 in the morning; not be getting good sleeps; depression; 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 69 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 69 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: FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "brain fog/fogginess in my head"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "inability to want to do everything"; DISTURBANCE IN ATTENTION (non-serious) with onset Mar2021, outcome "unknown", described as "lack of concentration"; MIDDLE INSOMNIA (non-serious) with onset Mar2021, outcome "unknown", described as "Waking up at 2-3 in the morning"; SLEEP DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "not be getting good sleeps"; DEPRESSION (non-serious) with onset Mar2021, outcome "unknown", described as "depression".   Additional information: Additional information: The patient reported "all went well". Doctor is giving him medication for antidepressants because his doctor thinks caller might not be getting good sleeps and questioning depression. Patient took antidepressant medication and said medication "knocked me out for hours".  The reporter stated that, "I received the shot one, a week ago today, Pfizer COVID-19 Vaccine Shot, the very first shot. I am 69 years old and extremely healthy; I don't take any medication and I have no underlying conditions. Therapeutic measures were taken as a result of depression.  No follow-up attempts are possible; information about lot/batch number cannot be obtained..
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Middle insomnia, Sleep disorder
Clinical narrative: brain fog/fogginess in my head; dizziness; inability to want to do everything; lack of concentration; Waking up at 2-3 in the morning; not be getting good sleeps; depression; 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 69 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 69 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: FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "brain fog/fogginess in my head"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "inability to want to do everything"; DISTURBANCE IN ATTENTION (non-serious) with onset Mar2021, outcome "unknown", described as "lack of concentration"; MIDDLE INSOMNIA (non-serious) with onset Mar2021, outcome "unknown", described as "Waking up at 2-3 in the morning"; SLEEP DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "not be getting good sleeps"; DEPRESSION (non-serious) with onset Mar2021, outcome "unknown", described as "depression".   Additional information: Additional information: The patient reported "all went well". Doctor is giving him medication for antidepressants because his doctor thinks caller might not be getting good sleeps and questioning depression. Patient took antidepressant medication and said medication "knocked me out for hours".  The reporter stated that, "I received the shot one, a week ago today, Pfizer COVID-19 Vaccine Shot, the very first shot. I am 69 years old and extremely healthy; I don't take any medication and I have no underlying conditions. Therapeutic measures were taken as a result of depression.  No follow-up attempts are possible; information about lot/batch number cannot be obtained..
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Thirst
Clinical narrative: lightheadedness/feels lightheaded; extreme thirst; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (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: DIZZINESS (non-serious) with onset 07Mar2021, outcome "unknown", described as "lightheadedness/feels lightheaded"; THIRST (non-serious) with onset 07Mar2021, outcome "unknown", described as "extreme thirst".  Additional information: The patient got the first shot of the Pfizer Covid vaccine on Wednesday and felt fine at first, but then Sunday, Monday, and Tuesday he felt light headed. These symptoms had not resolved yet at the time of initial report. He reported experiencing lightheadedness and extreme thirst. The patient wanted to know if these were expected side effects of the vaccine and if this was normal. The case was assessed as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Weight
Clinical narrative: diarrhea; really tired/Tiredness; headache; 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 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 15:00 (Lot number: EN6206, Expiration Date: Jun2021) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (ongoing), notes: Verbatim: Type 2 diabetes mellitus; "tested positive", start date: 28Dec2020 (unspecified if ongoing), notes: Caller stated he tested positive back on 28Dec2020 and was quarantined for 3 weeks and had fever and headaches, which all went away in 3-4 days and then developed diarrhea during that time; "fever" (unspecified if ongoing), notes: Caller stated he tested positive back on 28Dec2020 and was quarantined for 3 weeks and had fever and headaches, which all went away in 3-4 days and then developed diarrhea during that time; "headaches" (unspecified if ongoing), notes: Caller stated he tested positive back on 28Dec2020 and was quarantined for 3 weeks and had fever and headaches, which all went away in 3-4 days and then developed diarrhea during that time; "diarrhea" (unspecified if ongoing), notes: Caller stated he tested positive back on 28Dec2020 and was quarantined for 3 weeks and had fever and headaches, which all went away in 3-4 days and then developed diarrhea during that time. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 06Mar2021, outcome "recovering", described as "really tired/Tiredness"; HEADACHE (non-serious) with onset 06Mar2021, outcome "recovering", described as "headache"; DIARRHOEA (non-serious) with onset 07Mar2021, outcome "not recovered", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, headache, diarrhoea.  Additional Context: Caller received the first dose of Pfizers' COVID vaccine on Friday, 05Mar2021. On 06Mar2021, he started feeling really tired and had a little bit of a headache which is continuing now but has improved. For the past 3 days he had persisting diarrhea and was wondering if that was an expected side effect. Caller asking will the 2nd shot have the same side effects. Caller stated he tested positive back on 28Dec2020 and was quarantined for 3 weeks and had fever and headaches, which all went away in 3-4 days and then developed diarrhea during that time. After receiving the vaccine, he's having these symptoms again and having diarrhea again on Sunday.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling cold, Headache, Musculoskeletal stiffness, Osteitis
Clinical narrative: fatigue; Ringing in ears; aching and stiff; aching and stiff; has a calcified rib on the left side and she woke up this morning and it was inflamed; headache/head hurts; Later last night caller felt cold but, didn't take temp./got very cold/feels like there is a ball of ice in the middle of her chest; 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 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 10:30 (Lot number: E16004) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number=1, Route: Intramuscular, Anatomical Location: Right arm), administration date: 16Feb2021, when the patient was 69 years old, for COVID-19 immunisation, reaction(s): "right arm has a bruise". The following information was reported: HEADACHE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "headache/head hurts"; FEELING COLD (non-serious) with onset 09Mar2021, outcome "unknown", described as "Later last night caller felt cold but, didn't take temp./got very cold/feels like there is a ball of ice in the middle of her chest"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "fatigue"; TINNITUS (non-serious) with onset 10Mar2021, outcome "unknown", described as "Ringing in ears"; PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 10Mar2021, outcome "unknown" and all described as "aching and stiff"; OSTEITIS (non-serious) with onset 10Mar2021, outcome "unknown", described as "has a calcified rib on the left side and she woke up this morning and it was inflamed".  Additional Information: The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient did not have any type of illness at the time of vaccination. She had been taking a pill for high blood pressure, but clarified she had been taken that for more then 2 weeks before receiving the COVID-19 vaccine. She had been taking that medication for years.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: fatigue; Ringing in ears; aching and stiff; aching and stiff; has a calcified rib on the left side and she woke up this morning and it was inflamed; headache/head hurts; Later last night caller felt cold but, didn't take temp./got very cold/feels like there is a ball of ice in the middle of her chest; 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 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 10:30 (Lot number: E16004) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number=1, Route: Intramuscular, Anatomical Location: Right arm), administration date: 16Feb2021, when the patient was 69 years old, for COVID-19 immunisation, reaction(s): "right arm has a bruise". The following information was reported: HEADACHE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "headache/head hurts"; FEELING COLD (non-serious) with onset 09Mar2021, outcome "unknown", described as "Later last night caller felt cold but, didn't take temp./got very cold/feels like there is a ball of ice in the middle of her chest"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "fatigue"; TINNITUS (non-serious) with onset 10Mar2021, outcome "unknown", described as "Ringing in ears"; PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 10Mar2021, outcome "unknown" and all described as "aching and stiff"; OSTEITIS (non-serious) with onset 10Mar2021, outcome "unknown", described as "has a calcified rib on the left side and she woke up this morning and it was inflamed".  Additional Information: The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient did not have any type of illness at the time of vaccination. She had been taking a pill for high blood pressure, but clarified she had been taken that for more then 2 weeks before receiving the COVID-19 vaccine. She had been taking that medication for years.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Feeling abnormal, Illness, Pain, Pyrexia
Clinical narrative: fatigue; Ringing in ears; aching and stiff; aching and stiff; has a calcified rib on the left side and she woke up this morning and it was inflamed; headache/head hurts; Later last night caller felt cold but, didn't take temp./got very cold/feels like there is a ball of ice in the middle of her chest; 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 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 10:30 (Lot number: E16004) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number=1, Route: Intramuscular, Anatomical Location: Right arm), administration date: 16Feb2021, when the patient was 69 years old, for COVID-19 immunisation, reaction(s): "right arm has a bruise". The following information was reported: HEADACHE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "headache/head hurts"; FEELING COLD (non-serious) with onset 09Mar2021, outcome "unknown", described as "Later last night caller felt cold but, didn't take temp./got very cold/feels like there is a ball of ice in the middle of her chest"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "fatigue"; TINNITUS (non-serious) with onset 10Mar2021, outcome "unknown", described as "Ringing in ears"; PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 10Mar2021, outcome "unknown" and all described as "aching and stiff"; OSTEITIS (non-serious) with onset 10Mar2021, outcome "unknown", described as "has a calcified rib on the left side and she woke up this morning and it was inflamed".  Additional Information: The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient did not have any type of illness at the time of vaccination. She had been taking a pill for high blood pressure, but clarified she had been taken that for more then 2 weeks before receiving the COVID-19 vaccine. She had been taking that medication for years.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: fatigue; Ringing in ears; aching and stiff; aching and stiff; has a calcified rib on the left side and she woke up this morning and it was inflamed; headache/head hurts; Later last night caller felt cold but, didn't take temp./got very cold/feels like there is a ball of ice in the middle of her chest; 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 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 10:30 (Lot number: E16004) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number=1, Route: Intramuscular, Anatomical Location: Right arm), administration date: 16Feb2021, when the patient was 69 years old, for COVID-19 immunisation, reaction(s): "right arm has a bruise". The following information was reported: HEADACHE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "headache/head hurts"; FEELING COLD (non-serious) with onset 09Mar2021, outcome "unknown", described as "Later last night caller felt cold but, didn't take temp./got very cold/feels like there is a ball of ice in the middle of her chest"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "fatigue"; TINNITUS (non-serious) with onset 10Mar2021, outcome "unknown", described as "Ringing in ears"; PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 10Mar2021, outcome "unknown" and all described as "aching and stiff"; OSTEITIS (non-serious) with onset 10Mar2021, outcome "unknown", described as "has a calcified rib on the left side and she woke up this morning and it was inflamed".  Additional Information: The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient did not have any type of illness at the time of vaccination. She had been taking a pill for high blood pressure, but clarified she had been taken that for more then 2 weeks before receiving the COVID-19 vaccine. She had been taking that medication for years.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Sore Arm; Headache; Numbness on Left Side of face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 10:00 (Lot number: EL3247) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: Known allergy: Codeine; Oral clindamycin, reaction(s): "Drug allergy", notes: Known allergy: Oral Clindamycin. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Mar2021 10:45, outcome "recovered" (2021), described as "Sore Arm"; HEADACHE (non-serious) with onset 09Mar2021 10:45, outcome "recovered" (2021), described as "Headache"; HYPOAESTHESIA (non-serious) with onset 09Mar2021 10:45, outcome "recovered" (2021), described as "Numbness on Left Side of face". Therapeutic measures were not taken as a result of pain in extremity, headache, hypoaesthesia.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 76 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 76 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: VOMITING (non-serious), outcome "unknown", described as "vomiting".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Diarrhoea, Fatigue, Flatulence, Vaccination site pain
Clinical narrative: abundance of gas; extra bowel movements; experienced aching on the injection site; diarrhea; felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 89 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FLATULENCE (non-serious), outcome "unknown", described as "abundance of gas"; BOWEL MOVEMENT IRREGULARITY (non-serious), outcome "unknown", described as "extra bowel movements"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "experienced aching on the injection site"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "felt tired".  Additional information: Caller mentioned she has a "very sensitive gut" and reported to have experienced an "abundance of gas & a couple of extra bowel movements" after the vaccination. Caller also mentioned that she is unsure if this would be due to the vaccine since she also started a "special vitamin" which may have caused this also. Had her 1st dose of Covid 19 Vaccine (03Mar2021), experienced aching on the injection site and felt tired. Caller has IBS (Irritable bowel syndrome) wants to know more information if this vaccine has something to do with gas bloating, diarrhea or frequent bowel movement.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nausea, Pain
Clinical narrative: nausea; red spot on her arm; pain; 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 74 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (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: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "red spot on her arm"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain". Additional information: The patient is scheduled for a mammogram this Thursday. She was told that she should not have the mammogram since she received the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Neuralgia, Pain
Clinical narrative: muscle aches; nerve pain; not feeling well; pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from (RA). The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Feb2021 12:00 (Lot number: EL3247) at the age of 87 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Muscle problems" (ongoing); "Nerve problems" (ongoing); "Breast cancer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot No. EL8982, Administered on Right Arm.), administration date: 16Jan2021, for COVID-19 IMMUNISATION. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; PAIN (non-serious), outcome "unknown", described as "pains".  Additional Information: Patient had completed the 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE 06Feb21 - A week after she experienced muscle aches and nerve pain - Patient has history of breast cancer - Wanted to know if these are reported cases in the clinical trial and asking for recommendations. The patient said that she has had ongoing muscle aches, pains, and nerve problems since her second Pfizer COVID-19 vaccine shot. She said she had some problems before that that were worse after. She said her for first dose it says Pfizer EL8982 and was given 16Jan2021, and her second dose on 06Feb2021 was LOT: EL3247.She said both doses were given in her right arm in the morning or at noon, at 12:00PM. The patient said had not had any other recent vaccinations or started any new medications prior to getting her vaccines. The patient said she was having some muscle problems and nerve problems right before and she had occupation therapy and this got better then it got worse again and hasn't subsided. The patient said she was going to have a neck nerve test done the next day for the problem, she was concerned because it was getting worse after the vaccine. She said that was why she was calling, because the facility she lives at has 300 plus people living there and several others are having nerve problems and are just not feeling well. She said she wanted to know if other people have reported having these issues.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigued, unusually fatigued/tired; sore arm; 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 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 14:25 (Lot number: EN6198) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid condition" (ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "recovered" (Mar2021), described as "sore arm"; FATIGUE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "fatigued, unusually fatigued/tired".  Additional information: Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine(s) was None.AE(s) following prior vaccinations was None.Pertinent Details (include surgical procedures and dates) was not reported.Patient received the first dose of the Covid vaccine on 05Mar, this past Friday. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None.History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None.For the last couple of days, had been tired, fatigued, unusually fatigued. Knows that from the literature given that this was one of the possible side effects of the vaccine. Plus, patient  had a sore arm. The fatigue was still there and it had been 5 days into this since the vaccine. Wants to know if this was a normal reaction or is this something should be worried about. Noticed the tiredness and fatigue about the day after receiving the vaccine, that Saturday. States it was persisting and a little worse and then clarified outcome as persisting. States the sore arm started the same day of getting the vaccine, that night, but that had gone. No further details provided. Unable to provide the expiry or dose for the Covid vaccine given. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. Asks why was it asked his reason or indication for getting this vaccine. Reporter informed this was asked with all products. No further details provided. Family Medical History Relevant to AE(s) was as None. Patient did not visited Emergency Room and Physician Office.Relevant Tests was none.Noticed the tiredness and fatigue about the day after receiving the vaccine, that Saturday. States it was persisting and a little worse and then clarified outcome as persisting. States the sore arm started the same day of getting the vaccine, that night, but that has gone.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Therapeutic response unexpected
Clinical narrative: The right foot has previously been diagnosed as a dropped foot. In the week since the episode, the patient reports sustained improved sensation in the right foot; Intense pulsing pain in her right foot; interfered with her ability to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-2021277060.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Mar2021 (Lot number: Unknown) at the age of 67 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "spinal fusion" (unspecified if ongoing), notes: Verbatim: 2 x spinal fusion surgery; "Breast cancer" (unspecified if ongoing), notes: Verbatim:2 separate episodes of breast cancer, in remission not in active treatment; "Neuropathy" (unspecified if ongoing), notes: Verbatim:Neuropathy diagnosed in both legs; "cellulitis", start date: 2013 (unspecified if ongoing), notes: Verbatim:2013 cellulitis episode in the right foot. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 ({product=COVID -19, lot unknown=False,, dose number=1}), for covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 04Mar2021, outcome "recovered with sequelae", described as "The right foot has previously been diagnosed as a dropped foot. In the week since the episode, the patient reports sustained improved sensation in the right foot"; PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "recovered with sequelae", described as "Intense pulsing pain in her right foot"; INSOMNIA (non-serious) with onset 04Mar2021, outcome "recovered with sequelae", described as "interfered with her ability to sleep". Therapeutic measures were taken as a result of pain in extremity.  Additional information: A family member received their second dose of Pfizer's Covid-19 vaccine COMIRNATY and began experiencing intense pulsing pain in her right foot 12 hours after administration that interfered with her ability to sleep. Patient administered castor oil and alpine arnica to treat the pain. The pain progressively resolved over the next 24 hours (36 hours post-administration). The right foot has previously been diagnosed as a dropped foot. In the week since the episode, the patient reports sustained improved sensation in the right foot. Prior to 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; information about lot/batch number cannot be obtained. No further information is expected.