chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: His whole arm is tingling; arm is tingling and is numb.; This is a spontaneous report from a sponsored program. A contactable male consumer (patient) reported that:  A male patient received bnt162b2 (BNT162B2), administration date 05May2021 (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, administration date: 07Apr2021, for Covid-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 05May2021, outcome "unknown", described as "His whole arm is tingling"; HYPOAESTHESIA (non-serious) with onset 05May2021, outcome "unknown", described as "arm is tingling and is numb.".  Additional information: patient had his vaccine about 2 hours ago, my second dosage. About 10 minutes after patient had tiny tingling down my injection arm down to his elbow and then actually after he let the pharmacist know just make sure if this is a reported thing or something. he left as they told me it was, you know normal. After that it spreads to my full arm to knuckles of his hand like patches, numbness and tingling and little bit on my other arm. he wanted to know if this was normal or if I need medical attention."   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Falling out of bed, after the second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: FALL (non-serious), outcome "unknown", described as "Falling out of bed, after the second vaccine".  Additional Information: That ever since patient had the vaccine, Patient had a problem with falling out of bed. Patient has talked to his Pharmacist and his doctor, and they don't know why he is falling out of bed. The event happened right after he got the second vaccine. Patient is making the connection to his vaccine or to his Parkinsons Disease.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient received bnt162b2 (BNT162B2) (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: VISION BLURRED (non-serious), outcome "unknown", described as "Blurred vision".  Additional information: Pharmacist stated, "So its regarding adverse event for the COVID Vaccine. I have a patient that called me, and expressed concern about she experiencing Blurred Vision, like an hour after she received the first shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was very sore right where patient got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 (Lot number: EN6201) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (ongoing), notes: Verbatim: Psoriasis, Diagnosed at least 5 years ago.; "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis, Diagnosed at least 5 years ago. Concomitant medication(s) included: COSENTYX taken for arthritis, psoriasis (ongoing).  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Feb2021, outcome "recovered" (20Feb2021), described as "arm was very sore right where patient got the shot". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Family medical history   was reported as none. The patient prior vaccinations was reported as none. The vaccines administered on same date of the pfizer suspect was reported as none. The patient did not visit to emergency room and physician office.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (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: HEADACHE (non-serious), outcome "unknown", described as "headache". Therapeutic measures were not taken as a result of headache.  Additional information: patient could receive her 2nd dose today 06May2021 if she has a headache. Patient was not taken any medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Blood test, Lymphadenopathy, Pain, Paraesthesia
Clinical narrative: Its swollen lymph node; I have it like mass forming under in my armpit; I just got my first dose of the vaccine its pretty painful; getting like tingly feelings in my finger tips on my left arm; I just got my first dose of the vaccine its pretty painful; getting like tingly feelings in my finger tips on my left arm; Its swollen lymph node; I have it like mass forming under in my armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EW0179) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE; ELETRIPTAN taken for migraine; VENLAFAXINE taken for depression.  The following information was reported: LYMPHADENOPATHY (non-serious), AXILLARY MASS (non-serious) all with onset 2021, outcome "unknown" and all described as "Its swollen lymph node; I have it like mass forming under in my armpit"; PARAESTHESIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "I just got my first dose of the vaccine its pretty painful; getting like tingly feelings in my finger tips on my left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, paraesthesia, pain, axillary mass.  Additional information: Its swollen lymph node or what should be going on, but the patient had it like mass forming under in armpit. The patient just got first dose of the vaccine on Saturday but it was pretty painful and getting like tingly feelings in finger tips on left arm and got the arm the vaccine. The patient stated that he had just been resting pretty much and drinking water. When probed for any medication, the patient took for treatment, the patient stated as no.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Its swollen lymph node; I have it like mass forming under in my armpit; I just got my first dose of the vaccine its pretty painful; getting like tingly feelings in my finger tips on my left arm; I just got my first dose of the vaccine its pretty painful; getting like tingly feelings in my finger tips on my left arm; Its swollen lymph node; I have it like mass forming under in my armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EW0179) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE; ELETRIPTAN taken for migraine; VENLAFAXINE taken for depression.  The following information was reported: LYMPHADENOPATHY (non-serious), AXILLARY MASS (non-serious) all with onset 2021, outcome "unknown" and all described as "Its swollen lymph node; I have it like mass forming under in my armpit"; PARAESTHESIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "I just got my first dose of the vaccine its pretty painful; getting like tingly feelings in my finger tips on my left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, paraesthesia, pain, axillary mass.  Additional information: Its swollen lymph node or what should be going on, but the patient had it like mass forming under in armpit. The patient just got first dose of the vaccine on Saturday but it was pretty painful and getting like tingly feelings in finger tips on left arm and got the arm the vaccine. The patient stated that he had just been resting pretty much and drinking water. When probed for any medication, the patient took for treatment, the patient stated as no.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: I had runny nose before and after the second shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 08Apr2021 (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: RHINORRHOEA (non-serious) with onset 29Apr2021, outcome "unknown", described as "I had runny nose before and after the second shot.".  Additional Information: The event onset latency was 21 days after vaccination. Patient just took the second shot but before patient took the second shot. The patient had runny nose. So is that ok. patient went to take second shot already. Today is Tuesday, Monday, yesterday patient took the second shot. patient had runny nose before and after the second shot. The runny nose started last Friday (29th of April; Thursday). patient went to take the second shot. Consumer stated, "I want to know is this ok because I have friend who told me I shouldn't to go to take the second shot because I have runny nose but I took it already, already had it." Consumer was informed about the role of Pfizer Drug Safety and Medical Information Department for the concern and was provided with the contact# for Pfizer Medical Information as # Option 3, and was informed that the department is open from Monday to Friday, from 8 am to 8 pm and 9 am to 3 pm on Saturday and Sunday as per time zone. When asked for permission to probe questions, consumer stated, "No, that is okay because I do not have the time." When probed for LOT# and Expiration date, consumer stated, "What is the LOT#. I don't know. No, I couldn't find it." Further probing could not be done as consumer was unwilling to complete the report. Hence, limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Myalgia, Vomiting
Clinical narrative: Diarrhea; Vomiting; Muscle ache; Feeling bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: EW0172) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back ache" (unspecified if ongoing), notes: I have a bad back. I have 4 bulging disc and 1 herniated; "4 bulging disc and 1 herniated" (unspecified if ongoing), notes: I have a bad back. I have 4 bulging disc and 1 herniated. Concomitant medication(s) included: NORCO taken for back pain; PERCOCET-5. The following information was reported: DIARRHOEA (non-serious) with onset 01May2021, outcome "recovering", described as "Diarrhea"; VOMITING (non-serious) with onset 01May2021, outcome "recovering", described as "Vomiting"; MYALGIA (non-serious) with onset 01May2021, outcome "recovering", described as "Muscle ache"; FEELING ABNORMAL (non-serious) with onset 01May2021, outcome "recovering", described as "Feeling bad". Therapeutic measures were not taken as a result of diarrhoea, vomiting, myalgia, feeling abnormal. Additional information: When paraphrased the above concern patient stated, "It got the vaccine first dose on Wednesday (Confirmed as 28Apr2021) and last Wednesday and Saturday night when it went to bed it started feeling bad." When paraphrased the above concern consumer stated, "It got the vaccine first dose on Wednesday (Confirmed as 28Apr2021) and last Wednesday and Saturday night when it went to bed it started feeling bad."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Oropharyngeal discomfort, Rhinorrhoea
Clinical narrative: I am feeling like I have the flu; Having lots of troubles with my throat; Runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization.The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "I am feeling like I have the flu"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "Having lots of troubles with my throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose".  Additional Context: Reporter seriousness for all adverse events was Unspecified. It was reported that Consumer stated, "I do have some questions regarding the possible side effects after I got the Covid vaccine. I got my second dose like 14 days ago and I am feeling like I have the flu and I have been having lots of troubles with my throat and like runny nose. So, I don't know if this is normal, should I look for medical assistance? Is this is going to go way or should I wait for few more days or weeks?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (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: CONSTIPATION (non-serious) with onset Apr2021, outcome "unknown", described as "constipation".  Additional information: Reporter: Sister. NDC number: Not Provided. Reason for no lot number: Caller unwilling to complete the report. Caller stated her sister was experiencing constipation since getting her Pfizer Covid Vaccine. Verified with caller that her sister did receive the Pfizer Covid Vaccine. Caller verified she received it on 21Apr2021. Caller declines to complete report for sister; therefore, no further details obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia
Clinical narrative: My left side, I got the shot on the left arm, so my left side, lower back pain; Left leg is numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low on iron" (unspecified if ongoing), notes: Verbatim: Low on iron. Concomitant medication(s) included: FERRO SANOL DUODENAL taken for blood iron decreased. The following information was reported: BACK PAIN (non-serious) with onset 03May2021, outcome "unknown", described as "My left side, I got the shot on the left arm, so my left side, lower back pain"; HYPOAESTHESIA (non-serious) with onset May2021, outcome "unknown", described as "Left leg is numb".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: Extreme headache; vertigo; nausea; chills; fatigue; unable to sleep most nights; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 10:15 (Lot number: ER8731) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: ED6955, Administration time: 10:00 AM, Dose number: 1, Vaccine location: Right arm), administration date: 28Mar2021, when the patient was 57 years old, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "Extreme headache"; VERTIGO (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "vertigo"; NAUSEA (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "nausea"; CHILLS (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "fatigue"; INSOMNIA (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "unable to sleep most nights". The events "extreme headache", "vertigo", "nausea", "chills", "fatigue" and "unable to sleep most nights" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, vertigo, nausea, chills, fatigue, insomnia.  Additional information: Extreme headache, vertigo, nausea, chills, and fatigue starting about 36 hours after 2nd shot. Symptoms have continued on and off for 14 days. Symptoms are more severe during the night. Difficult to make it through work, have needed to take sick days, unable to sleep most nights. Some days patient was bed-ridden with severity of symptoms. Patient not received any other vaccine in four weeks. Patient not had covid prior vaccination. Patient did not had known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Extreme headache; vertigo; nausea; chills; fatigue; unable to sleep most nights; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 10:15 (Lot number: ER8731) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: ED6955, Administration time: 10:00 AM, Dose number: 1, Vaccine location: Right arm), administration date: 28Mar2021, when the patient was 57 years old, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "Extreme headache"; VERTIGO (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "vertigo"; NAUSEA (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "nausea"; CHILLS (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "fatigue"; INSOMNIA (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "unable to sleep most nights". The events "extreme headache", "vertigo", "nausea", "chills", "fatigue" and "unable to sleep most nights" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, vertigo, nausea, chills, fatigue, insomnia.  Additional information: Extreme headache, vertigo, nausea, chills, and fatigue starting about 36 hours after 2nd shot. Symptoms have continued on and off for 14 days. Symptoms are more severe during the night. Difficult to make it through work, have needed to take sick days, unable to sleep most nights. Some days patient was bed-ridden with severity of symptoms. Patient not received any other vaccine in four weeks. Patient not had covid prior vaccination. Patient did not had known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 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 was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Lot number: ER8737) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE; VITAMIN D3.  The following information was reported: DYSGEUSIA (non-serious), outcome "recovering", described as "metallic taste". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: I developed a strong metallic taste in my mouth and strong odor in my nose approximately twenty minutes after. Patient not taken any other vaccine in four weeks. No COVID prior vaccination. Patient not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: was feeling around my arm pit area after the first dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Thyroid cancer" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "tetanus toxoid" (unspecified if ongoing); "scoliosis" (unspecified if ongoing); "Car accident" (unspecified if ongoing), notes: brain bleed 15 years ago; "Back surgery" (unspecified if ongoing), notes: Back surgery wasn't effective. The patient's concomitant medications were not reported.  The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "was feeling around my arm pit area after the first dose".  Additional information: I am in a really small town, I had a GYN appointment and was feeling around my arm pit area after the first dose, before the second, and they told me that Pfizer says this can happen.  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: With the first shot, she had a little sore arm and that was it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female 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 "With the first shot, she had a little sore arm and that was it.".  Additional information: The NDC number and expiry dates were not provided and Lot number was not provided as the patient was unwilling to complete the report. There were no other products or investigation assessment provided. The patient was advised to follow up with primary care physician or local healthcare provider for treatment recommendations and medical advice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: First Dose: Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EWO153) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Verbatim: Asthma, States it started a long time ago, maybe around 2006-2007; "Virus" (unspecified if ongoing), notes: Caller states she had a virus 3.5-4 years ago. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 09Apr2021, outcome "recovered" (10Apr2021), described as "First Dose: Tiredness".  Additional information: Caller stated she had a virus 3.5-4 years ago. Stated something in an ER made her sick after she left the ER.The only reason she went was she thought she was having a heart attack. Stated that ER was not a clean ER. Caller stated something was around there lingering wherever they took her to check her. When she left there she was deathly ill for a week. Caller stated she needs her glasses to read the vaccine card. AE did not require a visit to Emergency Room or Physician Office. No vaccination was given within 4 weeks of Dose 1. AE(s) following prior vaccinations: None. No relevant tests were done.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: I still have pain in my left leg; Have kind of muscle pain in my left leg above the knee on the back side; Sometimes my foot starts to sleep like tingling; Sometimes my foot starts to sleep like tingling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 15Apr2021, for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I still have pain in my left leg"; MYALGIA (non-serious), outcome "unknown", described as "Have kind of muscle pain in my left leg above the knee on the back side"; PAIN IN EXTREMITY (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "Sometimes my foot starts to sleep like tingling". Therapeutic measures were not taken as a result of pain in extremity, myalgia, pain in extremity, paraesthesia.  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: Fatigue, Pain
Clinical narrative: Little bit sore; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) at the age of 89 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 (Dose: 1, Time: 14:00, First dose was in her left arm), administration date: 22Feb2021, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Little bit sore"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue".  Additional information: The patient received the second dose of the vaccine either in  Mar2021 or the beginning of Apr2021. Time of Vaccination for the second dose: 14:00. The second one she was a little bit sore but nothing with the first one. The reporter stated that the soreness ended sometime in Mar2021 or beginning of Apr2021 since by the next day it was all gone and it did not last more than a day. Patient also had fatigue. She recovered completely from this. Vaccination Facility Type was Other. Vaccine was not administered at Facility. No additional vaccines administered. No prior vaccination within 4 weeks. Investigation assessment was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm was hurting a little bit; had a little slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 16:10 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01May2021, outcome "recovered" (02May2021), described as "arm was hurting a little bit"; HEADACHE (non-serious) with onset 01May2021, outcome "recovered" (01May2021), described as "had a little slight headache".  Additional Information: It was reported that reason for no lot number: of COVID vaccine: Other: Patient was on the way to work, and patient didn't bring her daughter's COVID vaccination record card with her. Expiry Date, NDC number of COVID vaccine: Unknown. Investigation Assessment was no reported. Vaccine Administered at facility was not reported. Vaccination facility was at Pharmacy. AEs had not resulted emergency room or physician office. No other vaccines were given within 4 weeks. Relevant family history related to AE(S) was reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: fatigue; headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 11:15 (Lot number: ER8737) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma (controlled). Concomitant medication(s) included: CYANOCOBALAMIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ISIBLOOM; TOPIRAMATE.  The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue"; HEADACHE (non-serious), outcome "recovered", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of fatigue, headache, pain in extremity.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysphonia
Clinical narrative: Event: voice changed was reported as worsened.; voice changed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 03May2021 (Lot number: ER8736) at the age of 44 years as dose 2, single and administered in arm, administration date 12Apr2021 14:30 (Lot number: EW0150, Expiration Date: Jul2021) 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: DYSPHONIA (non-serious) with onset 13Apr2021, outcome "not recovered", described as "voice changed"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Event: voice changed was reported as worsened.". Additional information: The patient was calling about the covid vaccine. The patient had the second dose yesterday, 03May2021. When the patient got first dose, the next day her voice changed it went up and down and stuff. The caller thought it was a side effect of the covid vaccine, but it was no big deal. The patient got her second vaccine and was fine this morning and then about the same time as last time, the voice change started again. This voice changing event happened with the first and second dose of the vaccine. First dose event lasted about 2 days, maybe a little bit more than that and then it went right back to normal. Second dose event started today, 04May2021. The patient described it as ongoing and worsened. No additional Vaccines administered on same date of the Pfizer suspect. The events did not require a visit to emergency room or physician office. No prior vaccinations (within 4 weeks)/ events following prior vaccinations. No patient medical history. No family medical history relevant to events. No relevant tests.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I had headache ever since and has not gone away and its barging on migraine territory.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Lot number: ER8736) at the age of 32 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 (dose 1), when the patient was 32 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "I had headache ever since and has not gone away and its barging on migraine territory.". Therapeutic measures were not taken as a result of headache.  Additional information: Further stated that patient called to report a possible side effect. He just recently got my second dose of vaccine. It was about week and a half, he had headache ever since and had not gone away and it was barging on migraine territory."   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Ear discomfort, Facial pain, Fatigue, Feeling abnormal
Clinical narrative: I felt very tired not to much energy; I felt very tired not to much energy; Pain headach started on the right side of my face from my temple down to lower chin; more disconfort near my ear and sensitive when i stroke my face; Felt like muscle spasms; Felt like tension tightness ach; tingling in my ankle and feet but only on one side but mild.; more disconfort near my ear and sensitive when i stroke my face; Pain headach started on the right side of my face from my temple down to lower chin; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Cholestrole" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "I felt very tired not to much energy"; FACIAL PAIN (non-serious), HEADACHE (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "Pain headach started on the right side of my face from my temple down to lower chin"; EAR DISCOMFORT (non-serious), SENSITIVE SKIN (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "more disconfort near my ear and sensitive when i stroke my face"; MUSCLE SPASMS (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Felt like muscle spasms"; FEELING ABNORMAL (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Felt like tension tightness ach"; PARAESTHESIA (non-serious) with onset 23Apr2021, outcome "not recovered", described as "tingling in my ankle and feet but only on one side but mild.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, asthenia, facial pain, muscle spasms, feeling abnormal, paraesthesia, sensitive skin, headache. Therapeutic measures were taken as a result of ear discomfort.  Additional information: No covid prior vaccination. The patient tested post vaccination. No other vaccine in four weeks. Other medications in two weeks was vitamins. No known allergies. Facility type vaccine was hospital and vitamins had taken within two weeks. The patient experienced muscle spasms and thought was coming from my mouth. Went to the dentist did not find anything wrong. The pain came in went everyday. Felt like tension tightness ache. Took Advil or Tylenol for the disconfort only helped a little. It was may and I still had this ache off and on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Paraesthesia, SARS-CoV-2 test, Sensitive skin
Clinical narrative: I felt very tired not to much energy; I felt very tired not to much energy; Pain headach started on the right side of my face from my temple down to lower chin; more disconfort near my ear and sensitive when i stroke my face; Felt like muscle spasms; Felt like tension tightness ach; tingling in my ankle and feet but only on one side but mild.; more disconfort near my ear and sensitive when i stroke my face; Pain headach started on the right side of my face from my temple down to lower chin; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Cholestrole" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "I felt very tired not to much energy"; FACIAL PAIN (non-serious), HEADACHE (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "Pain headach started on the right side of my face from my temple down to lower chin"; EAR DISCOMFORT (non-serious), SENSITIVE SKIN (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "more disconfort near my ear and sensitive when i stroke my face"; MUSCLE SPASMS (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Felt like muscle spasms"; FEELING ABNORMAL (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Felt like tension tightness ach"; PARAESTHESIA (non-serious) with onset 23Apr2021, outcome "not recovered", described as "tingling in my ankle and feet but only on one side but mild.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, asthenia, facial pain, muscle spasms, feeling abnormal, paraesthesia, sensitive skin, headache. Therapeutic measures were taken as a result of ear discomfort.  Additional information: No covid prior vaccination. The patient tested post vaccination. No other vaccine in four weeks. Other medications in two weeks was vitamins. No known allergies. Facility type vaccine was hospital and vitamins had taken within two weeks. The patient experienced muscle spasms and thought was coming from my mouth. Went to the dentist did not find anything wrong. The pain came in went everyday. Felt like tension tightness ache. Took Advil or Tylenol for the disconfort only helped a little. It was may and I still had this ache off and on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Arm got real sore; Body aches really bad like she has the Flu; Sore underneath the armpit; Body aches really bad like she has the Flu/aches really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "With the first shot, she had a little sore arm and that was it".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm got real sore"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Body aches really bad like she has the Flu"; AXILLARY PAIN (non-serious), outcome "unknown", described as "Sore underneath the armpit"; PAIN (non-serious), outcome "unknown", described as "Body aches really bad like she has the Flu/aches really bad".  Additional information: It was stated that after receiving second dose of vaccine, the patient was fine until the middle of the night. The patient didn't know if she could take Aspirin or Ibuprofen. The patient didn't know if that was a 24 hour thing. The patient stated that she was unemployed. The patient informed that her husband has not been doing well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Paraesthesia, Throat irritation, Vaccination site pain
Clinical narrative: Back pain/back pain in her low back; Pain in the arm where she received the actual vaccine; The right arm pain shot down her arm, into her hand and pinky finger; Tingling in her right arm; Her throat became itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 09:30 (Lot number: ER8737) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing). The following information was reported: BACK PAIN (non-serious) with onset 15Apr2021, outcome "not recovered", described as "Back pain/back pain in her low back"; PARAESTHESIA (non-serious) with onset 14Apr2021, outcome "recovered" (14Apr2021), described as "Tingling in her right arm"; THROAT IRRITATION (non-serious) with onset 14Apr2021, outcome "recovered" (14Apr2021), described as "Her throat became itchy"; VACCINATION SITE PAIN (non-serious) with onset 15Apr2021, outcome "recovered" (15Apr2021), described as "Pain in the arm where she received the actual vaccine"; PAIN IN EXTREMITY (non-serious) with onset 14Apr2021, outcome "recovered" (14Apr2021), described as "The right arm pain shot down her arm, into her hand and pinky finger".  Additional information: She experienced back pain. Her experience started initially at that moment when she was being monitored after receiving her first dose. She experienced tingling in her right arm, but she had the injection in her left arm. The right arm pain shot down her arm, into her hand and pinky finger. Her throat became itchy. She wants to say 1 day later, she experienced pain in the arm where she received the actual vaccine. Her left arm. It lasted for only 2 and a half hours. A day later, she experienced back pain in her low back that lasted 4 days and came back on 29Apr2021, not as severe. The pain isn't as severe as it was on Thursday, but if she moves a certain way, she is back in pain. She has not been moving as she is used to and the pain has subsided, then clarifies her back pain is persisting and it comes and goes. No previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). No illness at time of vaccination.  No follow-up attempts are possible. No further information is expected.