chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (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) with onset 26Aug2021, outcome "unknown", described as "Headache". Additional information: It was reported that patient received the first dose of Pfizer Covid-19 vaccine on 26Aug2021 and experienced a bit of headache after receiving the vaccine. Asked if she can take Tylenol. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 43-year-old female patient (not pregnant) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3182), at the age of 43, in right arm, on Aug 27, 2021, at 11:30, single dose, for COVID-19 immunisation. Medical history included thyroid disease (unspecified if ongoing); and COVID-19 (unspecified if ongoing), notes: COVID-19 prior vaccination: Yes. Concomitant medication included synthroid. Vaccination history included 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA7485), at the age of 43, in left arm, on Aug 4, 2021, at 04:15 pm, single dose, for COVID-19 immunisation. The patient experienced menstrual disorder (menstruation - following a full cycle only a few days before), onset Aug 29, 2021, at 11:00, with outcome of not recovered. Therapeutic measures were not taken as a result of menstrual disorder. Additional information: Patient had COVID-19 prior vaccination. Patient not COVID-19 tested post vaccination. No other vaccine in four weeks. No follow-up attempts possible. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Uncomfortable tingling in calf and ankle of left leg for 2 days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Aug2021 13:00 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: PARAESTHESIA (non-serious) with onset 02Aug2021, outcome "recovered" (04Aug2021), described as "Uncomfortable tingling in calf and ankle of left leg for 2 days". Therapeutic measures were not taken as a result of paraesthesia.  Additional information: Lot number unknown reason reported as unable to locate or read the details. Facility type vaccine reported as pharmacy or drug Store. The patient was not received other vaccine in four weeks. The patient received other medication in two weeks was Rosuvastatin. The adverse event was not resulted in emergency room or physician office visit. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient had 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: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: I got first shot then was very confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 13:00 (Lot number: Er8732) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CONFUSIONAL STATE (non-serious) with onset 23Apr2021 09:00, outcome "not recovered", described as "I got first shot then was very confused". The event "i got first shot then was very confused" was evaluated at the physician office visit. Therapeutic measures were taken as a result of confusional state.  No follow-up attempts are possible. No further information is expected.  Additional information: It was reported that Dose 2 details: Suspect Product: Pfizer COVID 19, Batch/lot number: Ewo173, Date of start of drug: 07May2021 at 01:00 PM, Anatomical Location: Arm Right, Dose Number: 2. Reported Event: This started 5 was after I got first shot then was very confused and could not drive to get 2nd dose daughter drove me now seeing a neurologist since 28Jun2021. Outcome of reaction was Not Recovered/Not resolved. The patient had received treatment for adverse event. The patient no history of medical history, concurrent conditions and no past drug history. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medication within 2 weeks. Did the adverse event result in any of the following? Doctor or other healthcare professional office/clinic visit. What treatment received for the adverse event? Mental confusion. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination.  Follow-Up#1 (08Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: muscle soreness; tired; 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), administration date 05Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 15Jul2021, for Covid-19 Immunization, reaction(s): "fever", "muscle soreness", "body ache", "chills", "no appetite". The following information was reported: MYALGIA (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "muscle soreness"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "tired".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm the next day; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Feb2021 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing); "Autoimmune disease" (unspecified if ongoing); "meniere's diseas" (unspecified if ongoing); "Polypharmacy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Lot number: EL0142), administration date: 12Jan2021, for COVID-19 immunization, reaction(s): "arm pain", "fatigue", "malaise", "Periodic migraine headaches", "Increased ringing of affected ear". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Feb2021, outcome "unknown", described as "sore arm the next day".  Additional Information: It was reported that, the next day (13Jan2021) followed by vaccination dose 1 of BNT162B2 patient experienced fatigue and malaise for 7 days. On 08Aug2021, patient received booster dose of Pfizer lot # FC 3180.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Started my period following vaccine off cycle following both the first and second dose.; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Aug2021 16:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single and administered in arm right, administration date 25Aug2021 10:15 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Thimerosal" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Aug2021, outcome "recovering", described as "Started my period following vaccine off cycle following both the first and second dose.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did not take any other medications in two weeks. If covid prior vaccination was reported as Yes and if covid tested post vaccination reported as No. Covid test post vaccination reported as no. Adverse event start date reported as 26Aug2021 06:00 AM.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Investigation, Pain
Clinical narrative: Aching and all that so, For couple of days to first two vaccine; 1st dose: 09March2021; second dose: 24March2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: ER8734) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic type-I" (unspecified if ongoing); "Coronary artery disease" (unspecified if ongoing); "Imuno-deficiency syndrome" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Lot:EN6204), administration date: 09Mar2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "Aching and all that so, For couple of days to first two vaccine". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Aching and all that so, For couple of days to first two vaccine"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "1st dose: 09March2021; second dose: 24March2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: an immune deficiency (history) and I have had some of the side effects with the last two shot cause she had just achy and stuff for couple of days, but this one was two weeks out and she was still feeling that way, she don't know but she should still be feeling the effects this far out."  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Pain
Clinical narrative: Aching and all that so, For couple of days to first two vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient).  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Mar2021 (Lot number: EN6204) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Common variable immunodeficiency" (unspecified if ongoing); "Verbatim: Diabetic Type-I" (unspecified if ongoing), notes: Verbatim: Diabetic Type-I; "Verbatim: Coronary artery disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Aching and all that so, For couple of days to first two vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concern: Consumer stated, "My name is (name) (not spelled) last name spelled (name). My phone number #. I have an Immune deficiency so(Intent history; Not further clarify, Hence not captured in tab), 2 week ago, On Monday, I would have, Got my third booster and I am just wandering because I had side effect, Aching and all that so, For couple of days to first two vaccine. I think so, I am on two weeks off. I am trying this, I had this, Headache, Muscle ache and then had slightly fever so, I am afraid, I am wondering, If no longer we have interaction for this how." Consumer stated, "I take medicine for my heart, I would have all day if I tell you my medication, I have a list that long."(further clarification unknown). Consumer stated, "I am diabetic type-I, I have got a heart condition(further not clarified hence not captured in tab), I have got a coronary artery disease and I have an immune deficiency It's called CVID- common variable immuno-deficiency syndrome."   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Vaccination site pruritus
Clinical narrative: Both sites are little itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 (Lot number: EW0179) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low Thyroid" (unspecified if ongoing); "cancer" (unspecified if ongoing), notes: I have had several cancers, but I do not have cancer now.; "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; VITAMIN D [VITAMIN D NOS]; BABY ASPIRIN; COQ-10 taken for hypertension. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset Aug2021, outcome "unknown", described as "Both sites are little itchy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated, I need to tell you something. Sometimes not often now, I had high blood pressure (medical history). I think actually it's getting low. This is during pandemic this has changed. So I do occasionally take (voice not clear) about 20. But usually, my blood pressure is low. But used to be high. My doctor was treating me for high blood pressure. But I measure pressure everyday now it is no longer high. So, I don't know why it changed. It just has. Patient had no prior vaccination (within 4 weeks).  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: has something up her heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "has something up her heart".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Haematology test, Investigation, Metabolic function test
Clinical narrative: I am having tenderness and the pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP/nurse). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 27Aug2021 08:30 (Lot number: FC3184) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol; "hyperlipidemia", start date: 2019 (ongoing); "migraines", start date: 2016 (ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE; ROSUVASTATIN taken for blood cholesterol increased, hyperlipidaemia, start date: 2020 (ongoing); SUMATRIPTAN taken for migraine, start date: 2019 (ongoing); FROVATRIPTAN taken for migraine, start date: 2019 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1 Time: 09:00, Lot no: EW0181, Anatomical location: Left Deltoid, Route of administration: Intramuscular), administration date: 06Aug2021, when the patient was 46 years old, for COVID-19 immunization, reaction(s): "disc pain", "Severe depressed shortness of breath", "Severe sharp pain in left pleural space". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "I am having tenderness and the pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: consumer stated she is LPN. Confirmed as Licensed Practitioner Nurse. yesterday was her second shot. Confirmed the date of administration of first shot as 06Aug2021 and date of administration of second shot as 27Aug2021. So when she went to the health department she told them that this is the situation of the first one she got it on her left so she said okay this time put it on her right and then make sure that it is not, do not take same side again. So, she put it on her right. So, of course she had tenderness and the pain at the injection site but she do not feel the pain that is in her left area she do not feel like in her right side. Right yeah this morning she was in so much pain. Other medical conditions: Consumer stated no she do not have diabetes, she do not have hypertension. Causality: Consumer stated yes because I never had any pain in my body until I got it. Consumer stated yeah that is right the first one on the left and then the second yesterday was on her right that was all. When probed if consumer had any vaccination 4 weeks prior to COVID 19 Vaccine. consumer stated no she had not had any within 4 weeks those I had were from like a couple of months ago like about 5 or so months, so (voice not clear). The patient provided information regarding the reported adverse event(s) with the use of the product. Do you consider the Pfizer product had a causal effect to the adverse event: Yes  No follow-up attempts are possible. No further information was expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Troponin, Vaccination site pain, X-ray
Clinical narrative: I am having tenderness and the pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP/nurse). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 27Aug2021 08:30 (Lot number: FC3184) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol; "hyperlipidemia", start date: 2019 (ongoing); "migraines", start date: 2016 (ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE; ROSUVASTATIN taken for blood cholesterol increased, hyperlipidaemia, start date: 2020 (ongoing); SUMATRIPTAN taken for migraine, start date: 2019 (ongoing); FROVATRIPTAN taken for migraine, start date: 2019 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1 Time: 09:00, Lot no: EW0181, Anatomical location: Left Deltoid, Route of administration: Intramuscular), administration date: 06Aug2021, when the patient was 46 years old, for COVID-19 immunization, reaction(s): "disc pain", "Severe depressed shortness of breath", "Severe sharp pain in left pleural space". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "I am having tenderness and the pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: consumer stated she is LPN. Confirmed as Licensed Practitioner Nurse. yesterday was her second shot. Confirmed the date of administration of first shot as 06Aug2021 and date of administration of second shot as 27Aug2021. So when she went to the health department she told them that this is the situation of the first one she got it on her left so she said okay this time put it on her right and then make sure that it is not, do not take same side again. So, she put it on her right. So, of course she had tenderness and the pain at the injection site but she do not feel the pain that is in her left area she do not feel like in her right side. Right yeah this morning she was in so much pain. Other medical conditions: Consumer stated no she do not have diabetes, she do not have hypertension. Causality: Consumer stated yes because I never had any pain in my body until I got it. Consumer stated yeah that is right the first one on the left and then the second yesterday was on her right that was all. When probed if consumer had any vaccination 4 weeks prior to COVID 19 Vaccine. consumer stated no she had not had any within 4 weeks those I had were from like a couple of months ago like about 5 or so months, so (voice not clear). The patient provided information regarding the reported adverse event(s) with the use of the product. Do you consider the Pfizer product had a causal effect to the adverse event: Yes  No follow-up attempts are possible. No further information was expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Limb discomfort, Magnetic resonance imaging, Vaccination site swelling
Clinical narrative: Swelling but it was very sensitive to the touch; discomfort I felt on the left arm; 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 (Lot number: EWD177) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal; HYDROCHLOROTHIAZIDE taken for hypertension. Vaccination history included: Flu, for Immunization, reaction(s): "fatigue", "achy". The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Swelling but it was very sensitive to the touch"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "discomfort I felt on the left arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Consumer stated, "I went to my doctor prior to the first injection and I got an MRI of my brain which I annually get and it said there was no change and I was okay to get the shot and I also went to my internal medicine doctor for the blood pressure and he also said it would be okay. So, there is on file, I did a blood work for my internal medicine and the MRI for my brain! my MS doctor that was maybe, the date I got the first shot was on. On 8Aug and I think I went maybe the week before and had the MRI done. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Renal disorder
Clinical narrative: low back pain; it feels like her kidneys are affected; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) received via a Pfizer sales representative. 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:01), for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "low back pain"; RENAL DISORDER (non-serious), outcome "unknown", described as "it feels like her kidneys are affected". Additional information: low back pain approximately one week post dose. She states that it feels like her kidneys are affected and she will follow up with her physician. She states she is not sure if it is related to the vaccine however she was curious if it was a reported side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) 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 (1st dose), for COVID-19 immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional information: Patient reported tiredness post second dose of covid vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: This morning, 30Aug2021, woke up and has swollen lymph nodes on one of sides; Once in a while, feels a little ache in the same location of the swollen lymph node; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 (Lot number: FD8448) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: Verbatim: High blood pressure. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); LISINOPRIL taken for hypertension (ongoing); ATENOLOL taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (First dose: 30Jul2021 , Lot: FA7485, NDC: unknown , Expiration: Unknown , Route of administration: left arm), for Covid-19 Immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 30Aug2021, outcome "unknown", described as "This morning, 30Aug2021, woke up and has swollen lymph nodes on one of sides"; PAIN (non-serious) with onset 30Aug2021, outcome "unknown", described as "Once in a while, feels a little ache in the same location of the swollen lymph node".  Additional Information: Patient received the second dose Pfizer Covid 19 Vaccine on Monday, 23Aug2021, lot FD8448. This morning, 30Aug2021, has swollen lymph nodes on left hand side. The patient just noticed this morning when the patient woke up. agent asks if the swollen lymph nodes have improved, worsened or is persisting and the caller replies, the swollen lymph nodes happened this morning, 30Aug2021 and is pretty big and swollen lymph node is the size of the inside of the cup of palm of hand. The patient just noticed it this morning. Did not notice any swelling yesterday, 29Aug2021. Once in a while, the patient feels a little ache in the same location of the swollen lymph node and aching began about 5 hours ago today, 30Aug2021.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My lymph node was swollen; Lymph node, underneath, it was my lymph node on my left thigh and under the armpit; I was feeling discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Aug2021 17:30 (Lot number: EW0165) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Time:05:30 pm, Anatomical site of injection: left arm, Route of administration: intramuscular, Batch/lot number: EW0217), administration date: 04Aug2021, when the patient was 52 years old, for COVID-19 Immunisation. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "My lymph node was swollen; Lymph node, underneath, it was my lymph node on my left thigh and under the armpit; I was feeling discomfort".  Additional information: The patient stated lymph node, underneath and lymph node on  left thigh and under the armpit. That was on Friday that she was feeling discomfort and also the discomfort was more on Saturday and she just applied a warm compress to the area, monitored. She has no fever or anything like that, she was okay.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Vomiting
Clinical narrative: Caller states the first shot reactivated her hot flashes, after being gone the hot flashes came back with a vengeance; vomiting; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hot flashes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Caller states the first shot reactivated her hot flashes, after being gone the hot flashes came back with a vengeance"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gait disturbance, Headache, Illness
Clinical narrative: I had difficulty walking because I was so weak and dizzy.; I had difficulty walking because I was so weak and dizzy.; I had difficulty walking because I was so weak and dizzy.; headache; nausea; until the 4th day I was so sick; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 14:30 (Lot number: FC3180) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. The following information was reported: GAIT DISTURBANCE (non-serious), ASTHENIA (non-serious), DIZZINESS (non-serious) all with onset 25Aug2021 04:00, outcome "unknown" and all described as "I had difficulty walking because I was so weak and dizzy."; HEADACHE (non-serious) with onset 25Aug2021 04:00, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 25Aug2021 04:00, outcome "unknown", described as "nausea"; ILLNESS (non-serious) with onset 25Aug2021 04:00, outcome "unknown", described as "until the 4th day I was so sick". The events "i had difficulty walking because i was so weak and dizzy.", "i had difficulty walking because i was so weak and dizzy.", "i had difficulty walking because i was so weak and dizzy.", "headache", "nausea" and "until the 4th day i was so sick" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gait disturbance, asthenia, dizziness, headache, nausea, illness.  Additional information: The patient did not receive any vaccination, prior vaccine within Four weeks. The other medications in two weeks was Lisinopril. The patient was not tested for Covid-19 prior vaccination. The patient was tested for Covid-19, post vaccination. There were no Known allergies reported. The patient stated, it started with extreme weakness, dizziness, headache, and nausea the next morning. I had difficulty walking because I was so weak and dizzy. The headache would not go away even with 800mg of Motrin. Symptoms grew worse and worse until the 4th day I was so sick I thought I might have a stroke and die. It is now one week later and while I still have dizziness and a headache I can finally walk and eat. There is no way what happened to me is safe. I'm a healthy adult who is fully vaccinated with no problems ever with any other vaccine. Treatment was provided with Promethazine 25mg and Motrin 800mg.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: I had difficulty walking because I was so weak and dizzy.; I had difficulty walking because I was so weak and dizzy.; I had difficulty walking because I was so weak and dizzy.; headache; nausea; until the 4th day I was so sick; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 14:30 (Lot number: FC3180) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. The following information was reported: GAIT DISTURBANCE (non-serious), ASTHENIA (non-serious), DIZZINESS (non-serious) all with onset 25Aug2021 04:00, outcome "unknown" and all described as "I had difficulty walking because I was so weak and dizzy."; HEADACHE (non-serious) with onset 25Aug2021 04:00, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 25Aug2021 04:00, outcome "unknown", described as "nausea"; ILLNESS (non-serious) with onset 25Aug2021 04:00, outcome "unknown", described as "until the 4th day I was so sick". The events "i had difficulty walking because i was so weak and dizzy.", "i had difficulty walking because i was so weak and dizzy.", "i had difficulty walking because i was so weak and dizzy.", "headache", "nausea" and "until the 4th day i was so sick" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gait disturbance, asthenia, dizziness, headache, nausea, illness.  Additional information: The patient did not receive any vaccination, prior vaccine within Four weeks. The other medications in two weeks was Lisinopril. The patient was not tested for Covid-19 prior vaccination. The patient was tested for Covid-19, post vaccination. There were no Known allergies reported. The patient stated, it started with extreme weakness, dizziness, headache, and nausea the next morning. I had difficulty walking because I was so weak and dizzy. The headache would not go away even with 800mg of Motrin. Symptoms grew worse and worse until the 4th day I was so sick I thought I might have a stroke and die. It is now one week later and while I still have dizziness and a headache I can finally walk and eat. There is no way what happened to me is safe. I'm a healthy adult who is fully vaccinated with no problems ever with any other vaccine. Treatment was provided with Promethazine 25mg and Motrin 800mg.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: had a swollen lymph node under the right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Lot number: EN6205, Expiration Date: Jun2021) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing), notes: The patient had immuno therapy cancer treatment on 12Aug2021.; "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes; "Neuropathy" (unspecified if ongoing), notes: The patient has neuropathy and is on insulin; "Triglycerides high" (unspecified if ongoing), notes: Verbatim: Triglycerides high; "Atrial fibrillation" (unspecified if ongoing), notes: Verbatim: Atrial fibrillation; "immunocompromised" (unspecified if ongoing); "multiple myeloma" (unspecified if ongoing). Concomitant medication(s) included: DARZALEX; DEXAMETHASONE; SINGULAIR; BENADRYL; TYLENOL. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "not recovered", described as "had a swollen lymph node under the right arm". Additional information: Why was the patient taking covid 19 vaccine (Verbatim): immunocompromised. Concomitant Products Darzalex: injection in stomach. Other Conditions: direct result of Chemo in the beginning. Investigation Assessment: No. The patient got the two doses and had a swollen lymph node under the right arm which was the same arm he received the vaccines in. The lymph node swelling started a couple of days after the first day after the patient received the first dose. It comes and goes and the Nurse Practitioner said it wasn't unusual. This never went away before the second dose. They ordered an ultrasound for it but they haven't scheduled it yet. First Dose: Received 20Mar2021, lot EN6205, NDC unknown and expiration date Jun2021. The caller later clarifies and confirms that she received her first dose on 25Mar2021, not 20Mar2021 as previously reported. History: The patient had to take steroids, antihistamines, and Tylenol before his cancer treatment. The patient had neuropathy and was on insulin. An hour before Darzalex he takes dexamethasone, Singulair, benadryl, and Tylenol. The patient had multiple myeloma and was a diabetic. The patient had immuno therapy cancer treatment on 12Aug2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101134797 same reporter/drug/event, different patient
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: Heavy, painful menstrual cycle lasting 3 days longer than normal; Breakthrough spotting and cramping 9 days before next expected cycle; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: FA7485) at the age of 24 years as dose 1, single and administration date 21Aug2021 (Lot number: FC3181) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSMENORRHOEA (non-serious), outcome "not recovered", described as "Heavy, painful menstrual cycle lasting 3 days longer than normal"; DYSMENORRHOEA (non-serious), outcome "not recovered", described as "Breakthrough spotting and cramping 9 days before next expected cycle".  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Aug2021 10:30 (Lot number: FC3183) at the age of 65 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu vaccine (Adverse event to a flu vaccine 30 years ago.), administration date: 1991, for Immunization, reaction(s): "fatigue", "did not feel well", "Sore arm", "Pneumonia". The following information was reported: FATIGUE (non-serious) with onset 30Aug2021 14:00, outcome "not recovered", described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset 30Aug2021 18:00, outcome "not recovered", described as "Sore arm".  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Ear pain
Clinical narrative: Lightness in the head like dizziness; Ear pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 27Aug2021 11:00 (Lot number: FC3182, Expiration Date: 31Oct2021) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Lot number: FC3180, Time: 10:30 am, expiration date is 31Oct2021, Anatomical location: Arm), administration date: 06Aug2021, when the patient was 13 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 30Aug2021, outcome "unknown", described as "Lightness in the head like dizziness"; EAR PAIN (non-serious) with onset 30Aug2021, outcome "unknown", described as "Ear pain". Therapeutic measures were not taken as a result of dizziness, ear pain.  Additional information: NDC number and UPC number  of COVID 19 Vaccine was unknown. No other Products. Patient not received treatment for the adverse event. Reporter stated we took a blood test recently. it was like 2 weeks ago or may be more than that like may be like 9 or 10Aug. Reporter stated we didn't get any test result. It was just like it was a check up thing that is required. No prior vaccination. Family medical history was reporter stated mother had a heart disease.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fatigue; headaches; muscle aches; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Aug2021 (Lot number: FC3181) at the age of 24 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product COVID 19, Brand: Pfizer, Lot number: FA7485, Lot unknown: False, Administration date: 30Jul2021, Dose number: 1), administration date: 30Jul2021, when the patient was 24 years old, for Covid-19 Immunisation. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "Fatigue"; HEADACHE (non-serious), outcome "not recovered", described as "headaches"; MYALGIA (non-serious), outcome "not recovered", described as "muscle aches"; NAUSEA (non-serious), outcome "not recovered", described as "nausea". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, nausea.  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. The patient did not had any known allergy.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Rash macular
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 10:15 (Lot number: EW0183) at the age of 36 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: RASH MACULAR (non-serious) with onset 2021, outcome "not recovered", described as "It is explained that there was some splotchiness between the first and second shot"; DRY SKIN (non-serious) with onset 2021, outcome "unknown", described as "She thought it was dry skin". It is explained that there was some splotchiness between the first and second shot but today noticed it was worse and red. The patient clarifies the splotchiness went away after the first dose; it started a few days after getting the first dose and last a few days then went away. The patient thought it was dry skin. Now after the second dose, the patient notice it was worse than after the first dose. It did not itch but was red and there. She was not allergic to anything. 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: Fatigue
Clinical narrative: Feeling minor fatigue after her first Pfizer covid 19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  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: FATIGUE (non-serious), outcome "unknown", described as "Feeling minor fatigue after her first Pfizer covid 19 vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 28May2021 (Lot number: EWO177) as dose 1, single and administration date 18Jun2021 (Lot number: EWO180) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Extreme anxiety". Additional information: Event took place after use of product. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Arm ache; 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), intramuscular, administered in arm left, administration date 09Jul2021 12:00 (Lot number: EW0196) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 09Jul2021 14:00, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 09Jul2021 14:00, outcome "unknown", described as "Arm ache".  No follow-up attempts are possible. No further information is expected.