chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased
Clinical narrative: low heart rate after vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101117509 (Pfizer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthamtic" (unspecified if ongoing), notes: she is on a blood thinner, asthamtic, and has pacemaker; "pacemaker" (unspecified if ongoing), notes: she is on a blood thinner, asthamtic, and has pacemaker. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunisation. The following information was reported: HEART RATE DECREASED (non-serious), outcome "unknown", described as "low heart rate after vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: caller mentioned she experienced a low heart rate after receiving the 2nd dose. (Name withheld) also mentioned before having the 1st dose of Pfizer vaccine she is on a blood thinner, asthamtic, and has pacemaker.  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 jaw
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). A 52 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing); "difficulty remembering" (ongoing); "multiple sclerosis" (ongoing). Concomitant medication(s) included: Ocrevus; Colecalciferol; Vitamin B Complex. The following information was reported: PAIN IN JAW (non-serious) with onset 06Jun2021, outcome "recovered", described as "her jaw hurt from being so cold". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Since the second shot I have had a continuous ringing in the back of my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 16:30 (Batch/Lot number: unknown) at the age of 51 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 1, Administration time: 04:45 PM, Vaccine location: Left arm, Lot unknown reason: Unable to locate or read the details), administration date: 25Jul2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 16Aug2021 04:00, outcome "not recovered", described as "Since the second shot I have had a continuous ringing in the back of my head". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Facility type vaccine was reported as pharmacy or drug store. The patient had no known allergies. The patient did not receive other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 17:00 (Lot number: FC3183) at the age of 43 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: ST JOHN'S WORT; LION'S MANE; VITAMIN D [ERGOCALCIFEROL]. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 24Aug2021 21:00, outcome "unknown", described as "stomach cramps"; DIARRHEA (non-serious) with onset 24Aug2021 21:00, outcome "unknown", described as "diarrhea"; NAUSEA (non-serious) with onset 24Aug2021 21:00, outcome "unknown", described as "nauseous". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhea, and nausea. Additional information: Adverse event: I have been having stomach cramps, diarrhea, and nauseous for the last 3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Disturbance in attention, Insomnia, Investigation
Clinical narrative: After Pfizer shot I got severe shakes; My pulse control up and I mean my blood pressure kicks on to the roof, I mean really gone high; I am steady; I am little nervous; I haven't ready for a drive, the concentration is bad, all the equips goes mess; Real funny feeling in the out, in the summer. I feel like queasy or something; I cant sleep, I am so nervous at night, I don't sleep the moment at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Apr2021 (Batch/Lot number: unknown, Expiration Date: 05Aug2021) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OXYCODONE taken for insomnia; SEROFLO taken for sleep disorder. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "After Pfizer shot I got severe shakes"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "My pulse control up and I mean my blood pressure kicks on to the roof, I mean really gone high"; NERVOUSNESS (non-serious), outcome "unknown", described as "I am steady; I am little nervous"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "I haven't ready for a drive, the concentration is bad, all the equips goes mess"; NAUSEA (non-serious), outcome "unknown", described as "Real funny feeling in the out, in the summer. I feel like queasy or something"; INSOMNIA (non-serious), outcome "unknown", described as "I cant sleep, I am so nervous at night, I don't sleep the moment at night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive the second dose. The patient states that They told me (further not clarified) not to take the second shot till I found out why this was caused by the first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Nervousness, Tremor
Clinical narrative: After Pfizer shot I got severe shakes; My pulse control up and I mean my blood pressure kicks on to the roof, I mean really gone high; I am steady; I am little nervous; I haven't ready for a drive, the concentration is bad, all the equips goes mess; Real funny feeling in the out, in the summer. I feel like queasy or something; I cant sleep, I am so nervous at night, I don't sleep the moment at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Apr2021 (Batch/Lot number: unknown, Expiration Date: 05Aug2021) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OXYCODONE taken for insomnia; SEROFLO taken for sleep disorder. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "After Pfizer shot I got severe shakes"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "My pulse control up and I mean my blood pressure kicks on to the roof, I mean really gone high"; NERVOUSNESS (non-serious), outcome "unknown", described as "I am steady; I am little nervous"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "I haven't ready for a drive, the concentration is bad, all the equips goes mess"; NAUSEA (non-serious), outcome "unknown", described as "Real funny feeling in the out, in the summer. I feel like queasy or something"; INSOMNIA (non-serious), outcome "unknown", described as "I cant sleep, I am so nervous at night, I don't sleep the moment at night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive the second dose. The patient states that They told me (further not clarified) not to take the second shot till I found out why this was caused by the first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 14-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD8448), at the age of 14, in right arm, on Aug 26, 2021, at 16:30, single dose, for COVID-19 immunization. No medical history or concomitant medications reported. The patient experienced vaccination site pain (pain at the injection site) and pain in extremity (arm pain), onset Aug 27, 2021, at 08:00, with outcome of recovered (Aug 27, 2021). No therapeutic measures taken. Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Palpitations, Supraventricular tachycardia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 32 year-old female patient (pregnant) 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. The patient took concomitant medications. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", SUPRAVENTRICULAR TACHYCARDIA (non-serious), PALPITATIONS (non-serious) all with onset 25Feb2021, outcome "recovered" (May2021) and all described as "SVT and palpitations 1 week before delivery lasting until 2 months after delivery". Therapeutic measures were not taken as a result of supraventricular tachycardia, palpitations. Additional Information: Facility type vaccine: Workplace clinic. Other medications in two weeks: Prenatal. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Gait disturbance, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable other HCP. A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 13:30 (Lot number: EW0180) at the age of 57 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if Covid prior vaccination Yes. Concomitant medication(s) included: VITAMIN B-12; VITAMIN C [ASCORBIC ACID]; CETIRIZINE. Past drug history included: Augmentin, reaction(s): "allergy". The following information was reported: HEADACHE (non-serious) with onset 09Aug2021 13:00, outcome "recovered" (2021), described as "1st day mild headache"; NAUSEA (non-serious) with onset 09Aug2021 13:00, outcome "recovered" (2021), described as "nausea"; VACCINATION SITE PAIN (non-serious) with onset 09Aug2021 13:00, outcome "recovered" (2021), described as "soreness at injection sight"; CHILLS (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (10Aug2021 14:00), described as "an hour of cold chills"; CHILLS (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (10Aug2021 14:00), described as "onset of uncontrollable shivering and teeth chattering"; CHILLS (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (10Aug2021 14:00), described as "teeth chattering"; FEELING COLD (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (2021), described as "felt like I was freezing to death"; GAIT DISTURBANCE (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (2021), described as "felt unsteady walking". Therapeutic measures were not taken as a result of headache, nausea, vaccination site pain, chills, chills, chills, feeling cold, gait disturbance. Additional information: Patient reported for herself, patient took Multivitamin as concomitant drug. No vaccine in 4 weeks. Adverse event: 1st day mild headache & nausea, soreness at injection sight, 2nd day same with about an hour of cold chills, 3rd day same but, with onset of uncontrollable shivering & teeth chattering to the point of having to leave work- this lasted about an hour, felt like she was freezing to death, shivering to the point she could hardly use her hands and felt unsteady walking. Patient was infected with Covid prior vaccination and did not get Covid  tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable other HCP. A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 13:30 (Lot number: EW0180) at the age of 57 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if Covid prior vaccination Yes. Concomitant medication(s) included: VITAMIN B-12; VITAMIN C [ASCORBIC ACID]; CETIRIZINE. Past drug history included: Augmentin, reaction(s): "allergy". The following information was reported: HEADACHE (non-serious) with onset 09Aug2021 13:00, outcome "recovered" (2021), described as "1st day mild headache"; NAUSEA (non-serious) with onset 09Aug2021 13:00, outcome "recovered" (2021), described as "nausea"; VACCINATION SITE PAIN (non-serious) with onset 09Aug2021 13:00, outcome "recovered" (2021), described as "soreness at injection sight"; CHILLS (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (10Aug2021 14:00), described as "an hour of cold chills"; CHILLS (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (10Aug2021 14:00), described as "onset of uncontrollable shivering and teeth chattering"; CHILLS (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (10Aug2021 14:00), described as "teeth chattering"; FEELING COLD (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (2021), described as "felt like I was freezing to death"; GAIT DISTURBANCE (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (2021), described as "felt unsteady walking". Therapeutic measures were not taken as a result of headache, nausea, vaccination site pain, chills, chills, chills, feeling cold, gait disturbance. Additional information: Patient reported for herself, patient took Multivitamin as concomitant drug. No vaccine in 4 weeks. Adverse event: 1st day mild headache & nausea, soreness at injection sight, 2nd day same with about an hour of cold chills, 3rd day same but, with onset of uncontrollable shivering & teeth chattering to the point of having to leave work- this lasted about an hour, felt like she was freezing to death, shivering to the point she could hardly use her hands and felt unsteady walking. Patient was infected with Covid prior vaccination and did not get Covid  tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vision blurred, Visual impairment
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2021 19:00 (Lot number: EL9262) at the age of 38 years as dose 2, single and intramuscular, administered in arm left, administration date 17Jan2021 18:00 (Lot number: EL3302) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 08Feb2021, outcome "not recovered", described as "migraine headaches"; VISION BLURRED (non-serious) with onset 08Feb2021, outcome "not recovered", described as "blurred vision"; VISUAL IMPAIRMENT (non-serious) with onset 08Feb2021, outcome "not recovered", described as "seeing spots". The events "migraine headaches", "blurred vision" and "seeing spots" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of migraine, vision blurred, visual impairment. Additional Information: The patient had no COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive any other vaccinations or medication within 2 weeks. The patient did not receive other vaccine in four weeks. The patient was not tested for COVID post vaccination. Patient had no known allergies. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. A 15 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jun2021 (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 number: 1), for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset Aug2021, outcome "unknown", described as "she has been experiencing a left frontal lobe migraine". Additional information: For the last 3 days she had been experiencing a left frontal lobe migraine that she described as her skull cracking open or being broke. Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder, Tinnitus, Vision blurred
Clinical narrative: I began to have blurred vision; tinnitus; food and odors were no longer strong; food and odors were no longer strong; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "Stage 3b CKD" (unspecified if ongoing), notes: Other medical history: Stage 3b CKD, Degenerative Disc Disease; "Degenerative Disc Disease" (unspecified if ongoing), notes: Other medical history: Stage 3b CKD, Degenerative Disc Disease; "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: DIAZEPAM; AMLODIPINE; FLUOXETINE. Vaccination history included: Bnt162b2 (lot number L9262, administration date 24Jan2021, administration time 10:00 AM, dose number 1, vaccine location Right arm.), administration date: 24Jan2021, when the patient was 68 years old, for Covid-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 10Mar2021 18:00, outcome "not recovered", described as "I began to have blurred vision"; TINNITUS (non-serious) with onset 10Mar2021 18:00, outcome "not recovered", described as "tinnitus"; TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 10Mar2021 18:00, outcome "not recovered" and all described as "food and odors were no longer strong". Therapeutic measures were not taken as a result of vision blurred, tinnitus, taste disorder, parosmia.  Additional Details: There was no other vaccine in four weeks. Other medications in two weeks: Fluoxetine, Diazepam, Amlodipine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Rash, Swelling
Clinical narrative: Underneath his armpit he is getting 'bumps'; it is swollen and it hurts when he moves it; it is really bad today. It is causing him a lot of pain; Underneath his armpit he is getting 'bumps'; it is swollen and it hurts when he moves it; it is really bad today. It is causing him a lot of pain; Underneath his armpit he is getting 'bumps'; it is swollen and it hurts when he moves it; it is really bad today. It is causing him a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A male patient received bnt162b2 (BNT162B2), administration date 13Aug2021 (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. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious), RASH (non-serious), outcome "unknown" and all described as "Underneath his armpit he is getting 'bumps'; it is swollen, and it hurts when he moves it; it is really bad today. It is causing him a lot of pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Aug2021 14:30 (Batch/Lot number: unknown) at the age of 36 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: DYSGEUSIA (non-serious) with onset 29Aug2021 14:45, outcome "recovered" (2021), described as "Metallic taste in mouth". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: No other vaccine in four weeks. No medications in two weeks. No covid prior vaccination.  No covid tested post vaccination.No Known allergies  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: fatigue; have a minor loss of energy after the second vaccine /had no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 16Feb2021 (Lot number: EN6201) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low RBC Counts" (unspecified if ongoing), notes: Verbatim: Low RBC Counts; "pancytopenia" (unspecified if ongoing), notes: Verbatim: pancytopenia. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Administration date= 26Jan2021, Lot Number: EL3249), administration date: 26Jan2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; ASTHENIA (non-serious), outcome "unknown", described as "have a minor loss of energy after the second vaccine /had no energy".  Additional Context: Caller stated he already had 2 shots previously and only had a minor reaction such as fatigue from the second one. Caller reported history of low RBC counts and other immune deficiency characteristics such as pancytopenia. He didn't really have a reaction to the COVID vaccine 1 or 2. He did have a minor loss of energy after the second vaccine. He had just had no energy for a day. He just had fatigue for a day. He took it easy. He just wasn't quite right. No prior Vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: mild brain fog; she felt slight dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 (Lot number: FC3181) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing), notes: Verbatim: Psoriasis, She has a skin condition, She was diagnosed with both 6 years ago.; "Sjogren's" (unspecified if ongoing), notes: Verbatim: Sjogren's,dry eyes, and dry mouth. She was diagnosed with both 6 years ago. Concomitant medication(s) included: DIGESTIVE ENZYMES; VITAMIN D; VITAMIN K. The following information was reported: FEELING ABNORMAL (non-serious) with onset 09Aug2021, outcome "not recovered", described as "mild brain fog"; DIZZINESS (non-serious) with onset 09Aug2021, outcome "unknown", described as "she felt slight dizziness".  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Localized itching at the injection site after the first dose; Swelling at the injection site after the first dose; Redness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07Aug2021 11:30 (Lot number: FC3180, Expiration Date: Oct2021) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Hpv vaccine. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 09Aug2021, outcome "recovered" (Aug2021), described as "Localized itching at the injection site after the first dose "; VACCINATION SITE SWELLING (non-serious) with onset 09Aug2021, outcome "recovered" (Aug2021), described as "Swelling at the injection site after the first dose "; VACCINATION SITE ERYTHEMA (non-serious) with onset 09Aug2021, outcome "recovered" (Aug2021), described as "Redness at the injection site". It was unknown if therapeutic measures were taken as a result of vaccination site pruritus, vaccination site swelling, vaccination site erythema.  Additional information: Reporter states that a patient reported that they had localized itching, swelling, and redness at the injection site after the first dose. Report is not related to a study or programme. Reporter assessed causality, with event as yes. Reporter stated its unknown whether patient had laboratory tests.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Spinal stenosis
Clinical narrative: spinal stenosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EM9802) as dose 2, single and administration date 08Feb2021 (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: SPINAL STENOSIS (non-serious) with onset Mar2021, outcome "not recovered", described as "spinal stenosis".  Additional information: He got two vaccines from Pfizer shortly there after he had a spinal stenosis and still has it. He is wondering if its a coincidence or if its related. He clarified as the covid 19 vaccination and wants to know if that could be a symptom or related to getting his Pfizer vaccine.  No follow-up attempts are possible; No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dysphagia, Illness, Lacrimation increased, Lymphadenopathy
Clinical narrative: Eyes Watered; Nose was Running; Lymph Nodes Puffed Up; Hard to Swallow; Spitting up Phlegm; Got Sick; he was clogged up / Everything was clogged; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 10:00 (Lot number: EWO185) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabeteic" (ongoing). There were no concomitant medications. The following information was reported: LACRIMATION INCREASED (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Eyes Watered"; RHINORRHOEA (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Nose was Running"; LYMPHADENOPATHY (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Lymph Nodes Puffed Up"; DYSPHAGIA (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Hard to Swallow"; PRODUCTIVE COUGH (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Spitting up Phlegm"; ILLNESS (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Got Sick"; DISCOMFORT (non-serious) with onset 17Aug2021, outcome "not recovered", described as "he was clogged up / Everything was clogged". Therapeutic measures were not taken as a result of lacrimation increased, rhinorrhoea, lymphadenopathy, dysphagia, productive cough, illness, discomfort. No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Rhinorrhoea
Clinical narrative: Eyes Watered; Nose was Running; Lymph Nodes Puffed Up; Hard to Swallow; Spitting up Phlegm; Got Sick; he was clogged up / Everything was clogged; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 10:00 (Lot number: EWO185) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabeteic" (ongoing). There were no concomitant medications. The following information was reported: LACRIMATION INCREASED (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Eyes Watered"; RHINORRHOEA (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Nose was Running"; LYMPHADENOPATHY (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Lymph Nodes Puffed Up"; DYSPHAGIA (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Hard to Swallow"; PRODUCTIVE COUGH (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Spitting up Phlegm"; ILLNESS (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Got Sick"; DISCOMFORT (non-serious) with onset 17Aug2021, outcome "not recovered", described as "he was clogged up / Everything was clogged". Therapeutic measures were not taken as a result of lacrimation increased, rhinorrhoea, lymphadenopathy, dysphagia, productive cough, illness, discomfort. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: cardiac issues; 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), administration date 03Feb2021 (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: CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "cardiac issues".  Additional information: Question: "EUA vs Comirnaty does the FDA approved Comirnaty have any liability, if there are complications, for me to say to Pfizer I am having xyz problems from your vaccine. Just like any other FDA approved drug?" The caller received her Pfizer vaccine 2nd dose on 03Feb2021 still having cardiac issues. She had to deal with ever single day. Her job was making me get the booster dose.  Response: Spoke to the caller from the attached document. Provided the caller with the following information and resource website.  Question: Please continue to pass along our frustrations with this situation, the inability of the frontline agents to tell consumers if they receive a Comirnaty vaccine and it is labeled EUA, is Pfizer still possibly liable for damages like any other FDA approved drug? I am not an antivaxer. I am just trying to look out for my health and we feel like puppets on a string.  Response: Spoke to caller from vaccine injury program  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: After her second shot "I'm starting to get these weird muscle twitches, I had one in my back the other night, I had one in my arm, one in my leg".; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old 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 immunization. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "After her second shot "I'm starting to get these weird muscle twitches, I had one in my back the other night, I had one in my arm, one in my leg".".  Additional information:Patient going to get any vaccine dose until the delta variant, and she honestly felt pressured by society to get it". Caller states that she is a healthy 50-year woman who exercises daily and is under 127 pounds.Patient states that after her second shot "I'm starting to get these weird muscle twitches, I had one in my back the other night, I had one in my arm, one in my leg, they are randomly and sporadically coming and going".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had illness (become ill after the 1st dose), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Palpitations
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 62-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient experienced palpitations (heavy pounding of the heart), and abnormal blood pressure (has blood pressure problems now), with outcome of unknown. The events evaluated at an emergency room visit. Relevant laboratory tests and procedures available in the appropriate section. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Ear disorder, Influenza virus test, Oropharyngeal blistering, Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 07Jul2021 (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: OROPHARYNGEAL BLISTERING (medically significant) with onset Aug2021, outcome "recovering", described as "blisters on her throat/Blisters in throat"; PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "recovering", described as "had a really sore arm"; EAR DISORDER (non-serious) with onset Aug2021, outcome "recovering", described as "fluid behind her ears"; OROPHARYNGEAL PAIN (non-serious) with onset Aug2021, outcome "recovering", described as "had a sore throat". The patient underwent the following laboratory tests and procedures: blood test: no antibodies; influenza virus test: negative; sars-cov-2 test: negative; streptococcus test: negative. Therapeutic measures were taken as a result of oropharyngeal blistering, pain in extremity, ear disorder, oropharyngeal pain. Clinical course was reported as, the reporter reported that after the first dose of the Pfizer COVID 19 vaccine on 07Jul2021, she had a really sore arm, and she took Tylenol and Ibuprofen. The patient reported that, she took Tylenol and Ibuprofen before she got the first dose so that maybe she wouldn't have as bad of side effects. She relays that a month after (also reported as about 4 weeks after) the first dose she had fluid behind her ears and blisters on her throat. The patient still had a sore throat and some drainage, but she is feeling much better after a Z-pack. The patient would like to get her second dose of the Pfizer COVID 19 vaccine but when she asked the pharmacy, they were unsure of when she should get it and wants to make sure the second shot is going to be as effective. The patient felt bad and went to the doctors when the time frame came to take the second shot. At the time of report she was better and Just got off a Z-pack last week. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Streptococcus test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 07Jul2021 (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: OROPHARYNGEAL BLISTERING (medically significant) with onset Aug2021, outcome "recovering", described as "blisters on her throat/Blisters in throat"; PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "recovering", described as "had a really sore arm"; EAR DISORDER (non-serious) with onset Aug2021, outcome "recovering", described as "fluid behind her ears"; OROPHARYNGEAL PAIN (non-serious) with onset Aug2021, outcome "recovering", described as "had a sore throat". The patient underwent the following laboratory tests and procedures: blood test: no antibodies; influenza virus test: negative; sars-cov-2 test: negative; streptococcus test: negative. Therapeutic measures were taken as a result of oropharyngeal blistering, pain in extremity, ear disorder, oropharyngeal pain. Clinical course was reported as, the reporter reported that after the first dose of the Pfizer COVID 19 vaccine on 07Jul2021, she had a really sore arm, and she took Tylenol and Ibuprofen. The patient reported that, she took Tylenol and Ibuprofen before she got the first dose so that maybe she wouldn't have as bad of side effects. She relays that a month after (also reported as about 4 weeks after) the first dose she had fluid behind her ears and blisters on her throat. The patient still had a sore throat and some drainage, but she is feeling much better after a Z-pack. The patient would like to get her second dose of the Pfizer COVID 19 vaccine but when she asked the pharmacy, they were unsure of when she should get it and wants to make sure the second shot is going to be as effective. The patient felt bad and went to the doctors when the time frame came to take the second shot. At the time of report she was better and Just got off a Z-pack last week. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 31Aug2021 12:00 (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: HYPOAESTHESIA (non-serious), INJECTION SITE HYPOAESTHESIA (non-serious) all with onset 31Aug2021, outcome "unknown" and all described as "He is having numbness on the side of his face and the injection site is numb". Additional information: The caller reported that he just got his first dose of the Pfizer-BioNTech Covid-19 vaccine at 12:00 EST today. He is having numbness on the side of his face and the injection site is numb. He stated his face feels like he was at the dentist with less sensation. He stated these symptoms were pretty instant when he got the shot. He stated he is not having any issues breathing and has not gotten any worse and might be getting slightly better. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Hot flush, Muscle spasms, Pain assessment
Clinical narrative: Caller states when she had her second shot, she still had residuals for the first shot, and her whole left side cramped up on her and she couldn't move.; headaches; hot flashes; 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 67 year-old female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Attention deficit disorder" (ongoing), notes: Verbatim: Attention deficit disorder; "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis; "Nicked Pudendal Nerve" (ongoing), notes: Verbatim: Nicked Pudendal Nerve. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose), administration date: 01Apr2021, when the patient was 66 years old, for COVID-19 Immunisation. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "Caller states when she had her second shot, she still had residuals for the first shot, and her whole left side cramped up on her and she couldn't move."; CLUSTER HEADACHE (non-serious), outcome "unknown", described as "headaches"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information- Caller states that was in 2013, but after her second Covid Shot she took on 27Apr2021, it took her pain level from 6-7 out of 10 to 20 out of 10 and it hasn't let go get. Caller states her second Covid Vaccine was on 27Apr2021 and it has been kicking her butt. Caller states the first Covid Vaccine on 01Apr2021, tore her a new one. Caller states with the first one, she got all the effects from the first shot that they told her to look out for. Caller states for the Second shot, she had every single one of the effects as the first shot, except vomiting and headaches. Caller states the first shot reactivated her hot flashes, after being gone the hot flashes came back with a vengeance. Caller states when she had her second shot, she still had residuals for the first shot, and her whole left side cramped up on her and she couldn't move.  Follow-up attempts completed. No further information is expected.