chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging
Clinical narrative: Tiredness; headache; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 10:24 (Lot number: EN6201) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Open Heart Surgery", start date: 18Dec2013 (unspecified if ongoing), notes: Bicuspid valve; "Aortic Aneurysm", start date: 2013 (unspecified if ongoing), notes: Open heart Surgery, repaired.; "Total Knee Replacement", start date: 2011, stop date: 2015, notes: Total knee replaced Left Knee; "Thyroidectomy", start date: 2003, stop date: Aug2018, notes: Thyroid removed Aug2018; "High blood pressure" (ongoing); "AFIB" (ongoing); "Thyroid" (ongoing); "Heart" (ongoing). Concomitant medication(s) included: SOTALOL taken for hypertension, start date: 2017 (ongoing); METOPROLOL taken for atrial fibrillation, start date: 2013 (ongoing); LOSARTAN taken for hypertension, start date: 2015 (ongoing); SYNTHROID taken for thyroid disorder, start date: 2018 (ongoing); ASPIRIN 81 taken for cardiac disorder, start date: 2013 (ongoing); VITAMIN D3, start date: 2015 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date/Time:, Date: 16Feb2021, Time: 10:08AM, Site and Route of Injection: , Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN-6201), administration date: 16Feb2021, for COVID-19 Immunization, reaction(s): "Chills", "aches", "Headache", "Stomach Upset", "Tiredness", "Arm Swelling". The following information was reported: FATIGUE (non-serious) with onset 09Mar2021 18:00, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset 09Mar2021 18:00, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, headache.  Additional information: no prior vaccinations within 4 weeks. Relevant Tests: the patient had blood work done 3x a year due to heart and thyroid issues. She also had an echocardiogram done yearly since 2013. She had (6) stress tests since 2008. She had numerous MRI's and CT scans due to various issues. There was not enough room to list all of it on this page. This Questionnaire was not for the average person to complete. Most doctors will charge a fee to complete this form and the pharmacists say to see your doctor about this form. You people are not in the real world. Most people would become frustrated and throw this in the trash. Get real. What a joke.   Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Headache, Palpitations
Clinical narrative: Headache; Dehydrated; Heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05May2021 09:15 (Lot number: EW017) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lung nodules (scars)" (unspecified if ongoing); "Alcohol" (ongoing), notes: It has happened every time she drank alcohol. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, Time: 02:15AM, Anatomical location: Right arm, lot number: EW0164), administration date: 14Apr2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 15May2021 04:30, outcome "recovered with sequelae" (2021), described as "Headache"; DEHYDRATION (non-serious) with onset 15May2021 04:30, outcome "recovered with sequelae" (2021), described as "Dehydrated"; PALPITATIONS (non-serious) with onset 15May2021 04:30, outcome "recovered with sequelae" (2021), described as "Heart palpitations". Therapeutic measures were not taken as a result of headache, dehydration, palpitations.  Additional information: It was reported that when patient drank alcohol she woked up between 4-5 AM next morning with headache, dehydrated and heart palpitations. It had happened every time when she drank alcohol. 1 glass of white wine (15May2021 & 22May2021),1 gin tonic (01Jun2021). The facility where the most recent COVID-19 vaccine was administered was other. The patient had not been received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Limb discomfort, Pain in extremity, Shoulder injury related to vaccine administration, Vaccination site pain
Clinical narrative: Pain at injection site for starting 2 days after injection until now (2 1/2 months) and is not getting better and maybe worse.; Pain at injection site for starting 2 days after injection until now (2 1/2 months) and is not getting better and maybe worse.; SIRVA; Hurts to move arm and wears out; Hurts to move arm and wears out; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient reporting for himself.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 13:00 (Lot number: EN6199) at the age of 49 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: VACCINATION SITE PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 17May2021 13:00, outcome "not recovered" and all described as "Pain at injection site for starting 2 days after injection until now (2 1/2 months) and is not getting better and maybe worse."; SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (non-serious) with onset 17May2021 13:00, outcome "not recovered", described as "SIRVA"; LIMB DISCOMFORT (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 17May2021 13:00, outcome "not recovered" and all described as "Hurts to move arm and wears out". Therapeutic measures were not taken as a result of vaccination site pain, condition aggravated, shoulder injury related to vaccine administration, limb discomfort, pain in extremity.  Additional information: Relevant medical history and concurrent conditions were none. Relevant past drug history was none. Known allergies were None. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination were None. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Reported Event: Pain at injection site for starting 2 days after injection until now (2 1/2 months) and is not getting better and maybe worse. I am guessing SIRVA. Hurts to move arm and wears out. Will be scheduling visit with primary doctor to see about prognosis and therapy soon. AE resulted in None of the above. The reporter assessed the case as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: When using my muscle in left arm, it throbs/spasms uncontrollably until I stop using arm.; This is a spontaneous report from a contactable consumer (Patient). An 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Apr2021 13:00 (Lot number: EW0153) as dose 1, single and intramuscular, administered in arm left, administration date 29Apr2021 13:00 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious) with onset 08Apr2021 14:00, outcome "not recovered", described as "When using my muscle in left arm, it throbs/spasms uncontrollably until I stop using arm.". Therapeutic measures were not taken as a result of muscle spasms.   Additional information: When using my muscle in left arm, it throbs/spasms uncontrollably until I stop using arm. It is not painful, but it's odd that it spasms so much and so often. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/ Administration facility. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Antibiotics. Prior to vaccination, was the patient diagnosed with COVID-19? No. Since the vaccination, has the patient been tested for COVID-19? No. Prior vaccinations: None, Concomitant drugs: none, Patient medical history: none, relevant tests: None. Adverse event: muscle spasm, onset date: 29Apr2021 02:00, Seriousness criteria: Not serious, AE outcome: Not recovered, Treatment AE: No. After my second dose, my muscle at injection site spasms when I lift something. Problem still persists almost 2months after injection. No pain but very annoying.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Amenorrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 16:00 (Lot number: EW0UZ) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "high BP" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: VIT D; ALBUTEROL HFA; ADVAIR; MONTELUKAST; HYDROCHLOROTHIAZIDE; LISINOPRIL. Vaccination history included: Bnt162b2 (dose 1, single, vaccine location: Left arm, lot number: E86955, administration time: 02:15 PM), administration date: 17Mar2021, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to drug". The following information was reported: AMENORRHOEA (non-serious) with onset 09May2021, outcome "not recovered", described as "Amenorrhea". Therapeutic measures were not taken as a result of amenorrhoea.  Additional information: No other vaccine in four weeks. Adverse event Amenorrhea, last period 8-11Apr2021 no subsequent period after second dose of the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Pain, Vulval ulceration
Clinical narrative: Lipschutz ulcers; pain; oral pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24May2021 11:30 (Batch/Lot number: unknown) at the age of 13 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: VULVAL ULCERATION (non-serious) with onset 27May2021, outcome "not recovered", described as "Lipschutz ulcers"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain"; ORAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "oral pain". The event "lipschutz ulcers" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vulval ulceration, pain, oral pain.  Additional information: Patient was not pregnant at the time of vaccination. The patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event lipschutz ulcers and included treatment with topical steroid and pain, oral pain, antibiotic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea
Clinical narrative: Nausea; Weakness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 86 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Mar2021 (Lot number: EN5318) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "IgG Kappa monoclonal protein" (unspecified if ongoing), notes: years ago; "Gastritis" (ongoing); "HTN" (ongoing). Concomitant medication(s) included: PANTOPRAZOLE taken for gastritis (ongoing); AMLODIPINE BENAZEPRIL taken for hypertension (ongoing); HCTZ taken for hypertension (ongoing); METOPAR taken for hypertension (ongoing). The following information was reported: NAUSEA (non-serious) with onset 15Mar2021, outcome "recovering", described as "Nausea"; ASTHENIA (non-serious) with onset 15Mar2021, outcome "recovering", described as "Weakness"; FATIGUE (non-serious) with onset 15Mar2021, outcome "recovering", described as "Fatigue". The events "nausea", "weakness" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of nausea, asthenia, fatigue.  Additional information: No Prior vaccination (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Fatigue, Nausea, Spinal pain
Clinical narrative: nausea; Vomited 5x in one episode; weak; tired; sore spine all the way up and down my back; sore spine all the way up and down my back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29May2021 13:30 (Lot number: EW0168) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT D [COLECALCIFEROL]; VIT C. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer,, lot number= EW0167,, administration time= 01:30 PM,, dose number= 1,, vaccine location= Right arm), administration date: 08May2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 30May2021 04:30, outcome "recovered" (2021), described as "nausea"; VOMITING (non-serious) with onset 30May2021 04:30, outcome "recovered" (2021), described as "Vomited 5x in one episode"; ASTHENIA (non-serious) with onset 30May2021 04:30, outcome "recovered" (2021), described as "weak"; FATIGUE (non-serious) with onset 30May2021 04:30, outcome "recovered" (2021), described as "tired"; SPINAL PAIN (non-serious), BACK PAIN (non-serious) all with onset 30May2021 04:30, outcome "recovered" (2021) and all described as "sore spine all the way up and down my back". Therapeutic measures were not taken as a result of nausea, vomiting, asthenia, fatigue. Therapeutic measures were taken as a result of spinal pain, back pain.  Additional information; The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Vit D, Vit C . 15 hours after injection had nausea not relieved by eating and drinking cold clear liquids. Vomited 5x in one episode. Remained nauseous, weak, and tired for the next 12 hours.  Also had a sore spine all the way up and down my back from 19 hours till  26 hours after injection unrelieved by Tylenol or stretching/moving. Prior to vaccination,  the patient was not diagnosed with COVID-19.Since the vaccination, patient has not been tested for COVID-19   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nausea; Vomited 5x in one episode; weak; tired; sore spine all the way up and down my back; sore spine all the way up and down my back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29May2021 13:30 (Lot number: EW0168) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT D [COLECALCIFEROL]; VIT C. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer,, lot number= EW0167,, administration time= 01:30 PM,, dose number= 1,, vaccine location= Right arm), administration date: 08May2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 30May2021 04:30, outcome "recovered" (2021), described as "nausea"; VOMITING (non-serious) with onset 30May2021 04:30, outcome "recovered" (2021), described as "Vomited 5x in one episode"; ASTHENIA (non-serious) with onset 30May2021 04:30, outcome "recovered" (2021), described as "weak"; FATIGUE (non-serious) with onset 30May2021 04:30, outcome "recovered" (2021), described as "tired"; SPINAL PAIN (non-serious), BACK PAIN (non-serious) all with onset 30May2021 04:30, outcome "recovered" (2021) and all described as "sore spine all the way up and down my back". Therapeutic measures were not taken as a result of nausea, vomiting, asthenia, fatigue. Therapeutic measures were taken as a result of spinal pain, back pain.  Additional information; The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Vit D, Vit C . 15 hours after injection had nausea not relieved by eating and drinking cold clear liquids. Vomited 5x in one episode. Remained nauseous, weak, and tired for the next 12 hours.  Also had a sore spine all the way up and down my back from 19 hours till  26 hours after injection unrelieved by Tylenol or stretching/moving. Prior to vaccination,  the patient was not diagnosed with COVID-19.Since the vaccination, patient has not been tested for COVID-19   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: swollen lymph node on the underarm of the injection arm/lymph node was still swollen and painful; swollen lymph node on the underarm of the injection arm/lymph node was still swollen and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 13:30 (Lot number: EW0153) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; SYNTHROID; ASPIRIN [ACETYLSALICYLIC ACID]; ZYRTEK. Past drug history included: Zocor, reaction(s): "allergies", notes: known allergies: zocor; Sudafed, reaction(s): "allergies", notes: known allergies: sudafed. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer, lot number= EN6207, administration time= 04:30 PM, dose number= 1, vaccine location= Left arm), administration date: 23Mar2021, when the patient was 60 years old, for Covid-19 immunization.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "not recovered", described as "swollen lymph node on the underarm of the injection arm/lymph node is still swollen and painful". The event "swollen lymph node on the underarm of the injection arm/lymph node is still swollen and painful" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed a swollen lymph node on the underarm of the injection arm; it's been almost two months, and the lymph node was still swollen and painful. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. Patient had covid test post vaccination= PCR on 01Jun2021 with negative result (Nasal Swab). The event was reported as non-serious and event not resulted in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Mar2021 (Lot number: EN6205) at the age of 59 years as dose 1, single and administered in arm right, administration date Mar2021 (Lot number: ER8727) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). Concomitant medication(s) included: BENICAR. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Swollen lymph nodes". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: Hospitalization Prolonged was No. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported Event: swollen lymph nodes. Reaction Start Date : Mar2021 02:00 AM  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: June 2, began work at 6:00 am, as normal.  Memory fade was specific to co-workers' names and files I use on an hourly basis every day.  The feeling that came with it was terrifying.  I could not recal; This is a spontaneous report received from a contactable consumer. An 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 16:00 (Lot number: ER8735) at the age of 61 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 (product=COVID 19, brand=PFIZER, lot number=ER8737, administration date=07Apr2021, administration time=03:00 PM, dose number=1, vaccine location=Left arm), administration date: 07Apr2021, when the patient was 61 years old, for COVID-19 Immunization. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset 02Jun2021 06:30, outcome "unknown", described as "June 2, began work at 6:00 am, as normal.  Memory fade was specific to co-workers' names and files I use on an hourly basis every day.  The feeling that came with it was terrifying.  I could not recal". The event "june 2, began work at 6:00 am, as normal.  memory fade was specific to co-workers' names and files i use on an hourly basis every day.  the feeling that came with it was terrifying.  i could not recal" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of memory impairment.   Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Reported Event: 02Jun2021, began work at 6:00 am, as normal. Memory fade was specific to co-workers' names and files I use on an hourly basis every day. The feeling that came with it was terrifying. I could not recall several people I work with their names were wiped from my memory for approximately 15 minutes, NOT SECONDS. We talk daily and have for 8 months.  I revised a letter, it is tracked, and I can see my name and date, I have no recollection of these actions, and a few other actions I did that were very unlike me. it was terrifying. Prior to vaccination, was the patient diagnosed with COVID-19? No. Since the vaccination, has the patient been tested for COVID-19?No. known allergies: none. other medical history: none, I am very healthy.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large lymph node on left neck; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient. A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 12:00 (Batch/Lot number: unknown) at the age of 15 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: LYMPHADENOPATHY (non-serious) with onset 03Jun2021 12:00, outcome "not recovered", described as "Large lymph node on left neck".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reaction/event as reported: large lymph node on left neck. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Pain in extremity
Clinical narrative: This morning she also felt fatigued and had a stomach ache.; This morning she also felt fatigued and had a stomach ache.; Sore left arm started yesterday 6/2.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Jun2021 (Lot number: EW0185) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; CLARITINE. Vaccination history included: Bnt162b2 (Dose; 01, Lot number: EN5318, Route of administration: Intramuscular, Anatomical Location : Arm Left), administration date: 12May2021, when the patient was 12 years old, for COVID-19 immunization, reaction(s): "Sore left arm", "Tiredness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Jun2021, outcome "not recovered", described as "Sore left arm started yesterday 6/2."; FATIGUE (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 03Jun2021, outcome "not recovered" and all described as "This morning she also felt fatigued and had a stomach ache.". Therapeutic measures were not taken as a result of pain in extremity, fatigue, abdominal pain upper.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Reported Event: Sore left arm, fatigue, stomach ache. Sore left arm started yesterday 02Jun. This morning she also felt fatigued and had a stomach ache. Date of start of reaction/event: 02Jun2021, Outcome of reaction/event at the time of last observation: Not recovered /Not resolved. Hospitalization Prolonged: No, Prior to vaccination, was the patient diagnosed with COVID-19?:No, Since the vaccination, has the patient been tested for COVID-19?:No.   Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: face is twitching involuntarily/ right cheek is twitching very often; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 34 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 26May2021, outcome "not recovered", described as "face is twitching involuntarily/ right cheek is twitching very often". Therapeutic measures were not taken as a result of muscle twitching.  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.  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 have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: minor fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) (patient).  An adult female patient received bnt162b2 (BNT162B2), administration date 2021 (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) with onset Apr2021, outcome "recovered" (2021), described as "minor fatigue". Therapeutic measures were not taken as a result of fatigue.  Additional information: Age group: Adult (18-64 Years). If other vaccine in four weeks: Unknown. Other medications in two weeks: Unknown. Adverse event: This was a person cutting my hair who mentioned that after shot 1 she felt minor fatigue and that's it - but after shot 2 she felt like she had come down with the flu, complete with shivers, muscle pain, fatigue, and headache for a full 24 hours afterwards. This mention occurred 2 hours ago. If covid prior vaccination: Unknown. If covid tested post vaccination: Unknown. Known allergies: Unknown. Other medical history: Unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose of vaccine just have the arm hurts for couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 12:00 (Lot number: EW0171) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Apr2021 12:00, outcome "recovered" (2021), described as "First dose of vaccine just have the arm hurts for couple of days".  Additional information: 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 had not been tested for COVID-19.  No follow-up attempts are possible. No further information was expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash macular, Tenderness
Clinical narrative: My upper left arm developed a swollen spot that was tender to touch; that was tender to touch.; Now there is a red itchy spot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: STELARA taken for immunisation, administration date 13Apr2021. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot unknown: True, Lot unknown reason: Not available/provided to reporter at the time of report completion, Administration date Apr2021, Administration time: 02:00 PM, Dose number: 1, Vaccine location: Left arm), administration date: Apr2021, when the patient was 72 years old, for COVID-19 immunization; Smallpox vaccination (It is on my childhood smallpox vaccination scar), for Small Pox Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 28May2021 12:00, outcome "unknown", described as "My upper left arm developed a swollen spot that was tender to touch"; TENDERNESS (non-serious) with onset 28May2021 12:00, outcome "unknown", described as "that was tender to touch."; RASH MACULAR (non-serious) with onset 28May2021 12:00, outcome "unknown", described as "Now there is a red itchy spot". Therapeutic measures were not taken as a result of peripheral swelling, tenderness, rash macular.  Additional information: Patient was not tested covid positive post vaccination. Patient does not take any other medications in two weeks.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  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.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Vomiting; Stomachache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Jun2021 10:00 (Lot number: EW0191) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GUANFACINE; RITALIN; WELLBUTRIN; GEODON [ZIPRASIDONE HYDROCHLORIDE]; DULCOLAX [BISACODYL]. Vaccination history included: Bnt162b2 (product=COVID 19, lot number=Ew0177, lot unknown=False, administration date=15May2021, administration time=09:45, dose number=1, vaccine_location=Right arm), administration date: 15May2021, when the patient was 12 years old, for Covid-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 06Jun2021, outcome "recovering", described as "Vomiting"; ABDOMINAL PAIN UPPER (non-serious) with onset 06Jun2021, outcome "recovering", described as "Stomachache". Therapeutic measures were not taken as a result of vomiting, abdominal pain upper.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No treatment for adverse event. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: My body is totally magnetic and my forehead my arm and my chest the silverware can stick forks scissor spoons anything metal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), solution for injection, administered in arm left, administration date 12May2021 16:00 (Lot number: EW0186) at the age of 59 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Penicillin, reaction(s): "Known allergies: Penicillin", notes: Known allergies: Penicillin. The following information was reported: FEELING ABNORMAL (non-serious) with onset 06Jun2021 01:00, outcome "not recovered", described as "My body is totally magnetic and my forehead my arm and my chest the silverware can stick forks scissor spoons anything metal.". The event "my body is totally magnetic and my forehead my arm and my chest the silverware can stick forks scissor spoons anything metal." was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of feeling abnormal.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: reduce ability of the eye lense to accommodate for far and near vision.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Feb2021 11:00 (Lot number: en6202) at the age of 45 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: VISUAL IMPAIRMENT (non-serious) with onset May2021, outcome "not recovered", described as "reduce ability of the eye lense to accommodate for far and near vision.". The event "reduce ability of the eye lense to accommodate for far and near vision." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of visual impairment.  Additional information: The patient received no other vaccine in 4 weeks. The patient had covid prior vaccination. The patient had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Feeling abnormal
Clinical narrative: Brain fog and confusion 24 hours after 2nd dose; Brain fog and confusion 24 hours after 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jun2021 17:30 (Lot number: EW0217) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), CONFUSIONAL STATE (non-serious) all with onset 05Jun2021 10:00, outcome "recovering" and all described as "Brain fog and confusion 24 hours after 2nd dose". Therapeutic measures were not taken as a result of feeling abnormal, confusional state.  Additional information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies and no other medical history.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza, Myalgia
Clinical narrative: come down with the flu; shivers; muscle pain; fatigue; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose ,2 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt2162b2, for Covid-19 immunization, reaction(s): "Minor fatigue". The following information was reported: INFLUENZA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "come down with the flu"; CHILLS (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "shivers"; MYALGIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "muscle pain"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "fatigue"; HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "headache". Therapeutic measures were not taken as a result of influenza, chills, myalgia, fatigue, headache.as "headache".    Additional information: Patient is non pregnant. vaccine location-Left arm, dose number-2. if other vaccine in four weeks -Unknown. other medications in two weeks -unknown. Adverse Event start-  This was a person cutting my hair who mentioned that after shot 1 she felt minor fatigue and that's it - but after shot 2 she felt like she had come down with the flu, complete with shivers, muscle pain, fatigue, and headache for a full 24 hours afterwards. This mention occurred 2 hours ago. if treatment ae- No. If covid prior vaccination- Unknown.if covid tested post vaccination- unknown. known allergies -unknown. other medical history-unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: it was sore to move my arm; could not fall asleep until 4:30am; my arm became sore; a little tired; woke up at midnight drenched in sweat but not feeling cold just extremely hot; woke up at midnight drenched in sweat but not feeling cold just extremely hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 12:30 (Lot number: EW0202) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: OMEPRAZOLE; CARAFATE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28May2021 16:30, outcome "recovered" (2021), described as "my arm became sore"; FATIGUE (non-serious) with onset 28May2021 16:30, outcome "recovered" (2021), described as "a little tired"; HYPERHIDROSIS (non-serious), FEELING HOT (non-serious) all with onset 28May2021, outcome "recovered" (2021) and all described as "woke up at midnight drenched in sweat but not feeling cold just extremely hot"; SLEEP DISORDER (non-serious) with onset 29May2021, outcome "recovered" (29May2021 04:30), described as "could not fall asleep until 4:30am"; PAIN (non-serious) with onset 29May2021 13:00, outcome "recovered" (Jun2021), described as "it was sore to move my arm". Therapeutic measures were not taken as a result of pain in extremity, fatigue, hyperhidrosis, feeling hot, sleep disorder, pain.  Additional information: Patient did not take other vaccine in four weeks, did not test COVID prior vaccination and post vaccination.It was stated that He  was fine when he got his shot at 12:30pm 28May2021 around 4:30 his  arm became sore and a little tired, he went to bed around 10 woke up at midnight drenched in sweat but not feeling cold just extremely hot, could not fall asleep until 4:30am. Woke up around 1pm that afternoon with bo symptoms except for he felt like he fell down a flight of stairs (right arm) could not lift it for about 6 days it was sore to move his arm but not sore to the touch. Now he feel normal.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: it was sore to move my arm; could not fall asleep until 4:30am; my arm became sore; a little tired; woke up at midnight drenched in sweat but not feeling cold just extremely hot; woke up at midnight drenched in sweat but not feeling cold just extremely hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 12:30 (Lot number: EW0202) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: OMEPRAZOLE; CARAFATE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28May2021 16:30, outcome "recovered" (2021), described as "my arm became sore"; FATIGUE (non-serious) with onset 28May2021 16:30, outcome "recovered" (2021), described as "a little tired"; HYPERHIDROSIS (non-serious), FEELING HOT (non-serious) all with onset 28May2021, outcome "recovered" (2021) and all described as "woke up at midnight drenched in sweat but not feeling cold just extremely hot"; SLEEP DISORDER (non-serious) with onset 29May2021, outcome "recovered" (29May2021 04:30), described as "could not fall asleep until 4:30am"; PAIN (non-serious) with onset 29May2021 13:00, outcome "recovered" (Jun2021), described as "it was sore to move my arm". Therapeutic measures were not taken as a result of pain in extremity, fatigue, hyperhidrosis, feeling hot, sleep disorder, pain.  Additional information: Patient did not take other vaccine in four weeks, did not test COVID prior vaccination and post vaccination.It was stated that He  was fine when he got his shot at 12:30pm 28May2021 around 4:30 his  arm became sore and a little tired, he went to bed around 10 woke up at midnight drenched in sweat but not feeling cold just extremely hot, could not fall asleep until 4:30am. Woke up around 1pm that afternoon with bo symptoms except for he felt like he fell down a flight of stairs (right arm) could not lift it for about 6 days it was sore to move his arm but not sore to the touch. Now he feel normal.  No follow-up attempts are possible. No further information is expected.