chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Menstruation irregular
Clinical narrative: My periods which are normally 23 days became erratic. They were 18 days then 10 days the son days then 10 days.; Hot flashes; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 (Lot number: EN6205) as dose 1, single and administered in arm right, administration date 03Apr2021 (Lot number: ER732) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies: Sulphate drugs" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 05May2021, outcome "not recovered", described as "My periods which are normally 23 days became erratic. They were 18 days then 10 days the son days then 10 days."; HOT FLUSH (non-serious) with onset 05May2021, outcome "not recovered", described as "Hot flashes". The events "my periods which are normally 23 days became erratic. they were 18 days then 10 days the son days then 10 days." and "hot flashes" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular, hot flush.  Additional information: No covid prior vaccination. No covid tested post vaccination. No other medical history. No other vaccine in four weeks. No other medications in two weeks. Reporters comment: My periods which are normally 23 days became erratic. They were 18 days then 10 days the son days then 10 days. I thought it evened out but now I haven't had one in 49 days the most it's ever been in my life. Also now I am getting hot flashes for the first time ever this week.  Follow-up attempts are completed. No further information is expected
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Nausea, Palpitations
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 31Aug2021 (Lot number: FC3182) at the age of 40 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Liver disease" (unspecified if ongoing). Family history included: "Marfan syndrome" (unspecified if ongoing), notes: son does have a genetic disorder. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot: FC3180), administration date: 10Aug2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Heart is like pounding weird; l never had that feeling in my chest/felt it really very thumping; pounding on my chest felt like four times"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; CHILLS (non-serious), outcome "unknown", described as "Chills"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I just I felt weird". Therapeutic measures were not taken as a result of palpitations, nausea, chills, feeling abnormal. Additional Information: The patient son does have a genetic disorder (never been diagnosed with yet, so I don't know. He has a thing called Marfan syndrome (Further clarification was unknown). The patient stated event that never had that before. The patient received vaccine because she wanted to go and visit son in the hospital that just got heart surgery. The patient did not receive any prior vaccine. The patient stated that she doesn't like if she need to see a doctor for heart or what's going on you know what was mean like never had that feeling in chest before so after vaccination, both of them, it's after the second shot that's when heart started doing that. The patient stated that she cannot explain how she felt, she 'felt like' she was on drugs. The patient confused why her heart felt like that and she just do not know if maybe it was like heart problems in my family and it was making it effect more or what. The patient stated that after second dose felt it really very thumping and then this next time was yesterday, just felt it again just when was sitting the first time was lying down so was 3rd she believe of September and then yesterday which was 8th. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Investigation, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 71-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6207), at the age of 71, in right arm, on Mar 15, 2021, single dose, for COVID-19 immunization. Medical history included gum surgery (unspecified if ongoing); and collagen disorder (unspecified if ongoing). There were no concomitant medications. The patient experienced a headache, onset Mar 2021, with outcome of recovered (2021); and dizziness for 2 weeks, onset 2021, with outcome of not recovered. The events were evaluated at a physician office visit. Relevant laboratory tests and procedures available in the appropriate section. No follow-up attempts possible. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vision blurred, Visual impairment
Clinical narrative: First day I experienced sore arm; fatigue; the third day my vision became blurry and I could not see that morning, later on in the day I regained my vision back; the third day my vision became blurry and I could not see that morning, later on in the day I regained my vision back; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Aug2021 15:00 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Family history included: "High blood pressure" (unspecified if ongoing); "Diabetic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Aug2021, outcome "recovered", described as "First day I experienced sore arm"; FATIGUE (non-serious) with onset 20Aug2021, outcome "recovered", described as "fatigue"; VISION BLURRED (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset Aug2021, outcome "recovered" and all described as "the third day my vision became blurry and I could not see that morning, later on in the day I regained my vision back". Therapeutic measures were not taken as a result of pain in extremity, fatigue, vision blurred, visual impairment.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient not been tested for COVID-19 since the vaccination. Patient had no allergies. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient received second dose of Pfizer / Biontech COVID-19 Vaccine via intramuscular on 10Sep2021 3:00 pm.  No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haemoglobin, Headache, Lymphocyte count, Neutrophil count
Clinical narrative: Fatigue; headache; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: en6202) as dose 2, single and administered in arm right, administration date 06Feb2021 09:00 (Lot number: ema9809) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Rheumatism" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Radiation enteritis" (unspecified if ongoing); "migraine" (unspecified if ongoing); "periodic chronic fatigue" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin"; Meloxicam, reaction(s): "Known allergies: Meloxicam"; Codiene, reaction(s): "Known allergies: Codiene". The following information was reported: FATIGUE (non-serious) with onset 27Aug2021 19:00, outcome "recovered" (2021), described as "Fatigue"; HEADACHE (non-serious) with onset 27Aug2021 19:00, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 27Aug2021 19:00, outcome "recovered" (2021), described as "body aches". The events "fatigue", "headache" and "body aches" were 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 fatigue, headache, pain.  Additional Information: Facility type vaccine was Doctor's office/urgent care. Patient did not receive other vaccine in four weeks or other medications within two weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 after vaccination. After first shot: Fatigue, headache, body aches x 3 days. Then one day normal, then 1 days of fatigue. Second shot: Fatigue, headache, body aches x 4 days. Then one day normal, then 2 days of fatigue.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Fatigue; headache; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: en6202) as dose 2, single and administered in arm right, administration date 06Feb2021 09:00 (Lot number: ema9809) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Rheumatism" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Radiation enteritis" (unspecified if ongoing); "migraine" (unspecified if ongoing); "periodic chronic fatigue" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin"; Meloxicam, reaction(s): "Known allergies: Meloxicam"; Codiene, reaction(s): "Known allergies: Codiene". The following information was reported: FATIGUE (non-serious) with onset 27Aug2021 19:00, outcome "recovered" (2021), described as "Fatigue"; HEADACHE (non-serious) with onset 27Aug2021 19:00, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 27Aug2021 19:00, outcome "recovered" (2021), described as "body aches". The events "fatigue", "headache" and "body aches" were 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 fatigue, headache, pain.  Additional Information: Facility type vaccine was Doctor's office/urgent care. Patient did not receive other vaccine in four weeks or other medications within two weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 after vaccination. After first shot: Fatigue, headache, body aches x 3 days. Then one day normal, then 1 days of fatigue. Second shot: Fatigue, headache, body aches x 4 days. Then one day normal, then 2 days of fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Inappropriate schedule of product administration, SARS-CoV-2 test, Tonsillar disorder, Tonsillar hypertrophy
Clinical narrative: left tonsil got swollen; left tonsil got swollen and developed white spots; Bitter taste in mouth; 1st dose, 06Apr2021; 2nd dose, 07Sep2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 13:00 (Lot number: EW0217) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1,, Lot number=EW0153,, administration time=12:00 PM,, vaccine location=Left arm), administration date: 06Apr2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: TONSILLAR HYPERTROPHY (non-serious) with onset 07Sep2021 22:00, outcome "recovered" (Sep2021), described as "left tonsil got swollen"; TONSILLAR DISORDER (non-serious) with onset 07Sep2021 22:00, outcome "recovered" (Sep2021), described as "left tonsil got swollen and developed white spots"; DYSGEUSIA (non-serious) with onset 07Sep2021 22:00, outcome "recovered" (Sep2021), described as "Bitter taste in mouth"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Sep2021 13:00, outcome "unknown", described as "1st dose, 06Apr2021; 2nd dose, 07Sep2021". The events "left tonsil got swollen", "left tonsil got swollen and developed white spots" and "bitter taste in mouth" were 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 tonsillar hypertrophy, tonsillar disorder, dysgeusia.   Additional information: It was reported as no for serious, seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating, seriousness criteria-congenital anomaly/birth defect. No other medications in two weeks and other vaccine in four weeks. It was reported as covid prior vaccination and covid tested post vaccination. Known allergies reported as none. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: I found a cyst in my left breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (Lot number: EW0175) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer, lot number= EW0158, administration date= 12Apr2021, administration time= 03:00 PM, dose number= 1, vaccine location= Left arm), administration date: 12Apr2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: BREAST CYST (non-serious) with onset 19Jun2021, outcome "not recovered", described as "I found a cyst in my left breast". The event "i found a cyst in my left breast" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported Event: About 3 weeks later she found a cyst in her left breast which was not there prior to her shots. It was not a swollen lymph node-she went to her(withheld) and they did an ultrasound-it was a cluster of cysts. She found it interesting that it happened right after her shots and she want to know 3 other women who developed breast cysts after a Pfizer vaccine. Wanted to at least share this information in case other women also have been experiencing this. Thank you. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination The patient was not diagnosed with COVID-19, Prior to vaccination. The patient had been tested for COVID-19, Since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 male patient received bnt162b2 (BNT162B2), administration date 2021 (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: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information: Patient was concerned about "tomorrow it will be 1 week since his 2nd dose of the Pfizer BioNTech Covid. How long before he can take Excedrin for a headache and also take Cialis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: swollen neck glands on left side which lasted for 3 weeks.; 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), administered in arm left, administration date 03Aug2021 13:30 (Lot number: EWO217) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "hashimoto's" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; ARMOUR THYROID. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Aug2021 14:30, outcome "recovering", described as "swollen neck glands on left side which lasted for 3 weeks.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient received second dose on 24Aug2021. No other vaccine in four weeks. Other medication in two weeks: Bystolic, Armour Thyroid. After she got first shot on left side which caused swollen neck glands on left side which lasted for 3 weeks. No covid prior vaccination. Covid was tested post vaccination. No known allergy.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, SARS-CoV-2 test, Vomiting
Clinical narrative: Whole arm pain in injected arm; numbness in hands and leg and foot; Intense vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 28Aug2021 (Lot number: FC3184) 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 2021, outcome "not recovered", described as "Whole arm pain in injected arm"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "numbness in hands and leg and foot"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "Intense vomiting". The events "whole arm pain in injected arm", "numbness in hands and leg and foot" and "intense vomiting" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, hypoaesthesia, vomiting.  Additional information: Whole arm pain in injected arm. Numbness in hands and leg and foot. Intense vomiting after first dose. The patient did not receive other vaccine in four weeks. The patient did not had covid prior vaccination. No known allergies. Therapeutic measures taken as a result fo AE which was muscle relaxers and steroids just started.   Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nasal congestion, Vaccination site pain
Clinical narrative: Stomach pain/cramping with diarrhea; Stomach pain/cramping with diarrhea; headache; pain at injection site; Slight congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 13:15 (Lot number: 301308) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Administration time: 01:15 PM, Vaccine location: Left arm, Lot number: FC3182), administration date: 19Aug2021, when the patient was 29 years old, for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), DIARRHOEA (non-serious) all with onset 09Sep2021 15:00, outcome "not recovered" and all described as "Stomach pain/cramping with diarrhea"; HEADACHE (non-serious) with onset 09Sep2021 15:00, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 09Sep2021 15:00, outcome "not recovered", described as "pain at injection site"; NASAL CONGESTION (non-serious) with onset 09Sep2021 15:00, outcome "not recovered", described as "Slight congestion". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, headache, vaccination site pain, nasal congestion.  Additional Information: Patient had received Birth control, probiotic, and daily vitamin medications within two weeks of vaccination and also did not receive any vaccine within four weeks prior to covid vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 post vaccination. Patient had no known allergies. No other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Constant ringing in ears; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Sep2021 13:00 (Lot number: FC3184) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: ENALAPRIL. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EW0177, lot unknown=False, administration date=15Aug2021, administration time=12:00 PM, dose number=1,vaccine location=Right arm), administration date: 15Aug2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 06Sep2021 11:00, outcome "not recovered", described as "Constant ringing in ears"; HEADACHE (non-serious) with onset 06Sep2021 11:00, outcome "not recovered", described as "headaches". Therapeutic measures were not taken as a result of tinnitus, headache. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient  was not diagnosed with COVID-19, Prior to vaccination, was nor has the patient been tested for COVID-19 Since the vaccination  Pharmacy or Drug Store was the facility where the most recent COVID-19 vaccine was administered. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate, Heart rate increased, Nervousness, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Aug2021 16:15 (Lot number: EW0176) at the age of 53 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "known allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN; "anxiety" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; KLONOPIN; VITAMIN D NOS. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EW0176, lot unknown=False, administration date=14Jul2021, administration time=04:45 PM, dose number=1, vaccine location=Left arm), administration date: 14Jul2021, when the patient was 53 years old, for COVID-19 immunisation. The following information was reported: ANXIETY (non-serious) with onset 05Aug2021, outcome "not recovered", described as "have anxiety but this has gone to extreme anxiety all day"; NERVOUSNESS (non-serious) with onset 05Aug2021, outcome "not recovered", described as "feel shaky all day"; HEART RATE INCREASED (non-serious) with onset 05Aug2021, outcome "not recovered", described as "heart rate elevates up to 118 at resting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anxiety, nervousness, heart rate increased. Additional information: Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Zoloft and Klonopin. Vitamin D and multi vitamin. She had anxiety but this had gone to extreme anxiety all day. Noticed it after my second shot. She had to Increase her anxiety medication to more than she normally take. She had never had anxiety during the day she only had it in the mornings only in the morning but now she feel shaky all day and my heart rate elevates up to 118 at resting. Nothing helps the shaky feeling inside and this is not normal. The patient had no treatment for AE. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had Covid test post vaccination: [Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=PCR, Covid test date=29Jul2021, Covid test result=Negative]. The patient had Known allergies to PCN. Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Flatulence, Hypomenorrhoea
Clinical narrative: Blood spotting 8 days before regular period, extremely light. Then after one day it stopped.; This came along with cramps the next day; extreme gas not painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Sep2021 (Lot number: Fc3182) at the age of 29 years as dose 1,single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: KLONOPIN. Past drug history included: Macrobid, reaction(s): "Known Allergy: Macrobid", notes: known allergies :Macrobid. The following information was reported: HYPOMENORRHOEA (non-serious) with onset 09Sep2021 12:00, outcome "not recovered", described as "Blood spotting 8 days before regular period, extremely light. Then after one day it stopped."; DYSMENORRHOEA (non-serious) with onset 09Sep2021 12:00, outcome "not recovered", described as "This came along with cramps the next day"; FLATULENCE (non-serious) with onset 09Sep2021 12:00, outcome "not recovered", described as "extreme gas not painful". Therapeutic measures were not taken as a result of hypomenorrhoea, dysmenorrhoea, flatulence.  Additional information: No other vaccine in four weeks. 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. Patient had blood spotting 8 days before regular period, extremely light. Then after one day it stopped. This came along with cramps the next day. Another side effect extreme gas not painful, but no normal bowel movement without lots of gas released in between. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Left Facial Paresthesia/tingling in Left Ear; Numbness and tingling in Left Ear; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Sep2021 14:30 (Lot number: FC3184) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. The following information was reported: PARAESTHESIA (non-serious) with onset 11Sep2021 08:00, outcome "not recovered", described as "Left Facial Paresthesia/tingling in Left Ear"; HYPOAESTHESIA (non-serious) with onset 11Sep2021 08:00, outcome "not recovered", described as "Numbness and tingling in Left Ear". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia.  Additional information: Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination was Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Known allergies was none reported. The events were assessed as non-serious, did not result in death, did not result in medically significant, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, not intervention required, did not cause congenital anomaly/birth defect. Seriousness criteria-Other: No.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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 (1st dose, He took the Pfizer BioNTech Covid-19 Vaccine in June, with first dose experienced nausea for 12 to 14 hours), for COVID-19 Immunization, reaction(s): "nausea". The following information was reported: DIZZINESS (non-serious) with onset 09Sep2021, outcome "unknown", described as "dizzy".  Additional information: Patient took the Pfizer BioNTech Covid-19 Vaccine in June, with first dose experienced nausea for 12 to 14 hours and then after taking the second dose experienced dizzy for 12 hours. They could not remember the date but they just said both the first dose and second dose administered was in June.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Tooth disorder
Clinical narrative: he received both doses of the Pfizer-BioNTech Covid 19 Vaccine in Jan2021. 2 months ago, he had dental work done; 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 81 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (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: TOOTH DISORDER (non-serious), outcome "unknown", described as "he received both doses of the Pfizer-BioNTech Covid 19 Vaccine in Jan2021. 2 months ago, he had dental work done". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tooth disorder.  Additional information: Reporter stated that he happily wants to report that he doesn't have COVID, but he had the shots in him and he had a unique experience to report. He took the first two shots of the COVID vaccine back in Jan2021 and he went through all these months without a problem. He decided to go for a test, an antibody test, so he went to one it came back that he had 0. He then started thinking what could of caused it to be 0. He underwent a lot of dental work and was told to take amoxicillin so he had amoxicillin during that period, late in that period, with Pfizer's COVID vaccine and upon seeing that he was void of antibodies his doctor said to go for a third dose and so he went for the third. While he was waiting for those three weeks he went back for the test, for antibodies, and uniquely at that time he was still having trouble with his teeth and the dentist put him back on amoxicillin. He then went for the test to see how much antibodies he had and it was 0 after three the weeks. There was correlation with the amoxicillin. He said that this is the whole situation and he was only looking for an answer. He needs to know whether he should take another COVID vaccine, a 4th, because he had no antibodies whatsoever or what he should do.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Within 5 minutes after receiving vaccine and still in waiting area, developed a strong metallic taste in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Sep2021 11:45 (Lot number: FE3592) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; GLIPIZIDE; PANTOPRAZOLE; JANUVIA; EZETI. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin", notes: Ampicillin. The following information was reported: DYSGEUSIA (non-serious) with onset 10Sep2021 11:45, outcome "recovering", described as "Within 5 minutes after receiving vaccine and still in waiting area, developed a strong metallic taste in my mouth". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: No covid prior vaccination. Not tested for tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Vaccination site discomfort
Clinical narrative: she was breastfeeding; she was breastfeeding; The second shot it was just like just at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 20Aug2021 (Lot number: FC3182) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Batch/lot number: EW0181, The first one was on my left shoulder), administration date: 30Jul2021, when the patient was 38 years old, for Covid-19 immunization, reaction(s): "Soreness towards her arm and shoulder"; Bnt162b2 (Dose: 1st, Batch/lot number: EW0181, The first one was on my left shoulder), for Covid-19 immunization, reaction(s): "I couldn't move my arm; It was from the shoulder all the way down to the wrist". The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 2021, outcome "unknown" and all described as "she was breastfeeding"; VACCINATION SITE DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "The second shot it was just like just at the injection site". Therapeutic measures were not taken as a result of injection site discomfort.  Additional Information: No other prior vaccinations within 4 weeks. Consumer denied taking the number and stated, No its okay. Its all cleared up. The woman I spoke to before had read through the disclaimer with me and was able to make it clear that there were 2 separate lists, that the breastfeeding and pregnant women were not under the list of not to get the vaccine, it was just the location of it, it was just right under it and I just was kind of nervous reading it, so kind of like, I kind of read it like, my eyes kind of played a trick on me there. But yes, I don't really have any other questions. I was just asking her the 2 vaccines because there are  2 different type of vaccines. I was wondering if they were same or if they were different in any other way but she was just explaining that they are exactly the same. So, I really don't have any other question.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101192776 EDP (baby's 2nd dose);US-PFIZER INC-202101192586 EDP (baby's 1st dose)
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Hypoaesthesia, Influenza like illness, Muscular weakness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 28Aug2021 (Lot number: FC3184) at the age of 26 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 date: 2021, when the patient was 26 years old, for COVID-19 immunization, reaction(s): "Whole arm pain", "Intense vomiting"; Bnt162b2 (Dose: 1), administration date: 2021, when the patient was 26 years old, for COVID-19 Immunization, reaction(s): "numbness in hands and leg and foot". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "arm pain"; BACK PAIN (non-serious), NECK PAIN (non-serious), PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "muscle pain in upper back and neck"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "finger numbness"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "Vomiting"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "flulike symptoms"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered", described as "Weakness in legs"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue". The events "arm pain", "muscle pain in upper back and neck", "muscle pain in upper back and neck", "finger numbness", "vomiting", "flulike symptoms", "weakness in legs", "fatigue" and "muscle pain in upper back and neck" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, back pain, neck pain, hypoaesthesia, vomiting, influenza like illness, muscular weakness, fatigue, pain. Additional information: No other vaccine in four weeks and No Covid prior vaccination. AE treatment just started muscle relaxers and steroids. Clinical course: Whole arm pain in injected arm. numbness in hands and leg and foot. Intense vomiting after first dose. After second dose arm pain then intense muscle pain in upper back and neck radiating into arms and some finger numbness. Vomiting and flulike symptoms. Weakness in legs. Fatigue. Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, SARS-CoV-2 test, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 28Aug2021 (Lot number: FC3184) at the age of 26 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 date: 2021, when the patient was 26 years old, for COVID-19 immunization, reaction(s): "Whole arm pain", "Intense vomiting"; Bnt162b2 (Dose: 1), administration date: 2021, when the patient was 26 years old, for COVID-19 Immunization, reaction(s): "numbness in hands and leg and foot". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "arm pain"; BACK PAIN (non-serious), NECK PAIN (non-serious), PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "muscle pain in upper back and neck"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "finger numbness"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "Vomiting"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "flulike symptoms"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered", described as "Weakness in legs"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue". The events "arm pain", "muscle pain in upper back and neck", "muscle pain in upper back and neck", "finger numbness", "vomiting", "flulike symptoms", "weakness in legs", "fatigue" and "muscle pain in upper back and neck" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, back pain, neck pain, hypoaesthesia, vomiting, influenza like illness, muscular weakness, fatigue, pain. Additional information: No other vaccine in four weeks and No Covid prior vaccination. AE treatment just started muscle relaxers and steroids. Clinical course: Whole arm pain in injected arm. numbness in hands and leg and foot. Intense vomiting after first dose. After second dose arm pain then intense muscle pain in upper back and neck radiating into arms and some finger numbness. Vomiting and flulike symptoms. Weakness in legs. Fatigue. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: not being able to lift his arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "not being able to lift his arm".  Additional information: The patient had developed the issue of not being able to lift his arm after either the first or second COVID vaccine, patient already reported it on his own to Pfizer so she doesn't want to do a report for him.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Sep 10, 2021, at 11:45, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced dysgeusia (husband received the same vaccine at the same time and also developed metallic taste in his mouth), onset Sep 10, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Follow-up (Oct 14, 2021): 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 59-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA7484), at the age of 59, in left arm, on Aug 4, 2021, at 12:30, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had fatigue (after 1st dose, felt tired the following day), onset Aug 5, 2021, with outcome of unknown. Therapeutic measures were taken as a result of fatigue. Additional information: Patient felt tired the following day after 1st dose. Patient took 2 Motrins. Prior vaccination: none. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: phone and spoon also adhere to his arm/I have a friend who got the vaccine in March, she has the same problem on both arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "phone and spoon also adhere to his arm/I have a friend who got the vaccine in March, she has the same problem on both arms".  Additional information: Reporter had a friend who got the vaccine in march, she had same problem on both arms.  Follow-up attempts completed. No further information is expected.