chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Pain in extremity
Clinical narrative: just a little sore arm normal injection, left arm very sore; Fatigue; Walking anxiety attack/Anxiety; 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 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: EW0178) at the age of 43 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: FATIGUE (non-serious) with onset 20Aug2021, outcome "recovered" (21Aug2021), described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset 21Aug2021, outcome "recovering", described as "just a little sore arm normal injection, left arm very sore"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Walking anxiety attack/Anxiety". Therapeutic measures were not taken as a result of fatigue, pain in extremity, anxiety.  Additional information: Caller states he just got his first shot and he has to wait 21 days before the next one, and so far it has been fine, just a little sore arm normal injection, left arm very sore, and a little fatigue the first day but nothing out of the ordinary. He reported that he has anxiety, he was a walking anxiety attack. Patient had no relevant family history and no relevant tests done. Patient did not had any AE prior to vaccination and had no medication prior Vaccinations (within 4 weeks). Any AE(s) did  not require a visit to emergency Room or physician office.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dysgeusia, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: loss of appetite; food doesn't taste right; mild headache; tiredness; sore throat for 3 days; 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 parent.  A 17 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), when the patient was 17 years old, for Covid-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "recovered", described as "sore throat for 3 days"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; DYSGEUSIA (non-serious), outcome "unknown", described as "food doesn't taste right"; HEADACHE (non-serious), outcome "unknown", described as "mild headache"; FATIGUE (non-serious), outcome "unknown", described as "tiredness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Influenza, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 24 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13May2021 (Lot number: EW0161, Expiration Date: 20Jul2021) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 06Jan2021 (unspecified if ongoing), notes: Hospitalized for 5 days. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Site of injection: left arm, Site and route of injection: left arm, Batch/Lot no: ER8733 Exp.: 20Jul2021), administration date: 22Apr2021, for Covid-19 immunisation, reaction(s): "Lethargic", "fever". The following information was reported: INFLUENZA (non-serious) with onset 14May2021, outcome "recovered" (2021), described as "Flu Symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Vaccination facility type was other. No prior vaccination. The patient tested positive for Covid-19 on 06Jan2021 and hospitalized for 5 days and again Covid antibody test positive on 09Apr2021 which was prior to commencement of vaccine. No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Taste disorder
Clinical narrative: did not taste right; Sore throat; Tiredness; Mild headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 (Lot number: EW0187) at the age of 17 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot: EW0126, Anatomical Location: Arm left.), administration date: 23Jul2021, for Covid-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 21Aug2021, outcome "not recovered", described as "Sore throat"; FATIGUE (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Tiredness"; HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "Mild headaches"; TASTE DISORDER (non-serious), outcome "unknown", described as "did not taste right".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headaches; sore arms where the injection had taken place; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male 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: HEADACHE (non-serious), outcome "unknown", described as "headaches"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arms where the injection had taken place".  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: Abdominal pain lower, Blood test, Computerised tomogram, Decreased appetite, Diarrhoea
Clinical narrative: Abdominal pain lower right side; diarrhea; loss of appetite; spasms all unexplained; 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 right, administration date 24Mar2021 12:00 (Lot number: ER8727) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, administration time: 12:00 PM, vaccine location: Right arm, lot number: En6205), administration date: 03Mar2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN LOWER (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "Abdominal pain lower right side"; DIARRHOEA (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "diarrhea"; DECREASED APPETITE (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "loss of appetite"; MUSCLE SPASMS (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "spasms all unexplained". The events "abdominal pain lower right side", "diarrhea", "loss of appetite" and "spasms all unexplained" 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 not taken as a result of abdominal pain lower, diarrhoea, decreased appetite, muscle spasms.  Follow-up (02Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100617 Same reporter/drug/event, different patient.;US-PFIZER INC-202101100616 Same reporter/drug/event, different patient.;US-PFIZER INC-202101100615 Same reporter/drug/event, different patient.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Stool analysis
Clinical narrative: Abdominal pain lower right side; diarrhea; loss of appetite; spasms all unexplained; 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 right, administration date 24Mar2021 12:00 (Lot number: ER8727) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, administration time: 12:00 PM, vaccine location: Right arm, lot number: En6205), administration date: 03Mar2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN LOWER (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "Abdominal pain lower right side"; DIARRHOEA (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "diarrhea"; DECREASED APPETITE (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "loss of appetite"; MUSCLE SPASMS (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "spasms all unexplained". The events "abdominal pain lower right side", "diarrhea", "loss of appetite" and "spasms all unexplained" 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 not taken as a result of abdominal pain lower, diarrhoea, decreased appetite, muscle spasms.  Follow-up (02Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100617 Same reporter/drug/event, different patient.;US-PFIZER INC-202101100616 Same reporter/drug/event, different patient.;US-PFIZER INC-202101100615 Same reporter/drug/event, different patient.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Non-cardiac chest pain
Clinical narrative: sore under my left arm (armpit area) - presumably the lymph node - started approx. 48 hours after receiving the second dose; sore under my left arm (armpit area) - presumably the lymph node - started approx. 48 hours after receiving the second dose; soreness seems to radiated onto my upper pectoral area on my chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 (Lot number: EW0171) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: D3; GINKGO BILOBA; OSTEO BI-FLEX EASE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: EW0169 , Anatomical Location: Arm Left), administration date: 31Jul2021, for COVID-19 immunization.  The following information was reported: AXILLARY PAIN (non-serious), LYMPH NODE PAIN (non-serious) all with onset 23Aug2021 07:45, outcome "not recovered" and all described as "sore under my left arm (armpit area) - presumably the lymph node - started approx. 48 hours after receiving the second dose"; NON-CARDIAC CHEST PAIN (non-serious) with onset 23Aug2021 07:45, outcome "not recovered", described as "soreness seems to radiated onto my upper pectoral area on my chest". The events "sore under my left arm (armpit area) - presumably the lymph node - started approx. 48 hours after receiving the second dose", "sore under my left arm (armpit area) - presumably the lymph node - started approx. 48 hours after receiving the second dose" and "soreness seems to radiated onto my upper pectoral area on my chest" were evaluated at the physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of axillary pain, lymph node pain, non-cardiac chest pain.  Additional information: The patient had no relevant past drug history and concurrent conditions. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included fertility drug. Patient had sore under his left arm (armpit area) - presumably the lymph node -started approx. 48 hours after receiving the second dose. That soreness seems to radiated onto his upper pectoral area on his chest - making him think he had lung or heart related issues associated with the vaccine. Patient wanted to know if it was something to get tested. He scheduled a doctor appointment; however, did not require immediate attention.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Productive cough, Vaccination site pain
Clinical narrative: Elevated temperature; Extreme Fatigue; Pain at injection site; Deep productive cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101107725 (Pfizer).  A 79 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 23Aug2021 14:00 (Lot number: FC3182) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "Bee venom" (unspecified if ongoing). Concomitant medication(s) included: IGG. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 23Aug2021 14:30, outcome "recovered" (Aug2021), described as "Elevated temperature"; FATIGUE (non-serious) with onset 23Aug2021 14:30, outcome "recovered" (Aug2021), described as "Extreme Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 23Aug2021 14:30, outcome "recovered" (Aug2021), described as "Pain at injection site"; PRODUCTIVE COUGH (non-serious) with onset 23Aug2021 14:30, outcome "recovered" (Aug2021), described as "Deep productive cough". Therapeutic measures were not taken as a result of body temperature increased, fatigue, vaccination site pain, productive cough.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Sacroiliitis
Clinical narrative: Extreme lower pack pain diagnosed as sacroiliitis.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Tinnitus
Clinical narrative: Started to sweat and then I had ringing in my right ear.; I had ringing in my right ear.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FC3180) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies Latex" (unspecified if ongoing), notes: Known allergies: Latex. The patient took concomitant medications. The following information was reported: HYPERHIDROSIS (non-serious) with onset Aug2021, outcome "not recovered", described as "Started to sweat and then I had ringing in my right ear."; TINNITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "I had ringing in my right ear.". Therapeutic measures were not taken as a result of hyperhidrosis, tinnitus.  Additional Information: Administration time: 13:00 and Adverse event start time: 08:00 was given. Patient did not receive any other vaccine in four weeks. Patient receive Vitamin supplements in two weeks. Patient diagnosed with COVID prior vaccination. Patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring normal, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Shortness of breath, chest pain and faster heartbeat (experienced more than normal heartbeats in a min; 3-4 extra a min). Urgent care visit in January and referred to a cardiologist.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Specialist consultation
Clinical narrative: Shortness of breath, chest pain and faster heartbeat (experienced more than normal heartbeats in a min; 3-4 extra a min). Urgent care visit in January and referred to a cardiologist.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, Breast pain, Dysmenorrhoea, Fatigue, Mammogram abnormal
Clinical narrative: I had a routine mammogram on 2/5 and my left breast (shot was given on left side)  was abnormal. I was sent for an ultrasound on 2/10. They found multiple cysts in the left breast and believe the suspicious area is a cyst but I have to return in 6 months for a follow up. My left breast is slightly sore, especially when I lift my arm.  Also, not sure if it?s related but it is worth reporting that my PMS was extreme 2/21 (extreme exhaustion and cramping).  After my u/s I received a text from v-safe asking if I had any new symptoms and they called me and recommended I fill out this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Premenstrual syndrome, Ultrasound breast abnormal
Clinical narrative: I had a routine mammogram on 2/5 and my left breast (shot was given on left side)  was abnormal. I was sent for an ultrasound on 2/10. They found multiple cysts in the left breast and believe the suspicious area is a cyst but I have to return in 6 months for a follow up. My left breast is slightly sore, especially when I lift my arm.  Also, not sure if it?s related but it is worth reporting that my PMS was extreme 2/21 (extreme exhaustion and cramping).  After my u/s I received a text from v-safe asking if I had any new symptoms and they called me and recommended I fill out this report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Ovulation induction, Pain, Pyrexia
Clinical narrative: Severe headache, high fever (101-102), whole-body aches, chills and began ovulating for the first time in two years (my breastfeeding daughter was 16 months old at this time, and 11 months past being solely breast-fed).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in left arm where vaccine was given; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 12:00 (Lot number: Fa7484) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune hepatitis" (unspecified if ongoing), notes: Autoimmune hepatitis (currently in remission). Concomitant medication(s) included: GABAPENTIN; BENADRYL; ADVIL [IBUPROFEN]. Past drug history included: Penicillin, reaction(s): "Known allergies: Penicillin". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Aug2021 17:00, outcome "not recovered", described as "Pain in left arm where vaccine was given". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Pain in left arm where vaccine was given lasting more than a few days its been 21 days since the first dose was given. No other vaccine in four weeks. No COVID prior vaccination and not tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Paraesthesia
Clinical narrative: 1st dose - tingling "cold" in left arm and leg within 15min of  administration; 1st dose - tingling "cold" in left arm and leg within 15min of  administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 11:00 (Lot number: EW0181) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: yes" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. The following information was reported: PARAESTHESIA (non-serious), FEELING COLD (non-serious) all with onset Aug2021, outcome "not recovered" and all described as "1st dose - tingling "cold" in left arm and leg within 15min of  administration". It was unknown if therapeutic measures were taken as a result of paraesthesia, feeling cold.  Additional information: It was unknown that patient received treatment. Patient did not any received other vaccines prior vaccination. Patient did not tested for covid Post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Suppressed lactation
Clinical narrative: Breast milk supply decreased significantly less than 24 hours of first injection.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 (Lot number: FA7484) 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: COLACE. The following information was reported: SUPPRESSED LACTATION (non-serious) with onset 04Aug2021, outcome "recovering", described as "Breast milk supply decreased significantly less than 24 hours of first injection.". Therapeutic measures were not taken as a result of suppressed lactation.  Additional information: If covid prior vaccination was No If covid tested post vaccination was No   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101103243 Foetus case
Sex: M
Vaccine: COVID19
Symptoms: Finger deformity
Clinical narrative: Caller has been having finger snapping; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558) support. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: Apr2021, for Covid-19 immunization. The following information was reported: FINGER DEFORMITY (non-serious) with onset 2021, outcome "unknown", described as "Caller has been having finger snapping".  Additional information: Caller received the first dose of the Pfizer covid-19 vaccine in Apr and the second dose in May. Caller has been having finger snapping and would like compensation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: a little arm soreness after her first shot.; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little arm soreness after her first shot."; HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: The patient was eligible for her second dose of the Comirnaty vaccine tomorrow. She had a headache on that day and wanted to know if its ok if she could take Ibuprofen. She also reported that she only had a little arm soreness after her first dose of the Pfizer BioNtech covid 19 vaccine and wanted to know whether this happened because her body did not build antibodies. The patient also wanted to know about the Comirnaty vaccine still effective in people who have no side effects and how long does the spike protein for the Comirnaty vaccine stay in the body after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swelling in hands in feet with lot of pain; Swelling in hands in feet with lot of pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 15:30 (Lot number: EW1072) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN (non-serious) all with onset 21Aug2021 20:30, outcome "not recovered" and all described as "Swelling in hands in feet with lot of pain". The event "swelling in hands in feet with lot of pain" and "swelling in hands in feet with lot of pain" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of peripheral swelling, pain.  Additional information: No prolonged hospitalization required. The patient did not receive any other vaccines within four weeks prior to the vaccination. Swelling in hands in feet with lot of pain. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 25Aug2021. The patient did not provide information regarding the reported adverse event(s) with the use of the product. Pfizer/Biontech Covid-19 Vaccine details for 1st dose, Date 09Aug2021, Intramuscular, Lot: EW1074  and 2nd dose, Date 31Aug2021, Intramuscular, Lot: FC3183  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Inappropriate schedule of product administration, Pain
Clinical narrative: Any data on risk of waiting after 6 weeks from first dose?; Dizzy; sore; weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date 25Aug2021 18:15 (Lot number: FC3183) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose , Batch/lot number: Pfizer EM9810), administration date: 04Feb2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 25Aug2021, outcome "unknown", described as "Dizzy"; PAIN (non-serious) with onset 25Aug2021, outcome "unknown", described as "sore"; ASTHENIA (non-serious) with onset 25Aug2021, outcome "unknown", described as "weak"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25Aug2021 18:15, outcome "unknown", described as "Any data on risk of waiting after 6 weeks from first dose?". The events "dizzy", "sore" and "weak" were evaluated at the physician office visit.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Impaired work ability
Clinical narrative: the second dose I am still having some side effects keeping me out of work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jan2021 (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, Single, ), for Covid-19 immunisation. The following information was reported: IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "the second dose I am still having some side effects keeping me out of work".  Additional information: consumer had received the vaccine in January and the second dose and still having some side effects keeping the patient out of work.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain
Clinical narrative: the lower part of the caller's right arm felt extremely heavy; ached; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Aug2021 (Lot number: FC3180) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COZAAR. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 23Aug2021, outcome "recovered" (24Aug2021), described as "the lower part of the caller's right arm felt extremely heavy"; PAIN (non-serious) with onset 23Aug2021, outcome "recovered" (24Aug2021), described as "ached".  Additional information: Reporter stated that, on Monday, a little over 72 hours after the vaccine, time the vaccination was given closer to 10:30 EST, in the midafternoon, the patient noticed that the lower part of her right arm felt extremely heavy, and this was on the same arm that patient received the vaccine but not at the actual injection site. Reporter stated that, the patient never experienced this, not even when she had the flu. Patient lifted her arm it felt like 100 pounds, was heavy, and ached. The patient might have taken Ibuprofen but doesn't remember. Reporter stated that, event started intensifying so the patient went to bed early and then the next morning it was fine. Reporter stated that, patient's weight was 180 or 189. Patient did not visit emergency Room and physician Office. Patient did not take prior Vaccinations within 4 weeks and AE(s) following prior vaccinations were none. Patient's Medical History (including any illness at time of vaccination), family medical history relevant to ae(s) and relevant tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer suspect were none.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Condition aggravated
Clinical narrative: Mar2021 noticed some short term memory loss, got worse in Apr2021. Did not have memory issues before taking the shot.; Mar2021 noticed some short term memory loss, got worse in Apr2021. Did not have memory issues before taking the shot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EN6201) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other Medical History: Diabetes; "High blood pressure" (unspecified if ongoing), notes: Other Medical History: High blood pressure; "High cholesterol" (unspecified if ongoing), notes: Other Medical History: High cholesterol; "reflux" (unspecified if ongoing), notes: Other Medical History: reflux. Concomitant medication(s) included: SERTRALINE; LISINOPRIL; ATORVASTATIN; METFORMIN. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer, Lot number=EL9262, Administration date=21Jan2021, Dose number=1, Vaccine location=Left arm), administration date: 21Jan2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: AMNESIA (non-serious) with onset 15Mar2021, outcome "not recovered", CONDITION AGGRAVATED (non-serious) with onset Apr2021, outcome "not recovered" and all described as "Mar2021 noticed some short term memory loss, got worse in Apr2021. Did not have memory issues before taking the shot.". The event "mar2021 noticed some short term memory loss, got worse in apr2021. did not have memory issues before taking the shot." and "mar2021 noticed some short term memory loss, got worse in apr2021. did not have memory issues before taking the shot." was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of amnesia, condition aggravated.  Additional information: Psych eval; dementia meds; depression meds used for the treatment of the event. Patient did not had any Known allergies. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not had with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Fatigue, Headache, Heart rate
Clinical narrative: Cotton mouth; Rapid heart beat; Tiredness; Nauseous; Dizzy; Mild bodyaches; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 13:15 (Lot number: 2w0175) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRY MOUTH (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Cotton mouth"; HEART RATE INCREASED (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Rapid heart beat"; FATIGUE (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Tiredness"; NAUSEA (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Nauseous"; DIZZINESS (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Dizzy"; PAIN (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Mild bodyaches"; HEADACHE (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dry mouth, heart rate increased, fatigue, nausea, dizziness, pain, headache.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the 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 is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pain
Clinical narrative: Cotton mouth; Rapid heart beat; Tiredness; Nauseous; Dizzy; Mild bodyaches; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 13:15 (Lot number: 2w0175) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRY MOUTH (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Cotton mouth"; HEART RATE INCREASED (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Rapid heart beat"; FATIGUE (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Tiredness"; NAUSEA (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Nauseous"; DIZZINESS (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Dizzy"; PAIN (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Mild bodyaches"; HEADACHE (non-serious) with onset 25Aug2021 19:00, outcome "recovering", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dry mouth, heart rate increased, fatigue, nausea, dizziness, pain, headache.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the 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 is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Muscle pain; Extreme tiredness; Headache; 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 24Aug2021 12:00 (Lot number: FC3183) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex; "known allergies: Sulfa meds" (unspecified if ongoing), notes: known allergies: Sulfa meds. Concomitant medication(s) included: PROGESTERONE; SPIRONOLACTONE; ALLEGRA. The following information was reported: MYALGIA (non-serious) with onset 24Aug2021 22:00, outcome "recovering", described as "Muscle pain"; FATIGUE (non-serious) with onset 24Aug2021 22:00, outcome "recovering", described as "Extreme tiredness"; HEADACHE (non-serious) with onset 24Aug2021 22:00, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of myalgia, fatigue, headache.  Additional Information: The patient did not receive any vaccine in four weeks. The patient did not have covid prior to vaccination. The patient was not tested for covid post-vaccination.Device time stamp: 25Aug2021.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Mild but persistent bi-aural tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 12:30 (Lot number: EW0150) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Dose/Time: 15Mar2021 12:30, Site and route of injection: Left shoulder, Batch/Lot number: EN6207), administration date: 15Mar2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 16Apr2021 18:00, outcome "not recovered", described as "Mild but persistent bi-aural tinnitus". The event "mild but persistent bi-aural tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient had not taken other vaccine in two or four weeks. The patient had neither covid prior vaccination nor tested for covid post vaccination. The patient stated that a day after he was vaccinated, he noticed that he was hearing a high pitched and constant ringing. It wasn't loud (and remains the same volume) but it was constant 6 months later, I have the same constant ringing. The family doctor of the patient indicated that no treatment was suitable to the high pitched ringing especially since it was not loud enough to interfere with everyday hearing/activities.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Feeling abnormal, Palpitations
Clinical narrative: I have no thyroid. Removed Aug 2005 due to cancer. The morning after 1st vaccine, I felt just like I did before radiation treatment and being depleted of thyroid hormone. No energy, heart pounding and; I have no thyroid. Removed Aug 2005 due to cancer. The morning after 1st vaccine, I felt just like I did before radiation treatment and being depleted of thyroid hormone. No energy, heart pounding and; I have no thyroid. Removed Aug 2005 due to cancer. The morning after 1st vaccine, I felt just like I did before radiation treatment and being depleted of thyroid hormone. No energy, heart pounding and; I have no thyroid. Removed Aug 2005 due to cancer. The morning after 1st vaccine, I felt just like I did before radiation treatment and being depleted of thyroid hormone. No energy, heart pounding and; 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 24Aug2021 15:15 (Lot number: FD8448) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "1 kidney" (unspecified if ongoing), notes: 1 kidney, No thyroid, Bipolar 2,, MTHFR C677T/A1298C,; "No thyroid" (unspecified if ongoing), notes: 1 kidney, No thyroid, Bipolar 2,, MTHFR C677T/A1298C,; "MTHFR" (unspecified if ongoing), notes: 1 kidney, No thyroid, Bipolar 2,, MTHFR C677T/A1298C,; "Bipolar 2" (unspecified if ongoing), notes: 1 kidney, No thyroid, Bipolar 2,, MTHFR C677T/A1298C,; "Penicillin" (unspecified if ongoing), notes: Penicillin, Sulfa, Codeine; "Sulfa" (unspecified if ongoing), notes: Penicillin, Sulfa, Codeine. Concomitant medication(s) included: SYNTHROID; CYTOMEL; TRILEPTAL; ATARAX [ALPRAZOLAM]; XANAX. Past drug history included: Codeine, reaction(s): "known allergies:Codeine", notes: Penicillin, Sulfa, Codeine. The following information was reported: ASTHENIA (non-serious), PALPITATIONS (non-serious), FEELING ABNORMAL (non-serious), DECREASED APPETITE (non-serious) all with onset 25Aug2021 05:00, outcome "recovered" (2021) and all described as "I have no thyroid. Removed Aug 2005 due to cancer. The morning after 1st vaccine, I felt just like I did before radiation treatment and being depleted of thyroid hormone. No energy, heart pounding and". Therapeutic measures were not taken as a result of asthenia, palpitations, feeling abnormal, decreased appetite.  Additional information: Patient did not receive any other vaccines within 4 weeks. Patient do not have covid prior to the vaccination.  Patient did not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 03Aug2021 (Lot number: EW0169) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Diabetic" (unspecified if ongoing), notes: Verbatim: Diabetic; "Verbatim: Cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol; "Verbatim: Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: INSULIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: He took insulin and also a pill for diabetes, blood pressure, for cholesterol. It was reported that reporter (Wife) also experienced sore arm after the first shot. Reporter stated, "The only thing we had was sore arm for a day and half and nothing else but with the second dose this went with his blood sugar." My husband I received our second dose of the vaccine, yesterday and just my husband is diabetic (Intent: Medical history). Second Shot was on 24Aug2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Aug2021 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Sore arm".  Additional information: Reporter stated, the only thing we had was sore arm for a day and half and nothing else.  No follow-up attempts are possible. No further information is expected.