chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Soreness around the injection area/it's the injection area but the pain goes towards the back of arm towards my shoulder; Soreness around the injection area/it's the injection area but the pain goes towards the back of arm towards my shoulder; soreness around the injection area/it's the injection area but the pain goes towards the back of arm towards my shoulder; Hard to sleep; It's an unpleasant dull ache/still in pain; 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 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Jul2021 (Lot number: EW0180) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Trintellix for Anxiety, notes: 10 mg once a day. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 16Jul2021, outcome "not recovered" and all described as "Soreness around the injection area/it's the injection area but the pain goes towards the back of arm towards my shoulder"; ARTHRALGIA (non-serious) with onset 16Jul2021, outcome "not recovered", described as "soreness around the injection area/it's the injection area but the pain goes towards the back of arm towards my shoulder"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "Hard to sleep"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "It's an unpleasant dull ache/still in pain". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, arthralgia, insomnia, pain.  Additional information: Consumer stated that he did not receive any prior vaccinations (within four weeks). The patient was taking Trintellix sporadic actually, this is down to his last  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Myalgia, Pain
Clinical narrative: body ache; fever; muscle soreness; chills; no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Attack" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness"; PAIN (non-serious), outcome "unknown", described as "body ache"; CHILLS (non-serious), outcome "unknown", described as "chills"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite".  Additional information: 1st dose 15Jul - Had several adverse events including fever, muscle soreness, body ache, chills, and no appetite. Events lasted about three days. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: body ache; fever; muscle soreness; chills; no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Attack" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness"; PAIN (non-serious), outcome "unknown", described as "body ache"; CHILLS (non-serious), outcome "unknown", described as "chills"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite".  Additional information: 1st dose 15Jul - Had several adverse events including fever, muscle soreness, body ache, chills, and no appetite. Events lasted about three days. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Wheezing
Clinical narrative: flu like symptoms which included chills, fever, body aches.; swelling and pain in my left armpit all the way into my left pectoral muscle region; swelling and pain in my left armpit all the way into my left pectoral muscle region; tightness in my chest; wheezing while breathing and raw feeling in my lungs.; wheezing while breathing and raw feeling in my lungs.; The swelling and tenderness lasted for over two weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 09:00 (Lot number: EL9267) at the age of 45 years as dose 2, single and administered in arm right, administration date 29Jan2021 09:00 (Lot number: EL9262) 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: INFLUENZA LIKE ILLNESS (non-serious) with onset 16Feb2021 23:00, outcome "not recovered", described as "flu like symptoms which included chills, fever, body aches."; AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 16Feb2021 23:00, outcome "not recovered" and all described as "swelling and pain in my left armpit all the way into my left pectoral muscle region"; CHEST DISCOMFORT (non-serious) with onset 16Feb2021 23:00, outcome "not recovered", described as "tightness in my chest"; WHEEZING (non-serious), PULMONARY PAIN (non-serious) all with onset 16Feb2021 23:00, outcome "not recovered" and all described as "wheezing while breathing and raw feeling in my lungs."; TENDERNESS (non-serious) with onset 16Feb2021 23:00, outcome "not recovered", described as "The swelling and tenderness lasted for over two weeks". Therapeutic measures were not taken as a result of influenza like illness, axillary pain, swelling, chest discomfort, wheezing, pulmonary pain, tenderness. Additional Information: The night of the second shot, on 16Feb2021, the patient experienced flu like symptoms which included chills, fever, body aches. A couple days after the shot experienced swelling and pain in my left armpit all the way into my left pectoral muscle region. The swelling and tenderness lasted for over two weeks. Along with the swelling and tenderness, he experienced tightness in my chest, wheezing while breathing and raw feeling in my lungs. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not received any other medications within 2 weeks of vaccination. Patient was reported that most symptoms were temporary, except for the continuous tightness in chest like raw feeling in lungs with occasional wheezing or congested sound while breathing. Patient was not diagnosed with Covid prior to vaccination. patient was not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Exposure during pregnancy, Fluid retention, Limb discomfort, Vaccination site pain
Clinical narrative: Pregnancy at time of Vaccination: Yes; Injection site pain, heavy feeling in the arm, chest pain, fluid retention feeling in the area; Injection site pain, heavy feeling in the arm, chest pain, fluid retention feeling in the area; Injection site pain, heavy feeling in the arm, chest pain, fluid retention feeling in the area; Injection site pain, heavy feeling in the arm, chest pain, fluid retention feeling in the area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 (Lot number: Ew0182) at the age of 38 years as dose 1, single and administration date 20May2021 (Lot number: Ew0217) for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 05Oct2020. The patient was 32 weeks pregnant at the time of exposure to bnt162b2. The patient was 43 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 06Jul2021. The patient's concomitant medications were not reported. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious) with onset 03Aug2021 10:00, outcome "not recovered", described as "Pregnancy at time of Vaccination: Yes"; VACCINATION SITE PAIN (non-serious), LIMB DISCOMFORT (non-serious), CHEST PAIN (non-serious), FLUID RETENTION (non-serious) all with onset 03Aug2021 10:00, outcome "not recovered" and all described as "Injection site pain, heavy feeling in the arm, chest pain, fluid retention feeling in the area". Therapeutic measures were not taken as a result of exposure during pregnancy, vaccination site pain, limb discomfort, chest pain, fluid retention.  Additional Information: Reporter was reported that No any other vaccine was taken in four weeks and no other medication was taken in 2 weeks. No covid was reported prior to vaccination. It was also No if covid was tested positive post the vaccination. No known allergies and other medication history was reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: a rash a bunch of bumps all over my body mostly like check my breast my stomach my back my size; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (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: URTICARIA (non-serious) with onset 29Aug2021, outcome "unknown", described as "a rash a bunch of bumps all over my body mostly like check my breast my stomach my back my size". 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: Body temperature, Chills, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 09:00 (Lot number: EW0173) at the age of 59 years as dose 3, single for Covid-19 immunisation. Relevant medical history included: "Breast cancer" (ongoing), notes: I'm a breast cancer survivor. My breast cancer is in remission right now; "radiation", start date: May2021, stop date: May2021, notes: I have taken radiation in May of last year. Concomitant medication(s) included: LETROZOLE. Vaccination history included: Bnt162b2 (Dose: 1, LOT: EK9231, Anatomical location of administration: Left arm), administration date: 11Jan2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, LOT: EL3247, Anatomical location of administration: Left arm), administration date: 01Feb2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "not recovered", described as "My arm was little sore"; CHILLS (non-serious) with onset Aug2021, outcome "not recovered", described as "Chills"; PYREXIA (non-serious) with onset Aug2021, outcome "not recovered", described as "low grade fever 100.2"; PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "body aches like crazy"; RHINORRHOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "runny nose"; HYPOAESTHESIA (non-serious) with onset Aug2021, outcome "not recovered", described as "Numbness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, chills, pyrexia, pain, rhinorrhoea, hypoaesthesia. Additional information- It was reported that patient took Shingles Vaccine prior to the vaccination. Patient reported that Less fever her arm was sore but she didn't think it's swollen, it's just sore but she had fever, runny nose, and body ache. She just wanted to know if is it normal or Is it possible after to have the vaccine to test positive for COVID. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 09:00 (Lot number: EW0173) at the age of 59 years as dose 3, single for Covid-19 immunisation. Relevant medical history included: "Breast cancer" (ongoing), notes: I'm a breast cancer survivor. My breast cancer is in remission right now; "radiation", start date: May2021, stop date: May2021, notes: I have taken radiation in May of last year. Concomitant medication(s) included: LETROZOLE. Vaccination history included: Bnt162b2 (Dose: 1, LOT: EK9231, Anatomical location of administration: Left arm), administration date: 11Jan2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, LOT: EL3247, Anatomical location of administration: Left arm), administration date: 01Feb2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "not recovered", described as "My arm was little sore"; CHILLS (non-serious) with onset Aug2021, outcome "not recovered", described as "Chills"; PYREXIA (non-serious) with onset Aug2021, outcome "not recovered", described as "low grade fever 100.2"; PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "body aches like crazy"; RHINORRHOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "runny nose"; HYPOAESTHESIA (non-serious) with onset Aug2021, outcome "not recovered", described as "Numbness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, chills, pyrexia, pain, rhinorrhoea, hypoaesthesia. Additional information- It was reported that patient took Shingles Vaccine prior to the vaccination. Patient reported that Less fever her arm was sore but she didn't think it's swollen, it's just sore but she had fever, runny nose, and body ache. She just wanted to know if is it normal or Is it possible after to have the vaccine to test positive for COVID. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, SARS-CoV-2 test
Clinical narrative: itchy red rash appeared in right armpit about 2 weeks after the 2nd vaccination; 4 months later it is still there and the rash has spread to the left armpit as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Apr2021 10:00 (Lot number: EL9265) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Sorbitol, reaction(s): "Allergy", notes: all artificial sweeteners (aspartame, acesulphame K, sorbitol, sorbitan), mushrooms, cleocin; Cleocin, reaction(s): "Allergy"; Aspartame, reaction(s): "Allergy"; Acesulphame k, reaction(s): "Allergy"; Sorbitan, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Product COVID 19, brand: Pfizer, lot number: EP6955,, lot unknown: False,, administration date: 21Mar2021,, administration time: 04:15 PM, Dose number: 1, vaccine location: Right arm), for Covid-19 immunisation. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 27Apr2021, outcome "not recovered", described as "itchy red rash appeared in right armpit about 2 weeks after the 2nd vaccination; 4 months later it is still there and the rash has spread to the left armpit as well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash erythematous. Additional information- It was reported that the patient did not suffer from Covid-19prior vaccination. The patient also under went  for covid tested post vaccination No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Somnolence, Vaccination site pain, Vaccination site pruritus
Clinical narrative: dry cough; injection site was itchy; Fatigue; sleepy; injection site was swollen and sore; injection site was swollen and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 18:00 (Lot number: FC3181) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glucose-6-phosphate dehydrogenase deficiency" (unspecified if ongoing), notes: Other medical history: G6PD Deficiency; "sulfa based madicine" (unspecified if ongoing), notes: Known allergies: sulfa based medicine; "Yes - favs beans" (unspecified if ongoing), notes: Known allergies: Yes - favs beans. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EW0181, Lot unknown: False, Administration date: 02Aug2021, Administration time: 02:00 PM, Dose number: 1, Vaccine location: Right arm), administration date: 02Aug2021, when the patient was 28 years old, for COVID-19 immunisation. The following information was reported: COUGH (non-serious) with onset 28Aug2021, outcome "recovering", described as "dry cough"; FATIGUE (non-serious) with onset 24Aug2021, outcome "recovering", described as "Fatigue"; SOMNOLENCE (non-serious) with onset 24Aug2021, outcome "recovering", described as "sleepy"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 24Aug2021, outcome "recovering" and all described as "injection site was swollen and sore"; VACCINATION SITE PRURITUS (non-serious) with onset 28Aug2021, outcome "recovering", described as "injection site was itchy". Therapeutic measures were not taken as a result of cough, fatigue, somnolence, vaccination site swelling, vaccination site pain, vaccination site pruritus. No follow-up attempts are possible. No further information is expected. Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: dry cough; injection site was itchy; Fatigue; sleepy; injection site was swollen and sore; injection site was swollen and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 18:00 (Lot number: FC3181) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glucose-6-phosphate dehydrogenase deficiency" (unspecified if ongoing), notes: Other medical history: G6PD Deficiency; "sulfa based madicine" (unspecified if ongoing), notes: Known allergies: sulfa based medicine; "Yes - favs beans" (unspecified if ongoing), notes: Known allergies: Yes - favs beans. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EW0181, Lot unknown: False, Administration date: 02Aug2021, Administration time: 02:00 PM, Dose number: 1, Vaccine location: Right arm), administration date: 02Aug2021, when the patient was 28 years old, for COVID-19 immunisation. The following information was reported: COUGH (non-serious) with onset 28Aug2021, outcome "recovering", described as "dry cough"; FATIGUE (non-serious) with onset 24Aug2021, outcome "recovering", described as "Fatigue"; SOMNOLENCE (non-serious) with onset 24Aug2021, outcome "recovering", described as "sleepy"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 24Aug2021, outcome "recovering" and all described as "injection site was swollen and sore"; VACCINATION SITE PRURITUS (non-serious) with onset 28Aug2021, outcome "recovering", described as "injection site was itchy". Therapeutic measures were not taken as a result of cough, fatigue, somnolence, vaccination site swelling, vaccination site pain, vaccination site pruritus. No follow-up attempts are possible. No further information is expected. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Pain, Swelling face
Clinical narrative: Sore; My face swelled out; My chest hurts; I don't feel right; 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) (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: PAIN (non-serious), outcome "unknown", described as "Sore"; SWELLING FACE (non-serious), outcome "unknown", described as "My face swelled out"; CHEST PAIN (non-serious), outcome "unknown", described as "My chest hurts"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I don't feel right".  Additional Information: The consumer stated, "I want to report an effect I had from the shot, it made me "sore" (further not clarified) I don't feel right (well)." When probed for the experienced effect, consume stated, "Started my face swelled out and my chest hurts."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: dizziness; Injection site pain; extremely tired; migraine (headache); migraine (headache); chills; fever; nauseated; feeling sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Aug2021 14:45 (Lot number: EW0168) at the age of 51 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "gurd" (unspecified if ongoing); "Herpes" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN HCTZ; ACYCLOVIR [ACICLOVIR]; SIMVASTATIN; CARVEDILOL. Past drug history included: Sulfamethoxazole, reaction(s): "Known allergies"; Esomeprazole, reaction(s): "Known allergies"; Metronidazole, reaction(s): "Known allergies". The following information was reported: DIZZINESS (non-serious) with onset 28Aug2021, outcome "not recovered", described as "dizziness"; VACCINATION SITE PAIN (non-serious) with onset 28Aug2021, outcome "not recovered", described as "Injection site pain"; FATIGUE (non-serious) with onset 28Aug2021, outcome "not recovered", described as "extremely tired"; MIGRAINE (non-serious), HEADACHE (non-serious) all with onset 28Aug2021, outcome "not recovered" and all described as "migraine (headache)"; CHILLS (non-serious) with onset 28Aug2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 28Aug2021, outcome "not recovered", described as "fever"; NAUSEA (non-serious) with onset 28Aug2021, outcome "not recovered", described as "nauseated"; MALAISE (non-serious) with onset 28Aug2021, outcome "not recovered", described as "feeling sick". Therapeutic measures were not taken as a result of dizziness, vaccination site pain, fatigue, migraine, headache, chills, pyrexia, nausea, malaise.  Additional information: The patient was not pregnant at the time of vaccination. The patient race and ethnicity was withheld. The patient was not administered with other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had not tested COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: dizziness; Injection site pain; extremely tired; migraine (headache); migraine (headache); chills; fever; nauseated; feeling sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Aug2021 14:45 (Lot number: EW0168) at the age of 51 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "gurd" (unspecified if ongoing); "Herpes" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN HCTZ; ACYCLOVIR [ACICLOVIR]; SIMVASTATIN; CARVEDILOL. Past drug history included: Sulfamethoxazole, reaction(s): "Known allergies"; Esomeprazole, reaction(s): "Known allergies"; Metronidazole, reaction(s): "Known allergies". The following information was reported: DIZZINESS (non-serious) with onset 28Aug2021, outcome "not recovered", described as "dizziness"; VACCINATION SITE PAIN (non-serious) with onset 28Aug2021, outcome "not recovered", described as "Injection site pain"; FATIGUE (non-serious) with onset 28Aug2021, outcome "not recovered", described as "extremely tired"; MIGRAINE (non-serious), HEADACHE (non-serious) all with onset 28Aug2021, outcome "not recovered" and all described as "migraine (headache)"; CHILLS (non-serious) with onset 28Aug2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 28Aug2021, outcome "not recovered", described as "fever"; NAUSEA (non-serious) with onset 28Aug2021, outcome "not recovered", described as "nauseated"; MALAISE (non-serious) with onset 28Aug2021, outcome "not recovered", described as "feeling sick". Therapeutic measures were not taken as a result of dizziness, vaccination site pain, fatigue, migraine, headache, chills, pyrexia, nausea, malaise.  Additional information: The patient was not pregnant at the time of vaccination. The patient race and ethnicity was withheld. The patient was not administered with other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had not tested COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Nausea, Vomiting
Clinical narrative: Nausea; Mild vomiting (threw up small amount in mouth twice while sleeping); gestational period: 34; This is a spontaneous report from a non-contactable consumer, the patient. An 28 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Aug2021 at 14:00 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 11Oct2021. Concomitant medication(s) included: FISH OIL; VITAMIN D NOS; CALCIUM; MAGNESIUM. The following information was reported: NAUSEA (non-serious) with onset 31Aug2021 at 04:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 31Aug2021 at 04:00, outcome "not recovered", described as "Mild vomiting (threw up small amount in mouth twice while sleeping)"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 30Aug2021 at 14:00, outcome "unknown", described as "gestational period: 34".Therapeutic measures were not taken as a result of nausea, vomiting.  Additional information: The patient did not have any relevant medical history. The patient had no known allergies. The patient expected delivery date was 11Oct2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified prenatal (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN), all taken from unknown dates. On 31Aug2021 at 04:00, the patient experienced nausea and mild vomiting (threw up small amount in mouth twice while sleeping). The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea and mild vomiting were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 28 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08May2021 17:00 (Lot number: EW0168, Expiration Date: 05Aug2021) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism, start date: 2013 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 16:05 PM, Anatomical site of injection:  Left arm, Route of administration: Intramuscular, Batch/lot number: EW0171, Expiry date: 04Jul2021), administration date: 17Apr2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 08May2021, outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information : Treatment as Acetaminophen liquid. Prior vaccination (within 4 weeks): None.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Musculoskeletal stiffness
Clinical narrative: developed a stiff neck on my left side (the side I got my shots on); left elbow is sore / painful; not feeling so great; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: ER2613) at the age of 57 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: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 27Mar2021, outcome "not recovered", described as "developed a stiff neck on my left side (the side I got my shots on)"; ARTHRALGIA (non-serious) with onset 27Mar2021, outcome "not recovered", described as "left elbow is sore / painful"; MALAISE (non-serious) with onset 27Mar2021, outcome "not recovered", described as "not feeling so great". Therapeutic measures were not taken as a result of musculoskeletal stiffness, arthralgia, malaise.  Additional Information: Facility type vaccine: Hospital. No other vaccine in four weeks. I developed a stiff neck on my left side (the side I got my shots on) after getting the first shot, it started to go away after 2 weeks. My left elbow is sore / painful ever since I got the shots. Unknown if covid prior vaccination. Unknown if covid tested post vaccination: Unknown. Known allergies: No. Other medical history: None.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Arm felt feverish; Pain at the injection site; Arm felt feverish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  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 (Dose: 01), for COVID-19 immunization, reaction(s): "flu symptoms", "arm felt feverish", "sore arm on the injection arm". The following information was reported: PYREXIA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Arm felt feverish"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at the injection site".  Additional Information: He had a caller on the line who shared some adverse events after the COVID vaccine. After the first shot she had flu symptoms for a week, and a sore arm on the injection arm. For the second dose she pain at the injection site.  The details were confirmed provided by the transferring agent. She had the sore arm and pain at the injection site. Her arm felt feverish after both vaccines. She doesn't want to report it because she feels like it is normal. Her and daughter in law had the same side effects. She felt like she had the flu for 5-7 days. She doesn't really care to report it.  Follow up (31Aug2021): This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. The response included that: After reviewing the call recording, there were a total of 3 patients that were reported, the reporter, her son, and her daughter in law.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Aug2021 18:15 (Lot number: FC3189) at the age of 52 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. Concomitant medication(s) included: ENALAPRILAT taken for hypertension. The following information was reported: EPISTAXIS (non-serious) with onset 31Aug2021 21:00, outcome "not recovered", described as "I had a massive nosebleed. I continue to experience small nose bleeds thereafter". Therapeutic measures were not taken as a result of epistaxis. Additional information: The patient was not pregnant at vaccination. Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was ENALAPRILAT. The patient did not have Known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Clinical course: A little over 24 hours after getting the Pfizer vaccine I had a massive nosebleed. I continue to experience small nose bleeds thereafter. This is not normal for me. This is directly related to the vaccine. No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: arm began to get very sore; Every joint and muscle in my body aching; Every joint and muscle in my body aching; chills; shaking; Skin was on fire felt like a sunburn only no redness; heart was racing; Headache; fatigued; weakness; sick; 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 left, administration date 16Aug2021 12:15 (Lot number: FD8448) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: B COMPLEX [VITAMIN B COMPLEX]; VITAMIN C COMPLEX [ASCORBIC ACID;RUTOSIDE]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "arm began to get very sore"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021) and all described as "Every joint and muscle in my body aching"; CHILLS (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "chills"; TREMOR (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "shaking"; SKIN BURNING SENSATION (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "Skin was on fire felt like a sunburn only no redness"; PALPITATIONS (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "heart was racing"; HEADACHE (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (19Aug2021), described as "Headache"; FATIGUE (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (19Aug2021), described as "fatigued"; ASTHENIA (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (19Aug2021), described as "weakness"; ILLNESS (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "sick". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, myalgia, chills, tremor, skin burning sensation, palpitations, headache, fatigue, asthenia, illness.  Additional Information: If covid prior vaccination was reported as no. If covid tested post vaccination was reported as no. Known Allergies was reported as no. If other vaccine in four weeks was reported as no. Past Drug Event was reported as no. Other medications in two weeks: Multivitamin, Complete B Complex and Vitamin C. My heart was racing all night but not sure from reaction or how scary this was. No fever i kept checking. No fever she kept checking. Headache and very fatigued/weakness lasted 3 days. other symptoms lasted 2 days. Was terrible I am afraid to get second if it will be worse i have never been this sick before. Got the shot on A monday did not feel herself until Friday. My 22 year old daughter also got first shot next day and she was very ill as well as had two quarter size lumps on her neck for several days.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Mass
Clinical narrative: ill; had two quarter size lumps on her neck; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 22 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administration date 17Aug2021 (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: ILLNESS (non-serious), outcome "unknown", described as "ill"; MASS (non-serious), outcome "unknown", described as "had two quarter size lumps on her neck".  Additional information: My 22 year old daughter also got first shot next day and she was very ill as well as had two quarter size lumps on her neck for several days.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Pyrexia
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (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: ILLNESS (non-serious) with onset Aug2021, outcome "unknown", described as "got sick"; PYREXIA (non-serious) with onset Aug2021, outcome "unknown", described as "fever"; COUGH (non-serious) with onset Aug2021, outcome "unknown", described as "cough". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Erythema
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) form a Pfizer-sponsored program via Regulatory Authority. The reporter is the patient. A male 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: ERYTHEMA (non-serious), outcome "unknown", described as "Red Arm Immediately Upon Getting the Shot"; CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain". Additional information: A male patient of an unspecified age received bnt162b2 (BNT162B2) via unspecified route of administration. It was reported that the patient experienced adverse events within 3 days of his first dose of the Pfizer BioNTech Covid Vaccine. Reportedly the caller did not want to tell him any personal information and he will need to be transferred to Medical Information for questions. Call handler states that she will contact him with the Medical Information department to address his question. Call handler requests that call answer some additional questions about his experience before transfer about the adverse events he experienced. Caller states he had a red arm immediately upon getting the shot and he has had chest pains for the last 2 weeks. It was reported that the patient was upset and states he called to figure out the science behind the first shot and what was in it. Caller handler states is not call handler a medical professional, why cannot she tell him what is in it. Caller states each time he moved to another department; he loses more confidence in Pfizer. Additional information and details unable to be obtained. The reporter stated that he was recording this call as well and is going to show it to everyone. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low grade fever post 2nd dose of Pfizer covid vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "low grade fever post 2nd dose of Pfizer covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Heart rate irregular
Clinical narrative: Irregular heart beat; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administration date 27Jul2021 (Lot number: FA7984) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: HEART RATE IRREGULAR (non-serious) with onset Jul2021, outcome "recovered" (2021), described as "Irregular heart beat"; CHEST PAIN (non-serious) with onset Jul2021, outcome "recovered" (2021), described as "Chest pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was a caregiver, calling about the Pfizer covid 19 vaccine. Caller reported that her 14 year old son has a condition. Caller said her son received the first dose of the vaccine about four weeks ago. He experienced an irregular heart beat and chest pain for two days, and then two additional days. Caller said the second dose is due now. Caller asked if there was an option for splitting the second dose or giving a lesser amount than usual for the second dose. Caller asked if there was any information on if delaying the second dose reduces the side effects. Caller mentioned that she was aware in withheld and withheld the doses are given 6 weeks apart and in withheld 8 weeks apart. Response: Provided off label response to caller. She was an occupation therapist. Confirmed that this was the first dose, given on 27Jul2021 with a lot: FA7984. This started about 24 hours after getting the dose and confirms it was for 2 days, stopped for a bit and then lasted another 2 days. At this point, it has completely resolved. She states she is nervous about him getting the second vaccine. Caller asked if kids experience side effects from the first dose are they more likely to experience side effects with the second dose.  No follow-up attempts are possible. No further information was expected.