chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Joint swelling, Pain in extremity, Paraesthesia
Clinical narrative: right side of tongue started to swell; right side of my face became tingling; right side of my face became tingling and a numb feeling.; Next day sore arm; tired; left back and hip swelling; left back and hip swelling; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.   A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Nov2021 at 14:30 (Lot number: 33030BD) at the age of 45 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergy: Zinc. The patient did not receive any medications within two weeks of vaccination. Past drug history included: Erythromycin, reaction: "Drug allergy", notes: Known allergies: Erythromycin.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Nov2021, outcome "recovered with sequelae" (30Nov2021), described as "Next day sore arm"; FATIGUE (non-serious) with onset 29Nov2021, outcome "recovered with sequelae" (30Nov2021), described as "tired"; SWELLING (non-serious), JOINT SWELLING (non-serious) all with onset 01Dec2021 at 10:00, outcome "recovered with sequelae" (an unknown date in Dec2021), and all described as "left back and hip swelling"; SWOLLEN TONGUE (non-serious) with onset 01Dec2021 at 10:00, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "right side of tongue started to swell"; PARAESTHESIA (non-serious) with onset 01Dec2021 at 10:00, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "right side of my face became tingling"; HYPOAESTHESIA (non-serious) with onset 01Dec2021 at 10:00, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "right side of my face became tingling and a numb feeling". The events "Next day sore arm", "tired", "left back and hip swelling", "right side of tongue started to swell", "right side of my face became tingling" and "right side of my face became tingling and a numb feeling." were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, fatigue, swelling, joint swelling, swollen tongue, paraesthesia and hypoaesthesia which included treatment with BENADRYL every 4 hours.  Additional Information: 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swollen tongue
Clinical narrative: right side of tongue started to swell; right side of my face became tingling; right side of my face became tingling and a numb feeling.; Next day sore arm; tired; left back and hip swelling; left back and hip swelling; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.   A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Nov2021 at 14:30 (Lot number: 33030BD) at the age of 45 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergy: Zinc. The patient did not receive any medications within two weeks of vaccination. Past drug history included: Erythromycin, reaction: "Drug allergy", notes: Known allergies: Erythromycin.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Nov2021, outcome "recovered with sequelae" (30Nov2021), described as "Next day sore arm"; FATIGUE (non-serious) with onset 29Nov2021, outcome "recovered with sequelae" (30Nov2021), described as "tired"; SWELLING (non-serious), JOINT SWELLING (non-serious) all with onset 01Dec2021 at 10:00, outcome "recovered with sequelae" (an unknown date in Dec2021), and all described as "left back and hip swelling"; SWOLLEN TONGUE (non-serious) with onset 01Dec2021 at 10:00, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "right side of tongue started to swell"; PARAESTHESIA (non-serious) with onset 01Dec2021 at 10:00, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "right side of my face became tingling"; HYPOAESTHESIA (non-serious) with onset 01Dec2021 at 10:00, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "right side of my face became tingling and a numb feeling". The events "Next day sore arm", "tired", "left back and hip swelling", "right side of tongue started to swell", "right side of my face became tingling" and "right side of my face became tingling and a numb feeling." were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, fatigue, swelling, joint swelling, swollen tongue, paraesthesia and hypoaesthesia which included treatment with BENADRYL every 4 hours.  Additional Information: 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Feeling abnormal, Headache, Joint swelling
Clinical narrative: Temperature of 100; Right shoulder swollen; Bruised on the injection spot; Inflammation on lymphatic nodules on the right side, from neck to hip.; Headache; No appetite; Brain fog; Lethargy; This is a spontaneous report from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 29Nov2021 at 11:45 (Lot number: FH8027) at the age of 40 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FH8030, Anatomical location: Right arm, Administration time: 11:45), administration date: 08Nov2021, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Temperature of 100"; JOINT SWELLING (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Right shoulder swollen"; VACCINATION SITE BRUISING (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Bruised on the injection spot"; LYMPHADENITIS (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Inflammation on lymphatic nodules on the right side, from neck to hip"; HEADACHE (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Headache"; DECREASED APPETITE (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "No appetite"; FEELING ABNORMAL (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Brain fog"; LETHARGY (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Lethargy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, joint swelling, vaccination site bruising, lymphadenitis, headache, decreased appetite, feeling abnormal and lethargy.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenitis, Pyrexia, Vaccination site bruising
Clinical narrative: Temperature of 100; Right shoulder swollen; Bruised on the injection spot; Inflammation on lymphatic nodules on the right side, from neck to hip.; Headache; No appetite; Brain fog; Lethargy; This is a spontaneous report from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 29Nov2021 at 11:45 (Lot number: FH8027) at the age of 40 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FH8030, Anatomical location: Right arm, Administration time: 11:45), administration date: 08Nov2021, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Temperature of 100"; JOINT SWELLING (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Right shoulder swollen"; VACCINATION SITE BRUISING (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Bruised on the injection spot"; LYMPHADENITIS (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Inflammation on lymphatic nodules on the right side, from neck to hip"; HEADACHE (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Headache"; DECREASED APPETITE (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "No appetite"; FEELING ABNORMAL (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Brain fog"; LETHARGY (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Lethargy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, joint swelling, vaccination site bruising, lymphadenitis, headache, decreased appetite, feeling abnormal and lethargy.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Endocrine disorder, Facial pain, Feeling jittery
Clinical narrative: Change in menstrual cycle; Intense mood swings; Heavy bleeding; Spotting; Jitters; Anxiety; Depression; Facial pain; Tingling; Ongoing treatment to treat hormones; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Jun2021 (Lot number: EW0191) at the age of 36 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Gastroparesis" (unspecified if ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EW0177; Route of administration: Unspecified), administration date: 21May2021, when the patient was 36 years old, for COVID-19 immunisation.  The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Change in menstrual cycle"; MOOD SWINGS (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Intense mood swings"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Heavy bleeding"; INTERMENSTRUAL BLEEDING (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Spotting"; FEELING JITTERY (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Jitters"; ANXIETY (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Anxiety"; DEPRESSION (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Depression"; FACIAL PAIN (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Facial pain"; PARAESTHESIA (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Tingling"; ENDOCRINE DISORDER (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Ongoing treatment to treat hormones". The events "Change in menstrual cycle", "Intense mood swings", "Heavy bleeding", "Spotting", "Jitters", "Anxiety", "Depression", "Facial pain", "Tingling" and "Ongoing treatment to treat hormones" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anxiety and endocrine disorder.  Additional Information: Therapeutic measures included ongoing treatment to treat hormones and anxiety. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Mood swings, Paraesthesia
Clinical narrative: Change in menstrual cycle; Intense mood swings; Heavy bleeding; Spotting; Jitters; Anxiety; Depression; Facial pain; Tingling; Ongoing treatment to treat hormones; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Jun2021 (Lot number: EW0191) at the age of 36 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Gastroparesis" (unspecified if ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EW0177; Route of administration: Unspecified), administration date: 21May2021, when the patient was 36 years old, for COVID-19 immunisation.  The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Change in menstrual cycle"; MOOD SWINGS (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Intense mood swings"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Heavy bleeding"; INTERMENSTRUAL BLEEDING (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Spotting"; FEELING JITTERY (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Jitters"; ANXIETY (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Anxiety"; DEPRESSION (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Depression"; FACIAL PAIN (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Facial pain"; PARAESTHESIA (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Tingling"; ENDOCRINE DISORDER (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Ongoing treatment to treat hormones". The events "Change in menstrual cycle", "Intense mood swings", "Heavy bleeding", "Spotting", "Jitters", "Anxiety", "Depression", "Facial pain", "Tingling" and "Ongoing treatment to treat hormones" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anxiety and endocrine disorder.  Additional Information: Therapeutic measures included ongoing treatment to treat hormones and anxiety. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Change in menstrual cycle; Intense mood swings; Heavy bleeding; Spotting; Jitters; Anxiety; Depression; Facial pain; Tingling; Ongoing treatment to treat hormones; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Jun2021 (Lot number: EW0191) at the age of 36 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Gastroparesis" (unspecified if ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EW0177; Route of administration: Unspecified), administration date: 21May2021, when the patient was 36 years old, for COVID-19 immunisation.  The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Change in menstrual cycle"; MOOD SWINGS (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Intense mood swings"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Heavy bleeding"; INTERMENSTRUAL BLEEDING (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Spotting"; FEELING JITTERY (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Jitters"; ANXIETY (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Anxiety"; DEPRESSION (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Depression"; FACIAL PAIN (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Facial pain"; PARAESTHESIA (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Tingling"; ENDOCRINE DISORDER (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Ongoing treatment to treat hormones". The events "Change in menstrual cycle", "Intense mood swings", "Heavy bleeding", "Spotting", "Jitters", "Anxiety", "Depression", "Facial pain", "Tingling" and "Ongoing treatment to treat hormones" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anxiety and endocrine disorder.  Additional Information: Therapeutic measures included ongoing treatment to treat hormones and anxiety. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: Body aches; Dose number:3; This is a spontaneous report from a contactable reporter (Consumer or other nonHCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 03Dec2021 at 11:45 (Lot number: EN5318) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FF2589, Route of administration: Unspecified), administration date: 03Mar2021, when the patient was 42 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EN5318, Route of administration: Unspecified), administration date: 23Mar2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 at 11:45, outcome "unknown", described as "Dose received: 3"; PAIN (non-serious) with onset 05Dec2021 at 01:00, outcome "unknown", described as "Body aches".  Additional Information: The patient had no known allergies. 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Pain
Clinical narrative: Muscle pain and entire body ache for more than 48 hours; Muscle pain and entire body ache for more than 48 hours; Dose received: 3; This is a spontaneous report received from non-contactable reporter (Consumer or other non-HCP).  The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: unknown) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Known allergy: Latex. Concomitant medications included: VITAMIN C; VITAMIN D and IBUPROFEN. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown, Route of Administration: Unknown), administration date: 28Jan2021, when the patient was 35 years old, for COVID-19 immunisation and bnt162b2 (DOSE 2, SINGLE, Lot Number: Unknown, Route of Administration: Unknown, Anatomical Location: Left arm), administration date: 18Feb2021, when the patient was 35 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose received: 3"; MYALGIA (non-serious), PAIN (non-serious) all with onset 04Dec2021, outcome "recovering", and all described as "Muscle pain and entire body ache for more than 48 hours".  Therapeutic measures were not taken as a result of myalgia and pain.  Additional Information: 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, SARS-CoV-2 test, Swelling
Clinical narrative: Some swelling and pain in armpit after vaccination; Some swelling and pain in armpit after vaccination; dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 31-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 02Dec2021 (Lot number: FH8030) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing), notes: Cancer, currently healthy. Concomitant medications included: ADDERALL and IBUPROFEN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP7534), administration date: 31Mar2021, when the patient was 30 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EP7534), administration date: 21Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "dose number: 3"; SWELLING (non-serious) and AXILLARY PAIN (non-serious) both with onset 03Dec2021, outcome "recovering", both described as "Some swelling and pain in armpit after vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling and axillary pain.  Additional Information: The patient had no known allergies. 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 COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuropathy peripheral, Pain
Clinical narrative: neuropathy in my hands; pain; numbness in my hands; 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 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy in my hands"; PAIN (non-serious), outcome "unknown", described as "pain"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in my hands".  Patient got bitten by a scorpion last week and had her booster on tomorrow for covid-19 and getting Pfizer. Patient spoke to the pharmacist at the placed. They said that patient did not have any information but patient was not sure would be a problem then patient directed to withheld, they also did not have anything about this, and they kind a thought maybe it would be ok to. Caller also stated that they recommend her to call the manufacturer and see if they have any information regarding to that. Upon clarification, caller clarified, She had no adverse effect to the Pfizer other than just 36 hours of pain. Patient had numbness in her hands and neuropathy in her hands but patient would not consider that to be a severe reaction, that was a, because they attacked her nerves. Patient did not have like anaphylactic, and any flooting issue, or tongue swelling or throat swelling, none of them typical reactions to a bite or sting. Caller also said, the pharmacist she did not think that it would necessary be a problem otherwise then that there are people who are getting the flu along with the covid and there not had issues. But patient was felt like at her age should have it. Patient could wait longer, because the only alternative for her was to wait for 28 days you know for her to complete her system. Caller wanted to know if they did have any information regarding all that and if she should wait another or should she get it for tomorrow. Upon checking the official PI they did not find any potential interaction or INT study for administration with patients who got bitten by a scorpion a week ago, this may not have been studied. Referred to HCP for further guidance.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Mast cell activation syndrome, Muscle twitching, Neuropathy peripheral, Paraesthesia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 (Lot number: EWO150) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS; FISH OIL; TURMERIC; MAGNE B. Other medications in two weeks: multivitamin. Past drug history included: Keflex, reaction(s): "Allergy"; Remicade, reaction(s): "Allergy"; Asacol, reaction(s): "allergy"; Azithromycin, reaction(s): "allergy". Vaccination history included: Flu vaccine, reaction(s): "allergy". The following information was reported: NEUROPATHY PERIPHERAL (disability, medically significant), PARAESTHESIA (disability) all with onset Apr2021, outcome "not recovered" and all described as "worsening of my long Covid peripheral neuropathy symptoms (paresthesias)"; MUSCLE TWITCHING (disability) with onset Apr2021, outcome "not recovered", described as "muscle twitching"; MAST CELL ACTIVATION SYNDROME (disability, medically significant) with onset Apr2021, outcome "not recovered", described as "A specialist thinks I may have mast cell activation syndrome"; HYPERSENSITIVITY (disability) with onset Apr2021, outcome "not recovered", described as "I have also developed new allergic-like reactions to many things". The events "worsening of my long covid peripheral neuropathy symptoms (paresthesias)", "worsening of my long covid peripheral neuropathy symptoms (paresthesias)", "muscle twitching", "a specialist thinks i may have mast cell activation syndrome" and "i have also developed new allergic-like reactions to many things" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (May2021) negative, notes: Nasal swab; (Oct2021) negative, notes: Nasal swab; (Nov2021) negative, notes: Nasal swab; (Dec2021) negative, notes: Nasal swab. Therapeutic measures were taken as a result of neuropathy peripheral, paraesthesia, muscle twitching, mast cell activation syndrome, hypersensitivity.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 (Lot number: EWO150) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS; FISH OIL; TURMERIC; MAGNE B. Other medications in two weeks: multivitamin. Past drug history included: Keflex, reaction(s): "Allergy"; Remicade, reaction(s): "Allergy"; Asacol, reaction(s): "allergy"; Azithromycin, reaction(s): "allergy". Vaccination history included: Flu vaccine, reaction(s): "allergy". The following information was reported: NEUROPATHY PERIPHERAL (disability, medically significant), PARAESTHESIA (disability) all with onset Apr2021, outcome "not recovered" and all described as "worsening of my long Covid peripheral neuropathy symptoms (paresthesias)"; MUSCLE TWITCHING (disability) with onset Apr2021, outcome "not recovered", described as "muscle twitching"; MAST CELL ACTIVATION SYNDROME (disability, medically significant) with onset Apr2021, outcome "not recovered", described as "A specialist thinks I may have mast cell activation syndrome"; HYPERSENSITIVITY (disability) with onset Apr2021, outcome "not recovered", described as "I have also developed new allergic-like reactions to many things". The events "worsening of my long covid peripheral neuropathy symptoms (paresthesias)", "worsening of my long covid peripheral neuropathy symptoms (paresthesias)", "muscle twitching", "a specialist thinks i may have mast cell activation syndrome" and "i have also developed new allergic-like reactions to many things" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (May2021) negative, notes: Nasal swab; (Oct2021) negative, notes: Nasal swab; (Nov2021) negative, notes: Nasal swab; (Dec2021) negative, notes: Nasal swab. Therapeutic measures were taken as a result of neuropathy peripheral, paraesthesia, muscle twitching, mast cell activation syndrome, hypersensitivity.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional via medical information team for a sponsored program. The reporter is the patient. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: not reported), via unspecified route of administration on unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Patient previously received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: not reported), via unspecified route of administration on unspecified date as DOSE 1, SINGLE and DOSE 2, SINGLE for COVID-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date the patient experienced Pericarditis, Myocarditis, Booster dose, chest pain, shortness of breath, fast beating and heart rate. The patient underwent the following laboratory tests and procedures which includes electrocardiogram, heart rate and troponin with unknown results. Reporter quired for how does the symptoms of chest pain, shortness of breath, fast beating and heart rate associated with Pericarditis and Myocarditis differ from Anxiety. Reporter stated that he received his third dose of the Pfizer Covid-19 vaccine and had no underlying medical condition. Reporter stated that he was trying to figure out how to reliably differentiate these symptoms. Reporter queried for what was the onset or time frame for an individual to develop these condition. Reporter queried for when to seek medical help when they experience such symptoms, to which health care professional does he need to consult with. In response to the query it was provided that referred to health care professional to assess and evaluate his symptoms. Advised the reporter on the likelihood of having Myocarditis based on PI Warnings and attached document. Post marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. Outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Myocarditis, Pericarditis, Troponin
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional via medical information team for a sponsored program. The reporter is the patient. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: not reported), via unspecified route of administration on unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Patient previously received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: not reported), via unspecified route of administration on unspecified date as DOSE 1, SINGLE and DOSE 2, SINGLE for COVID-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date the patient experienced Pericarditis, Myocarditis, Booster dose, chest pain, shortness of breath, fast beating and heart rate. The patient underwent the following laboratory tests and procedures which includes electrocardiogram, heart rate and troponin with unknown results. Reporter quired for how does the symptoms of chest pain, shortness of breath, fast beating and heart rate associated with Pericarditis and Myocarditis differ from Anxiety. Reporter stated that he received his third dose of the Pfizer Covid-19 vaccine and had no underlying medical condition. Reporter stated that he was trying to figure out how to reliably differentiate these symptoms. Reporter queried for what was the onset or time frame for an individual to develop these condition. Reporter queried for when to seek medical help when they experience such symptoms, to which health care professional does he need to consult with. In response to the query it was provided that referred to health care professional to assess and evaluate his symptoms. Advised the reporter on the likelihood of having Myocarditis based on PI Warnings and attached document. Post marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. Outcome of events was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Changes to menstrual cycle; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Nov2021 (Lot number: 32030BD) at the age of 28 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: MENSTRUAL DISORDER (non-serious) with onset 02Nov2021, outcome "unknown", described as "Changes to menstrual cycle". Therapeutic measures were not taken as a result of menstrual disorder.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: Swollen and painful armpit, size of softball; Swollen and painful armpit, size of softball; Dose received: 3; This is a spontaneous report received from a contactable reporter (Other healthcare professional). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Dec2021 at 08:45 (Lot number: unknown) at the age of 42 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Immunocompromised" (unspecified if ongoing), notes: Rmmunocompromised. Concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Drug allergy", notes: patient drug name: IB Profen. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Anatomical site: left arm; Lot number: Unknown; Administration time: 09:00), administration date: 13Mar2021, when the patient was 41 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Anatomical site: left arm; Lot number: unknown; Administration time: 09:00), administration date: 17Apr2021, when the patient was 41 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021 at 08:45, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 05Dec2021 at 21:00, outcome "unknown", and all described as "Swollen and painful armpit, size of softball". The event "Swollen and painful armpit, size of softball" was evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling and axillary pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment included heat and appointment.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Joint swelling, Pain in extremity
Clinical narrative: leg pain; swelling knee to mid back; upset stomach; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-years-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2, Batch/Lot number: unknown) administered in leg right, administration date 27Feb2021 (at 12:15) (age at the time of vaccination was 71-years-old) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "Enlarged pulmonary artery" (unspecified if ongoing), notes: other medical history; "uranium poisoning" (unspecified if ongoing), notes: other medical history; "nephritis" (unspecified if ongoing), notes: other medical history; "Known allergies: Egg, Chicken" (unspecified if ongoing); "Known allergies: Rice" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL; ACETAMINOPHEN; MELOXICAM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Feb2021 16:30, outcome "recovered" (2021), described as "leg pain"; JOINT SWELLING (non-serious) with onset 27Feb2021 16:30, outcome "recovered" (2021), described as "swelling knee to mid back"; ABDOMINAL DISCOMFORT (non-serious) with onset 27Feb2021 16:30, outcome "recovered" (2021), described as "upset stomach". Therapeutic measures were taken as a result of pain in extremity, joint swelling, abdominal discomfort.  Additional Information: At 11:45 100mg Benadryl, 12:30 COVID shot, 50 mg BENADRYL every 4 hours for next 72 hours, leg pain and swelling knee to mid back, upset stomach, started METHYL PREDNISOLONE at 3:00 am itching on entire body. At 72 hours, all symptoms are gone feeling great. The patient did not have COVID prior to vaccination and since the vaccination was not tested for COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain
Clinical narrative: back (twisted); 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 patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 02Feb2021 (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: MUSCLE STRAIN (non-serious), outcome "unknown", described as "back (twisted)". Additional information: The patient pulled her back (twisted). The patient wanted to know if she could take a muscle relaxant (Advil or Naproxen).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm was so sore, hurt; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 29Jan2021 09:52 (Lot number: EL9264) at the age of 65 years, as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Meniere's disease" (not ongoing), notes: in 1993 or 1994; last episode was probably about 15 years ago; "High Cholesterol" (ongoing); "Thyroid pill use" (ongoing); "lost hearing in left ear" (unspecified if ongoing); "allergy to wasps/wasp venom" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: 1991 (ongoing); ATORVASTATIN taken for blood cholesterol increased, start date: Nov2020 (ongoing). Vaccination history included: Pneumococcal vaccine (around late Oct2020 or Nov2020), administration date: 2020, for immunization; Flu vaccine, for immunization, reaction(s): "no adverse effects". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Jan2021, outcome "recovered" (Feb2021), described as "left arm was so sore, hurt". Additional information: The event onset was at late night of 29Jan2021 and lasted for 3-4 days (as reported).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A 65-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), on Jan 30, 2021, single dose, for COVID-19 immunisation. Medical history included COPD (unspecified if ongoing). The patient's concomitant medications not reported. The patient experienced pain in extremity/arm a little sore, with outcome of unknown. Laboratory tests and procedures are available in the appropriate section. Additional information: The patient reported she was exposed to someone with COVID-19 virus that weekend following the second dose. She also reported she should get the monoclonal infusion. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided. On 13-OCT-2021 the patient was vaccinated with a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-RVAXPRO) however reporter was unsure about which lot number administered to patient (Lot T000890 with expiration date reported 08-JAN-2022 and Lot T010650 with expiration date reported 26-MAR-2022 (dose, strength, frequency, route of administration and anatomical location were not provided) for prophylaxis, which was improperly stored (product storage error). The temperature of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RVAXPRO) was stored had been above was 46F (49.6F) for 2 hours 21 minutes for lot T000890 and was 46F (56.1F) for 3 hours 33 minutes for Lot T010650. No additional adverse effect was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2112USA000033: US-009507513-2112USA000050: US-009507513-2112USA000051.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided. On 13-OCT-2021 the patient was vaccinated with a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-RVAXPRO) however reporter was unsure about which lot number administered to patient (Lot T000890 with expiration date reported 08-JAN-2022 and Lot T010650 with expiration date reported 26-MAR-2022 (dose, strength, frequency, route of administration and anatomical location were not provided) for prophylaxis, which was improperly stored (product storage error). The temperature of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RVAXPRO) was stored had been above was 46F (49.6F) for 2 hours 21 minutes for lot T000890 and was 46F (56.1F) for 3 hours 33 minutes for Lot T010650. No additional adverse effect was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2112USA000049: US-009507513-2112USA000033: US-009507513-2112USA000051.