chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: diagnosed with hypothyroidism; joints in the patient's right shoulder started to be painful / excruciating joint pain in his right shoulder, elbow, wrist; pain in thumb, hand, fingers; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [12Dec2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date 02Nov2021 (Lot number: FF2593) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: HYPOTHYROIDISM (disability, medically significant) with onset 10Dec2021, outcome "not recovered", described as "diagnosed with hypothyroidism"; ARTHRALGIA (non-serious) with onset 04Nov2021, outcome "not recovered", described as "joints in the patient's right shoulder started to be painful / excruciating joint pain in his right shoulder, elbow, wrist"; PAIN IN EXTREMITY (non-serious) with onset 04Nov2021, outcome "not recovered", described as "pain in thumb, hand, fingers". The events "diagnosed with hypothyroidism", "joints in the patient's right shoulder started to be painful / excruciating joint pain in his right shoulder, elbow, wrist" and "pain in thumb, hand, fingers" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (Nov2021) normal; (10Dec2021) diagnosed with hypothyroidism, notes: full panel; thyroid function test: (12Oct2021) positive; x-ray: (Nov2021) normal. Therapeutic measures were taken as a result of hypothyroidism, arthralgia, pain in extremity. Clinical course: 2 days after getting the Covid vaccine (on 04Nov2021), the joints in the patient's right shoulder started to be painful. At the time of report, patient continued to have excruciating joint pain in his right shoulder, elbow, thumb, hand, wrist, and fingers. Patient had an X-ray done as well as blood work, and those results have come back as normal. The doctor put him on Celecoxib 200MG & Prednisone 10MG. These medications have not helped him much. No Covid test post vaccination. Seriousness of 'excruciating joint pain in his right shoulder, elbow, thumb, hand, wrist, and fingers' from reporter was non-serious (Results in death: No, Life threatening: No, Caused/prolonged hospitalization: No, Disabling/Incapacitating: No, Congenital anomaly/birth defect: No). Patient was diagnosed with hypothyroidism on 10Dec2021 after doing full panel blood work. Thyroid medication was prescribed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report received from a 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 right, administration date 13Oct2021 15:00 (Lot number: EW0217) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometriosis", start date: 2018 (unspecified if ongoing), notes: Verbatim: Endometriosis since 2018; "COVID-19" (unspecified if ongoing), notes: Verbatim: If Covid prior vaccination: Yes. Concomitant medication(s) included: PROBIOTIC GUMMIES; FISH OIL. Past drug history included: Ceclor, reaction(s): "Rash", notes: Verbatim: Ceclor- when I was a baby I got a rash. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset 29Oct2021, outcome "recovered" (2021), described as "UTI".  Additional information: Prior to vaccination, the patient was diagnosed with covid-19 and post vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccine in four weeks. Concomitant medications (also reported as other medications in two weeks) noted as womens multi-vitamin. It was reported that patient got UTI (urinary tract infection) 16 days after the first dose of the vaccine and it took 23 days to go away also patient was concerned that was from the vaccine. Device timestamp noted as 21Nov2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Heart rate, Heart rate increased, Immunisation, Interchange of vaccine products
Clinical narrative: fast heartbeat; asthma attack; Full body is aching; I had booster shot of Pfizer, and first two shots were of Moderna; first and second shot/Moderna; first and second shot/Moderna; 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 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Nov2021 (Lot number: FH8027) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (First dose), for COVID-19 immunization; Moderna (Second dose), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 2021, outcome "unknown" and all described as "first and second shot/Moderna"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "I had booster shot of Pfizer, and first two shots were of Moderna"; HEART RATE INCREASED (non-serious) with onset 18Nov2021, outcome "not recovered", described as "fast heartbeat"; ASTHMA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "asthma attack"; PAIN (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Full body is aching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased, asthma, pain.  Additional information: For Taking the pain relief medicines (Unspecified medications) but after every two hour like I get relief for only two hour and again after two hours I experience all the same symptoms: Unspecified  QR Comment: Reporter type could not be probed over the call as the consumer was unwilling to share any further information, hence captured by default as consumer or other non-health professional in tab. Since majority of the information was provided by the consumer itself, so 'is patient also the reporter?' checked as yes in tab.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Pain
Clinical narrative: fast heartbeat; asthma attack; Full body is aching; I had booster shot of Pfizer, and first two shots were of Moderna; first and second shot/Moderna; first and second shot/Moderna; 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 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Nov2021 (Lot number: FH8027) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (First dose), for COVID-19 immunization; Moderna (Second dose), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 2021, outcome "unknown" and all described as "first and second shot/Moderna"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "I had booster shot of Pfizer, and first two shots were of Moderna"; HEART RATE INCREASED (non-serious) with onset 18Nov2021, outcome "not recovered", described as "fast heartbeat"; ASTHMA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "asthma attack"; PAIN (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Full body is aching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased, asthma, pain.  Additional information: For Taking the pain relief medicines (Unspecified medications) but after every two hour like I get relief for only two hour and again after two hours I experience all the same symptoms: Unspecified  QR Comment: Reporter type could not be probed over the call as the consumer was unwilling to share any further information, hence captured by default as consumer or other non-health professional in tab. Since majority of the information was provided by the consumer itself, so 'is patient also the reporter?' checked as yes in tab.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Anxiety, Asthenia, Cardiac failure congestive, Dizziness, Dyspnoea
Clinical narrative: He also has congestive heart failure/couldn't lay down; has been in a bad funk since he got the shot; He is very concerned; emphysema; made me feel woozy; feel weak; The initial case was missing the following minimum criteria: No product. Upon receipt of follow-up information on 30Nov2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191). The reporter is the patient.   A 74 year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), administration date 2021 (Lot number: EE3120, Expiration Date: 31May2022) as dose 1, single for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The consumer stated he had a lot of concomitant medication. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant) with onset 2021, outcome "unknown", described as "He also has congestive heart failure"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "has been in a bad funk since he got the shot"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "He is very concerned"; EMPHYSEMA (non-serious) with onset 2021, outcome "unknown", described as "emphysema"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "made me feel woozy"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "feel weak". All events stated about 2 weeks ago in 2021 (based on 30Nov2021). His breathing and patient had a bad heart, he had congestive heart failure (CHF) and he also had emphysema, so whenever he had his breathing impaired it catches his attention by the quickly, it also made he feel weak. Last night patient went to sleep sitting upon on his sofa because he couldn't lay down, it just made he feel woozy, since he first got the vaccine 2 weeks ago. No investigation assessment.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Emphysema, Feeling abnormal, Sleep disorder
Clinical narrative: He also has congestive heart failure/couldn't lay down; has been in a bad funk since he got the shot; He is very concerned; emphysema; made me feel woozy; feel weak; The initial case was missing the following minimum criteria: No product. Upon receipt of follow-up information on 30Nov2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191). The reporter is the patient.   A 74 year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), administration date 2021 (Lot number: EE3120, Expiration Date: 31May2022) as dose 1, single for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The consumer stated he had a lot of concomitant medication. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant) with onset 2021, outcome "unknown", described as "He also has congestive heart failure"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "has been in a bad funk since he got the shot"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "He is very concerned"; EMPHYSEMA (non-serious) with onset 2021, outcome "unknown", described as "emphysema"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "made me feel woozy"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "feel weak". All events stated about 2 weeks ago in 2021 (based on 30Nov2021). His breathing and patient had a bad heart, he had congestive heart failure (CHF) and he also had emphysema, so whenever he had his breathing impaired it catches his attention by the quickly, it also made he feel weak. Last night patient went to sleep sitting upon on his sofa because he couldn't lay down, it just made he feel woozy, since he first got the vaccine 2 weeks ago. No investigation assessment.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Off label use, Pain in extremity, Product use issue, Pruritus, Vaccination site mass
Clinical narrative: plum sized, hot, hard lump on my left arm where I got the shot; plum sized, hot, hard lump on my left arm where I got the shot; It is sore if I touch it or move a certain way.; I am a little worried that this is infected, because it's starting to itch a little.; off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:30 (Lot number: FE3590) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), administered in arm right, administration date 18Nov2021 (Batch/Lot number: unknown) as 0.5ml for immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "edema in ankles" (unspecified if ongoing); "Known allergy: Latex bandaids itch" (unspecified if ongoing), notes: Latex bandaids itch; "Known allergy: Fake gold and silver" (unspecified if ongoing), notes: Fake gold and silver. Concomitant medication(s) included: ESTRADIOL; PROGESTERONE; IRON; PRILOSEC [OMEPRAZOLE]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Right), administration date: 10Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Right), administration date: 13Mar2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE MASS (non-serious) all with onset 22Nov2021, outcome "not recovered" and all described as "plum sized, hot, hard lump on my left arm where I got the shot"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021, outcome "not recovered", described as "It is sore if I touch it or move a certain way."; PRURITUS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "I am a little worried that this is infected, because it's starting to itch a little."; OFF LABEL USE (non-serious) with onset 18Nov2021, outcome "unknown", described as "off label use"; PRODUCT USE ISSUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "Product use for unapproved combination". Therapeutic measures were not taken as a result of vaccination site warmth, vaccination site mass, pain in extremity, pruritus.  Additional information: With the two previous shots, she did not have these symptoms and was a little worried that this was infected. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine facility type was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Vaccination site warmth
Clinical narrative: plum sized, hot, hard lump on my left arm where I got the shot; plum sized, hot, hard lump on my left arm where I got the shot; It is sore if I touch it or move a certain way.; I am a little worried that this is infected, because it's starting to itch a little.; off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:30 (Lot number: FE3590) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), administered in arm right, administration date 18Nov2021 (Batch/Lot number: unknown) as 0.5ml for immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "edema in ankles" (unspecified if ongoing); "Known allergy: Latex bandaids itch" (unspecified if ongoing), notes: Latex bandaids itch; "Known allergy: Fake gold and silver" (unspecified if ongoing), notes: Fake gold and silver. Concomitant medication(s) included: ESTRADIOL; PROGESTERONE; IRON; PRILOSEC [OMEPRAZOLE]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Right), administration date: 10Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Right), administration date: 13Mar2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE MASS (non-serious) all with onset 22Nov2021, outcome "not recovered" and all described as "plum sized, hot, hard lump on my left arm where I got the shot"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021, outcome "not recovered", described as "It is sore if I touch it or move a certain way."; PRURITUS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "I am a little worried that this is infected, because it's starting to itch a little."; OFF LABEL USE (non-serious) with onset 18Nov2021, outcome "unknown", described as "off label use"; PRODUCT USE ISSUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "Product use for unapproved combination". Therapeutic measures were not taken as a result of vaccination site warmth, vaccination site mass, pain in extremity, pruritus.  Additional information: With the two previous shots, she did not have these symptoms and was a little worried that this was infected. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine facility type was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Immunisation, Influenza like illness, Interchange of vaccine products
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 16:00 (Lot number: 331268D) at the age of 54 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. Past drug history included: Codeine, reaction(s): "Allergy". Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 010m21a, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 18Mar2021, when the patient was 54 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 031L20A, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 11Feb2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), OFF LABEL USE (non-serious) all with onset 24Nov2021 16:00, outcome "not recovered" and all described as "Moderna 1st&2nd dose, Pfizer booster dose"; IMMUNISATION (non-serious) with onset 24Nov2021 16:00, outcome "not recovered", described as "booster"; HERPES ZOSTER (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "Shingles"; SKIN LESION (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "lesions appeared on abdomen"; HEADACHE (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "headache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "flu like achiness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of interchange of vaccine products, immunization, off label use, herpes zoster, skin lesion, headache, influenza like illness. Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test, Skin lesion
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 16:00 (Lot number: 331268D) at the age of 54 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. Past drug history included: Codeine, reaction(s): "Allergy". Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 010m21a, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 18Mar2021, when the patient was 54 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 031L20A, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 11Feb2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), OFF LABEL USE (non-serious) all with onset 24Nov2021 16:00, outcome "not recovered" and all described as "Moderna 1st&2nd dose, Pfizer booster dose"; IMMUNISATION (non-serious) with onset 24Nov2021 16:00, outcome "not recovered", described as "booster"; HERPES ZOSTER (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "Shingles"; SKIN LESION (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "lesions appeared on abdomen"; HEADACHE (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "headache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "flu like achiness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of interchange of vaccine products, immunization, off label use, herpes zoster, skin lesion, headache, influenza like illness. Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Breast enlargement, Breast pain, Breast tenderness, Inappropriate schedule of product administration, Lymphoedema
Clinical narrative: Dose 1: 02Mar2020 14:00/ dose 2: 02Apr2021 14:00; lymphdemia; enlarged chest/breast with burning and sensitivity; enlarged chest/breast with burning and sensitivity; enlarged chest/breast with burning and sensitivity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 14:00 (Lot number: Ep7533) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: En6207, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 02Mar2020, when the patient was 34 years old, for COVID-19 Immunization. The following information was reported: LYMPHOEDEMA (non-serious) with onset 2021, outcome "recovering", described as "lymphdemia"; BREAST PAIN (non-serious), BREAST ENLARGEMENT (non-serious), BREAST TENDERNESS (non-serious) all with onset 2021, outcome "recovering" and all described as "enlarged chest/breast with burning and sensitivity"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Apr2021 14:00, outcome "recovering", described as "Dose 1: 02Mar2020 14:00/ dose 2: 02Apr2021 14:00". The events "lymphdemia", "enlarged chest/breast with burning and sensitivity", "enlarged chest/breast with burning and sensitivity" and "enlarged chest/breast with burning and sensitivity" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of lymphoedema, breast pain, breast enlargement, breast tenderness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Adverse event required a visit to doctor or other healthcare professional office/clinic visit and Emergency Room/ department or urgent care. The patient also reported that after 3rd shot, via an unspecified route of administration in Arm left on 23Nov2021 at 10:00 AM, experienced lymphdemia, and enlarged chest/breast with burning and sensitivity on 26Nov2021 08:45 PM.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Headache, Immunisation, Myalgia
Clinical narrative: Fever (104.2F); muscles and bone ache; muscles and bone ache; headache; soreness left arm; Dose number= 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 00:45 (Lot number: FH8471) at the age of 62 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Nickel" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; VITAMIN D3; ATORVASTATIN; MAGNESIUM. Past drug history included: Nitrofurantoin, reaction(s): "Known allergies: Nitrofurantoin"; Formalin, reaction(s): "Known allergies: Formalin"; Cobalt sulfate, reaction(s): "Known allergies: Cobalt sulfate". Vaccination history included: Bnt162b2 (Dose Number: 2, lot number: EP6955, administrated route: Intramuscular, vaccine location: Left arm), administration date: 25Mar2021, when the patient was 61 years old, for covid 19 immunization; Bnt162b2 (Dose Number: 1, lot number: EL3247, administrated route: Intramuscular, vaccine location: Left arm), administration date: 04Mar2021, when the patient was 61 years old, for covid 19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 00:45, outcome "unknown", described as "Dose number= 3"; PYREXIA (non-serious) with onset 29Nov2021 20:00, outcome "not recovered", described as "Fever (104.2F)"; MYALGIA (non-serious), BONE PAIN (non-serious) all with onset 29Nov2021 20:00, outcome "not recovered" and all described as "muscles and bone ache"; HEADACHE (non-serious) with onset 29Nov2021 20:00, outcome "not recovered", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 29Nov2021 20:00, outcome "not recovered", described as "soreness left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, myalgia, bone pain, headache, pain in extremity.  Additional information: Patient did not receive other vaccines within four weeks of the COVID vaccine. Patient did not have COVID prior to vaccination. Patient was not COVID tested post vaccination. Patient had a fever of 104.2  Fahrenheit on 29Nov2021.  No follow-up attempts are possible. No further information is expected.  Follow-up (03Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever (104.2F); muscles and bone ache; muscles and bone ache; headache; soreness left arm; Dose number= 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 00:45 (Lot number: FH8471) at the age of 62 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Nickel" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; VITAMIN D3; ATORVASTATIN; MAGNESIUM. Past drug history included: Nitrofurantoin, reaction(s): "Known allergies: Nitrofurantoin"; Formalin, reaction(s): "Known allergies: Formalin"; Cobalt sulfate, reaction(s): "Known allergies: Cobalt sulfate". Vaccination history included: Bnt162b2 (Dose Number: 2, lot number: EP6955, administrated route: Intramuscular, vaccine location: Left arm), administration date: 25Mar2021, when the patient was 61 years old, for covid 19 immunization; Bnt162b2 (Dose Number: 1, lot number: EL3247, administrated route: Intramuscular, vaccine location: Left arm), administration date: 04Mar2021, when the patient was 61 years old, for covid 19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 00:45, outcome "unknown", described as "Dose number= 3"; PYREXIA (non-serious) with onset 29Nov2021 20:00, outcome "not recovered", described as "Fever (104.2F)"; MYALGIA (non-serious), BONE PAIN (non-serious) all with onset 29Nov2021 20:00, outcome "not recovered" and all described as "muscles and bone ache"; HEADACHE (non-serious) with onset 29Nov2021 20:00, outcome "not recovered", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 29Nov2021 20:00, outcome "not recovered", described as "soreness left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, myalgia, bone pain, headache, pain in extremity.  Additional information: Patient did not receive other vaccines within four weeks of the COVID vaccine. Patient did not have COVID prior to vaccination. Patient was not COVID tested post vaccination. Patient had a fever of 104.2  Fahrenheit on 29Nov2021.  No follow-up attempts are possible. No further information is expected.  Follow-up (03Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Immunisation, Insomnia, Intervertebral disc protrusion
Clinical narrative: My Lumbar spine (right L-2 and L-3) has bulging disk and (left L-4, L5, and S1) problems, as well.; I could not walk, stand, nor sleep.; I could not walk, stand, nor sleep.; I could not walk, stand, nor sleep.; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Oct2021 16:00 (Lot number: FH8020) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm, administration date 15Oct2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "degenerative disc - discectomy in 2018" (unspecified if ongoing); "degenerative disc - discectomy in 2018", start date: 2018 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asprin, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Mar2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 01Apr2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: On 23Oct2021 12:00, her Lumbar spine (right L-2 and L-3) has bulging disk and (left L-4, L5, and S1) problems, as well. She could not walk, stand, nor sleep. The patient was Hospitalized for the events (hospitalization duration: 7 days) (Hospitalized for 2 weeks was also reported, pending clarify). The events were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of events included Steroid injections into all L discs involved. Outcome of events was Recovered with Sequel.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: My Lumbar spine (right L-2 and L-3) has bulging disk and (left L-4, L5, and S1) problems, as well.; I could not walk, stand, nor sleep.; I could not walk, stand, nor sleep.; I could not walk, stand, nor sleep.; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Oct2021 16:00 (Lot number: FH8020) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm, administration date 15Oct2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "degenerative disc - discectomy in 2018" (unspecified if ongoing); "degenerative disc - discectomy in 2018", start date: 2018 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asprin, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Mar2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 01Apr2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: On 23Oct2021 12:00, her Lumbar spine (right L-2 and L-3) has bulging disk and (left L-4, L5, and S1) problems, as well. She could not walk, stand, nor sleep. The patient was Hospitalized for the events (hospitalization duration: 7 days) (Hospitalized for 2 weeks was also reported, pending clarify). The events were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of events included Steroid injections into all L discs involved. Outcome of events was Recovered with Sequel.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Confusional state, Ear discomfort, Ear pain, Feeling abnormal
Clinical narrative: feels like she's dying or going to commit suicide; confused; panic attacks; feels like she's dying or going to commit suicide; too much inflammation; ringing in the right ear/tinnitus symptoms/back noise, whistling sound; pressure in the ear; pain / pain in her temple/some pain in her ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Sep2021 06:30 (Lot number: 30145BA) at the age of 58 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: Patient mentioned she received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 30Sep2021. Second dose was scheduled for 21Oct2021 and confirmed she has not yet received the second dose. On the 2nd week after the shot (in Oct2021), she experienced "ringing in the right ear", "pressure in the ear", "back noise, whistling sound". Went for a consult and the doctor said could be tinnitus, was prescribed 2 corticosteroids (did not specify which medication). After 2 whole months of using the steroid, still have the "noise, whistling, and some pain in her ear ". Doctor also stated that there is "too much inflammation", such that they can't use the measuring device. She additionally reported being confused, having panic attacks, and feels like she's dying or going to commit suicide. She verified she has been given 2 unspecified corticosteroids, having taken unspecified steroids for 2 months. Tinnitus symptoms: Further described as including ringing in her ear; noise; some whistling; some pain in her ear and temple; pressure in her ear; inflammation; thinks the pressure in her ear is probably giving her the noise symptom. She went to see her Medical Doctor/Family Doctor for the pain in her temple. She also had consult with the Ear, Nose and Throat Doctor; and Specialist: Doctor of Audiology. The Doctor of Audiology performed test to measure the pressure in her ear with a device caller thinks; and also gave her a hearing test-she had no further details on testing details or results. Doctor of Audiology told patient she believes the symptoms could be tinnitus. The outcome of tinnitus, confused, panic attacks was not recovered, outcome of other events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Investigation, Panic attack, Suicidal ideation, Tinnitus
Clinical narrative: feels like she's dying or going to commit suicide; confused; panic attacks; feels like she's dying or going to commit suicide; too much inflammation; ringing in the right ear/tinnitus symptoms/back noise, whistling sound; pressure in the ear; pain / pain in her temple/some pain in her ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Sep2021 06:30 (Lot number: 30145BA) at the age of 58 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: Patient mentioned she received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 30Sep2021. Second dose was scheduled for 21Oct2021 and confirmed she has not yet received the second dose. On the 2nd week after the shot (in Oct2021), she experienced "ringing in the right ear", "pressure in the ear", "back noise, whistling sound". Went for a consult and the doctor said could be tinnitus, was prescribed 2 corticosteroids (did not specify which medication). After 2 whole months of using the steroid, still have the "noise, whistling, and some pain in her ear ". Doctor also stated that there is "too much inflammation", such that they can't use the measuring device. She additionally reported being confused, having panic attacks, and feels like she's dying or going to commit suicide. She verified she has been given 2 unspecified corticosteroids, having taken unspecified steroids for 2 months. Tinnitus symptoms: Further described as including ringing in her ear; noise; some whistling; some pain in her ear and temple; pressure in her ear; inflammation; thinks the pressure in her ear is probably giving her the noise symptom. She went to see her Medical Doctor/Family Doctor for the pain in her temple. She also had consult with the Ear, Nose and Throat Doctor; and Specialist: Doctor of Audiology. The Doctor of Audiology performed test to measure the pressure in her ear with a device caller thinks; and also gave her a hearing test-she had no further details on testing details or results. Doctor of Audiology told patient she believes the symptoms could be tinnitus. The outcome of tinnitus, confused, panic attacks was not recovered, outcome of other events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: lost a wife and farm from the shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (COMIRNATY) (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: death (death), outcome "fatal", described as "lost a wife and farm from the shot". The reporter was reporting on the shot. When asked the product he is calling about he says the Comirnaty shot though he doesn't know why we say that and why he chose that option because it isn't called that. He lost a wife (patient) and farm from the shot. The patient date of death was unknown. The reported cause of death was "lost a wife and farm from the shot". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: lost a wife and farm from the shot
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Insomnia, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: She had tested positive for Covid; She had tested positive for Covid; in her 3rde trimester of pregnancy; Debilitating insomnia; 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 37 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 13Aug2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "insomnia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had tested positive for Covid"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "in her 3rde trimester of pregnancy"; INSOMNIA (non-serious), outcome "unknown", described as "Debilitating insomnia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug interaction, Feeling jittery, Heart rate, Heart rate increased
Clinical narrative: Drug Interaction; tested positive for Covid-19/Received 1st adult Pfizer Covid-19 Vaccine on 19Nov2021 and tested positive to Covid two days later; jitters in the body/Experiencing like severe jatter in whole body; rapid heart rate/I am not cold and I have no fever, not cold with rapid heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: EW0191) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "Cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 22Nov2021, outcome "unknown", described as "tested positive for Covid-19/Received 1st adult Pfizer Covid-19 Vaccine on 19Nov2021 and tested positive to Covid two days later"; DRUG INTERACTION (non-serious), outcome "unknown", described as "Drug Interaction"; FEELING JITTERY (non-serious) with onset Nov2021, outcome "unknown", described as "jitters in the body/Experiencing like severe jatter in whole body"; HEART RATE INCREASED (non-serious) with onset Nov2021, outcome "unknown", described as "rapid heart rate/I am not cold and I have no fever, not cold with rapid heart rate". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) rapid heart rate; (Nov2021) increased; sars-cov-2 test: (22Nov2021) positive, notes: she tested positive to Covid on 22Nov2021. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient took her first dose of the Pfizer BioNTech Covid-19 vaccine and two days later patient tested positive for Covid-19. Patient states on 24Nov2021 she received an infusion of two products being bamlanivimab and etesevimab for treatment. After the infusion, patient experience severe jitters in the whole body and a rapid heart rate. Patient stated that she was not cold and she had no fever, not cold with rapid heart rate. Patient also takes cholesterol medication (atorvastatin) and D-tab blocker (lisinopril). Patient would like to know if the jitter in her body and the rapid heart rate were caused by the infusion or the Covid-19 vaccine she received and if there is any drug interaction with atorvastatin, lisinopril and the Covid-19 vaccine. She also wanted to know if there be any chance that might be causing her jatter because it seems like every time, she took that and she got jatter, or possible the Infusion as well. Patient states that due to the infusion she received on 24Nov2021, she was advised to wait 90 days to receive her second dose.   No follow-up attempts are possible. No further information is expected.