chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Well, I was experiencing pain with the first one and everything. But though that was still tolerable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (Lot number: EW0173) at the age of 41 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: PAIN (non-serious) with onset May2021, outcome "unknown", described as "Well, I was experiencing pain with the first one and everything. But though that was still tolerable". Therapeutic measures were not taken as a result of pain.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Experiencing flu-like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient.   A female patient in her 50's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Experiencing flu-like symptoms".   Additional information: Description of Event: Female patient in mid-50s reported experiencing flu-like symptoms following second dose of COVID 19 vaccine. Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cognitive disorder, Dyspnoea, Exercise tolerance decreased, Fatigue
Clinical narrative: extreme physical and mental fatigue; malaise (feels like 24 hr flu 7 days a week for moths); shortness of breath; headache; cognitive disfunction; light source sensitivity; body on high alert; continuous anxiety; panic attacks; exercise intolerant; malaise (feels like 24 hr flu 7 days a week for moths); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 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: FATIGUE (non-serious), outcome "unknown", described as "extreme physical and mental fatigue"; MALAISE (non-serious), INFLUENZA (non-serious), outcome "unknown" and all described as "malaise (feels like 24 hr flu 7 days a week for moths)"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; HEADACHE (non-serious), outcome "unknown", described as "headache"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "cognitive disfunction"; PHOTOPHOBIA (non-serious), outcome "unknown", described as "light source sensitivity"; HYPERVIGILANCE (non-serious), outcome "unknown", described as "body on high alert"; ANXIETY (non-serious), outcome "unknown", described as "continuous anxiety"; PANIC ATTACK (non-serious), outcome "unknown", described as "panic attacks"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "exercise intolerant".  Additional information:Follow-up (01Nov2021): The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 01Nov2021, this case now contains all required information to be considered valid.Exercise intolerant - Minor execise results in crash and Tsunami.My life is horrible! Understand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypervigilance, Influenza, Malaise, Panic attack
Clinical narrative: extreme physical and mental fatigue; malaise (feels like 24 hr flu 7 days a week for moths); shortness of breath; headache; cognitive disfunction; light source sensitivity; body on high alert; continuous anxiety; panic attacks; exercise intolerant; malaise (feels like 24 hr flu 7 days a week for moths); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 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: FATIGUE (non-serious), outcome "unknown", described as "extreme physical and mental fatigue"; MALAISE (non-serious), INFLUENZA (non-serious), outcome "unknown" and all described as "malaise (feels like 24 hr flu 7 days a week for moths)"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; HEADACHE (non-serious), outcome "unknown", described as "headache"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "cognitive disfunction"; PHOTOPHOBIA (non-serious), outcome "unknown", described as "light source sensitivity"; HYPERVIGILANCE (non-serious), outcome "unknown", described as "body on high alert"; ANXIETY (non-serious), outcome "unknown", described as "continuous anxiety"; PANIC ATTACK (non-serious), outcome "unknown", described as "panic attacks"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "exercise intolerant".  Additional information:Follow-up (01Nov2021): The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 01Nov2021, this case now contains all required information to be considered valid.Exercise intolerant - Minor execise results in crash and Tsunami.My life is horrible! Understand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: extreme physical and mental fatigue; malaise (feels like 24 hr flu 7 days a week for moths); shortness of breath; headache; cognitive disfunction; light source sensitivity; body on high alert; continuous anxiety; panic attacks; exercise intolerant; malaise (feels like 24 hr flu 7 days a week for moths); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 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: FATIGUE (non-serious), outcome "unknown", described as "extreme physical and mental fatigue"; MALAISE (non-serious), INFLUENZA (non-serious), outcome "unknown" and all described as "malaise (feels like 24 hr flu 7 days a week for moths)"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; HEADACHE (non-serious), outcome "unknown", described as "headache"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "cognitive disfunction"; PHOTOPHOBIA (non-serious), outcome "unknown", described as "light source sensitivity"; HYPERVIGILANCE (non-serious), outcome "unknown", described as "body on high alert"; ANXIETY (non-serious), outcome "unknown", described as "continuous anxiety"; PANIC ATTACK (non-serious), outcome "unknown", described as "panic attacks"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "exercise intolerant".  Additional information:Follow-up (01Nov2021): The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 01Nov2021, this case now contains all required information to be considered valid.Exercise intolerant - Minor execise results in crash and Tsunami.My life is horrible! Understand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Loss of personal independence in daily activities
Clinical narrative: some confusion affecting life activities; some confusion affecting life activities; Having fatigue considerably; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Apr2021 11:00 (Lot number: ER8729) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep Apnea" (ongoing), notes: Pertinent details : N/A; "Schizophrenia" (ongoing), notes: Pertinent details : N/A; "High Blood Pressure" (ongoing); "Mental illness" (ongoing). Concomitant medication(s) included: CLOZARIL taken for tension (ongoing); LAMICTAL taken for tension (ongoing); KLONOPIN taken for tension (ongoing); DILTIAZEM taken for hypertension (ongoing). The following information was reported: CONFUSIONAL STATE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 2021, outcome "unknown" and all described as "some confusion affecting life activities"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Having fatigue considerably".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC20
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "sick".  Additional information: This PREVNAR 20 shot has no benefits for the patient because it made him sick (patient age: 68, unit unspecified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Malaise, Vomiting, Weight
Clinical narrative: vomited; felt bad; Diarrhea episode; has bee up and down few pounds; feeling sick; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (041488).  A 57 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2nd), when the patient was 57 years old, for Covid-19 immunization. The following information was reported: VOMITING (non-serious), outcome "not recovered", described as "vomited"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt bad"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea episode"; WEIGHT ABNORMAL (non-serious), outcome "unknown", described as "has bee up and down few pounds"; MALAISE (non-serious), outcome "unknown", described as "feeling sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Weight abnormal
Clinical narrative: vomited; felt bad; Diarrhea episode; has bee up and down few pounds; feeling sick; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (041488).  A 57 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2nd), when the patient was 57 years old, for Covid-19 immunization. The following information was reported: VOMITING (non-serious), outcome "not recovered", described as "vomited"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt bad"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea episode"; WEIGHT ABNORMAL (non-serious), outcome "unknown", described as "has bee up and down few pounds"; MALAISE (non-serious), outcome "unknown", described as "feeling sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Aug2021 13:30 (Lot number: EW0177) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: he already had COVID before. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Aug2021, outcome "unknown", described as "First dose: sore arm".  Additional Information: Description of complaint: The caller confirms he is a Pfizer Employee calling on behalf of himself. The caller mentions he tried to do it on the website but it wouldn't take. He is calling in regards to the COVID-19 vaccine. He clarifies that he had the vaccine on 15 or 16th of last month. He is still experiencing inflammation in his joints, he is very sore and he has a hard time moving without pain. The caller states everything has subsided except for his hips and legs. He is taking a pretty significant amount of anti-inflammatories every day which may last a day but the next it come back. He clarifies the pain comes and goes, but it comes more than it goes. It's hard to walk. He clarifies it's uncomfortable to walk. He has been thinking maybe it would go away as he is taking anti-inflammatories. He has been to the chiropractor, massage therapist trying to work it out but the the pain is just sticking with him.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Muscle spasms, Nausea, SARS-CoV-2 test
Clinical narrative: Headaches; nausea; muscle cramps; Date of start of drug: 09Feb2021, dose number: 01/09Feb2021, dose number: 02; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 09Feb2021, for COVID-19 immunisation, reaction(s): "headache", "nausea", "muscle cramps". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "Date of start of drug: 09Feb2021, dose number: 01/09Feb2021, dose number: 02"; HEADACHE (non-serious) with onset 01Jul2021, outcome "not recovered", described as "Headaches"; NAUSEA (non-serious) with onset 01Jul2021, outcome "not recovered", described as "nausea"; MUSCLE SPASMS (non-serious) with onset 01Jul2021, outcome "not recovered", described as "muscle cramps". The events "headaches", "nausea" and "muscle cramps" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, nausea, muscle spasms. Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination was Lisinopril 2.5mg, Hydrochlorothiazide 25 mg. Treatment received for the adverse events was doppler ultrasound and Zofran medication. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient had been tested for COVID-19. Hospitalization Prolonged: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: Headaches; nausea; muscle cramps; Date of start of drug: 09Feb2021, dose number: 01/09Feb2021, dose number: 02; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 09Feb2021, for COVID-19 immunisation, reaction(s): "headache", "nausea", "muscle cramps". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "Date of start of drug: 09Feb2021, dose number: 01/09Feb2021, dose number: 02"; HEADACHE (non-serious) with onset 01Jul2021, outcome "not recovered", described as "Headaches"; NAUSEA (non-serious) with onset 01Jul2021, outcome "not recovered", described as "nausea"; MUSCLE SPASMS (non-serious) with onset 01Jul2021, outcome "not recovered", described as "muscle cramps". The events "headaches", "nausea" and "muscle cramps" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, nausea, muscle spasms. Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination was Lisinopril 2.5mg, Hydrochlorothiazide 25 mg. Treatment received for the adverse events was doppler ultrasound and Zofran medication. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient had been tested for COVID-19. Hospitalization Prolonged: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Fatigue, Vaccination site pain
Clinical narrative: extreme fatigue; burning at injection site; sore feeling like bruise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 19:00 (Lot number: FF8839) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "back injuries", start date: 27Feb1995 (ongoing), notes: No surgical procedure; "endometriosis", start date: 1984 (ongoing), notes: Diagnostic laparoscopies; "internal adhesions", start date: 1998 (ongoing), notes: Diagnostic laparoscopies. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "burning at injection site"; CONTUSION (non-serious), outcome "unknown", described as "sore feeling like bruise". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that just reporting side effects from the Covid-19 vaccine. The patient reported that symptoms are extreme fatigue and moderate fever. Patient was (O-NEGATIVE) blood type our temperature runs lower at (96.1-96.4) and fever was standing at 99.4. O Negative blood attacks certain viruses, vaccines, etc. causing extreme fatigue. Patient stated that many O-neg people do not have a tendency report symptom. 1st vaccine side effects were awful. Patient had extreme fatigue for 2 days after injection, upon injection there was burning at injection site and the expected sore feeling like a bruise. Patient was not sure if the side effects with the 1st vaccine are due to blood type, O negative. Relevant Test: None. Prior vaccination: None.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Laboratory test
Clinical narrative: Joint pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  An elderly 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: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". The patient underwent the following laboratory tests and procedures: laboratory test: labs are normal. Additional information:The caller is a Nurse Practitioner and reports several cases where patients come in with joint pain after receiving the Pfizer Covid 19 Vaccine. The caller has an elderly patient that came in 6 months after receiving the Pfizer Covid 19 Vaccine with joint pain. The elderly patient's labs are normal and the caller can't correlate anything else. The patient has concerns that the joint pain is because of the Pfizer Covid 19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Pain in extremity, Pruritus, Rash
Clinical narrative: shingles; States that it started with a rash; My arm started Itching; lower upper arm started hurting; blisters; 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 79-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Oct2021 11:00 (Lot number: FH8020) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMBIEN taken for sleep disorder (ongoing); SYNTHROID taken for thyroid disorder (ongoing); DILTIAZEM taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Time: 2 PM, Anatomical Site of injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EL3362), administration date: 20Jan2021, for covid-19 immunization; Bnt162b2 (Time: 11 AM, Anatomical Site of injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 10Feb2021, for Covid-19 immunization; Flu shot. The following information was reported: HERPES ZOSTER (non-serious), outcome "not recovered", described as "shingles"; RASH (non-serious), outcome "unknown", described as "States that it started with a rash"; PRURITUS (non-serious) with onset Oct2021, outcome "unknown", described as "My arm started Itching"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "lower upper arm started hurting"; BLISTER (non-serious) with onset Oct2021, outcome "unknown", described as "blisters". The events "shingles" and "states that it started with a rash" were evaluated at the physician office visit. Therapeutic measures were taken as a result of herpes zoster, pruritus, pain in extremity, blister.  Additional information: Caller states that she had the Covid 19 shots, and she did fine with those, then she got the booster and now she has shingles, and she knows that it's related because there is no reason in the world that she would get shingles one week after getting the booster. States that it started with a rash. Got the 7-day prescription for antiviral medicine and gabapentin. Shingles: so, a month later no blisters occasional itching and continual pain taking Tylenol. Still having side effects from shingles.    No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: having a really bad swelling under the right armpit; 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 53 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 31Oct2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: SWELLING (non-serious) with onset 31Oct2021, outcome "recovering", described as "having a really bad swelling under the right armpit".  Additional information: Caller wanted to know if anyone else has reported having a really bad swelling under the armpit. Caller stated she has gotten this after receiving the 2nd dose of Comirnaty. Area under arm pit swelled up, like a third breast, after second vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: Fh8027) at the age of 66 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: VACCINATION SITE RASH (non-serious) with onset 14Nov2021, outcome "recovering", described as "rash at site of injection". Therapeutic measures were not taken as a result of vaccination site rash. Additional information:  The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Chills, Fatigue, Headache
Clinical narrative: really bad chills; really ill; weak; tired; body aches; headaches; She was in bed for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EW0171) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: 2016 (ongoing); "Chronic kidney disease", start date: 2014 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot: EP7533, Expiry: Unknown, Right arm, first time she received the shot in Apr2021 she broke out in hives and itched and went to urgent care and they gave her Benadryl.), administration date: 01Apr2021, when the patient was 53 years old, for Covid-19 immunization, reaction(s): "she broke out in hives", "itched". The following information was reported: CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "really bad chills"; ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "really ill"; ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "weak"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "tired"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "headaches"; BEDRIDDEN (non-serious) with onset Apr2021, outcome "unknown", described as "She was in bed for 2 days".  Additional information: No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She said that she had the second dose on a Thursday and came home from work early on Friday and stayed in bed on Saturday and Sunday.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: really bad chills; really ill; weak; tired; body aches; headaches; She was in bed for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EW0171) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: 2016 (ongoing); "Chronic kidney disease", start date: 2014 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot: EP7533, Expiry: Unknown, Right arm, first time she received the shot in Apr2021 she broke out in hives and itched and went to urgent care and they gave her Benadryl.), administration date: 01Apr2021, when the patient was 53 years old, for Covid-19 immunization, reaction(s): "she broke out in hives", "itched". The following information was reported: CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "really bad chills"; ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "really ill"; ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "weak"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "tired"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "headaches"; BEDRIDDEN (non-serious) with onset Apr2021, outcome "unknown", described as "She was in bed for 2 days".  Additional information: No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She said that she had the second dose on a Thursday and came home from work early on Friday and stayed in bed on Saturday and Sunday.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast scan, Investigation, Mammogram, SARS-CoV-2 test
Clinical narrative: breast pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12May2021 16:30 (Lot number: ER8729) as dose 1, single and administered in arm right, administration date 02Jun2021 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination:Yes" (unspecified if ongoing); "known_allergies:gastrointestinal sensitivity to eggs" (unspecified if ongoing); "known_allergies:avacados" (unspecified if ongoing); "known allergies:broccoli" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BREAST PAIN (non-serious) with onset 24May2021, outcome "recovered with sequelae" (2021), described as "breast pain". The event "breast pain" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast pain. Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. Reported Event: Approximately 12 days after my first shot on 12May2021, I began to have severe breast pain. This lasted a couple weeks. I got my second shot on 2Jun2021 and approximately 2 weeks later I experienced breast pain again. This lasted for several weeks. I decided I needed my Healthcare provider's input. She wanted me to come in to be seen. After a clinical breast exam where she could not feel any lumps, she wanted me to have a diagnostic mammogram and breast ultrasound. These Dx tests did not show any indication of breast cancer. The radiologist did not have any answers as to why I had breast pain.  No follow-up attempts are possible. No further information is expected.  Follow up (01Dec2021): New information received from a contactable consumer in response to Non-HCP letter via telephonic follow-up activity that includes to obtain other HCP mailing address and occupation, updated information and additional information.   Follow-Up (06Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Blood testosterone, Dyspepsia, SARS-CoV-2 test
Clinical narrative: Heartburn; Severe bloating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 12:00 (Lot number: ER2613) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE taken for blood testosterone decreased. The following information was reported: DYSPEPSIA (non-serious) with onset 23Feb2021 12:00, outcome "not recovered", described as "Heartburn"; ABDOMINAL DISTENSION (non-serious) with onset 23Feb2021 12:00, outcome "not recovered", described as "Severe bloating". The events "heartburn" and "severe bloating" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dyspepsia, abdominal distension.  Additional information: No known allergies. Other medications in two week included Testosterone. No other vaccine in four weeks. No covid prior vaccination. Patient covid tested post vaccination (Nasal Swab). Received BNT162B2, administered in arm left, administration date 16Mar2021 12:00 (Lot number: ER9262) at the age of 43-year as dose 2, single for covid-19 immunisation. Facility type vaccine was Workplace clinic.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depressed mood, Erythema, Inflammation, Lymphadenopathy
Clinical narrative: Swollen lymph nodes/entire armpit swollen, also on the arm; Reddening or of the skin below the vaccination or injection site/reddening; It was not pain just the reddening and inflamed; Reddening or of the skin below the vaccination or injection site/reddening; Chills; whole arm hurts; upset; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 (Lot number: FJ1620) at the age of 71 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "She is a heart patient" (unspecified if ongoing), notes: Verbatim: She is a heart patient. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Lot EN6205), administration date: 02Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, single, Lot ER8733), administration date: 30Mar2021, for COVID-19 Immunization, reaction(s): "TAVR Surgery, Heart Valve Replaced", "TIA"; Pneumonia, reaction(s): "it hurt". The following information was reported: INFLAMMATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "It was not pain just the reddening and inflamed"; CHILLS (non-serious) with onset 19Nov2021, outcome "recovered" (Nov2021), described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 20Nov2021, outcome "recovering", described as "Swollen lymph nodes/entire armpit swollen, also on the arm"; ERYTHEMA (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "Reddening or of the skin below the vaccination or injection site/reddening"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "whole arm hurts"; DEPRESSED MOOD (non-serious) with onset Nov2021, outcome "unknown", described as "upset". Therapeutic measures were taken as a result of inflammation, chills, lymphadenopathy, erythema, vaccination site erythema.  Additional information: Friday she had chills which she took aspirin for and it went away. She took a lot of Tylenol throughout the day.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: Swollen lymph nodes/entire armpit swollen, also on the arm; Reddening or of the skin below the vaccination or injection site/reddening; It was not pain just the reddening and inflamed; Reddening or of the skin below the vaccination or injection site/reddening; Chills; whole arm hurts; upset; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 (Lot number: FJ1620) at the age of 71 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "She is a heart patient" (unspecified if ongoing), notes: Verbatim: She is a heart patient. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Lot EN6205), administration date: 02Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, single, Lot ER8733), administration date: 30Mar2021, for COVID-19 Immunization, reaction(s): "TAVR Surgery, Heart Valve Replaced", "TIA"; Pneumonia, reaction(s): "it hurt". The following information was reported: INFLAMMATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "It was not pain just the reddening and inflamed"; CHILLS (non-serious) with onset 19Nov2021, outcome "recovered" (Nov2021), described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 20Nov2021, outcome "recovering", described as "Swollen lymph nodes/entire armpit swollen, also on the arm"; ERYTHEMA (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "Reddening or of the skin below the vaccination or injection site/reddening"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "whole arm hurts"; DEPRESSED MOOD (non-serious) with onset Nov2021, outcome "unknown", described as "upset". Therapeutic measures were taken as a result of inflammation, chills, lymphadenopathy, erythema, vaccination site erythema.  Additional information: Friday she had chills which she took aspirin for and it went away. She took a lot of Tylenol throughout the day.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Headache, Illness, Lymphadenopathy
Clinical narrative: much worse; 4 days - higher fever; bad headache; body aches; lymph node swollen for 60 days; Get so very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 16:00 (Lot number: ER8731) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "no health issues other than extreme sensitivity to medications" (unspecified if ongoing); "migraines" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, administration time: 04:00 pm, brand=Pfizer, dose lot number=EW0161, dose vaccine location=Left arm), administration date: 16Apr2021, when the patient was 64 years old, for COVID-19 immunization, reaction(s): "very sick for 3 days", "fever", "headache", "body aches", "lymph node soreness", "Get so very sick". The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "much worse"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "4 days - higher fever"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "bad headache"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "body aches"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered", described as "lymph node swollen for 60 days"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Get so very sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated got so very sick with each one, but the Booster has been so bad that I feel I'm dying, literally, and the side effects of high fever, horrendous migraines, horrible body aches go on for many days and weeks. My lymph nodes are swollen for about 2 months. Patient did not receive any other vaccines with in 4 weeks prior to vaccination. Patient did not receive any other medications with in 2 weeks of the vaccination. Prior to vaccination patient did not diagnosed with Covid-19. Patient did not test for Covid-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: much worse; 4 days - higher fever; bad headache; body aches; lymph node swollen for 60 days; Get so very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 16:00 (Lot number: ER8731) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "no health issues other than extreme sensitivity to medications" (unspecified if ongoing); "migraines" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, administration time: 04:00 pm, brand=Pfizer, dose lot number=EW0161, dose vaccine location=Left arm), administration date: 16Apr2021, when the patient was 64 years old, for COVID-19 immunization, reaction(s): "very sick for 3 days", "fever", "headache", "body aches", "lymph node soreness", "Get so very sick". The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "much worse"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "4 days - higher fever"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "bad headache"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "body aches"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered", described as "lymph node swollen for 60 days"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Get so very sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated got so very sick with each one, but the Booster has been so bad that I feel I'm dying, literally, and the side effects of high fever, horrendous migraines, horrible body aches go on for many days and weeks. My lymph nodes are swollen for about 2 months. Patient did not receive any other vaccines with in 4 weeks prior to vaccination. Patient did not receive any other medications with in 2 weeks of the vaccination. Prior to vaccination patient did not diagnosed with Covid-19. Patient did not test for Covid-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.