chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort
Clinical narrative: discomfort on both breasts; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 10Mar2021 13:00 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medications included: AMLODIPINE and simvastatin (SIMVASTAT). Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 1, single; Batch/Lot number: unknown, vaccine location: left arm), administration date: 17Feb2021 at 01:00 PM, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: BREAST DISCOMFORT (non-serious) with onset 17Mar2021, outcome "recovering," described as "discomfort on both breasts." The event "discomfort on both breasts" was evaluated at the physician office visit. Therapeutic measures were taken as a result of breast discomfort, which included Mortin and ice was applied.  Additional information: The vaccination facility type was the workplace clinic. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not tested for covid post vaccination. The patient had no known allergies. Exactly one week after the patient received the second dosage, the patient started having discomfort on both breasts. The patient started feeling better on 24Mar2021, exactly two weeks after she got the second dosage.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Vaccination site inflammation
Clinical narrative: inflammation of her lymph nodes near the neck at the injection site; inflammation of her lymph nodes near the neck at the injection site; 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 female patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 19Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LYMPHADENITIS (non-serious), VACCINATION SITE INFLAMMATION (non-serious), outcome "unknown" and all described as "inflammation of her lymph nodes near the neck at the injection site". Therapeutic measures were taken as a result of lymphadenitis, vaccination site inflammation.  Additional information: Treatment: She took anti Inflammatory medication.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: nausea; Body pain; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558).  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 55 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: NAUSEA (non-serious), outcome "unknown", described as "nausea"; PAIN (non-serious), outcome "unknown", described as "Body pain".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Paraesthesia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: injection site swelling; chills; injection site rednes; tingling sensation in her fingers; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) for a Pfizer sponsored program Support (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "injection site swelling"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; VACCINATION SITE ERYTHEMA (non-serious) with onset Mar2021, outcome "unknown", described as "injection site rednes"; PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "tingling sensation in her fingers". Therapeutic measures were taken as a result of vaccination site swelling, chills, vaccination site erythema, paraesthesia.  Additional information: The patient had 1st shot the previous day, she experienced injection site swelling, chills, injection site redness, chills, tingling sensation in her fingers. Also took Tylenol and her hand was coloured orange.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Insomnia
Clinical narrative: asks if she can get the vaccine even though she feels weak and can't fall asleep; can't fall asleep; This is Spontaneous report from a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "asks if she can get the vaccine even though she feels weak and can't fall asleep"; INSOMNIA (non-serious), outcome "unknown", described as "can't fall asleep".  Additional information: Caller stated that she got the 1st dose on 28Mar2021 and has a 2nd dose schedule tomorrow 21Mar2021. Caller asks if she can get the vaccine even though she feels weak and can't fall asleep. Caller called in yesterday saying that she received the 1st dose a few weeks ago. She is scheduled for the 2nd dose today but is not feeling well. Yesterday rep transferred to alternate department to report AE but caller was on hold for three hours then call was disconnected. caller wants to know if she can reschedule the 2nd dose of the covid vaccine read off scheduling FAQ and offered number for PMI for more info on if it is okay to get vaccine late but caller declined and disconnected call.  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, Heart rate, Heart rate increased
Clinical narrative: headaches; fast heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program Support. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got her 1st dose and she experienced headaches and a fast heart rate for like a day or two. And the fast heart rate scared her. She's scheduled to get her 2nd dose on 5Apr2021, and she wants to know if the side effect will be the same or will there be a more intense side effect. She wants to know the severity of the side effect of the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 78-year-old female patient received BNT162B2 (BNT162B2), administration date 11Feb2021 (Lot number: EM9810) at the age of 78 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, single (Lot Number: EL3249),  Anatomical location of Administration: Arm Left, Administration Time: 01:00 PM), administration date: 21Jan2021, when the patient was 78 years old, for COVID-19 immunisation, reactions: "Flu like symptoms", "Arm pain", "the pain is going up higher and higher.", "I feel flush", "tiredness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm soreness".  Additional Information: The patient did not experience adverse events following prior vaccinations and had no relevant tests done.   No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021086786 Same reporter, patient, and product; Different dose and events.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed malaise/not feeling well, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia
Clinical narrative: still has dry mouth; metallic taste in his mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRY MOUTH (non-serious), outcome "unknown", described as "still has dry mouth"; DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste in his mouth".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: diarrhea; tiredness; leg ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a sponsored program. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cardiac ablation" (unspecified if ongoing), notes: Caller says she has had cancer in past and cardiac ablation, and additional health history.; "Cancer" (unspecified if ongoing), notes: Caller says she has had cancer in past and cardiac ablation, and additional health history. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Caller says, "2 years ago I got flu shot. as soon as I was stuck with a needle, it hurt. my whole arm started hurting down to my wrist), for Immunisation, reaction(s): "my whole arm started hurting down to my wrist".The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tiredness"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "leg ache"; DIARRHOEA (non-serious) with onset 15Mar2021, outcome "unknown", described as "diarrhea".  Additional Information: Patient Age was 66 years old. The patient had 1st dose 2 weeks ago 04March2021, then felt tiredness, leg ache for 5 days, and also diarrhoea last Monday 15Mar2021. 2nd dose is due on 26March2021 and asking if we do have an underlying condition does the 2nd shot will cause more serious side effects. Patient received 2nd dose this morning. Patient says she continues to have leg aches, "off and on". Caller says the diarrhoea after 1st dose was related to food. Patient says she has had cancer in past and cardiac ablation, and additional health history. Patient was asking if health history will cause increased side effects. Patient also asks, "since she had 2nd dose, more likely to get more severe side effects. Patient says, "2 years ago she got flu shot. as soon as she was stuck with a needle, it hurt. my whole arm started hurting down to my wrist."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Feb 24, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain in extremity/sore arms, with outcome of unknown. Additional information: The patient also already completed the second dose. She did not experience major symptoms aside from the sore arms after the first shot. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: doesn't feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "doesn't feel well". Additional information: The patient received first dose 1 week ago today. She had no reactions until today. But currently doesn't feel well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had vaccination site pain/mild soreness at the injection site after their 1st dose of Pfizer COVID-19 vaccine, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: they had mild soreness at the injection site after their 1st dose of Pfizer COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "they had mild soreness at the injection site after their 1st dose of Pfizer COVID 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: Asthenia, Pain
Clinical narrative: ache-y and had low energy after her 2nd dose of the Pfizer COVID vaccine.; ache-y and had low energy after her 2nd dose of the Pfizer COVID vaccine.; This is a spontaneous report from a Non-contactable reporter (consumer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "ache-y and had low energy after her 2nd dose of the Pfizer COVID vaccine.".  Additional information: My female friend (49) told me that she felt ache-y and had low energy after her 2nd dose of the Pfizer COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: A little injection site soreness; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The patient was reporter's friend.  A female patient in her 40's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 5 decade 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 PAIN (non-serious), outcome "unknown", described as "A little injection site soreness"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  Additional information: Reporter's female friend, mid-40s told reporter, she had a little injection site soreness and fatigue following her 1st dose of Pfizer COVID vaccine. She also told me her husband (mid-30s) experienced pain at the time of the injection of his 1st dose of the Pfizer COVID vaccine. These were all reported to me 21Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: experienced pain at the time of the injection of his 1st dose of the Pfizer COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose-1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "experienced pain at the time of the injection of his 1st dose of the Pfizer COVID vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Dec2020 07:00 (Lot number: EJ1685) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension.The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at the site of the injection"; FATIGUE (non-serious), outcome "unknown", described as "Feeling tired".No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dreamy state, Hyperventilation
Clinical narrative: shivering; breathing heavily; felt like he was still in the dream he had at that time; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via an unspecified route of administration on an unknown date (at the age of 24-years-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient woke up 3 hours after he fell asleep, shivering and breathing heavily. The patient felt like he was still in the dream he had at that time. The clinical outcome of the events was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: New event (felt like he was still in the dream he had at that time) added.
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Eye pruritus, Pruritus, Throat irritation, Wheezing
Clinical narrative: Itchy skin; Itchy ears; Itchy eyes; Itchy throat; Wheezing; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: En6201) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itchy skin, ears, eyes, throat, and wheezing. The clinical outcome of the events itchy skin, ears, eyes, throat and wheezing were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Deleted event onset dates, vaccination date, and age at vaccination details and updated vaccination facility details.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Joint dislocation, Joint lock, Musculoskeletal stiffness
Clinical narrative: Patient reports received first Pfizer covid vaccine 1Apr2021 2nd 15Apr2021; right thumb has been stiff and locking up seceral times and increased pain; right thumb has been stiff and locking up seceral times and increased pain; almost like a dislocation or tendon slipped; almost like a dislocation or tendon slipped; headaches; almost like a dislocation or tendon slipped; This is a spontaneous report from a contactable or other Health Care Professional (nurse). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Apr2021 (at the age of 43-years-old) as dose 2, single for COVID-19 immunization and received first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Apr2021 (at the age of 43-years-old) as dose 1, single for COVID-19 immunization. It was unknown that the patient was pregnant at the time of vaccination. The patient's medical history included ligament sprain from 2013 to an unknown date, migraines related to hormonal changes, diarrhoea from Feb2021 to an unknown date. The patient's concomitant medications included tofacitinib citrate (XELJANZ XR, Batch/Lot number was not reported; Expiration Date: 28Feb2023) from oral route on 19Feb2021 to an unspecified date as 11 mg daily tablet for an unspecified indication. Any medications patient was using around the time of adverse event and dates of therapy [exclude medications used to treat event] include OTC and herbals was unknown. On unspecified date patient reports received first Pfizer covid vaccine 01Apr2021 and second dose on 15Apr2021 missed doses one week before and one week after dose after resuming right thumb has been stiff and locking up several times and increased pain states almost like this location are tendon slipped. Patient stated she has had issues with six to eight years ago and had received a cortisone shot in area also reports the area first 12 weeks of starting cells and it has subsided. Patient had headache. The outcome of the events was unknown.Follow-up attempts completed. No further information is expected.Amendment: This follow-up report is being submitted to amend previously reported information: updated Xeljanz XR to concomitant medication. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021591696.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tendon injury
Clinical narrative: Patient reports received first Pfizer covid vaccine 1Apr2021 2nd 15Apr2021; right thumb has been stiff and locking up seceral times and increased pain; right thumb has been stiff and locking up seceral times and increased pain; almost like a dislocation or tendon slipped; almost like a dislocation or tendon slipped; headaches; almost like a dislocation or tendon slipped; This is a spontaneous report from a contactable or other Health Care Professional (nurse). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Apr2021 (at the age of 43-years-old) as dose 2, single for COVID-19 immunization and received first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Apr2021 (at the age of 43-years-old) as dose 1, single for COVID-19 immunization. It was unknown that the patient was pregnant at the time of vaccination. The patient's medical history included ligament sprain from 2013 to an unknown date, migraines related to hormonal changes, diarrhoea from Feb2021 to an unknown date. The patient's concomitant medications included tofacitinib citrate (XELJANZ XR, Batch/Lot number was not reported; Expiration Date: 28Feb2023) from oral route on 19Feb2021 to an unspecified date as 11 mg daily tablet for an unspecified indication. Any medications patient was using around the time of adverse event and dates of therapy [exclude medications used to treat event] include OTC and herbals was unknown. On unspecified date patient reports received first Pfizer covid vaccine 01Apr2021 and second dose on 15Apr2021 missed doses one week before and one week after dose after resuming right thumb has been stiff and locking up several times and increased pain states almost like this location are tendon slipped. Patient stated she has had issues with six to eight years ago and had received a cortisone shot in area also reports the area first 12 weeks of starting cells and it has subsided. Patient had headache. The outcome of the events was unknown.Follow-up attempts completed. No further information is expected.Amendment: This follow-up report is being submitted to amend previously reported information: updated Xeljanz XR to concomitant medication. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021591696.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Fatigue, Headache, Neutrophil count
Clinical narrative: increased fatigue; headache; body ache; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a sponsored program.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) at the age of 55 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 (Dose number: 01, Batch/lot number: Unknown), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "increased fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports low neutrophil count so md lowered Ibrance to 100 mg/daily. feeling a bit better with some energy but lethargic at times, mouth sore, headaches/migraines at times, chills with low temperature and low blood pressure on occasion, small weight gain, constipation at end of cycle, hip/arm pain. Increased fatigue/headache/body ache after covid vaccine number 2 on 28Feb2021 but much improved. Patient states md aware of cycle which has been 14 days on, 7 off since start and was not per order of 21 days on, 7 off. md aware of all symptoms. seeing md 24Mar2021 and will review. Patient began medication 08Jan2021 and was taking Ibrance 125 mg/daily for 14 days on, 7 off until dose lowered 05Mar2021 (as reported).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Weight
Clinical narrative: increased fatigue; headache; body ache; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a sponsored program.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) at the age of 55 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 (Dose number: 01, Batch/lot number: Unknown), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "increased fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports low neutrophil count so md lowered Ibrance to 100 mg/daily. feeling a bit better with some energy but lethargic at times, mouth sore, headaches/migraines at times, chills with low temperature and low blood pressure on occasion, small weight gain, constipation at end of cycle, hip/arm pain. Increased fatigue/headache/body ache after covid vaccine number 2 on 28Feb2021 but much improved. Patient states md aware of cycle which has been 14 days on, 7 off since start and was not per order of 21 days on, 7 off. md aware of all symptoms. seeing md 24Mar2021 and will review. Patient began medication 08Jan2021 and was taking Ibrance 125 mg/daily for 14 days on, 7 off until dose lowered 05Mar2021 (as reported).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Very enlarged lymph nodes in left arm pit. Swollen to almost double the size of my normal right arm pit. Very very painful; Very enlarged lymph nodes in left arm pit. Swollen to almost double the size of my normal right arm pit. Very very painful; Very enlarged lymph nodes in left arm pit. Swollen to almost double the size of my normal right arm pit. Very very painful; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 12:30 (Lot number: FT1611) at the age of 31 years as dose 3 (booster dose), single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03Mar2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6303, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 20Feb2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 12:30, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious), LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 30Dec2021 20:00, outcome "not recovered" and all described as "Very enlarged lymph nodes in left arm pit. Swollen to almost double the size of my normal right arm pit. Very very painful". Therapeutic measures were not taken as a result of lymphadenopathy, lymphadenopathy, lymph node pain.  Additional information: Patient has no COVID prior to vaccination and patient having known allergies to penicillin's.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pruritus, SARS-CoV-2 test
Clinical narrative: Dose Number:3; Persistent nonthrobbing headaches.; intense scalp itching 1 hour after vaccination x 15 minutes,; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Nov2021 (Lot number: 301558A) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose 2, Lot No: EL3248, Location of injection: Arm Left), administration date: 15Jan2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Lot No: EK9231, Location of injection: Arm Left), administration date: 24Dec2020, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Dose Number:3"; HEADACHE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Persistent nonthrobbing headaches."; PRURITUS (non-serious) with onset 30Nov2021, outcome "recovering", described as "intense scalp itching 1 hour after vaccination x 15 minutes,". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache and included treatment with ibuprofen. Additional information: Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. There were no known allergies. Facility where the most recent COVID-19 vaccine was administered was at the Hospital. The patient received atorvastatin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced intense scalp itching 1 hour after vaccination x 15 minutes, recurred after another hour x 10 minutes.
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Immunisation, Sleep disorder
Clinical narrative: got more energy than she normally had; She hasn't slept yet until now; Booster; 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 female patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "Booster"; ENERGY INCREASED (non-serious), outcome "unknown", described as "got more energy than she normally had"; SLEEP DISORDER (non-serious), outcome "unknown", described as "She hasn't slept yet until now".  Additional information: The patient reported that she took the Pfizer Booster vaccine yesterday afternoon, and that she got more energy than she normally had. She haven't slept yet until now.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Immunisation, Muscle mass, Pyrexia
Clinical narrative: swelling at the arm where the vaccine was injected; joint pain (pelvis, knee and wrist); fatigue; high fever; muscles forming a lump; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 19Nov2021 09:00 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 03Mar2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 09:00, outcome "unknown", described as "booster"; VACCINATION SITE SWELLING (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "swelling at the arm where the vaccine was injected"; ARTHRALGIA (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "joint pain (pelvis, knee and wrist)"; FATIGUE (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "fatigue"; PYREXIA (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "high fever"; MUSCLE MASS (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "muscles forming a lump". It was unknown if therapeutic measures were taken as a result of vaccination site swelling, arthralgia, fatigue, pyrexia, muscle mass.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling at the arm where the vaccine was injected; joint pain (pelvis, knee and wrist); fatigue; high fever; muscles forming a lump; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 19Nov2021 09:00 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 03Mar2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 09:00, outcome "unknown", described as "booster"; VACCINATION SITE SWELLING (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "swelling at the arm where the vaccine was injected"; ARTHRALGIA (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "joint pain (pelvis, knee and wrist)"; FATIGUE (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "fatigue"; PYREXIA (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "high fever"; MUSCLE MASS (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "muscles forming a lump". It was unknown if therapeutic measures were taken as a result of vaccination site swelling, arthralgia, fatigue, pyrexia, muscle mass.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Injection site pain, Menstrual disorder, Muscular weakness
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A female patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- Unknown, Dose 1), for COVID-19 Immunization; Covid-19 vaccine (Manufacturer- Unknown, Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Menstrual cycle is also currently 5 days late"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: to get a Pfizer booster was a little sore; to get a Pfizer booster was a little sore; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (054550).  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), PAIN (non-serious), outcome "unknown" and all described as "to get a Pfizer booster was a little sore".  Additional information: Patient stated off xeljanz for a week to get Pfizer booster was a little sore on day 3 but not bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Allergy" (ongoing); "Heterozygous Factor V Leiden " (unspecified if ongoing); "psoriatic arthritis " (unspecified if ongoing). Concomitant medication(s) included: HUMIRA taken for psoriatic arthropathy. Past drug history included: Warfarin for Heterozygous Factor V Leiden ; adalimumab (HUMIRA) for psoriatic arthritis , notes: it worked; however, had to come on and off Humira a couple times due to unspecified surgery and other issues. Vaccination history included: BNT162B2 (Dose 1), for COVID-19 immunisation, reaction(s): "developed swelling in his normal arthritic area". The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "inflammation". Therapeutic measures were taken as a result of inflammation.  Additional Information: The patient stated when he received his first Pfizer COVID vaccine, he developed swelling in his normal arthritic area. After his second shot, he developed inflammation and then the Humira stopped working. Due to this, patient saw his rheumatologist a month or so later. The rheumatologist reported that she confirmed that a lot of people were having problems with inflammation after the vaccine, even with new patients. They were doing this thing where they put you on prednisone (MANUFACTURER UNKNOWN) for a bit and start you up again. The patient tried the aforementioned regimen, but it was not effective. No co-suspect medications were reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: PRIOR TO RECEIVING THE BOOSTER VACCINE; Pain; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (054550).  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "PRIOR TO RECEIVING THE BOOSTER VACCINE"; PAIN (non-serious), outcome "unknown", described as "Pain". Therapeutic measures were taken as a result of pain.  Additional information: Pt stated she has been on leflunomide to help with pain. Pt delayed [xeljanz] dose due to md instructions prior to receiving the booster vaccine. Xeljanz start date not provided  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.