chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rash, Rash erythematous, Scab, Ulcer
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 (Lot number: FG3527) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot: EN5318, Site: right arm), administration date: 02Feb2021, when the patient was 74 years old, for COVID-19 immunization; Bnt162b2 (Second Dose, Lot: EN6200, Site: right arm), administration date: 01Mar2021, when the patient was 74 years old, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "Booster"; PSORIASIS (non-serious) with onset Nov2021, outcome "not recovered", described as "Body was covered from head to my feet with psoriasis and it is bad; Whole body was covered from top of my head I even got it on the bottom of my feet"; FEELING ABNORMAL (non-serious) with onset 20Nov2021, outcome "unknown", described as "Have been through hell and back since the 20Nov and it is caused from your stupid booster shot"; EMOTIONAL DISTRESS (non-serious) with onset Nov2021, outcome "unknown", described as "Pain and suffering"; NAIL DISORDER (non-serious) with onset Nov2021, outcome "unknown", described as "I got my booster shot on the 18Nov and 2 days later I noticed these 'things' on my finger nails"; RASH (non-serious) with onset Nov2021, outcome "not recovered", described as "she got the booster vaccine and 2 days later developed an ugly rash around her fingernails of her right hand, and then progressed to her whole body from head to toe"; SCAB (non-serious), ULCER (non-serious) all with onset Nov2021, outcome "unknown" and all described as "crusty sores"; RASH ERYTHEMATOUS (non-serious) with onset Nov2021, outcome "unknown", described as "Rash as bloody". The event "she got the booster vaccine and 2 days later developed an ugly rash around her fingernails of her right hand, and then progressed to her whole body from head to toe" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. Additional information: The patient had not received any other vaccine within 4 weeks of covid-19 vaccine. After two days of booster dose, the patient developed an ugly rash around her fingernails of her right hand, and then progressed to her whole body from head to toe. The reporter described the rash as bloody, and crusty sores. The reporter stated that her doctor sent photos to the dermatologist confirmed it was psoriasis. The reporter stated that she had taken Prednisone as treatment since that Friday and that had dried up some of the rash. The reporter stated that she would see a dermatologist in Feb2022.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Tinnitus, Vision blurred
Clinical narrative: neuropathy; muscle pain; muscle weakness; brain fog; insomnia; twitching; tinnitus; blurry vision; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A female patient in her 50's received bnt162b2 (BNT162B2), administration date 31Aug2021 (Lot number: XC3182, Expiration Date: Aug2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, lot: EW0167), administration date: Aug2021, for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "neuropathy"; MYALGIA (medically significant) with onset 2021, outcome "not recovered", described as "muscle pain"; MUSCULAR WEAKNESS (medically significant) with onset 2021, outcome "not recovered", described as "muscle weakness"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "insomnia"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "twitching"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus"; VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "blurry vision".  Clinical Course included: Caller states the patient was concerned that the lot number of the 2nd dose of her Pfizer Covid vaccine was maybe expired and caller does not think it is expired because she found a report on the beyond use date. Caller states the patient got her Pfizer Covid vaccine at another pharmacy. Caller states the patient had the 1st dose of the Pfizer Covid vaccine with lot EW0167 and does not know the date of that but it was 3 weeks from her 2nd dose which was administered caller clarifies on 31Aug2021 with lot XC3182; states she has no expiry date but the patient thinks the expiry date for the 2nd dose of her vaccine is Aug2021 and it would be the last day of that month and she has no NDC numbers to provide.  Caller states for causality, she does not think the Pfizer Covid vaccine is related to the reported events and she would not say the reported events are life threatening but they are medically significant since the patient has had the reported events since Sep; states the reported events began when the patient had the 2nd dose of the Pfizer Covid Vaccine.; Sender's Comments: Based on the information in the case report, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Swollen lymph node; Dose number :3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. This is the first of two reports.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 17Dec2021 at 10:00 (Lot number: FE3594) at the age of 61 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8730,  Administration Time: 10:00, Anatomical Location: Left arm, Route of Administration: unspecified), administration date: 03Mar2021, when the patient was 61 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0162, Administration Time: 10:00, Anatomical Location: Left arm, Route of Administration: unspecified), administration date: 15Apr2021, when the patient was 61 years old, for COVID-19 immunisation, reaction: "Inappropriate schedule of vaccine administered".  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 10:00, outcome "unknown", described as "Dose number :3"; LYMPHADENOPATHY (non-serious) with onset 19Dec2021 at 08:00, outcome "recovering", described as "Swollen lymph node". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  Follow-Up (04Jan2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101862262 similar report from same reporter
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Breast injury, Fall, Immunisation, Malaise, Peripheral swelling
Clinical narrative: breast hurts a little; left arm swollen; Booster; fell; doesn't feel that good; The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting. Upon receipt of follow-up information on (20Dec2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Dec2021 11:30 (Lot number: FD7218) at the age of 71 years as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: had it for a long time, took medication and is ok, has been under control for years; "thyroid" (ongoing), notes: had this condition for over 20 years, took medication; "Little overweight" (ongoing). There were no concomitant medications. : Hasn't taken any new mediations in a long time. Vaccination history included: BNT162B2 (dose 1), administration date: 2020, for COVID-19 immunization, reaction(s): "didn't feel any reaction"; BNT162B2 (dose 2), administration date: 2020, for COVID-19 immunization, reaction(s): "didn't feel any reaction". The following information was reported: IMMUNISATION (medically significant) with onset 18Dec2021 11:30, outcome "unknown", described as "Booster"; FALL (medically significant) with onset 18Dec2021, outcome "unknown", described as "fell"; BREAST INJURY (medically significant), outcome "unknown", described as "breast hurts a little"; PERIPHERAL SWELLING (medically significant), outcome "unknown", described as "left arm swollen"; MALAISE (non-serious) with onset 18Dec2021, outcome "unknown", described as "doesn't feel that good". The patient stated that she thought she got the booster dose, however, when looking at the papers, it says to come back for a second shot, she didn't think there was a second shot for the booster. She was already given the two vaccines last year, already had the first two doses of the COVID-19 Vaccine. She went to the pharmacy at the grocery store, asked for the booster and was given a shot she already had, received it on 18Dec2021. She fell Saturday, 18Dec2021, evening when she went home and was going up the stairs, fell, hit her knee, and the breast, and shoulder, was in bed all day Saturday night and Sunday. Her left arm was now swollen, and her breast hurt a little. Had not gone to the doctor. Her left arm was swollen after the fall. She got the Pfizer COVID-19 Vaccine, came home, fell, hit her left arm, and right knee. She didn't feel that good from Saturday. Couldn't believe it. She took two of the COVID-19 Vaccines last year and didn't feel any reaction. She was given this extra dose. She asked for the booster and was given the wrong one.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chronic obstructive pulmonary disease, Disease recurrence, HIV infection, Immunisation
Clinical narrative: dose 3 (booster), single; HIV; heart condition; Chronic obstructive pulmonary disease (COPD); heart condition and Chronic obstructive pulmonary disease (COPD); visually impaired; This is a spontaneous report received from a contactable reporter (consumer) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old male patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "heart condition" and "Chronic obstructive pulmonary disease (COPD)", both unspecified if ongoing. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose and 2nd dose), for COVID-19 immunization, reactions: "HIV", "heart condition", "Chronic obstructive pulmonary disease (COPD)", "disease recurrence" and "visually impaired". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose 3 (booster), single "; HIV INFECTION (medically significant), outcome "unknown", described as "HIV"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "Chronic obstructive pulmonary disease (COPD)"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "heart condition and Chronic obstructive pulmonary disease (COPD)"; and VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "visually impaired". The patient mentioned that he has a heart condition and Chronic obstructive pulmonary disease (COPD) now. He already had his first and second dose of the vaccine and already had his Booster Shot. He was asking if he can get an antibody test to assess the effectiveness of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) booster dose 4 months after vaccination and if there are currently any ongoing investigation for a 4th dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) for people that are immunocompromised.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101837932 same reporter/patient/vaccine, similar events and different dose
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: dose 3 (booster), single; HIV; heart condition; Chronic obstructive pulmonary disease (COPD); heart condition and Chronic obstructive pulmonary disease (COPD); visually impaired; This is a spontaneous report received from a contactable reporter (consumer) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old male patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "heart condition" and "Chronic obstructive pulmonary disease (COPD)", both unspecified if ongoing. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose and 2nd dose), for COVID-19 immunization, reactions: "HIV", "heart condition", "Chronic obstructive pulmonary disease (COPD)", "disease recurrence" and "visually impaired". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose 3 (booster), single "; HIV INFECTION (medically significant), outcome "unknown", described as "HIV"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "Chronic obstructive pulmonary disease (COPD)"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "heart condition and Chronic obstructive pulmonary disease (COPD)"; and VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "visually impaired". The patient mentioned that he has a heart condition and Chronic obstructive pulmonary disease (COPD) now. He already had his first and second dose of the vaccine and already had his Booster Shot. He was asking if he can get an antibody test to assess the effectiveness of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) booster dose 4 months after vaccination and if there are currently any ongoing investigation for a 4th dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) for people that are immunocompromised.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101837932 same reporter/patient/vaccine, similar events and different dose
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Paraesthesia, Rash
Clinical narrative: pins and needles sensation of tingling in her hands and feet; allergic reaction/rash on arm that went up to her chest and face; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 26Apr2021 (Lot number: EW0164, Expiration Date: Aug2021) at the age of 22 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st single dose; Lot number: ER8732, expiration date: Jul2021), administration date: 05Apr2021, when the patient was 22 years old, for Covid-19 immunization, reaction: "didn't have anything from the first one". The following information was reported: RASH (medically significant) with onset 26Apr2021, outcome "recovered", described as "allergic reaction/rash on arm that went up to her chest and face"; PARAESTHESIA (medically significant) with onset 27Apr2021, outcome "unknown", described as "pins and needles sensation of tingling in her hands and feet". The events "allergic reaction/rash on arm that went up to her chest and face" and "pins and needles sensation of tingling in her hands and feet" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: unknown results. Therapeutic measures were taken as a result of rash, paraesthesia. Clinical course: Patient had what she stated her allergist stated was likely an allergic reaction after receiving 2nd vaccination. Ten minutes after receipt of vaccine, patient had rash on arm that went up to her chest and face; this was treated with diphenhydramine hydrochloride (BENADRYL) and a steroid injection and resolved. On 27Apr2021 the patient awoke with pins and needles sensation of tingling in her hands and feet. Patient got a dose of BENADRYL in urgent care and then had a steroid injection, she didn't know what steroid it was in urgent care as well then in ER in the next day she thought they gave a dose of magnesium and did some blood work. Patient didn't have the allergic reaction to the first one, and just confused because she didn't have anything from the first one but with the second one she did and ended up in ER next day so it might be an inactive ingredient that have something to do.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Intermenstrual bleeding
Clinical narrative: Started spotting during it even though it wasn't during my cycle. The same thing happened after each vaccine dose and is happening again after the booster.; Dose received 3; 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 left, administration date 16Dec2021 08:30 (Lot number: FH8028) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "had covid", start date: Jan2021 (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: KARIVA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW1076, Location of injection: Arm Left), administration date: 03May2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Spotting menstrual"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW1062, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Spotting menstrual". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 08:30, outcome "unknown", described as "Dose received 3"; INTERMENSTRUAL BLEEDING (non-serious) with onset 17Dec2021, outcome "recovering", described as "Started spotting during it even though it wasn't during my cycle. The same thing happened after each vaccine dose and is happening again after the booster.". Therapeutic measures were not taken as a result of intermenstrual bleeding. Additional information: The patient did not receive any other vaccine within 4 weeks.  The patient was on tricycle birth control so, she only get her period once every three months. The patient had covid in Jan2021 and started spotting during it even though it wasn't during my cycle. The same thing happened after each vaccine dose and happened again after the booster. The patient informed the reason why she was reporting this was because when she contacted her gynecologist the last time it happened, they felt it was a coincidence and put her through lots of expensive tests and visits, all of which resulted in no answers. The patient wanted to report it so others can be aware before they make the same mistake as the patient did.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea exertional, Electroencephalogram, Heart rate
Clinical narrative: AFib occurred again; Dyspnea on exertion in my work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (115193). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (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), administration date: Mar2021, for Covid-19 immunization, reaction(s): "AFib", "Palpitations". The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "unknown", described as "AFib occurred again"; DYSPNOEA EXERTIONAL (non-serious) with onset 2021, outcome "unknown", described as "Dyspnea on exertion in my work". The patient underwent the following laboratory tests and procedures: electroencephalogram: (2021) atrial fibrillation; heart rate: (2021) elevated. Therapeutic measures were taken as a result of atrial fibrillation with metoprolol to manage elevated resting heart rate.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Respiratory tract infection
Clinical narrative: Heart surgery and repeat respiratory infection; Heart surgery and repeat respiratory infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: CARDIAC DISORDER (non-serious), RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown" and all described as "Heart surgery and repeat respiratory infection". Therapeutic measures were taken as a result of cardiac disorder. Additional information: Reporter states a patient had heart surgery and a repeat respiratory infection after getting both doses of the Pfizer Covid vaccine, patient is scheduled for booster tomorrow, caller would like to know if it is okay for the patient to take the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Eye movement disorder
Clinical narrative: Experiencing eye rolling; Head movements to the right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 17:00 (Lot number: Fk5618) at the age of 10 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing), notes: Other medical history: Autism. The patient did not have any other known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient did not have COVID-19 prior to vaccination. The following information was reported: EYE MOVEMENT DISORDER (medically significant) with onset 29Nov2021 14:00, outcome "not recovered", described as "Experiencing eye rolling"; DYSKINESIA (medically significant) with onset 29Nov2021 14:00, outcome "not recovered", described as "Head movements to the right". The events "experiencing eye rolling" and "head movements to the right" were evaluated at the physician office visit. Therapeutic measures were taken as a result of eye movement disorder, dyskinesia with unspecified medication. The patient was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Limb discomfort, Malaise, Vaccination site lymphadenopathy
Clinical narrative: booster shot; baseball sized lymph node swell under his arm at the side of the injection in left arm; could not put his arm down; felt ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 (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 (Dose Number: 2, Batch/Lot No: Unknown, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown, unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster shot"; VACCINATION SITE LYMPHADENOPATHY (non-serious) with onset 16Dec2021, outcome "recovering", described as "baseball sized lymph node swell under his arm at the side of the injection in left arm"; LIMB DISCOMFORT (non-serious) with onset 16Dec2021, outcome "recovering", described as "could not put his arm down"; MALAISE (non-serious) with onset 16Dec2021, outcome "recovering", described as "felt ill". Therapeutic measures were not taken as a result of vaccination site lymphadenopathy, limb discomfort, malaise.  Additional Information: The patient did not receive other vaccine in four weeks. The patient had not COVID prior vaccination and COVID tested post vaccination.  The reporter stated that the reporter was talking to daughter on Sunday, 19Dec2021, and she told that she and her husband got the booster shot on Thursday and experienced a close to a baseball sized lymph node swell under his arm at the side of the injection in left arm. He could not put his arm down. The reporter asked if he saw a doctor and he said he had not. As spoke to her the swelling had gone down to about the size of a golf ball. She got it too and they both felt ill also.  She felt that since his swelling was going down he would not go to the doctors.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Humerus fracture, Pain, Road traffic accident, Wrist fracture
Clinical narrative: Car accident; Broke left wrist; Humerus bone; Achiness; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4200465-00.  A 57 year-old patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 57 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ROAD TRAFFIC ACCIDENT (medically significant), outcome "recovering", described as "Car accident"; WRIST FRACTURE (medically significant), outcome "recovering", described as "Broke left wrist"; HUMERUS FRACTURE (medically significant), outcome "recovering", described as "Humerus bone"; PAIN (non-serious), outcome "recovered", described as "Achiness". The action taken for adalimumab was unknown.  Causality for Humira : The reporter's causality for the event(s) of broke left wrist and humerus bone unknown onset, broke left wrist and humerus bone unknown onset, achiness for day due to vaccination and car accident with humira(adalimumab) was no reasonable possibility. opinion is that there is no reasonable possibility that the events of broke left wrist and humerus bone unknown onset, broke left wrist and humerus bone unknown onset, achiness for day due to vaccination and car accident are related to humira(adalimumab).  Causality for BNT162B2: The reporter's assessment of the causal relationship of the events with the BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events wrist fracture, humerus fracture, pain and road traffic accident cannot be excluded, However co-suspect humira, is the confounding factor for causality assessment that seems to be more likely explanation for causing the events.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Immunisation
Clinical narrative: Booster for Covid vaccine; Arm was sore to the touch; dizziness; fatigue; chills; headache; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 72 year-old 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 (Dose 1 , 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), outcome "unknown", described as "Booster for Covid vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore to the touch"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PYREXIA (non-serious), outcome "unknown", described as "fever".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Booster for Covid vaccine; Arm was sore to the touch; dizziness; fatigue; chills; headache; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 72 year-old 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 (Dose 1 , 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), outcome "unknown", described as "Booster for Covid vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore to the touch"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PYREXIA (non-serious), outcome "unknown", described as "fever".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Immunisation
Clinical narrative: A soft mass under left armpit approximately 5 inches in diameter; dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 17:00 (Lot number: FL3197) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LYRICA; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; ALLEGRA; ADDERALL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLELot number: EP6955 Anatomical location: Arm Left Vaccine Administration Time: 09:15), administration date: 27Feb2021, when the patient was 53 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLELot number: EP6955 Anatomical location: Arm Left Vaccine Administration Time: 09:15), administration date: 17Apr2021, when the patient was 53 years old, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 17:00, outcome "unknown", described as "dose number=3"; AXILLARY MASS (non-serious) with onset 18Dec2021 09:00, outcome "not recovered", described as "A soft mass under left armpit approximately 5 inches in diameter". Therapeutic measures were not taken as a result of axillary mass.  Additional information: Soft mass was noticed on morning of December 18th (approximately 38 hours after injection). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Immunisation
Clinical narrative: booster shot; it took a substantial amount of effort to walk from the bedroom to the kitchen; chills; extreme exhaustion/it took a substantial amount of effort to walk from the bedroom to the kitchen; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 59 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 1, single), administration date: 24Mar2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "chills", "extreme exhaustion", "it took a substantial amount of effort to walk from the bedroom to the kitchen"; Bnt162b2 (Dose 2, single), administration date: 2021, for COVID-19 Immunization, reaction(s): "chills", "extreme exhaustion", "it took a substantial amount of effort to walk from the bedroom to the kitchen". The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "booster shot"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "it took a substantial amount of effort to walk from the bedroom to the kitchen"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "extreme exhaustion/it took a substantial amount of effort to walk from the bedroom to the kitchen".  Additional information: The patient reported that she had experienced "extreme exhaustion" for about a week after each shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: tiredness; headache; fever; nausea; chills; Pain at injection site; Booster; This is a spontaneous report received from a 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 15Dec2021 13:30 (Lot number: FH8027) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PANTOPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 13:30, outcome "not recovered", described as "Booster"; FATIGUE (non-serious) with onset 16Dec2021, outcome "recovered" (20Dec2021), described as "tiredness"; HEADACHE (non-serious) with onset 16Dec2021, outcome "recovered" (20Dec2021), described as "headache"; PYREXIA (non-serious) with onset 16Dec2021, outcome "recovered" (20Dec2021), described as "fever"; NAUSEA (non-serious) with onset 16Dec2021, outcome "recovered" (20Dec2021), described as "nausea"; CHILLS (non-serious) with onset 16Dec2021, outcome "recovered" (20Dec2021), described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 15Dec2021 18:00, outcome "recovered" (20Dec2021), described as "Pain at injection site". Therapeutic measures were not taken as a result of immunisation, fatigue, headache, pyrexia, nausea, chills, vaccination site pain.  Additional information: Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient not tested for COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: tiredness; headache; fever; nausea; chills; Pain at injection site; Booster; This is a spontaneous report received from a 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 15Dec2021 13:30 (Lot number: FH8027) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PANTOPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 13:30, outcome "not recovered", described as "Booster"; FATIGUE (non-serious) with onset 16Dec2021, outcome "recovered" (20Dec2021), described as "tiredness"; HEADACHE (non-serious) with onset 16Dec2021, outcome "recovered" (20Dec2021), described as "headache"; PYREXIA (non-serious) with onset 16Dec2021, outcome "recovered" (20Dec2021), described as "fever"; NAUSEA (non-serious) with onset 16Dec2021, outcome "recovered" (20Dec2021), described as "nausea"; CHILLS (non-serious) with onset 16Dec2021, outcome "recovered" (20Dec2021), described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 15Dec2021 18:00, outcome "recovered" (20Dec2021), described as "Pain at injection site". Therapeutic measures were not taken as a result of immunisation, fatigue, headache, pyrexia, nausea, chills, vaccination site pain.  Additional information: Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient not tested for COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Positive Covid test; Positive Covid test; Congestion; Exposure last Tuesday to someone that tested positive Thursday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single and (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 DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome unknown; EXPOSURE TO SARS-COV-2 (non-serious) with onset 15Dec2021, outcome unknown; NASAL CONGESTION (non-serious) with onset 19Dec2021, outcome unknown. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation
Clinical narrative: I had sharp shooting pains intermittently in my joints; dose_number = 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 12:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ankle had been sprained" (unspecified if ongoing); "knee had had surgery" (unspecified if ongoing); "prior injuries/ One injury was recent" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: 19Mar2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: 09Apr2021, for Covid-19 Immunization, reaction(s): "With the booster shot generally my side effects were similar and slightly milder than the 2nd shot". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 12:30, outcome "unknown", described as "dose_number = 3"; ARTHRALGIA (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "I had sharp shooting pains intermittently in my joints". Therapeutic measures were not taken as a result of arthralgia.  Additional information: With the booster shot generally her side effects were similar and slightly milder than the 2nd shot. Except there was a new side effect. The patient had sharp shooting pains intermittently in her joints but only joints that had prior injuries (ankle had been sprained, knee had had surgery) but not the other joints. One injury was recent while the other was 7 years old. The patient had not received any vaccine within four weeks. The patient was not tested since vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Pulmonary embolisms in both lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 12:00 (Lot number: FJ1620) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Diagnosed prior to vaccination; "Allergies" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent vaccine was administered in a doctor's office or urgent care facility. The following information was reported: PULMONARY EMBOLISM (caused and prolonged hospitalization, medically significant, life threatening) with onset 06Dec2021 15:00, outcome "recovered with sequelae" (Dec2021), described as "Pulmonary embolisms in both lungs". The patient was hospitalized and prolonged hospitalization for pulmonary embolism (start date: Dec2021, discharge date: Dec2021, hospitalization duration: 2 day(s)). The event "pulmonary embolisms in both lungs" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Dec2021) negative. Therapeutic measures were taken as a result of pulmonary embolism which included blood thinners. Since the vaccination, the patient has been tested for COVID-19 (nasal swab) that was negative on 07Dec2021.  Follow-up (22Dec2021): Follow-up attempts are completed. No further information is expected.