chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Electromyogram, Lumbar puncture, Magnetic resonance imaging, Paralysis
Clinical narrative: paralyzed; ALS; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: she had an autoimmune disease. The patient's concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant) with onset Jan2021, outcome "unknown", described as "ALS"; PARALYSIS (disability, medically significant) with onset Jan2021, outcome "unknown", described as "paralyzed". Therapeutic measures were taken as a result of paralysis, amyotrophic lateral sclerosis. The clinical course was reported as follows: the patient had the Pfizer vaccine and was now paralyzed and on breathing tubes and the Doctor had no idea what was going on and diagnosed her with ALS and related to the Pfizer Covid-19 vaccines. The patient had two kids and she was suffering significant neuromuscular issues. She was a young wife and seen several Doctors across the country and had done testing. The patient first experienced issues in Jan2021. Treatment reported as follows: over the past year she had been seen by several Doctors in the country. EMG, MRI, X-rays, spinal taps etc. She first experienced drop foot in Jan2021 and weakness in right leg and weakness in the left leg and confined to a wheel chair and unable to walk. Now she was experiencing weakness in her core, hands and arms and that was before and now she was paralyzed. The effects on her hands were devastating and there was no specific treatment was available and intravenous immune globulin (IVIG) treatment may be done at discretion. She was being treated at the top hospital. The patient was 39 or 40 years old and after the symptoms started post vaccine and she had an autoimmune disease that did not surface until the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: paralyzed; ALS; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: she had an autoimmune disease. The patient's concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant) with onset Jan2021, outcome "unknown", described as "ALS"; PARALYSIS (disability, medically significant) with onset Jan2021, outcome "unknown", described as "paralyzed". Therapeutic measures were taken as a result of paralysis, amyotrophic lateral sclerosis. The clinical course was reported as follows: the patient had the Pfizer vaccine and was now paralyzed and on breathing tubes and the Doctor had no idea what was going on and diagnosed her with ALS and related to the Pfizer Covid-19 vaccines. The patient had two kids and she was suffering significant neuromuscular issues. She was a young wife and seen several Doctors across the country and had done testing. The patient first experienced issues in Jan2021. Treatment reported as follows: over the past year she had been seen by several Doctors in the country. EMG, MRI, X-rays, spinal taps etc. She first experienced drop foot in Jan2021 and weakness in right leg and weakness in the left leg and confined to a wheel chair and unable to walk. Now she was experiencing weakness in her core, hands and arms and that was before and now she was paralyzed. The effects on her hands were devastating and there was no specific treatment was available and intravenous immune globulin (IVIG) treatment may be done at discretion. She was being treated at the top hospital. The patient was 39 or 40 years old and after the symptoms started post vaccine and she had an autoimmune disease that did not surface until the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: experienced that joint pain; from his very initial Pfizer Covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "experienced that joint pain; from his very initial Pfizer Covid shot".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site infection, Weight
Clinical narrative: infection on her right upper arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol (ongoing). Vaccination history included: BNT162b2 (first dose, Lot: EL9261), administration date: 10Feb2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (second dose, Lot: EN6202), administration date: 03Mar2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (third dose, Lot: 30125BA), administration date: 05Oct2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE INFECTION (non-serious) with onset Oct2022, outcome "unknown", described as "infection on her right upper arm". The event "infection on her right upper arm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site infection.  Additional information: Patient called on 14Oct2022 about the Pfizer COVID shot, the COVID vaccine, the last one. She went back to where she got the shot at a pharmacy. She was on an antibiotic since she had a reaction to it. She did not know what's in it but got a reaction to it. Patient weighed 155 at the doctor this morning. Doctor put her on antibiotics this morning for the infection. The patient clarified that the reaction was the infection on her right upper arm. She noticed where she was given the shot that it was a little red where the needle went in, that's normal, then red spot got bigger to about size of a quarter or half dollar. The mark got bigger as time went on, she did not think it was anymore bigger but could be. She started the antibiotic today, took one today. All her medications are her normal medications. She takes atorvastatin for years for cholesterol. Vaccination was given in the early afternoon before pharmacy closed for lunch, administered at the right upper arm.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Binax Result: Positive; Binax Result: Positive; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 15:15 as dose 3 (booster), single (Lot number: Gj3277) at the age of 48 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Dec2021 at 13:00 as dose 1, single (Lot number: Elo140), in right arm and on 12Jan2021 at 12:00 as dose 2 , single (Lot number: El0140), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATIVAN; CYMBALTA; LUNESTA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "not recovered" and all described as "Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow up information has been requested; Sender's Comments: Based on the available information in the case, the causal association between the events "COVID-19', 'vaccination failure' and the suspect drug BNT162B2 cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Ear swelling, Nausea, Rash
Clinical narrative: Binax Result: Positive; Binax Result: Positive; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 15:15 as dose 3 (booster), single (Lot number: Gj3277) at the age of 48 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Dec2021 at 13:00 as dose 1, single (Lot number: Elo140), in right arm and on 12Jan2021 at 12:00 as dose 2 , single (Lot number: El0140), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATIVAN; CYMBALTA; LUNESTA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "not recovered" and all described as "Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow up information has been requested; Sender's Comments: Based on the available information in the case, the causal association between the events "COVID-19', 'vaccination failure' and the suspect drug BNT162B2 cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Memory impairment, Somnolence
Clinical narrative: Feeling really bad...she has been out of it all day; she has been sleeping most of the day; she is forgetting things; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: Dec2021, for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling really bad...she has been out of it all day"; SOMNOLENCE (non-serious), outcome "unknown", described as "she has been sleeping most of the day"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "she is forgetting things". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, somnolence, memory impairment.  Additional information: Reporter stated that patient takes blood pressure medicine. The past two weeks patient did go to the doctor and they did blood work but reporter was not sure if it was last 2 week.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201236368 same reporter, product, and event, different patient;
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Dizziness, Off label use, Product use issue
Clinical narrative: woke up little dizzy and kind of been that way all day.; receive both the COVID-19 vaccine (one that is supposed to be the latest booster) and a Flu vaccine; receive both the COVID-19 vaccine (one that is supposed to be the latest booster) and a Flu vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 12Oct2022 as single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Oct2022, outcome "unknown" and all described as "receive both the COVID-19 vaccine (one that is supposed to be the latest booster) and a Flu vaccine"; DIZZINESS (non-serious) with onset 15Oct2022, outcome "unknown", described as "woke up little dizzy and kind of been that way all day.". Additional information: Patient did receive both the COVID-19 vaccine (one that was supposed to be the latest booster) and also received a Flu vaccine immunization that was on Wednesday this week, the 12th. Patient didn't really had a problem until this morning, kind of woke up little dizzy and kind of been that way all day. Patient asked can a reaction happen like 60 hours later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: having arthritic kind of joint pain in both hands, in my left arm; some other joints in my body too but eventually it went away in rest of my body; I still occasionally have kind of arthritic joint pain; I had gotten the shot in the left arm and that was the arm in the hand that the pain was the strongest; arthritic kind of joint pain in both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8730), administration date: 01Apr2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "I had the initial series of two shots, no problem"; BNT162b2 (DOSE 2, SINGLE), administration date: 22Apr2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "I had the initial series of two shots, no problem"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FD0809), administration date: 23Nov2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Apr2022, outcome "unknown", described as "arthritic kind of joint pain in both hands"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "having arthritic kind of joint pain in both hands, in my left arm"; PAIN (non-serious), outcome "not recovered", described as "some other joints in my body too but eventually it went away in rest of my body"; ARTHRALGIA (non-serious), outcome "not recovered", described as "I still occasionally have kind of arthritic joint pain"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "I had gotten the shot in the left arm and that was the arm in the hand that the pain was the strongest". Therapeutic measures were taken as a result of pain in extremity, pain in extremity, pain, arthralgia, vaccination site pain.  Additional information: It was reported that, patient started having arthritic kind of joint pain in both hands, in her left arm and then over the next couple months, The patient had a considerable joint pain, some other joints in her body too but eventually it went away in rest of her body, in her right arm, left arm but she still occasionally have kind of arthritic joint pain that she never had before. Treatment included over the counter like Ibuprofen for the arthritis thing. Prior to vaccination, the patient was not diagnosed with COVID.  Follow-up (19Oct2022): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), in left arm and on 16Mar2021 as dose 2, single (Lot number: EL3247) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19; Positive, notes: covid testwas positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received other medication in 2 weeks were Unknown. 11 days after initial infection covid test was positive again with same symptoms "bad disease".   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events  and the suspect drug  BNT162b2
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck mass, Oropharyngeal pain
Clinical narrative: I feel like nodules on the side of my neck; it's swollen glands; I have been having a sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GT2524) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed and unknown manufacturer), for COVID-19 immunization. The following information was reported: NECK MASS (non-serious), outcome "unknown", described as "I feel like nodules on the side of my neck"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "it's swollen glands"; OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "I have been having a sore throat".  Additional information: Patient received a booster shot (Clarified as Pfizer COVID-19 Booster) on Thursday and have been having a sore throat and it's not going away and felt like nodules on the side of patient's neck, like it's swollen glands. Patient asked if these were one of the things from the shot.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4:Moderna / Dose Number: 3:Pfizer / Dose Number: 2:Pfizer / Dose Number 1:Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: en9581), in left arm, on 25Feb2021 as dose 2, single (Lot number: en6203), in right arm and on 31Dec2021 as dose 3 (booster), single (Lot number: 701-021) at the age of 79 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Lot number: 59267-1000-02), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Semvistatin, start date: 05Mar2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Dose Number: 4:Moderna / Dose Number: 3:Pfizer / Dose Number: 2:Pfizer / Dose Number 1:Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had received other medication in 2weeks. Patient had not known allergies.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine; Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6198), on 19Apr2021 as dose 2, single (Lot number: EP7534), on 23Oct2021 as dose 3 (booster), single (Lot number: FA8839) and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "High Blood Pressure" (ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Oct2022, outcome "unknown" and all described as "Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2022) Positive, notes: Caller states her husband tested positive for Covid 19. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 15:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history Obesity; "SVT" (unspecified if ongoing), notes: Other medical history SVT. Concomitant medication(s) included: FOSAMAX; DILTIAZEM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 Paxlovid started on 02Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine; Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 58 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6198), on 19Apr2021 as dose 2, single (Lot number: EP7534), on 23Oct2021 as dose 3 (booster), single (Lot number: FA8839) and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (ongoing), notes: Comments: High Blood Pressure; "Overweight for her Height" (ongoing), notes: Comments: Overweight for her Height. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "unknown" and all described as "Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine". The events "tested positive for covid 19 after receiving 4 doses of the covid 19 vaccine and 1 dose of the bivalent vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: she tested positive for Covid 19 on 15Oct2022.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss". Additional information: It was reported that since getting the COVID VACCINES, she was having a lot of hair loss. She confirmed that she has had "every one of them", the Pfizer Covid 19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 71-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), on 21Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: Other medical history diabetes; "hypertension" (unspecified if ongoing), notes: Other medical history: hypertension; "CAD" (unspecified if ongoing), notes: Other medical history: CAD; "Hyperlipidemia" (unspecified if ongoing), notes: Other medical history: Hyperlipidemia. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product=COVID 19 Treatment; Negative, notes: Patient has a positive test after having a negative test; Positive, notes: Patient has a positive test after having a negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient received other medication in 2 weeks. Anti viral details product=COVID 19 Treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events "COVID-19', 'vaccination failure' and the suspect drug BNT162B2 cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for covid; Tested positive for covid; her first 2 doses were from Pfizer, her 3rd dose was Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (COMIRNATY), on 05Jan2021 as dose 1, single (Lot number: EK9231) and on 26Jan2021 as dose 2, single (Lot number: EL9261) at the age of 42 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2021 as dose 3 (booster), single (Lot number: 032F21A) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Oct2021, outcome "unknown", described as "her first 2 doses were from Pfizer, her 3rd dose was Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Oct2022, outcome "recovered" (14Oct2022) and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Oct2022) positive, notes: She had tested positive for covid with an at home test; (14Oct2022) negative, notes: she tested negative for covid on 14Oct2022 with an at home test.  Clinical course: No other conditions and allergies to patient. The patient tested positive for covid after the covid vaccine. She had tested positive for covid with an at home test, it was taken on the 05Oct2022, she tested negative for covid on 14Oct2022 with an at home test.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events "COVID-19', 'vaccination failure', 'Interchange of vaccine products' and the suspect drug BNT162B2 cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Bone crushing pain lasting 24 hours requiring opiate medication; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 at 12:00 as dose 3 (booster), single (Lot number: Ff2593) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts, mold, dust mites; "Known allergies: mold" (unspecified if ongoing), notes: Known allergies: Tree nuts, mold, dust mites; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: Tree nuts, mold, dust mites; "Known allergies: mites" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid Prior vaccination: Yes. Concomitant medication(s) included: BUPROPION; GUANFACINE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 18May2021, when the patient was 42-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27Apr2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Bone crushing pain lasting 24 hours requiring opiate medication". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Facility type vaccine: Pharmacy or drug store. No other vaccine in four weeks. Other medication in two weeks: Bupropion and guanfacine. Event treatment: Pain medication. Patient was covid tested post vaccination. Covid test post vaccination: Type post vaccination: Nasal swab, name: PCR and result: Negative.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Bone crushing pain lasting 24 hours requiring opiate medication; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 at 12:00 as dose 3 (booster), single (Lot number: Ff2593) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts, mold, dust mites; "Known allergies: mold" (unspecified if ongoing), notes: Known allergies: Tree nuts, mold, dust mites; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: Tree nuts, mold, dust mites; "Known allergies: mites" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid Prior vaccination: Yes. Concomitant medication(s) included: BUPROPION; GUANFACINE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 18May2021, when the patient was 42-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27Apr2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Bone crushing pain lasting 24 hours requiring opiate medication". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Facility type vaccine: Pharmacy or drug store. No other vaccine in four weeks. Other medication in two weeks: Bupropion and guanfacine. Event treatment: Pain medication. Patient was covid tested post vaccination. Covid test post vaccination: Type post vaccination: Nasal swab, name: PCR and result: Negative.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 09Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). Concomitant medication(s) (received in 2 weeks) included: LOSARTAN, start date: Sep2016; METOPROLOL, start date: Sep2008; PANTOPRAZOLE, start date: Sep2006; ROSUVASTATIN, start date: Nov2019; CHLORPHENIRAMINE [CHLORPHENAMINE], start date: Feb1982. Past drug history included: Metranidazole, reaction(s): "Known allergies: Metronidazole". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; negative, notes: after having tested negative for 7 days. Therapeutic measures were taken as a result of vaccination failure, covid-19. She received Paxloid for COVID 19 treatment on 01Oct2022 and stopped on 06Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Mobility decreased
Clinical narrative: Weakness; Dizziness; could hardly get up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 12Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Oct2022, outcome "unknown"; ASTHENIA (non-serious) with onset Oct2022, outcome "unknown", described as "Weakness"; MOBILITY DECREASED (non-serious) with onset Oct2022, outcome "unknown", described as "could hardly get up".  Additional information: The patient was just concerned that they had side effects, weakness and dizziness. About three days, patient had the shot on Wednesday (12Oct2022) and when patient woke up in morning (unspecified date), patient could hardly get up. Patient never had that before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fine motor skill dysfunction, Lipoma, Magnetic resonance imaging, Mass, Muscular weakness
Clinical narrative: I was diagnosed with a lipoma, and I have to have it removed.; I ended up getting a small lump right after the shot. It stayed there for a year and a half and then started growing; I started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm; I started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: prior vaccination. There were no concomitant medications. The following information was reported: MASS (non-serious) with onset 11Mar2021, outcome "not recovered", described as "I ended up getting a small lump right after the shot. It stayed there for a year and a half and then started growing"; FINE MOTOR SKILL DYSFUNCTION (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 11Mar2021, outcome "not recovered" and all described as "I started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm"; LIPOMA (medically significant) with onset 11Mar2021, outcome "not recovered", described as "I was diagnosed with a lipoma, and I have to have it removed.". The events "i was diagnosed with a lipoma, and i have to have it removed.", "i ended up getting a small lump right after the shot. it stayed there for a year and a half and then started growing" and "i started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Unknown results, notes: post vaccination. Other. Therapeutic measures were taken as a result of lipoma, mass, fine motor skill dysfunction, muscular weakness with MRI and surgery. Clinical course: The patient did not received other vaccine in four weeks. Patient ended up getting a small lump right after the shot. It stayed there for a year and a half and then started growing. She started losing the dexterity of her hand, and some of the use of her right arm and her strength in her right arm. She was diagnosed with a lipoma, and she had to have it removed. The patient was tested for covid post vaccination. The patient did not have any known allergy.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: I was diagnosed with a lipoma, and I have to have it removed.; I ended up getting a small lump right after the shot. It stayed there for a year and a half and then started growing; I started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm; I started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: prior vaccination. There were no concomitant medications. The following information was reported: MASS (non-serious) with onset 11Mar2021, outcome "not recovered", described as "I ended up getting a small lump right after the shot. It stayed there for a year and a half and then started growing"; FINE MOTOR SKILL DYSFUNCTION (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 11Mar2021, outcome "not recovered" and all described as "I started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm"; LIPOMA (medically significant) with onset 11Mar2021, outcome "not recovered", described as "I was diagnosed with a lipoma, and I have to have it removed.". The events "i was diagnosed with a lipoma, and i have to have it removed.", "i ended up getting a small lump right after the shot. it stayed there for a year and a half and then started growing" and "i started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Unknown results, notes: post vaccination. Other. Therapeutic measures were taken as a result of lipoma, mass, fine motor skill dysfunction, muscular weakness with MRI and surgery. Clinical course: The patient did not received other vaccine in four weeks. Patient ended up getting a small lump right after the shot. It stayed there for a year and a half and then started growing. She started losing the dexterity of her hand, and some of the use of her right arm and her strength in her right arm. She was diagnosed with a lipoma, and she had to have it removed. The patient was tested for covid post vaccination. The patient did not have any known allergy.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "unknown" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: COVID test type post vaccination: Nasal swab. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Imodium and Ibuprofen.  Clinical Course: The patient did not received other vaccine within four weeks. Patient tested for covid post vaccination.  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 available information in the case, the causal association between the events "COVID-19', 'drug ineffective' and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech - Dose Number: 4 ... Moderna - Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jul2022 as dose 4 (booster), single (Lot number: FN2908) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Mar2021 as dose 1, single (Lot number: 030A21A), on 03Mar2021 as dose 2, single (Lot number: 019B21A) and on 09Nov2021 as dose 3 (booster), single (Lot number: 071F21) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies : Steroids" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; SIMVASTATIN; HYDROCHLOROTHIAZIDE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Jul2022, outcome "unknown", described as "Pfizer / BioNTech - Dose Number: 4 ... Moderna - Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 06Oct2022 to 10Oct2022 as covid-19 treatment. Other medication in 2 weeks included losartan potassium, simvastatin and hydrochlorothiazide.