chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood pressure measurement, Echocardiogram, Heart rate
Clinical narrative: sore underarm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: EW0177) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nightmares" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing), notes: Caller states that because of that the doctor put her on the Clonazepam for anxiety in 2016. Concomitant medication(s) included: CLONAZEPAM taken for anxiety, start date: 2016 (ongoing); AMLODIPINE BESYLATE taken for blood pressure measurement (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262, Anatomical location: Left arm.), administration date: 23Jan2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "sore underarm"; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9266, Anatomical location: Left arm.), administration date: 13Feb2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "sore underarm". The following information was reported: AXILLARY PAIN (non-serious) with onset 14Oct2021, outcome "recovering", described as "sore underarm". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair is falling out; 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), on 27Mar2021 as dose 1, single (Lot number: ER8730, Expiration Date: 31Mar2021) 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). The patient took concomitant medications. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "Hair is falling out".  Additional information: The patient did not had any other conditions, investigations and other products. The patient had all of the shots and everything, even the last one she had. Since she started getting vaccines the patient had noticed her hair was falling out. She started to do research and back tracking everything and noticed it was the vaccine. The patient wanted to know if anything she can do to prevent losing all her hair. The patient always had thick hair and now all of a sudden it was extremely thin. Several months later noticed hair was falling out, like noticed it 6 to 8 months after getting the vaccine. Her drain was full of hair and never had that. Had not talked to her doctor about it yet. The patient was given a blood pressure medicine around this time by her doctor. The patient thought at first it was the blood pressure medicine. However, she stopped the medicine and her hair would continue to fall out and she realized it was not the blood pressure medicine. She confirmed she does not remember the name of the blood pressure medicine. The adverse event did not resulted in Physician Office or Emergency Room visit. The patient did not undergo any relevant lab tests. When probed for details started as, probably when she was 75 or 76. It had been going on however long she had been getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201239009 Same patient/AE/drug, different dose of vaccine;US-PFIZER INC-202201239010 Same patient/AE/drug, different dose of vaccine;US-PFIZER INC-202201236667 Same patient/AE/drug, different dose of vaccine;US-PFIZER INC-202201239008 Same patient/drug, different AE, different dose of vaccine;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration
Clinical narrative: Hair is falling out; First dose: 27Mar2021, Second dose: 13Apr2021; 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), on 13Apr2021 as dose 2, single (Lot number: EW0151, Expiration Date: 31Mar2021) 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). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: ER8730; Anatomical location: Left Arm), administration date: 27Mar2021, when the patient was 75-year-old, for COVID-19 immunization, reaction(s): "Hair is falling out". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 13Apr2021, outcome "unknown", described as "First dose: 27Mar2021, Second dose: 13Apr2021"; ALOPECIA (non-serious), outcome "not recovered", described as "Hair is falling out".  Additional information: It was reported that since the patient started getting vaccines she noticed her hair was falling out. She started to do research and back tracking everything and noticed it was the vaccine. She was calling to see if there was anything she can do to prevent losing all her hair. She always had thick hair and now all of a sudden it was extremely thin. When probed for details started as, probably when she was 75 or 76. It had been going on however long she had been getting the vaccine. She had not talked to her doctor about it yet. The exact date of event was unknown. It started several months later noticed hair was falling out, like noticed it 6-8 months after getting the vaccine. Her drain was full of hair and never had that. When probing for concomitant medications reporter added she had talked to her doctor because she was given a blood pressure medicine around this time. She thought at first it was the blood pressure medicine. However, she stopped the medicine and her hair would continue to fall out and she realized it was not the blood pressure medicine. She confirmed she did not remember the name of the blood pressure medicine. There were no relevant tests.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201238945 Same patient/drug, different AE, different dose of vaccine;
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair is falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Lot number: FB509) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot number: EW0151, Expiration Date: 31Mar2021, Anatomical location: left arm), administration date: 13Apr2021, when the patient was 75-year-old, for COVID-19 immunisation, reaction(s): "Hair is falling out"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "Hair is falling out".  Additional information: The patient did not had any other conditions. The patient has had all of the shots and everything, even the last one she had. Since she started getting vaccines the patient had noticed her hair was falling out. She started to do research and back tracking everything and noticed it was the vaccine. The patient wanted to know if anything she can do to prevent losing all her hair. The patient always had thick hair and now all of a sudden it was extremely thin. Several months later noticed hair was falling out, like noticed it 6 to 8 months after getting the vaccine. Her drain was full of hair and never had that. The patient was given a blood pressure medicine around this time by her doctor. The patient thought at first it was the blood pressure medicine. However, she stopped the medicine and her hair would continue to fall out and she realized it was not the blood pressure medicine. She confirmed she does not remember the name of the blood pressure medicine. The adverse event did not resulted in Physician Office or Emergency Room visit. The patient did not undergo any relevant lab tests.   The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "Hair is falling out".; Sender's Comments: Linked Report(s) : 202201238945 Same patient/AE/drug, different dose of vaccine;
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair is falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FV4989) at the age of 76 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: ER8730; Anatomical location: left arm), administration date: 27Mar2021, when the patient was 75-year-old, for COVID-19 immunization, reaction(s): "Hair is falling out"; BNT162b2 (DOSE 2, SINGLE; Lot number: EW0151; Exp Date: 31Mar2021; Anatomical location: left arm), administration date: 13Apr2021, when the patient was 75-year-old, for COVID-19 immunization, reaction(s): "Hair is falling out"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FB509; Anatomical location: left arm), administration date: 10Oct2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "Hair is falling out". The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "Hair is falling out".  Additional information: The patient did not had any other conditions. The patient has had all of the shots and everything, even the last one she had. Since she started getting vaccines the patient had noticed her hair was falling out. She started to do research and back tracking everything and noticed it was the vaccine. The patient wanted to know if anything she can do to prevent losing all her hair. The patient always had thick hair and now all of a sudden it was extremely thin. Several months later noticed hair was falling out, like noticed it 6 to 8 months after getting the vaccine. Her drain was full of hair and never had that. The patient was given a blood pressure medicine around this time by her doctor. The patient thought at first it was the blood pressure medicine. However, she stopped the medicine and her hair would continue to fall out and she realized it was not the blood pressure medicine. She confirmed she does not remember the name of the blood pressure medicine. The adverse event did not resulted in Physician Office or Emergency Room visit. The patient did not undergo any relevant lab tests.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, ears are ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM taken for anxiety, start date: 2021 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical location: left upper deltoid), for COVID-19 Immunization, reaction(s): "None". The following information was reported: TINNITUS (non-serious) with onset 2022, outcome "not recovered", described as "Tinnitus, ears are ringing".  Additional information: The patient did not receive any prior vaccinations within 4 weeks. The patient started Escitalopram about 1 to 1 and a half years ago, supposed to take daily but occasionally miss a day here or there. The patient got the 1st shot about 1 year ago and there was a period of time they said to wait. He does not recall what date and thought it was in beginning of this year. The patient thought that the 2nd shot was might be in Jan2022 or Feb2022. The vaccination was given probably in the afternoon. Since second Pfizer vaccine, he was having tinnitus that was constant, it does not go away. The patient had not really sought out, but this had been bothering him since his second Pfizer vaccine. The patient cannot pinpoint the exact time of tinnitus, but he had been dealing with it a few months. He thought it was weird. It was like when you are at a concert as a kid and come home from loud music and your ears are ringing and it goes away by the next morning. That was constant for him and was not going away. It was persistent. If he sits down and wanted it to be quiet. If he sits, he heard ringing and he was on edge, he needed white noise to not be anxious. The patient did not visit Emergency Room or physician Office. The patient mentioned it to his doctor in passing at a visit and he did not seem to take it too seriously; doctor said there was no cure, and he has it too. The patient did not have any relevant tests done. The patient did not get the booster, he did not want more as he felt that was when the tinnitus started.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Vaccine brand other: Moderna/ Vaccine dose number: 3; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the  patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications within 2 weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other: Moderna/ Vaccine dose number: 3"; DRUG INEFFECTIVE (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. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Oct2022 to 12Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Nausea, Vaccination site pain, Vomiting
Clinical narrative: Heart pain; nausea; vomiting; soreness around injection site; weakness overall; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Lot number: GJ2524) at the age of 22 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Is bivalent: False, lot number: EW0173, dose number: 2), for Covid-19 Immunization; Bnt162b2 (Prev dose product: COVID 19, Is bivalent: False, lot number: EW0151, dose number: 1), for Covid-19 Immunization. The following information was reported: ANGINA PECTORIS (medically significant), outcome "recovering", described as "Heart pain"; NAUSEA (non-serious), outcome "recovering"; VOMITING (non-serious), outcome "recovering"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "soreness around injection site"; ASTHENIA (non-serious), outcome "recovering", described as "weakness overall". Therapeutic measures were not taken as a result of angina pectoris, nausea, vomiting, vaccination site pain, asthenia.  Clinical course: The patient received other vaccine Regular Flu Shot (non allergy one) in four weeks. The patient did not have covid prior vaccination, was not covid tested post vaccination, Known allergies: None  No follow-up atempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: arm and hand soreness; numbness; tingling; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "arm and hand soreness"; HYPOAESTHESIA (non-serious) with onset 2022, outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious) with onset 2022, outcome "unknown", described as "tingling".  Additional information: He is particularly concerned about the numbness and tingling and is looking for guidance for this particular side effect. Is it serious? Does he need to go to the hospital immediately?   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.
Age: 72.0
Sex: M
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 a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 17Feb2021 as dose 2, single (Lot number: Em9310), in right arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 320308D), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication received in two weeks. Patient received treatment for covid-19 with Paxlovid. Patient started paxlovid on 08Oct2022 and stopped on 12Oct2022. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6207), on 13Apr2021 as dose 2, single (Lot number: ER8729), on 08Dec2021 as dose 3 (booster), single (Lot number: FJ8762) and on 13Jun2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 17Sep2021; MUCINEX, start date: 13Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 which included paxlovid from 15Oct2022 to 16Oct2022.  Clinical course: The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Slight headache; achiness to the injection arm; 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 71-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EM9810) at the age of 71 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing), notes: High blood pressure Diagnosed for 20 years; "High cholesterol" (ongoing), notes: it wasn't really high, she had a stressful job. Had high cholesterol for the last 10 years; "Arthritis" (ongoing), notes: Arthritis Diagnosed for last 5 years. It's been bothering her. Concomitant medication(s) included: LISINOPRIL taken for hypertension; SIMVASTATIN taken for blood cholesterol increased. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Slight headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "achiness to the injection arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain in extremity.  Additional information: The vaccine has been administered in hospital. The patient had slight headache. Had achiness to the injection arm, put ice on it and it was gone within an hour. The same day as of her Pfizer COVID-19 Vaccines, she took Tylenol 500mg, formulation: blue and red 250mg each capsule administered three hours after the vaccine administration. The patient did not received any prior vaccinations within 4 weeks, nor any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Just took the Flu shot on 03Oct2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240607 Same patient and drug, different event separated in time;US-PFIZER INC-202201240608 Same patient and drug, different event separated in time;US-PFIZER INC-202201240609 Same patient and drug, different event separated in time;US-PFIZER INC-202201240610 Same patient and drug, different event separated in time;
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Oral mucosal blistering, Pyrexia
Clinical narrative: Flu; Fever; blisters all around her mouth and inside her mouth.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: INFLUENZA (non-serious), outcome "unknown", described as "Flu"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; ORAL MUCOSAL BLISTERING (non-serious), outcome "unknown", described as "blisters all around her mouth and inside her mouth.".  Additional information: patient took the COVID 19 shot. Patient stated she got the flu and fever after getting the vaccine. Last sunday she got blisters all around her mouth and inside her mouth.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have previously had all of the medications by Pfizer; I was diagnosed with COVID 19; I had the two shot was the two boosters; I had the shot already; 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), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I have previously had all of the medications by Pfizer"; COVID-19 (medically significant), outcome "unknown", described as "I was diagnosed with COVID 19; I had the two shot was the two boosters; I had the shot already". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was diagnosed with COVID 19.  Clinical Course: Reported as, Patient went to the doctor Sunday and patient was diagnosed with COVID 19 and patient have previously had all of the medications by Pfizer. patient had the two shot was the two boosters (Clarified as Pfizer Covid19 vaccine).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had the usual sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "heart trouble" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Had the usual sore arm".  Additional Information: It was reported that, the patient did not have any real problems with first 2, original doses of Covid vaccine. Had a little sore arm but not bad.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240238 similar report from same reporter;US-PFIZER INC-202201240542 similar report from same reporter;
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had the usual sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "heart trouble" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (First Dose: 14Jan2021 NDC, LOT, EXP: Unknown), administration date: 14Jan2021, when the patient was 82-year-old, for COVID-19 immunization, reaction(s): "Had the usual sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Had the usual sore arm".  Additional information: With the original 2 vaccines, the injections, really had nothing more than usual. They were all Pfizer. Had the usual sore arm and nothing else. Did not have any real problems with first 2, original doses Covid vaccine. Had a little sore arm but not bad. Has got several medical conditions and is on gobs of medicine. No Family Medical History Relevant to adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240528 similar report from same reporter;US-PFIZER INC-202201240238 similar report from same reporter;
Age: 53.0
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 contactable reporter(s) (Consumer or other non HCP) from quality. The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 at 10:00 as dose 1, single (Lot number: ER8727), in right arm, on 11Apr2021 at 10:00 as dose 2, single (Lot number: EW0153), in right arm and on 04Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8020) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history Asthma; "Known allergies Penicillin" (unspecified if ongoing), notes: Known allergies Penicillin. Concomitant medication(s) included: OMEPRAZOL. 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: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid used for treatment of COVID-19. Other medication in 2 weeks reported as yes Omeprazole.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Left arm had typical pain day of 13Oct & after shot 14Oct.; Arm felt fine until 17Oct2022 when an ache in left arm from shoulder to elbow started and continues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GJ2524) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "known allergies : penicillin" (unspecified if ongoing), notes: known allergies : penicillin; "known allergies : trees" (unspecified if ongoing), notes: known allergies : trees; "known allergies : grass" (unspecified if ongoing), notes: known allergies : grass; "known allergies : molds" (unspecified if ongoing), notes: known allergies : molds; "known allergies : Weeds" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination Yes. The patient's 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; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 13Oct2022, outcome "not recovered", described as "Arm felt fine until 17Oct2022 when an ache in left arm from shoulder to elbow started and continues"; PAIN IN EXTREMITY (non-serious) with onset 13Oct2022, outcome "not recovered", described as "Left arm had typical pain day of 13Oct & after shot 14Oct.". It was unknown if therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not tested for COVID-19
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Headache, Vaccination site pain
Clinical narrative: Slight headache; achiness to the injection arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single, injection given in arm (Lot number: ER2613) at the age of 71 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: Start date asked but unknown. High blood pressure Diagnosed for 20 years; "High cholesterol" (ongoing); "Arthritis" (unspecified if ongoing), notes: Start date asked but unknown. Arthritis diagnosed for last 5 years. It's been bothering her. Concomitant medication(s) included: LISINOPRIL taken for hypertension; SIMVASTATIN taken for blood cholesterol increased. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: EM9810, EXP: Unknown, Dose and Route: Unknown dose, injection given in arm), administration date: 04Mar2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "Slight headache", "Had achiness to the injection arm".  The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Slight headache"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "achiness to the injection arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, vaccination site pain.  Clinical course: The patient had no prior vaccinations within 4 weeks. High cholesterol sort of has high cholesterol. Stated it wasn't really high, she had a stressful job. Had high cholesterol for the last 10 years. The patient had achiness to the injection arm, put ice on it and it was gone within an hour. The same day as each of her Pfizer COVID-19 Vaccines, she took Tylenol three hours after the vaccine administration. She does this with any vaccine she gets. Tylenol: Dose: 500mg just once. Formulation: blue and red 250mg each capsule, Date Administered: Same day as each of her COVID-19 Vaccines. Time of Use: 3 hours after vaccine administration. History and Investigations: Given a gel injection for her right knee after she was negative for COVID-19. It had nothing to do with COVID-19. Had a Cortisone shot to the right knee in Feb2022, before getting COVID-19. Her right knee has been giving her problems.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240143 Same patient and drug, different event separated in time;
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: achiness to the injection arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 12May2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 73 years, in arm for covid-19 immunisation; paracetamol (TYLENOL), as 500 mg, 1x/day (500mg just once ) (Batch/Lot number: unknown). The patient's relevant medical history included: "High cholesterol" (ongoing), notes: Sort of has high cholesterol. Had high cholesterol for the last 10 years; "Arthritis" (unspecified if ongoing), notes: Arthritis Diagnosed for last 5 years. It's been bothering her; "high blood pressure" (ongoing), notes: High blood pressure Diagnosed for 20 years. Concomitant medication(s) included: LISINOPRIL taken for hypertension; SIMVASTATIN taken for blood cholesterol increased. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, COVID-19 Vaccine: Dose 1, Manufacturer: Pfizer, Date: 04Mar2021, NDC: Unknown, LOT: EM9810, EXP: Unknown, Dose and Route: Unk dose, injection given in arm), administration date: 04Mar2021, for COVID-19 Immunization, reaction(s): "slight Headache"; BNT162b2 (COVID-19 Vaccine: Dose 2, Manufacturer: Pfizer, Date: 25Mar2021, NDC: Unknown, LOT: ER2613, EXP: Unknown, Dose and Route: Unknown dose, injection given in arm), administration date: 25Mar2021, for Covid-19 immunization, reaction(s): "Slight headache"; BNT162b2 (COVID-19 Vaccine: Dose 3, Manufacturer: Pfizer, Date: 05Nov2021, NDC: Unknown, LOT: FH8020, EXP: Unknown, Dose and Route: Unknown dose, injection given in arm), administration date: 05Nov2021, for Covid-19 immunization, reaction(s): "Had achiness to the injection arm"; Bnt162b2 (DOSE 1, SINGLE, COVID-19 Vaccine: Dose 1, Manufacturer: Pfizer, Date: 04Mar2021, NDC: Unknown, LOT: EM9810, EXP: Unknown, Dose and Route: Unknown dose, injection given in arm), for Covid-19 immunization, reaction(s): "Had achiness to the injection arm"; Bnt162b2 (COVID-19 Vaccine: Dose 2, Manufacturer: Pfizer, Date: 25Mar2021, NDC: Unknown, LOT: ER2613, EXP: Unknown, Dose and Route: Unknown dose, injection given in arm), for Covid-19 immunization, reaction(s): "Had achiness to the injection arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "achiness to the injection arm". The action taken for paracetamol was unknown.  Additional information: Had a reaction: Had achiness to the injection arm, put ice on it and it was gone within an hour.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240143 Same patient and drug, different event separated in time;
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: achiness to the injection arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 12May2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 73 years, in arm for covid-19 immunisation; paracetamol (TYLENOL), as 500 mg, 1x/day (500mg just once ) (Batch/Lot number: unknown). The patient's relevant medical history included: "High cholesterol" (ongoing), notes: Sort of has high cholesterol. Had high cholesterol for the last 10 years; "Arthritis" (unspecified if ongoing), notes: Arthritis Diagnosed for last 5 years. It's been bothering her; "high blood pressure" (ongoing), notes: High blood pressure Diagnosed for 20 years. Concomitant medication(s) included: LISINOPRIL taken for hypertension; SIMVASTATIN taken for blood cholesterol increased. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, COVID-19 Vaccine: Dose 1, Manufacturer: Pfizer, Date: 04Mar2021, NDC: Unknown, LOT: EM9810, EXP: Unknown, Dose and Route: Unk dose, injection given in arm), administration date: 04Mar2021, for COVID-19 Immunization, reaction(s): "slight Headache"; BNT162b2 (COVID-19 Vaccine: Dose 2, Manufacturer: Pfizer, Date: 25Mar2021, NDC: Unknown, LOT: ER2613, EXP: Unknown, Dose and Route: Unknown dose, injection given in arm), administration date: 25Mar2021, for Covid-19 immunization, reaction(s): "Slight headache"; BNT162b2 (COVID-19 Vaccine: Dose 3, Manufacturer: Pfizer, Date: 05Nov2021, NDC: Unknown, LOT: FH8020, EXP: Unknown, Dose and Route: Unknown dose, injection given in arm), administration date: 05Nov2021, for Covid-19 immunization, reaction(s): "Had achiness to the injection arm"; Bnt162b2 (DOSE 1, SINGLE, COVID-19 Vaccine: Dose 1, Manufacturer: Pfizer, Date: 04Mar2021, NDC: Unknown, LOT: EM9810, EXP: Unknown, Dose and Route: Unknown dose, injection given in arm), for Covid-19 immunization, reaction(s): "Had achiness to the injection arm"; Bnt162b2 (COVID-19 Vaccine: Dose 2, Manufacturer: Pfizer, Date: 25Mar2021, NDC: Unknown, LOT: ER2613, EXP: Unknown, Dose and Route: Unknown dose, injection given in arm), for Covid-19 immunization, reaction(s): "Had achiness to the injection arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "achiness to the injection arm". The action taken for paracetamol was unknown.  Additional information: Had a reaction: Had achiness to the injection arm, put ice on it and it was gone within an hour.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240143 Same patient and drug, different event separated in time;
Sex: F
Vaccine: PNC20
Symptoms: Hypersensitivity
Clinical narrative: allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Allergies: Thimerosal" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies". Additional information: The patient had allergies and she wanted to know the ingredients.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Polymerase chain reaction
Clinical narrative: diagnosed with Bells's Palsy on 18Oct2022; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 at 11:30 as dose 4 (booster), single (Lot number: G02524) at the age of 53 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination. Concomitant medication(s) included: DOXYCYCLINE; ATORVASTATIN; ZYRTEK; BETAMETHASONE; WYNZORA received within 2 weeks of vaccination. Vaccination history included: Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 18Oct2022 at 06:45, outcome "not recovered", described as "diagnosed with Bells's Palsy on 18Oct2022". The event "diagnosed with bells's palsy on 18oct2022" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (18Oct2022) Pending, notes: Nasal Swab. Therapeutic measures were taken as a result of bell's palsy (Steriod and anti-viral medication).  Clinical Course: The patient receive did not any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Awareness Date : 18Oct2022.  Follow-up (20Oct2022): Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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) from product quality group.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 16:15 as dose 1, single (Lot number: EN9581), in left arm, on 27Feb2021 at 16:15 as dose 2, single (Lot number: EN6202), in left arm and on 28Sep2021 at 16:15 as dose 3 (booster), single (Lot number: 30145BA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Kidney disease" (unspecified if ongoing), notes: Kidney disease. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient took Paxlovid as a treatment for COVID-19 from 08Oct2022 to 12Oct2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she had a positive COVID test on 27Jan2022 from Lab; she had a positive COVID test on 27Jan2022 from Lab; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP).  A 51-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 2, single (Lot number: EN6200) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Jan2022, outcome "unknown" and all described as "she had a positive COVID test on 27Jan2022 from Lab". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jan2022) Positive.  Clinical course: They were contacted about this case as the bivalent was captured as suspect when the date of event was Feb2022 which was prior to the bivalent being available. Further the lot number refers to the monovalent (PBS-purple cap). Below was the information from VAERS for the case. Also note the vaccine given on 17Feb2021 was the second dose-therefore the patient had received dose one of an unspecified COVID vaccine. Also, there was present as the patient tested positive on 27Jan2022-this information does not seem to be captured anywhere. 51-year female patient. Date died was 05Feb2022. Patient passed away at home, she had a positive COVID test on 27Jan2022 from lab.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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) from product quality group. The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 at 10:30 as dose 1, single (Lot number: ER8727), in left arm, on 18Apr2021 at 10:30 as dose 2, single (Lot number: EW0161), in left arm and on 06Dec2021 at 19:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 32 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) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was treated with Paxlovid for treatment of covid-19 from 11Oct2022 to 16Oct2022. Patient was taking other medications/products within two weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.