chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; immunocompromised patient, no 3rd dose/1st booster dose administered instead of 3rd dose; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient, no 3rd dose/1st booster dose administered instead of 3rd dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A, 014M20A and 008B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and Lupus erythematosus since 2019. Concomitant products included HYDROXYCHLOROQUINE for Lupus erythematosus.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient, no 3rd dose/1st booster dose administered instead of 3rd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient, no 3rd dose/1st booster dose administered instead of 3rd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient are immunocompromised asks when they can can get the new bivalent booster dose. They were diagnosed with lupus in 2019 and was on hydroxychloroquine since then.  Patient took 2nd Booster dose on 4-Jun-2022 lot number 014B22A No treatment medication was provided by reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: they had Covid from their self testing; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (they had Covid from their self testing) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On 03-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced COVID-19 (they had Covid from their self testing). At the time of the report, COVID-19 (they had Covid from their self testing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2022, SARS-CoV-2 test: (Positive) positive.         Patient was concomitantly receiving statin.  Patient received first dose on 04-Feb-2021 with lot number 013L20A. Patient received second dose on 05-Mar-2021 with Lot number 016M20A. Patient received first booster dose on 17-Sep-2021 with Lot number 037F21A. Patient received second booster dose on 13-May-2022 with lot number 005M21A.  Patient experienced bit of sniffles, felt crumy, little of tenderness in the arm. and had a bad cold, as symptoms of COVID-19 diagnosis.  No treatment drug was reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: little flat white spots, like little white round things, here and there, in that whole area of arm; spot was very hot; spot was very itchy; about 3 inches below the injection, there was a big red round spot/spread out; spot was very burning; high fever because her head was boiling; wasn't feeling good for the first 24 hours at all; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (wasn't feeling good for the first 24 hours at all), SKIN DEPIGMENTATION (little flat white spots, like little white round things, here and there, in that whole area of arm), VACCINATION SITE WARMTH (spot was very hot), VACCINATION SITE PRURITUS (spot was very itchy) and VACCINATION SITE ERYTHEMA (about 3 inches below the injection, there was a big red round spot/spread out) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced MALAISE (wasn't feeling good for the first 24 hours at all). On an unknown date, the patient experienced SKIN DEPIGMENTATION (little flat white spots, like little white round things, here and there, in that whole area of arm), VACCINATION SITE WARMTH (spot was very hot), VACCINATION SITE PRURITUS (spot was very itchy), VACCINATION SITE ERYTHEMA (about 3 inches below the injection, there was a big red round spot/spread out), VACCINATION SITE PAIN (spot was very burning) and PYREXIA (high fever because her head was boiling). At the time of the report, MALAISE (wasn't feeling good for the first 24 hours at all), VACCINATION SITE WARMTH (spot was very hot), VACCINATION SITE PRURITUS (spot was very itchy), VACCINATION SITE ERYTHEMA (about 3 inches below the injection, there was a big red round spot/spread out), VACCINATION SITE PAIN (spot was very burning) and PYREXIA (high fever because her head was boiling) had resolved and SKIN DEPIGMENTATION (little flat white spots, like little white round things, here and there, in that whole area of arm) was resolving.      No relevant concomitant medications were reported. It was reported that, the patient thought she had a strange effect after she had an injection. She had a high fever because her head was boiling. She didn't take her temperature and she waited. Eventually it went away. For the next couple of days, about 3 inches below the injection, there was a big red round spot. The spot was very hot and itchy and burning. After that it spread out and disappeared. On top of that came little flat white spots, like little white round things, here and there, in that whole area. It's just on her arm. It was getting better. It was not hot anymore.  Treatment medication was not provided by the reporter.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Received Bivalent Booster instead of first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Bivalent Booster instead of first primary dose) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Bivalent Booster instead of first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Bivalent Booster instead of first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Bivalent Booster instead of first primary dose).    No concomitant medication was reported. No treatment medication was reported.  Patient never had any previous COVID-19 Vaccines.  Reporter states that the patient presented to their pharmacy and seemed to be aware about receiving the Bivalent booster as the first dose.  Reporter stated that the patient requested the Bivalent vaccine from the other pharmacy and was trying to schedule an appointment now to get the primary doses.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 4), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer.    On 03-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-655151 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655151:Husband's case.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Vaccination site pain
Clinical narrative: Was sick for 24 hours, didn't feel well for couple days; Was sick for 24 hours, didn't feel well for couple days; Site of vaccine has no pain, unlike previos 3 Pfizer and one Moderna vaccine or booster.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Was sick for 24 hours, didn't feel well for couple days), MALAISE (Was sick for 24 hours, didn't feel well for couple days) and VACCINATION SITE PAIN (Site of vaccine has no pain, unlike previos 3 Pfizer and one Moderna vaccine or booster.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1. Lot: EL9262. Route: unknown) on 31-Jan-2021, Pfizer (Dose 2. Lot: EN6201. Route: unknown) on 21-Feb-2021 and Pfizer (Dose 3. Lot: EW0196. Route: unknown) on 29-Sep-2021. Past adverse reactions to the above products included Vaccination site pain with Pfizer, Pfizer and Pfizer. Concomitant products included VITAMINS NOS for an unknown indication.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced ILLNESS (Was sick for 24 hours, didn't feel well for couple days), MALAISE (Was sick for 24 hours, didn't feel well for couple days) and VACCINATION SITE PAIN (Site of vaccine has no pain, unlike previos 3 Pfizer and one Moderna vaccine or booster.). In 2022, ILLNESS (Was sick for 24 hours, didn't feel well for couple days), MALAISE (Was sick for 24 hours, didn't feel well for couple days) and VACCINATION SITE PAIN (Site of vaccine has no pain, unlike previos 3 Pfizer and one Moderna vaccine or booster.) had resolved.            Patient ethnicity was reported as other.  The patient was taking couple of vitamins.  No treatment information was provided.   This case was linked to MOD-2022-654980 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "NonAlcholic Fatty Liver" (unspecified if ongoing); "asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "ICP" (unspecified if ongoing); "Meniere's" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "anemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (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: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had no known allergies. The patient did not receive any other medication in 2weeks. By the second treatment there was a rotten taste in mouth that won't go away, and the patient had semi-solid diarrhea. Taste went away temporarily when eating or using cough drops. Grateful to take Paxlovid because she could swallow now (throat was swelling up/swelling shut from covid) so she just wanted to notify you that she was part of the 6% that had the really bad rotten taste in mouth and could not seem to stop going to the bathroom. That had kept her out of the hospital and she will keep taking the full round. The patient thanked for developing this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Dysgeusia, Immunisation, Myalgia
Clinical narrative: stomach pain, Dizziness, tinnitus, muscle aches, severe metallic taste; stomach pain, Dizziness, tinnitus, muscle aches, severe metallic taste; stomach pain, Dizziness, tinnitus, muscle aches, severe metallic taste; stomach pain, Dizziness, tinnitus, muscle aches, severe metallic taste; severe metallic taste; dose number=5; dose number=5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetic" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: dairy" (unspecified if ongoing), notes: Known allergies: Dairy. The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro; Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Ceftin, reaction(s): "Known allergies: Ceftin", notes: Known allergies: Ceftin. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose: 4, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 13Sep2022, outcome "unknown" and all described as "dose number=5"; DYSGEUSIA (non-serious) with onset 17Sep2022, outcome "recovering", described as "severe metallic taste"; ABDOMINAL PAIN UPPER (non-serious), DIZZINESS (non-serious), TINNITUS (non-serious), MYALGIA (non-serious) all with onset 17Sep2022, outcome "recovering" and all described as "stomach pain, Dizziness, tinnitus, muscle aches, severe metallic taste".  Additional information: Patient received Plxlovid for trecament of covid 19 on start date 24Sep2022 and stop date 28Sep2022. patient had known allergies of  latex, Cipro, Codeine, Sulfa, Penicillin, Ceftin, dairy.  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.  Amendment: This follow-up report is being submitted to amend previous information: Added the events General GI with stomach pain, Dizziness, tinnitus, muscle aches and severe metallic taste.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Tinnitus
Clinical narrative: stomach pain, Dizziness, tinnitus, muscle aches, severe metallic taste; stomach pain, Dizziness, tinnitus, muscle aches, severe metallic taste; stomach pain, Dizziness, tinnitus, muscle aches, severe metallic taste; stomach pain, Dizziness, tinnitus, muscle aches, severe metallic taste; severe metallic taste; dose number=5; dose number=5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetic" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: dairy" (unspecified if ongoing), notes: Known allergies: Dairy. The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro; Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Ceftin, reaction(s): "Known allergies: Ceftin", notes: Known allergies: Ceftin. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose: 4, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 13Sep2022, outcome "unknown" and all described as "dose number=5"; DYSGEUSIA (non-serious) with onset 17Sep2022, outcome "recovering", described as "severe metallic taste"; ABDOMINAL PAIN UPPER (non-serious), DIZZINESS (non-serious), TINNITUS (non-serious), MYALGIA (non-serious) all with onset 17Sep2022, outcome "recovering" and all described as "stomach pain, Dizziness, tinnitus, muscle aches, severe metallic taste".  Additional information: Patient received Plxlovid for trecament of covid 19 on start date 24Sep2022 and stop date 28Sep2022. patient had known allergies of  latex, Cipro, Codeine, Sulfa, Penicillin, Ceftin, dairy.  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.  Amendment: This follow-up report is being submitted to amend previous information: Added the events General GI with stomach pain, Dizziness, tinnitus, muscle aches and severe metallic taste.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Neck pain, Pain
Clinical narrative: shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders; shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders; shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders; shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders; shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ5342, Expiration Date: 23Jun2023) 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: BACK PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), PAIN (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders".  Additional information: The reporter called to report some side effects for his mother patient. She has shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Blindness, Cerebrovascular accident, Off label use, Pain in extremity, Presyncope
Clinical narrative: She also took the flu shot and bivalent shot on the same day; She also took the flu shot and bivalent shot on the same day; couldn't see; thought she was having a stroke; feeling like she was almost about to pass out; arm pain; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 30Sep2022 as dose number unknown, single (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, manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "recovering", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "arm pain"; BLINDNESS (medically significant) with onset 2022, outcome "unknown", described as "couldn't see"; PRESYNCOPE (non-serious) with onset 2022, outcome "unknown", described as "feeling like she was almost about to pass out"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2022, outcome "unknown", described as "thought she was having a stroke"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "She also took the flu shot and bivalent shot on the same day". The reporter who is 77-year-old and got the Bivalent COVID-19 Vaccine on Friday (30Sep2022) and is reporting arm pain and couldn't get out of bed, couldn't see, and couldn't do anything. She was feeling like she was almost passing out when she woke up. She also took the flu shot and bivalent shot on the same day. The reporter was just reporting this and wasn't planning on getting all those shots but her doctor had the shots available and asked her if she wanted to receive the shots. She just wanted to let Pfizer know. Her husband was home with her and got her coffee and water as she knows she needs to hydrate herself. She felt better and had to go on an errand as her glasses broke and went to the glasses place. She got her glasses fixed and came home and developed a fever at night but the fever wasn't high. The next day she was better. When she couldn't get out of bed her husband thought she was having a stroke.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Product use issue, Pyrexia
Clinical narrative: She also took the flu shot and bivalent shot on the same day; She also took the flu shot and bivalent shot on the same day; couldn't see; thought she was having a stroke; feeling like she was almost about to pass out; arm pain; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 30Sep2022 as dose number unknown, single (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, manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "recovering", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "arm pain"; BLINDNESS (medically significant) with onset 2022, outcome "unknown", described as "couldn't see"; PRESYNCOPE (non-serious) with onset 2022, outcome "unknown", described as "feeling like she was almost about to pass out"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2022, outcome "unknown", described as "thought she was having a stroke"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "She also took the flu shot and bivalent shot on the same day". The reporter who is 77-year-old and got the Bivalent COVID-19 Vaccine on Friday (30Sep2022) and is reporting arm pain and couldn't get out of bed, couldn't see, and couldn't do anything. She was feeling like she was almost passing out when she woke up. She also took the flu shot and bivalent shot on the same day. The reporter was just reporting this and wasn't planning on getting all those shots but her doctor had the shots available and asked her if she wanted to receive the shots. She just wanted to let Pfizer know. Her husband was home with her and got her coffee and water as she knows she needs to hydrate herself. She felt better and had to go on an errand as her glasses broke and went to the glasses place. She got her glasses fixed and came home and developed a fever at night but the fever wasn't high. The next day she was better. When she couldn't get out of bed her husband thought she was having a stroke.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4: Pfizer/Dose Number: 3:Moderna /Dose Number: 2: Moderna/Dose Number: 1: Moderna; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2022 as dose 4 (booster), single (Lot number: FX9894) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: 048A21A), in left arm, on 15Apr2021 as dose 2, single (Lot number: 040B21A), in left arm and on 20Nov2021 as dose 3 (booster), single (Lot number: 066F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL; PRAVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07May2022, outcome "not recovered", described as "Dose Number: 4: Pfizer/Dose Number: 3:Moderna /Dose Number: 2: Moderna/Dose Number: 1: Moderna"; 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: (unspecified date) Positive, notes: COVID 19 Treatment; (03Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details reported as COVID 19 Treatment, treatment start date was 20Sep2022, treatment stop date was 25Sep2022 and indication was treatment of COVID-19. No known allergies were reported.; Sender's Comments: Based on the available information in the case, the causal association between the events of and the suspect drug BNT162B2 cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had a little soreness in her arm.; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL9367) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "She has had reactions in the past to sulfa drugs" (unspecified if ongoing), notes: She has had reactions in the past to sulfa drugs. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a little soreness in her arm.".  Additional information: Patient was not visited to emergency room or physician office visit. Patient not received any vaccine within 4 weeks.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had a a little soreness in her arm; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 2, single (Lot number: FL9262) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "had reactions in the past to sulfa drugs " (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; SINGLE; Lot number: EL9367), administration date: 22Feb2021, when the patient was 64-year-old, for COVID-19 immunisation, reaction(s): "she had a little soreness in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a a little soreness in her arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201201262 Same product, patient, different AEs, different dose;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Immunisation, Nasal congestion, Nasopharyngitis
Clinical narrative: Two days after vaccine it feels like a common cold with coughing and with congestion; Two days after vaccine it feels like a common cold with coughing and with congestion; Two days after vaccine it feels like a common cold with coughing and with congestion; Minor dizziness; Minor soreness at the site of injection the day after and continuing; dose number 5; dose number 5; This is a spontaneous report received from non-contactable reporter (Consumer). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN; ATORVASTATIN; THYROXINE. Vaccination history included: Tetanus vaccine (negative reaction to tetanus vaccine 5 weeks earlier); 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 (BOOSTER), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022 at 10:00, outcome "unknown" and all described as "dose number 5"; VACCINATION SITE PAIN (non-serious) with onset 01Oct2022 at 22:00, outcome "not recovered", described as "Minor soreness at the site of injection the day after and continuing"; DIZZINESS (non-serious) with onset 02Oct2022 at 22:00, outcome "not recovered", described as "Minor dizziness"; NASOPHARYNGITIS (non-serious), COUGH (non-serious), NASAL CONGESTION (non-serious) all with onset 02Oct2022 at 22:00, outcome "not recovered" and all described as "Two days after vaccine it feels like a common cold with coughing and with congestion". Therapeutic measures were not taken as a result of vaccination site pain, nasopharyngitis, cough, nasal congestion, dizziness.  Additional information: Patent did not have Covid-19 prior vaccination. Patient did not test positive for Covid-19 post vaccination. No known allergies. Thyroid replacement medicine, negative reaction to tetanus vaccine 5 weeks earlier.  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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Vaccination site pain
Clinical narrative: Two days after vaccine it feels like a common cold with coughing and with congestion; Two days after vaccine it feels like a common cold with coughing and with congestion; Two days after vaccine it feels like a common cold with coughing and with congestion; Minor dizziness; Minor soreness at the site of injection the day after and continuing; dose number 5; dose number 5; This is a spontaneous report received from non-contactable reporter (Consumer). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN; ATORVASTATIN; THYROXINE. Vaccination history included: Tetanus vaccine (negative reaction to tetanus vaccine 5 weeks earlier); 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 (BOOSTER), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022 at 10:00, outcome "unknown" and all described as "dose number 5"; VACCINATION SITE PAIN (non-serious) with onset 01Oct2022 at 22:00, outcome "not recovered", described as "Minor soreness at the site of injection the day after and continuing"; DIZZINESS (non-serious) with onset 02Oct2022 at 22:00, outcome "not recovered", described as "Minor dizziness"; NASOPHARYNGITIS (non-serious), COUGH (non-serious), NASAL CONGESTION (non-serious) all with onset 02Oct2022 at 22:00, outcome "not recovered" and all described as "Two days after vaccine it feels like a common cold with coughing and with congestion". Therapeutic measures were not taken as a result of vaccination site pain, nasopharyngitis, cough, nasal congestion, dizziness.  Additional information: Patent did not have Covid-19 prior vaccination. Patient did not test positive for Covid-19 post vaccination. No known allergies. Thyroid replacement medicine, negative reaction to tetanus vaccine 5 weeks earlier.  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.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: In your shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days; I was so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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: PYREXIA (non-serious), outcome "unknown", described as "In your shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days"; ILLNESS (non-serious), outcome "unknown", described as "I was so sick". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: how much time he needs to wait to take the 2nd Pfizer COVID 19 booster shot after taking Paxlovid.; how much time he needs to wait to take the 2nd Pfizer COVID 19 booster shot after taking Paxlovid.; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "how much time he needs to wait to take the 2nd Pfizer COVID 19 booster shot after taking Paxlovid.". 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.  Additional Information: Caller would like to know how much time he needs to wait to take the 2nd Pfizer COVID 19 booster shot after taking Paxlovid. consent for report. Caller states he's out of time and out of breath. Wants to know if Pfizer recommends 3 months or 4 months to wait for the COVID-19 Vaccine second booster. Patient states he just wants an answer to his question. there a product complaint to report is Yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Rhinitis
Clinical narrative: she has a terrible infection in her eyes and nose; she has a terrible infection in her eyes and nose; 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 93-year-old female patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 93 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunization; BNT162B2 (DOSE 2, SINGLE), for COVID-19 immunization; BNT162B2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: EYE INFECTION (non-serious), RHINITIS (non-serious) all with onset 01Oct2022, outcome "unknown" and all described as "she has a terrible infection in her eyes and nose".  Additional information: The events started a couple of days after the shot. She had the other ones and haven't had a reaction from them.  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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: 2nd vaccination with Pfizer 04May2021/1st vaccination with Pfizer 02Nov2020; her arms were slightly sore; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDEM22-02829 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 04May2021 as dose 2, single (Lot number: EW4109) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Medication for fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: COCODAMOL; MORPHINE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot: EK4244244), administration date: 02Nov2020, for COVID-19 Immunization, reaction(s): "arms were slightly sore", "had headache". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04May2021, outcome "unknown", described as "2nd vaccination with Pfizer 04May2021/1st vaccination with Pfizer 02Nov2020"; HEADACHE (non-serious) with onset 04May2021, outcome "recovered" (05May2021); PAIN IN EXTREMITY (non-serious) with onset 04May2021, outcome "recovered" (05May2021), described as "her arms were slightly sore".  Additional information: It was also reported that patient was taking Morphine, which she had not taken for 3 weeks, she was taking inhaler for asthma and she was also taking medication for fibromyalgia, which she had not taken any in the last few days.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200075643 same patient/drug, similar event, different dose number;
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: she usually have body and muscle ache after getting the vaccine; she usually have body and muscle ache after getting the vaccine; For the first two she felt a little tired; 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 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: PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "she usually have body and muscle ache after getting the vaccine"; FATIGUE (non-serious), outcome "unknown", described as "For the first two she felt a little tired".  Additional Information: It was reported that patient usually had body and muscle ache after getting the vaccine. For the first two she felt a little tired. Case was reported as non-serious.  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: Fatigue, Myalgia, Pain
Clinical narrative: she usually have body and muscle ache after getting the vaccine; she usually have body and muscle ache after getting the vaccine; For the first two she felt a little tired; 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 BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "For the first two she felt a little tired", "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine". The following information was reported: PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "she usually have body and muscle ache after getting the vaccine"; FATIGUE (non-serious), outcome "unknown", described as "For the first two she felt a little tired".  Additional Information: It was reported that patient usually had body and muscle ache after getting the vaccine. For the first two she felt a little tired. Case was reported as non-serious.  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: Myalgia, Pain
Clinical narrative: she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches; she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches; 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 BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "For the first two she felt a little tired", "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine"; Bnt162b2 (Dose 2, Single), for COVID-19 immunization, reaction(s): "For the first two she felt a little tired", "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine". The following information was reported: PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches". Therapeutic measures were taken as a result of pain, myalgia.  Additional information: Caller was a consumer stating that she received her Pfizer COVID vaccine "last Saturday" where she felt "little sore, nothing terrible" and "felt no pain the next day, Sunday". Caller added that she actually felt a little sore yesterday, but she was experiencing muscle soreness at the injection site area this time. Caller stated that her arm hurt a lot today and expressed "I can't barely lift my arm and I never had that muscle ache before." Caller also mentioned that she usually has body and muscle ache after getting the vaccine, but this time is different. Caller wanted to know if it was normal for the arm to hurt a lot after skipping a day. Caller also mentioned that she took Tylenol but the pain was still there. She was also asking for recommendations whether to put heat or cold compress to the area of muscle pain. After providing response, caller wants to know information for bivalent about how long muscle pain was experienced by the subjects during clinical trial.   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.