chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) 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 UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about patient 11th out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Master case  (Elderly Patient no 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Received COVID-19 Moderna Vaccine and "had side effects".; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Received COVID-19 Moderna Vaccine and "had side effects".) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced IMMUNISATION REACTION (Received COVID-19 Moderna Vaccine and "had side effects".). At the time of the report, IMMUNISATION REACTION (Received COVID-19 Moderna Vaccine and "had side effects".) outcome was unknown.            Concomitant medications were not reported.  Patient received COVID-19 Moderna Vaccine and had side effects.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: an adult patient between 12 and 64 years of age received the 1st dose of the primary series monovalent Moderna COVID-19 Vaccine on DEC2021 and they never got a 2nd dose of the primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (an adult patient between 12 and 64 years of age received the 1st dose of the primary series monovalent Moderna COVID-19 Vaccine on DEC2021 and they never got a 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history, allergy, concomitant diseases and risk factor or received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (an adult patient between 12 and 64 years of age received the 1st dose of the primary series monovalent Moderna COVID-19 Vaccine on DEC2021 and they never got a 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (an adult patient between 12 and 64 years of age received the 1st dose of the primary series monovalent Moderna COVID-19 Vaccine on DEC2021 and they never got a 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (an adult patient between 12 and 64 years of age received the 1st dose of the primary series monovalent Moderna COVID-19 Vaccine on DEC2021 and they never got a 2nd dose of the primary series).    No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: HCP stated patience received a vaccine after a temperature excursion; The maximum temperature reached is 22.1 F. The minimum temperature reach was unknown; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated patience received a vaccine after a temperature excursion), PRODUCT STORAGE ERROR (The maximum temperature reached is 22.1 F. The minimum temperature reach was unknown) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated patience received a vaccine after a temperature excursion), PRODUCT STORAGE ERROR (The maximum temperature reached is 22.1 F. The minimum temperature reach was unknown) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated patience received a vaccine after a temperature excursion), PRODUCT STORAGE ERROR (The maximum temperature reached is 22.1 F. The minimum temperature reach was unknown) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated patience received a vaccine after a temperature excursion) and PRODUCT STORAGE ERROR (The maximum temperature reached is 22.1 F. The minimum temperature reach was unknown).    No concomitant medication was reported.  It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. 1st lot number 066H21A. The excursion in the freezer was between the beginning of January to November 2022 for a total of 123 hour 10 minutes not in a row. Something was wrong with the freezer and the temperature kept changing. 2nd lot number 002M21A. The expiration date was 11-Sep-2022. The excursion in the freezer was between the beginning of January to November 2022 in 15 minutes increments in a course of a few hours. 3rd lot number 215K22A and the expiration date is 19-Aug-2023. The excursion in the freezer was between 10March2023 to 01May2023.  No treatment information was reported.   Reporter did not allow further contact
Age: 54.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 24Mar2021 as dose 2, single (Lot number: EP6955), in right arm, on 26Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 11May2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary Sarcoidosis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Apr2003; METFORMIN, start date: Sep2021; LORATADINE, start date: May2012. Past drug history included: Ace inhibitors, reaction(s): "Known allergies: ACE Inhibitors". The following information was reported: 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, notes: Treatment of COVID-19; negative, notes: Tested negative for the next several days; Positive, notes: I tested Positive for COVID-19 with an at home COVID-19 test kit. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 15May2023 to 20May2023  Clinical course: Patient finished 5 days of Paxlovid. Tested negative for the next several days. Then stuffy nose and shortness of breathing. 6 days later patient tested Positive for COVID-19 with an at home COVID-19 test kit.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Pain in extremity
Clinical narrative: Guillain-Barre syndrome; Pain in her toes", "Pain in legs".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the parent.  A 50-year-old female patient received BNT162b2 (BNT162B2 NOS), 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 patient's family history included mother "had hives" from fragrance, Propylene glycol (not Polyethylene glycol) and Balsam of Peru/from many years ago".  The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in her toes", "Pain in legs".". Therapeutic measures were taken as a result of guillain-barre syndrome, pain in extremity.  Clinical information: Reporter reported that his 50-year-old daughter "developed Guillain-Barre syndrome 6 weeks after receiving a Pfizer Covid Vaccine. She continues to have Pain in her toes and legs and was now on medication." He stated it took 2 months for the doctors to diagnose. He also stated "she will probably have this forever. Reportedly, serious: no.  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
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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 was not reported. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medications in 2 weeks. Patient received COVID 19 treatment with Paxlovid from 19May2023 to 26May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: developed cellulitis after receiving the shot of Prevnar 20; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GN1898), in right deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant), outcome "unknown", described as "developed cellulitis after receiving the shot of Prevnar 20".  Clinical course: Caller mentioned that they have two patients who developed cellulitis after receiving the shot of Prevnar 20 and they believe that there is something wrong with the batch; Sender's Comments: Based on the available information in the case, an association between the reported events CELLULITIS and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Seizure, Syncope, Tremor
Clinical narrative: syncope; seizure; Tremors; heart pauses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2021 at 15:45 as dose 2, single (Lot number: Ew0172) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "TBI" (unspecified if ongoing); "migraines" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "syncope" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies"; Gluten, reaction(s): "Known allergies". Vaccination history included: BNT162b2 (Dose 1, single, dose lot number=Ew0172, dose administration time: 03:45 PM,, dose vaccine location: Right arm), administration date: 24Aug2021, when the patient was 36-year-old, for COVID-19 immunization. The following information was reported: TREMOR (life threatening) with onset 15Sep2021 at 08:00, outcome "not recovered", described as "Tremors"; CARDIAC DISORDER (life threatening) with onset 15Sep2021 at 08:00, outcome "not recovered", described as "heart pauses"; SEIZURE (medically significant, life threatening) with onset 15Sep2021 at 08:00, outcome "not recovered"; SYNCOPE (medically significant, life threatening) with onset 15Sep2021 at 08:00, outcome "not recovered". The events "syncope", "seizure", "tremors" and "heart pauses" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of syncope, seizure, tremor, cardiac disorder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300205478 same reporter/patient/vaccine, different dose/event;
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: syncope; seizure; Tremors; heart pauses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2021 at 15:45 as dose 2, single (Lot number: Ew0172) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "TBI" (unspecified if ongoing); "migraines" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "syncope" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies"; Gluten, reaction(s): "Known allergies". Vaccination history included: BNT162b2 (Dose 1, single, dose lot number=Ew0172, dose administration time: 03:45 PM,, dose vaccine location: Right arm), administration date: 24Aug2021, when the patient was 36-year-old, for COVID-19 immunization. The following information was reported: TREMOR (life threatening) with onset 15Sep2021 at 08:00, outcome "not recovered", described as "Tremors"; CARDIAC DISORDER (life threatening) with onset 15Sep2021 at 08:00, outcome "not recovered", described as "heart pauses"; SEIZURE (medically significant, life threatening) with onset 15Sep2021 at 08:00, outcome "not recovered"; SYNCOPE (medically significant, life threatening) with onset 15Sep2021 at 08:00, outcome "not recovered". The events "syncope", "seizure", "tremors" and "heart pauses" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of syncope, seizure, tremor, cardiac disorder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300205478 same reporter/patient/vaccine, different dose/event;
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Seizure, Syncope, Tremor
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 24Aug2021 at 15:45 as dose 1, single (Lot number: Ew0172), in right arm and on 14Sep2021 at 15:45 as dose 2, single (Lot number: Ew0172) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: codeine" (unspecified if ongoing); "TBI" (unspecified if ongoing); "migraines" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "syncope" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 09Sep2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 09Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Nov2022) Negative, notes: Nasal Swab; (25Nov2022) Negative, notes: Nasal Swab; (09Sep2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204073 same reporter/patient/vaccine, different dose/event;
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 24Aug2021 at 15:45 as dose 1, single (Lot number: Ew0172), in right arm and on 14Sep2021 at 15:45 as dose 2, single (Lot number: Ew0172) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: codeine" (unspecified if ongoing); "TBI" (unspecified if ongoing); "migraines" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "syncope" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 09Sep2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 09Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Nov2022) Negative, notes: Nasal Swab; (25Nov2022) Negative, notes: Nasal Swab; (09Sep2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204073 same reporter/patient/vaccine, different dose/event;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient contracted COVID-19 approximately 3 weeks after receiving her most recent booster shot; Patient contracted COVID-19 approximately 3 weeks after receiving her most recent booster shot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "recovering" and all described as "Patient contracted COVID-19 approximately 3 weeks after receiving her most recent booster shot". The event "patient contracted covid-19 approximately 3 weeks after receiving her most recent booster shot" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not have COVID prior to vaccination. No known allergies. Patient contracted COVID-19 approximately 3 weeks after receiving her most recent booster shot.  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: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included treatment with Paxlovid from 17May2023 to 21May2023.  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: Therapeutic response unexpected
Clinical narrative: Three weeks later, her inflammation was down at least 60%; 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 65-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Lot number: EW0153) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: has a history of autoimmune diseases; "Hashimotos" (unspecified if ongoing); "mixed connective tissue disease" (unspecified if ongoing); "psoriasis on her ankle" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Single, Lot: ER8733), administration date: 25Mar2021, for COVID-19 Immunization, reaction(s): "Three weeks later, her inflammation was down at least 60%". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Three weeks later, her inflammation was down at least 60%".  Additional information: Reported as, History of autoimmune diseases, including Hashimotos, mixed connective tissue disease, and the other one is like no big deal, its annoying, but no one sees it. Its just psoriasis on her ankle that she puts coconut oil on. It just kind of soothes it so it doesn't get itchy. With her autoimmune disease, when she has one of them attacks, tendons and ligaments, they get inflamed and she can't move.By the first week of June she felt amazing. She was able to do her life long dream of driving cross country and visiting glass museums. She thought the improvement was going to last only a couple days but she hasn't had to take pain meds. She didn't really measure it. She thought she was just having a couple good days like that, which happens. It wears off in 5 months and in 6 months its gone, then she does it all over again. She was not 100%, but if you can keep your pain level below a 4, its easier to deal with it than when its constantly at an 8, 9, or 10. She slept in her car at camp grounds. She can't set up a tent and if she got on the ground in a sleeping back someone would have to come pick her up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204036 same patient/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Three weeks later, her inflammation was down at least 60%; 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 65-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8733) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune diseases" (unspecified if ongoing), notes: has a history of autoimmune diseases; "Hashimotos" (unspecified if ongoing); "mixed connective tissue disease" (unspecified if ongoing); "psoriasis on her ankle" (unspecified if ongoing), notes: Its just psoriasis on her ankle that she puts coconut oil on. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Three weeks later, her inflammation was down at least 60%".  Additional information: Reported as, History of autoimmune diseases, including Hashimotos, mixed connective tissue disease, and the other one is like no big deal, its annoying, but no one sees it. Its just psoriasis on her ankle that she puts coconut oil on. It just kind of soothes it so it doesn't get itchy. With her autoimmune disease, when she has one of them attacks, tendons and ligaments, they get inflamed, and she can't move. She was actually in a nasty flare up at that time. It was at a fairground. Because of where you had to park, you were supposed to walk all around the build and she wasn't going to be able to do it, it was too far. So, they actually figured out a way for her to cut through all this stuff and just to come through the front so she could get the vaccine. It was great because it would've been nasty. Three weeks later, her inflammation was down at least 60%, not pain free but could move, she said oh my gosh this is amazing, she hasn't felt this good in at least 15 years.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204036 same patient/event, different dose;
Age: 43.0
Sex: F
Vaccine: COVID19, 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Jan2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" 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 treated with Paxlovid started on 20May2023 and stopped on 24May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 10:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 15May2023 to 20May2023.  Additional information: The patient received no other medications within 2 weeks of vaccination. No known allergies reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: acidic like tomatoes, oranges" (unspecified if ongoing); "Known allergies: Anything acidic like tomatoes, oranges, birth control" (unspecified if ongoing); "Known allergies: Anything acidic like tomatoes, oranges, birth control" (unspecified if ongoing); "papillary thyroid cancer" (unspecified if ongoing); "post procedural hypothyroidism" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "Mast cell activation syndrome" (unspecified if ongoing); "ehlers-dahlos" (unspecified if ongoing); "narc keratoconus" (unspecified if ongoing); "IC" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL, start date: Mar2016; NUVIGIL, start date: Mar2007; ELMIRON, start date: Mar2013; FLUOXETINE, start date: 01Sep2006; ALOE VERA, start date: Mar2013; VITAMIN D NOS, start date: Mar2003. Past drug history included: Cardizem, reaction(s): "Known allergies: cardizem"; Nuvigil, reaction(s): "Known allergies: Nuvigil". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details:  Product: COVID 19 Treatment; Brand: Pfizer; From May2023 to May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events drug ineffective, covid-19 and BNT162B2 is considered possible.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product=COVID 19 Treatment; product=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.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: still tested positive after 10 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medication in 2 weeks. The patient received Anti-viral treatment as Paxlovid from 19May2023 to 23May2023 for Covid-19. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 90-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 89 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CELECOXIB, start date: 01Jun2018, stop date: 28May2023; CARBIDOPA AND LEVODOPA, start date: 01Sep2020, stop date: 28May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204139 same patient/reporter, different drug/AE;
Sex: F
Vaccine: COVID19, 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 20May2023 to 24May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204050 same reporter/patient, different drug/event;
Age: 71.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 27Sep2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Known allergies: batrim" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (May2023) Positive, notes: tested positive again; (May2023) Positive, notes: testing positive; (May2023) negative, notes: I had tested negative at first when finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient took Paxlovid Treatment from 12May2023 to 17May2023.  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-202300204125 same reporter/patient, different drug/event;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2 NOS), on 07Jan2023 as dose number unknown, single (Lot number: FL329) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: mango" (unspecified if ongoing); "Menopause" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". 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. Clinical course: Patient had Paxlovid treatment from 16May2023 to 21May2023. Patient also took concomitant in 2 weeks.  Suspect product: HET for menopause with start date: 01Dec2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204129 same reporter/patient, different drug/event;
Sex: U
Vaccine: PNC13
Symptoms: Vaccination site irritation, Vaccination site mass, Vaccination site swelling
Clinical narrative: Injection site reaction/Irritation/leave a very nice large bump; Injection site reaction/Irritation/leave a very nice large bump; This is a spontaneous report received from a contactable reporter (other HCP).  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE IRRITATION (non-serious), outcome "unknown" and all described as "Injection site reaction/Irritation/leave a very nice large bump". Additional information: The HCP reported that they know that where were they put the PCV13, it's going to leave a very nice large bump. They caution parents about that all the time.   The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: caused a permanent and significant jump in my blood pressure!; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure abnormal" (unspecified if ongoing), notes: Had been stable for decades!. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Lot number and expiration date not provided.), for COVID-19 immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "caused a permanent and significant jump in my blood pressure!". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood pressure increased.  Additional Information: It was reported that "your" (as reported) first damned booster caused a permanent and significant jump in my blood pressure! Had been stable for decades!  Had to double one of my two meds!  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: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted COVID-19; contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received BNT162b2 (BNT162B2 NOS), 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), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "contracted COVID-19".  Clinical course: The patient contracted COVID-19 in Feb2023 after having been vaccinated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: The patient contracted COVID-19 twice after having been vaccinated.; The patient contracted COVID-19 twice after having been vaccinated.; The patient contracted COVID-19 twice after having been vaccinated.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received BNT162b2 (BNT162B2 NOS), 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), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "The patient contracted COVID-19 twice after having been vaccinated.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Also reported a heart attack following their second Pfizer vaccine shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received BNT162b2 (BNT162B2 NOS), 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Also reported a heart attack following their second Pfizer vaccine shot". Clinical course: Patient received a COVID-19 monovalent booster (manufacturer not specified) and had a mild case of COVID-19 "sometime afterwards". Also reported a heart attack following their second Pfizer vaccine shot (Reporter is unsure if this was referring to primary series or booster).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: dizziness; pounding of the heart; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness) and PALPITATIONS (pounding of the heart) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DIZZINESS (dizziness) and PALPITATIONS (pounding of the heart). At the time of the report, DIZZINESS (dizziness) and PALPITATIONS (pounding of the heart) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.