chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 3:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 3:55 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 64.02.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 9 AM, temp was 34 and at 10 AM temp was 37; total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vial was moved to clinic. Vaccine BUD date was 08-Apr-2021.  Vial was stored on cooler 1, on 20-Mar-2021, Excursion duration At 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM : 44, 2 PM : 44, 3 PM: 44, 4 PM: 44 and 5 PM : 43  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.   On 03-Apr-2021, Excursion time was 9 AM, temp was 34 , total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021, 20 vial was moved to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1 , on 03-Apr-2021, Excursion duration at 8 AM:38,  9 AM:34, 10 AM: 38, 11 AM:42, 12 AM:41, 1PM : 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Vials only punctured right before administration  Treatment medications were not reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Incorrect route of product administration, Uveitis
Clinical narrative: Inappropriate route of vaccination; Uveitis flare up; Flare-Up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4360985-00 (AbbVie).  A 13-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, cf, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 04Mar2022, outcome "recovered" (2022), described as "Flare-Up"; UVEITIS (medically significant) with onset 04Mar2022, outcome "recovering", described as "Uveitis flare up"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination". The action taken for adalimumab was unknown.  The reporter considered "uveitis flare up" and "flare-up" related to BNT162b2. The reporter's assessment of the causal relationship of "inappropriate route of vaccination" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Uveitis Flare Up (Uveitis): Causality as per reporter (Drug/Vaccine): Possible The reporter's causality for the event(s) of Uveitis flare up with HUMIRA (ADALIMUMAB) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20May2022): This is a solicited follow-up report based on the information received by Pfizer from AbbVie (Mfr Control No.: 22K-163-4360985-00). A contactable 13-year-old female patient reported for herself that: Updated Information included: New adverse event and additional information updated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the inappropriate route of vaccination" ,uveitis Flare-up and condition aggravated and the suspect drug. 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: Swollen lymph node under my left arm after 3rd dose.; Lasted about 3 days and was noticeably sore but did not interfere with activity.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 38-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 14Mar2021, when the patient was 38-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 10Nov2021, outcome "recovered" (13Nov2021), described as "Lasted about 3 days and was noticeably sore but did not interfere with activity."; LYMPHADENOPATHY (non-serious) with onset 10Nov2021, outcome "recovered" (13Nov2021), described as "Swollen lymph node under my left arm after 3rd dose.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 at 16:00 as dose 1, single (Lot number: ER8729), in left arm and on 01May2021 at 12:00 as dose 2, single (Lot number: ER8736) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 24Nov2021 at 16:00 as dose 3 (booster), single (Lot number: 939902), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression and anxiety" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; BUPROPION; BUSPIRONE; ACETAMINOPHEN; PSEUDOEPHEDRINE. Past drug history included: Cefaclor, reaction(s): "known allergies: Cefaclor". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19.
Sex: F
Vaccine: MEN
Symptoms: Feeling hot, Hypoaesthesia, Musculoskeletal discomfort
Clinical narrative: her arm was numb and today it is still bothering her and it is hot; she says it feels like her shoulder has been ripped off; her arm was numb and today it is still bothering her and it is hot; she says it feels like her shoulder has been ripped off; her arm was numb and today it is still bothering her and it is hot; she says it feels like her shoulder has been ripped off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received meningococcal group b Rlp2086 (MENINGOCOCCAL GROUP B RLP2086), on 13May2022 as dose number unknown, single (Batch/Lot number: unknown) for meningitis bacterial. The patient's relevant medical history and concomitant medications were not reported. Patient had the Meningitis B injection (Unspecified Medication) yesterday and she complained all day that her arm was numb and today it is still bothering her and it is hot. She says it feels like her shoulder has been ripped off and I am just wondering if this is a normal reaction to that injection." The following information was reported: HYPOAESTHESIA (non-serious) with onset 13May2022, outcome "not recovered", FEELING HOT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 14May2022, outcome "unknown" and all described as "her arm was numb and today it is still bothering her and it is hot; she says it feels like her shoulder has been ripped off".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information includes: product coding was updated to reflect changes made in previous report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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. Concomitant medication(s) included: Macrobid [Clarithromycin]. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from 05May2022 to till 10May2022. 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 information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), in Oct2021 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. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "I received - 2 doses of Pfizer Vaccine + 1 Booster/ Positive COVID test+ symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of Covid-19 and Drug ineffective. Clinical course: It was reported that symptoms resumed after I completed my 5 day dose of Paxlovid. The patient took tylenol for relief from cold/flu symptoms the symptoms that returned after Paxlovid were milder than initial Covid symptoms. The patient received 2 dose of Pfizer vaccine + 1 Booster (Booster was Oct2021). The patient reported that one of those cases where Covid symptoms resumed after he completed 5 day dose of Paxlovid. He never tested negative for Covid and tested positive when he finished the round of Paxlovid. He felt back to normal, but couple of days later he had cold/ flu symptoms return and still testing positive with the at home quick test. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
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) from product quality group. The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2021 as dose 2, single (Lot number: EW0185, Expiration Date: 31Aug2021) at the age of 29 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROPRANOLOL. 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: (unspecified date) Positive; (unspecified date) Negative; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible and no further information is expected.  Follow-up (17May2022): This is a follow-up spontaneous report from product quality group providing investigation results. This report included that:  Updated Information Included Batch and lot tested and found within specifications was checked. (All release testing performed prior to the release of the reported batch was within specifications). Clinical course: Investigation results reported: This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the business process. Product Description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 with Lot-# (CR): EW0185 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0185 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, an analysis of complaint history for the reported lot and analytical release test results. The final scope included the reported finished goods lot EW0185, fill lot EP8735, and the formulated drug product lot EP8616. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 49-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 48 years for Covid-19 immunization (Patient received vaccine in Workplace clinic). The patient's family history included: "wife sick 13May and tested positive" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient's relevant medical history and concomitant medications were not reported. It was unknown If other vaccine in four weeks. It was unknown If Covid prior vaccination: Unknown. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15May2022, outcome "unknown" and all described as "he tested positive 15May with SX same day mild cold like SX". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: wife sick 13May and tested positive and he tested positive 15May with SX same day mild cold like SX. The patient was positive for COVID-19 in home AG, Covid test on 15May2022. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and Covid-19 and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Heart rate, SARS-CoV-2 test positive
Clinical narrative: Taken COVID 19 Treatment; Taken COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 3, booster ,single (Batch/Lot number: unknown) at the age of 50 years 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 included: "Atrial Fibrilator" (unspecified if ongoing); "Pulmonary embolism" (unspecified if ongoing); "Melanoma" (unspecified if ongoing), notes: Cured 15 years ago; "Hypogonadism" (unspecified if ongoing); "BMI" (unspecified if ongoing), notes: BMI33. Concomitant medication(s) included: TESTOSTERONE CYPIONATE; ANASTROZOLE.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Taken COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Heart rate increased: 170; SARS-CoV-2 test positive: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  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 known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 49 years, in left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "I took another test and it came back positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: I had taken a test on Saturday (about two days ago) and it was negative; (May2022) Positive, notes: I took another test and it came back positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. No other medications were taken in 2 weeks. Anti-viral Paxlovid (treatment start date: 09May2022 and treatment stop date: 13May2022) was taken by the patient for the treatment of COVID-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Viral rebound on day 15 symptoms and tested positive again; Viral rebound on day 15 symptoms and tested positive again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "Viral rebound on day 15 symptoms and tested positive again". 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.  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-202200730181 Same patient, different product and event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Polymyalgia rheumatica
Clinical narrative: Two days after the vaccine (7Sep2021), I awoke with severe pain all over my body. It never went away. I have since been diagnosed with Polymyalgia Rheumatica; Two days after the vaccine (7Sep2021), I awoke with severe pain all over my body. It never went away. I have since been diagnosed with Polymyalgia Rheumatica; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination Yes" (unspecified if ongoing), notes: if covid prior vaccination Yes. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergic to codeine", notes: known allergies Yes, allergic to codeine. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Left Arm), administration date: 22Aug2021, when the patient was 58-year-old, for Covid-19 Immunization.  The following information was reported: POLYMYALGIA RHEUMATICA (disability, medically significant), PAIN (disability) all with onset 07Sep2021, outcome "not recovered" and all described as "Two days after the vaccine (7Sep2021), I awoke with severe pain all over my body. It never went away. I have since been diagnosed with Polymyalgia Rheumatica". The event "two days after the vaccine (7sep2021), i awoke with severe pain all over my body. it never went away. i have since been diagnosed with polymyalgia rheumatica" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica, pain.  Clinical course: Facility type vaccine Pharmacy or Drug Store. No other vaccine in four weeks. Two days after the vaccine (7Sep2021), she awoke with severe pain all over her body. It never went away. She has since been diagnosed with Polymyalgia Rheumatica (PMR). She was in a support group for PMR and have found that thousands of people across the globe also experienced the same thing following their 2nd dose. Adverse event resulted in [Doctor or other healthcare professional office/clinic visit, Disability or permanent damage]. Adverse event treatment: High dose steroids, long-term. The patient had covid prior vaccination. She had covid tested post vaccination.  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: Feeling abnormal
Clinical narrative: she feels funny; 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 female patient received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "she feels funny". The event "she feels funny" required physician office visit.  Additional information: The patient reported that she would like to schedule her booster shot. Patient reported that she went to the doctor's office and she feels funny.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: mild sx HA ST covid after international travel from from DR.; mild sx HA ST covid after international travel from from DR.; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 23-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 18Feb2022 as dose 3 (booster), single (Lot number: FF2589) at the age of 23 years 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 16May2022, outcome "unknown" and all described as "mild sx HA ST covid after international travel from from DR.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: cough 18May and positive Ag test; cough 18May and positive Ag test; cough 18May and positive Ag test; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 28 years 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), COUGH (non-serious) all with onset 18May2022, outcome "unknown" and all described as "cough 18May and positive Ag test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (18May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, cough. Clinical information: It was reported that ST cough 18May and positive Ag test after travel to (name) this weekend. Covid was tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller completed her first, second, and booster dose of Pfizer covid vaccine/testing positive for covid; Caller completed her first, second, and booster dose of Pfizer covid vaccine/testing positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL1283, Expiration Date: 30Apr2021), in left arm, on 10Feb2021 as dose 2, single (Lot number: EM9810, Expiration Date: 30Jun2021), in left arm and on 22Sep2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "Caller completed her first, second, and booster dose of Pfizer covid vaccine/testing positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: The caller is a consumer who tested positive for Covid last Thursday. Therapeutic measures were taken as a result of vaccination failure, covid-19.The patient was treated with Paxlovid.  Clinical course: The patient did not received other vaccine on the same date as of suspect vaccine. The patient did not receive any other vaccine within 4 week to covid vaccination. The NDC number was unknown.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Drug intolerance, Malaise, Nervous system disorder
Clinical narrative: had side effects and she realized that she was administered with the gray cap formulation; patient still did not feel well; central nervous system side effects; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, purple cap and tolerate it well.), administration date: Sep2021, for COVID-19 immunization, reaction(s): "tolerate it well"; Bnt162b2 (Dose 2, single, purple cap), administration date: Sep2021, for COVID-19 immunization, reaction(s): "tolerate it well". The following information was reported: NERVOUS SYSTEM DISORDER (medically significant) with onset 16May2022, outcome "recovering", described as "central nervous system side effects"; DRUG INTOLERANCE (non-serious), outcome "unknown", described as "had side effects and she realized that she was administered with the gray cap formulation"; MALAISE (non-serious), outcome "recovering", described as "patient still did not feel well".  Clinical course: Patient weight was about 140 pounds. Her first two in September were Covid19 vaccine purple cap and she tolerated them well. She chose Pfizer's because the buffer was little salts that were quite innocuous. She didn't know they had switched to gray cap that has Tromethamine buffer. She did not tolerate the gray cap due to the buffer, but tolerated the purple cap Covid19 vaccine. When they switched to Tromethamine the amines can be biologically activated. Caller clarified the Covid19 Vaccine gray cap has the Tromethamine buffer. She wanted to make sure they know people are not reacting well to the Tromethamine. Caller was a retired doctor of pharmacy. They weren't typical immunological side effects like with the immune system. They were more central nervous system side effects. That was why it was concerning. When they switched to Tromethamine the amines can be biologically activated. She is not sure how big of a population will not tolerate the Tromethamine. Seriousness Criteria: serious enough that she was considered contacting an ambulance. Patient clarified that she felt it was medically significant. Outcome of event: patient still did not feel well. The side effects was ongoing. She felt better than she did that night, but still has residual. Causality: the side effects were caused by the Covid19 Vaccine. The gray cap, the buffer.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Central nervous system disorder and the suspect drug cannot be established, hence the causality was kept as Unrelated. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 at 09:30 as dose 1, single (Lot number: EN6199), in left arm, on 03Apr2021 at 09:00 as dose 2, single (Lot number: ER8737), in left arm and on 06Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Mar2015. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: The patient took Pfizer Paxlovid anti-viral as Covid-19. The treatment started since 13May2022 to 18May2022 with lot number lot number= FY5656. The other medication took in 2 weeks product Lupin Losartan started on 01Mar2015.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
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) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9263), in left arm, on 25Feb2021 as dose 2, single (Lot number: EL9263), in left arm and on 13Sep2021 as dose 3 (booster), single (Lot number: 3.1308A) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). There were no concomitant medications. 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: (08May2022) Positive, notes: Tested positive on 08May2022; (16May2022) Negative, notes: Tested negative on the 16May2022; (18May2022) Positive, notes: Do not feel well. Tested positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: It was reported that Paxlovid that evening. Felt better within hours. finished course on the 13May in the a.m. Tested negative on the 16May. Developed upper respiratory infection with profuse sneezing, runny nose, fever (100). yesterday. Do not feel well. Tested positive today.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 13:15 as dose 1, single (Lot number: EL3246), in right arm, on 09Feb2021 at 13:15 as dose 2, single (Lot number: EL9262), in right arm and on 06Oct2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Hypothyrode. Concomitant medication(s) included: LEVOTHYROXINE, start date: Apr2001, stop date: 04May2022; ESCITALOPRAM, start date: Jul2019, stop date: 04May2022. 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: (unspecified date) Positive; (09May2022) Negative, notes: Took full course of Paxlovid starting 04May and finishing 08May; tested negative on 09May; (15May2022) Positive, notes: On 15May awoke with head cold and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 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's relevant medical history was not reported. The patient took concomitant medications. 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. Therapeutic measures were taken as a result of Covid-19. Clinical Course: Anti viral details product: COVID-19 Treatment, treatment start date:16May2022, indication: Treatment of COVID-19. Adverse event: Vomiting, nausea, bad taste in mouth. Adverse event start date: 16May2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team and product quality group. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL8982), on 17Feb2021 as dose 2, single (Lot number: EN6200), on 29Sep2021 as dose 3 (booster), single (Lot number: 1301308A) and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Dry Eye" (unspecified if ongoing). Concomitant medication(s) included: RESTASIS taken for dry eye. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: COVID-19: (unspecified date) Positive; (17May2022) Positive, notes: she tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: She just had a dentist appointment today. Her dentist told her she was good to go to the appointment. She had a dental cleaning. She also takes Restasis for dry eye, and a vaginal cream twice a week. She was surprised her and her husband got COVID. They just got the booster in Apr 2022. They weren't even really sick. There was a couple of days where they were tired, achy, and feverish one day. They have both had head colds that were worse. She started having symptoms the Monday after mother's day, 9May2022. Her husband woke up stuffed up on mother's day, and then she was stuffed up shortly after. They are both feeling good. She didn't know that calling would turn in to all of this. She could test positive for a while. She was surprised she got COVID. She just got the booster in Apr2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive again for COVID on 17May; tested positive again for COVID on 17May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 42 years 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "not recovered" and all described as "tested positive again for COVID on 17May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: I tested positive for COVID on 03May; (06May2022) Negative, notes: negative on 06May; (17May2022) Positive, notes: tested positive again for COVID on 17May. Therapeutic measures were taken as a result of covid-19. Clinical course: Other medication in 2weeks: No. I tested positive for COVID on 03May, negative on 06May, finished Paxlovid on 08May, and tested positive again for COVID on 17May. Additionally, I redeveloped symptoms, namely runny nose and cough. No follow-up attempts are possible. No further information is expected.