chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: fell backwards after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 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 following information was reported: FALL (non-serious), outcome "unknown", described as "fell backwards after getting the vaccine".  Additional information: Caller also reports that her girlfriend also experienced something from the vaccine and that her girlfriend fell backwards after getting the vaccine. Caller also wanted to know if anyone else had it (experienced the same AE's she had).   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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Copd" (unspecified if ongoing); "obesity" (unspecified if ongoing); "TIA" (unspecified if ongoing). 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: COVID 19 Treatment from 07Jan2023 to 12Jan2023. Patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 49-year-old 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), 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; (Jan2023) Positive, notes: Tested positive 5 days ago. Therapeutic measures were taken as a result of drug ineffective, covid-19 treated with Paxlovid started on 06Jan2023 and stopped on 10Jan2023.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 11Jul2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in right arm 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 "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid treatment from 09Jan2023 to 15Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Dose 3: Moderna; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 19:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13May2022 at 19:00 as dose 4 (booster), single (Lot number: FK9729), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2021 at 19:00 as dose 3 (booster), single (Lot number: 038C21A), 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 included: "RAD" (unspecified if ongoing);" pulmonary disease" (unspecified if ongoing); "bronchiectasis" (unspecified if ongoing); "remote history of breast cancer" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL], start date: Apr2010; SYMBICORT, start date: Apr2015; VIT D [COLECALCIFEROL], start date: Feb2018; VIT B 12, start date: Apr2018; MAGNESIUM, start date: Jan2001. Past drug history included: Anzemet, reaction(s): "Known allergies: Anzemet"; Scopolamine, reaction(s): "Known allergies: scopolamine"; Zofran, reaction(s): "Known allergies: zofran". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13May2022, outcome "not recovered", described as "Dose 3: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" 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.  Clinical course: The patient was received other medication in 2 weeks. She took Paxlovid from 09Jan2023 to 13Jan2023 for the treatment of COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 62-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "seasonal asthma" (unspecified if ongoing); "borderline diabetic" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: iodine intravenously, reaction(s): "Known allergies: Iodine intravenously"; Known allergies: immetrix, reaction(s): "Known allergies: Immetrix"; Known allergies: morphine, reaction(s): "Known allergies: Morphine". 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.  Additional information: Report about covid treatment: Yes, If vaccine received: Yes with Paxlovid (Treatment start date: 09Jan2023 and Treatment stop date: 14Jan2023).  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9702), 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), 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), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: tested negative during treatment with Paxlovid; (17Jan2023) Positive, notes: positive antigen test 2 days after last dose of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Rebound/recurrence of Covid symptoms and positive antigen test 2 days after last dose of Paxlovid. Had been asymptomatic and tested negative during treatment with Paxlovid
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Oropharyngeal pain, Throat tightness
Clinical narrative: Her throat hurts still, and when she eats her throat is tight.; Her throat hurts still, and when she eats her throat is tight.; Stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, She knows she has received 5 Pfizer vaccines though), for Covid-19 immunization; Bnt162b2 (Dose 2, She knows she has received 5 Pfizer vaccines though), for Covid-19 immunization; Bnt162b2 (Dose 3, She knows she has received 5 Pfizer vaccines though), for Covid-19 immunization; Bnt162b2 (Dose 4, She knows she has received 5 Pfizer vaccines though), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 30Oct2022, outcome "unknown", described as "Stroke"; OROPHARYNGEAL PAIN (non-serious), THROAT TIGHTNESS (non-serious), outcome "not recovered" and all described as "Her throat hurts still, and when she eats her throat is tight."  Clinical Course: She took the Corona booster on 25Oct2022. She had a stroke on 30Oct2022. She thought it had something to do with the booster. Her throat hurts still, and when she eats her throat was tight. She did not think she had recovered. Her throat hurts when she eats. Her family doesn't let her be by herself now. Her son and family were afraid she might have another stroke. She doesn't have her vaccine card with her information on it. She knows she had received 5 Pfizer vaccines though. This most recent booster was given in her left arm. She received it before noon that day. She was fine before this. She would still cut grass and drive her car. She could mop and vacuum. She didn't even feel bad before the stroke. She was older and felt like she should, but she didn't feel bad. Patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). There was no Family Medical History Relevant to Adverse Events (AEs). No Relevant Tests performed.  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: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Rash, Tenderness
Clinical narrative: Itching/Itchiness; Rash; Tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14Jan2023 as dose number unknown, single (Lot number: GF7610) at the age of 63 years, in left arm for immunisation. The patient's relevant medical history included: "Elevated Blood pressure" (ongoing), notes: Elevated Blood pressure Taking Amlodipine for this. Onset, in her 30s, about 20-30 yrs ago.; "allergies to seashells" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: pneumococcal pneumovax, administration date: 26Sep2020, for Immunization. The following information was reported: TENDERNESS (non-serious) with onset 15Jan2023, outcome "not recovered"; RASH (non-serious) with onset 18Jan2023, outcome "not recovered"; PRURITUS (non-serious) with onset 19Jan2023, outcome "not recovered", described as "Itching/Itchiness". Therapeutic measures were taken as a result of rash, tenderness.  Additional information: She experienced adverse events of rash, tenderness and itching after receiving Prevnar 20. Rash: Affected area is left arm, same arm that product was administered in. She described as delayed reaction relative to date of administration of product. Initial onset of rash was just a small spot, now half of her arm has rashes. Rash is getting bigger every day. Itchiness: Worsened today, itchiness increasing 20Jan2023. As treatment for rash she already took a prescription antihistamine: Loratadine as directed by the pharmacy when she called them; and As treatment for the tenderness she already took over the counter product Tylenol as directed by the pharmacy when she called them; but it just looks like it is not working because the rashes are getting much bigger and the tenderness has worsened. As treatment for rash took Loratadine; and as treatment for tenderness took over the counter product Tylenol; but it just looks like it is not working because the rashes are getting much bigger and the tenderness has worsened.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Malaise, Nausea, Pyrexia
Clinical narrative: Severe headache; Nausea; Axillary Adenopathy; Fever; Malaise; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, and all previous Pfizer COVID-19-19 vaccines [Comirnaty]), for Covid-19 Immunization, reaction(s): "Severe headache", "Axillary Adenopathy", "Malaise", "Nausea", "Fever". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Severe headache"; NAUSEA (non-serious), outcome "unknown"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Axillary Adenopathy"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; MALAISE (non-serious), outcome "unknown".  Additional Information: It was reported that within 14 hours after administration of Pfizer COVID-19 vaccine, bi-valent (and all previous Pfizer COVID-19-19 vaccines [Comirnaty]). Name of Product: Pfizer-Moderna COVID-19 vaccine, bi-valent. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Feeling abnormal, Heart rate
Clinical narrative: fast heart rate; Shortness of breath; drained; fatigued; really felt bad; The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart rate"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; ASTHENIA (non-serious), outcome "unknown", described as "drained"; FATIGUE (non-serious), outcome "unknown", described as "fatigued"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "really felt bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was calling about the Pfizer 2nd booster that caller got in October. Upon attempting to clarify which Pfizer 2nd booster patient was calling about, patient looked at vaccination card and clarified the product was the Pfizer bivalent COVID-19 vaccine. She stated she had the lot number, however declined to complete report or provide additional information prior to transfer, therefore patient did not provide the lot number prior to transfer. Had side effects, really felt bad after the vaccine, didn't get allergic side effects, but caller was drained, fatigued, had shortness of breath which that hasn't really subsided. Had maybe a fast heart rate, was not really exerting self for fear of not a good sign.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heart rate; Shortness of breath; drained; fatigued; really felt bad; The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart rate"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; ASTHENIA (non-serious), outcome "unknown", described as "drained"; FATIGUE (non-serious), outcome "unknown", described as "fatigued"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "really felt bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was calling about the Pfizer 2nd booster that caller got in October. Upon attempting to clarify which Pfizer 2nd booster patient was calling about, patient looked at vaccination card and clarified the product was the Pfizer bivalent COVID-19 vaccine. She stated she had the lot number, however declined to complete report or provide additional information prior to transfer, therefore patient did not provide the lot number prior to transfer. Had side effects, really felt bad after the vaccine, didn't get allergic side effects, but caller was drained, fatigued, had shortness of breath which that hasn't really subsided. Had maybe a fast heart rate, was not really exerting self for fear of not a good sign.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mental disorder
Clinical narrative: Read our brain/when I think about something and talk about that matter, example, when I am washing my dishes, and in my mind, I search for, it comes to my phone, and it is exactly what was in my mind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 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: MENTAL DISORDER (non-serious), outcome "unknown", described as "Read our brain/when I think about something and talk about that matter, example, when I am washing my dishes, and in my mind, I search for, it comes to my phone, and it is exactly what was in my mind".  Additional information: Caller stated I am not kidding; this was really serious about that. I got the COVID 19 vaccine, the Pfizer for the COVID. After that, I want to know if this medication can read our brain. After receiving the medication, and this also happen to other people, when I think about something and talk about that matter, for example, when I was washing my dishes, and in my mind, I search for, it comes to my phone, and it was exactly what was in my mind, you know. I talk about everything that happen, but it was not only for me, I saw many people reporting this. I know that tech was improving but this was a lil bit scary. When asked if this was after a booster or a primary series dose, the caller did not clarify the type of dose and just mentioned she know people that report this after just two doses.  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: Arthralgia, Back pain, Swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SWELLING (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Pain in their back and shoulders as well as swelling".  Additional information: caller also wants to know : If any seniors have had big time pain in their back and shoulders as well as swelling. Caller would like a list of the reported side effects/adverse events for her own behalf at this time. She states she is "having a rough time with this." Caller stated that her "phone is hacked due to attempted drug sales due to a felony drug charge, her phone is hacked by a criminal." No medical information provided to caller during phone call. I was speaking to Withheld earlier and was telling her about a bad reaction I had to the Pfizer COVID shot and I forgot to tell her about one other symptom.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 72.0
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Computerised tomogram, Magnetic resonance imaging, Off label use, Product use issue, Transient ischaemic attack
Clinical narrative: TIA; off label use; Product use for unapproved combination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 14:00 as dose 4 (booster), single (Lot number: C7J3277) at the age of 72 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), single; manufacturer unknown), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 27Oct2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 27Oct2022, outcome "unknown"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant) with onset 22Nov2022 at 16:30, outcome "recovered", described as "TIA". The patient was hospitalized for transient ischaemic attack (hospitalization duration: 2 day(s)). The event "tia" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: unknown, notes: CT (2); unknown, notes: CT (2); Magnetic resonance imaging: unknown. Therapeutic measures were taken as a result of transient ischaemic attack.  Clinical course:  Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. AE treatment: CT (2), MRI.
Age: 63.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 18:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 63 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (12Jan2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jan2023) Negative; (13Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about COVID treatment: Yes. No other medication in 2 weeks: No. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid. Treatment start date: 06Jan2023, Treatment stop date: 10Jan2023, Paxlovid completed 10Jan2023. All symptoms resolved, and two negative antigen tests on 12Jan2023 and 13Jan2023.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 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: "mitral valve repair in 2017", start date: 2017, stop date: 2017, notes: mitral valve repair in 2017. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jan2023) negative, notes: Tested negative on day 10; (19Jan2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti viral product COVID 19 treatment, Paxlovid, from 08Jan2023 to 13Jan2023. Patient had no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 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 included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was previously received a COVID-19 Vaccine. Patient was received Paxlovid as treatment. Treatment start date: 11Jan2023, Treatment stop date: 16Jan2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Extra dose administered, Feeling abnormal, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose number: 5, Brand: Pfizer /  Dose number: 4, Product: Moderma; Unusual weakness, sleeping longer hours, all over feeling strange.; Unusual weakness, sleeping longer hours, all over feeling strange.; Unusual weakness, sleeping longer hours, all over feeling strange.; Extra Dose Administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 14:30 as dose 5 (booster), single (Lot number: GJ3275) at the age of 79 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2022 as dose 4 (booster), single (Lot number: 054A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: CRESTOR; HYDRALAZINE; XARELTO. Past drug history included: Codine, reaction(s): "Known allergies: Codine", notes: Known allergies: Codine. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, life threatening) with onset 17Nov2022 at 14:30, outcome "unknown", described as "Dose number: 5, Brand: Pfizer /  Dose number: 4, Product: Moderma"; EXTRA DOSE ADMINISTERED (non-serious) with onset 17Nov2022 at 14:30, outcome "unknown"; ASTHENIA (caused and prolonged hospitalization, life threatening), SLEEP DISORDER (caused and prolonged hospitalization, life threatening), FEELING ABNORMAL (caused and prolonged hospitalization, life threatening) all with onset 20Nov2022 at 12:00, outcome "recovered with sequelae" and all described as "Unusual weakness, sleeping longer hours, all over feeling strange.". The patient was hospitalized and prolonged hospitalization for asthenia, sleep disorder, feeling abnormal (hospitalization duration: 25 day(s)). The event "unusual weakness, sleeping longer hours, all over feeling strange." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2022) Negative, notes: COVID test name post vaccination: In hospital. Therapeutic measures were taken as a result of asthenia, sleep disorder, feeling abnormal.  Clinical information: Patient had not received other vaccines in four weeks. Other medication in two weeks: Crestor, Hydralazine, Xarelto. AE treatment: new meds and therapy. No COVID prior vaccination, COVID tested post vaccination: yes
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: Dose number: 5, Brand: Pfizer /  Dose number: 4, Product: Moderma; Unusual weakness, sleeping longer hours, all over feeling strange.; Unusual weakness, sleeping longer hours, all over feeling strange.; Unusual weakness, sleeping longer hours, all over feeling strange.; Extra Dose Administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 14:30 as dose 5 (booster), single (Lot number: GJ3275) at the age of 79 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2022 as dose 4 (booster), single (Lot number: 054A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: CRESTOR; HYDRALAZINE; XARELTO. Past drug history included: Codine, reaction(s): "Known allergies: Codine", notes: Known allergies: Codine. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, life threatening) with onset 17Nov2022 at 14:30, outcome "unknown", described as "Dose number: 5, Brand: Pfizer /  Dose number: 4, Product: Moderma"; EXTRA DOSE ADMINISTERED (non-serious) with onset 17Nov2022 at 14:30, outcome "unknown"; ASTHENIA (caused and prolonged hospitalization, life threatening), SLEEP DISORDER (caused and prolonged hospitalization, life threatening), FEELING ABNORMAL (caused and prolonged hospitalization, life threatening) all with onset 20Nov2022 at 12:00, outcome "recovered with sequelae" and all described as "Unusual weakness, sleeping longer hours, all over feeling strange.". The patient was hospitalized and prolonged hospitalization for asthenia, sleep disorder, feeling abnormal (hospitalization duration: 25 day(s)). The event "unusual weakness, sleeping longer hours, all over feeling strange." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2022) Negative, notes: COVID test name post vaccination: In hospital. Therapeutic measures were taken as a result of asthenia, sleep disorder, feeling abnormal.  Clinical information: Patient had not received other vaccines in four weeks. Other medication in two weeks: Crestor, Hydralazine, Xarelto. AE treatment: new meds and therapy. No COVID prior vaccination, COVID tested post vaccination: yes
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 3: Pfizer BNT162B2// Dose 1, 2, 4, 5: Moderna COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and on 06Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2021, outcome "unknown", described as "Dose 3: Pfizer BNT162B2// Dose 1, 2, 4, 5: Moderna COVID-19 Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 11Jan2023 to 15Jan2023.  No follow-up attempts are possible. No further information is expected.
Sex: M
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 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Day 7; Negative, notes: Day 8; Negative, notes: Day 9; Positive, notes: Day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about COVID vaccine yes, Reporter type patient, Relevant medical history and concurrent conditions, Structured information(Patient episode name) no, Did you the patient previously receive a COVID-19 Vaccine yes, product COVID 19 Treatment, vaccine lot unknown reason unable to locate or read the details, Device timestamp: 21Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose number unknown (booster), single (Lot number: GH9702) at the age of 31 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Nov2021 as dose number unknown, single (Lot number: FF2590), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Apr2021 as dose number unknown, single (Lot number: 008C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive rapid test after days of no symptoms and testing negative; Negative, notes: positive rapid test after days of no symptoms and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Experienced rebound of COVID-19 symptoms along with positive rapid test after days of no symptoms and testing negative. Proprietary medicinal product name: Paxlovid (Indication for use in the case: Treatment of COVID-19, Date of start of drug: 09Jan2023, Date of last administration: 13Jan2023).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300031642 same patient, different vaccine dose and event;
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Lot number: Gh9703) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Oct2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17May2022 as dose 3 (booster), single (Lot number: F54991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "RNY gastric bypass" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: cephalosporins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levofloxacin, reaction(s): "known allergies: levofloxacin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Negative, notes: Did have negative COVID test at end of treatment; (21Jan2023) Positive, notes: Positive COVID test 4 days after end of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral COVID 19 Treatment Paxlovid from 11Jan2023 to 17Jan2023  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 close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 and the reported events drug ineffective, COIVD-19.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore at the injection site for the previous vaccines/sore arm at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 at 19:00 as dose 1, single (Lot number: EL3249, Expiration Date: May2021) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pacemaker placement", start date: 2021 (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Had all vaccines, from shingles to whatever, for immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore at the injection site for the previous vaccines/sore arm at the injection site".  Additional Information: Patient had the first shot Jan2021. Patient didn't have any side effects with the previous vaccines except maybe just a sore arm at the injection site. He has noticed references to heart issues, and he has a pacemaker. Pacemaker placed: sometime in the year of 2021, but he had issues before the COVID-19 vaccines. More recently he had atrial fibrillation and was given two medications. The atrial fibrillation was light, so they didn't want to shock his heart. Appears the atrial fibrillation was gone. Had symptoms of that at night before receiving the COVID-19 vaccines. Thought muscles were twitching before they discovered it was tied in with the heart. When he would lay on his left shoulder, it felt like a light vibration. He was given the pacemaker, then had Atrial fibrillation, then given the medicine to take care of it. Investigations: none. Primary doctor and specialist are really good about keeping bloodwork up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300029209 same reporter/patient, different events/doses;
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, Body height, Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter. An 80-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 79 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "heart issues" (unspecified if ongoing); "Pacemaker placed", start date: 2021 (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Manufacturer: Pfizer , NDC: Unknown , LOT: EL3249 , EXP: May2021 , Dose and Route: injected into left arm; dose amount unknown Time: 7PM), administration date: 18Jan2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "a sore arm at the injection site"; BNT162b2 (Dose 2, single, Manufacturer: Pfizer , NDC: Unknown , LOT: EN9581 , EXP: May2021 , Dose and Route: injected into left arm; dose amount unknown Time: 10AM), administration date: 08Feb2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "a sore arm at the injection site"; Shingles, for Immunization agains shingles.  Additional information: Patient and his wife both had the primary two doses. Then a 3rd dose that they thought was a booster dose on 11Oct2021 at 8AM-9AM. The 4th dose was actually a booster took on 27Apr2022. The 5th dose was a bivalent COVID-19 Vaccine took on 09Sep2022. Then today (19Jan2023), received another bivalent COVID-19 Vaccine. Patient stated all of their shots were Pfizer. Stated they did not have any side effects with the vaccines but maybe sore at the injection site for the previous vaccines. Medical conditions: Nothing necessarily. He has noticed references to heart issues and he has a pacemaker. Pacemaker placed: sometime in the year of 2021, but he had issues before the COVID-19 vaccines More recently he had atrial fibrillation and was given two medications. The atrial fibrillation was light, so they did not want to shock his heart. Appears the atrial fibrillation is gone. Atrial fibrillation: had symptoms of that at night before receiving the COVID-19 vaccines. Thought muscles were twitching before they discovered it was tied in with the heart. When he would lay on his own left shoulder, it felt like a light vibration. He was given the pacemaker, then had Atrial fibrillation, then given the medicine to take care of it. Investigations: none primary doctor and specialist are really good about keeping bloodwork up. Patient gave blood today (as reported). The report is not related to a study or programme.