chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus
Clinical narrative: left arm became very red; itching from the injection site muscle; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: left arm became very red) and injection site itching (Verbatim: itching from the injection site muscle). The outcome of the injection site erythema was resolving and the outcome of the injection site itching was resolved (duration 10 days).   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  It was unknown if the company considered the injection site erythema and injection site itching to be related to Shingrix.   Additional Information: GSK Receipt date: 23-JUN-2023 A reporter reported about him self he received the first dose of Shingrix at his left arm on end of Apr 2023. The reporter states that after his injection, his left arm became very red and was itching from the injection site muscle, down the top for 10 days, but the redness lasted a little longer and got lighter and lighter after 10 days. The reporter was consent to follow up.   Upon internal review the case was updated on 20-NOV-2023. This case was initially processed as invalid, however upon significant follow-up received on 23-JUN-2023, case became valid and it was missed to add appropriate significant follow-up tracking, due to which regulatory reports had not been scheduled. The case was amended for error correction. Summary of Changes: Significant amendment tracking added with description as error correction and narrative updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: her neuropathy was also a bit worse after those doses; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (her neuropathy was also a bit worse after those doses) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 030620A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Neuropathy.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (her neuropathy was also a bit worse after those doses) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (her neuropathy was also a bit worse after those doses) outcome was unknown.            It was reported that patient had no any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that She experienced no other symptoms. She didn´t experience anything with the previous doses. Maybe her neuropathy was also a bit worse after those doses, but it was not unbearable, she could deal with it.  Treatment information was not provided. Company Comment: This is a spontaneous case concerning a 68-year-old female patient with a history of Diabetes and Neuropathy, who experienced the serious (due to medically significant) unexpected, event of neuropathy peripheral, which occurred on an unknown date after a dose of mRNA-1273 vaccine. It was reported that she experienced no other symptoms. She didn´t experience anything with the previous doses. Maybe her neuropathy was also a bit worse after those doses, but it was not unbearable, she could deal with it. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749431, US-MODERNATX, INC.-MOD-2023-749436 (E2B Linked Report). This case was linked to MOD-2023-749431, MOD-2023-749436 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749431:Same patient, spikevax 2023-2024 US-MODERNATX, INC.-MOD-2023-749436:same patient spikevax NOS case
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: had blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (had blood clots) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (had blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (had blood clots) outcome was unknown.            No concomitant medications were reported. It was reported that patient had the blood clots after Moderna covid shot and clarified it was either the 2nd Moderna covid shot or the third Moderna covid shot, not sure but it was the Moderna covid vaccine. Patient received all moderna shots. So patient was hesitant to get the new latest version of covid19 vaccine.  No treatment medications were reported.  Company Comment This spontaneous case concerns an unknown age and gender patient with no medical history reported who experienced the unexpected medically significant seriousness criteria AESIs of thrombosis unknown days after 3rd. dose of SPIKEVAX NOS vaccine. Concomitant medication details nor Treatment details were reported. At the time of the report, the outcome of the event was unknown. The medical history is a contributor for the events. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeding disorder, Illness, Influenza like illness, Nausea
Clinical narrative: She did experience flu like symptoms with the 2nd shot; she got very sick after receiving the 2nd shot.; she couldn't eat anything after receiving the 2nd shot.; she felt dizzy after receiving the 2nd shot.; she was nauseous after receiving the 2nd shot.; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (She did experience flu like symptoms with the 2nd shot), ILLNESS (she got very sick after receiving the 2nd shot.), FEEDING DISORDER (she couldn't eat anything after receiving the 2nd shot.), DIZZINESS (she felt dizzy after receiving the 2nd shot.) and NAUSEA (she was nauseous after receiving the 2nd shot.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy (Patient is allergic to penicillin and does receive a shot every month for allergies.).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (She did experience flu like symptoms with the 2nd shot), ILLNESS (she got very sick after receiving the 2nd shot.), FEEDING DISORDER (she couldn't eat anything after receiving the 2nd shot.), DIZZINESS (she felt dizzy after receiving the 2nd shot.) and NAUSEA (she was nauseous after receiving the 2nd shot.). At the time of the report, INFLUENZA LIKE ILLNESS (She did experience flu like symptoms with the 2nd shot), ILLNESS (she got very sick after receiving the 2nd shot.), FEEDING DISORDER (she couldn't eat anything after receiving the 2nd shot.), DIZZINESS (she felt dizzy after receiving the 2nd shot.) and NAUSEA (she was nauseous after receiving the 2nd shot.) had resolved.            No concomitant medication was reported.  Patient received all Moderna COVID-19 shots in the past and she did experience flu like symptoms with the 2nd shot. She states that she got very sick and couldn't eat anything, was nauseous and felt dizzy after receiving the 2nd shot. These symptoms lasted for half a day to one day. Patient reported that the side effects after the 2nd dose were the worst for her.   She did not have any side effects after the 1st or 3rd dose. However, later during the call, patient stated that she did feel dizzy 2-3 hours after receiving the 3rd dose of the Moderna COVID-19 vaccine.   She wants to know if this could be a side effect of the vaccine and wants advice on whether she called her doctor regarding this.   No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-749372 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749372:Same reporter (SPIKEVAX 2023-2024)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Spikevax (Dose 2) and Spikevax (Dose 1). Past adverse reactions to the above products included No adverse event with Spikevax and Spikevax. Concurrent medical conditions included Autoimmune disorder and Hashimoto's thyroiditis. Concomitant products included LEVOTHYROXINE SODIUM (UNITHROID) for Hashimoto's thyroiditis.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2022, the patient experienced COVID-19 (covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) outcome was unknown.            It was reported that it came out later that people with thyroid disease should not get the vaccine. Caller did not go get the recent one because it affects the results.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Patient stated they had the vaccine on Sunday (12Nov2023). Monday night at 5:30 pm she had severe vertigo.; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Patient stated they had the vaccine on Sunday (12Nov2023). Monday night at 5:30 pm she had severe vertigo.) in a 56-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (3rd vaccine) and Pfizer (first 2 vaccine). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and Pfizer.    On 12-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 13-Nov-2023 at 5:30 PM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VERTIGO (Patient stated they had the vaccine on Sunday (12Nov2023). Monday night at 5:30 pm she had severe vertigo.). At the time of the report, VERTIGO (Patient stated they had the vaccine on Sunday (12Nov2023). Monday night at 5:30 pm she had severe vertigo.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she received the first 2 vaccine where Pfizer and that she does not remember the 3rd dose.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Chills, Headache, Illness, Injection site pain
Clinical narrative: First break out in a rash, under my chin, on the side of my face my jaw on one side; headache; fever; muscle aches; chills; my Covid vaccines have all been Pfizer's Fine. I've had reactions; my Covid vaccines have all been Pfizer's Fine. I've had reactions; I was feeling ill; On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore; injection site pain; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I was feeling ill), PERIPHERAL SWELLING (On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore), INJECTION SITE PAIN (injection site pain), RASH (First break out in a rash, under my chin, on the side of my face my jaw on one side) and HEADACHE (headache) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203g23a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included PARACETAMOL (TYLENOL) for Fever and Pain.    On 12-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 12-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INJECTION SITE PAIN (injection site pain). On an unknown date, the patient experienced ILLNESS (I was feeling ill), PERIPHERAL SWELLING (On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore), RASH (First break out in a rash, under my chin, on the side of my face my jaw on one side), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches), CHILLS (chills), INTERCHANGE OF VACCINE PRODUCTS (my Covid vaccines have all been Pfizer's Fine. I've had reactions) and COVID-19 IMMUNISATION (my Covid vaccines have all been Pfizer's Fine. I've had reactions). At the time of the report, ILLNESS (I was feeling ill), INJECTION SITE PAIN (injection site pain), RASH (First break out in a rash, under my chin, on the side of my face my jaw on one side), HEADACHE (headache), PYREXIA (fever) and MYALGIA (muscle aches) had not resolved, PERIPHERAL SWELLING (On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore), INTERCHANGE OF VACCINE PRODUCTS (my Covid vaccines have all been Pfizer's Fine. I've had reactions) and COVID-19 IMMUNISATION (my Covid vaccines have all been Pfizer's Fine. I've had reactions) outcome was unknown and CHILLS (chills) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. The rash on patient's face went away and it's just now the one on the arm.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Myalgia, Peripheral swelling, Pyrexia, Rash
Clinical narrative: First break out in a rash, under my chin, on the side of my face my jaw on one side; headache; fever; muscle aches; chills; my Covid vaccines have all been Pfizer's Fine. I've had reactions; my Covid vaccines have all been Pfizer's Fine. I've had reactions; I was feeling ill; On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore; injection site pain; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I was feeling ill), PERIPHERAL SWELLING (On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore), INJECTION SITE PAIN (injection site pain), RASH (First break out in a rash, under my chin, on the side of my face my jaw on one side) and HEADACHE (headache) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203g23a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included PARACETAMOL (TYLENOL) for Fever and Pain.    On 12-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 12-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INJECTION SITE PAIN (injection site pain). On an unknown date, the patient experienced ILLNESS (I was feeling ill), PERIPHERAL SWELLING (On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore), RASH (First break out in a rash, under my chin, on the side of my face my jaw on one side), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches), CHILLS (chills), INTERCHANGE OF VACCINE PRODUCTS (my Covid vaccines have all been Pfizer's Fine. I've had reactions) and COVID-19 IMMUNISATION (my Covid vaccines have all been Pfizer's Fine. I've had reactions). At the time of the report, ILLNESS (I was feeling ill), INJECTION SITE PAIN (injection site pain), RASH (First break out in a rash, under my chin, on the side of my face my jaw on one side), HEADACHE (headache), PYREXIA (fever) and MYALGIA (muscle aches) had not resolved, PERIPHERAL SWELLING (On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore), INTERCHANGE OF VACCINE PRODUCTS (my Covid vaccines have all been Pfizer's Fine. I've had reactions) and COVID-19 IMMUNISATION (my Covid vaccines have all been Pfizer's Fine. I've had reactions) outcome was unknown and CHILLS (chills) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. The rash on patient's face went away and it's just now the one on the arm.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Spotting; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERMENSTRUAL BLEEDING (Spotting) in a 55-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer ((Dose 1) Lot number: EH9A99) on 21-Dec-2020, Pfizer ((Dose 2) Lot number: EL12A3) on 11-Jan-2021, Pfizer ((Dose 3) Lot number: EW0161) on 30-Sep-2021, MODERNA COVID-19 VACCINE ((Dose 4) Lot number: 056A22A) on 05-Jun-2022 and MODERNA COVID-19 VACCINE ((Dose 5) Lot number: 030G22B) on 30-Sep-2022. Past adverse reactions to the above products included No adverse reaction with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, Pfizer, Pfizer and Pfizer.    On 13-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 15-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INTERMENSTRUAL BLEEDING (Spotting). At the time of the report, INTERMENSTRUAL BLEEDING (Spotting) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient asked if Spikevax can cause post-menopause bleeding. Her condition was still ongoing.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: the connection between the antigen vial and diluent syringe not going well; other Abrysvo vaccines that had the connection between the antigen vial and diluent syringe not going well/ those were all administered to patients; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown,single (Lot number: HF5020, Expiration Date: Feb2025) for immunisation; for immunisation, Device Lot Number: F655, Device Expiration Date: 01May2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE CONNECTION ISSUE (non-serious), described as "the connection between the antigen vial and diluent syringe not going well"; POOR QUALITY DEVICE USED (non-serious), described as "other Abrysvo vaccines that had the connection between the antigen vial and diluent syringe not going well/ those were all administered to patients".  Causality for "the connection between the antigen vial and diluent syringe not going well" and "other abrysvo vaccines that had the connection between the antigen vial and diluent syringe not going well/ those were all administered to patients" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: The reporter called that he had been having experiences with the connection between the antigen vial and diluent syringe which was not going well and he did have one yesterday (09Nov2023) that actually came apart and he wasted that dose. It was at the collar of the vial and looked to him like the collar had broken possibly and he couldn't quite tell but when putting the two together for the diluent syringe and vial and after connecting them and pushing the diluent syringe, it came apart completely and sometimes he noted the connection was not complete and it wanted to unscrew. The Abrysvo vaccine from yesterday that came apart was not administered to any patient. Lot number for yesterday one: Antigen vial: lot number HF5020, expiry date Feb2025. Vial Adaptor: lot number F655, expiry date 01May2027. Diluent syringe: lot is HA3217 with expiry date Mar2025. For the other Abrysvo vaccines that had the connection between the antigen vial and diluent syringe not going well and for the Abrysvo vaccines that want to come unscrewed, he was dealing with it and did not have an explanation on why they were trying to come unscrewed and he was able to deal with those and still operate with those using dexterity with his fingers and it keeps those vaccines viable and those were all administered to patients.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 78.0
Sex: M
Vaccine: COVID19, FLUX, PPV, RSV
Symptoms: Retinal artery occlusion, Retinal vein occlusion
Clinical narrative: loss of vision; Retinal Vein or Artery Occlusion; Retinal Vein or Artery Occlusion; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 13:00 as dose 1, single (Lot number: HH7595) at the age of 78 years, in left arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 18Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for immunisation; influenza vaccine (INFLUENZA), on 18Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 18Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Prediabetic" (unspecified if ongoing); "CKD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: RETINAL ARTERY OCCLUSION (hospitalization, disability, medically significant), RETINAL VEIN OCCLUSION (hospitalization, disability, medically significant) all with onset 25Sep2023, outcome "not recovered" and all described as "Retinal Vein or Artery Occlusion"; BLINDNESS (hospitalization, disability, medically significant) with onset 25Sep2023, outcome "not recovered", described as "loss of vision". The patient was hospitalized for blindness, retinal artery occlusion, retinal vein occlusion (hospitalization duration: 5 days). The events "loss of vision" and "retinal vein or artery occlusion" required emergency room visit. Clinical course: On 25Sep2023, the patient suffered sudden onset of retinal vein or artery occlusion in left eye which resulted in loss of vision in that eye. The adverse events resulted in an emergency room/department or urgent care, hospitalization, disability, or permanent damage.  The patient did not receive any other vaccines within four weeks prior to the vaccines. The patient did not receive any other medications within two weeks to the vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies.  It was unknown if therapeutic measures were taken as a result of blindness, retinal artery occlusion, retinal vein occlusion.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Interchange of vaccine products
Clinical narrative: lost taste and lost smell; lost taste and lost smell; tiredness; mixing the moderna covid vaccine and then taking the Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 67-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "dosen't somke" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE (ongoing); AZELASTINE (ongoing). Vaccination history included: Moderna covid vaccine (dose number unknown), for COVID-19 immunisation, reaction(s): "tired", "body aches". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10Nov2023, outcome "unknown", described as "mixing the moderna covid vaccine and then taking the Pfizer vaccine"; FATIGUE (non-serious) with onset 10Nov2023, outcome "unknown", described as "tiredness"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 10Nov2023 at 01:00, outcome "not recovered" and all described as "lost taste and lost smell".  Additional information: The patient was taking the Moderna vaccine and was given advice to get the Pfizer COVID booster. The patient stated every time she got vaccinated, she got sick, always, every time brings a new COVID booster. Confirmed all prior doses the patient received were the Moderna COVID vaccine. This was the patient's first dose of a Pfizer COVID vaccine. When pharmacist gave the patient the booster, pharmacist said if the patient has any discomfort to just take some Tylenol, the patient didn't have any discomfort so the patient didn't take any. In the past when vaccinated the patient had body aches, terrible, laying on couch, wanted to die, the patient didn't want to get vaccine, sick and tired, makes she sick every time that she took vaccine, but this time with Pfizer COVID booster, was different, this time lost taste and lost smell. Has never has lost smell or taste, this is the first time. When the patient got home, was doing something, felt like almost for a lack or words like when had driven in a car and had to go to a stick shift, felt like body for a split second got tiredness, then from that started cooking tacos, thought why can't smell the spice, so strong. Realized what was going on, felt that change in body, so sad. She said at about 1 o'clock on Friday (10Nov2023), she lost taste and lost smell, had been like that since Friday. The patient asked If mixing the moderna covid vaccine and then taking the Pfizer vaccine would that create the problem of smell and taste. Additional concomitant medication included vitamins. The patient stated she is pretty healthy. The patient doesn't drink or smoke or do drugs.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: arms swelled up to like twice the size; turned all red; it was hot; reddish; turned all red; it was hot; reddish; felt little nauseous; Fever; 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 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), on 26Sep2018 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for pneumococcal immunisation; for pneumococcal immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "chronic illness" (unspecified if ongoing); "allergic" (unspecified if ongoing), notes: allergic to certain things. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Sep2018, outcome "unknown", described as "Fever"; PERIPHERAL SWELLING (non-serious) with onset Sep2018, outcome "unknown", described as "arms swelled up to like twice the size"; NAUSEA (non-serious) with onset Sep2018, outcome "unknown", described as "felt little nauseous"; ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset Sep2018, outcome "unknown" and all described as "turned all red; it was hot; reddish". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, erythema, feeling hot, nausea, pyrexia.  Additional information: Reporter was patient, who calling in and asking about the RSV (Abrysvo) shot. She mentioned that she has MS and for some strange reason when she got the Pneumonia shot back in 2018, she had a reaction and she is trying to find out if that has the same ingredients as the Pneumonia shot. She said that she wanted to get the shot but she don't want to have a reaction. Patient would like to report an adverse event with the product Prevnar 13. The patient received a dose of Prevnar 13, last 2018 and she developed a reaction after the administration of the drug (Prevnar 13) but she did not specify the symptoms of the reactions that she had. Reporter stated, It didn't happen right away, it happened like her arms swelled up to like twice the size, it turned all red, it was hot, and she had a fever and felt little nauseous. It was hot and reddish. Other Medical Condition and Concomitant medications, Patient stated, she had and that is why it was important for her to get all shots, so she was told to get them, but she mean that is the only chronic illness that she have. No Prior vaccinations. Treatment included just Tylenol and warm compression that is it.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Sneezing
Clinical narrative: cold; stuffy nose; sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 at 16:30 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 11Nov2023, outcome "recovering", described as "cold"; SNEEZING (non-serious) with onset 11Nov2023, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 11Nov2023, outcome "recovering", described as "stuffy nose". Therapeutic measures were not taken as a result of nasopharyngitis, nasal congestion, sneezing.  Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: problems regarding my memory; 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.  An 85-year-old female patient received bnt162b2 (BNT162B2), as dose number unknown, single (Lot number: EL9269) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "problems regarding my memory".
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  An 81-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure", start date: 2012 (unspecified if ongoing); "passed out" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Primary Immunization series completed), for Covid-19 immunization; Bnt162b2 (dose number unknown (booster), single), for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 15Nov2023, outcome "unknown", described as "passed out". Clinical course: Reporter and his wife got both Covid 19 vaccines since it started including the booster. His wife passed out three times within the past 1.5 years. Most recently that day. Had heard that this was a possible side effect of the vaccine. Wanted to report the experience and find out if this was indeed coming from the vaccine. Reporter stated his wife passed out that day and the first time she was age 81 when it happened first and she was then age 82. The dates his wife passed out were 15Jul2022, 16Dec2022, and that day 15Nov2023. The only date of the Pfizer covid vaccine he had was for her last booster shot that was on 14Nov2023 at (Withheld) and he had no other dates of her other doses and no lots, expiry dates or NDC numbers to provide for any of her covid vaccines. One time when she went to the hospital, they said they did not know what it was and it might be her heart so they went to a heart specialist who said it was probably not and to keep checking it and the last thought was that she might be dehydrated. When the patient went to the hospital she was there for a day and was there overnight and then the next day they went home.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Vaccination site pain
Clinical narrative: headaches; itchy; pain on the arm like it has been punched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (maybe 10 years before this report), for Immunization; Shingrix, for Immunization, reaction(s): "arms started to itch", "rash on her whole arm". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; PRURITUS (non-serious), outcome "unknown", described as "itchy"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain on the arm like it has been punched".  Additional information: Patient mentioned that she got the Pfizer Covid-19 vaccine "booster" yesterday. She said she never had a bad reaction to the Pfizer covid-19 vaccines. She only felt slight headaches. She wants to check if it is normal to feel itchy and have pain on the arm like it has been punched.  The patient mentioned that she got the Pfizer Covid-19 vaccine "booster" yesterday. She said she never had a bad reaction to the Pfizer covid-19 vaccines. She is looking to get the Pfizer RSV vaccine (Abrysvo). She wants to know if she should space out the vaccination. She also mentioned that her doctor told her to space them out and not get them all at once. Additional research is ongoing to further inform guidance on same-day administration of the RSV vaccine and other adult vaccines, including the COVID-19 vaccine. The patient had several questions regarding the pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), rsv vaccine prot.subunit pref 2v (ABRYSVO) and Pfizer Covid-19 vaccine for adults.  The patient mentioned that she got the Pfizer Covid-19 vaccine "booster" yesterday. She is planning to get the ABRYSVO vaccine a four more weeks after. She wants to know if it is okay to have it on her left arm where she got her covid-19 vaccine. The patient said she took the Prevnar 13 vaccine when it first came out and she doesn't know if she should take the Prevnar 20 vaccine now since she already has the Prevnar 13 vaccine. The patient is looking to get the Pfizer RSV vaccine. She mentioned that she had a reaction with the Shingrix, a shingles vaccine. She thinks the Shingrix vaccine is an adjuvanted vaccine because she had a reaction where her arms started to itch and there is rash on her whole arm. She went to the dermatologist and was advised to not take the second dose anymore. She wants to know if the Pfizer RSV vaccine is adjuvanted.
Age: 70.0
Sex: F
Vaccine: COVID19, FLUX, TTOX
Symptoms: Cough, Fatigue, Hyperhidrosis, Pain, Upper respiratory tract congestion
Clinical narrative: Achy; head stuffy; cough; tired; sweaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Lot number: Unknown) at the age of 70 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 09Nov2023 (Batch/Lot number: unknown), in left arm for immunisation; tetanus vaccine (TETANUS VACCINE), on 09Nov2023 (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; ZOLOFT; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; CLARITIN [LORATADINE]. The following information was reported: PAIN (non-serious) with onset 12Nov2023 at 07:00, outcome "recovering", described as "Achy"; COUGH (non-serious) with onset 12Nov2023 at 07:00, outcome "recovering"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 12Nov2023 at 07:00, outcome "recovering", described as "head stuffy"; HYPERHIDROSIS (non-serious) with onset 12Nov2023 at 07:00, outcome "recovering", described as "sweaty"; FATIGUE (non-serious) with onset 12Nov2023 at 07:00, outcome "recovering", described as "tired". Therapeutic measures were not taken as a result of pain, upper respiratory tract congestion, cough, fatigue, hyperhidrosis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Vaccination site pain
Clinical narrative: Nasal congestion; Full body aches; Soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Nov2023 at 08:15 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "anemia" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: PAIN (non-serious) with onset 14Nov2023 at 20:30, outcome "recovering", described as "Full body aches"; NASAL CONGESTION (non-serious) with onset 14Nov2023 at 20:30, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 14Nov2023 at 20:30, outcome "recovering", described as "Soreness at injection site". Therapeutic measures were taken as a result of nasal congestion, pain, vaccination site pain, a self administered Sudafed and ibuprofen.   Additional information: Since the vaccination, the patient has not been tested for COVID-19 and prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient had not known allergies.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: taste issues/taste was very muted/pasty or nondescript; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 09Nov2023 at 11:00 as dose 1, single (Lot number: HJ7221) at the age of 65 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious) with onset 11Nov2023, outcome "not recovered", described as "taste issues/taste was very muted/pasty or nondescript". Therapeutic measures were not taken as a result of taste disorder.  Additional information: Patient had no past drug allergy. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Three days after injection, patient developed taste issues.  First, sense of smell seemed normal.  When patient consumed food, patient could taste it with the first-third of  tongue, then as patient continued to chew working the food to the rear two-thirds of tongue the taste was very muted.  Everything, no matter what patient consumed, tasted pasty or nondescript.  It's kind of maddening.
Sex: M
Vaccine: COVID19
Symptoms: Sperm concentration decreased
Clinical narrative: believe his son loss sperm count due to COVID-19 shot.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPERM CONCENTRATION DECREASED (non-serious), outcome "unknown", described as "believe his son loss sperm count due to COVID-19 shot.".
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Defaecation urgency, Diarrhoea, Muscular weakness
Clinical narrative: diarrhea; muscle weakness; she has a constant urgency for bowel movement every hour and the feeling in my belly is uncomfortable; she has a constant urgency for bowel movement every hour and the feeling in my belly is uncomfortable; the feeling in my belly is uncomfortable' very discomforting and almost pain at some point; 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 95-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bad colon issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness"; DEFAECATION URGENCY (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "she has a constant urgency for bowel movement every hour and the feeling in my belly is uncomfortable"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "the feeling in my belly is uncomfortable' very discomforting and almost pain at some point".  Additional information: The patient had a very bad colon issues. And all of a sudden, especially yesterday, she  felt like she had to go all the time, a constant urgency for bowel movement every hour and the feeling in her belly was uncomfortable, very discomforting and almost pain at some point.  It's not really diarrhea but it bordered on it a couple of times. That was very unusual for her because she have not been having good bowel movements at all. This all started the night before last and it has abated. She had not started taking anything different like lactulose for this condition and it can't be what she am eating since she have not changed that. she have had this condition for so long.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.