chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Lethargy, Pain, Pyrexia
Clinical narrative: lethargic; body ache; He cannot raise his arm very high; pain in the injection area; fever; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargic), PAIN (body ache), VACCINATION SITE MOVEMENT IMPAIRMENT (He cannot raise his arm very high), VACCINATION SITE PAIN (pain in the injection area) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU vaccine (He had felt like he got the flu with flu vaccines in the past.), COVID-19 vaccine (Dose 2, He did not had a reaction this bad with previous doses), COVID-19 vaccine (Dose 1 and He did not had a reaction this bad with previous doses). Past adverse reactions to the above products included Influenza like illness with FLU vaccine; and Vaccination adverse reaction with COVID-19 vaccine and COVID-19 vaccine. Concurrent medical conditions included Agoraphobia (He had fairly severe agoraphobia and does not leave the house often.).    On 25-Oct-2023 at 5:30 PM, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced LETHARGY (lethargic), PAIN (body ache), VACCINATION SITE MOVEMENT IMPAIRMENT (He cannot raise his arm very high), VACCINATION SITE PAIN (pain in the injection area) and PYREXIA (fever). The patient was treated with IBUPROFEN in October 2023 for General body pain, at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic), PAIN (body ache), VACCINATION SITE PAIN (pain in the injection area) and PYREXIA (fever) had not resolved and VACCINATION SITE MOVEMENT IMPAIRMENT (He cannot raise his arm very high) outcome was unknown.            It was reported that patient did not receives any other vaccines 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient receives his third covid-19 vaccine on 25-Oct-2023 around 5:30 P.M.  It was reported that he had pain in the injection area that was pretty severe. He could not raise his arm very high. He was also feeling lethargic, fever, body aches really bad. He had taken ibuprofen for his body aches.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Injection site pain, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: cold symptoms; stomach pain; I have pain at the site; fever; nauseous; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold symptoms), ABDOMINAL PAIN UPPER (stomach pain), INJECTION SITE PAIN (I have pain at the site), PYREXIA (fever) and NAUSEA (nauseous) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031912) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Treatment with Paxlovid and used oxygen) on 24-Nov-2022 and COVID-19 (Treatment with Paxlovid and used oxygen) on 11-Jun-2023.    On 25-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 26-Oct-2023, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), INJECTION SITE PAIN (I have pain at the site), PYREXIA (fever) and NAUSEA (nauseous). On an unknown date, the patient experienced NASOPHARYNGITIS (cold symptoms). At the time of the report, NASOPHARYNGITIS (cold symptoms) had not resolved and ABDOMINAL PAIN UPPER (stomach pain), INJECTION SITE PAIN (I have pain at the site), PYREXIA (fever) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2023, SARS-CoV-2 test: Negative.         No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747342 (E2B Linked Report). This case was linked to MOD-2023-747350, MOD-2023-747355 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747342:Husband case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: cold symptoms; stomach pain; I have pain at the site; fever; nauseous; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold symptoms), ABDOMINAL PAIN UPPER (stomach pain), INJECTION SITE PAIN (I have pain at the site), PYREXIA (fever) and NAUSEA (nauseous) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031912) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Treatment with Paxlovid and used oxygen) on 24-Nov-2022 and COVID-19 (Treatment with Paxlovid and used oxygen) on 11-Jun-2023.    On 25-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 26-Oct-2023, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), INJECTION SITE PAIN (I have pain at the site), PYREXIA (fever) and NAUSEA (nauseous). On an unknown date, the patient experienced NASOPHARYNGITIS (cold symptoms). At the time of the report, NASOPHARYNGITIS (cold symptoms) had not resolved and ABDOMINAL PAIN UPPER (stomach pain), INJECTION SITE PAIN (I have pain at the site), PYREXIA (fever) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2023, SARS-CoV-2 test: Negative.         No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747342 (E2B Linked Report). This case was linked to MOD-2023-747350, MOD-2023-747355 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747342:Husband case
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The husband was also on the line, informed that he also had covid twice.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The husband was also on the line, informed that he also had covid twice.) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (The husband was also on the line, informed that he also had covid twice.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (The husband was also on the line, informed that he also had covid twice.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2023, SARS-CoV-2 test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-747310 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747310:Wife case (master case)
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Inflammation, Nasal discomfort
Clinical narrative: Inflammation in the spine, lower back, under the armpit, under his triceps, right shoulder, and the right side of his back; His nose and chest feel like a wet sack; His nose and chest feel like a wet sack; This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (Inflammation in the spine, lower back, under the armpit, under his triceps, right shoulder, and the right side of his back), NASAL DISCOMFORT (His nose and chest feel like a wet sack) and CHEST DISCOMFORT (His nose and chest feel like a wet sack) in a 43-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 037A220) for COVID-19 prophylaxis.     It was reported that he does not know if he had allergies. It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Wrist fracture on 02-Nov-2021. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (014S21A, dose 1) on 30-Sep-2021, Moderna COVID-19 vaccine (037C21A and dose 2) on 20-Oct-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. Family history included Ovarian cancer (except an aunt who may have had ovarian cancer).    On 14-Mar-2023, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation in the spine, lower back, under the armpit, under his triceps, right shoulder, and the right side of his back), NASAL DISCOMFORT (His nose and chest feel like a wet sack) and CHEST DISCOMFORT (His nose and chest feel like a wet sack). At the time of the report, INFLAMMATION (Inflammation in the spine, lower back, under the armpit, under his triceps, right shoulder, and the right side of his back), NASAL DISCOMFORT (His nose and chest feel like a wet sack) and CHEST DISCOMFORT (His nose and chest feel like a wet sack) outcome was unknown.            No concomitant medication was reported. It was reported that patient had been to the ER a couple weeks ago. No one in his family had cancer, except an aunt who may have had ovarian cancer. His nose and chest feel like a wet sack. When he went to the ER doctor, he asked him to check him on the X-ray. Base on the information he saw online this could be cancer. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (Dose 1), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.   On 31-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Oct-2022, received fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 06-May-2023, received sixth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient started with the 4th Covid-19 dose the patient switched to Moderna Covid-19 vaccine because her doctor thought that it was better and with less side effects. The patient had a reaction of a fever, chills, muscle aches, and fatigue for 48 hours. After second Moderna Covid-19 vaccine had a reaction of a fever, chills, muscle aches, and fatigue for 48 hours. After third Moderna Covid-19 vaccine the patient had a reaction of a fever, chills, muscle aches, and fatigue for 48 hours.   This case was linked to US-MODERNATX, INC.-MOD-2023-747054.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747054:Same Patient (SPIKEVAX 2023-2024 case)
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Caller mentioned that she took the new vaccine and was wanting to know which medicine would be best to reduce pain in the arm.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Caller mentioned that she took the new vaccine and was wanting to know which medicine would be best to reduce pain in the arm.) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Caller mentioned that she took the new vaccine and was wanting to know which medicine would be best to reduce pain in the arm.). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Caller mentioned that she took the new vaccine and was wanting to know which medicine would be best to reduce pain in the arm.) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  Patient wanted to know which medicine would be best to reduce pain in the arm and if she can take Advil.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Intermenstrual bleeding
Clinical narrative: spotting; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (spotting) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On 05-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 19-Oct-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.     Concomitant product use was not provided by the reporter.  Approx 2 weeks after receiving the 2023 Moderna vaccine, the patient began spotting. The patient was post menopause 66-year-old woman. It became slightly worse at 2.5 weeks after receiving the Moderna vaccine. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Sex: U
Vaccine: UNK
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site rash, Muscle discomfort
Clinical narrative: developed an itching burning rash as the sight of where injection was given; developed an itching burning rash as the sight of where injection was given; developed an itching burning rash as the sight of where injection was given/ uncomfortable rash; tiredness; muscle discomfort; joint/ muscle discomfort; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (joint/ muscle discomfort), VACCINATION SITE PRURITUS (developed an itching burning rash as the sight of where injection was given), FATIGUE (tiredness) and VACCINATION SITE PAIN (developed an itching burning rash as the sight of where injection was given) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (joint/ muscle discomfort) and FATIGUE (tiredness). On 27-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PRURITUS (developed an itching burning rash as the sight of where injection was given), VACCINATION SITE PAIN (developed an itching burning rash as the sight of where injection was given) and VACCINATION SITE RASH (developed an itching burning rash as the sight of where injection was given/ uncomfortable rash). In October 2023, MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (joint/ muscle discomfort) and FATIGUE (tiredness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (developed an itching burning rash as the sight of where injection was given), VACCINATION SITE PAIN (developed an itching burning rash as the sight of where injection was given) and VACCINATION SITE RASH (developed an itching burning rash as the sight of where injection was given/ uncomfortable rash) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medications were not reported.  It was reported that for 4 days patient had joint/ muscle discomfort and tiredness.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2023: Live follow-up received. AE reference number added.
Sex: U
Vaccine: UNK
Symptoms: Musculoskeletal discomfort
Clinical narrative: developed an itching burning rash as the sight of where injection was given; developed an itching burning rash as the sight of where injection was given; developed an itching burning rash as the sight of where injection was given/ uncomfortable rash; tiredness; muscle discomfort; joint/ muscle discomfort; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (joint/ muscle discomfort), VACCINATION SITE PRURITUS (developed an itching burning rash as the sight of where injection was given), FATIGUE (tiredness) and VACCINATION SITE PAIN (developed an itching burning rash as the sight of where injection was given) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (joint/ muscle discomfort) and FATIGUE (tiredness). On 27-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PRURITUS (developed an itching burning rash as the sight of where injection was given), VACCINATION SITE PAIN (developed an itching burning rash as the sight of where injection was given) and VACCINATION SITE RASH (developed an itching burning rash as the sight of where injection was given/ uncomfortable rash). In October 2023, MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (joint/ muscle discomfort) and FATIGUE (tiredness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (developed an itching burning rash as the sight of where injection was given), VACCINATION SITE PAIN (developed an itching burning rash as the sight of where injection was given) and VACCINATION SITE RASH (developed an itching burning rash as the sight of where injection was given/ uncomfortable rash) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medications were not reported.  It was reported that for 4 days patient had joint/ muscle discomfort and tiredness.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2023: Live follow-up received. AE reference number added.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Investigation, Muscle disorder, Pericarditis
Clinical narrative: Pericarditis; couldn't breathe; with every dose of the vaccine caller has had muscle problems; 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 75-year-old female patient received bnt162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (ongoing), notes: in her late 30s. Doctor tried to figure out if it was rheumatoid arthritis or Lupus.; "Rheumatoid arthritis" (ongoing), notes: Patient's aunt had rheumatoid arthritis; "Hashimoto's" (ongoing); "Fibromyalgia" (ongoing); "Sjogren's" (ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE , Batch/lot number: EN6205 , Anatomical location: Upper left arm), administration date: 02Mar2021, for Covid-19 immunization, reaction(s): "polymyalgia rheumatica", "had muscle problems", "arm irritation", "arm tenderness"; bnt162b2 (DOSE 2, SINGLE , Batch/lot number: ER8727 , Anatomical location: Upper left arm), administration date: 23Mar2021, for Covid-19 immunization, reaction(s): "polymyalgia rheumatica", "arm sensitive/ had tenderness", "every muscle in body was bothering patient/ muscle problems", "leg cramps", "very tired"; bnt162b2 (DOSE 2, SINGLE , Batch/lot number: ER8727 , Anatomical location: Upper left arm), administration date: 23Mar2021, for COVID-19 immunization, reaction(s): "headache", "sore throat". The following information was reported: MUSCLE DISORDER (non-serious) with onset 21Oct2021, outcome "unknown", described as "with every dose of the vaccine caller has had muscle problems"; DYSPNOEA (hospitalization) with onset Mar2022, outcome "unknown", described as "couldn't breathe"; PERICARDITIS (hospitalization) with onset 26Mar2022, outcome "unknown". The patient was hospitalized for pericarditis, dyspnoea (start date: 31Mar2022, discharge date: 04Apr2022, hospitalization duration: 5 day(s)). The events "pericarditis" and "couldn't breathe" required emergency room visit. The patient underwent the following laboratory tests and procedures: did lots of tests: unknown results. Therapeutic measures were taken as a result of muscle disorder. Clinical course: In 2022 patient had an emergency visit to hospital, had pericarditis, was in late Mar2022, in between vaccines, does not know if connected, was very odd. Patient had no idea, thought it was her bra causing the pain caller was experiencing. The patient had chest pain under rib on left side. It was clarified and confirmed that when the patient went to the emergency room, was admitted into the hospital, did lots of tests. Clarified the reason for admission was that the patient could not breathe.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300337361 same patient/vaccine, different doses/event;
Age: 73.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Dysphagia, Dyspnoea, Hypertension, Palpitations
Clinical narrative: after getting vaccine patient approached the consultation and said he has trouble breathing and his heart is racing. Phearmacist asked him to seat in immunization area and asked him if he needs EpiPen. He said yes and gave permission for pharmacist to give him the shot. Mean while the 2nd pharmacist called 911 with patient permission again and they arrived in less than 10 minutes. on the phone they've asked the pharmacist if he is allergic to any vaccine? at this time he said he had reaction to first covid vaccine. before vaccine given immunizer asked him what reaction he did not specify and wanted to proceed with vaccine. He asked pharmacist for reaction and side effect he was told there is a possibility of sever reaction for anyone he still wanted to get the vaccine each time he was given choice. Paramedic came less than 10 minutes and he was on the phone with his wife they asked him to hang up so they can help him. he didn't want to hang up they told him to do that so they can help him. He finally hang up .At this time he was berating ok. They checked his blood pressure and asked him if he wanted to go to hospital he refused and said he if he needed to he wants to go with his family as a group. paramedic left at 4:59 and he left at 5:02. he called pharmacy at 6:45pm to get the lot number because he was reporting the reaction. Pharmacist asked him how he is feeling he said he feeling much better and thanked her for giving him EpiPen.
Age: 73.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Dyspnoea, Palpitations
Clinical narrative: after getting vaccine patient approached the consultation and said he has trouble breathing and his heart is racing. Phearmacist asked him to seat in immunization area and asked him if he needs EpiPen. He said yes and gave permission for pharmacist to give him the shot. Mean while the 2nd pharmacist called 911 with patient permission again and they arrived in less than 10 minutes. on the phone they've asked the pharmacist if he is allergic to any vaccine? at this time he said he had reaction to first covid vaccine. before vaccine given immunizer asked him what reaction he did not specify and wanted to proceed with vaccine. He asked pharmacist for reaction and side effect he was told there is a possibility of sever reaction for anyone he still wanted to get the vaccine each time he was given choice. Paramedic came less than 10 minutes and he was on the phone with his wife they asked him to hang up so they can help him. he didn't want to hang up they told him to do that so they can help him. He finally hang up .At this time he was berating ok. They checked his blood pressure and asked him if he wanted to go to hospital he refused and said he if he needed to he wants to go with his family as a group. paramedic left at 4:59 and he left at 5:02. he called pharmacy at 6:45pm to get the lot number because he was reporting the reaction. Pharmacist asked him how he is feeling he said he feeling much better and thanked her for giving him EpiPen.
Age: 73.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Anaphylactic reaction, Anxiety, Blood pressure increased, Dyspnoea, Hypertension
Clinical narrative: after getting vaccine patient approached the consultation and said he has trouble breathing and his heart is racing. Phearmacist asked him to seat in immunization area and asked him if he needs EpiPen. He said yes and gave permission for pharmacist to give him the shot. Mean while the 2nd pharmacist called 911 with patient permission again and they arrived in less than 10 minutes. on the phone they've asked the pharmacist if he is allergic to any vaccine? at this time he said he had reaction to first covid vaccine. before vaccine given immunizer asked him what reaction he did not specify and wanted to proceed with vaccine. He asked pharmacist for reaction and side effect he was told there is a possibility of sever reaction for anyone he still wanted to get the vaccine each time he was given choice. Paramedic came less than 10 minutes and he was on the phone with his wife they asked him to hang up so they can help him. he didn't want to hang up they told him to do that so they can help him. He finally hang up .At this time he was berating ok. They checked his blood pressure and asked him if he wanted to go to hospital he refused and said he if he needed to he wants to go with his family as a group. paramedic left at 4:59 and he left at 5:02. he called pharmacy at 6:45pm to get the lot number because he was reporting the reaction. Pharmacist asked him how he is feeling he said he feeling much better and thanked her for giving him EpiPen.
Age: 73.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Immediate post-injection reaction, Loss of consciousness, Panic attack, Pharyngeal swelling
Clinical narrative: after getting vaccine patient approached the consultation and said he has trouble breathing and his heart is racing. Phearmacist asked him to seat in immunization area and asked him if he needs EpiPen. He said yes and gave permission for pharmacist to give him the shot. Mean while the 2nd pharmacist called 911 with patient permission again and they arrived in less than 10 minutes. on the phone they've asked the pharmacist if he is allergic to any vaccine? at this time he said he had reaction to first covid vaccine. before vaccine given immunizer asked him what reaction he did not specify and wanted to proceed with vaccine. He asked pharmacist for reaction and side effect he was told there is a possibility of sever reaction for anyone he still wanted to get the vaccine each time he was given choice. Paramedic came less than 10 minutes and he was on the phone with his wife they asked him to hang up so they can help him. he didn't want to hang up they told him to do that so they can help him. He finally hang up .At this time he was berating ok. They checked his blood pressure and asked him if he wanted to go to hospital he refused and said he if he needed to he wants to go with his family as a group. paramedic left at 4:59 and he left at 5:02. he called pharmacy at 6:45pm to get the lot number because he was reporting the reaction. Pharmacist asked him how he is feeling he said he feeling much better and thanked her for giving him EpiPen.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: She got her vaccine, she felt good and felt the way she did when she walked in.  She finished her shopping, and went home.  She did her regular kitchen routine, and sat down and was on the computer about 8:00 PM.  She felt something like creepy around her jaws, and she felt it and felt it was like hives.  Then it continued and she went and looked at her face, and low and behind her entire chest from where her breast starts to her neck had very tiny red bumps.  Then she called the nurse and she was asking her if her tongue was swollen and if her breathing was fine, and she asked her to go to the UC the next morning.  When she went to the UC they felt that it was a reaction from the shot.  She wanted her to take Zyrtec and took one and did not get better.  She called her doctor and was told to come into the office.  Dr. said that he thought it was a reaction from the booster.  He prescribed her the 5 days of Prednisone and some cream to rub over the affected area.  She got the cream yesterday as they did not have it earlier, and this is the 3rd day on prednisone.  Dr. also ordered her to have lab work done, and she has those results.  They said that nothing has spiked.  She is to return to see him in 3 weeks.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Laboratory test, Rash, Rash erythematous, Swollen tongue
Clinical narrative: She got her vaccine, she felt good and felt the way she did when she walked in.  She finished her shopping, and went home.  She did her regular kitchen routine, and sat down and was on the computer about 8:00 PM.  She felt something like creepy around her jaws, and she felt it and felt it was like hives.  Then it continued and she went and looked at her face, and low and behind her entire chest from where her breast starts to her neck had very tiny red bumps.  Then she called the nurse and she was asking her if her tongue was swollen and if her breathing was fine, and she asked her to go to the UC the next morning.  When she went to the UC they felt that it was a reaction from the shot.  She wanted her to take Zyrtec and took one and did not get better.  She called her doctor and was told to come into the office.  Dr. said that he thought it was a reaction from the booster.  He prescribed her the 5 days of Prednisone and some cream to rub over the affected area.  She got the cream yesterday as they did not have it earlier, and this is the 3rd day on prednisone.  Dr. also ordered her to have lab work done, and she has those results.  They said that nothing has spiked.  She is to return to see him in 3 weeks.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: She got her vaccine, she felt good and felt the way she did when she walked in.  She finished her shopping, and went home.  She did her regular kitchen routine, and sat down and was on the computer about 8:00 PM.  She felt something like creepy around her jaws, and she felt it and felt it was like hives.  Then it continued and she went and looked at her face, and low and behind her entire chest from where her breast starts to her neck had very tiny red bumps.  Then she called the nurse and she was asking her if her tongue was swollen and if her breathing was fine, and she asked her to go to the UC the next morning.  When she went to the UC they felt that it was a reaction from the shot.  She wanted her to take Zyrtec and took one and did not get better.  She called her doctor and was told to come into the office.  Dr. said that he thought it was a reaction from the booster.  He prescribed her the 5 days of Prednisone and some cream to rub over the affected area.  She got the cream yesterday as they did not have it earlier, and this is the 3rd day on prednisone.  Dr. also ordered her to have lab work done, and she has those results.  They said that nothing has spiked.  She is to return to see him in 3 weeks.
Sex: F
Vaccine: COVID19
Symptoms: Ear inflammation, Ear pruritus, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: fever; swollen enlarged lymph nodes; a burning rash on her neck and face; layers of skin that would peel off/ ears were peeling; her ears were inflamed; her ears were itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001270.  A 69-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "achy"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "fever". The following information was reported: RASH (non-serious) with onset 2022, outcome "unknown", described as "a burning rash on her neck and face"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "fever"; EAR INFLAMMATION (non-serious) with onset 2022, outcome "unknown", described as "her ears were inflamed"; EAR PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "her ears were itchy"; SKIN EXFOLIATION (non-serious) with onset 2022, outcome "unknown", described as "layers of skin that would peel off/ ears were peeling"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "swollen enlarged lymph nodes". The events "fever", "swollen enlarged lymph nodes" and "a burning rash on her neck and face" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the 2nd dose, the patient had a fever, swollen enlarged lymph nodes and a burning rash on her neck and face. She went to the doctor and they scanned her lymph nodes since they were enlarged. She also had layers of skin that would peel off and her ears were inflamed, itchy and peeling. She had these symptoms that would come and go for 10 months.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300176225 Same patient, different AE/vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Scan, Skin exfoliation
Clinical narrative: fever; swollen enlarged lymph nodes; a burning rash on her neck and face; layers of skin that would peel off/ ears were peeling; her ears were inflamed; her ears were itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001270.  A 69-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "achy"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "fever". The following information was reported: RASH (non-serious) with onset 2022, outcome "unknown", described as "a burning rash on her neck and face"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "fever"; EAR INFLAMMATION (non-serious) with onset 2022, outcome "unknown", described as "her ears were inflamed"; EAR PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "her ears were itchy"; SKIN EXFOLIATION (non-serious) with onset 2022, outcome "unknown", described as "layers of skin that would peel off/ ears were peeling"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "swollen enlarged lymph nodes". The events "fever", "swollen enlarged lymph nodes" and "a burning rash on her neck and face" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the 2nd dose, the patient had a fever, swollen enlarged lymph nodes and a burning rash on her neck and face. She went to the doctor and they scanned her lymph nodes since they were enlarged. She also had layers of skin that would peel off and her ears were inflamed, itchy and peeling. She had these symptoms that would come and go for 10 months.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300176225 Same patient, different AE/vaccine dose;
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Pain at injection site
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, nausea, headache and whole body ache - Same effects when I got the first Moderna vaccine. These side effects did not happen in later boosters. But now they are back. I reported all side effects in Vsafe but I could not get in Vsafe yesterday
Age: 26.0
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 27-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Amoxicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 16Oct2023 to 21Oct2023. 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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as treatment of COVID-19 from 15Oct2023 to 20Oct2023. Patient had other medications Estradiol patch (0.025) and Progesterone in 2 weeks of Paxlovid treatment. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received bnt162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "addison's" (unspecified if ongoing); "sulfa-trimethoprim" (unspecified if ongoing); "chronic HSV" (unspecified if ongoing); "hypgonadal hypoT" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE oral, start date: 01Jan2008, stop date: 26Oct2023; FLUDROCORTISONE oral, start date: 2008, stop date: 26Oct2023; TESTOSTERONE topical, start date: 2008, stop date: 26Oct2023; ACYCLOVIR [ACICLOVIR] oral, start date: 2000, stop date: 26Oct2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; 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. Treatment included Paxlovid from 15Oct2023 to 19Oct2023.  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 available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW01705), in left arm, on 05May2021 as dose 2, single (Lot number: EW0187), in left arm and on 09Feb2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures included Paxlovid from 15Oct2023 to 19Oct2023 were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Is Bivalent: False), for COVID-19 Immunization. The following information was reported: SEIZURE (medically significant) with onset May2021, 2 hrs after the suspect product(s) administration, outcome "recovered". Patient woke up from a nap having a seizure 2 hours after receiving 2nd dose of Pfizer COVID-19 vaccine. It was unknown if patient had COVID or COVID tested prior vaccination. Therapeutic measures were not taken as a result of seizure. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported event Seizure cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea exertional, SARS-CoV-2 test
Clinical narrative: Exacerbated asthma symptoms; Difficulty during exercise and deep breathing after 3rd Pfizer booster received Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: DYSPNOEA EXERTIONAL (medically significant) with onset Oct2022, outcome "recovering", described as "Difficulty during exercise and deep breathing after 3rd Pfizer booster received Oct2022"; ASTHMA (medically significant) with onset Oct2022, outcome "recovering", described as "Exacerbated asthma symptoms". The events "exacerbated asthma symptoms" and "difficulty during exercise and deep breathing after 3rd pfizer booster received oct2022" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of asthma, dyspnoea exertional. Clinical course: No Known allergies. No Covid prior vaccination. Since the vaccination, has the patient been tested for COVID-19. Exacerbated asthma symptoms. Previously no difficulty during exercise, deep breathing. Difficulty during exercise and deep breathing after 3rd Pfizer booster received Oct2022. Symptoms controlled with alvesco, but have not resolved. Treatment included Ciclesonide.  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.