chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Device issue, No adverse event, Product dose omission issue
Clinical narrative: HCP attempted to administer the vaccine to patient. The PFS was placed into the arm, the plunger would not depress; The HCP feels none of the vaccine was ever administered. The patient refused to reattempt administration; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP attempted to administer the vaccine to patient. The PFS was placed into the arm, the plunger would not depress), PRODUCT DOSE OMISSION ISSUE (The HCP feels none of the vaccine was ever administered. The patient refused to reattempt administration) and NO ADVERSE EVENT (No adverse effect) in a 74-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043391) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3043391) for COVID-19 prophylaxis.    No Medical History information was reported.   On 07-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (HCP attempted to administer the vaccine to patient. The PFS was placed into the arm, the plunger would not depress), PRODUCT DOSE OMISSION ISSUE (The HCP feels none of the vaccine was ever administered. The patient refused to reattempt administration) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP attempted to administer the vaccine to patient. The PFS was placed into the arm, the plunger would not depress), PRODUCT DOSE OMISSION ISSUE (The HCP feels none of the vaccine was ever administered. The patient refused to reattempt administration) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The HCP feels none of the vaccine was ever administered. The patient refused to reattempt administration. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2024: Live follow-up received contains non-significant information. Added reference numbers.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Large, red itching hive lasting 3 days at injection site; Large, red itching hive lasting 3 days at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE URTICARIA (Large, red itching hive lasting 3 days at injection site) and VACCINATION SITE ERYTHEMA (Large, red itching hive lasting 3 days at injection site) in a 36-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042646) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 09-Oct-2024, the patient experienced VACCINATION SITE URTICARIA (Large, red itching hive lasting 3 days at injection site) and VACCINATION SITE ERYTHEMA (Large, red itching hive lasting 3 days at injection site). At the time of the report, VACCINATION SITE URTICARIA (Large, red itching hive lasting 3 days at injection site) and VACCINATION SITE ERYTHEMA (Large, red itching hive lasting 3 days at injection site) was resolving.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was reported that patient had large, red itching hive lasting 3 days at injection site.  It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported.  No treatment information was provided.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyskinesia, Dysphagia, Mastication disorder
Clinical narrative: The caller reiterated that her friend died 8 days after receiving the vaccine; her friend has lost the ability to chew and swallow; her friend has lost the ability to chew and swallow; her friend all of a sudden start jerking; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (The caller reiterated that her friend died 8 days after receiving the vaccine) in a 91-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (The caller reiterated that her friend died 8 days after receiving the vaccine) (seriousness criteria death and medically significant), MASTICATION DISORDER (her friend has lost the ability to chew and swallow), DYSPHAGIA (her friend has lost the ability to chew and swallow) and DYSKINESIA (her friend all of a sudden start jerking). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MASTICATION DISORDER (her friend has lost the ability to chew and swallow), DYSPHAGIA (her friend has lost the ability to chew and swallow) and DYSKINESIA (her friend all of a sudden start jerking) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It was reported that patient died 8 days after vaccination. Further it was reported that patient lost the ability to chew and swallow and patient felt jerk while walk and patient stated that symptom of jerk felt like he got hit with a lightning bolt. No treatment medications provided by the reporter.  Company comment: Patient´s elderly age remains as a contributor for fatal outcome. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-775175 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2024: Live non-significant follow-up received in which new reference number was added.; Reporter's Comments: Company comment: Patient´s elderly age remains as a contributor for fatal outcome. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775175:Reporter's case (Master case); Reported Cause(s) of Death: The caller reiterated that her friend died 8 days after receiving the vaccine
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Oct2024 at 15:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), on 09Oct2024) for immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid vaccines (Manufacturer Unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 10Oct2024 at 13:00, outcome "recovering"; PYREXIA (non-serious) with onset 10Oct2024 at 13:00, outcome "recovering", described as "fever". Therapeutic measures were not taken as a result of pyrexia, chills.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the vaccines. The patient was not taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug interaction, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: I take the blood thinners (Unspecified medications); They said don't take it (Covid vaccine) if you take a blood thinner; Nauseated; My arm, it is very painful and it is swollen; My arm, it is very painful and it is swollen; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Oct2024 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "I take the blood thinners (Unspecified medications); They said don't take it (Covid vaccine) if you take a blood thinner"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "My arm, it is very painful and it is swollen".  Additional information: The patient got the COVID vaccine yesterday, in the right arm. Arm was very painful and it is swollen and the pharmacist did not give this information, the caregivers. When patient was reading it said if you have heart problem, which patient do and they said don't take it if you take a blood thinner, don't take it but reported that the pharmacist did not give this information to the patient until after the shot was administered. Patient don't know what to do. Patient stated, "I take the blood thinners (Unspecified medications) twice a day and I am nauseated."  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 95.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Cerebrovascular accident, Immunisation reaction
Clinical narrative: having a mild reaction to her Covid19/flu booster shot; stroke; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2022SA501919 (Sanofi).  A 95-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 30Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 95 years for covid-19 immunisation; dupilumab (DUPILUMAB), first regimen from 29Nov2022) to 16Jun2024 at 300 mg (300 mg qow (every other week)), subcutaneous and second regimen since 2024) at 300 mg (300 mg qow (every other week)) for dermatitis atopic; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown (booster), single) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LATANOPROST; FAMOTIDINE; LOSARTAN [LOSARTAN POTASSIUM]; TYLENOL; DORZOLAMIDE HYDROCHLORIDE; COSOPT; METFORMIN [METFORMIN HYDROCHLORIDE]; ASPIRIN [ACETYLSALICYLIC ACID]; ROSUVASTATIN [ROSUVASTATIN CALCIUM]; ACETAZOLAMIDE; GABAPENTIN; ASMANEX; NORVASC; METOPROLOL SUCCINATE; MUPIROCIN [MUPIROCIN CALCIUM]; HALOBETASOL PROP; TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 16Jun2024, outcome "recovered" (2024), described as "stroke"; IMMUNISATION REACTION (non-serious), outcome "recovering", described as "having a mild reaction to her Covid19/flu booster shot". The action taken for dupilumab was unknown. Reporter Causality: Unassessable for the event (cerebrovascular accident) and not related for another event with Dupilumab and not reported for both the events with Covid-19 vaccine. Company Causality: Not reportable for both the events with Dupilumab and immunisation reaction. Seriousness criteria: Medically significant for the event (cerebrovascular accident). Company comment: Sanofi: company comment dated 05Sep2024: This case involves a 95 year old female patient who had stroke while being treated with Dupilumab [Dupixent] via unknow device. The casual role of drug can be excluded for the event, However, lack of information regarding event details, patient's compliance, treatment received, lab data, medical history precludes the comprehensive assessment of the case. The case would be re-evaluated post the receipt of follow up information.   Batch/lot number is not provided, and it cannot be obtained.  SUSPECT PRODUCT is under agreement with BIONTECH SE.
Sex: F
Vaccine: PNC20
Symptoms: Tinnitus
Clinical narrative: ringing in the ears/ tinnitus; lymphatic reactions; This is a spontaneous report received from a Pharmacist from medical information team.  An adult female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08Oct2024 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing in the ears/ tinnitus"; LYMPHATIC DISORDER (non-serious), outcome "unknown", described as "lymphatic reactions".  Additional information: Caller transferring agent stated they have a pharmacy intern holding on their back line. She stated she had a patient that received Prevnar 20. She said adult patient, but she did not get an age, and patient had experienced Tinnitus or ringing in the ears and she said patient also had experienced lymphatic reactions but nothing more specific. Regarding treatment reporter stated, she did not thought that she was taking anything because she went on pharmacy on reporting day by phone. It was unknown on which arm vaccine was administered. No information if the patient had any vaccination 4 weeks prior.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Lymphadenopathy, Otorrhoea, Swelling, Tinnitus
Clinical narrative: swelling neck; swelling nodes and enlarged nodes in the neck/have swelling in my lymph nodes in my neck; tinnitus/ringing in her ears; Eyes have watered continuously; dizzy; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumonia shot (taken several years ago), for Immunisation. The following information was reported: LACRIMATION INCREASED (non-serious) with onset Oct2024, outcome "not recovered", described as "Eyes have watered continuously"; DIZZINESS (non-serious) with onset Oct2024, outcome "not recovered", described as "dizzy"; SWELLING (non-serious) with onset Oct2024, outcome "not recovered", described as "swelling neck"; LYMPHADENOPATHY (non-serious) with onset Oct2024, outcome "not recovered", described as "swelling nodes and enlarged nodes in the neck/have swelling in my lymph nodes in my neck"; TINNITUS (non-serious) with onset Oct2024, outcome "not recovered", described as "tinnitus/ringing in her ears".  Additional information: The Consumer reported that the last week she was administered with the last update of Pfizer's pneumonia vaccine and had a swelling neck, swelling nodes, enlarged nodes in the neck, tinnitus and a constant ringing in her ears. The Consumer requested information about which OTC or prescription medication could be used for the management of her symptoms. Patient previously had pneumonia shot and her pharmacist said, she probably should take this vaccine because it was an upgrade, and it was more advanced than the one she had taken several years ago. Patient mentioned "since I have taken the vaccine, I have swelling in my lymph nodes in my neck and I have constant screaming in my ears, my eyes have watered continuously, and I am dizzy".  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got the first covid illness after my first two Pfizer Covid vaccines; I got the first covid illness after my first two Pfizer Covid vaccines; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An adult female patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I got the first covid illness after my first two Pfizer Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Caller states she have had covid before (after getting the vaccines) and the vaccine twice before, and the, patient didn't get the most recent vaccine. She stated she received the Pfizer covid 19 vaccines and reported this information to Pfizer before. Patient took an over the counter covid test and tested positive. Caller has not taken Paxlovid and does not have a prescription yet. Caller stated she received the first two doses of the Original covid vaccine when it came out. She got the first covid illness after her first two Pfizer Covid vaccines.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200000883 same patient/product, different dose/event;US-PFIZER INC-202400276345 same patient/product, different dose/event;US-PFIZER INC-202400276778 same patient/product, different dose/event;
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: a delayed (2 days post vaccination) of a local reaction that was red, inflamed, sore and elevated /raised reaction at the injection site; a delayed (2 days post vaccination) of a local reaction that was red, inflamed, sore and elevated /raised reaction at the injection site; a delayed (2 days post vaccination) of a local reaction that was red, inflamed, sore and elevated /raised reaction at the injection site; This is a spontaneous report received from a Physician from a sales representative.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 07Oct2024 as dose 1, single (Batch/Lot number: unknown) intramuscular for maternal immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing). The patient was 32 weeks pregnant at the event onset. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 09Oct2024, outcome "unknown" and all described as "a delayed (2 days post vaccination) of a local reaction that was red, inflamed, sore and elevated /raised reaction at the injection site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site inflammation, vaccination site pain.  Additional information: The patient did not receive any other vaccines on the same date as Abrysvo. The maternal patient that was immunized in the office had a delayed (2 days post vaccination) of a local reaction that was red, inflamed, sore, and elevated/raised reaction at the injection site. The patient called the doctor concerned and texted pictures on the injection site to the provider. The provider was also a little concerned. The patient did not call the office anymore or call/text the provider afterwards.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Oct2024 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in left deltoid for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 13Oct2024 at 16:30 as dose number unknown, single), in left deltoid for immunisation. The patient's relevant medical history included: "Rhinitis" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN D; FLONASE [FLUTICASONE PROPIONATE]; ORAL CONTRACEPTIVE NOS. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Oct2024, outcome "recovering", described as "Injection site pain". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Injection site pain approximately 4 hours after injection of Comirnaty and inactivated influenza vaccine, both in left deltoid. Injection site pain continued into second day after vaccination.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT in left lower leg; This is a spontaneous report received from a Consumer or other non HCP. An 82-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Aug2024 at 15:00 as dose 1, single (Batch/Lot number: unknown), in muscle of left arm for covid-19 immunization (NDC:00069-2432-10). The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS, start date: 01Jan2021 as blood thinner. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant) with onset 29Sep2024 at 20:00, outcome "not recovered", described as "DVT in left lower leg". Clinical details: When the patient received the first Covid vaccine, he did have a bad reaction where he developed DVT in his left lower leg for which he was hospitalized for two days and put on an intravenous blood thinner. He then went to see a vascular doctor who put him on 5 milligrams of Eliquis. He also saw an ophthalmologist the next day. The patient has no known allergies.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Lot of itching pretty much all over the body; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: PRURITUS (non-serious), outcome "unknown", described as "Lot of itching pretty much all over the body".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Myalgia, Pain
Clinical narrative: Body ache; feeling sick/ feel ill; Chills; Low graded fever; Muscle ache; Very tired; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Oct2024 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: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization, reaction(s): "Little soreness where I got the shot". The following information was reported: PAIN (non-serious) with onset 12Oct2024, outcome "recovering", described as "Body ache"; CHILLS (non-serious) with onset 12Oct2024, outcome "recovering"; PYREXIA (non-serious) with onset 12Oct2024, outcome "recovering", described as "Low graded fever"; MYALGIA (non-serious) with onset 12Oct2024, outcome "recovering", described as "Muscle ache"; FATIGUE (non-serious) with onset 12Oct2024, outcome "recovering", described as "Very tired"; MALAISE (non-serious) with onset 12Oct2024, outcome "not recovered", described as "feeling sick/ feel ill".  Additional information: Consumer stated, on Saturday, Patient had all the shots, the Covid shots (Further not clarified). Patient never experienced any side effects before not a single problem except a little soreness where patient got the shot. On Saturday patient got the new vaccine (Later clarified as Pfizer COVID-19 Vaccine) and patient had been feeling sick since then. It did not start right way but by Saturday evening patient started having chills, low graded fever and body ache, muscle ache and very tired and even though that day it had improved patient felt little better but still felt ill. Was that something common with the new vaccine". When paraphrased the above concern, consumer stated, "Yes." Name of vaccine got on Saturday and experienced side effects, consumer stated, "Patient was at work so patient did not had the vaccination card with but Knew it's Pfizer because number one, it was at the (Redacted) fair and patient told him that patient wanted a Pfizer and once patient put the sticker he said Pfizer and you have the name of the vaccine but patient did not know the last one, the latest version because patient had all the other ones prior to that." When probe to clarify that Pfizer COVID-19 vaccine was took on Saturday, consumer stated, "Yes". Further probing could not be done as the consumer was unwilling to file a safety report.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body ache; feeling sick/ feel ill; Chills; Low graded fever; Muscle ache; Very tired; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Oct2024 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: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization, reaction(s): "Little soreness where I got the shot". The following information was reported: PAIN (non-serious) with onset 12Oct2024, outcome "recovering", described as "Body ache"; CHILLS (non-serious) with onset 12Oct2024, outcome "recovering"; PYREXIA (non-serious) with onset 12Oct2024, outcome "recovering", described as "Low graded fever"; MYALGIA (non-serious) with onset 12Oct2024, outcome "recovering", described as "Muscle ache"; FATIGUE (non-serious) with onset 12Oct2024, outcome "recovering", described as "Very tired"; MALAISE (non-serious) with onset 12Oct2024, outcome "not recovered", described as "feeling sick/ feel ill".  Additional information: Consumer stated, on Saturday, Patient had all the shots, the Covid shots (Further not clarified). Patient never experienced any side effects before not a single problem except a little soreness where patient got the shot. On Saturday patient got the new vaccine (Later clarified as Pfizer COVID-19 Vaccine) and patient had been feeling sick since then. It did not start right way but by Saturday evening patient started having chills, low graded fever and body ache, muscle ache and very tired and even though that day it had improved patient felt little better but still felt ill. Was that something common with the new vaccine". When paraphrased the above concern, consumer stated, "Yes." Name of vaccine got on Saturday and experienced side effects, consumer stated, "Patient was at work so patient did not had the vaccination card with but Knew it's Pfizer because number one, it was at the (Redacted) fair and patient told him that patient wanted a Pfizer and once patient put the sticker he said Pfizer and you have the name of the vaccine but patient did not know the last one, the latest version because patient had all the other ones prior to that." When probe to clarify that Pfizer COVID-19 vaccine was took on Saturday, consumer stated, "Yes". Further probing could not be done as the consumer was unwilling to file a safety report.  Batch/lot number is not provided, and it cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Headache
Clinical narrative: Headache; chills; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), on 15Oct2024 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 15Oct2024 as dose number unknown, single), in arm for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 15Oct2024 at 17:00, outcome "recovering"; CHILLS (non-serious) with onset 15Oct2024 at 17:00, outcome "recovering". Therapeutic measures were not taken as a result of headache, chills. Additional information: Patient have no drug allergy.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This is a spontaneous report received from a Physician from a sales representative.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: CARDIAC ARREST (death, medically significant), outcome "fatal". It was unknown if therapeutic measures were taken as a result of cardiac arrest. The patient date of death was unknown. Reported cause of death: "Cardiac arrest". It was not reported if an autopsy was performed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the available limited information , the relationship between the event Cardiac arrest and suspect drug BNT162b2 omicron(kp.2) cannot be excluded considering the events like myocarditis, pericarditis are expected as per the drug safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest
Sex: U
Vaccine: COVID19
Symptoms: Cognitive disorder, Memory impairment
Clinical narrative: Cognitive Impairment; my memory was starting to fail me; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EL0140) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COGNITIVE DISORDER (disability), outcome "unknown", described as "Cognitive Impairment"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "my memory was starting to fail me". The events "cognitive impairment" and "my memory was starting to fail me" required physician office visit. Clinical course: Patient needed someone from Corporate to contact immediately. Patient received the Covid Shot. Patient's Psychiatrist, patient had been seeing says had Cognitive Impairment now from the Vaccine. It was after receiving the shot patient's memory was starting to fail. Patient was now on Disability from the Cognitive Impairment. Patient was going to contact Lawyer and file a Lawsuit. No, medical inquiry was not forwarded to MI.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate increased, Malaise, Vision blurred
Clinical narrative: Dizziness / light headedness; headache; increased heart rate; flickering vision; general sick feeling; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Oct2024 at 10:10 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 12Oct2024, outcome "recovered", described as "Dizziness / light headedness"; VISION BLURRED (non-serious) with onset 12Oct2024, outcome "recovered", described as "flickering vision"; MALAISE (non-serious) with onset 12Oct2024, outcome "recovered", described as "general sick feeling"; HEADACHE (non-serious) with onset 12Oct2024, outcome "recovered"; HEART RATE INCREASED (non-serious) with onset 12Oct2024, outcome "recovered", described as "increased heart rate".   Additional information: The patient was fine after the vaccination, then 3 hours later, he suddenly started experiencing dizziness, light headedness, headache, increased heart rate, flickering vision with inability to focus and general sick feeling. The patient was worried about a stroke, laid down, napped and things settled down.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune reaction; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00562 (Novavax).  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune reaction". The clinical course was reported as follows: The patient reported that they had an autoimmune reaction to the Pfizer COVID-19 vaccine and they had been told not to get another mRNA vaccine. The patient would like to know if they can get the COVID-19 vaccine COVID-19 prot. subunit (nvx cov 2373) (NOVAVAX) vaccine safely.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick/more ill; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: ILLNESS (non-serious) with onset 2024, outcome "unknown", described as "sick/more ill".  Additional information: Reporter was called about the Covid vaccine and mentioned that they've taken the shot, including his wife and daughter who got really sick and more ill after taking the shot, he would like to know what was in the vaccine that they took because they got sick  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400134265 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick/ more ill; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: ILLNESS (non-serious) with onset 2024, outcome "unknown", described as "sick/ more ill".  Additional information: Patient (father), was called about the Covid vaccine and mentioned that they've taken the shot, including his wife and daughter who got really sick and more ill after taking the shot, he would like to know what was in the vaccine that they took because they got sick  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400134263 same reporter/drug/event, different patient;
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given Fluzone HD mistakenly. Patient had already received flu vaccine from his doctor. The patient and his doctor  were both notified, no negative effects.
Age: 63.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Abdominal pain upper, Amylase normal, Asthenia, Fatigue, Hypersomnia
Clinical narrative: NOVAVAX COVID 2024-2025 is co-administered with the Flu vaccine. The patient experiences fatigue, flu-like symptoms, weakness, nausea, and excessive sleeping?Sharp stomach pain in the upper left quadrant.
Age: 63.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Influenza like illness, Lipase normal, Nausea
Clinical narrative: NOVAVAX COVID 2024-2025 is co-administered with the Flu vaccine. The patient experiences fatigue, flu-like symptoms, weakness, nausea, and excessive sleeping?Sharp stomach pain in the upper left quadrant.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: PATIENT REPORTS THAT SHE GOT A SORE ARM THAT LASTED FOR 2 DAYS, SHE ALSO REPORTS GETTING A MILD RASH AROUND THE AREA OF INJECTION. SHE DID NOT TAKE ANYTHING FOR THE SYMPTOMS ABOVE.  AFTER FOLLOW UP WITH THE PATIENT, SHE REPORTS THAT SHE IS DOING JUST FINE
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient walk-in for MMR incorrect vaccine was administered (Varicella).
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Accidentally administered 2 doses of influenza vaccine instead of one dose influenza and one dose of covid vaccine
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was giving 3x the dose.  The vial was an undiluted multidose vial of 0.9mL.  Patient was supposed to get 0.3 mL.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was giving 3x the dose.  The vial was an undiluted multidose vial of 0.9mL.  Patient was supposed to get 0.3 mL.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse events noted.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Myalgia
Clinical narrative: Immediately after injection patient said her arm was very painful deep in the muscle like it hit a nerve.  I checked back in with her around 10 minutes after vaccination and she said it felt better.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Client reported severe nausea, diarrhea, and stomach cramping with first dose which resolved within 24 hours.  Stated 2 hours following second dose, client experienced severe stomach pain, vomiting, diarrhea, bloating, and abdominal cramping.  Client stated vomiting and diarrhea lasted several hours.  Stomach pain, nausea, bloating, and abdominal cramping continue 31 hours after second dose.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Client reported severe nausea, diarrhea, and stomach cramping with first dose which resolved within 24 hours.  Stated 2 hours following second dose, client experienced severe stomach pain, vomiting, diarrhea, bloating, and abdominal cramping.  Client stated vomiting and diarrhea lasted several hours.  Stomach pain, nausea, bloating, and abdominal cramping continue 31 hours after second dose.
Age: 0.25
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt had redness from the site of injection and described it as being itchy.
Age: 62.0
Sex: M
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Patient tolerated rabies immune globulin and dose ONE of RabAvert on 10/10/24. Patient received dose TWO on  10/13/24 and developed hives and urticaria three days after dose number TWO in series (10/16/24). He was given dose number THREE in the emergency department on 10/17/24 and developed mild hives and urticaria thirty minutes later.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flu vaccine nurse reposted 61 year old patient was given Fluzone high- dose instead of regular Fluzone.  Patient was assessed by RN and  Physician On Call was notified of incident. no adverse reactions noted to the vaccine. patient was kept in observation for at least 30 minutes. Vital signs remained stable and within normal limits. no signs and symptoms of distress.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain
Clinical narrative: Patient's husband came in and said patient has been more achy than with past vaccines.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: Pt stated symptoms started one day after receiving vaccination. Pt noticed a bump the size of a "small apple', was hard to the touch and warm. Pt declines fever, anaphylaxis, or any other symptoms. She said today is day 2 and the bump is slightly smaller than yesterday.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: PATIENT REPORTED OF SEVERE HEADACHE , HIGH FEVER, REDNESS AND SWELLINESS AROUND THE INJECTION SITE.
Age: 81.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Impaired work ability, Pruritus, Rash, Rash macular, Urticaria
Clinical narrative: FROM HEAD TO TOE ITCHING, RED BLOTCH RASHES ALL OVER BODY FROM HEAD TO TOES, HIVES, ALL EXTERNAL ON SKIN
Age: 81.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Diarrhoea
Clinical narrative: PT reported having diarrhea for 4 days
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Local reaction, Tenderness
Clinical narrative: He wanted to show me his arm. It didnt seem bright red, more bruised than anything, tender. Appeared to me to be local injection reaction. Advised ice and if it gets WORSE to be seen.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Misadministration of high-dose flu vaccine to pediatric patient.  No adverse affects reported at this time.
Age: 19.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient received this vaccination intramuscularly in error. No adverse side effects were noted at the time of administrstion. Patient was alert, oriented, and social with vaccinator.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: COVID vaccine dose was given to patient without reconstituting the product as instructed by manufacturer.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Misadministration of high-dose flu vaccine to pediatric patient.  No adverse affects reported at this time.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Misadministration of high-dose flu vaccine to pediatric patient.  No adverse affects reported at this time.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Misadministration of high-dose flu vaccine to pediatric patient.  No adverse affects reported at this time.
Age: 66.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Arthralgia, Back pain, Chills, Feeling cold, Immediate post-injection reaction
Clinical narrative: On 10/11/2024 I received both flu (I don?t know the brand they used it just is marked as, ?Influenza, High Dose Seasonal?) and the Prevnar 20 vaccine in my right arm. The male nurse (??) gave the injections at the same location of the right arm. My daughter took a photo of my arm afterwards so I could see where the injections were made. He was standing up and I was sitting down.  Injections were given at around 11:00 AM and pain in arm was immediate. The pneumonia vaccine was very painful when injected. By 7:00 PM that evening the pain in right arm was increasing to a solid 7 on the pain index scale. Pain radiates down the front and underside of the right deltoid muscle. There was radiation down the forearm, upper right shoulder into the top of the right side of upper back and neck area even into the wrist when trying to use my hand.  Shooting pain whenever I tried to use my hand, wrist or arm.  I was unable to move or lift my arm from its normal relaxed position without intense pain. It was difficult to grasp things in my hand because of the weakness. Nearly impossible to undress to use the bathroom, change clothes to go to bed or actually get into the bed without the use of my arm. My medications, ice and heat didn?t touch the pain.  At one point whenI was moving I felt an icy feeling in my upper back on the right side for about an hour. I had no fever but started having chills. Chills were diminished the following morning but pain increased. In a sitting position the pain increased when barely shifting my upper body to reposition myself. On day 5, I began to finally have more range of motion with somewhat less intense pain-it being at 6 on the pain scale instead of 7. On day 6 I?m able to have further range of motion with the pain at a 5.  I?m still very limited using my arm to do household tasks, changing sheets, carrying laundry, personal care such as dressing, shampooing hair, due to my range and pain level.  On 10/17/2024, six days after the vaccination, I requested an appointment to be seen at the clinic to evaluate my arm. She looked at the arm and felt the skin. No redness or warmth and suggested heat application or lidocaine patch. I asked her about whether the location of injection was too high, but she said it wasn?t. She stated it was just a strong reaction to the pneumonia vaccine since previously having never received one before. She said no imaging was necessary and to just give it time to resolve over the next weeks.