chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Facial spasm, Hypertension, Neck pain
Clinical narrative: I have developed symptoms of tetanus after receiving the covid 19 vaccine.; My symptoms include jaw contraction/Jaw spasm; stomach spasms; severe neck pain; fever; facial spasms; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TETANUS (medically significant), outcome "unknown", described as "I have developed symptoms of tetanus after receiving the covid 19 vaccine."; TRISMUS (medically significant), outcome "unknown", described as "My symptoms include jaw contraction/Jaw spasm"; ABDOMINAL PAIN UPPER (medically significant), outcome "unknown", described as "stomach spasms"; NECK PAIN (medically significant), outcome "unknown", described as "severe neck pain"; PYREXIA (medically significant), outcome "unknown", described as "fever"; FACIAL SPASM (medically significant), outcome "unknown", described as "facial spasms"; HYPERTENSION (medically significant), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical course: Patient had developed symptoms of tetanus after recieving the covid 19 vaccine. Patient symptoms include jaw contraction, stomach spasms, severe neck pain, fever, high blood pressure, facial spasms.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tetanus, Trismus
Clinical narrative: I have developed symptoms of tetanus after receiving the covid 19 vaccine.; My symptoms include jaw contraction/Jaw spasm; stomach spasms; severe neck pain; fever; facial spasms; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TETANUS (medically significant), outcome "unknown", described as "I have developed symptoms of tetanus after receiving the covid 19 vaccine."; TRISMUS (medically significant), outcome "unknown", described as "My symptoms include jaw contraction/Jaw spasm"; ABDOMINAL PAIN UPPER (medically significant), outcome "unknown", described as "stomach spasms"; NECK PAIN (medically significant), outcome "unknown", described as "severe neck pain"; PYREXIA (medically significant), outcome "unknown", described as "fever"; FACIAL SPASM (medically significant), outcome "unknown", described as "facial spasms"; HYPERTENSION (medically significant), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical course: Patient had developed symptoms of tetanus after recieving the covid 19 vaccine. Patient symptoms include jaw contraction, stomach spasms, severe neck pain, fever, high blood pressure, facial spasms.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2, FLU4, COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria across the right side of neck, jaw, and torso; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 16:45 as dose 1, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation; influenza vaccine inact split 4v (AFLURIA QUADRIVALENT), on 26Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm. The patient's relevant medical history included: "Prolactinoma" (unspecified if ongoing). Concomitant medication included: CABERGOLINE. The following information was reported: URTICARIA (non-serious) with onset 06Oct2023, outcome "not recovered", described as "Urticaria across the right side of neck, jaw, and torso". Therapeutic measures were taken as a result of urticaria. Additional information: The event was treated with antihistamine (Loratadine) and Hydrocortisone cream. The patient had no COVID prior to vaccination. The patient did not tested positive for COVID post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 5.0
Sex: M
Vaccine: MMR, DTAP, HEPA, MMR
Symptoms: Parotitis
Clinical narrative: Patient received the vaccines on October 4th, then went into the ER on October 5th, right face was swollen and ER diagnosed PT with mumps & peritonitis. Patient was treated with amoxicillin (10mL 3x times a day) mom informed us that after day 3 of treatment he was back to his usual self as in feeling better.
Age: 5.0
Sex: M
Vaccine: MMR, DTAP, HEPA, MMR
Symptoms: Mumps, Peritonitis, Swelling face
Clinical narrative: Patient received the vaccines on October 4th, then went into the ER on October 5th, right face was swollen and ER diagnosed PT with mumps & peritonitis. Patient was treated with amoxicillin (10mL 3x times a day) mom informed us that after day 3 of treatment he was back to his usual self as in feeling better.
Age: 53.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Administered an improperly stored dose; This spontaneous report was received from a medical assistant concerning a 53-year-old unknown gender patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.   On 13-SEP-2023 at 10:09, measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection (lot# U039664, expiry date: 15-DEC-2023) was improperly stored at room temperature (22 degree Celsius). It never returned to recommended range because the refrigerator was not operational. On 20-SEP-2023, the patient was vaccinated with the improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection 0.5 mL (route of administration, and anatomical location not provided) as prophylaxis (product storage error). There were no adverse effects reported. No additional adverse event (AE) was reported (no adverse event).  This is one of 2 reports received from the same reporter (RA #2309USA007541).; Sender's Comments:  US-009507513-2309USA007541:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reported PROQUAD was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved PROQUAD X009129 9/24/2024        ?    Temperature 8.1°F        ?    Time frame 3 hours; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 28-SEP-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # X009129, expiration date: 24-SEP-2024, therapy type stablished as rHA) (strength, route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion at 8.1 Fahrenheit (F) during 3 hours. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reported PROQUAD was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved PROQUAD X013909 11/10/2024        ?    Temperature 8.1°F        ?    Time frame 3 hour; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 29-SEP-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # X013909, expiration date: 10-NOV-2024) (strength, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion at 8.1 Fahrenheit (F) during 3 hours. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQCs; Nurse reported PROQUAD was administered after TE; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 18-SEP-2023, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection that had suffered a temperature excursion (product storage error), administered for prophylaxis (lot number X007537 has been determined to be an invalid number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)) (strength, lot #, expiry date, and route of administration were not provided). The temperature excursion happened within a timeframe of 3 hours at a temperature of 8.1 Fahrenheit (F). No adverse events were reported for this patient.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/no PQCs; Nurse reported VARIVAX was administered after TE; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 21-SEP-2023, the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) injection after it had suffered a temperature excursion (product storage error) (lot number W025274 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), with an expiration date established as 10-AUG-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). The temperature excursion took place within a timeframe of 3 hours at a temperature of 8.1 Fahrenheit (F). No adverse events were reported for this patient.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Caller reported PROQUAD was administered to an 18 year old.  No other information provided.  No Additional AEs or PQC reported.; lot # W010526, expiration date reported as 25-SEP-2023 but upon internal verification stablished as 25-SEP-2022 administered on 04-AUG-2023; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 04-AUG-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # W010526, expiration date reported as 25-SEP-2023 but upon internal verification stablished as 25-SEP-2022, therapy type stablished as rHA) administered subcutaneously (SQ) in the right arm as prophylaxis, at an age of 18 years old (product administered to patient of inappropriate age). No additional adverse event was reported.
Age: 65.0
Sex: M
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age, Vaccination error
Clinical narrative: No adverse event; HCP calling to inquire about immunogenicity for 65 y/o male pt. that inadvertently received PEDVAXHIB prior to splenectomy which is scheduled on 10/24/2023.  No adverse effects reported.  No additional AE.  No PQC.; This spontaneous report was received from a nurse, concerning a 65-year-old male patient.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 06-OCT-2023, the patient was vaccinated with an inadvertently single dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection,(lot #W028535, has been verified to be valid, expiration date: 10-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided) prior to splenectomy which was schedule for 24-OCT-2023. No adverse event reported. The patient was 65-year-old when vaccinated (Inappropriate age at vaccine administration)
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: HCP has no further AE information. No PQC.; HCP called to report that an expired dose of PNEUMOVAX 23 was given to a patient on 10/10/2023. Dose expired on 9/30/2023. Product has had a prior TE. HCP has no further AE information. No PQC.  Name of vaccine: PNEUMOVAX 23 Temperature: 50.5F Time f; HCP called to report that an expired dose of PNEUMOVAX 23 was given to a patient on 10/10/2023. Dose expired on 9/30/2023. Product has had a prior TE. HCP has no further AE information. No PQC.  Name of vaccine: PNEUMOVAX 23 Temperature: 50.5F Time f; This spontaneous report was received from a certified medical Assistant referred to a patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On 02-SEP-2023, the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) experienced a temperature excursion under 50.5 Fahrenheit Degrees during a time frame of 3 hours and 36 minutes.     On 10-OCT-2023, the patient was vaccinated with an expired and improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # W019533, expiration date 30-SEP-2023, 0.5 milliliter, once (strength, route, and anatomical location were not reported), for prophylaxis (expired product administered and product storage error).  No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed no other AE occurred; The caller said an expired dose was administered; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 03-OCT-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (expired product administered) (lot number w004863 has been determined to be valid for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with an expiration date established as 21-AUG-2023), administered for prophylaxis (strength, and anatomical site of administration were not provided). No adverse event was reported for this patient.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Cardiac disorder, Immunisation reaction, Necrosis
Clinical narrative: cell death and necrosis of organs; vaccine killing of my heart; vaccine killing of my body; This spontaneous case was reported by a consumer and describes the occurrence of NECROSIS (cell death and necrosis of organs) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    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 and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECROSIS (cell death and necrosis of organs) (seriousness criterion medically significant), CARDIAC DISORDER (vaccine killing of my heart) and IMMUNISATION REACTION (vaccine killing of my body). At the time of the report, NECROSIS (cell death and necrosis of organs), CARDIAC DISORDER (vaccine killing of my heart) and IMMUNISATION REACTION (vaccine killing of my body) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were provided.  Patient reported that Comirnaty pfizer and moderna corona virus spike proteins are evil and cause cell death and necrosis of organs 38 39 low count hard time retention. Patient reported that vaccine is killing patient's heart and body.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history information reported, who experienced the unexpected serious (medically significant) event of necrosis and unexpected non serious events of cardiac disorder and immunisation reaction. The events occurred on an unknown date. Temporal relationship with dose of SPIKEVAX 2023-2024 is unclear. The patient reported that Comirnaty pfizer and moderna corona virus spike proteins are evil and cause cell death and necrosis of organs describing additionally 38 39 low count hard time retention (unclear information). Patient also reported that vaccine is killing patient's heart and body. Additional information provided by the patient is incoherent. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Crohn's disease, Immunodeficiency
Clinical narrative: crohn's disease; immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (crohn's disease) and IMMUNODEFICIENCY (immunocompromised) in a 45-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (crohn's disease) (seriousness criterion medically significant) and IMMUNODEFICIENCY (immunocompromised) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (crohn's disease) and IMMUNODEFICIENCY (immunocompromised) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  They recommended him to get another dose of COVID-19 Vaccine. Treatment medications were not reported.  Company comment:  This spontaneous case concerns a 45  year  old male patient, with no clear medical history reported, who received one dose with Janssen COVID  19 vaccine and 3 doses with Spikevax 2023-2024 vaccine, and experienced the unexpected, serious (medically significant) events of Crohn's disease and Immunodeficiency. Latency cannot be properly assessed since exact onset and vaccination dates were not provided. Patient stated he has Crohn's disease, and he is immunocompromised; however, it was not clarified if this condition started before or after any COVID-19 Vaccine. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax 2023-2024 is not affected by this report.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain, Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; had some reaction/some stuff for one day; achy; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 90-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) 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 fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant), IMMUNISATION REACTION (had some reaction/some stuff for one day) and PAIN (achy). The patient was treated with PREDNISONE for Polymyalgia rheumatica, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) outcome was unknown and IMMUNISATION REACTION (had some reaction/some stuff for one day) and PAIN (achy) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient was taking Prednisone from 6-10 months. Patient took all Moderna vaccin  Company Comment This spontaneous case concerns  a 90-years-old female patient with no medical history reported who experienced the seriousness criteria medically significant unexpected event of polymyalgia rheumatica; the unexpected events of pain and immunization reaction unknown days after 5th. dose of SPIKEVAX NOS vaccine. The age could be a contributor for the events. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report. es and only had some reaction - achy and some stuff for one day.
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue, No adverse event, Poor quality product administered
Clinical narrative: He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.; He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 28Sep2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team and a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), LIQUID PRODUCT PHYSICAL ISSUE (non-serious) and all described as "He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.". Additional information:White particles floating around in 2nd and 3rd box with one PFS having a 'white blob'. He still noticed the presence of the white particles after shaking the product vigorously. Patient has given approximately  doses out of the first box. Noticed some particles floating in the syringe.After vigorously shaking it has to be homogenous suspension before administration. He went and looked that up in the package insert to check the suspension. After shaking one syringe there was a white blob. He said several syringes had multiple particles. He has opened the other 2 boxes to make observations.   The reporter considered "he has given approximately 5 doses out of the first box. noticed some particles floating in the syringe." not related to pneumococcal 20-val conj vac (dipht crm197 protein). Causality for "he has given approximately 5 doses out of the first box. noticed some particles floating in the syringe." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320516 same reporter/product, different patient;US-PFIZER INC-202300322487 same reporter/product/event, different patient;US-PFIZER INC-202300322488 same reporter/product/event, different patient;US-PFIZER INC-202300322489 same reporter/product/event, different patient;
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue, Poor quality product administered
Clinical narrative: He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.; He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 28Sep2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team and a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), LIQUID PRODUCT PHYSICAL ISSUE (non-serious) and all described as "He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.". Additional information:White particles floating around in 2nd and 3rd box with one PFS having a 'white blob'. He still noticed the presence of the white particles after shaking the product vigorously. Patient has given approximately  doses out of the first box. Noticed some particles floating in the syringe.After vigorously shaking it has to be homogenous suspension before administration. He went and looked that up in the package insert to check the suspension. After shaking one syringe there was a white blob. He said several syringes had multiple particles. He has opened the other 2 boxes to make observations.   The reporter considered "he has given approximately 5 doses out of the first box. noticed some particles floating in the syringe." not related to pneumococcal 20-val conj vac (dipht crm197 protein). Causality for "he has given approximately 5 doses out of the first box. noticed some particles floating in the syringe." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300313027 same reporter/product/event, different patient;
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Product use issue, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site is swollen, red and hot and very itchy.; Injection site is swollen, red and hot and very itchy.; Injection site is swollen, red and hot and very itchy.; Other Vaccine on Same date product: Flu; Other Vaccine on Same date product: Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Oct2023, outcome "unknown" and all described as "Other Vaccine on Same date product: Flu"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 05Oct2023, outcome "not recovered" and all described as "Injection site is swollen, red and hot and very itchy.". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pruritus.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive test for COVID-19; positive test for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 74 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 24Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6206), in right arm and on 29Mar2021 at 14:30 as dose 2, single (Lot number: EN6201), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL (Lupin Pharmaceutical), start date: 01Oct2013; LEVOTHYROXINE (Mylan), start date: 01Aug2014; ALENDRONATE SODIUM (Aurobindo), start date: 01Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (2023) and all described as "positive test for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) positive; (2023) negative, notes: after 5 days of Paxlovid; (2023) negative, notes: one day later to confirm. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Following a positive test for COVID, patient asked her doctor to prescribe Paxlovid based on her age. She took it on Tuesday and had reduced symptoms within a day after she finished the 5 days of Paxlovid, she tested again. She was negative for COVID. Then she tested one day later to confirm and was negative again.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Nasopharyngitis, Pyrexia
Clinical narrative: shivering; cold; Site of the injection was quite sore; Shakes that would give me a fever; got up to a 100.1; Shakes that would give me a fever; got up to a 100.1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), single, Unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), single, Unknown manufacturer.), for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 07Oct2023, outcome "unknown", PYREXIA (non-serious) with onset 07Oct2023, outcome "recovered" and all described as "Shakes that would give me a fever; got up to a 100.1"; VACCINATION SITE PAIN (non-serious) with onset 07Oct2023, outcome "unknown", described as "Site of the injection was quite sore"; NASOPHARYNGITIS (non-serious) with onset 07Oct2023, outcome "unknown", described as "cold"; CHILLS (non-serious) with onset 07Oct2023, outcome "unknown", described as "shivering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: The patient was just calling to report a side effect because he had never had one and up and till now, he had 4 shots for COVID (suspect captured as Pfizer Covid Shot), the two initials and then two boosters last year and then he saw the commercials, he asked if he should be getting a new one for this year. They said yes, that is a good idea and what they gave was the Comirnaty and he was fine until yesterday (from the time of report), from the time he got it, so waving there. But at 3o'clock this morning, he was woken up and was shivering and cold he had to put blanket on. Beside the effect of these, site of the injection was quite sore and had that before but not as bad and never accompanied by the shakes that would give him a fever and that was what he had. He got up to a 100.1 and then in the morning it came back down. He took a non-Aspirin tablet and that did the trick because his fever came right down and disappeared. So, this is the first thing that he had ever had with any of them, in the first 4 of Pfizer shots.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: shivering; cold; Site of the injection was quite sore; Shakes that would give me a fever; got up to a 100.1; Shakes that would give me a fever; got up to a 100.1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), single, Unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), single, Unknown manufacturer.), for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 07Oct2023, outcome "unknown", PYREXIA (non-serious) with onset 07Oct2023, outcome "recovered" and all described as "Shakes that would give me a fever; got up to a 100.1"; VACCINATION SITE PAIN (non-serious) with onset 07Oct2023, outcome "unknown", described as "Site of the injection was quite sore"; NASOPHARYNGITIS (non-serious) with onset 07Oct2023, outcome "unknown", described as "cold"; CHILLS (non-serious) with onset 07Oct2023, outcome "unknown", described as "shivering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: The patient was just calling to report a side effect because he had never had one and up and till now, he had 4 shots for COVID (suspect captured as Pfizer Covid Shot), the two initials and then two boosters last year and then he saw the commercials, he asked if he should be getting a new one for this year. They said yes, that is a good idea and what they gave was the Comirnaty and he was fine until yesterday (from the time of report), from the time he got it, so waving there. But at 3o'clock this morning, he was woken up and was shivering and cold he had to put blanket on. Beside the effect of these, site of the injection was quite sore and had that before but not as bad and never accompanied by the shakes that would give him a fever and that was what he had. He got up to a 100.1 and then in the morning it came back down. He took a non-Aspirin tablet and that did the trick because his fever came right down and disappeared. So, this is the first thing that he had ever had with any of them, in the first 4 of Pfizer shots.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19; patient was treated with PAXLOVID.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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 Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received paxlovid from 23Sep2023 to 27Sep2023 as Treatment of COVID-19. Patient did not had known allergies.  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-202300322072 same patient, different drug/event;
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea, Fatigue, Pain
Clinical narrative: Bouts of high anxiety; Exhausted; Aching body; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 10:30 as dose 1, single (Lot number: HG4665) at the age of 48 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VENLAFAXINE; FAMOTIDINE; PANTOPRAZOLE; ATORVASTATIN. The following information was reported: PAIN (non-serious) with onset 07Oct2023 at 18:00, outcome "not recovered", described as "Aching body"; ANXIETY (non-serious) with onset 07Oct2023 at 18:00, outcome "not recovered", described as "Bouts of high anxiety"; DIARRHOEA (non-serious) with onset 07Oct2023 at 18:00, outcome "not recovered", described as "Diarrhea"; FATIGUE (non-serious) with onset 07Oct2023 at 18:00, outcome "not recovered", described as "Exhausted". Therapeutic measures were not taken as a result of anxiety, fatigue, pain, diarrhoea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 16:30 as dose 4 (booster), single (Lot number: GJ6665) at the age of 61 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 10Jun2022 as dose 3 (booster), single (Lot number: FM0173), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 26Mar2021 as dose 2, single (Lot number: EP6955), in right arm for covid-19 immunisation. The patient's relevant medical history included: "T2 diabetes" (unspecified if ongoing); "migraines" (unspecified if ongoing); "obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN, start date: 01Jul2021; TRUBIOTICS ONE A DAY, start date: 01Oct2021; ZOLMITRIPTAN, start date: 06Jul2005. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 22Sep2023 to 27Sep2023 for the treatment of Covid-19.
Age: 68.0
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 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Apr2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "allergies to pets" (unspecified if ongoing); "allergies to trees" (unspecified if ongoing); "allergies to dust" (unspecified if ongoing); "allergies to grass" (unspecified if ongoing); "Known allergies: whey" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known allergies: doxycycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 29Sep2023 to 03Oct2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322179 same patient, different drug/AE;
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Investigation, Troponin increased, Ventricular extrasystoles
Clinical narrative: Developed PVCs; Mild elevation of cardiac troponin and HS-CPR; Mild elevation of cardiac troponin and HS-CPR; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 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 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious) with onset 22Sep2023, outcome "recovered" (03Oct2023), described as "Developed PVCs"; TROPONIN INCREASED (non-serious), C-REACTIVE PROTEIN INCREASED (non-serious) all with onset 22Sep2023, outcome "recovered" (03Oct2023) and all described as "Mild elevation of cardiac troponin and HS-CPR". The events "developed pvcs" and "mild elevation of cardiac troponin and hs-cpr" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ventricular extrasystoles, troponin increased, c-reactive protein increased. Additional information: Suspect dose is patient's 4th COVID vaccination dose. Developed PVCs (premature ventricular contractions) 3 days after vaccine (as reported). Went from none to rare to 13 or more PVCs/30 second strip. Patient was better after 12 days. Therapeutic measures were taken as a result of ventricular extrasystoles, troponin increased, c-reactive protein increased which included corticosteroids and NSAIDs.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.