chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: ER8729), on 01May2021 as dose 2, single (Lot number: EW0173) and on 13Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 42 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 24May2022 as dose 4 (booster), single (Lot number: 056M21A) and on 22Sep2022 as dose 5 (booster), single (Lot number: AS7163B) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative using at-home antigen tests on Day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient tested negative using at-home antigen tests on Day 7 and Day 8 of illness (1 day and 2 days after completing Paxlovid series). Sinus congestion, nasal drip and sore throat reemerged on Day 12 (6 days after completing Paxlovid series).  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2023, outcome "recovered" (21Jun2023); COVID-19 (medically significant) with onset Jun2023, outcome "recovered" (21Jun2023), described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2023) Negative; (28Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 16Jun2023 to 21Jun2023.  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-202300235007 same reporter/patient, different product/AE;
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Has felt drained since second vaccination and reported getting ignored by doctors and health care system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19 , Prev dose brand: Pfizer , Prev dose brand unknown: False , Is bivalent: False , Prev dose lot unknown: True , Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose dose number: 1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Has felt drained since second vaccination and reported getting ignored by doctors and health care system". The events "has felt drained since second vaccination and reported getting ignored by doctors and health care system" required physician office visit. It was unknown if therapeutic measures were taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: aching arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "aching arms".  Additional information: Product strength is 15 ug. The patient is asking if anyone else has reported aching arms months after receiving the Pfizer COVID-19 bivalent vaccine and what to do to treat it and how long does it usually last.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05May2023 as dose 6 (booster), single (Lot number: GJ3270) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "bronchitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of COVID-19; (2023) Negative, notes: testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid for COVID-19 treatment from 19Jun2023 to 24Jun2023.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: clot in the leg; Safety information originally reported under manufacturer case 202101559190 has been nullified and re-entered under this new manufacturer report number 202300237421.  This is a spontaneous report from a contactable consumer. A patient (no qualifiers provided) received BNT162B2 (COMIRNATY) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had clot in the leg. Outcome of the event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (10Oct2022): Follow-up attempts are completed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: patient's information (name, address details, gender) were removed and patient initials was updated to unknown.  Follow-up (30Jun2023): This is a follow-up report to notify that the case 202101559190 and case 202300237421 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202300237421.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Swelling
Clinical narrative: chills; swelling; muscle pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (004756). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: CHILLS (non-serious), outcome "unknown"; SWELLING (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain".  Additional Information: A patient called in reporting symptoms she was experiencing after getting the Pfizer COVID-19 vaccines. She mentioned she was experiencing chills, swelling and muscle pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Approximately six to seven months after receiving his last booster, he developed blood clots in his leg; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, (received the primary series and two boosters of the Pfizer Covid vaccine)), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Approximately six to seven months after receiving his last booster, he developed blood clots in his leg". She stated it was so severe, he (her dad) almost had to have his leg amputated.  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: Based on the information in the case report, a possible causal relationship between the event Thrombosis and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she developed Covid; she developed Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she developed Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Investigation, Mycobacterium test
Clinical narrative: tested positive for SARS-CoV-2 infection on a home antigen test; tested positive for SARS-CoV-2 infection on a home antigen test; This is a literature report for the following literature source(s): (Withheld)  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "asthma", start date: Feb2022 (unspecified if ongoing); "chronic lymphocytic leukemia", start date: Feb2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Venetoclax, start date: Jan2022, for chronic lymphocytic leukemia; Obintutuzumab, start date: Jan2022, for chronic lymphocytic leukemia. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "recovered" and all described as "tested positive for SARS-CoV-2 infection on a home antigen test". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 38.8 Centigrade, notes: Fever; non-SARS-CoV-2 viruses: (unspecified date) Negative; Mycobacterium test: (unspecified date) Negative; SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; (Feb2022) Positive; (14Mar2022) Positive, notes: Repeat SARS-CoV-2 PCR; (22Mar2022) Positive, notes: Despite the COVID-19-directed therapy; (Apr2022) Positive; (01May2022) Positive, notes: repeated PCR at a cycle threshold of 22, possibly consistent with a high SARS-CoV-2 load. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: In early Feb2022, a 64-year old man with asthma and CLL who previously received 3 doses of the Pfizer COVID-19 mRNA vaccine developed cough and dyspnea and tested positive for sars-cov-2 infection on a home antigen test. CLL was followed expectantly until Jan2022, when he started venetoclax and obintutuzumab (humanized anti-CD20 monoclonal antibody) for progression of disease.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2. 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.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for SARS-CoV-2 infection on a home antigen test; tested positive for SARS-CoV-2 infection on a home antigen test; This is a literature report for the following literature source(s): (Withheld)  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "asthma", start date: Feb2022 (unspecified if ongoing); "chronic lymphocytic leukemia", start date: Feb2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Venetoclax, start date: Jan2022, for chronic lymphocytic leukemia; Obintutuzumab, start date: Jan2022, for chronic lymphocytic leukemia. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "recovered" and all described as "tested positive for SARS-CoV-2 infection on a home antigen test". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 38.8 Centigrade, notes: Fever; non-SARS-CoV-2 viruses: (unspecified date) Negative; Mycobacterium test: (unspecified date) Negative; SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; (Feb2022) Positive; (14Mar2022) Positive, notes: Repeat SARS-CoV-2 PCR; (22Mar2022) Positive, notes: Despite the COVID-19-directed therapy; (Apr2022) Positive; (01May2022) Positive, notes: repeated PCR at a cycle threshold of 22, possibly consistent with a high SARS-CoV-2 load. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: In early Feb2022, a 64-year old man with asthma and CLL who previously received 3 doses of the Pfizer COVID-19 mRNA vaccine developed cough and dyspnea and tested positive for sars-cov-2 infection on a home antigen test. CLL was followed expectantly until Jan2022, when he started venetoclax and obintutuzumab (humanized anti-CD20 monoclonal antibody) for progression of disease.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2. 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.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of DAPTACEL was administered to a patient with no reported adverse event; Initial information received on 27-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown age and gender who was administered expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Jun-2023 the patient was administered expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot C5893AA; expiry date: 21-Jun-2023) with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: daptacel administered a week past the expiration date with no reported adverse event; Initial information was received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 19 months old male patient who experienced daptacel(diphtheria-15/tetanus/5 ac pertussis vaccine) administered a week past the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine; and HIB VACCINE CONJ (TET TOX) (Acthib).  On 28-Jun-2023, the patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot C5893AA) (strength, expiry date unknown) via intramuscular route in unknown administration site for Immunization and daptacel administered a week past the expiration date with no reported adverse event (expired product administered) (latency : same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Daptacel) was not applicable.  At time of reporting, the outcome was Unknown for the event daptacel administered a week past the expiration date with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA199359:01671773 2023SA199793:01671983
Sex: U
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: one patient was administered a 6-month expired YF VAX with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves patient with unknown demographics who was administered a 6-month expired yellow fever vaccine [YF-VAX] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Yellow Fever Vaccine solution for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).Information on the batch number was requested.  On an unknown date the patient developed a non-serious one patient was administered a 6-month expired yf vax with no reported adverse event (expired product administered) on the same day following the administration of Yellow Fever Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event one patient was administered a 6-month expired yf vax with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Axillary pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Pt stated she got a tetanus shot to her left arm Wednesday and is having arm pain worse with movement and the pain is radiating to the shoulder/neck/axilla area. No recent injury or trauma.  No recent lifting.  Negative recent fever.  Negative nausea, vomiting, diarrhea.  The pain feels muscular. Patient is stable, well appearing, nontoxic, afebrile.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Albumin globulin ratio, Allergy test negative, Differential white blood cell count, Discomfort
Clinical narrative: On 10/23/2022, I noticed there were hives on my son's belly, his groin area, the entire area of both his legs, his buttocks, and his lumbar area. Within 24 hours after we first noticed them, the hives worsened. They then were everywhere from head to toe. My son complained of discomfort. We tried treating the hives with calamine lotion, but it didn't help. We also gave him Benadryl to take internally, but that also didn't help.  We took my son to an urgent care clinic first on 10/24/2022. The staff there said that he was having a reaction to something, though they didn't know what. They prescribed prednisone, which didn't help at all. They also advised us to continue giving him Benadryl until we found another doctor. On 10/28/2022, we took him to his pediatrician. The pediatrician diagnosed unspecified urticaria. The pediatrician then recommended that we take him to an allergist.  On 11/2/2022, we took him to another urgent care clinic. The staff there weren't able to figure out the cause of the hives. However, they prescribed him a hydrocortisone topical ointment and hydroxyzine tablets, neither of which helped. We took my son to an allergist on 12/6/2022. She also diagnosed unspecified urticaria and conducted lab work. The lab work included tests for environmental allergies, a CBC test with differential/platelets, a hematocrit levels test, a liver profile, a globulin blood test, a test for the erythrocyte sedimentation rate, and an infectious diseases test. The hematocrit level was 49.0, which is high. The globulin level was 1.7, which is low. The albumin/globulin ratio was 2.8, which is high. No infectious diseases or environmental allergies were detected. The allergist diagnosed unspecified or chronic urticaria. She prescribed hydroxyzine. She also instructed us to apply the hydrocortisone cream to the affected areas. She recommended that he take fexofenadine for the hives, plus cetirizine hydrochloride. My son takes only the fexofenadine in the morning and only cetirizine hydrochloride in the evening. He will sometimes have a breakout shortly after taking the fexofenadine; in such cases, he takes hydroxyzine. Usually, within an hour or so after he takes the hydroxyzine, the hives are gone. About five or six hours later, when it's about his bedtime, the hives usually reappear. He will then take his cetirizine hydrochloride and his hydroxyzine.  Things have not improved since we have sought medical attention for my son, because we're still in limbo about what the possible cause of the hives is.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Globulins decreased, Haematocrit increased, Laboratory test abnormal, Laboratory test normal
Clinical narrative: On 10/23/2022, I noticed there were hives on my son's belly, his groin area, the entire area of both his legs, his buttocks, and his lumbar area. Within 24 hours after we first noticed them, the hives worsened. They then were everywhere from head to toe. My son complained of discomfort. We tried treating the hives with calamine lotion, but it didn't help. We also gave him Benadryl to take internally, but that also didn't help.  We took my son to an urgent care clinic first on 10/24/2022. The staff there said that he was having a reaction to something, though they didn't know what. They prescribed prednisone, which didn't help at all. They also advised us to continue giving him Benadryl until we found another doctor. On 10/28/2022, we took him to his pediatrician. The pediatrician diagnosed unspecified urticaria. The pediatrician then recommended that we take him to an allergist.  On 11/2/2022, we took him to another urgent care clinic. The staff there weren't able to figure out the cause of the hives. However, they prescribed him a hydrocortisone topical ointment and hydroxyzine tablets, neither of which helped. We took my son to an allergist on 12/6/2022. She also diagnosed unspecified urticaria and conducted lab work. The lab work included tests for environmental allergies, a CBC test with differential/platelets, a hematocrit levels test, a liver profile, a globulin blood test, a test for the erythrocyte sedimentation rate, and an infectious diseases test. The hematocrit level was 49.0, which is high. The globulin level was 1.7, which is low. The albumin/globulin ratio was 2.8, which is high. No infectious diseases or environmental allergies were detected. The allergist diagnosed unspecified or chronic urticaria. She prescribed hydroxyzine. She also instructed us to apply the hydrocortisone cream to the affected areas. She recommended that he take fexofenadine for the hives, plus cetirizine hydrochloride. My son takes only the fexofenadine in the morning and only cetirizine hydrochloride in the evening. He will sometimes have a breakout shortly after taking the fexofenadine; in such cases, he takes hydroxyzine. Usually, within an hour or so after he takes the hydroxyzine, the hives are gone. About five or six hours later, when it's about his bedtime, the hives usually reappear. He will then take his cetirizine hydrochloride and his hydroxyzine.  Things have not improved since we have sought medical attention for my son, because we're still in limbo about what the possible cause of the hives is.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test, Platelet count, Red blood cell sedimentation rate, Urticaria, Urticaria chronic
Clinical narrative: On 10/23/2022, I noticed there were hives on my son's belly, his groin area, the entire area of both his legs, his buttocks, and his lumbar area. Within 24 hours after we first noticed them, the hives worsened. They then were everywhere from head to toe. My son complained of discomfort. We tried treating the hives with calamine lotion, but it didn't help. We also gave him Benadryl to take internally, but that also didn't help.  We took my son to an urgent care clinic first on 10/24/2022. The staff there said that he was having a reaction to something, though they didn't know what. They prescribed prednisone, which didn't help at all. They also advised us to continue giving him Benadryl until we found another doctor. On 10/28/2022, we took him to his pediatrician. The pediatrician diagnosed unspecified urticaria. The pediatrician then recommended that we take him to an allergist.  On 11/2/2022, we took him to another urgent care clinic. The staff there weren't able to figure out the cause of the hives. However, they prescribed him a hydrocortisone topical ointment and hydroxyzine tablets, neither of which helped. We took my son to an allergist on 12/6/2022. She also diagnosed unspecified urticaria and conducted lab work. The lab work included tests for environmental allergies, a CBC test with differential/platelets, a hematocrit levels test, a liver profile, a globulin blood test, a test for the erythrocyte sedimentation rate, and an infectious diseases test. The hematocrit level was 49.0, which is high. The globulin level was 1.7, which is low. The albumin/globulin ratio was 2.8, which is high. No infectious diseases or environmental allergies were detected. The allergist diagnosed unspecified or chronic urticaria. She prescribed hydroxyzine. She also instructed us to apply the hydrocortisone cream to the affected areas. She recommended that he take fexofenadine for the hives, plus cetirizine hydrochloride. My son takes only the fexofenadine in the morning and only cetirizine hydrochloride in the evening. He will sometimes have a breakout shortly after taking the fexofenadine; in such cases, he takes hydroxyzine. Usually, within an hour or so after he takes the hydroxyzine, the hives are gone. About five or six hours later, when it's about his bedtime, the hives usually reappear. He will then take his cetirizine hydrochloride and his hydroxyzine.  Things have not improved since we have sought medical attention for my son, because we're still in limbo about what the possible cause of the hives is.
Age: 73.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Arthralgia, Burning sensation, Electric shock sensation, Headache, Hypoaesthesia
Clinical narrative: 6/01/23 Shringrix Vaccination.  Very sore right arm headache.  6/03/23 Injection site bruised blackened. 6/07/23 Nerve pain in feet & ankles, knees 6/16/23 Numbness started in hands, arms while in bed sleeping.  6/19/23 Nerve pain & pain in joints of hands, knees, ankles, fingers, wrists. 6/20/23 Felt like a electrical current going through my legs, arms, feet.6/22/23 Stinging burning tingling in hands & ankles  6/26/23 Contacted DO's office.  Informed Dr's Assistant of adverse reaction to Shingrix vaccination & I was going to file report with VAERS.  Informed her taking Vitamin B12, B Complex Vitamins.  She going to talk to Dr. Outcome: Some stinging pain in knees, feet, ankles.
Age: 73.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Neuralgia, Pain, Pain in extremity
Clinical narrative: 6/01/23 Shringrix Vaccination.  Very sore right arm headache.  6/03/23 Injection site bruised blackened. 6/07/23 Nerve pain in feet & ankles, knees 6/16/23 Numbness started in hands, arms while in bed sleeping.  6/19/23 Nerve pain & pain in joints of hands, knees, ankles, fingers, wrists. 6/20/23 Felt like a electrical current going through my legs, arms, feet.6/22/23 Stinging burning tingling in hands & ankles  6/26/23 Contacted DO's office.  Informed Dr's Assistant of adverse reaction to Shingrix vaccination & I was going to file report with VAERS.  Informed her taking Vitamin B12, B Complex Vitamins.  She going to talk to Dr. Outcome: Some stinging pain in knees, feet, ankles.
Age: 73.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Paraesthesia
Clinical narrative: 6/01/23 Shringrix Vaccination.  Very sore right arm headache.  6/03/23 Injection site bruised blackened. 6/07/23 Nerve pain in feet & ankles, knees 6/16/23 Numbness started in hands, arms while in bed sleeping.  6/19/23 Nerve pain & pain in joints of hands, knees, ankles, fingers, wrists. 6/20/23 Felt like a electrical current going through my legs, arms, feet.6/22/23 Stinging burning tingling in hands & ankles  6/26/23 Contacted DO's office.  Informed Dr's Assistant of adverse reaction to Shingrix vaccination & I was going to file report with VAERS.  Informed her taking Vitamin B12, B Complex Vitamins.  She going to talk to Dr. Outcome: Some stinging pain in knees, feet, ankles.
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Loss of personal independence in daily activities, Nausea
Clinical narrative: Nausea, stomachache (severe enough to pre life any normal activities)
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: A patient received a Shingrix vaccination on Saturday. He experienced an injection site reaction that started Sunday afternoon and consisted of a raised, red, feverish area that streaked around to the back of his arm where the vaccine was given. He went to the ER because he was experiencing chest pain and was worried that he might be having a heart attack, and the ER doctor told the patient his radiating pain was likely inflammation from the vaccination.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: A patient received a Shingrix vaccination on Saturday. He experienced an injection site reaction that started Sunday afternoon and consisted of a raised, red, feverish area that streaked around to the back of his arm where the vaccine was given. He went to the ER because he was experiencing chest pain and was worried that he might be having a heart attack, and the ER doctor told the patient his radiating pain was likely inflammation from the vaccination.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt. came in to pick up her medications today (7/3/23) and informed me that MD had diagnosed her with Guillain-Barre Syndrome after hospital admission 2 weeks from vaccination (3/7/23).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypoaesthesia, Myalgia
Clinical narrative: The pt came into the pharmacy on 7/1/2023 and stated that he had normal side effects from the vaccine, like fatigue and muscle soreness, but then the next day on the 6/30/2023 he started to notice numbness on the left side of his back. He had gone into urgent care and they prescribed valacyclovir, the clinic didn't really know what to do, but told him to try the antiviral anyway. The clinic told him to come back to the pharmacy and tell us about it. I told him that I was look into the issue and report the incident into this database. He stated that was fine and I also instructed him to get to his primary to discuss the incident. I let him know that if the numbness spreads or any new changes pop up he should go to the emergency room, if his primary was unavailable.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram abnormal, Fatigue, Heart rate irregular
Clinical narrative: started with immediate and severe chest pain during exercise in late august of 2021 culminating with physical collapse from intense pain well performing sprints. I attempted to use vaers but upon entering my symptoms I was instructed to contact a medical professional. Upon reaching out to primary care provider was told I could not be seen due upcoming time, during time attempted to receive treatment but was told facilities weren't available in country. during time experienced less frequent chest pain but onset of fatigue and heart palpitations and had an EKG performed that showed an irregular heartbeat. Upon returning I sought medical attention again and was told that if it wasn't life threatening i would not be seen for chest pain. I went to an outside provider and test revealed i no longer had an irregular heartbeat but that i had an developed an early heart beat occurring at low frequency with no explanation as to why. Chest is far less frequent but still present and heart palpations occur after periods of intense exercise. No cause as to why has been discovered yet.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Pain, Palpitations, Syncope
Clinical narrative: started with immediate and severe chest pain during exercise in late august of 2021 culminating with physical collapse from intense pain well performing sprints. I attempted to use vaers but upon entering my symptoms I was instructed to contact a medical professional. Upon reaching out to primary care provider was told I could not be seen due upcoming time, during time attempted to receive treatment but was told facilities weren't available in country. during time experienced less frequent chest pain but onset of fatigue and heart palpitations and had an EKG performed that showed an irregular heartbeat. Upon returning I sought medical attention again and was told that if it wasn't life threatening i would not be seen for chest pain. I went to an outside provider and test revealed i no longer had an irregular heartbeat but that i had an developed an early heart beat occurring at low frequency with no explanation as to why. Chest is far less frequent but still present and heart palpations occur after periods of intense exercise. No cause as to why has been discovered yet.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient came to the pharmacy complaining of sore arm and rash and redness and pain around the injection site following second dose of Shingrix 48 hours ago. She stated she started feeling body ache and dizziness within a couple of hours of receiving the Shingrix and the fever lasted 24 hours despite taking Tyleonol. Her arm was still red around the injection site and painful. She was asked to contact her doctor for further evaluation. She stated she had similar reactions with the first Shingles shot but the adverse reactions are much more severe and lasts longer this time.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: patient said she got the vaccine and a few hours later she noticed arm was swollen and painful. Swelling  continued through out the night and ended up past her elbow
Age: 13.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: HPV (Gardasil) due today 07/03/2023, Bexsero and MenQuadfi given to patient instead. Pt. did not receive HPV
Age: 69.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Patient started developing redness, itching and pain on left arm where vaccine was injected. Patient went to emergency room on 6/5/23 and was given benadryl and hydrocortisone cream
Age: 47.0
Sex: F
Vaccine: HEPA, TDAP, VARZOS
Symptoms: No adverse event
Clinical narrative: Patient did not have an adverse event following administration of this vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint muscle pain rate of 8. Persisted from May 28 til June 1st RA doctor (who told me to get it notified) told to take Tylenol 650mg. up to 3000mg. Pain continued RA MD again called June 8 - told to see PCP or ER unable to see PCP. Seen @ hospital 6/12/23. Placed on prednisone 40mg x 4 days, 30mg x 3 days, 20mg x 2 days, 10mg x 1 day. Pain gradually decreased
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Acute kidney injury, Biopsy kidney, Blood urine, Cushing's syndrome, Fatigue
Clinical narrative: Bloody urine, fatigue, heaviness in legs nephrotic range proteinuria, hypoalbuminemia, nephrotic syndrome, Glomerulonephritis ISA nephropathy, Acute crescentric glomerulonephritis Acute Renal Failure PO and IV steroids Imuran, Lisinopril Cushing syndrome
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Glomerulonephritis, Glomerulonephritis rapidly progressive, Hypoalbuminaemia, Limb discomfort, Nephropathy
Clinical narrative: Bloody urine, fatigue, heaviness in legs nephrotic range proteinuria, hypoalbuminemia, nephrotic syndrome, Glomerulonephritis ISA nephropathy, Acute crescentric glomerulonephritis Acute Renal Failure PO and IV steroids Imuran, Lisinopril Cushing syndrome
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Nephrotic syndrome, Proteinuria, Urine analysis
Clinical narrative: Bloody urine, fatigue, heaviness in legs nephrotic range proteinuria, hypoalbuminemia, nephrotic syndrome, Glomerulonephritis ISA nephropathy, Acute crescentric glomerulonephritis Acute Renal Failure PO and IV steroids Imuran, Lisinopril Cushing syndrome
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Gait disturbance, Incoherent, Mobility decreased, Tremor
Clinical narrative: Person woke up on Sept 17 & was very shaky and could not get out of lift chair. Walked finally to bathroom (took very long time to walk) could not get off toilet. Very weak. EMS came & wanted him to go to hospital. He was okay & coherent in ER & Sunday - after being admitted, on Monday incoherent!
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE/PQC; tient was administered GARDASIL 9 ( not supported ) After TE.; This spontaneous report was received from a nurse prescriber regarding a patient of unspecified age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.  On 28-JUN-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5ml as prophylaxis (lot number (w015188) and expiration date (06-JAN-2025) both confirmed as valid (no more vaccination details provided) after a temperature excursion (TE) (temperature: 0.0 Fahrenheit (F), time frame: 0 hours 20 minutes 0 seconds) (product storage error). No additional adverse event (AE) happened (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE/PQC; patient was administered GARDASIL 9 ( not supported )after TE; This spontaneous report was received from a nurse prescriber regarding a patient of unspecified age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.  On 28-JUN-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5ml as prophylaxis (lot number (w015188) and expiration date (06-JAN-2025) both confirmed as valid (no more vaccination details provided) after a temperature excursion (TE) (temperature: 0.0 Fahrenheit (F), time frame: 0 hours 20 minutes 0 seconds) (product storage error). No additional adverse event (AE) happened (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX was administered to patient after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 23-JUN-2023, the patient received vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, lot #W008904, expiration date: 15-MAR-2024, administered for prophylaxis (strength, dose and route of administration were not provided) after a temperature excursion (Product storage error). Administered dose of suspect vaccine experienced the temperature excursion of 23 degree Fahrenheit for 2 hours 17 minutes. There was no temperature excursion occurred previously. No additional adverse event reported.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: menquadfi on 6/16/23 and then the same 2 vaccines administered 6/27/23 with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 11 years old male patient who received meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] on 6/16/23 and then the same vaccines on 6/27/23 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination (immunization).  On 27-Jun-2023, the patient again received 0.5 mL dose 1 of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (lot: u7616ab) (expiry date unknown) via intramuscular route in the right arm for immunization with no reported adverse event (inappropriate schedule of product administration) (same day latency). The patient had received Menquadfi vaccine 11 days prior at a different location.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi on 6/16/23 and then the same 2 vaccines administered 6/27/23 with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA202758:01672015: related case for adacel
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Myocarditis
Clinical narrative: Chest pain, probably myocarditis, relived a bit by stretching but rather persistent. Started at 10:30pm and persisting to this time.