chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Incorrect product formulation administered
Clinical narrative: AREXVY is not approved for use in pregnant women; 33 years old received Arexvy; This non-serious prospective pregnancy case was reported by a consumer and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-SEP-2023, the patient received Arexvy. On 28-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 33 years old received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: AREXVY is not approved for use in pregnant women). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 29-SEP-2023 The patient reported that she had entered a pharmacy intending to receive the Abrysvo rsv vaccine. Soon afterward, she discovered that she had been administered the Arexvy rsv vaccine instead.  Since Arexvy was not approved for use in pregnant women, she was advised to report that event to GSK. She asked if there was any data on the use of this vaccine in pregnant women. As pregnant patient received a dose of Arexvy instead of Abrysvo which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy.
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: AREXVY is not approved for use in pregnant women; 33 years old received Arexvy; This non-serious prospective pregnancy case was reported by a consumer and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-SEP-2023, the patient received Arexvy. On 28-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 33 years old received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: AREXVY is not approved for use in pregnant women). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 29-SEP-2023 The patient reported that she had entered a pharmacy intending to receive the Abrysvo rsv vaccine. Soon afterward, she discovered that she had been administered the Arexvy rsv vaccine instead.  Since Arexvy was not approved for use in pregnant women, she was advised to report that event to GSK. She asked if there was any data on the use of this vaccine in pregnant women. As pregnant patient received a dose of Arexvy instead of Abrysvo which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Unevaluable event
Clinical narrative: Pizer-BioNTech COVID-19 Vaccine, Bivalent EUA: Date of start of drug 30Sep2023; I occurred chills and fever  lasting 24 hours; I occurred chills and fever  lasting 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "chronic kidney disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CHILLS (non-serious), PYREXIA (non-serious) all with onset 30Sep2023, outcome "recovered" and all described as "I occurred chills and fever  lasting 24 hours"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 30Sep2023 at 11:00, outcome "unknown", described as "Pizer-BioNTech COVID-19 Vaccine, Bivalent EUA: Date of start of drug 30Sep2023". Therapeutic measures were not taken as a result of chills, pyrexia.  Additional information: Patient had no known allergies. Around 3pm on 30Sep2023 occurred chills and fever lasting 24 hours. No covid prior vaccination and not covid tested post vaccination.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Chills, Pyrexia, Wrong product administered
Clinical narrative: Pizer-BioNTech COVID-19 Vaccine, Bivalent EUA: Date of start of drug 30Sep2023; I occurred chills and fever  lasting 24 hours; I occurred chills and fever  lasting 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "chronic kidney disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CHILLS (non-serious), PYREXIA (non-serious) all with onset 30Sep2023, outcome "recovered" and all described as "I occurred chills and fever  lasting 24 hours"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 30Sep2023 at 11:00, outcome "unknown", described as "Pizer-BioNTech COVID-19 Vaccine, Bivalent EUA: Date of start of drug 30Sep2023". Therapeutic measures were not taken as a result of chills, pyrexia.  Additional information: Patient had no known allergies. Around 3pm on 30Sep2023 occurred chills and fever lasting 24 hours. No covid prior vaccination and not covid tested post vaccination.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Vomiting
Clinical narrative: She is sleeping a lot; dizziness; headache; nausea; vomiting; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (She is sleeping a lot), DIZZINESS (dizziness), VOMITING (vomiting), HEADACHE (headache) and NAUSEA (nausea) in a 59-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VOMITING (vomiting). On an unknown date, the patient experienced HYPERSOMNIA (She is sleeping a lot), DIZZINESS (dizziness), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HYPERSOMNIA (She is sleeping a lot) and VOMITING (vomiting) outcome was unknown and DIZZINESS (dizziness), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was healthy. Patient's previous doses were Moderna vaccines, and she never experienced this kind of symptom before. Patient did not have previous vaccination information. Patient stated that On 02-Oct-2023 she vomited after every 20 minutes, and it was horrible. She stated that the side effects made her not want to get vaccinated again. Treatment information was not provided. Company Comment: This is a spontaneous case concerning a 59-year-old female patient no reported medical history, who experienced the non-serious unexpected, AESI event of Hypersomnia, together with other non-serious events (dizziness, vomiting, headache and nausea). Event vomiting occurred on the following day after receiving a dose of mRNA-1273.815 (Spikevax 2023-2024) vaccine. The rest of the events occurred on an unknown date.  It was reported that patient was healthy, and patient's previous doses were Moderna vaccines, and she never experienced this kind of symptoms before. Patient stated that on she vomited every 20 minutes on the following day after vaccination. The benefit-risk relationship mRNA-1273.815 (Spikevax 2023-2024) is not affected by this report.
Age: 59.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Dizziness, Headache, Hypersomnia, Nausea, Vomiting
Clinical narrative: She is sleeping a lot; dizziness; headache; nausea; vomiting; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (She is sleeping a lot), DIZZINESS (dizziness), VOMITING (vomiting), HEADACHE (headache) and NAUSEA (nausea) in a 59-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VOMITING (vomiting). On an unknown date, the patient experienced HYPERSOMNIA (She is sleeping a lot), DIZZINESS (dizziness), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HYPERSOMNIA (She is sleeping a lot) and VOMITING (vomiting) outcome was unknown and DIZZINESS (dizziness), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was healthy. Patient's previous doses were Moderna vaccines, and she never experienced this kind of symptom before. Patient did not have previous vaccination information. Patient stated that On 02-Oct-2023 she vomited after every 20 minutes, and it was horrible. She stated that the side effects made her not want to get vaccinated again. Treatment information was not provided. Company Comment: This is a spontaneous case concerning a 59-year-old female patient no reported medical history, who experienced the non-serious unexpected, AESI event of Hypersomnia, together with other non-serious events (dizziness, vomiting, headache and nausea). Event vomiting occurred on the following day after receiving a dose of mRNA-1273.815 (Spikevax 2023-2024) vaccine. The rest of the events occurred on an unknown date.  It was reported that patient was healthy, and patient's previous doses were Moderna vaccines, and she never experienced this kind of symptoms before. Patient stated that on she vomited every 20 minutes on the following day after vaccination. The benefit-risk relationship mRNA-1273.815 (Spikevax 2023-2024) is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: she tested positive for covid the afternoon she reported her symptoms; she tested positive for covid the afternoon she reported her symptoms; 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 59-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 11:20 as dose 6 (booster), 0.3 ml single (Lot number: HG4628, Expiration Date: Nov2023) at the age of 59 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (Dose 1, Product Details (Moderna Unspecified Vaccine):, Lot# (First Dose): Consumer stated, "027A2119, I am not sure. I guess it is an A."), for COVID-19 immunization; Moderna (Dose 2, Lot#: 039A2114), for COVID-19 immunization; Moderna (Dose 3, Lot# (Third Dose): 064H21A (Captured in tab)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 4, Name: Pfizer COVID Bivalent the it some work, it says EUA, 12 years and up, EUA.", Lot#: GJ3274, Expiration date: May2023, NDC# and UPC#: Consumer stated, "No, they does not gave it to me."), for COVID-19 Immunization; Bnt162b2 (Dose 5, COVID-19 Vaccine, Is this a Pfizer product? Yes, NDC number: Unknown, UPC number: Unknown, Lot Number: FN2908, Expiry date: Sep2022), for COVID-19 Immunization; Flucelvax quad (Flucelvax Quad, Is this a Pfizer product? No, Manufacturer name: Seqirus, NDC number: Unknown, UPC number: Unknown, Lot Number: 9424O9, Expiry date: Jun2023, Consumer stated, "I did not take the flu shot this year."), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she tested positive for covid the afternoon she reported her symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive for covid.  Additional information: the patient had the vaccine last Saturday (30Sep2023) and called to report the symptoms she has experienced after getting the vaccine. However, she tested positive for covid the afternoon she reported her symptoms. She explained that the symptoms may have been from covid rather than the covid vaccine. She added that she called Safety again to report this. She wanted to know if the covid19 vaccine can worsen the covid symptoms.  She said that she was initially fine and then few hours after, she started to have symptoms.  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: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Illness, Malaise, Nausea, Pain
Clinical narrative: she tested positive for covid the afternoon she reported her symptoms; she tested positive for covid the afternoon she reported her symptoms; 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 59-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 11:20 as dose 6 (booster), 0.3 ml single (Lot number: HG4628, Expiration Date: Nov2023) at the age of 59 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (Dose 1, Product Details (Moderna Unspecified Vaccine):, Lot# (First Dose): Consumer stated, "027A2119, I am not sure. I guess it is an A."), for COVID-19 immunization; Moderna (Dose 2, Lot#: 039A2114), for COVID-19 immunization; Moderna (Dose 3, Lot# (Third Dose): 064H21A (Captured in tab)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 4, Name: Pfizer COVID Bivalent the it some work, it says EUA, 12 years and up, EUA.", Lot#: GJ3274, Expiration date: May2023, NDC# and UPC#: Consumer stated, "No, they does not gave it to me."), for COVID-19 Immunization; Bnt162b2 (Dose 5, COVID-19 Vaccine, Is this a Pfizer product? Yes, NDC number: Unknown, UPC number: Unknown, Lot Number: FN2908, Expiry date: Sep2022), for COVID-19 Immunization; Flucelvax quad (Flucelvax Quad, Is this a Pfizer product? No, Manufacturer name: Seqirus, NDC number: Unknown, UPC number: Unknown, Lot Number: 9424O9, Expiry date: Jun2023, Consumer stated, "I did not take the flu shot this year."), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she tested positive for covid the afternoon she reported her symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive for covid.  Additional information: the patient had the vaccine last Saturday (30Sep2023) and called to report the symptoms she has experienced after getting the vaccine. However, she tested positive for covid the afternoon she reported her symptoms. She explained that the symptoms may have been from covid rather than the covid vaccine. She added that she called Safety again to report this. She wanted to know if the covid19 vaccine can worsen the covid symptoms.  She said that she was initially fine and then few hours after, she started to have symptoms.  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: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sinus disorder, Urticaria, Vomiting
Clinical narrative: she tested positive for covid the afternoon she reported her symptoms; she tested positive for covid the afternoon she reported her symptoms; 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 59-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 11:20 as dose 6 (booster), 0.3 ml single (Lot number: HG4628, Expiration Date: Nov2023) at the age of 59 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (Dose 1, Product Details (Moderna Unspecified Vaccine):, Lot# (First Dose): Consumer stated, "027A2119, I am not sure. I guess it is an A."), for COVID-19 immunization; Moderna (Dose 2, Lot#: 039A2114), for COVID-19 immunization; Moderna (Dose 3, Lot# (Third Dose): 064H21A (Captured in tab)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 4, Name: Pfizer COVID Bivalent the it some work, it says EUA, 12 years and up, EUA.", Lot#: GJ3274, Expiration date: May2023, NDC# and UPC#: Consumer stated, "No, they does not gave it to me."), for COVID-19 Immunization; Bnt162b2 (Dose 5, COVID-19 Vaccine, Is this a Pfizer product? Yes, NDC number: Unknown, UPC number: Unknown, Lot Number: FN2908, Expiry date: Sep2022), for COVID-19 Immunization; Flucelvax quad (Flucelvax Quad, Is this a Pfizer product? No, Manufacturer name: Seqirus, NDC number: Unknown, UPC number: Unknown, Lot Number: 9424O9, Expiry date: Jun2023, Consumer stated, "I did not take the flu shot this year."), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she tested positive for covid the afternoon she reported her symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive for covid.  Additional information: the patient had the vaccine last Saturday (30Sep2023) and called to report the symptoms she has experienced after getting the vaccine. However, she tested positive for covid the afternoon she reported her symptoms. She explained that the symptoms may have been from covid rather than the covid vaccine. She added that she called Safety again to report this. She wanted to know if the covid19 vaccine can worsen the covid symptoms.  She said that she was initially fine and then few hours after, she started to have symptoms.  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: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for covid the afternoon she reported her symptoms; she tested positive for covid the afternoon she reported her symptoms; 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 59-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 11:20 as dose 6 (booster), 0.3 ml single (Lot number: HG4628, Expiration Date: Nov2023) at the age of 59 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (Dose 1, Product Details (Moderna Unspecified Vaccine):, Lot# (First Dose): Consumer stated, "027A2119, I am not sure. I guess it is an A."), for COVID-19 immunization; Moderna (Dose 2, Lot#: 039A2114), for COVID-19 immunization; Moderna (Dose 3, Lot# (Third Dose): 064H21A (Captured in tab)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 4, Name: Pfizer COVID Bivalent the it some work, it says EUA, 12 years and up, EUA.", Lot#: GJ3274, Expiration date: May2023, NDC# and UPC#: Consumer stated, "No, they does not gave it to me."), for COVID-19 Immunization; Bnt162b2 (Dose 5, COVID-19 Vaccine, Is this a Pfizer product? Yes, NDC number: Unknown, UPC number: Unknown, Lot Number: FN2908, Expiry date: Sep2022), for COVID-19 Immunization; Flucelvax quad (Flucelvax Quad, Is this a Pfizer product? No, Manufacturer name: Seqirus, NDC number: Unknown, UPC number: Unknown, Lot Number: 9424O9, Expiry date: Jun2023, Consumer stated, "I did not take the flu shot this year."), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she tested positive for covid the afternoon she reported her symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive for covid.  Additional information: the patient had the vaccine last Saturday (30Sep2023) and called to report the symptoms she has experienced after getting the vaccine. However, she tested positive for covid the afternoon she reported her symptoms. She explained that the symptoms may have been from covid rather than the covid vaccine. She added that she called Safety again to report this. She wanted to know if the covid19 vaccine can worsen the covid symptoms.  She said that she was initially fine and then few hours after, she started to have symptoms.  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: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Electrocardiogram, Fatigue, Headache, Muscle twitching
Clinical narrative: Pt was not initially symptomatic after receiving the vaccine, and left the pharmacy without incident. Mother stated that pt fainted 14.5 hours after receiving her vaccine. After awakening, she experienced tremors, headache and nausea that are still persisting. She followed up with her PCP and was immediately referred to the ER. Pt has been instructed to follow up with a cardiologist within the next few weeks. Pt is currently stable and at home.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Orthostatic heart rate response increased, Somnolence, Syncope, Vomiting
Clinical narrative: Pt was not initially symptomatic after receiving the vaccine, and left the pharmacy without incident. Mother stated that pt fainted 14.5 hours after receiving her vaccine. After awakening, she experienced tremors, headache and nausea that are still persisting. She followed up with her PCP and was immediately referred to the ER. Pt has been instructed to follow up with a cardiologist within the next few weeks. Pt is currently stable and at home.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Syncope, Tremor
Clinical narrative: Pt was not initially symptomatic after receiving the vaccine, and left the pharmacy without incident. Mother stated that pt fainted 14.5 hours after receiving her vaccine. After awakening, she experienced tremors, headache and nausea that are still persisting. She followed up with her PCP and was immediately referred to the ER. Pt has been instructed to follow up with a cardiologist within the next few weeks. Pt is currently stable and at home.
Sex: F
Vaccine: MMR
Symptoms: Biopsy skin, Condition aggravated, Granuloma, Skin lesion
Clinical narrative: Necrotizing granuloma; Patient with common variable immunodeficiency used MMR; Literature Report.   Information has been received from the authors in a published literature article entitled as stated above concerning a 46-year-old female patient with a history of Common variable immunodeficiency (CVID) presented with nontender, non-pruritic, enlarging right knee lesions present for over 20 years. She reported a history of trauma of the right knee prior to lesion onset. Physical exam showed violaceous verrucous papules and crusted plaques from the right knee to the distal anterior shin. She reported that occasionally the right knee plaque would ulcerate, for which she self-treated with silver nitrate.   The patient had received two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R) vaccine in childhood (Contraindicated product administered). In the context of reports emerging in recent years of RuV-associated granulomatous inflammation in patients with inborn errors of immunity (IEI), Vaccine strain rubella virus (RuV) was suspected to be involved in her skin pathology. Fresh tissue from a granulomatous skin lesion, nasopharyngeal (NP) swab, and whole blood were sent to the Centers for Disease Control and Prevention (CDC) for RuV molecular testing, and serum was submitted for rubella serology. Vaccine-derived RuV was detected in the skin biopsy specimen by RT-PCR and viral RNA sequencing. The NP swab and neutrophils isolated from the whole blood were negative for RuV by RT-PCR. Serum was negative for rubella IgM and positive for rubella IgG (ISR = 3.45). Repeat biopsy specimen of one of the small papules showed persistent necrotizing granulomatous (Necrotising granuloma) and neutrophilic inflammation in the same histopathologic pattern as in her prior biopsies.   The outcome of Necrotising granuloma was not reported.  The authors considered that The presence of mmunodeficiency-related vaccine-derived rubella viruses (iVDRVs) in M-type rubella-associated granulomas, the most frequently observed pattern in IEI patients, has been repeatedly confirmed by RT-PCR and sequencing of RNA isolated from these granulomas..  A copy of the published article is attached as further documentation of the patient's experience.
Age: 57.0
Sex: F
Vaccine: MMR, TDAP, UNK
Symptoms: Injection site swelling, Injection site warmth, Neck mass, Peripheral swelling
Clinical narrative: Left arm swelling; Bump at injection site; Injection site hot; Lump on back of neck; This spontaneous report was received from a pharmacist and refers to a 57-year-old female patient.  The patient's concurrent conditions included high cholesterol and breast cancer. Medical history, drug allergies or reactions were not reported. Concomitant therapies were anastrozole and rosuvastatin calcium (CRESTOR).  On 12-AUG-2023, the patient started therapy with creatine (+) galantamine hydrobromide (+) royal jelly (+) sodium phytate (ENERGIX), one time on her left arm, lot # 4JG5Y expiry date 12-AUG-2024 (dose, strength, formulation, indication, and route of administration were not provided). On 14-AUG-2023, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin (rHA)) one time, lot #W035041 (which was confirmed to be a valid lot # for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)), expiration date reported as 01-MAY-2024 but confirmed to be 24-MAY-2024, intramuscularly on her left arm (strength not provided) as prophylaxis for immigration. On 15-AUG-2023, she was vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), one time on her left arm, lot # 2CA61C1, expiry date 30-JUN-2025 (strength, formulation, indication, and route of administration were not provided).   On 19-AUG-2023, the patient experienced left arm swelling (peripheral swelling), bump at injection site and hot (vaccination site mass, vaccination site warmth), as well as a lump back of neck (neck mass), she sought medical attention and received treatment for the events. The action taken with creatine (+) galantamine hydrobromide (+) royal jelly (+) sodium phytate (ENERGIX), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not applicable. At the time of reporting, the patient was recovering from the events.  The causality between the events and creatine (+) galantamine hydrobromide (+) royal jelly (+) sodium phytate (ENERGIX), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No symptoms to report; HBP calling to report a patient received their first dose of PROQUAD at the age of 15 in TEXAS.  Caller stated no symptoms to report and no further details available from HBP.  No other AE and no PQC; This spontaneous report was received from a nurse and refers to a 15 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 11-AUG-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot #, expiration date, strength, route of administration, anatomical location not provided) as prophylaxis at the age of 15 (product administered to patient of inappropriate age). No symptoms were reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reported PROQUAD was administered after a temperature excursion to one patient. Product was administered on Sep 27, 2023. No further information provided. No additional AE reported. No PQC reported.; No additional AE; This spontaneous report was received from a nurse and refers to a 10 year old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 27-SEP-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # W036929, expiration date: 19-MAY-2024,  therapy type stablished as rHA) (strength, route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion (product storage error). No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: HBP calling to report an unknown of administrations of GARDASIL 9 following a temperature excursion. No symptoms or further details reported.  No other AE and no PQC; no adverse event; This spontaneous report was received from Other Health Professional and refers to an unspecified patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W021345, expiration date: 01-DEC-2024 (strength, route of administration, and indication were not provided).  On an unknown date, the HBP calling to report an unknown of administrations of GARDASIL 9 following a temperature excursion (Product storage error). At the time of reporting, the outcome of the event  was unknown.   The action taken with GARDASIL 9 regarding the event was reported as Not Applicable.
Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: giving a dose of VAXNEUVANCE to a baby and the syringe broke at the hub while it was still in the baby's leg.; giving a dose of VAXNEUVANCE to a baby and the syringe broke at the hub while it was still in the baby's leg.; Confirmed no injuries/No additional AE/no additional PQC; This spontaneous report was received from nurse via company representative referring to an infant patient (reported as "baby") of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as "a few weeks ago"), the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) (strength, dose, lot #, expiry date, and route of administration were not provided) in the leg for prophylaxis. The nurse reported that while giving the dose, the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe broke at the hub while still in the baby's leg (Poor quality device used, Syringe issue). The nurse removed the detached part from the leg quickly and confirmed that no injuries occurred. The patient received the full dose. No additional adverse event (AE) reported.
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Patient had a sore left arm; Drug exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore left arm) and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylaxis.    Patient was taking Prenatal vitamins.  Concurrent medical conditions included Asthma and Allergy (patient takes over the counter allergy medication).   On 28-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and INFLUENZA VACCINE (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 28-Oct-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient had a sore left arm). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, VACCINATION SITE PAIN (Patient had a sore left arm) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported. Company Comment: This is a spontaneous case of Maternal exposure during pregnancy concerning an adult female patient with no relevant medical history, who experienced the non-serious expected, event of vaccination site pain, which occurred on an unknown date after a dose of mRNA-1273 BIVALENT .222 (original and omicron BA.4/BA.5, received as the fifth dose of COVID-19 vaccination schedule. Patient received Influenza vaccine on the same day of vaccination with mRNA-1273 BIVALENT .222, which was considered as a co-suspect drug. The benefit-risk relationship of mRNA-1273 BIVALENT .222 (original and omicron BA.4/BA.5) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-743819, US-MODERNATX, INC.-MOD-2023-743824 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743819:Same patient, PFS vaccine dose US-MODERNATX, INC.-MOD-2023-743824:Same patient, Monovalent dose
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Pulmonary embolism
Clinical narrative: pulmonary embolism; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 6 days due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: All tests came back unprovoked..         No relevant concomitant medications were reported. It was reported that patient had received the vaccine and two boosters. He developed pulmonary embolism that practically shut down his right lung and was lucky to catch it as it could have been lethal. He consulted with blood doctor specialist. So he needs to be on blood thinners for the rest of his life.  Company comment:  This spontaneous case concerns a 49  year  old male patient, with no medical history reported, who received one dose and two booster doses with Moderna COVID  19 vaccine (mRNA  1273) and experienced the unexpected, serious (medically significant and hospitalization) AESI pulmonary embolism. The event occurred approximately 13 months after the first dose of vaccine. Latency between last booster dose and the event cannot be properly assessed since exact vaccination date was not provided. The report stated that the patient experienced pulmonary embolism that "practically shut down his right lung". He was hospitalized for 6 days, and it was reported that he should be under blood thinners treatment for the rest of his life. The outcome was reported as recovering. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Moderna COVID-19 Vaccine (mRNA - 1273) is not affected by this report.
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Oropharyngeal pain, Pruritus, Swelling
Clinical narrative: itch; swelling; throat was sore; Red; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itch), SWELLING (swelling), OROPHARYNGEAL PAIN (throat was sore) and ERYTHEMA (Red) in a 52-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3915B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 04-Oct-2023, the patient experienced PRURITUS (itch), SWELLING (swelling), OROPHARYNGEAL PAIN (throat was sore) and ERYTHEMA (Red). At the time of the report, PRURITUS (itch), SWELLING (swelling), OROPHARYNGEAL PAIN (throat was sore) and ERYTHEMA (Red) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that after one hour of vaccination patient experienced symptoms of itch, red swelling, throat was sore. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: I came down with COVID/ I tested positive on 27Sep2023; I came down with COVID/ I tested positive on 27Sep2023; I had Pfizer a long time ago the first one (COVID-19 Vaccine). The last one I had was Moderna (Clarified as Moderna COVID-19 Vaccine). Booster number three is Moderna."; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Sep2022 as dose 3 (booster), single (Lot number: AS71642) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "unknown", described as "I had Pfizer a long time ago the first one (COVID-19 Vaccine). The last one I had was Moderna (Clarified as Moderna COVID-19 Vaccine). Booster number three is Moderna.""; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Sep2023, outcome "unknown" and all described as "I came down with COVID/ I tested positive on 27Sep2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient reported that he was a retired Pharmacist. His last COVID booster was on 30Sep2022. He called his Pharmacy and thought they knew he was on Paxlovid but they said do you want the COVID shot today? He wanted to know if one could get a COVID shot while taking Paxlovid. He stated that he took Pfizer a long time ago the first one (COVID-19 Vaccine). The last one he had was Moderna (Clarified as Moderna COVID-19 Vaccine). Booster number three was Moderna. Paxlovid came on Wednesday. That was the first day of his definite symptoms and he tested positive on Wednesday, 27Sep2023. He took Paxlovid (Batch/lot number: GG2270) for COVID-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300316002 Same reporter/patient, different drug/event.;
Sex: U
Vaccine: RSV
Symptoms: Ear pain, Eye pain, Headache, Increased upper airway secretion, Pain
Clinical narrative: developed much mucous in my throat and chest area; developed much mucous in my throat and chest area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 22Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPUTUM INCREASED (non-serious), INCREASED UPPER AIRWAY SECRETION (non-serious) all with onset 2023, outcome "recovering" and all described as "developed much mucous in my throat and chest area". Therapeutic measures were taken as a result of sputum increased, increased upper airway secretion.  Additional information: The patient received the RSV shot on 22Sep2023 then developed much mucous in throat and chest area. The patient started taking a Z pack which seems to be getting rid of these but since then, the patient developed a pain in head. It was constant 24/7, sharp pain which radiates from behind left eyeball to left ear. The eye doctor is stumped. The patient was asking where to go to get rid of the pain.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Known allergies: Pine nuts" (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 Sep2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Sep2023) negative; (28Sep2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment started on 23Sep2023 and ended on 27Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on current information available the causal association between the events DRUG INEFFECTIVE, COVID-19 and suspect drug BNT162B2 cannot be excluded completely.