chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain
Clinical narrative: Significant body aches; Dizziness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 23Oct2023 as dose number unknown, single. Past drug history included: Epinephrine, reaction(s): "Drug allergies: Epinephrine". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 01Nov2023 at 03:00, outcome "recovering"; PAIN (non-serious) with onset 01Nov2023 at 03:00, outcome "recovering", described as "Significant body aches"; FATIGUE (non-serious) with onset 01Nov2023 at 03:00, outcome "recovering". It was unknown if therapeutic measures were taken as a result of pain, dizziness, fatigue.  Additional information: Significant body aches within 24 hrs. Dizziness and fatigue has persisted 7 days later.  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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; 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 50-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 17:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 48 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 31Jul2021 as dose 2, single (Lot number: EW0150), in right arm and on 05Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing); "Shell fish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Drug allergy: Amoxicillin"; Macrodantin, reaction(s): "Drug allergy: macrodantin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 26Oct2023 to 30Oct2023.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 51 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was given Paxlovid from 25Oct2023 to 29Oct2023.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: developed rebound symptoms and tested positive for Covid-19 antigen 10 days after symptom resolution and negative test on day 6 following treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Ear infection, Fatigue
Clinical narrative: COVID twice; COVID twice; shortness of breath; chronic fatigue; headaches; ear infection; shingles; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 02Jul2021 as dose 1, single (Lot number: FA6780), in left arm and on 16Aug2021 as dose 2, single (Lot number: FC3182) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cold sores" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2021, outcome "not recovered" and all described as "COVID twice"; FATIGUE (non-serious) with onset 01Sep2021, outcome "not recovered", described as "chronic fatigue"; EAR INFECTION (non-serious) with onset 01Sep2021, outcome "not recovered"; HEADACHE (non-serious) with onset 01Sep2021, outcome "not recovered", described as "headaches"; HERPES ZOSTER (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shingles"; DYSPNOEA (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shortness of breath". The events "covid twice", "shortness of breath", "chronic fatigue", "headaches", "ear infection" and "shingles" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were not taken as a result of drug ineffective, covid-19, dyspnoea, fatigue, headache, ear infection, herpes zoster. Clinical course: The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient reported that he immediately went from jogging 6-8 miles at 10:30 pace. To only being able to run 2-3 miles at 12 min pace. This continues 2 years later. The patient stated, "I experience random shortness of breath - I battle chronic fatigue - I have headaches - I got an ear infection, COVID twice, and shingles all in one year since the vaccines." The patient had no covid prior to vaccination. The patient was tested for covid (nasal swab) post vaccination. The patient has no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360531 Same product, patient, different AEs, different dose;
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Herpes zoster, SARS-CoV-2 test
Clinical narrative: COVID twice; COVID twice; shortness of breath; chronic fatigue; headaches; ear infection; shingles; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 02Jul2021 as dose 1, single (Lot number: FA6780), in left arm and on 16Aug2021 as dose 2, single (Lot number: FC3182) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cold sores" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2021, outcome "not recovered" and all described as "COVID twice"; FATIGUE (non-serious) with onset 01Sep2021, outcome "not recovered", described as "chronic fatigue"; EAR INFECTION (non-serious) with onset 01Sep2021, outcome "not recovered"; HEADACHE (non-serious) with onset 01Sep2021, outcome "not recovered", described as "headaches"; HERPES ZOSTER (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shingles"; DYSPNOEA (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shortness of breath". The events "covid twice", "shortness of breath", "chronic fatigue", "headaches", "ear infection" and "shingles" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were not taken as a result of drug ineffective, covid-19, dyspnoea, fatigue, headache, ear infection, herpes zoster. Clinical course: The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient reported that he immediately went from jogging 6-8 miles at 10:30 pace. To only being able to run 2-3 miles at 12 min pace. This continues 2 years later. The patient stated, "I experience random shortness of breath - I battle chronic fatigue - I have headaches - I got an ear infection, COVID twice, and shingles all in one year since the vaccines." The patient had no covid prior to vaccination. The patient was tested for covid (nasal swab) post vaccination. The patient has no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360531 Same product, patient, different AEs, different dose;
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear infection, Herpes zoster, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: COVID twice; COVID twice; shortness of breath; chronic fatigue; headaches; ear infection; shingles; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 02Jul2021 as dose 1, single (Lot number: FA6780), in left arm and on 16Aug2021 as dose 2, single (Lot number: FC3182) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cold sores" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2021, outcome "not recovered" and all described as "COVID twice"; FATIGUE (non-serious) with onset 01Sep2021, outcome "not recovered", described as "chronic fatigue"; EAR INFECTION (non-serious) with onset 01Sep2021, outcome "not recovered"; HEADACHE (non-serious) with onset 01Sep2021, outcome "not recovered", described as "headaches"; HERPES ZOSTER (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shingles"; DYSPNOEA (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shortness of breath". The events "covid twice", "shortness of breath", "chronic fatigue", "headaches", "ear infection" and "shingles" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were not taken as a result of drug ineffective, covid-19, dyspnoea, fatigue, headache, ear infection, herpes zoster. Clinical course: The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient reported that he immediately went from jogging 6-8 miles at 10:30 pace. To only being able to run 2-3 miles at 12 min pace. This continues 2 years later. The patient stated, "I experience random shortness of breath - I battle chronic fatigue - I have headaches - I got an ear infection, COVID twice, and shingles all in one year since the vaccines." The patient had no covid prior to vaccination. The patient was tested for covid (nasal swab) post vaccination. The patient has no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360531 Same product, patient, different AEs, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Magnetic resonance imaging head, Transverse sinus thrombosis
Clinical narrative: Cerebral sinus thrombosis in the transverse sinus thing; Cerebral sinus thrombosis in the transverse sinus thing; 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 received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine. The following information was reported: CEREBRAL THROMBOSIS (medically significant), TRANSVERSE SINUS THROMBOSIS (medically significant), outcome "unknown" and all described as "Cerebral sinus thrombosis in the transverse sinus thing". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging head: Unknown results. Clinical course: Patient confirmed that she developed 'Cerebral sinus thrombosis' in the 'transverse sinus thing.' She also received the Moderna vaccine but the majority she received was the Pfizer COVID vaccine and the brain MRI that was performed was prior to the Moderna vaccine.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 home test Positive; COVID-19 home test Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "red food eye" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfameth, reaction(s): "known allergies: Sulfameth". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Nov2022, outcome "not recovered" and all described as "COVID-19 home test Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Positive, notes: Nasal Swab.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events drug ineffective and covid19  cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient contracted COVID 1 month after vaccination.; patient contracted COVID 1 month after vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "patient contracted COVID 1 month after vaccination.". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: purple/brown spot under the left corner of my eye/It doesn't hurt/right underneath the corner of my left eye, it looks like I got punched or ran into a wall; really sore arm; 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 male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 06Nov2023 at 11:00 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Nov2023, outcome "unknown", described as "really sore arm"; SKIN DISCOLOURATION (non-serious) with onset 06Nov2023 at 19:00, outcome "unknown", described as "purple/brown spot under the left corner of my eye/It doesn't hurt/right underneath the corner of my left eye, it looks like I got punched or ran into a wall".  Additional information: The patient developed a really sore arm after the vaccination. He also had a purple/brown spot under the right underneath corner of his left eye that wasn't there before he had the shot. It looked like someone punched him near the eye or walked into a wall but it doesn't hurt. Stated that this showed up about 8 hours after the shot. None of the doctors seem to be overly concerned about it.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: still has "red arm" and it is still "painful"; still has "red arm" and it is still "painful"; 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 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Nov2023, outcome "not recovered" and all described as "still has "red arm" and it is still "painful"".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, RSV
Symptoms: Investigation, Memory impairment, Nervous system disorder
Clinical narrative: neurological problems; memory is terribly bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological problems"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memory is terribly bad". The events "neurological problems" and "memory is terribly bad" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter is calling for his wife who took the Pfizer COVID booster vaccine and the RSV shot. After his wife took the vaccines, she experienced neurological problems. He would like to know if this is because of the vaccines. Confirmed his wife received the Pfizer RSV vaccine. His wife consulted a neurologist, got an MRI done which came back normal, had Cefogram done which came back normal. The neurologist said she does not have enough information to know if the vaccines triggered this. Something triggered this after the vaccines. Her memory is terribly bad since the vaccines. She was like this until she had the vaccines. His 70-year-old wife did not know they were married, and they have been married for 53 years. There are days like yesterday she was like that for a couple of minutes, and then a few minutes later she is back to normal, but not totally.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rhinorrhoea, SARS-CoV-2 test, Somnolence
Clinical narrative: Today, they both tested positive for COVID-19.; needing a nap; snotty nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 63-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 09Nov2023, outcome "unknown", described as "Today, they both tested positive for COVID-19."; SOMNOLENCE (non-serious) with onset Nov2023, outcome "unknown", described as "needing a nap"; RHINORRHOEA (non-serious) with onset Nov2023, outcome "unknown", described as "snotty nose". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.  Additional information: seriousness was reported as no. she travelled during the weekend and got the Pfizer COVID-19 vaccine last evening. The caller wants to know if what the positive COVID-19 test is due to the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19/all the COVID-19 symptoms icky, fever, sore throat, snotty nose, chest congestion and cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 09Nov2023, outcome "unknown", described as "tested positive for COVID-19/all the COVID-19 symptoms icky, fever, sore throat, snotty nose, chest congestion and cough". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter and patient took the vaccine, and they were having symptoms. They were both testing positive. The reporter would like to know if that was because of the vaccine. The reporter mentioned she and patient (her husband) travelled during the weekend and got the Pfizer COVID-19 vaccine last evening (08Nov2023). Today (09Nov2023), they both tested positive for COVID-19. Patient "was miserable". He was experiencing all the COVID-19 symptoms icky, fever, sore throat, snotty nose, chest congestion and cough.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Dose Number: 1 and Dose Number: 2: Moderna; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: 320308D) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: 013420A), on 09Feb2021 as dose 2, single (Lot number: 016M20A), on 08Apr2022 as dose 4 (booster), single (Lot number: 065K21A) and on 13Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation; elasomeran (SPIKEVAX), on 02Oct2023 at 10:00 as dose 6 (booster), single (Lot number: AU3832B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Multinodular Goiter" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Oct2021, outcome "unknown", described as "Dose Number: 1 and Dose Number: 2: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received treatment with Paxlovid from 26Oct2023 to 30Oct 2023 (lot number GJ7157).; Sender's Comments: The contributory role of the suspect product to the reported event drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. Considering interchange of vaccine, the contributory role of company suspect drug BNT162b2 to all the reported events drug ineffective, covid-19 cannot be excluded completely.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Neck pain
Clinical narrative: cold chills; neck pain; Headache; feeling dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Liver disease" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TRULICITY; ROSUVASTATIN; LOSARTIN. Past drug history included: Keflex [cefalexin], reaction(s): "Hypersensitivity". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION. The following information was reported: HEADACHE (non-serious) with onset 10Nov2023 at 19:00, outcome "recovering"; CHILLS (non-serious) with onset 10Nov2023 at 19:00, outcome "recovering", described as "cold chills"; DIZZINESS (non-serious) with onset 10Nov2023 at 19:00, outcome "recovering", described as "feeling dizzy"; NECK PAIN (non-serious) with onset 10Nov2023 at 19:00, outcome "recovering". Therapeutic measures were not taken as a result of chills, neck pain, headache, dizziness.  Additional information: horrible cold chills in the early evening with neck pain. Headache to the point of feeling dizzy. Did the patient receive any other vaccines on the same date as the vaccine(s) for which you are reporting?: No. Did the patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting?: No.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I ended up with COVID; I ended up with COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), 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: DRUG INEFFECTIVE (hospitalization, life threatening), COVID-19 (hospitalization, life threatening), outcome "unknown" and all described as "I ended up with COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Last season she received the Pfizer vaccine and all the recommended boosters. Patient ended up with COVID & spent 6 weeks in the ICU. She nearly died. so this year she will try another vaccine. Reporter considered events was caused by suspect product. Seriousness criteria was life-threatening, Event(s) resulted in (or prolonged) hospitalization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I still caught Covid; I still caught Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I still caught Covid". Additional information: patient just did not know yet what to think about these vaccines. He still caught Covid even though he was fully vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: he's have colds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2023, outcome "unknown", described as "he's have colds".  Additional information: Caller's concern: Caller said on 25Sep he got his Comirnaty vaccine shot at Pharmacy, and the person who gave him the shot said to come back in Nov2023 for his second shot as he's going to need two of them. The caller went online and tried to see information but didn't see anything that talks about a second shot. The caller would just like to make sure of the dosing of the vaccine because he thinks he's misunderstanding the dosing schedule for ages 12 and older in the 2023-2024 formula. Resolution: Transferred call from one of the health and science representatives and had a patient who had called her. Caller had mentioned he's have colds and not sure about the second dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: vaccinated with Covid-19 vaccine but still got diagnosed with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "vaccinated with Covid-19 vaccine but still got diagnosed with Covid-19".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: caller have a heart disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "caller have a heart disease".  Additional Information: Reporter calling in about the vaccines that were offered one from Pfizer, Moderna and there's another one.  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: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: he is really sore and he's having a hard time moving his body because he's sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 07Nov2023, outcome "unknown", described as "he is really sore and he's having a hard time moving his body because he's sore". Therapeutic measures were taken as a result of pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: his wife died from the vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "his wife died from the vaccination". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: The reporter mentioned that he doesn't believe in the Covid-19 vaccination because his wife died from the vaccination, and it has been proven that the vaccine doesn't really cure Covid-19. Reporter also mentioned that his wife died after taking her second vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: his wife died from the vaccination
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: so many people got COVID and have lost their sense of taste and smell, like her brother had for the last two and a half years; so many people got COVID and have lost their sense of taste and smell, like her brother had for the last two and a half years; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "so many people got COVID and have lost their sense of taste and smell, like her brother had for the last two and a half years".  Clinical Course: Reporter called from the clinic and trying to find out as she's thinking about how so many people got COVID and have lost their sense of taste and smell, like her brother had for the last two and a half years, and luckily she has not. The caller is asking if somebody is working on a solution on how to get back the sense of taste and smell and if we have a solution for that.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The causal association cannot be excluded between the reported event of drug ineffective, suspected COVID 19 and BNT162b2 use.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: reported as a medication error due to patient receiving double doses of vaccine products (with no reported adverse event); Initial information received on 01-Nov-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 1-year-old male patient and the reporter reported as a medication error due to patient receiving double doses of vaccine products (with no reported adverse event) after receiving vaccine diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine for Immunisation.  On 31-Oct-2023, the patient received a 0.5 ml dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (strength: unknown) (lot: C6013AA, expiry date: 07-Jun-2024) in the left thigh for Immunization and reported as a medication error due to patient receiving double doses of vaccine products (with no reported adverse event) (extra dose administered) (latency: same day).  Reportedly, Caller states the patient was behind on a vaccinations and was on a catch up regimen. Patient was due for about 6 to 7 vaccine products, but the parents wanted to only get a few vaccines at a time. The prescribing doctor wrote the order for "Penta, DTaP, Polio, and hib" at the bottom of the order which may have confused the MA that administered the vaccine products    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-2023SA344255:
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Product prescribing error
Clinical narrative: patient that received 2 FLUZONE QIV NP injections within 2 weeks with no reported adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 55 years old male patient who received 2 Influenza Quadrival A-B Vaccine [Fluzone Qiv] injections within 2 weeks 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 Covid-19 Vaccine (Covid-19 Vaccine) for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml total (1X) of suspect Influenza Quadrival A-B Vaccine Suspension for injection (with an unknown strength, expiry date and lot number) via unknown route in unknown administration site for immunisation.  On an unknown date, the patient received 2 Influenza Quadrival A-B Vaccine injections within 2 weeks with no reported adverse event (extra dose administered) (latency: same day).  It was reported, Caller sated she needs to inform her manager so is asking if we can reach back out to her today. Caller is asking for recommendations regarding a patient that received 2 Fluzone QIV NP injections within 2 weeks. She stated when she went to administer the shot today, the orders were in the computer for it, but after it had been given, the orders were changed to the Covid vaccine. The patient did not speak up until after the shot as well that he had already received the flu shot last week. The provider stated the patient was fine, and the patient still wants to receive the Covid vaccine, but the nurse is requesting guidance or recommendations regarding the situation. Asking if there are any AEs the patient or provider needs to be aware of. Caller stated that when we call back it will go to a call center. The nurse clarified that when he received the extra dose of the flu shot, after it was realized he actually wanted the Covid vaccine, he did receive the Covid vaccine that day also.  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: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Swelling face
Clinical narrative: experienced swelling of his face; shortness of breath; Initial information received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 68 years old male patient who experienced swelling of his face and shortness of breath after receiving influenza quadrival A-b high dose HV vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or: no other vaccines   On 30-Oct-2023, the patient received a dose of 0.7 mL of suspect influenza quadrival A-b high dose HV vaccine (lot U8156AA, expiry date- 30-JUN-2024) (with an unknown strength, formulation) via intramuscular route in the left upper arm for Immunisation.  On 30-OCT-2023, (latency- same day), the patient developed swelling of his face (swelling face) and shortness of breath (dyspnoea) following the administration of influenza quadrival A-b high dose HV vaccine.  Reportedly, There was no apparent rash. The patient contacted the physician the next day and was instructed to take Benadryl. Patient noticed improvement with Benadryl. Patient was seen by the physician today, 01NOV2023. The physician was not able to see any swelling on the patient's face. The patient's symptoms lasted 2 days. The patient noted that this was the first time he had received a flu vaccine.   Action taken was not applicable.  Treatment: Physician recommended patient take Benadryl for symptoms. Patient noticed some improvement after taking Benadryl.  At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2023 for both the events.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered Quadracel to an underage patient with no reported adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient was administered Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] 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 an 0.5 ml total (1X) of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine Suspension for injection (lot number: U7452AA) (expiry date: 29-Jun-2024) (Frequency: once) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was administered Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, A clinical director of operations reported that they have invertedly administered Quadracel to an underage patient and would like to know what to do moving forward. She said that she saw an article (abbreviation meaning not known) CDC (abbreviation meaning not known) from 2015 that if an underage patient was administered Quadracel, that dose would be counted. She would like to know to know what information we have in regards to this. This situation is reported as a medication error.  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.