chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Extreme nausea for 2 1/2 hours but could not vomit; Fever of 101 degrees for hours; Chills; Joint and Muscle pain; Joint and Muscle pain; Ache all over; some dizziness; felt like a bad flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 11:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Non-Hodgkin's Lymphoma - in remission" (unspecified if ongoing). Concomitant medication(s) included: RSV VACCINE taken for immunisation, on 13Sep2023 as dose 1, single; TRAMADOL; GABAPENTIN; NORCO; ATORVASTATIN. Past drug history included: Epinephrine, reaction(s): "Known allergies: Epinephrine"; Lyrica, reaction(s): "Known allergies: Lyrica"; Prozac, reaction(s): "Known allergies: Prozac". 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 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "Ache all over"; CHILLS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering"; NAUSEA (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "Extreme nausea for 2 1/2 hours but could not vomit"; PYREXIA (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "Fever of 101 degrees for hours"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 03Oct2023 at 02:00, outcome "recovering" and all described as "Joint and Muscle pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "felt like a bad flu"; DIZZINESS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "some dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, pyrexia, chills, arthralgia, myalgia, pain, dizziness, influenza like illness. Additional information: 15 hours after receiving vaccine: Extreme nausea for 2 1/2 hours but could not vomit. This was the worst nausea she had ever had since she was a kid, fever of 101 degrees for hours, chills, joint and muscle pain, ache all over, some dizziness; all of this felt like a bad flu. The patient did not have covid prior vaccination. No covid tested post vaccination.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Yes" (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 including Paxlovid. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: 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). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: lymph nodes under my arm and by my collar bone gets inflamed and is painful/swelling and pain in my lymph nodes; lymph nodes under my arm and by my collar bone gets inflamed and is painful/swelling and pain in my lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 14:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization Complete, Unknown Manufacturer), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 3 (Booster), Single, Unknown Manufacturer), for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 04Oct2023 at 06:00, outcome "not recovered" and all described as "lymph nodes under my arm and by my collar bone gets inflamed and is painful/swelling and pain in my lymph nodes". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy. Additional information: The patient had no Covid prior vaccination and had not tested post vaccination. The patient has no known allergies. The patient had received her 4th dose and reported that, each dose, her lymph nodes under her arm and by her collar bone gets inflamed and is painful. This occurs about 10 hours after the dose. She received her 4th dose the day prior (03Oct) at the Pfizer clinic at 2PM. She woke up that morning with swelling and pain in her lymph nodes.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200016214 same reporter/patient; different dose number/event;
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 Immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations". 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.  Additional information: One of her husband's golfing buddies had heart palpitations from Covid booster. The event was reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300319508 same reporter and suspect product, similar events, with different patients;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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 (BNT162B2 OMI XBB.1.5), on 19Sep2023 at 09:00 as dose 6 (booster), single (Lot number: 3030342) at the age of 69 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: tested positive again; (03Oct2023) negative, notes: Tested negative two days in a row; (04Oct2023) negative, notes: Tested negative two days in a row; (05Oct2023) positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 27Sep2023 to 02Oct2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech. Moderna; 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 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fragrance allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech. Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 26Sep2023 to 01Oct2023. Clinical course: Severe pain, severe congestion, cough, headache, feeling bone chilling pain 7 days after positive Covid test. Had been getting a slow positive Covid test for a short time after completing Paxlovid then got an immediate positive test after symptoms began again and symptoms are much worse and unbearable.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy can be affected by several factors such as the vaccine concentration, the kind of pathogen and the immune response mounted by the patient. Thus, the association between the event lack of effect (CoVID-19) with the suspect bnt162b2 (BNT162B2 NOS) cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral congestion, Chills, Headache, Malaise
Clinical narrative: headache chills and head congestion; headache chills and head congestion; headache chills and head congestion; she feels horrible; 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 62-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 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: HEADACHE (non-serious), CHILLS (non-serious), CEREBRAL CONGESTION (non-serious) all with onset 04Oct2023, outcome "unknown" and all described as "headache chills and head congestion"; MALAISE (non-serious) with onset 04Oct2023, outcome "unknown", described as "she feels horrible". Therapeutic measures were taken as a result of headache, chills, cerebral congestion.  Additional information: She was calling about the Pfizer Covid 19 vaccine, She wanted to know, she felt horrible how long side effects headache chills and head congestion lasts and Is there anything she could do or take aside from Tylenol. She stated, she had it Tuesday, she was sick on the reporting day and the day before reporting day.   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: UNK
Symptoms: Vaccination site haemorrhage
Clinical narrative: blood came out and ran down her arm; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 03Oct2023 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: VACCINATION SITE HAEMORRHAGE (non-serious) with onset 03Oct2023, outcome "unknown", described as "blood came out and ran down her arm".  Additional information: Physician stated that he and his wife (patient) received doses of the Pfizer Comirnaty 2023/2024 vaccine for adults two days ago. When the dose was administered to the patient, about 2cc's of blood came out and ran down her arm when the needle was removed. The person who administered the vaccine said this had been happening with other patients when he administered the product. He wanted to know if it is a successful vaccination. Physician stated that per his nursing experience giving IM injections, it would be possible for some of the vaccine to run out of the arm with the blood but there is no way to know if that happened. Physician was unable to say if this has been reported before since this is considered patient privacy info similar to HIPAA. Physician asked if the injection went into her vein instead of her muscle and was circulated throughout her system, is it a valid dose or does it have to be administered into the muscle? The administrator did not aspirate to ensure he was not injecting into a vein. Physician was told that there is no information regarding administration into a vein, if aspiration is recommended, and if it would be a valid dose. In regard to aspiration, that would be up to the facility to follow whatever best practices there are for IM injections from the board of pharmacy or board of nursing. Physician also asked, "if these answers are no that it is not a valid dose, should she consider getting another vaccination and if so, when? Is there a way to measure the immunity of the dose she received?". Physician also mentioned, "It seems like this may be a more common occurrence than one realizes and that It should be looked at and that Pfizer should have a position on it and make recommendations on it to people who administer their product. That's just my advice."  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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood grouping, Fatigue, Feeling hot, Headache, Vaccination site pain
Clinical narrative: soreness in arm at injection site; headache; forehead feels a little warm; a little of the fatigue; 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 63-year-old female patient received bnt162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 63 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "gastro issue" (unspecified if ongoing), notes: Her gastro issue was not effected by the vaccinations.; "Migraines" (unspecified if ongoing), notes: Her migraines were not effected by the vaccinations.; "Fibromyalgia" (unspecified if ongoing), notes: She has fibromyalgia and it was not effected by the vaccinations.; "Dry eyes" (unspecified if ongoing), notes: Her dry eyes were not effected.; "Tonsil" (ongoing), notes: She still has tonsil and appendix; "Appendix" (ongoing), notes: She still has tonsil and appendix. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "a little of the fatigue"; FEELING HOT (non-serious) with onset Apr2021, 1 day after the suspect product(s) administration, outcome "unknown", described as "forehead feels a little warm"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "soreness in arm at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain.  Additional information: Caller reported that she was experiencing "soreness on her arm at the injection site, has a little bit of a headache, and her forehead feels a little warm, however the rest of her body doesn't feel warm." Caller stated all the covid vaccines that she has received have been from Pfizer in which she "believes her reactions are normal and thought she experienced them with the prior administrations. She believes she experienced the same things with the previous ones. She has had a total of 5 vaccinations during Covid period and all were Pfizer. Prior to 05Apr2021 when she got first vaccination she had never got flu shot and never got the flu. She still has tonsil and appendix.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood grouping, Fatigue, Feeling hot, Headache, Vaccination site pain
Clinical narrative: soreness in arm at injection site/ tenderness in the arm at the injection site; little bit of a headache/ little mild headache; a little of the fatigue; forehead feels a little warm; 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 63-year-old female patient received bnt162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Lot number: EW0169, Expiration Date: 31Aug2021) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "gastro issues" (unspecified if ongoing), notes: not affected by the vaccinations; "migraines" (unspecified if ongoing), notes: not affected by the vaccinations; "fibromyalgia" (unspecified if ongoing), notes: not affected by the vaccinations; "dry eyes" (unspecified if ongoing), notes: not affected by the vaccinations; "tonsil" (ongoing); "appendix" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot number: EW0150, Expiration date: 31Jul2021, Anatomical Location: Arm Left), administration date: 05Apr2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "a little of the fatigue", "soreness in arm at injection site/ tenderness in the arm at the injection site", "little bit of a headache/ little mild headache", "forehead feels a little warm". The following information was reported: FATIGUE (non-serious) with onset 26Apr2021, outcome "unknown", described as "a little of the fatigue"; HEADACHE (non-serious) with onset 26Apr2021, outcome "unknown", described as "little bit of a headache/ little mild headache"; VACCINATION SITE PAIN (non-serious) with onset 26Apr2021, outcome "unknown", described as "soreness in arm at injection site/ tenderness in the arm at the injection site"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "forehead feels a little warm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had soreness on her arm at the injection site, had a little bit of a headache, and her forehead felt a little warm, however the rest of her body did not feel warm. She remembered when she got each of her Covid vaccinations, she would get them in the morning. She would fly to place (Withheld) and the driver would take her to clinic and then he would take her back to airport. If she got vaccinated at 8:30 AM or 9 AM by 2 PM when she got back to airport, she would get tenderness in the arm at the injection site. With all her vaccination a little over 5 hours after vaccination the soreness and fatigue and little mild headache started.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 25Sep2023 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "known allergies: Demerol", notes: known allergies: Demerol morphine; Morphine, reaction(s): "known allergies: morphine", notes: known allergies: Demerol morphine. The following information was reported: COVID-19 (non-serious) with onset Sep2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Additional information: The patient received Paxlovid from 25Sep2023 to 29Sep2023 for COVID 19 Treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Panic attack
Clinical narrative: the patient had their heart rate go up (after 15-30 minutes); panic attack; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001192 (RA).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "the patient had their heart rate go up (after 15-30 minutes)"; PANIC ATTACK (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 15Sep2023, it was reported that a patient started treatment on unreported dates with 4 doses of Pfizer BioNTech COVID-19 vaccine (primary series and two boosters) for COVID-19 immunisation. It was reported that after the last 2 boosters, on unreported dates, the patient had their heart rate go up (after 15-30 minutes) and had a panic attack. No further follow-up is anticipated.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300164032 same reporter/patient/AE, different doses;
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: HEADACHE (non-serious), outcome "not recovered"; PAIN (non-serious), outcome "not recovered", described as "body aches". 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu-like sxs; fever; full body muscle pain; weakness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 12:15 as dose 5 (booster), single (Lot number: HD9835) at the age of 39 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Lot number: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Lot number: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Lot number: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Lot number: Unknown), for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 04Oct2023 at 18:00, outcome "recovered", described as "Flu-like sxs"; FATIGUE (non-serious) with onset 04Oct2023 at 18:00, outcome "recovered"; PYREXIA (non-serious) with onset 04Oct2023 at 18:00, outcome "recovered", described as "fever"; MYALGIA (non-serious) with onset 04Oct2023 at 18:00, outcome "recovered", described as "full body muscle pain"; ASTHENIA (non-serious) with onset 04Oct2023 at 18:00, outcome "recovered", described as "weakness". Therapeutic measures were not taken as a result of influenza like illness, pyrexia, myalgia, asthenia, fatigue.  Additional Information: It was reported that the patient did not take any other vaccine in four weeks. Flu-like symptoms (fever, full body muscle pain and weakness, fatigue) for approx 24 hours - symptoms started approx 6 hours after injection. The patient was not tested for COVID Prior to and post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site swelling, Peripheral swelling
Clinical narrative: fatigue; headache; chills; fever; swelling at injection site; swelling on body and limbs; swelling on body and limbs; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 11:30 as dose 1, single (Lot number: HF9275) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, start date: 19Sep2023, stop date: 19Sep2023. Vaccination history included: Covid-19 vaccine (Dose 4 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1, 2 Manufacturer unknown, Primary immunization completed), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering"; FATIGUE (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering"; PYREXIA (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering"; INJECTION SITE SWELLING (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering", described as "swelling at injection site"; SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 03Oct2023 at 21:30, outcome "recovering" and all described as "swelling on body and limbs"; VOMITING (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering". Therapeutic measures were not taken as a result of fatigue, headache, chills, pyrexia, injection site swelling, swelling, peripheral swelling, vomiting. Additional information: The patient did not diagnose covid prior vaccination and was not tested for covid post vaccination. The patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: fatigue; headache; chills; fever; swelling at injection site; swelling on body and limbs; swelling on body and limbs; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 11:30 as dose 1, single (Lot number: HF9275) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, start date: 19Sep2023, stop date: 19Sep2023. Vaccination history included: Covid-19 vaccine (Dose 4 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1, 2 Manufacturer unknown, Primary immunization completed), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering"; FATIGUE (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering"; PYREXIA (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering"; INJECTION SITE SWELLING (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering", described as "swelling at injection site"; SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 03Oct2023 at 21:30, outcome "recovering" and all described as "swelling on body and limbs"; VOMITING (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering". Therapeutic measures were not taken as a result of fatigue, headache, chills, pyrexia, injection site swelling, swelling, peripheral swelling, vomiting. Additional information: The patient did not diagnose covid prior vaccination and was not tested for covid post vaccination. The patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 13Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Allergy to NSAIDs" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing); "Partial thryrodectomy" (unspecified if ongoing); "pre-diabetes" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 03Oct2023 to 05Oct2023. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, Sudden death
Clinical narrative: sudden death; getting COVID; getting COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUDDEN DEATH (death), outcome "fatal"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 1 week after the suspect product(s) administration, outcome "unknown" and all described as "getting COVID". The patient date of death was unknown. Reported cause of death: "sudden death". It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300166993 same reporter/drug/event, different patient;; Reported Cause(s) of Death: sudden death
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I ended up with COVID anyway; I ended up with COVID anyway; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant), outcome "unknown" and all described as "I ended up with COVID anyway".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-PV202300167224 same patient, different events after different doses of the vaccine;
Sex: M
Vaccine: RSV
Symptoms: Lung disorder
Clinical narrative: lung disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A  male (reported as 42, no units)  patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: LUNG DISORDER (medically significant), outcome "unknown", described as "lung disease". Patient is 42 but he's special needs and has critical lung disease." 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: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: fever; she's feeling down; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 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: PYREXIA (non-serious), outcome "unknown", described as "fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she's feeling down". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Drug ineffective, Neoplasm malignant, Pneumonia, Suspected COVID-19
Clinical narrative: had three cancers; two strokes; she had COVID in early Jun; she had COVID in early Jun; lung infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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: PNEUMONIA (medically significant) with onset 2023, outcome "unknown", described as "lung infection"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "she had COVID in early Jun"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "had three cancers"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "two strokes". The event "lung infection" required physician office visit. Clinical course: Reporter mentioned that she tried to get the new COVID vaccine for a long time and her local pharmacy said they think they cannot get any that they only had Moderna. Her doctor had said to get the shot from Pfizer which is preferred just when she had all the other shots. She added she have been to pharmacies and frustrated because she had COVID in early Jun, had three cancers, two strokes but still functioning beautifully, she further said right now she have a lung infection and the doctor wants her to get the shot but cant find one any help at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Ill-defined disorder, Immunodeficiency
Clinical narrative: immunocompromised; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised". Clinical course: patient reported "I have two diseases and I'm immunocompromised."  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: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthma; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Jul2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4513759-00 (Agency).  A 66-year-old female patient received bnt162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis in thumb", start date: 2016 (unspecified if ongoing); "Allergy", start date: 2016 (unspecified if ongoing); "Osteoarthritis in knees" (unspecified if ongoing); "Surgery to drain fluid in knee" (unspecified if ongoing); "right knee swollen" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfasalazine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Sep2022, outcome "recovered" (2022) and all described as "Covid-19".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Sudden death
Clinical narrative: Sudden death; getting COVID; getting COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUDDEN DEATH (death), outcome "fatal"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 1 week after the suspect product(s) administration, outcome "unknown" and all described as "getting COVID". The patient date of death was unknown. Reported cause of death: "Sudden death". It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320987 same reporter/drug/event, different patient;; Reported Cause(s) of Death: Sudden death
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Incorrect route of product administration, No adverse event, Pain, Paraesthesia, Pyrexia
Clinical narrative: skin felt like it was burning; pins and needles; fever of 99.6; aches and pains; patient received vaccine via subcutaneous route with no adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves a 66-year-old female patient who stated skin felt like it was burning, pins and needles, fever of 99.6 and aches and pains and patient received vaccine via subcutaneous route with no adverse event  after receiving influenza quadrivalent recombinant vaccine [Flublok Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rivaroxaban (Xarelto); verapamil; and paracetamol (Tylenol).  On 03-Oct-2023, the patient received an unknown dose of suspect influenza quadrivalent recombinant vaccine, prefilled syringe (strength, lot, expiry date: unknown) via subcutaneous route in left arm for Prophylactic Vaccination (immunization). Information on batch number was requested and patient received vaccine via subcutaneous route with no adverse event (incorrect route of product administration) (latency: same day)  On 03-Oct-2023 the patient had events of skin felt like it was burning (skin burning sensation), pins and needles (paraesthesia), fever of 99.6 (pyrexia) and aches and pains (pain) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  It was reported, Received 65+ shot at Pharmacy at 11:00 AM. Was fine all day. At 7:00 PM, took xarelto 15 mg and verapamil 240 mg. Within 1/2 hour, my skin felt like it was burning with pins and needles. I developed a fever of 99.6 with Tylenol in my system. I had severe aches and pains .  Relevant laboratory test results included: Body temperature - On 03-Oct-2023: 99.6 UNK  Action taken with quadrivalent recombinant influenza vaccine (Flublok Qiv) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome:  Unknown for the event patient received vaccine via subcutaneous route with no adverse event and Recovering / Resolving for all other events.    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.