chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PCR positive; PCR positive; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: F63527), in left arm, as dose 2, single (Lot number: EL9262), in right arm and as dose 3 (booster), single (Lot number: EL1284), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy", start date: 06Jun2022 (unspecified if ongoing), notes: Hysterectomy 06Jun2022 complicated by, infection; "infection", start date: 06Jun2022 (unspecified if ongoing), notes: Hysterectomy 06Jun2022 complicated by, infection. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "PCR positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Results unknown; (01Jan2022) Positive, notes: Nasal Swab.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. covid test post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. facility type vaccine: Pharmacy or Drug Store; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201358671 same patient different dose/drug/event;US-PFIZER INC-202201358672 same patient different dose/drug/event;US-PFIZER INC-202201345760 same patient different dose/drug/event;
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 at 16:45 as dose 4 (booster), single (Lot number: GJ6742) at the age of 48 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: QUADRIVALENT INFLUENZA VACCINE taken for immunisation, on 16Nov2022 as dose 1, single; PREMPRO LOW DOSE oral. Vaccination history included: Bnt162b2 (Dose 3, single, lot number: 33130BA, vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Chills", "Fatigue", "Body Aches", "Fever"; Bnt162b2 (Dose 2, single, lot number: EN6207, vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Chills", "Fatigue", "Body Aches", "Fever"; Bnt162b2 (Dose 1, single, lot number: EN6205, vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Chills", "Fatigue", "Body Aches", "Fever". The following information was reported: PAIN (non-serious) with onset 06Dec2022 at 04:30, outcome "recovered" (Dec2022), described as "Body Aches"; CHILLS (non-serious) with onset 06Dec2022 at 04:30, outcome "recovered" (Dec2022); FATIGUE (non-serious) with onset 06Dec2022 at 04:30, outcome "recovered" (Dec2022); PYREXIA (non-serious) with onset 06Dec2022 at 04:30, outcome "recovered" (Dec2022), described as "Fever". Therapeutic measures were not taken as a result of pyrexia, chills, pain, fatigue. Additional information: The seriousness of the events was reported as non-serious. The patient had no COVID prior vaccination and not tested COVID post vaccination. The patient had no known allergies. Fever, Chills, Body Aches, Fatigue began approximately 12 hrs post dose and continued for 12-16 hrs.; Sender's Comments: Linked Report(s): PFIZER INC-202201359444 same patient/AE, different vaccine dose; PFIZER INC-202201359445 same patient/AE, different vaccine dose; PFIZER INC-202201359446 same patient/AE, different vaccine dose.
Sex: U
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: 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 (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: WEIGHT DECREASED (non-serious), outcome "unknown", described as "experiencing weight loss after getting the COVID vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Transferring agent stated, "I had a caller on the line, name (Name withheld), she was experiencing weight loss after getting the COVID vaccine." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Pain, Sciatica
Clinical narrative: siatic pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from information team. The reporter is the patient.  An elderly male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: SCIATICA (non-serious), outcome "unknown", described as "siatic pain".  Additional Information: Caller is asking if Prevnar 13 is a 2 dose medication. Caller says that he took Prevnar 13 0.5 mL on 30Dec2016, and then took the Pneumovax 23 25 mcg/0.5 mL (which he also asks if we manufacture it and that it has "PF-SYR" marked on it so he assumes it is from Pfizer) on 02Feb2018. Caller reports he experienced "siatic pain" from his first pfizer shot and that he has already made a report regarding this, provided previous case number (INT-00638986). Caller then mentions that his local (withheld) suggested for him to take a newer version so he asks us if he should take Prevnar 20?Caller would like to know if Pneumovax 23 is a Pfizer product and if Prevnar 13 is a two dose medication. He also mentioned he took the Prevnar 13 more than 12 years ago.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 33130BA) at the age of 48 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREMPRO LOW DOSE oral. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EN6207, Vaccine location: left Arm), for COVID-19 immunization, reaction(s): "Fatigue", "Body Aches", "Fever", "Chills"; Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6205, Vaccine location: left Arm), for COVID-19 immunization, reaction(s): "Chills", "Fatigue", "Body Aches", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body Aches"; FATIGUE (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of pyrexia, chills, pain, fatigue. Additional information: patient experienced the events fever, chills, body aches, fatigue began Approximately 12 hrs post dose and continued for 12-16 hrs. This has happened after each of the vaccination doses. No COVID prior vaccination. Patient was not tested for COVID post vaccination. No known allergies. Patient received the other vaccine in four weeks included Influenza Vac Quadrivalent Prsv Free 3 Yrs + IM) on 16Nov2022, as dose 1, single in the left arm for immunisation. Sender's Comments: Linked Report(s) :PFIZER INC-202201358718 same patient/AE, different vaccine dose; PFIZER INC-202201359445 same patient/AE, different vaccine dose;
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Body Aches; Fever; Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6205) at the age of 48 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREMPRO LOW DOSE oral. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Body Aches"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  Additional information: Fever, Chills, Body Aches, Fatigue began approximately 12 hrs. post dose and continued for 12-16 hrs. This has happened after each of the vaccination doses.; Sender's Comments: Linked Report(s): PFIZER INC-202201358718 same patient/AE, different vaccine dose; PFIZER INC-202201359445 same patient/AE, different vaccine dose;
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Feeling abnormal, Headache, Inflammation, Skin disorder
Clinical narrative: markings on his right legs; Felt a pinching feeling; Tired; Headache; On his left leg longer lines from 2 to 7 inches long  that looks like inflammation; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 at 15:00 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. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "Tired", "Headache", "On his left leg longer lines from 2 to 7 inches long  that looks like inflammation"; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "Tired", "Headache", "On his left leg longer lines from 2 to 7 inches long  that looks like inflammation"; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "Tired", "Headache", "On his left leg longer lines from 2 to 7 inches long  that looks like inflammation"; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "Tired", "Headache", "On his left leg longer lines from 2 to 7 inches long  that looks like inflammation". The following information was reported: FEELING ABNORMAL (non-serious) with onset 07Dec2022, outcome "recovered" (Dec2022), described as "Felt a pinching feeling"; HEADACHE (non-serious) with onset Dec2022, outcome "unknown"; INFLAMMATION (non-serious) with onset Dec2022, outcome "unknown", described as "On his left leg longer lines from 2 to 7 inches long  that looks like inflammation"; FATIGUE (non-serious) with onset Dec2022, outcome "unknown", described as "Tired"; SKIN DISORDER (non-serious), outcome "unknown", described as "markings on his right legs ". Additional information: It was reported that, vaccine causes marking on the legs and doctor convinced it was from the vaccine. Patient experienced headache, gets tired, last for 24-36 hours, within an hour or two gets markings on his right legs which was verified with his doctor and were not blood clots, and on his left leg longer lines from 2 to 7 inches long that looks like inflammation which last for 3-4 weeks and disappears until he gets the vaccine again. Patient stated it seems like circulation issue. Patient get the same reaction every time he received the vaccine. Patient stated last night he felt a pinching feeling to where the markings were and then it goes away, any pressure that happens on his legs it causes that issue to arise. Patient emphasizes that it was like long indentations on his skin. 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.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69-year-old female patient received BNT162b2 (BNT162B2), 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "covid"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Covid". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Additional information: I was asked to go off Xeljanz a week before + a week after the TAVR Procedure. I was asked to go off Xeljanz a week after each vaccines. I was off Xeljanz for 2 weeks then I got covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got Covid about 6 months after receiving Pfizer vaccines; got Covid about 6 months after receiving Pfizer vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004306.  A male patient received BNT162b2 (BNT162B2), 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), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid about 6 months after receiving Pfizer vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: patient got Covid about 6 months after receiving Pfizer vaccines.  Clinical course: Adverse Event Information: On 22Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine as primary series for COVID-19 immunization. It was reported the patient got Covid about 6 months after receiving Pfizer vaccines and then received 3rd shot (1st booster dose) of Pfizer. No further follow-up was anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Myalgia
Clinical narrative: extreme muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, 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 included: "extreme muscle pain" (unspecified if ongoing), notes: patient had symptoms similar to those (extreme muscle pain) when taking statin. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete, manufacturer unknown), for Covid-19 Immunisation. The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "extreme muscle pain".  Additional information: It was reported that patient had symptoms similar to those when taking statin - extreme muscle pain - since receiving new COVID booster. Patient inquired what to do to relieve pain.  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: 11.0
Sex: F
Vaccine: YF
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: medication error due to administration of vaccine that was reconstituted with wrong diluent, with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old female patient who had medication error due to administration of vaccine that was reconstituted with wrong diluent, with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TYPHOID VACCINE (TYPHOID VACCINE) for Immunisation; and RABIES VACCINE (RABIES VACCINE) for Immunisation.  On 18-Nov-2022, the patient received a 1 dose of suspect YELLOW FEVER VACCINE at a dose of 0.5 ml (lot no. UJ412AB and expiry date: 22 Nov-2025) via subcutaneous route in the right arm for immunisation.  On 18-Nov-2022 the patient had a non-serious event of medication error due to administration of vaccine that was reconstituted with wrong diluent, with no reported adverse event (product preparation error)(latency: 1 day) following the administration of YELLOW FEVER VACCINE.  Action taken: not applicable.  Outcome: Unknown   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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu shot and still caught the flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced i got the flu shot and still caught the flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, expiration date, route, dose, frequency, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed i got the flu shot and still caught the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Lab data was not reported.  Action taken was not applicable.  corrective treatment: not reported for the event (I got the flu shot and still caught the flu).  Outcome: Unknown for the event i got the flu shot and still caught the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age/gender who experienced flu after being vaccinated with INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, route, dose, strength, formulation, administration site: unknown) for flu (influenza).  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that "You can say not today flu all you want but I've had it for 2 weeks. When it comes around, even the flu shot doesn't always help"  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  Outcome: Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 06-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves Adult and unknown gender patient who experienced flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In October 2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (with lot number, pharmaceutical form, strength, dose not reported) via unknown route in unknown administration site for prophylaxis.  On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Yes and got the flu anyway; Initial information received on 06-Dec-2022 regarding an unsolicited valid social media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who experienced yes and got the flu anyway after receiving vaccine INFLUENZA VACCINE.  It was  unknown if the patient experienced any additional symptoms/events .  It was unknown if the patient had any medical history, concomitant disease or risk factor  On an unknown date, the patient received a suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination  .  On an unknown date the patient developed a non-serious event yes and got the flu anyway (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available  Action Taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (Yes and got the flu anyway).  At time of reporting, the outcome was Unknown for the event yes and got the flu anyway.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Had out shots and got the Flu; Initial information was received on 06-Dec-2022 regarding an unsolicited valid non-serious social media case received from a patient.  This case involves a patient with unknown demographics who had out shots and got the flu after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient had out shots and got the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 06-Dec-2022 regarding an unsolicited valid  non-serious social media case received from a patient.  This case involves a patient with unknown demographics who got flu after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient got flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 07-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient of unknown age and gender who developed flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, formulation, lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  Reportedly, Got the flu shot still got the flu.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got it, also my daughter. She's hospitalized; Initial information was received on 07-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient and reporter reported that i got it, also my daughter. She was hospitalized after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the reporter reported that i got it, also my daughter. She was hospitalized (influenza) (unknown latency) following the administration of Influenza vaccine. The patient was hospitalized for this event.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.; Sender's Comments: Sanofi company comment dated 12-Dec-2022: This case involves an unknown age female patient and reporter reported that i got it, also my daughter. She was hospitalized after being vaccinated with Influenza vaccine. Case will be reevaluated post further update on concurrent condition during vaccination, underlying diseases excluding alternative etiologies for the reported events, which will aid a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: took the flu shot it gave him the flu; Initial information received on 06-Dec-2022 regarding an unsolicited valid Social media non-serious case from a consumer/non-health care professional.  This case involves an unknown age and unknown gender patient who took the Influenza Vaccine shot it gave him the flu.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s),and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, frequency, formulation, lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient took the flu shot it gave him the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.   The outcome was Unknown.
Age: 8.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Conditions of the excursion 12.3 C for 3 and half hours with no reported AE; product administered to patient with no adverse event reported.; Initial information received on 06-Dec-2022 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 8 years old male patient and it was reported Conditions of the excursion 12.3 c for 3 and half hours with no reported ae and IPV (VERO) [IPOL] administered to patient with no adverse event reported.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (PROQUAD) for Immunisation; hepatitis a vaccine inact (HAVRIX) for Immunisation; and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) for Immunisation.  On 21-Nov-2022, the patient received a dose 4 at dosage 0.5 ml of suspect IPV (VERO), Suspension for injection, (lot number: V1B891M; expiry date: 01-Jun-2024) (strength, frequency: not reported) via intramuscular route in the right deltoid for immunization with Conditions of the excursion 12.3 c for 3 and half hours with no reported ae (product storage error) (unknown latency).  On an unknown date the product administered to patient with no adverse event reported (poor quality product administered) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  The outcome was Unknown.   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: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired diluent was used to reconstitute ACTHIB and administered to a patient with no adverse event; an expired diluent was used to reconstitute ACTHIB and administered to a patient with no adverse event; Initial information was received on 07-Dec-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 3 months old male patient and reporter reported that an expired diluent was used to reconstitute HIB (PRP/T) vaccine [ACT-HIB] and administered to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Dec-2022, an expired diluent (lot number: U7178AA; Expiry date: 30-Nov-2022) was used to reconstitute 0.5 ml of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (lot UJ635AA, expiry date for product: 27-Jan-2023) via intramuscular route in the right leg for immunization and administered to a patient with no adverse event (expired product administered) and (product preparation error) (latency: same day).  Action taken: Not applicable.  Corrective treatment: Not reported for both the events.  Outcome: Unknown for both the 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: administered an expired pentacel with no reported ae; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4 months old female patient who administered with an expired diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [PENTACEL] with no reported ae.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine for Prophylactic vaccination (Immunisation); and pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination (Immunisation).  On 08-Dec-2022, the patient received a dose 1 at dosage 0.5 ml once of suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, Suspension for injection, (strength: not reported) (lot number: UJ625AA, expiry date: 07-Dec-2022) via intramuscular route in the thigh nos for Immunization with no reported ae (expired product administered) (Latency: same day).  It was reported as: Nurse called to report that they have administered an expired PENTACEL to a patient and is requesting some guidance what to look for and what to do moving forward."  Action taken was not applicable.  The outcome was Unknown.   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.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: PERICARDITIS; This 37-year-old, female subject was participating in Blind, Placebo-Controlled Study.    The subject's medical history, as provided by the investigator, included polycystic ovarian syndrome, anemia, multiple cysts on ovaries, congenital atrioventricular septal defect, pulmonary stenosis, tricuspid valve regurgitation, mitral valve regurgitation, nummular eczema, and acne of the back. Concomitant medications reported included cetirizine hydrochloride, iron ferrous sulfate, methylprednisolone, metformin, betamethasone, tazarotene, colecalciferol, ethinylestradiol/norgestimate, paracetamol, and nirmatrelvir/ritonavir (prescribed for symptomatic covid-19 infection, from 7-Sep-2022 till 09-Oct-2022).   The subject was randomized to receive intramuscular mRNA-1273 (Dose 1) on 09 Aug 2020 and (Dose 2) on 11 Sep 2020. Prior to event onset, the subject received intramuscular mRNA-1273 (Dose 3, booster) for SARS-CoV-2 vaccination on 26 Oct 2021, approximately 10 months and 29 days before onset of the event.   On 23 Sep 2022, the subject experienced pericarditis. Treatment for the event included oral colchicine.   The subject received all scheduled doses of study drug prior to the event; therefore, action taken with study drug in response to the event was not applicable.    The event, pericarditis, was reported as resolved on 02 Dec 2022.    The investigator assessed the event, pericarditis, as not related to study drug and not related to study procedure.  Follow-up received on 07 Dec 2022 included removal of the event seriousness criteria (previously life-threatening), updated event outcome and end date.    Company comment: This case concerns a 37-year-old, female subject with a medical history of polycystic ovarian syndrome, anemia, congenital atrioventricular septal defect, pulmonary stenosis, tricuspid valve regurgitation and mitral valve regurgitation among others, who experienced the non-serious adverse event of special interest of pericarditis. The event occurred 2 years 1 month 15 days after the first dose of IP, and 10 months 29 days after the third and booster dose. The event was reported as resolved and was considered unrelated to IP in agreement with the Investigator. The event might be explained by COVID-19 infection as suggested by indication of nirmatrelvir/ritonavir that was administered from 7-Sep-2022 till 09-Oct-2022.
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chills, Pain, Pain of skin, Pyrexia, Sensitive skin
Clinical narrative: I received the COVID booster in my left arm and the flu shot in my right. For the first day and a half I had typical symptoms of a low grade fever, aches, and chills as well as very sensitive and sore skin everywhere. On the evening of the second day, when these subsided, I noticed my neck on the side of the COVID shot was swollen and tender. I looked it up online and saw that it was swollen lymph nodes and that the reaction was listed as ?uncommon? so I thought I better report it.
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Swelling, Tenderness
Clinical narrative: I received the COVID booster in my left arm and the flu shot in my right. For the first day and a half I had typical symptoms of a low grade fever, aches, and chills as well as very sensitive and sore skin everywhere. On the evening of the second day, when these subsided, I noticed my neck on the side of the COVID shot was swollen and tender. I looked it up online and saw that it was swollen lymph nodes and that the reaction was listed as ?uncommon? so I thought I better report it.
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Blood pressure increased, Dysgeusia, Musculoskeletal chest pain, Nausea, Pulse abnormal
Clinical narrative: Odd taste, elevated blood pressure, loud pulse, sharp pain in ribs, slight nausea. I then doubled my doasge of Lisinopril to bring the blood pressure back down a little. I haven't had a chance to see my doctor over the weekend but will try to see him tomorrow as this is not normal.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: VAERS ID: 2512453 E-Report Number: 915666 VAERS ID: 2511673 E-Report Number: 915140 VAERS ID: 2511672 E-Report Number: 915139 VAERS ID: 2511674 E-Report Number: 915141 VAERS ID: 2511660 E-Report Number: 915127 VAERS ID: 2511663 E-Report Number: 915130 VAERS ID: 2511653 E-Report Number: 915120 VAERS ID: 2511651 E-Report Number: 915118 VAERS ID: 2510734 E-Report Number: 914759 VAERS ID: 2510735 E-Report Number: 914760 VAERS ID: 2510741 E-Report Number: 914766 VAERS ID: 2508408 E-Report Number: 913840 VAERS ID: 2508419 E-Report Number: 913850 VAERS ID: 2508431 E-Report Number: 913860 VAERS ID: 2508413 E-Report Number: 913845 VAERS ID: 2508429 E-Report Number: 913858 VAERS ID: 2508399 E-Report Number: 913832 VAERS ID: 2508403 E-Report Number: 913836 VAERS ID: 2508426 E-Report Number: 913856 VAERS ID: 2508421 E-Report Number: 913851 VAERS ID: 2508410 E-Report Number: 913842 VAERS ID: 2506796 E-Report Number: 913218 VAERS ID: 2506797 E-Report Number: 913219 VAERS ID: 2506799 E-Report Number: 913221
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: VAERS ID: 2506834-E-Report Number: 913256. VAERS ID: 2506806- E-Report Number: 913228. VAERS ID: 2506809- E-Report Number: 913231. VAERS ID: 2506831- E-Report Number: 913253. VAERS ID: 2506824- E-Report Number: 913246. VAERS ID: 2506823- E-Report Number: 913245. VAERS ID: 2506835- E-Report Number: 913257. VAERS ID: 2506840- E-Report Number: 913262. VAERS ID: 2506819- E-Report Number: 913241. VAERS ID: 2506832- E-Report Number: 913254. VAERS ID: 2506816- E-Report Number: 913238. VAERS ID: 2506802- E-Report Number: 913224. VAERS ID: 2506837- E-Report Number: 913259. VAERS ID: 2506804- E-Report Number: 913226. VAERS ID: 2506812- E-Report Number: 913234. VAERS ID: 2506821- E-Report Number: 913243. VAERS ID: 2506818- E-Report Number: 913240. VAERS ID: 2506827- E-Report Number: 913249. VAERS ID: 2506820- E-Report Number: 913242.
Sex: U
Vaccine: FLUN4, FLUN4
Symptoms: Product storage error
Clinical narrative: VACCINE WITH AN OUT OF RANGE TEMPERATURE EXCURSION  AND WAS ADMINISTERED; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number PJ3267) (expiration date 26-DEC-2022), via nasal route, on 03-NOV-2022. The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     A UNKNOWN administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.   A UNKNOWN administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced vaccine with an out of range temperature excursion  and was administered (preferred term: Product storage error).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v) and Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event was unknown.    The event was considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): vaccine with an out of range temperature excursion  and was administered. The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): vaccine with an out of range temperature excursion  and was administered.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: FLUX
Symptoms: Chills, Headache, Illness, Nausea
Clinical narrative: chills; headaches; nauseated; so sick; Initial information received on 06-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an elderly patient of unknown gender who experienced chills, headaches, nauseated and so sick after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed chills, headaches (headache), nauseated (nausea) and so sick (illness) (latency: unknown) following the administration of influenza vaccine.  It was reported that I have gotten a flu shot every year with no problems, last year got one, next day was so sick, chills, headaches and nauseated, felt that way for two days, then I find out there is the flu shot, then there is an extra strength flu shot for people 65 and over (which I am). So they gave me the stronger dose, that's why I felt sick!   It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for all the events.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received the ACTHIB vaccine that was expired with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2 years old male patient who received the HIB (PRP/T) VACCINE [ACT-HIB]  that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  On 07-Dec-2022, the patient received a  dose of 0.5ml of suspect HIB (PRP/T) VACCINE, (frequency: once) (lot: UJ635AAA  ; expiry date: 30-Nov-2022) via unknown route in unknown administration site for immunization. It was reported that the  patient received the Acthib vaccine that was expired with no reported adverse event (expired product administered) (onset date: 07-Dec-2022; latency: same day). Thee reporter will reschedule the patient to come in to get another dose of the vaccine   Action taken: not applicable.  Outcome: unknown   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.
Sex: U
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: neck pain; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 4-DEC-2022. Reporter's Comment: This case was received from consumer via interactive digital media. The reporter want to know was a neck pain side effect of shingles shot The follow up would not possible as no contact details were available.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva640z, expiry date 30th November 2022) for prophylaxis.   On 6th December 2022, the patient received Menveo. On 6th December 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comment: The reporter was clinic manager. The reporter reported that, patient received a dose of Menveo and the dose had expiration date November 2022. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Menveo ,which led to expired vaccine used.