chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: neuropathy tingling sensation and aches in both feet had almost gone away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): INT-20600 (BioNTech SE).  A 78-year-old patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II", start date: 1997 (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; HYDROCHLOROTHIAZIDE; LOSARTAN; AMLODIPINE; METFORMIN; CARVEDILOL. Vaccination history included: Covid-19 janssen (dose 1, Lot number: 202A21A), for COVID-19 Immunization; Covid-19 janssen (dose 2 (booster), Lot number: 202A21A), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "neuropathy tingling sensation and aches in both feet had almost gone away".  Additional information: Patient has been diagnosed with diabetes II for the past twenty-five years. The neuropathy has become more and more pronounced over the years. It was a constant tingling along with aches and sometimes constriction in the toes. The soles of feet were where the tingling and aches occurred every day and continued to a lesser degree throughout the day. The patient noticed that after two-three days after the Pfizer covid vaccine booster injection (received on 07Dec2022) that the neuropathy tingling sensation and aches in both feet had almost gone away. This cessation had also occurred after the previous Pfizer COVID booster on 20Dec2021. The previous cessation gradually diminished after six months and the neuropathy symptoms returned. The patient has other health issues (not further specified).  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-PV202200120946 same patient/event, different drug;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: Swelling in the face, jaw and lymph nodes; Swelling in the face, jaw and lymph nodes; This is a spontaneous report received from contactable reporter(s) (Nurse)..  A 76-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, In Feb2021 with Pfizer BioNTech COVID-19 Vaccine (Tozinameran) at dose 1 and dose 2 for COVID-19 immunisation), administration date: Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "Swelling in the face, jaw and lymph nodes", "Swelling in the face, jaw and lymph nodes". The following information was reported: SWELLING FACE (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "Swelling in the face, jaw and lymph nodes".  Additional information: On 17Nov2022, it was reported that a patient started treatment on an unspecified date in Feb2021 with Pfizer BioNTech COVID-19 Vaccine (Tozinameran) at dose 1 and dose 2 for COVID-19 immunization. It was reported that the patient had swelling in the face, jaw and lymph nodes. No further follow-up is anticipated means that company will not perform any follow-up for this report as it is a non-company product.  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-PV202200116707 same patient/event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Nasal congestion
Clinical narrative: stuffy nose; flu-like symptoms; headache; muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "headache", "flu-like symptoms", "muscle ache", "stuffy nose". The following information was reported: NASAL CONGESTION (non-serious), outcome "recovered", described as "stuffy nose"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu-like symptoms"; HEADACHE (non-serious), outcome "recovered"; MYALGIA (non-serious), outcome "recovered", described as "muscle ache".  Additional information:  The patient recently went to to get a COVID-19 booster. This would be patient's 4th shot in the last 2 years. With each of the previous vaccines, patient ended up showing flu-like symptoms (headache, muscle ache, stuffy nose, etc.) within 24 hours of receiving the vaccine. The symptoms went away within a day.  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-202201363306 same patient/AE, different vaccine dose number;US-PFIZER INC-PV202200121275 same patient/AE, different vaccine dose number;
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Nasal congestion
Clinical narrative: stuffy nose; flu-like symptoms; headache; muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "headache", "flu-like symptoms", "muscle ache", "stuffy nose"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "headache", "flu-like symptoms", "muscle ache", "stuffy nose". The following information was reported: NASAL CONGESTION (non-serious), 24 hrs after the suspect product(s) administration, outcome "recovered", described as "stuffy nose"; INFLUENZA LIKE ILLNESS (non-serious), 24 hrs after the suspect product(s) administration, outcome "recovered", described as "flu-like symptoms"; HEADACHE (non-serious), 24 hrs after the suspect product(s) administration, outcome "recovered"; MYALGIA (non-serious), 24 hrs after the suspect product(s) administration, outcome "recovered", described as "muscle ache".  Additional information: With each of the previous vaccines, the patient ended up showing flu-like symptoms (headache, muscle ache, stuffy nose, etc.) within 24 hours of receiving the vaccine. The symptoms went away within a day.    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-202201363305 same patient/AE, different vaccine dose number;US-PFIZER INC-PV202200121275 same patient/AE, different vaccine dose number;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: have covid; have covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "have covid".  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: Herpes virus infection
Clinical narrative: herpes; 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 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "herpes" (unspecified if ongoing), notes: herpes because she's been suffering for 10 years now. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, he took three shots of the Covid-19 vaccine from Pfizer), for COVID-19 immunization; Bnt162b2 (Dose: 2, he took three shots of the Covid-19 vaccine from Pfizer), for COVID-19 immunization.  The following information was reported: HERPES VIRUS INFECTION (non-serious) with onset 2022, outcome "recovering", described as "herpes".  Additional information: it was reported that the patient was begging Pfizer to make a cure for herpes because she's been suffering for 10 years now. She took three shots of the Covid-19 vaccine from Pfizer and it worked very well for her, she felt good about them.  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: Pemphigoid
Clinical narrative: I developed a very rare autoimmune disease called bullis pemphigoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), in 2021 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: PEMPHIGOID (medically significant), outcome "unknown", described as "I developed a very rare autoimmune disease called bullis pemphigoid".   Clinical course: Patient received the Pfizer vaccination for coronavirus in fall of last year. After receiving the vaccination, she developed a very rare autoimmune disease called bullis pemphigoid. The medications and treatments are very expensive. Her doctors attribute her disability that was very rare for a healthy 40-year-old mother of two to develop as a result of the vaccinations received through Pfizer.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia, Muscular weakness, Pain in extremity
Clinical narrative: slight paralyzing in the arm; weakness in the arm; 1st vaccine was painful/ pain in my R arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2 (BNT162B2), on 05Jun2021 as dose 1, single (Lot number: EW0217) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Jun2021 at 10:00, outcome "recovering", described as "1st vaccine was painful/ pain in my R arm"; MONOPLEGIA (medically significant) with onset 05Jun2021 at 10:00, outcome "recovering", described as "slight paralyzing in the arm"; MUSCULAR WEAKNESS (medically significant) with onset 05Jun2021 at 10:00, outcome "recovering", described as "weakness in the arm". Therapeutic measures were not taken as a result of monoplegia, muscular weakness, pain in extremity.  Clinical course: it was reported that patient was not administered with booster dose. 1st vaccine was painful for 3 months. I am trained in medical therapeutics as well. I have Experienced pain in my R arm for other a year, I have weakness in the arm to do normal takes like walking my pet, carrying item and rotation mobility. Upon awakening from sleep, I have slight paralysis in the arm having to pick it up with my L arm until I get up. Abductor/abduction is my about 12 inch from my side to left R arm. My rotation is about 80 percent now, seems to be improving some.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202200089160 Same patient/vaccine, different vaccine dose;US-PFIZER INC-202201359617 Same patient/vaccine, different vaccine dose;
Sex: U
Vaccine: COVID19-2
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: chills; fever; body aches; headache; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had covid" (unspecified if ongoing), notes: I had covid slightly over 90 days ago. The patient's 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: PAIN (non-serious) with onset 2022, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 2022, outcome "unknown"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got a covid booster shot earlier this morning (at time of report) and woke up in the middle of the night with chills, fever and body aches and headache. The patient's thermometer broke in the first few seconds of turning it on, but the temperature was at least 100. The patient had covid slightly over 90 days ago so perhaps the patient's immune system was already high for covid. The event took place after the use of the product.  The lot number for BNT162b2, BNT162b2 omi ba.4-5 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: neuropathy tingling sensation and aches in both feet had almost gone away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): INT-20600 (BioNTech SE).  A 78-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ6738, Expiration Date: 31Jul2023) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II", start date: 1997 (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; HYDROCHLOROTHIAZIDE; LOSARTAN; AMLODIPINE; METFORMIN; CARVEDILOL. Vaccination history included: BNT162b2 (dose 3 (booster), Lot number: unknown), administration date: 20Dec2021, for COVID-19 immunization, reaction(s): "neuropathy tingling sensation and aches in both feet had almost gone away"; Covid-19 janssen (dose 1, Lot number: 202A21A), for COVID-19 Immunization; Covid-19 janssen (dose 2 (booster), Lot number: 202A21A), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Nov2022, outcome "unknown", described as "neuropathy tingling sensation and aches in both feet had almost gone away".  Additional information: Patient has been diagnosed with diabetes II for the past twenty-five years. The neuropathy has become more and more pronounced over the years. It was a constant tingling along with aches and sometimes constriction in the toes. The soles of feet were where the tingling and aches occurred every day and continued to a lesser degree throughout the day. The patient noticed that after two-three days after the Pfizer covid vaccine booster injections that the neuropathy tingling sensation and aches in both feet had almost gone away. This cessation had also occurred after the previous Pfizer COVID booster on 20Dec2021. The previous cessation gradually diminished after six months and the neuropathy symptoms returned. The patient has other health issues (not further specified). NDC: 59267-0304-02.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201362450 same patient/event, different drug;
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu shot and still got the flu.; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown demographics who had the flu shot (INFLUENZA VACCINE) and still got the flu.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site for flu.  On an unknown date the patient had the flu shot and still got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE..  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had the flu shot and still got the flu.).  At time of reporting, the outcome was Unknown for the event had the flu shot and still got the flu.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: took the shot, took him 3 months get over the flu; Initial information received on 06-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who took the shot, took him 3 months get over the flu  after receiving vaccine INFLUENZA VACCINE.  The patient's past  medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any  concomitant disease or risk factor.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, ( lot number and expiry date:  not reported) via unknown route in unknown administration site for prophylactic vaccination. Information regarding batch number has been requested  On an unknown date the patient took the shot, took him 3 months get over the flu  (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.. 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 event (took the shot, took him 3 months get over the flu ).  Outcome: unknown
Sex: U
Vaccine: FLUX
Symptoms: Cough
Clinical narrative: lot of dry coughing; Initial information received on 07-Dec-2022 regarding an unsolicited non-serious case received from a consumer/non-hcp (non-healthcare professional) via social media.  This case involves a patient of an unknown age and gender who experienced lot of dry coughing after receiving  Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown administration site, route, expiry date, batch number, formulation, strength) for immunisation.  On an unknown date, the patient developed lot of dry coughing (cough) (latency: unknown) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.  It was reported 5 days after receiving my flu injection I can down with that RS thing. No aches, pains or fever. I really do believe the flu injection help make it a mild case. This was the 1st time I ever got a flu injection. Believe me I will be getting my next year as well.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (lot of dry coughing).  Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: real sick now; Initial information received on 07-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves 7 patients who were real sick now while receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, route: unknown) lot number not reported in unknown administration site as flu vaccine.  On an unknown date the patients were real sick now (illness) (unknown latency) following the administration of influenza vaccine..  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization  Action taken wwas not applicable.  It was not reported if the patient received a corrective treatment for the event (real sick now).  At time of reporting, the outcome was Unknown for the event real sick now.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: my arm still hurts; Initial information received on 07-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced my arm still hurts after 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 suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Flu vaccination (Influenza immunisation).  On an unknown date, the patient developed a non-serious event of my arm still hurts (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (my arm still hurts).  At time of reporting, the outcome was Unknown for the event my arm still hurts.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Influenza
Clinical narrative: Got the worst kind of flu  have ever had; Initial information received on 07-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 got the worst kind of flu he/she have ever had , after receiving vaccine INFLUENZA VACCINE.  The patient's past  medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer , with an unknown formulation and strength, (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient  got the worst kind of flu that he or she  have ever had (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.. The patient was on medication and totally miserable right then. The patient never had a flu like this before. It is unknown if there were lab data/results available  Action taken: not applicable.  Corrective treatment: not reported  Outcome: unknown
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was given out of indication by accident to a two year old child, with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] was given out of indication by accident to a two year old child, with no reported adverse event.  The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 09-Dec-2022, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine suspension for injection (strength, batch number and expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination, which was given out of indication by accident to a two year old child, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It is unknown if there were lab data/results available.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 18.0
Sex: M
Vaccine: TYP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Typhim Vi was administered to an underage patient in the left thigh with no reported adverse event; Initial information received on 07-Dec-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 18 months old male patient who experienced typhim vi was administered to an underage patient in the left thigh with no reported adverse event after receiving vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RABIES VACCINE INACT (CHICK EMBRYO) (RABAVERT).  On 07-Dec-2022, the patient received a (Series: N/A) suspect TYPHOID VI POLYSACCHARIDE VACCINE(Dose- 0.5mL)(Frequency-Total)(Formulation-Solution for injection) via unknown route (Batch/lot number -U2A292V)(Expiry Date-30-Sep-2023) in the left thigh for Immunization    On 07-DEC-2022 the patient developed a non-serious event typhim vi was administered to an underage patient in the left thigh with no reported adverse event (product administered to patient of inappropriate age) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.( Latency- Same day)  It was reported The safety and immunogenicity of Typhim Vi vaccine in children under two years of age has not been established. As with other polysaccharide vaccines, the antibody response may be inadequate. The decision whether to vaccinate children under 2 years of age depends upon the risk incurred by the child on the basis of the epidemiological context.  Action Taken : not applicable.  At time of reporting, the outcome was Unknown for the event typhim vi was administered to an underage patient in the left thigh with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Inappropriate schedule of product administration, Medication error, No adverse event, Product preparation error
Clinical narrative: Expired ACTHIB given to Patient with No reported Adverse Event; the risk for giving the vaccine twice to a 4-month old with no reported adverse event; ACTHIB given to a patient since the product itself expires of 28MAY2023 and the diluent expired on 30NOV2022 with no reported adverse event; Initial information received on 07-Dec-2022 regarding an unsolicited valid  non-serious case received from a Non health Care professional   This case involves a 4 months old male patient who experienced expired acthib given to patient with no reported adverse event, the risk for giving the vaccine twice to a 4-month old with no reported adverse event and acthib given to a patient since the product itself expires of 28may2023 and the diluent expired on 30-Nov2022 with no reported adverse event  after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix) for immunisation; pneumococcal vaccine conj 13v (crm197) (prevnar 13) and rotavirus vaccine (rotavirus vaccine) for prophylactic vaccination  On 06-Dec-2022, the patient received a Series 1 of suspect HIB (PRP/T) VACCINE (Lot #Product: UJ679AA Diluent: U7178AA o Expiration Date: Product: 28MAY2023 Diluent: 30NOV2022 )(Dose-0.5mL) (Strength:standard)(Formulation: Powder and solvent for solution for injection) via intramuscular route on left leg for Immunization   On 06-Dec-2022 the patient developed a non-serious events expired acthib given to patient with no reported adverse event (expired product administered), the risk for giving the vaccine twice to a 4-month old with no reported adverse event (inappropriate schedule of product administration), acthib given to a patient since the product itself expires of 28may2023 and the diluent expired on 30-Nov2022 with no reported adverse event  (product preparation error) following the administration of HIB (PRP/T) VACCINE.(Latency- Same day)  It was reported She also wants to know the risk for giving the vaccine twice to a 4-month old.   Action taken : Not applicable.  At time of reporting, the outcome was Unknown for all 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: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was administered expired acthib with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 months old male patient to whom expired HIB (PRP/T) vaccine [ACT-HIB] was administered 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination(immunization).  On 07-Dec-2022, the patient received 0.5 ml(milliliter), 1x(once)(dose 4) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UJ614ABA)(expiry date: 30-Nov-2022) (with unknown  dose) via intramuscular route in the left thigh for immunization.  On 07-Dec-2022, patient received expired HIB (PRP/T) vaccine with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 17.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Poor quality product administered, Product preparation error
Clinical narrative: 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 health professional.  This case is linked to cases 2022SA502558 and 2022SA489108.   This case involves a 17 years old male patient who was administered with Yellow Fever Vaccine - YF-VAX] that was reconstituted with wrong diluent 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 Typhoid Vaccine (Typhoid) for Prophylactic vaccination; and Rabies Vaccine (Imovax) for Prophylactic vaccination.  On 18-Nov-2022, the patient received 0.5 ml Total (Dose 1) of suspect Yellow Fever Vaccine - Solution for injection that was reconstituted with wrong diluent with no reported adverse event (product preparation error) (latency: same day) (lot number UJ412AB) (Expiry date: 22-Nov-2025) via subcutaneous route in the right arm for prophylactic vaccination.  It was reported She also provided information for the 4 patients who received the vaccine, She confirmed that each patient was contacted and none of them had safety issues nor side effects reported. Patients declined revaccination despite knowledge that the vaccine was invalid.  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 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: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired pentacel vaccine being administered with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who experienced expired pentacel vaccine being administered with no reported adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 08-Dec-2022, the patient received 2 dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ320AAA)(unknown strength and expiry date) via intramuscular route at Vastus Lateralis for prophylactic immunisation(immunisation).  On 08-Dec-2022 the patient had a non-serious event of expired pentacel vaccine being administered with no reported adverse event (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired pentacel vaccine being administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: was prescribed a DTaP vaccine (manufacturer not named). The administering HCP gave a QUADRACEL DTaP/ IPV instead with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old male patient who was prescribed a dtap vaccine (manufacturer not named). The administering hcp(health care professional) gave a quadracel dtap/ ipv instead (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE)with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) (PCV13)for Immunisation.  On 08-Dec-2022, the patient received a  dose of 0.5 ml of  suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot U7564AA , expiration date: 08-Nov-2024, via intramuscular route in left VL (full form not specified) as Immunization.  On 08-DEC-2022 the patient was prescribed a dtap vaccine (manufacturer not named). the administering hcp gave a quadracel dtap/ ipv instead with no reported adverse event (wrong product administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (was prescribed a DTaP vaccine (manufacturer not named). The administering HCP gave a QUADRACEL DTaP/ IPV instead with no reported adverse event).  At time of reporting, the outcome was Unknown for the event     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 5.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given the incorrect dose. She was given the dose for age 6 and older, and she is only 5. Within 12 hours of vaccine she started feeling unwell with nausea, vomiting, fatigue. she continues to experience those symptoms.
Age: 5.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Fatigue, Incorrect dose administered, Malaise, Nausea, Vomiting
Clinical narrative: Patient was given the incorrect dose. She was given the dose for age 6 and older, and she is only 5. Within 12 hours of vaccine she started feeling unwell with nausea, vomiting, fatigue. she continues to experience those symptoms.
Age: 66.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: Patient said that symptoms started about 2 days after she received vaccine.  Left arm was swollen and she noticed skin redness around the injection site and it spread down to the elbow. She stated it was very itchy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Tinnitus
Clinical narrative: Tinnitus approximately week or so after the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Palpitations, Upper-airway cough syndrome
Clinical narrative: Palpitations, post nasal drip. Was under observation.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, Anger, Anosmia, COVID-19, Head discomfort
Clinical narrative: see drugs section
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Insomnia, Irritability, Mood altered, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: see drugs section
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus pain
Clinical narrative: see drugs section
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had two doses of Shingrix, got shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mepolizumab (Nucala) unknown for asthma.   Concurrent medical conditions included bronchiectasis and asthma.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 11th November 2022, the patient started Nucala at an unknown dose and frequency. On 12th November 2022, unknown after receiving Shingrix and Shingrix and not applicable after starting Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir (Valacyclovir). The action taken with Nucala was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles to be related to Nucala.     Additional Information: GSK receipt date: 07-DEC-2022 Reporter's comment: The patient reported that she had the Shingrix vaccine soon after it came on the market.  She had the two complete dose series of Shingrix.  She started Nucala about a year ago in 2021.  On 11th November 2022 she had the Nucala dose at the physician's office. She came down with shingles on 12th November 2022.  She visited her physician, who prescribed valacyclovir and she took it for 7 days.  She was completely recovered from shingles.  The reporter was consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: PROBLEMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of problems was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient that was outside the 12 hours after it was punctured / vial was exposed to room temperature range 21.5 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient that was outside the 12 hours after it was punctured / vial was exposed to room temperature range 21.5 hours) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient that was outside the 12 hours after it was punctured / vial was exposed to room temperature range 21.5 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient that was outside the 12 hours after it was punctured / vial was exposed to room temperature range 21.5 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient that was outside the 12 hours after it was punctured / vial was exposed to room temperature range 21.5 hours).    Concomitant medications were not reported.  The vaccine that was given to the patient that was outside the 12 hours after it was punctured. They wanted to check if they had to revaccinate the patient or if it is ok for them to keep it. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 06Dec2022 at 8 AM. The vial was first punctured on 09Dec2022 at 3:45 PM. The administration of vaccine on 10Dec2022 at 1:15 PM. The vial did not undergo any temperature excursions. The vial was exposed to room temperature for 21.5 hours. Treatment medications were not reported.