chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Bivalent booster dose instead of the second dose of the primary series dose; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 2 (bivalent), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (one dose of the primary series vaccine for ages 5-11, Manufacturer unknown), administration date: Dec2021, for COVID-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset Nov2022, outcome "unknown", described as "Bivalent booster dose instead of the second dose of the primary series dose".  Additional information: A pediatrician called inquiring about the COVID-19 vaccine. He has a patient who only received one dose of the primary series vaccine for ages 5-11 in Dec2021. The second dose was given to the patient with the Bivalent booster dose instead of the second dose of the primary series dose in Nov2022. HCP wants to know how to proceed. HCP thought he was ordering the vaccine for ages 12 and up and had given the Bivalent and wanted to know how to proceed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site reaction
Clinical narrative: Had a reaction to the bivalent shot of persistent muscle pain but not to the four Covid shots before it.; Had a reaction to the bivalent shot of persistent muscle pain but not to the four Covid shots before it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4, Unknown manufacturer), for Covid-19 immunization; Flu shot (I have been told not to take a flu shot because of the same pain that had persisted for years. Suspect that it has a stabilizer (or something else) which is my problem.), for Immunization, reaction(s): "Muscle pain"; Flu shot (I have been told not to take a flu shot because of the same pain that had persisted for years. Suspect that it has a stabilizer (or something else) which is my problem), for Immunization, reaction(s): "same pain". The following information was reported: MYALGIA (non-serious), VACCINATION SITE REACTION (non-serious), outcome "not recovered" and all described as "Had a reaction to the bivalent shot of persistent muscle pain but not to the four Covid shots before it.".  Additional information: Patient did Inquiry that what was in the bivalent shot that was not in the first Covid shots. Had a reaction to the bivalent shot of persistent muscle pain but not to the four Covid shots before it. Patient have been told not to take a flu shot because of the same pain that had persisted for years. Suspect that it has a stabilizer (or something else) which may be a problem. Patient further asked "regarding a booster that does not have the new extra ingredient.  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: Pain in extremity
Clinical narrative: Sore arm after primary series of vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm after primary series of vaccine".  Additional information: Sore arm after primary series of vaccine. The reporter considered that the event was caused by suspect product(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Well when I had the regular [Pfizer] vaccine I still got sick; 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), 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: ILLNESS (non-serious), outcome "not recovered", described as "Well when I had the regular [Pfizer] vaccine I still got sick". 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: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea; Nausea; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset 2022, outcome "unknown"; VOMITING (non-serious) with onset 2022, outcome "unknown".  Additional information: Diarrhea and nausea the evening after receiving the COVID bivalent booster and vomiting the next day. The patient was 10, M, 52 lb, >4'. Name of Product: COVID 19 bivalent booster, kid's dose. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: sore swollen arm; sore swollen arm; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female 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: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "sore swollen arm"; NAUSEA (non-serious), outcome "unknown".  Additional information: The patient received the Pfizer vaccine herself and experienced some of those symptoms such as a sore swollen arm, nausea etc.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete: unknown manufacturer), for COVID-19 Immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations".  Additional information: The patient reported that it reminded her of how hard it was to go through Covid. Also, the list of side effects reminded her that she had heart palpitations after her [Pfizer] booster. Age of the patient was also reported as 47 (unit not reported).  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: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete., the regular series of Pfizer I had no symptoms.), for COVID-19 Immunization, reaction(s): "no symptoms". The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "sick".  Additional information: The last booster of the Pfizer Bivalent made her sick for two days. However the regular series of Pfizer she had no symptoms.  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: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in my arm from the [Pfizer COVID-19] shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in 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), outcome "unknown", described as "soreness in my arm from the [Pfizer COVID-19] shots".  Additional information: Patient remember the soreness in his arm from the [Pfizer COVID-19] shots.  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-202201341130 Same patient/vaccine/event, different vaccine dose;
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt pretty awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Not reported), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt pretty awful".  Additional information: Patient dread the possible side effects. patient felt pretty awful for 24 hours after my second dose of the original [Pfizer] vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Lymphadenopathy, Pain in extremity, Tenderness
Clinical narrative: left arm soreness; left armpit lymph nodes swollen; arm tenderness; I developed paralyzing pain in the lower back on the left side; I still have pain in the lower back on the left side and armpit; 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), on 25Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 Immunization, reaction(s): "left armpit lymph nodes swollen", "left arm soreness". The following information was reported: BACK PAIN (non-serious) with onset Nov2022, outcome "not recovered", described as "I developed paralyzing pain in the lower back on the left side"; AXILLARY PAIN (non-serious) with onset Nov2022, outcome "not recovered", described as "I still have pain in the lower back on the left side and armpit"; TENDERNESS (non-serious) with onset 27Nov2022, outcome "not recovered", described as "arm tenderness"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2022, outcome "not recovered", described as "left arm soreness"; LYMPHADENOPATHY (non-serious) with onset 27Nov2022, outcome "unknown", described as "left armpit lymph nodes swollen".  Additional information: 25Nov2022 evening received booster left arm. 27Nov2022 in addition to left arm soreness and left armpit lymph nodes swollen (Happened with previous vaccines for Covid), the patient developed paralyzing pain in the lower back on the left side, this never occurred previously. Today the patient still has pain in the lower back on the left side and armpit and arm tenderness. No other medications or underlying conditions. This was a self-report. Event took place after use of product.  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: Interchange of vaccine products, Off label use, Rash
Clinical narrative: Janssen covid-19 vaccine; Dose 1, Pfizer Covid-19 vaccine; Dose 2; Janssen covid-19 vaccine; Dose 1, Pfizer Covid-19 vaccine; Dose 2; rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 20221121516(8) (RA).  A female patient received BNT162b2 (BNT162B2), as dose 2 (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: Janssen covid-19 vaccine (Dose 1), for COVID-19 prophylaxis. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Janssen covid-19 vaccine; Dose 1, Pfizer Covid-19 vaccine; Dose 2"; RASH (non-serious), outcome "recovered".  Additional information: The patient recovered from rash for 2 months after a Pfizer booster. This report was non-serious.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Two weeks of the most horrible illness; Initial information received on 24-Nov-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 two weeks of the most horrible illness 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(Immunization).  On an unknown date the patient developed a non-serious event two weeks of the most horrible illness (illness) unknown latency following the administration of INFLUENZA VACCINE.  It was reported Author/Reporter Comment: I was averaging one flu every 10 years or so. Not any more. Haven't had the flu since 2007. I had one shot in 1981 and I thought I was going to die. Two weeks of the most horrible illness I've ever been through. NEVER, EVER AGAIN!  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 (Two weeks of the most horrible illness).  At time of reporting, the outcome was Unknown for the event two weeks of the most horrible illness.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 26-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves a patient of an unknown age and gender who experienced 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 an unknown dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, route, formulation, administration site, lot number and expiry date) for immunisation.  On an unknown date, the patient developed flu (influenza) (latency: unknown) following the administration of Influenza Vaccine.  It was reported that Got mine. But came down with the flu on Thanksgiving day.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: it gave me the flu; Initial information received on 25-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves Adult and unknown gender patient who reported it gave me the flu 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, dose, frequency, formulation, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious event of it gave me the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported "This is a social media case: I never get yhe flu. But my doctor encouraged me to get a flu shot.. And it gave me the flu.. Never get another flu shot."  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Yes and it made me sick an put in Hospital; Initial information received on 28-Nov-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated yes and it made me sick an put in hospital after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for immunization. Information on  batch number and expiry date was requested.  On an unknown date the patient had an event of yes and it made me sick an put in hospital (illness) (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.  Seriousness Criteria: The event caused hospitalization.; Sender's Comments: Sanofi company comment dated 01-Dec-2022: This case involves an unknown age and unknown gender patient who stated yes and it made me sick an put in hospital after receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: YF
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: YF-VAX was administered that was inadvertently reconstituted with the sterile water from an MMR vaccine and not the provided diluent with no reported adverse event; Initial information was received on 29-Nov-2022 regarding an unsolicited valid non-serious case received from healthcare professional.  This case involves a patient with unknown demographics who was administered Yellow fever vaccine [YF-VAX] that was inadvertently reconstituted with the sterile water from an MMR vaccine and not the provided diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient administered a dose of suspect Yellow fever vaccine (with unknown strength, dose, route, administration site, lot number and expiration date) for immunization that was inadvertently reconstituted with the sterile water from an MMR vaccine and not the provided diluent with no reported adverse event (product preparation error) (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  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: FLUC3
Symptoms: Back pain, Fatigue, Neck pain, Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: Sinus congestion and draining; Sinus congestion and draining; Significant achiness in my neck and upper back; Significant achiness in my neck and upper back; Low fever; Significant fatigue; This spontaneous case was received on 17-Nov-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-05900) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On 16-Nov-2022, around 3 pm, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, anatomical location: not reported) for active immunisation for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number was not reported.  On the same date, within three hours after receiving Flucelvax Quadrivalent, the patient began to experience significant achiness in neck and upper back. Around 7:30 pm, the patient began to have a low fever and significant fatigue, and into the night began to experience sinus congestion and draining.   At the time of initial reporting on 17-Nov-2022, the patient had not recovered from the events of sinus congestion, 'nasal sinus discharge', 'neck pain', 'upper back pain' and fatigue. As reported, sinus congestion and draining continued on into the second day, and the patient was still experiencing achiness, fatigue and sinus congestion after 24 hours.  The outcome of the event of fever was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A patient of an unreported age experienced fatigue, fever, upper back pain, neck pain, and sinus congestion and hypersecretion on the same day after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A patient of an unreported age experienced fatigue, fever, upper back pain, neck pain, and sinus congestion and hypersecretion on the same day after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.
Sex: U
Vaccine: FLUC3
Symptoms: Sinus congestion
Clinical narrative: Sinus congestion and draining; Sinus congestion and draining; Significant achiness in my neck and upper back; Significant achiness in my neck and upper back; Low fever; Significant fatigue; This spontaneous case was received on 17-Nov-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-05900) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On 16-Nov-2022, around 3 pm, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, anatomical location: not reported) for active immunisation for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number was not reported.  On the same date, within three hours after receiving Flucelvax Quadrivalent, the patient began to experience significant achiness in neck and upper back. Around 7:30 pm, the patient began to have a low fever and significant fatigue, and into the night began to experience sinus congestion and draining.   At the time of initial reporting on 17-Nov-2022, the patient had not recovered from the events of sinus congestion, 'nasal sinus discharge', 'neck pain', 'upper back pain' and fatigue. As reported, sinus congestion and draining continued on into the second day, and the patient was still experiencing achiness, fatigue and sinus congestion after 24 hours.  The outcome of the event of fever was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A patient of an unreported age experienced fatigue, fever, upper back pain, neck pain, and sinus congestion and hypersecretion on the same day after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A patient of an unreported age experienced fatigue, fever, upper back pain, neck pain, and sinus congestion and hypersecretion on the same day after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.
Sex: U
Vaccine: FLU4
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Continuous "bruised" tissue pain around dosage site; Continuous "bruised" tissue pain around dosage site; I recorded many other different symptoms; This spontaneous case was received on 19-Nov-2022 from other non-health professional (consumer) (reference number: SEQW22-05943) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in 2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose, route of administration, anatomical location, and indication: not reported). The batch number reported was not reported.  On 04-Nov-2022, an unknown amount of time after receiving Afluria Quadrivalent, the patient experienced continuous bruised tissue pain around the dosage site.   On an unspecified date in 2022, within 24 hours after receiving Afluria Quadrivalent the patient experienced many other different symptoms, measured by the patient's cardiologist at the cardiologist's normal annual appointment.  At the time of initial reporting, the patient had not recovered from the events of 'vaccination site pain', and 'vaccination site bruising'.  The outcome of the event of adverse event NOS' was not reported.  The reporter did not provide a causality assessment.  Company comment: A patient of unreported age or gender experienced vaccination site pain and vaccination site bruising an unknown amount of time after being vaccinated with the suspect Afluria Quadrivalent vaccine. Reportedly, within 24 hours, the patient experienced adverse event NOS. Information regarding the underlying medical history and concomitant medications has not been provided. Causality for vaccination site pain and vaccination site bruising is unassessable due to unclear temporal relationship. Causality for adverse event NOS is assessed as possibly related.; Sender's Comments: A patient of unreported age or gender experienced vaccination site pain and vaccination site bruising an unknown amount of time after being vaccinated with the suspect Afluria Quadrivalent vaccine. Reportedly, within 24 hours, the patient experienced adverse event NOS. Information regarding the underlying medical history and concomitant medications has not been provided. Causality for vaccination site pain and vaccination site bruising is unassessable due to unclear temporal relationship. Causality for adverse event NOS is assessed as possibly related.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Administered the wrong dose to patient. Patient received dose for 12+ (0.3 mcg/0.3 ml) instead of 5-11 dose (0.2 mcg/0.2 ml).
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction, Injection site hypersensitivity, Injection site pain, Pain, Pain in extremity
Clinical narrative: ?COVID arm? - raised rash/welt that is warm to the touch and very painful. Rash may have started last night but I didn?t see it until this evening. Pain and sensitivity around injection site and moderate pain radiating down left arm
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Rash papular, Skin warm, Urticaria
Clinical narrative: ?COVID arm? - raised rash/welt that is warm to the touch and very painful. Rash may have started last night but I didn?t see it until this evening. Pain and sensitivity around injection site and moderate pain radiating down left arm
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Hypoaesthesia, Neurological examination normal, Paraesthesia, Photophobia
Clinical narrative: Patient reports "numbness and tingling " in arm distal to the vaccination with normal neuro and Musculoskeletal exam. this began the moring after vaccination.  Also reporting headache, light sensitivity, (though unsure if related to ear infection or vaccination
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Dyspnoea, Pruritus
Clinical narrative: 02DEC22 @ 1330 RECEIVED TYPHOID VACCINE AND @1332 BEGAN TO HAVE ITCHINESS THROUGHOUT BODY.  AT THAT POINT SHE ALSO HAD DIFFICULTY BREATHING AND WAS GIVEN EPIPEN 0.3 MG AS WELL AS BENADRYL 50 MG IM.  AT ABOUT 1350 PT WAS GIVEN PREDNISONE 20 MG 3 TABS NOW.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tenderness, Urticaria
Clinical narrative: Welt on arm about 2.5 inches in diameter. It itches and is sore to the touch.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Biopsy peripheral nerve, Blood test, Burning sensation, Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Finally diagnosed with CIDP,  Progressive difficulty walking and with balance. Need a walker, have progressed from a cane which was needed after first booster October 2021. Foot numbness pain tingling and burning. Have had several falls and broken bones. Currently housebound.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, Housebound, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Finally diagnosed with CIDP,  Progressive difficulty walking and with balance. Need a walker, have progressed from a cane which was needed after first booster October 2021. Foot numbness pain tingling and burning. Have had several falls and broken bones. Currently housebound.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Multiple fractures, Pain in extremity, Paraesthesia
Clinical narrative: Finally diagnosed with CIDP,  Progressive difficulty walking and with balance. Need a walker, have progressed from a cane which was needed after first booster October 2021. Foot numbness pain tingling and burning. Have had several falls and broken bones. Currently housebound.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Walking aid user
Clinical narrative: Finally diagnosed with CIDP,  Progressive difficulty walking and with balance. Need a walker, have progressed from a cane which was needed after first booster October 2021. Foot numbness pain tingling and burning. Have had several falls and broken bones. Currently housebound.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was vaccinated with this vaccine after the excursion; No adverse event; Patient was vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022 at 11:31 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 30-Sep-2022 at 11:31 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion).    Concomitant medications were not reported. It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Vaccine was not viable. No adverse events were reported.  Treatment information was not provided.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients that were vaccinated with this vaccine after the excursion; No adverse event; patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Sleep apnea and Anxiety.    On 04-Oct-2022 at 1:30 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 04-Oct-2022 at 1:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion).    Concomitant products were not reported.  It was reported that moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events. Vaccine was not viable. It was unknown if the patient was ever diagnosed with or tested positive for Covid 19.   Treatment medications were not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients that were vaccinated with this vaccine after the excursion; No adverse event; patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Hypertension, Cholesterol, Depression and Anxiety.    On 04-Oct-2022 at 9:25 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 04-Oct-2022 at 9:25 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion).    It was unknown if the patient had ever been diagnosed or tested positive for Covid-19. Acute illness at the time of vaccination and up to one month before was unknown.  No concomitant medication was reported.  It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events.   No treatment information was provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired VAQTA on 11/23/2022; This spontaneous report was received from the healthcare business professional (in charge of vaccine storage/stability) and referred to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug reactions/allergies, and concomitant therapy were not reported.  On 23-NOV-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular pre-filled syringe injection (valid lot #U026792 with the expiration date: 28-OCT-2022; strength, dose, and route of administration were not provided) for prophylaxis (Expired product administered). There was no temperature excursion reported. There was no additional adverse event reported (No adverse event).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: injection site is itchy; injection site is red; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were not recovered/not resolved.   The reporter considered the injection site itching and injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's Comments:  This case was self reported by the patient. The patient received Shingrix in the left arm. The reporter stated that the injection site was itchy and red. The patient was currently exhibiting these symptoms. The reporter did not consent to follow up. No HCP for follow up.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired boostrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number AB374, expiry date 21st November 2022) for prophylaxis.   On 22nd November 2022, the patient received Boostrix. On 22nd November 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's Comment: The certified nursing assistant reported that the patient received a dose of Boostrix on the day of reporting and it was already expired.  The reporter consented to follow up. Additional Supportive Information: The use of Boostrix dose, which was already expired on 21st November 2022, which led to expired vaccine used.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose was given on 30-Mar-2021 and second dose on 21-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 30-Mar-2021 and second dose on 21-Apr-2021) and NO ADVERSE EVENT (No adverse event) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055F22B, 071f21a, 002C21A and 016B21A) for COVID-19 prophylaxis.     The patient's past medical history included Generalized anxiety disorder. Concomitant products included SERTRALINE from 09-Feb-2018 to 26-Nov-2022 for an unknown indication.   On 30-Mar-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 30-Mar-2021 and second dose on 21-Apr-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 30-Mar-2021 and second dose on 21-Apr-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The patient had Paxlovid for the treatment of COVID-19 from 16-Nov-2022 to 20-Nov-2022 and had COVID-19 rebound on 26-Nov-2022. Rebound COVID on day 11 of isolation after successfully completing a round of Paxlovid taken days 2-6. All symptoms originally went away by day 8, and tested negative 3 times on rapid tests until symptoms returned day 11, confirmed with 2 positive rapid tests and positive PCR.  No treatment medication was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0-2H221B, ER9731 and 018B21A) for COVID-19 vaccination.     Patient had no allergies.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: Positive.         No concomitant medication details was reported.  No treatment medication details was reported.   This case was linked to MOD-2022-679872 (Patient Link).