chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok quad was accidentally given to 2 patients under the age of 18, with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2022SA418789(CLUSTER).  This case involves a 16 years old female patient to whom influenza quadrivalent recombinant vaccine [flublok] was accidentally given under the age of 18 with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2022, the patient under the age of 18 received a dose of 1 DF (dosage form) total of standard suspect influenza quadrivalent recombinant vaccine with no reported adverse event (product administered to patient of inappropriate age) with an unknown formulation (lot UJ 887AA, expiry date- 09-Jun-2023) via intramuscular route in the left deltoid for immunization. (latency: same day)  Action taken: not applicable.  Outcome Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inadvertently given expired product with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA419169(CLUSTER).  This case involves a 11 years old male patient who was inadvertently given expired product influenza usp trival a-b subvirion no preservative vaccine [Fluzone] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection (lot: UT7378MA, expiry date: 30-Jun-2022) (Strength: unknown) 300mg total at once via intramuscular route in the left deltoid for immunization.  On an unknown date the patient was inadvertently given expired product with no reported adverse event (expired product administered) (unknown latency) following the administration of vaccine.  No lab data reported.  Action taken was 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: reported as a medication error due to inadvertently given expired product, 30Jun2022 with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA419169(CLUSTER) and 2022SA420010(CLUSTER).  This case involves a 7 years old male patient who experienced reported as a medication error due to inadvertently given expired product, 30jun2022 with no reported adverse event while receiving vaccine influenza quadrival a-b vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect  influenza quadrival a-b vaccine at dose of 0.5 mL 1X  lot UT7378MA, Expiry date: 30-Jun-2022 via intramuscular route in the right deltoid for Immunization.  On 07-Oct-2022 the patient developed a non-serious reported as a medication error due to inadvertently given expired product, 30jun2022 with no reported adverse event (expired product administered) (unknown latency) following the administration of influenza quadrival a-b vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (reported as a medication error due to inadvertently given expired product, 30Jun2022 with no reported adverse event).  At time of reporting, the outcome was Unknown for the event reported as a medication error due to inadvertently given expired product, 30jun2022 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired was administered with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old male patient who was inadvertently given expired product influenza quadrival a-b vaccine [Fluzone QIV] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Oct-2022,the patient received a dose of suspect influenza quadrival a-b vaccine Suspension for injection (lot UT7378MA, expiry date: 30-JUN-2022) 0.5ml (milliliter) total at once (strength: unknown) via intramuscular route in the left vastus lateralis for Immunization.  On 07-Oct-2022 the patient was inadvertently given expired product with no reported adverse event (expired product administered) same day following the administration of vaccine.  No lab data reported.  Action taken was 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 6.0
Sex: M
Vaccine: FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK being administered to pediatric patient with no reported adverse event.; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old male patient who stated that influenza quadrivalent recombinant vaccine [Flublok] being administered to pediatric patient with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2022, the patient received suspect standard influenza quadrivalent recombinant vaccine at a dose of 0.5 ml once (lot QFAA223, expiry date - 30-Jun-2023) (formulation unknown) via intramuscular route in the left deltoid for influenza and was being administered to pediatric patient with no reported adverse event. (product use issue) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event flublok being administered to pediatric patient 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: FLUR3
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was administered to pediatric patients with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA419186(CLUSTER), 2022SA418226(CLUSTER), 2022SA420021(CLUSTER), 2022SA419213(CLUSTER) and 2022SA420025(CLUSTER).  This case involves a 2 years old female patient to whom influenza quadrivalent recombinant vaccine [flublok] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2022, the pediatric patient received a 0.5 ml (once) dose of suspect influenza quadrivalent recombinant vaccine with no reported adverse event (product administered to patient of inappropriate age) (lot QFAA223, expiry date: 30-Jun-2022) via intramuscular route in the left thigh for influenza (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chest X-ray, Chills, Electrocardiogram, Fatigue
Clinical narrative: have a lingering upset stomach; having a little difficult with mobility,symptoms continued to get worse, was experiencing a complete loss of mobility; fever; vomiting; tiredness; condition aggravated; began to experience chills; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 76 years old male patient who began to experience chills, have a lingering upset stomach, having a little difficult with mobility,symptoms continued to get worse, was experiencing a complete loss of mobility, fever, vomiting and tiredness after receiving vaccine Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, vaccination(s) and family history were not provided.   On 29-Sep-2022 around 10:00 am, the patient received a 0.7 ml (Milliliter) dose of suspect Influenza Quadrival A-B High Dose HV Vaccine (lot- UJ900AA, expiry date- unknown) via intramuscular route in the deltoid nos for immunization.  On 29-Sep-2022 the patient began to experience chills (chills), having a little difficult with mobility, was experiencing a complete loss of mobility (mobility decreased) with condition aggravated, fever (pyrexia), vomiting, tiredness (Latency- same day) following the administration of Influenza Quadrival A-B High Dose HV Vaccine. On an unknown date the patient have a lingering upset stomach (abdominal discomfort) (unknown latency) following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  It was reported that "the patient was transported via ambulance to the emergency room (ER) of where he was seen and treated by. Patient stated that he was there for around 5 hours, and they "did every test under the sun," including a Covid test, an electrocardiogram, a chest X-ray. They gave him fluids, either glucose or saline, he was not sure which, and they monitored his blood pressure. He was told that if he regained his mobility, they would sign him out, but if he did not, they were going to admit him to the hospital. Around 5 am he had improved and regained his mobility, so he was released from the ER without being admitted to the hospital".  Action taken: not applicable.  The corrective treatment was unknown for other events and the patient was treated with PARACETAMOL (TYLENOL) for Fever, IBUPROFEN (ADVIL [IBUPROFEN]) for Fever and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Upset stomach.  At time of reporting, the outcome was Recovering / Resolving for the events and was Recovered / Resolved on 30-Sep-2022 for the event Mobility decreased.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Immobile, Mobility decreased, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: have a lingering upset stomach; having a little difficult with mobility,symptoms continued to get worse, was experiencing a complete loss of mobility; fever; vomiting; tiredness; condition aggravated; began to experience chills; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 76 years old male patient who began to experience chills, have a lingering upset stomach, having a little difficult with mobility,symptoms continued to get worse, was experiencing a complete loss of mobility, fever, vomiting and tiredness after receiving vaccine Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, vaccination(s) and family history were not provided.   On 29-Sep-2022 around 10:00 am, the patient received a 0.7 ml (Milliliter) dose of suspect Influenza Quadrival A-B High Dose HV Vaccine (lot- UJ900AA, expiry date- unknown) via intramuscular route in the deltoid nos for immunization.  On 29-Sep-2022 the patient began to experience chills (chills), having a little difficult with mobility, was experiencing a complete loss of mobility (mobility decreased) with condition aggravated, fever (pyrexia), vomiting, tiredness (Latency- same day) following the administration of Influenza Quadrival A-B High Dose HV Vaccine. On an unknown date the patient have a lingering upset stomach (abdominal discomfort) (unknown latency) following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  It was reported that "the patient was transported via ambulance to the emergency room (ER) of where he was seen and treated by. Patient stated that he was there for around 5 hours, and they "did every test under the sun," including a Covid test, an electrocardiogram, a chest X-ray. They gave him fluids, either glucose or saline, he was not sure which, and they monitored his blood pressure. He was told that if he regained his mobility, they would sign him out, but if he did not, they were going to admit him to the hospital. Around 5 am he had improved and regained his mobility, so he was released from the ER without being admitted to the hospital".  Action taken: not applicable.  The corrective treatment was unknown for other events and the patient was treated with PARACETAMOL (TYLENOL) for Fever, IBUPROFEN (ADVIL [IBUPROFEN]) for Fever and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Upset stomach.  At time of reporting, the outcome was Recovering / Resolving for the events and was Recovered / Resolved on 30-Sep-2022 for the event Mobility decreased.
Sex: U
Vaccine: FLU4
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: was receiving a dose of FLUZONE QIV PFS and the staff member administering reporting most of the dose leaked out and dripped down the employees arm (patient's arm with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a Other Health Care Professional.  This case involves an unknown age and unknown gender patient who was receiving a dose of fluzone qiv pfs and the staff member administering reporting most of the dose leaked out and dripped down the employees arm (patient's arm with no reported adverse event (Influenza quadrival A-B vaccine) [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Sep-2022 the patient was receiving a dose of influenza quadrival A-B vaccine (form, strength, dose, frequency, batch number and expiry date: unknown) via unknown route in unknown administration site for Immunization and the staff member administering reporting most of the dose leaked out and dripped down the employees arm (patient's arm with no reported adverse event" (accidental exposure to product) (latency : same day) .  It was reported Caller reporting that an employee was receiving a dose of FLUZONE QIV PFS and the staff member administering reporting most of the dose leaked out and dripped down the employees arm (patient's arm). Caller reporting that they are assuming that the needle was not screwed on all the way. Caller with question on whether dose need repeating. Caller did not have any patient or vaccine details, therefore smart script not completed.  Action taken was 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Confusional state, Full blood count, Tremor, Urine analysis
Clinical narrative: WOKE UP FEELING WEAK, INCREASED SHAKINESS, MARKED MENTAL CONFUSION. CONTINUED THROUGHOUT THE DAY
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Eczema, Injection site pruritus, Injection site rash, Rash papular
Clinical narrative: Each dose of mRNA vaccine I have received has been followed by a flair up in my eczema. This most recent bivalent booster has resulted in my worst eczema breakout yet. I also have a raised ichy spot at the injection site since receiving this most recent dose on 9/14/22
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Discomfort, Pain, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Pain and discomfort for a few days that then started getting worse.  By 6 days after shot went to urgent care.  Have now been diagnosed with polymyalgia rheumatica.  Significant disabling pain that requires medication with serious side effects to manage, apparently over the course of at least a year.  Note:  I do not know what "dose number in series" means.  It was my 2nd booster.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Menstruation irregular, Muscle tightness, Paraesthesia, Vertigo
Clinical narrative: Paraethesia, bilateral but mainly right side of body Hypothesis , right side of body Muscle tension Vertigo Irregular Menstrual Cycle
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Chest pain, Fatigue, Renal pain, Tinnitus
Clinical narrative: Chest pain, unknown kidney pain, AKI acute kidney injury , ringing ears. Chronic fatigue.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Arthralgia, Blood glucose increased, Diabetic ketoacidosis, Immediate post-injection reaction
Clinical narrative: Extreme pain in joints, muscles, and skin immediately following second shot. Development of Type 1 diabetes a few months later.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain of skin, Type 1 diabetes mellitus, Visual impairment
Clinical narrative: Extreme pain in joints, muscles, and skin immediately following second shot. Development of Type 1 diabetes a few months later.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Shingrix administered to a 47YO; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old male patient who received Herpes zoster (Shingrix) (batch number 252JX, expiry date 23rd September 2023) for prophylaxis.   On 26th July 2022, the patient received Shingrix (intramuscular). On 26th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The patient was immunocompetent. The reporter consented to follow up. Additional Supportive Information: The patient was administered Shingrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: 1st dose on Oct2020, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in October 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The pharmacist reported that the patient was late for the 2nd dose of Shingrix. No adverse event was reported. Only the first dose was administrated. No patient's identifiers was provided. No lot number and expiration date was provided. No vaccination date was provided. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Shingrix 3rd dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 34L52, expiry date 6th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 10th October 2019) and Shingrix (received 2nd dose of Shingrix on 23rd December 2019).   On 5th July 2022, the patient received the 3rd dose of Shingrix. On 5th July 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The pharmacist called to inquire that, any report of adverse effects.  The reporter wanted to know how to proceed. The reporter confirmed that the patient was administered the third dose of Shingrix in their facility.  No additional details were provided.  The reporter consented to follow up. Additional Supportive Information: The patient inadvertently received third dose of Shingrix, which led to extra dose administered.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe pain in whole arm, down to fingers; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4fk7y, expiry date 29th September 2023) for prophylaxis.   On 8th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 8th September 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comments:The reporter stated that the patient got her first Shingrix vaccine about 5 weeks ago and she was still having severe pain in her whole arm.   The patient stated the pain goes all the way down to her fingers. The reporter gave consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood glucose increased, Blood urea increased, Cellulitis, Electrocardiogram, Full blood count
Clinical narrative: Severe pain in whole arm, down to fingers; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4fk7y, expiry date 29th September 2023) for prophylaxis.   On 8th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 8th September 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comments:The reporter stated that the patient got her first Shingrix vaccine about 5 weeks ago and she was still having severe pain in her whole arm.   The patient stated the pain goes all the way down to her fingers. The reporter gave consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Magnetic resonance imaging normal, Metabolic function test, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in whole arm, down to fingers; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4fk7y, expiry date 29th September 2023) for prophylaxis.   On 8th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 8th September 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comments:The reporter stated that the patient got her first Shingrix vaccine about 5 weeks ago and she was still having severe pain in her whole arm.   The patient stated the pain goes all the way down to her fingers. The reporter gave consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product administered at inappropriate site, Renal function test abnormal, Ultrasound Doppler normal, X-ray limb
Clinical narrative: Severe pain in whole arm, down to fingers; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4fk7y, expiry date 29th September 2023) for prophylaxis.   On 8th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 8th September 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comments:The reporter stated that the patient got her first Shingrix vaccine about 5 weeks ago and she was still having severe pain in her whole arm.   The patient stated the pain goes all the way down to her fingers. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: "it" has gotten worse since the vaccines/Suspected vaccination failure; "it" has gotten worse since the vaccines; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The patient self-reported this case through a voicemail for Shingrix vaccine. The reporter did not spell her name or address. The patient received both the Shingrix vaccines and stated it (shingles) gotten worse since the vaccines. The reporter did not consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Vaccine associated immune thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Vaccine associated immune thrombocytopenia) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Vaccine associated immune thrombocytopenia) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Vaccine associated immune thrombocytopenia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Vaccine associated immune thrombocytopenia) to be related.    Treatment and concomitant medications were not reported.  Company comment: This literature non study case concerns a 83-year-old, male patient with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of immune thrombocytopenia. The events occurred on an unknown date after the fourth dose of mRNA-1273. No further information about the events was available at the time of this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MODERNATX, INC.-MOD-2022-658144 (E2B Linked Report).; Sender's Comments: This literature non study case concerns an 83-year-old, male patient with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of immune thrombocytopenia. The events occurred on an unknown date after the fourth dose of mRNA-1273. No further information about the events was available at the time of this report. The benefit-risk relationship of mRNA-1273 is not affected by this report. MODERNATX, INC.-MOD-2022-658144:66 YO Female
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Vaccination site swelling
Clinical narrative: swelling underneath armpit on left arm/You can see a little bulge/It's feeling sore; swelling underneath armpit on left arm/You can see a little bulge; swelling underneath his armpit on the left side where he got the booster; This spontaneous case was reported by a patient and describes the occurrence of AXILLARY PAIN (swelling underneath armpit on left arm/You can see a little bulge/It's feeling sore), LYMPHADENOPATHY (swelling underneath armpit on left arm/You can see a little bulge) and VACCINATION SITE SWELLING (swelling underneath his armpit on the left side where he got the booster) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 vaccination.     The patient had no allergies. The patient had not receive other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes, Blood pressure high and High cholesterol. Concomitant products included INFLUENZA VACCINE from 08-Oct-2022 to an unknown date for an unknown indication.    On 22-Sep-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 07-Oct-2022, the patient experienced LYMPHADENOPATHY (swelling underneath armpit on left arm/You can see a little bulge) and VACCINATION SITE SWELLING (swelling underneath his armpit on the left side where he got the booster). On an unknown date, the patient experienced AXILLARY PAIN (swelling underneath armpit on left arm/You can see a little bulge/It's feeling sore). At the time of the report, AXILLARY PAIN (swelling underneath armpit on left arm/You can see a little bulge/It's feeling sore), LYMPHADENOPATHY (swelling underneath armpit on left arm/You can see a little bulge) and VACCINATION SITE SWELLING (swelling underneath his armpit on the left side where he got the booster) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received 1st dose of Moderna COVID-19 vaccine on 06-Jan-2021, Lot number: 037K20A, 2nd dose on 03-Feb-2021, Lot number: 015M20A and received 1st booster on 05-Nov-2021, Lot number: 066F21A. The patient stated that this did not happen with previous Moderna doses.  Patient never had COVID positive test or diagnosis. Patient mentioned the symptoms didn't happen right away either because this is 2 weeks after his dose. On 10Oct2022, patient saw his primary care doctor. His doctor couldn't feel a lump, so he told the patient to monitor it. It hasn't gotten better but hasn't gotten worse either. Patient did not experienced similar event of swelling underneath armpit previously.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Peripheral swelling, Pharyngeal swelling
Clinical narrative: hands were swollen; Swollen throat; Had a bad reaction to the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (hands were swollen), PHARYNGEAL SWELLING (Swollen throat) and IMMUNISATION REACTION (Had a bad reaction to the vaccine) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-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 12-Oct-2022, the patient experienced PERIPHERAL SWELLING (hands were swollen), PHARYNGEAL SWELLING (Swollen throat) and IMMUNISATION REACTION (Had a bad reaction to the vaccine). At the time of the report, PERIPHERAL SWELLING (hands were swollen), PHARYNGEAL SWELLING (Swollen throat) and IMMUNISATION REACTION (Had a bad reaction to the vaccine) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   Reporter did not allow further contact
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; My children received a Moderna bivalent booster yesterday; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (2nd dose) in January 2022 and Pfizer COVID-19 vaccine (1st dose). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 11-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported by the reporter.  The patient's mother was not sure if the patient was eligible to receive a booster dose at this time. Patient was then inadvertently administered a dose of the Moderna COVID-19 bivalent vaccine, instead. Mother was told by the clinic that the Moderna COVID-19 bivalent vaccine just got authorized for use in children 6 and older and that it should not be an issue. The patient is doing okay so far and have not reported any adverse reactions at this time.  No treatment medication was reported.    This case was linked to US-MODERNATX, INC.-MOD-2022-658448 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658448:Patient 2 - BL
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pain in extremity, Walking aid user
Clinical narrative: Patient needed a walker because she can hardly walk; pain in her right leg and she cannot even put pressure on it; Patient needed a walker because she can hardly walk; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (Patient needed a walker because she can hardly walk), PAIN IN EXTREMITY (pain in her right leg and she cannot even put pressure on it) and WALKING AID USER (Patient needed a walker because she can hardly walk) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Food allergy (Artificial colors and flavors). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced GAIT INABILITY (Patient needed a walker because she can hardly walk), PAIN IN EXTREMITY (pain in her right leg and she cannot even put pressure on it) and WALKING AID USER (Patient needed a walker because she can hardly walk). In March 2021, GAIT INABILITY (Patient needed a walker because she can hardly walk), PAIN IN EXTREMITY (pain in her right leg and she cannot even put pressure on it) and WALKING AID USER (Patient needed a walker because she can hardly walk) had resolved.            No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-658243, MOD-2022-658252 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse Event; Patients received 0.5 ml of a Moderna bivalent booster, However, the patients stated verbally that they had not received any COVID19 vaccine before,so that might have been their first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml of a Moderna bivalent booster, However, the patients stated verbally that they had not received any COVID19 vaccine before,so that might have been their first dose) and NO ADVERSE EVENT (No adverse Event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml of a Moderna bivalent booster, However, the patients stated verbally that they had not received any COVID19 vaccine before,so that might have been their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml of a Moderna bivalent booster, However, the patients stated verbally that they had not received any COVID19 vaccine before,so that might have been their first dose) 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 WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml of a Moderna bivalent booster, However, the patients stated verbally that they had not received any COVID19 vaccine before,so that might have been their first dose).    No concomitant drug was reported. The reporter admitted that patient had not actually confirmed in the system that was true. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-658663 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658663:same reporter
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Trichorrhexis
Clinical narrative: Patient hair to come out/ Right side of patient head has less hair than the other/ It is thinning and breaking off on one side; Patient hair to come out/ Right side of patient head has less hair than the other/ It is thinning and breaking off on one side; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Patient hair to come out/ Right side of patient head has less hair than the other/ It is thinning and breaking off on one side) and TRICHORRHEXIS (Patient hair to come out/ Right side of patient head has less hair than the other/ It is thinning and breaking off on one side) in an 85-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery. Concurrent medical conditions included Blood pressure high and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Patient hair to come out/ Right side of patient head has less hair than the other/ It is thinning and breaking off on one side) and TRICHORRHEXIS (Patient hair to come out/ Right side of patient head has less hair than the other/ It is thinning and breaking off on one side). At the time of the report, ALOPECIA (Patient hair to come out/ Right side of patient head has less hair than the other/ It is thinning and breaking off on one side) and TRICHORRHEXIS (Patient hair to come out/ Right side of patient head has less hair than the other/ It is thinning and breaking off on one side) outcome was unknown.            Patient does not had any allergies. Other concomitant medication included unspecified medication for the high blood pressure.  Patient had Pfizer for the 1st booster dose.  Patient would like to know if the vaccines could cause her hair to come out. Patient said she was not in too much trouble after the 1st 2 doses.  No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; The patient thinks that may have received a full dose instead of a half dose; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (The patient thinks that may have received a full dose instead of a half dose) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 012M20A and 043L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (The patient thinks that may have received a full dose instead of a half dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (The patient thinks that may have received a full dose instead of a half dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided. Patient did not remember which arm she received the vaccine in.   This case was linked to MOD-2022-658743, MOD-2022-658756 (Patient Link).