chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Wrong technique in product usage process
Clinical narrative: Product Storage Error and Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received HBV (Engerix B) for prophylaxis.   On 27-JUN-2023, the patient received Engerix B. On 27-JUN-2023, an unknown time after receiving Engerix B, the patient experienced wrong technique in drug usage process (Verbatim: Product Storage Error and Administration). The outcome of the wrong technique in drug usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUN-2023 The reporter stated that she believed the Engerix-B was activated yesterday (day before reporting) but was not discarded and was administered to a patient today (on the reporting day), which led to wrong technique in drug usage process. However, she was not certain. The reporter asked how long an Engerix-B PFS (pre-filled syringe) stable for once a needle had been placed. Provided CDC (Centers for Disease Control and Prevention) recommendations that state that the PFS should be used or discarded at the end of the workday.  The vaccine administration facility was the same as primary reporter. The reporter did not have any additional details surrounding the event (no patient identifiers, lot number, expiry date). She also declined follow up.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: patient was accidentally administered an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J953N, expiry date 11-MAY-2023) for prophylaxis.   On 28-JUN-2023, the patient received the 3rd dose of Pediarix. On 28-JUN-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient was accidentally administered an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jun-2023 The registered medical assistant provided information about vaccines, dose, vaccination but declined to receive follow up information. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received an expired dose of Pediarix, which led to expired vaccine used.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Kinrix unintended extra dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included Kinrix (1st dose received on an unknown date in 9-AUG-2022).   On 28-JUN-2023, the patient received the 2nd dose of Kinrix. On 28-JUN-2023, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: Kinrix unintended extra dose). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-JUN-2023 Nurse called to report a patient received another dose of Kinrix by mistake 10 months after the first dose.  Consented to follow up via email. This case is linked to the case US2023089770, reported by the same reporter.; Sender's Comments:  US-GSK-US2023089770:Same reporter, same event, different patient (twin)
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: received another dose of Kinrix by mistake 10 months after the first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included Kinrix (1st dose of kinrix received on 9-AUG-2022).   On 28-JUN-2023, the patient received the 2nd dose of Kinrix. On 28-JUN-2023, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: received another dose of Kinrix by mistake 10 months after the first dose). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Jun-23 Nurse called to report a patient received another dose of Kinrix by mistake 10 months after the first dose. Consented to follow up via email. This case is linked to the case US2023089768, reported by the same reporter.; Sender's Comments:  US-GSK-US2023089768:Same reporter, same event, different patient (twin)
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age, Underdose
Clinical narrative: A 62 year old patient was mistakenly given the pediatric dose (0.5 ml) of Havrix yesterday; A 62 year old patient was mistakenly given the pediatric dose (0.5 ml) of Havrix yesterday; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 62-year-old male patient who received HAV (Havrix pediatric) for prophylaxis.   On 27-JUN-2023, the patient received Havrix pediatric (intramuscular) .5 ml. On 27-JUN-2023, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: A 62 year old patient was mistakenly given the pediatric dose (0.5 ml) of Havrix yesterday) and adult use of a child product (Verbatim: A 62 year old patient was mistakenly given the pediatric dose (0.5 ml) of Havrix yesterday). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-JUN-2023 A 62 year old patient was mistakenly given the pediatric dose (0.5 ml) of Havrix. Nothing else was reported.  The Vaccine Administration Facility was the same as Primary reporter. Consented to follow up with HCP/reporter.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: expired dose of INFANRIX was administered to an adult patient; expired dose of INFANRIX was administered to an adult patient today.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30-APR-2023) for prophylaxis.   On 28-JUN-2023, the patient received Infanrix. On 28-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired dose of INFANRIX was administered to an adult patient) and adult use of a child product (Verbatim: expired dose of INFANRIX was administered to an adult patient today.). The outcome of the expired vaccine used and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-JUN-2023 Nurse reported that an expired dose of Infanrix was administered to an adult patient, which led to expired vaccine used and adult use of a child product. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: injection site pain; low grade fever; body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included evolocumab.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain), low grade fever (Verbatim: low grade fever) and general body pain (Verbatim: body aches). The outcome of the injection site pain, low grade fever and general body pain were resolved (duration 5 days).   It was unknown if the reporter considered the injection site pain, low grade fever and general body pain to be related to Shingrix.     It was unknown if the company considered the injection site pain, low grade fever and general body pain to be related to Shingrix.   Additional Information: GSK receipt date 28 Jun 2023 The reporter was the patient.   The patient stated she had her first dose of Shingrix two years ago (incomplete series) and she had body aches, injection site pain, and low grade fever that lasted 5 days.  Due to her adverse reactions she did not know if she would have the 2nd dose of Shingrix. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 28-JUN-2023, the patient received Infanrix. On 28-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUN-2023. A nurse reported that a patient received an expired dose of Infanrix.  The vaccine expired on 10 June 2023 which led to expired vaccine used. The healthcare professional consented to follow up via email.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the liquid adjuvant portion only of Shingrix; administered the liquid adjuvant portion only of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 9AT7A, expiry date 06-AUG-2024) for prophylaxis.   On 19-JUN-2023, the patient received the 1st dose of Shingrix. On 19-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered the liquid adjuvant portion only of Shingrix) and inappropriate dose of vaccine administered (Verbatim: administered the liquid adjuvant portion only of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jun-2023 Department supervisor reported that the patient was administered the liquid adjuvant portion only of Shingrix and it was not reconstituted with the lyophilized component.  At the time of reporting a repeat dose has not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. This is 1 of 3 linked patients, reported by same reporter. The patient received only liquid adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023090170:Same reporter US-GSK-US2023090171:Same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AT7A, expiry date 06-AUG-2024) for prophylaxis.   On 20-JUN-2023, the patient received the 1st dose of Shingrix. On 20-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jun-2023 Department supervisor reported that the patient was administered the liquid adjuvant portion only of Shingrix and it was not reconstituted with the lyophilized component.  At the time of reporting a repeat dose has not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. This is 2 of 3 linked patients, reported by same reporter. The patient received only liquid adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023090171:Same Reporter US-GSK-US2023090167:Same reporter
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique/patient was administered the liquid adjuvant portion only of Shingrix; Inappropriate Reconstitution Technique/patient was administered the liquid adjuvant portion only of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 9AT7A, expiry date 06-AUG-2024) for prophylaxis.   On 23-JUN-2023, the patient received the 1st dose of Shingrix. On 23-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/patient was administered the liquid adjuvant portion only of Shingrix) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/patient was administered the liquid adjuvant portion only of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jun-2023 Department supervisor reported that the patient was administered the liquid adjuvant portion only of Shingrix and it was not reconstituted with the lyophilized component.  At the time of reporting a repeat dose has not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. This is 3 of 3 linked patients, reported by same reporter. The patient received only liquid adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023090167:Same reporter US-GSK-US2023090170:Same Reporter
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received First dose of modenra Bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received First dose of modenra Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received First dose of modenra Bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received First dose of modenra Bivalent vaccine) 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 (Patient received First dose of modenra Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction, Wrong product administered
Clinical narrative: Vaccination adverse reaction; Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose.) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose.). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose.) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: I had small sores and since I was vaccinated / my sores have turned into permanent daily pain.; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I had small sores and since I was vaccinated / my sores have turned into permanent daily pain.) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced PAIN (I had small sores and since I was vaccinated / my sores have turned into permanent daily pain.). At the time of the report, PAIN (I had small sores and since I was vaccinated / my sores have turned into permanent daily pain.) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a 0.2ml dose of a pink cap vial Moderna COVID19 vaccine bivalent as a second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a 0.2ml dose of a pink cap vial Moderna COVID19 vaccine bivalent as a second dose) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First dose AS1417b) on 11-Apr-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 09-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a 0.2ml dose of a pink cap vial Moderna COVID19 vaccine bivalent as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a 0.2ml dose of a pink cap vial Moderna COVID19 vaccine bivalent as a second 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 (Patient received a 0.2ml dose of a pink cap vial Moderna COVID19 vaccine bivalent as a second dose).    No concomitant medication was reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: since this vaccination my labial herpes 6 to 8 times a year no longer develops in the same way.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (since this vaccination my labial herpes 6 to 8 times a year no longer develops in the same way.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Oral herpes (lasted for 12 days with bubble formation and intense facial pain) and Facial pain.    On 15-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (since this vaccination my labial herpes 6 to 8 times a year no longer develops in the same way.) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (since this vaccination my labial herpes 6 to 8 times a year no longer develops in the same way.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for THERAPEUTIC RESPONSE UNEXPECTED (since this vaccination my labial herpes 6 to 8 times a year no longer develops in the same way.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that after this vaccination patient labial herpes (oral herpes) that occurred 6 to 8 times a year no longer develop in the same way. Patient herpes starts, does not bubble, no more pain and disappears in 2 to 3 days. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        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 information was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: voice box in her neck area, like another voice box. It has a chain inside like a massager machine; It is very painful.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (voice box in her neck area, like another voice box. It has a chain inside like a massager machine) and PAIN (It is very painful.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high and Potassium low.    In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (voice box in her neck area, like another voice box. It has a chain inside like a massager machine) and PAIN (It is very painful.). At the time of the report, FEELING ABNORMAL (voice box in her neck area, like another voice box. It has a chain inside like a massager machine) and PAIN (It is very painful.) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the voice box in the neck area, like another voice box. It has a chain inside like a massager machine. The patient a sensation under the chin. And it does the thing a camera does around her gums and it twists the teeth and gum area, around the mouth. It was very painful. It was like the patient had another tongue and another mouth.The patient also felt  in her head. it's like someone was doing something with the body. There was a chip in the vaccine and the patient wanted to knowhow it can be taken away. Patient was out of the hospital for the reason mentioned above.  No treatment medication was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Poor quality product administered
Clinical narrative: The staff inadvertently gave a dose of Moderna Covid 19 Bivalent to a patient from a vial that had been punctured the previous day. It had been 28 hours since the vial was punctured; Moderna Covid 19 Bivalent vaccine administred to a patient 28 hours post puncture; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The staff inadvertently gave a dose of Moderna Covid 19 Bivalent to a patient from a vial that had been punctured the previous day. It had been 28 hours since the vial was punctured), POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 28 hours post puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The staff inadvertently gave a dose of Moderna Covid 19 Bivalent to a patient from a vial that had been punctured the previous day. It had been 28 hours since the vial was punctured), POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 28 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The staff inadvertently gave a dose of Moderna Covid 19 Bivalent to a patient from a vial that had been punctured the previous day. It had been 28 hours since the vial was punctured), POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 28 hours post puncture) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (The staff inadvertently gave a dose of Moderna Covid 19 Bivalent to a patient from a vial that had been punctured the previous day. It had been 28 hours since the vial was punctured) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 28 hours post puncture).    No concomitant medication was reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Pharmacist advises that his pharmacy administer vaccine to patient that already expired. Vaccine expiration date was for 6-13-23; Patient received first dose of MODERNA COVID-19 VACCINE, BIVALENT; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist advises that his pharmacy administer vaccine to patient that already expired. Vaccine expiration date was for 6-13-23), WRONG PRODUCT ADMINISTERED (Patient received first dose of MODERNA COVID-19 VACCINE, BIVALENT) and NO ADVERSE EVENT (No adverse event) in an adolescent female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient had no relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 28-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist advises that his pharmacy administer vaccine to patient that already expired. Vaccine expiration date was for 6-13-23) and WRONG PRODUCT ADMINISTERED (Patient received first dose of MODERNA COVID-19 VACCINE, BIVALENT). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist advises that his pharmacy administer vaccine to patient that already expired. Vaccine expiration date was for 6-13-23), WRONG PRODUCT ADMINISTERED (Patient received first dose of MODERNA COVID-19 VACCINE, BIVALENT) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist advises that his pharmacy administer vaccine to patient that already expired. Vaccine expiration date was for 6-13-23) and WRONG PRODUCT ADMINISTERED (Patient received first dose of MODERNA COVID-19 VACCINE, BIVALENT).    Patient did not received any other vaccine in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vaccine expiry date was reported as 13-Jun-2023.  Treatment information was not provided.
Age: 75.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 22 May 2023, BUD was 21 Jun 2023, Date of administration of vaccine 27 Jun 2023; No adverse event; A dose was administered on 27 Jun 2023 and the BUD was 21 Jun 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was administered on 27 Jun 2023 and the BUD was 21 Jun 2023), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22 May 2023, BUD was 21 Jun 2023, Date of administration of vaccine 27 Jun 2023) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was administered on 27 Jun 2023 and the BUD was 21 Jun 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22 May 2023, BUD was 21 Jun 2023, Date of administration of vaccine 27 Jun 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose was administered on 27 Jun 2023 and the BUD was 21 Jun 2023), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22 May 2023, BUD was 21 Jun 2023, Date of administration of vaccine 27 Jun 2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (A dose was administered on 27 Jun 2023 and the BUD was 21 Jun 2023) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22 May 2023, BUD was 21 Jun 2023, Date of administration of vaccine 27 Jun 2023).    The vial did not undergo temperature excursions. Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Gastrointestinal disorder, Nausea, Wrong product administered
Clinical narrative: Mainly stomach problems. Things that messed with my abdomen area; Nausea; Chills; Patient received First dose of modenra Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of GASTROINTESTINAL DISORDER (Mainly stomach problems. Things that messed with my abdomen area), NAUSEA (Nausea), CHILLS (Chills) and WRONG PRODUCT ADMINISTERED (Patient received First dose of modenra Bivalent vaccine) in an adult female 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 an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (Mainly stomach problems. Things that messed with my abdomen area), NAUSEA (Nausea), CHILLS (Chills) and WRONG PRODUCT ADMINISTERED (Patient received First dose of modenra Bivalent vaccine). At the time of the report, GASTROINTESTINAL DISORDER (Mainly stomach problems. Things that messed with my abdomen area), NAUSEA (Nausea), CHILLS (Chills) and WRONG PRODUCT ADMINISTERED (Patient received First dose of modenra Bivalent vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   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.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Malaise
Clinical narrative: he had been having potential adverse events after receiving the Moderna COVID-19 vaccine; asked how he was doing. Caller stated "Not good."; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (he had been having potential adverse events after receiving the Moderna COVID-19 vaccine) and MALAISE (asked how he was doing. Caller stated "Not good.") in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (he had been having potential adverse events after receiving the Moderna COVID-19 vaccine) and MALAISE (asked how he was doing. Caller stated "Not good."). At the time of the report, IMMUNISATION REACTION (he had been having potential adverse events after receiving the Moderna COVID-19 vaccine) and MALAISE (asked how he was doing. Caller stated "Not good.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Poor quality product administered
Clinical narrative: no adverse event; Patient was administered with a dose more than 12 hours after the initial vial puncture; Moderna Covid 19 Bivalent vaccine administred to a patient 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with a dose more than 12 hours after the initial vial puncture), POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 12 hours post puncture) and NO ADVERSE EVENT (no adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2023, 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 13-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with a dose more than 12 hours after the initial vial puncture) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with a dose more than 12 hours after the initial vial puncture), POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 12 hours post puncture) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with a dose more than 12 hours after the initial vial puncture) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 12 hours post puncture).    No concomitant medication was reported.  No treatment information was reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bone marrow transplant
Clinical narrative: He got his COVID vaccines in 2021, but then had a bone marrow transplant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 03Feb2021, when the patient was 58-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE), administration date: 24Feb2021, when the patient was 58-year-old, for COVID-19 immunisation. The following information was reported: BONE MARROW TRANSPLANT (medically significant) with onset 2021, outcome "unknown", described as "He got his COVID vaccines in 2021, but then had a bone marrow transplant".  Clinical course: The reporter is vaccine coordinator reporting for office in general and stated that patient got his COVID vaccines in 2021, but then had a bone marrow transplant and had to get revaccinated. Patient had other conditions, but the reporter has no other details about his bone marrow transplant or other medical history for patient. This report is not related to a study or programme.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Infertility female, Menstrual disorder
Clinical narrative: I have not been able to conceive since I received the Pfizer vaccine; my period didn't start when it was supposed to; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 1, single (Lot number: FK9896) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Mucinex, reaction(s): "Known allergies: Mucinex". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 17Feb2022, outcome "not recovered", described as "my period didn't start when it was supposed to"; INFERTILITY FEMALE (non-serious), outcome "not recovered", described as "I have not been able to conceive since I received the Pfizer vaccine". The events "my period didn't start when it was supposed to" and "i have not been able to conceive since i received the pfizer vaccine" required physician office visit.  Additional information: It was reported that after 1st dose, patient period didn't start when it was supposed to. Patient have not been able to conceive since she received the Pfizer vaccine. Patient did not had problems with her menstruation before Feb2022. Patient had covid prior vaccination. Covid was not tested positive post vaccination. Patient did not received other vaccine in four weeks.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph node on the left side of neck; The initial case was missing the following minimum criteria: no specific adverse event. Upon receipt of follow-up information on 27Jun2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 2, single (Lot number: EK9231) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "never smoked" (ongoing); "have not drunk alcohol", start date: 1975 (ongoing), notes: have not drunk alcohol since 1975; "never used illegal recreational drugs" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EL1284, Anatomical Location of Administration: right arm), administration date: 23Dec2020, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "enlarged lymph node on the left side of neck". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jan2021, outcome "not recovered", described as "enlarged lymph node on the left side of neck".  Additional information: It started with an enlargement lymph node on the left side of neck. It would reduce in size but never go away completely, enlarging each time she got another vaccine for covid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101142 Same patient and similar event, different vaccine doses;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph node on the left side of my neck; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 27Jun2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "never used illegal recreational drugs" (unspecified if ongoing), notes: never used illegal recreational drugs; "obesity" (unspecified if ongoing); "never smoked" (unspecified if ongoing); "have not drunk alcohol", stop date: 1975, notes: I have never smoked, have not drunk alcohol since 1975. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Product name/manufacturer Lot number: Pfizer EK9231 MRNA, Date: 13Jan2021), administration date: 13Jan2021, when the patient was 66-year-old, for enlarged lymph node on the left side of my neck; BNT162b2 (DOSE 1, SINGLE, Product name/manufacturer Lot number: Pfizer EL1284 MRNA, Date: 23Dec2020), administration date: 23Dec2020, when the patient was 66-year-old, for enlarged lymph node on the left side of my neck. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "enlarged lymph node on the left side of my neck".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101142 Same patient and similar event, different vaccine doses.;