chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, COVID-19, Chest discomfort, Cough, Eye swelling
Clinical narrative: anaphylactic reaction; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004150.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown"; SWELLING FACE (non-serious), LIP SWELLING (non-serious), PHARYNGEAL SWELLING (non-serious), SWOLLEN TONGUE (non-serious), outcome "unknown" and all described as "face, lips, throat and tongue swelled up". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Lip swelling, Pharyngeal swelling, SARS-CoV-2 test positive, Wheezing
Clinical narrative: anaphylactic reaction; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004150.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown"; SWELLING FACE (non-serious), LIP SWELLING (non-serious), PHARYNGEAL SWELLING (non-serious), SWOLLEN TONGUE (non-serious), outcome "unknown" and all described as "face, lips, throat and tongue swelled up". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Lip swelling, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: anaphylactic reaction; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; face, lips, throat and tongue swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004150.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown"; SWELLING FACE (non-serious), LIP SWELLING (non-serious), PHARYNGEAL SWELLING (non-serious), SWOLLEN TONGUE (non-serious), outcome "unknown" and all described as "face, lips, throat and tongue swelled up". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram, Disability, Dyspepsia, Dyspnoea
Clinical narrative: Tachycardia, unspecified neurological auot immune illness, trouble breathing due to intense chest pains, digestive issues, rectal bleeding, instense chest pains, change in menstrual cycle that resulted in loss of period 4 months after vaccine, tremors, fasciculations, muscle spasms, shaking, insomnia, activity intolerance, unable to work 8 months, exercise intolerance, bedridden 8 months, bradychardia - heart rate of 33 at night for several months, weight loss, muscle weakness, intense pain and pressure in abdomen and chest for 8 months now not stopping. My life has been destroyed I have no income  and Im unable to work or do any acitivity due to muscle weakness, inability to breathe properly due to muscle weakness in chest.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endoscopy, Gastritis, Heart rate increased, Heavy menstrual bleeding, Insomnia
Clinical narrative: Tachycardia, unspecified neurological auot immune illness, trouble breathing due to intense chest pains, digestive issues, rectal bleeding, instense chest pains, change in menstrual cycle that resulted in loss of period 4 months after vaccine, tremors, fasciculations, muscle spasms, shaking, insomnia, activity intolerance, unable to work 8 months, exercise intolerance, bedridden 8 months, bradychardia - heart rate of 33 at night for several months, weight loss, muscle weakness, intense pain and pressure in abdomen and chest for 8 months now not stopping. My life has been destroyed I have no income  and Im unable to work or do any acitivity due to muscle weakness, inability to breathe properly due to muscle weakness in chest.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Polymenorrhoea, Rectal haemorrhage, Weight decreased
Clinical narrative: Tachycardia, unspecified neurological auot immune illness, trouble breathing due to intense chest pains, digestive issues, rectal bleeding, instense chest pains, change in menstrual cycle that resulted in loss of period 4 months after vaccine, tremors, fasciculations, muscle spasms, shaking, insomnia, activity intolerance, unable to work 8 months, exercise intolerance, bedridden 8 months, bradychardia - heart rate of 33 at night for several months, weight loss, muscle weakness, intense pain and pressure in abdomen and chest for 8 months now not stopping. My life has been destroyed I have no income  and Im unable to work or do any acitivity due to muscle weakness, inability to breathe properly due to muscle weakness in chest.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Amenorrhoea, Autoimmune disorder, Bedridden
Clinical narrative: Tachycardia, unspecified neurological auot immune illness, trouble breathing due to intense chest pains, digestive issues, rectal bleeding, instense chest pains, change in menstrual cycle that resulted in loss of period 4 months after vaccine, tremors, fasciculations, muscle spasms, shaking, insomnia, activity intolerance, unable to work 8 months, exercise intolerance, bedridden 8 months, bradychardia - heart rate of 33 at night for several months, weight loss, muscle weakness, intense pain and pressure in abdomen and chest for 8 months now not stopping. My life has been destroyed I have no income  and Im unable to work or do any acitivity due to muscle weakness, inability to breathe properly due to muscle weakness in chest.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Bradycardia, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Tachycardia, unspecified neurological auot immune illness, trouble breathing due to intense chest pains, digestive issues, rectal bleeding, instense chest pains, change in menstrual cycle that resulted in loss of period 4 months after vaccine, tremors, fasciculations, muscle spasms, shaking, insomnia, activity intolerance, unable to work 8 months, exercise intolerance, bedridden 8 months, bradychardia - heart rate of 33 at night for several months, weight loss, muscle weakness, intense pain and pressure in abdomen and chest for 8 months now not stopping. My life has been destroyed I have no income  and Im unable to work or do any acitivity due to muscle weakness, inability to breathe properly due to muscle weakness in chest.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electromyogram, Exercise tolerance decreased, Gastrointestinal disorder, Impaired work ability
Clinical narrative: Tachycardia, unspecified neurological auot immune illness, trouble breathing due to intense chest pains, digestive issues, rectal bleeding, instense chest pains, change in menstrual cycle that resulted in loss of period 4 months after vaccine, tremors, fasciculations, muscle spasms, shaking, insomnia, activity intolerance, unable to work 8 months, exercise intolerance, bedridden 8 months, bradychardia - heart rate of 33 at night for several months, weight loss, muscle weakness, intense pain and pressure in abdomen and chest for 8 months now not stopping. My life has been destroyed I have no income  and Im unable to work or do any acitivity due to muscle weakness, inability to breathe properly due to muscle weakness in chest.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Menstrual disorder, Muscle contractions involuntary, Muscle spasms
Clinical narrative: Tachycardia, unspecified neurological auot immune illness, trouble breathing due to intense chest pains, digestive issues, rectal bleeding, instense chest pains, change in menstrual cycle that resulted in loss of period 4 months after vaccine, tremors, fasciculations, muscle spasms, shaking, insomnia, activity intolerance, unable to work 8 months, exercise intolerance, bedridden 8 months, bradychardia - heart rate of 33 at night for several months, weight loss, muscle weakness, intense pain and pressure in abdomen and chest for 8 months now not stopping. My life has been destroyed I have no income  and Im unable to work or do any acitivity due to muscle weakness, inability to breathe properly due to muscle weakness in chest.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Nervous system disorder, Rectal haemorrhage, Tachycardia, Tremor
Clinical narrative: Tachycardia, unspecified neurological auot immune illness, trouble breathing due to intense chest pains, digestive issues, rectal bleeding, instense chest pains, change in menstrual cycle that resulted in loss of period 4 months after vaccine, tremors, fasciculations, muscle spasms, shaking, insomnia, activity intolerance, unable to work 8 months, exercise intolerance, bedridden 8 months, bradychardia - heart rate of 33 at night for several months, weight loss, muscle weakness, intense pain and pressure in abdomen and chest for 8 months now not stopping. My life has been destroyed I have no income  and Im unable to work or do any acitivity due to muscle weakness, inability to breathe properly due to muscle weakness in chest.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased, X-ray
Clinical narrative: Tachycardia, unspecified neurological auot immune illness, trouble breathing due to intense chest pains, digestive issues, rectal bleeding, instense chest pains, change in menstrual cycle that resulted in loss of period 4 months after vaccine, tremors, fasciculations, muscle spasms, shaking, insomnia, activity intolerance, unable to work 8 months, exercise intolerance, bedridden 8 months, bradychardia - heart rate of 33 at night for several months, weight loss, muscle weakness, intense pain and pressure in abdomen and chest for 8 months now not stopping. My life has been destroyed I have no income  and Im unable to work or do any acitivity due to muscle weakness, inability to breathe properly due to muscle weakness in chest.
Age: 44.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hyperhidrosis, Hypotension, Nausea, Oxygen saturation decreased, Pallor
Clinical narrative: Systemic: cold, clammy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: patient remained in clinic for 30 minutes until vital signs stable and back to baseline.
Age: 44.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Cold sweat, Flushing, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Systemic: cold, clammy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: patient remained in clinic for 30 minutes until vital signs stable and back to baseline.
Age: 1.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administration of Kinrix instead of Infanrix; Kinrix administered to a 20-month-old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 20-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 15-Nov-2022 Reporter's comment: The medical assistant called to ask for information about the administration of Kinrix instead of Infanrix. The reporter asked for safety information and recommendations about patient vaccination. The reporter consented to follow-up. Additional supportive information: The patient received Kinrix instead of Infanrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: Product Complaint; leaky vial, content got over pharmacist's hands; leaky vial, content got over pharmacist's hands; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while administering product in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number HE4P4, expiry date 25th January 2024) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient did not receive Shingrix. On 15th November 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while administering product and exposure via skin contact. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the occupational exposure while administering product, exposure via skin contact and product complaint were unknown.   Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comments: Pharmacist reported a leaky vial during reconstitution. Pharmacist stated she added the adjuvant into vial 2 and the liquid came out from the needle puncture in the stopper, having the impression that too much pressure was inside vial 2.  Suspect product was not administered, part of the content got over the hands of the pharmacist.  Both components were impacted, a single dose of Shingrix would be replaced. Prepaid and preaddressed label would be sent to pharmacy to return vials.  Questions were asked to reporter that, did the he/she inject air from the syringe into the vial during preparation, at what step of reconstitution was the air injected and how much air was injected. The reporter replied that yes, 0.5 ml air was injected during reconstitution of vial 2  Reporter was asked if the leak coming from the stopper at the neck of the vial or from a needle puncture in the stopper and did the vial rubber stopper or metallic skirt detach or become loose during handling or without any manipulation, did customer remove only the plastic flip-off or also the metallic skirt or ring of the vial before handling. The reporter replied that leak was from the needle puncture in the stopper and only the plastic flip-off of the vial before handling. there was no evidence of leakage in package or carton (e.g. wet PIL or faded label) Additional Supportive Information: while administering Shingrix, part of the content got over the hands of the pharmacist, which led to Occupational exposure while administering product and exposure via skin contact.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Boostrix given in 2018 and 2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 15-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included boostrix (dose received on 25th June 2018).   On 15th November 2022, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 15th November 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, 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: 17-NOV-2022 Reporter's Comments: Licensed practical nurse reported on 16th November 2022, that male patient received a dose of Boostrix on 15th November 2022 and they had not realized that the last dose of Boostrix was administered on 25th June 2018. Did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received 2nd dose after receiving 1st dose on 25th August 2018, which led to extra dose administered.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the MenA component; received only the MenA component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA762A, expiry date 30th November 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's Comments: A nurse reported that a female patient received only the Men A component of Menveo. The consented to follow up. Additional Supportive Information: the patient received only the Men A component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine.; Sender's Comments:  US-GSK-US2022170328:same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the MenA component; received only the MenA component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA762A, expiry date 30th November 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: A nurse reported that a male patient received only the Men A component of Menveo. The consented to follow up. Additional Supportive Information: the patient received only the Men A component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine.; Sender's Comments:  US-GSK-US2022170326:same reporter
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix instead of Infanrix; Boostrix to a 15 month old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number G7749, expiry date 3rd November 2024) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: MA reported that she administered a dose of Boostrix to a 15-month-old patient inadvertently.  Patient was supposed to get his 4th dose of Infanrix. The consented to follow up via HCP email. Additional Supportive Information: the 15 month old patient received Bosstrix instead of 4th dose of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 57.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 15th November 2022, the patient received Havrix. On 15th November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: Nurse manager reported a patient was administered an expired dose of Havrix. The reporter consented to follow up via email. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient was administered with expired dose, which led to expired dose administered.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Kinrix instead of Pediarix/Kinrix was the 3rd Dtap and IPV dose for patient; 12 month old patient received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included pediarix (1st dose received on 11th August 2022), pediarix (2nd dose received on 10th November 2022) and hepatitis B vaccine (received 3 hapatitis B vaccine on an unknown date).   On 19th May 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th May 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 16-NOV-2022 Reporter's Comments: The health care professional (HCP) called to report a medical error, patient was supposed to receive Pediarix but received Kinrix.  On 19th May 2022, a 12 months female baby received a Kinrix vaccine.  This was the third Dtap dose on patient's schedule.  It was the patient's 3rd dose of IPV too.  The reporter consented to follow up. Additional Supportive Information: The patient was administered with kinrix instead of Pediarix, which led to Wrong vaccine administered and inappropriate age at vaccine administration.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 4-month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5R3KX, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 16-NOV-2022 Reporter's Comments: A nurse called to asked for information about the administration of Kinrix to a 4 month-old patient. Vaccine was administered on 7th October 2022. The reporter asked for safety information. The reporter consented to follow up. Additional Supportive Information: The patient was administered with kinrix instead of Pediarix, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: PATIENT RECEIVE THE ADJUVANT ONLY; PATIENT RECEIVE THE ADJUVANT ONLY; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number Z7GH5, expiry date 25th January 2024) for prophylaxis.   On 15th November 2022, the patient received Shingrix. On 15th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-NOV-2022 Reporter's comment: The nurse called to asked for information about the administration of only the adjuvant component of Shingrix to three patients.  The reported asked for information about safety and re vaccination. The reporter provided the identifiers of two patients and mentioned that she will call back once she get the data of the third patient. The reporter consented to follow-up. This case was for 1 of 3 linked patients reported by same reporter. Additional supportive information: The patient only received the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022170378:Same reporter US-GSK-US2022170376:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: PATIENT RECEIVE THE ADJUVANT ONLY; PATIENT RECEIVE THE ADJUVANT ONLY; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number Z7GH5, expiry date 25th January 2024) for prophylaxis.   On 15th November 2022, the patient received Shingrix. On 15th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-NOV-2022 Reporter's comment: The nurse called to asked for information about the administration of only the adjuvant component of Shingrix to three patients.  The reported asked for information about safety and re vaccination. The reporter provided the identifiers of two patients and mentioned that she will call back once she get the data of the third patient. The reporter consented to follow-up. This case was for 2 of 3 linked patients reported by same reporter. Additional supportive information: The patient only received the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022170375:Same reporter US-GSK-US2022170378:Same reporter
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9YO received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 19th October 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 16-Nov-2022 Reporter's comment: The health manager called to ask information on how to proceed after administration of Infanrix to two patients who were given their first dose at an inappropriate age. The vaccine administration facility was the same as primary reporter. The health care professional asked for follow-up from safety via email. The reporter consented to follow-up. This case was for 1 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received a dose of Infanrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022170379:Same reporter
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 YO was given Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 19th October 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 16-Nov-2022 Reporter's comment: The health manager called to ask information on how to proceed after administration of Infanrix to two patients who were given their first dose at an inappropriate age. The vaccine administration facility was the same as primary reporter. The health care professional asked for follow-up from safety via email. The reporter consented to follow-up. This case was for 2 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received a dose of Infanrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022170377:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: RECEIVE THE ADJUCVANT ONLY; RECEIVE THE ADJUCVANT ONLY; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number NR2X5, expiry date 24th November 2023) for prophylaxis.   On 7th November 2022, the patient received the 2nd dose of Shingrix. On 7th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-Nov-2022 Reporter's comment: The information for the adverse event was given and medical information was relayed about recommendations made by the vaccine coalition. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. This case was for 3 of 3 linked patients, reported by same reporter. Additional supportive information: The patient only received the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022170375:Same reporter US-GSK-US2022170376:Same reporter
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose two weeks after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number KK3KM, expiry date 25th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 17th November 2022, the patient received the 2nd dose of Shingrix. On 17th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's Comments: A pharmacist reported that a female patient received the 2nd dose of shingrix only two weeks after the 1st dose. The patient received 1st dose either in October or November 2022. The reporter did not consent to follow-up. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Underdose
Clinical narrative: patient had received an underdose of Fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 3-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number JN7YG, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 17th November 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose 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: 18-NOV-2022 Reporter's comment: Pharmacist reported that a patient had received an underdose of Fluarix QIV. The vaccine administration facility was the same as primary reporter. HCP (Health Care Professional) gave consented to Follow-up via phone number. Additional Supportive Information: The patient had received an underdose of Fluarix Quadrivalent 2022-2023 season, which led to underdose.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: Since shot 2 has had more outbreaks/suspected Vaccination failure; after shot 1 had 1 outbreak on ankle/ 2 more shingles outbreaks; first ever shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Additional patient notes included never had a shingles outbreak in the past.   In September 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received 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), shingles and shingles. The patient was treated with medication unknown (Pill (Medication Unknown)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the shingles was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The reporter considered the shingles to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR174105   Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comments:  The reporter was the patient and was 67 years old.  The patient said that right after receiving 1st dose he had his first ever shingles outbreak.  Since receiving Shingrix 2nd shot (about 2 months prior to the reporting) he had 2 more shingles outbreaks.  The outbreaks were the same intensity or even worse than the intensity of the first outbreak.  All of the outbreaks occurred on his left ankle.  He jokingly or sarcastically said that he now wanted to get his left leg amputated to cure the shingles. The reporter provided limited information.  He did not want to answer any further questions therefore he did not have his street address or email address or date of birth or MD contact.  The reporter ended call abruptly.  He said, his doctor prescribed pill for shingles.  The patient took the pills for 7 days. The pills did not help resolve the shingles.  They were big pills taken 3 times a day.  The reporter tried to get him to look on his pill bottle to confirm if the pills were brand name Valtrex  or another other antiviral pill but he indicated that he would have to call his doctor to find out the name of the pills and he was unwilling to did any research or any work for GSK because Shingrix did not work. 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 and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2022AMR174105:same patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, General physical condition abnormal
Clinical narrative: HEALTH PROBLEMS; HAD COVID SEVERAL TIMES; This spontaneous report received from a patient via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the patient experienced health problems, and had covid several times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the health problems and had covid several times was not reported. This report was non-serious. The report is associated with product quality complaint.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection was sick for three days (Dose number in series 2). It was reported as "You people amaze me I had all the shots but the last booster and I got Covid and let tell you i am so glad I had them I was sick for three days but I could have been much worse" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Stress
Clinical narrative: MAJOR FLARES; STRESS; ANXIETY; This spontaneous report received from a patient via other manufacturer concerned a 4 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAY-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 116850 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for an unspecified indication. Age at time of vaccination 36 years old. No concomitant medications were reported. On an unspecified date, the patient experienced major flares, stress, and anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from major flares, and stress, and the outcome of anxiety was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 220A21A expiry: 01-MAR-2022) dose was not reported, administered on 12-MAR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported.  On 12-MAR-2022, the patient experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: she had issues with the monovalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (she had issues with the monovalent vaccine) in a 52-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had issues with the monovalent vaccine). At the time of the report, IMMUNISATION REACTION (she had issues with the monovalent vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-674372 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Musculoskeletal stiffness
Clinical narrative: Inflammation; Stiffness; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) and MUSCULOSKELETAL STIFFNESS (Stiffness) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced INFLAMMATION (Inflammation) and MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, INFLAMMATION (Inflammation) and MUSCULOSKELETAL STIFFNESS (Stiffness) was resolving.            No Concomitant medication was provided by reporter. The patient had less stiffness and improved sleep. The second injection was what triggered the Rheumatoid arthritis to be diagnosed. She developed inflammation within twelve hours that would not go away. She was improving. No Treatment medication was provided by reporter.