chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Fatigue
Clinical narrative: Death; Cardiac arrest; Fatigue; This case was received on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.  This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), CARDIAC ARREST (Cardiac arrest) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hemodialysis. Concurrent medical conditions included Chronic kidney disease (On HD).   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant) and FATIGUE (Fatigue) (seriousness criterion death). The patient died on 02-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment/concomitant medications were reported.  Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Unknown cause of death
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Lymphadenopathy
Clinical narrative: Bell's palsy; Lymphadenopathy; This case was received via FDA VAERS (Reference number: 1369999) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and LYMPHADENOPATHY (Lymphadenopathy). At the time of the report, BELL'S PALSY (Bell's palsy) and LYMPHADENOPATHY (Lymphadenopathy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  The patient reported Bell's palsy was on right side of face and he was taking an oral steroid. Patient reported swollen lymph node was in left armpit and nothing had changed and he was not treating it. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Product dose omission issue, Pyrexia, Social problem
Clinical narrative: gave me fever; missed the 2nd Shingles vaccine /was supposed to take it in Jan 2021/ I put off the 2nd one.; I was ill for 12 hours; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced fever, illness and social problem. On an unknown date, the outcome of the fever and social problem were unknown and the outcome of the illness was recovered/resolved.   It was unknown if the reporter considered the fever and illness to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received 1st dose of Shingles vaccine and experienced fever and was ill for about 12 hours. The patient missed the second dose of shingles vaccine as it was supposed to take in January 2021 and as the COVID hit the patient and needed that second vaccine.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: administered liquid only portion of Menveo to patient/ mixed two liquid vials instead of the powder vial; administered liquid only portion of Menveo to patient/ mixed two liquid vials instead of the powder vial; liquid component contains MenCYW-135'; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate reconstitution technique in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate reconstitution technique, incorrect dose administered and accidental overdose. On an unknown date, the outcome of the inappropriate reconstitution technique, incorrect dose administered and accidental overdose were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse mistakenly administered liquid only portion of Menveo to patient. She mixed two liquid vials instead of the powder vial and the liquid vial which led to inappropriate reconstitution technique, incorrect dose administered (Men A component not received) and accidental overdose of MenCYW components. Event detected when a different patient was about to received Menveo and it was noted that the vial counts were off. There were no longer a matching number of liquid and powder vials.  No known harm to the patient. The reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: experienced the allergic reactions; This case was reported by a consumer and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On 19th April 2021, between 5 and 7 months after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself or herself. The age at vaccination was not reported. The patient had received the first shot of Shingrix and experienced the allergic reactions. This case has been linked to US2021AMR137685, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137685:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient had recently received Shingrix and had experienced pain at the injection site.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137655:Same reporter US-GLAXOSMITHKLINE-US2021AMR137642:Same reporter US-GLAXOSMITHKLINE-US2021AMR137652:Same reporter US-GLAXOSMITHKLINE-US2021AMR137653:Same reporter
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137642:Same reporter US-GLAXOSMITHKLINE-US2021AMR137654:Same reporter US-GLAXOSMITHKLINE-US2021AMR137652:Same reporter US-GLAXOSMITHKLINE-US2021AMR137653:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient of mine got his first Shingrix dose 18 months ago.; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose by patient 18 months ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Till the time of reporting, the patient not yet received 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I've had/ a full round consisting of 2 shots & I still had them!/suspected vaccination failure; I've had/ a full round consisting of 2 shots & I still had them!; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had 2 shots of the old one and a full round consisting of 2 shots and still had shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt after the first dose / arm felt better after exercising; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows:  The patient reported the case for himself/herself. The age at vaccination was not reported. The patient's arm hurt after the first dose of Shingrix but he/she went to the gym and exercised anyway.  Then arm felt better after exercising.  The patient enquired if it was ok to exercise 4 hours after Shingrix shot or he/she should have waited until the next day. Patient also questioned if exercising had effect his/her shot.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Had the two shots for it, they made me sick; This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for himself/herself The age at vaccination was not reported. The patient received Shingrix shot and got sick. No other information was reported. For tolerance to 2nd dose, refer case US2021AMR137806.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137806:Same patient, Same reporter, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: Had the two shots for it, they made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine with an associated reaction of illness (received 1st dose on an unknown date and experienced sickness, refer case - US2021AMR137802).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself The age at vaccination was not reported. The patient had received Shingrix shot and got sick. No other information was reported. For tolerance to 2nd dose, refer case US2021AMR137802.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137802:Same patient, Same reporter, 1st dose
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: reconstituted lyophilized menA with normal saline and administered; reconstituted lyophilized menA with normal saline and administered; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The age at vaccination was not reported. The case was reported by nurse for patient. Nurse reported that the new office staff member incorrectly reconstituted lyophilized menA with normal saline and administered to patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not agree to follow up from GSK
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Migraine
Clinical narrative: sick with flu like symptoms; sick with migraine headache; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced influenza-like symptoms and migraine headache. On an unknown date, the outcome of the influenza-like symptoms and migraine headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms and migraine headache to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient recently received  1st shot of Shingles vaccine and got sick the same night with flu like symptoms and a migraine headache and was in bed for 2 days.  He/she had another shot in September, really not looking forward to it but the patient did not want the shingles either.
Sex: U
Vaccine: FLUX
Symptoms: Product packaging confusion, Wrong product administered
Clinical narrative: grabbed the wrong green box and gave flu instead; grabbed the wrong green box and gave flu instead; This case was reported by a pharmacist via sales rep and described the occurrence of wrong vaccine administered in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced wrong vaccine administered and product packaging confusion. On an unknown date, the outcome of the wrong vaccine administered and product packaging confusion were unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The patient was due for both vaccines, but the nurse was trying to administer tdap and grabbed the wrong green box and gave flu instead, which led to wrong vaccine administered and product packaging confusion. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Myocardial infarction
Clinical narrative: heart attack caused by this vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of heart attack in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced heart attack (serious criteria death and GSK medically significant). On an unknown date, the outcome of the heart attack was fatal. The reported cause of death was heart attack.   The reporter considered the heart attack to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter stated that, his or her friend died due to heart attack from  the vaccine.; Reported Cause(s) of Death: Heart attack
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix on 2018 / have not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On 23rd December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 23rd December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix on 2018 and came back today to receive the second one.  Till the time of reporting did not received 2nd dose which led incomplete course of vaccination. Consented to follow up. This case has been linked with case US2020254932, reported by same reporter.   Follow up information was received from pharmacist on 23rd June 2021: The batch number and expiry details were updated. On 23rd December 2020, the patient had received second dose of Shingrix (0.5 ml) Intramuscularly, which led to lengthening of vaccination schedule. The VAERS details were updated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020254932:same reporter
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Underdose
Clinical narrative: 52 y/o adult / 2nd dose of 10mcg; 52 y/o adult / 2nd dose of 10mcg; 1st dose / on 05/25/2021 and 2nd dose / on 06/02/2021; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 52-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HBV (Engerix B adult).   On 2nd June 2021, the patient received the 2nd dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose, adult product administered to child and drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult product administered to child and drug dose administration interval too short 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 details were provided as follows: The patient previously received 1st dose of Engerix 20 ug dose on 25th of May 2021. The pharmacist reported that, the adult patient received dose of Engerix 10 ug earlier than the recommended interval, which led to underdose, adult use of child product and shortening of the vaccine schedule. No further information was reported. The reporter consented to follow up. This case is linked US2021134490 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134490:same reporter
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received DOSE 1 of twinrix on Dec 2020 never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose on December 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 5.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: on Jun 18th 2021 / received Pediarix /with expiration date on Jun 14th 2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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 was provided as follows: The patient received expired Pediarix vaccine, which led to expired vaccine used. The reporter consented to follow up via email. This case was linked with US2021134505, for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134505:same reporter
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: An expired dose was given to patient on June 18th, 2021 / vaccine had expired on May 24th, 2021.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number K7TF9, expiry date 24th May 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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 details were provided as follows: The patient had received an expired dose of Pediarix on 18th June 2021 which had already expired on 24th May 2021.  The reporter consented to follow-up via email.
Age: 17.0
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration /of the Twinrix vaccine  to a /17 year old patient.; 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 17-year-old female patient who received HAB (Twinrix) (batch number A955S, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th May 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 17th May 2021, unknown after receiving Twinrix and Twinrix 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 case details were reported as follows: The 17 year old female patient was administered the Twinrix vaccine, which led to inappropriate age at vaccine administration.   No further events were reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Administration of only the diluent portion of the / vaccine / on 3/20/2021; Administration of only the diluent portion of the / vaccine / on 3/20/2021; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2021, the patient received Shingrix. On 20th March 2021, 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 details were provided as follows: The age at vaccination was not reported. The nurse was reported that the pharmacy administration only the diluent portion of the Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further events were reported. The reporter consented to follow up. No further information was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021135664:Same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Swollen arm that was hurting; Swollen arm; shoulder blade and hip pain; very fatigue; Diarrhea; Difficult breathing; Headache; Stomachache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 14th June 2021, 7 days after receiving Shingrix, the patient experienced pain in arm, swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved and the outcome of the arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient. The patient reported that patient received Shingrix vaccine and after one week experienced stomachache, headache, difficult breathing diarrhea and very fatigue, shoulder blade and hip pain all of which were continuing to affect her. The patient also stated that a swollen arm that was hurting at the time of these other symptoms, but has resolved at the time of the call. Consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm that was hurting; Swollen arm; shoulder blade and hip pain; very fatigue; Diarrhea; Difficult breathing; Headache; Stomachache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 14th June 2021, 7 days after receiving Shingrix, the patient experienced pain in arm, swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved and the outcome of the arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient. The patient reported that patient received Shingrix vaccine and after one week experienced stomachache, headache, difficult breathing diarrhea and very fatigue, shoulder blade and hip pain all of which were continuing to affect her. The patient also stated that a swollen arm that was hurting at the time of these other symptoms, but has resolved at the time of the call. Consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Headache, Pain of skin, Restless legs syndrome, Swelling
Clinical narrative: Swollen arm that was hurting; Swollen arm; shoulder blade and hip pain; very fatigue; Diarrhea; Difficult breathing; Headache; Stomachache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 14th June 2021, 7 days after receiving Shingrix, the patient experienced pain in arm, swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved and the outcome of the arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient. The patient reported that patient received Shingrix vaccine and after one week experienced stomachache, headache, difficult breathing diarrhea and very fatigue, shoulder blade and hip pain all of which were continuing to affect her. The patient also stated that a swollen arm that was hurting at the time of these other symptoms, but has resolved at the time of the call. Consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Herpes zoster, Vaccination failure
Clinical narrative: second Shingrix vaccine on February 21, 2021/patient received both the first and second doses of Shingrix/ on June 21, 2021/ have an active shingles outbreak.; active shingles symptoms on her abdomen /have an active shingles outbreak; abdominal pain; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 12th June 2021, 111 days after receiving Shingrix and unknown after receiving Shingrix, the patient experienced abdominal pain. On 18th June 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and abdominal pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and abdominal pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccionation was not reported. The reported confirm that, the patient received both the first and second doses of Shingrix, but unsure of the date of the first dose of vaccine. On the weekend of 12th June 2021, the patient was treated at the emergency department for abdominal pain. The patient began experiencing active shingles symptoms on her abdomen on 18th June 2021. The patient was evaluated by the doctor on 21st June 2021 and found to have an active shingles outbreak (Lack of effect). The field professional did not have information regarding the Lot number and physical location of the vaccines received. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on 5/6/2019 / has not had a 2nd dose yet /  First dose / on May 16, 2019 / never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional detials were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details for 1st dose were updated. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021137218:Same reporter
Age: 1.42
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration of a dose of Boostrix to a 15 month old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number C5JL7, expiry date 28th November 2021) for prophylaxis.   On 24th June 2021, the patient received Boostrix. On 24th June 2021, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided are as follows : Reporter called to informed about the administration of a dose of Boostrix to a 15 month old patient which led to inappropriate age at vaccine administration. Patient was given this dose 20 minutes prior to the call on 24th June 2021. Reporter consented to follow-up via email.  Note: The product start date was captured as 24th June 2021 conservatively as per narrative it seems that the patient received vaccine 20 minutes prior to the call on  24th June 2021.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Periorbital swelling, Rash, Skin lesion, Tryptase
Clinical narrative: He reports on the morning of 9 May he awakened with swelling of his lips and around his eyes and a generalized rash (described as non-pruritic, red, coin-shaped/sized ?patches? sparing palms and soles). He took a dose of oral Benadryl with some improvement and then presented to the ER where he received an oral corticosteroid. Total serum tryptase level draw in the ER normal. His rash resolved over the next 24 hours. Lesions not pruritic or painful; resolved without post-inflammatory changes. No laryngeal, rhinoconjunctival, pulmonary, GI, neurologic, or cardiovascular symptoms. No blistering lesions, mucosal ulcers, fever/chills, or painful/swollen joints. Episode not associated with cold, food, heat/sweating, exercise, medications, NSAID use, latex exposure, alcohol, or insect bites/stings. While he had ingested beef the night before he reports he has since ingested and tolerated beef without adverse reaction. He received his second dose of the Moderna mRNA vaccine three days prior.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Decreased activity, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: DIARRHEA(GASSY, UPSET STOMACH, RUNNING TO BATHROOM); FEELING WORST, FEELING DOWN MORE THAN UP, NOT TO MOTIVATED TO GO OUTSIDE; NO PHYSICAL ACTIVITY; FEELING FEVERISH; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ustekinumab for drug used for unknown indication. On JUN-2021, the subject experienced diarrhea (gassy, upset stomach, running to bathroom). On JUN-2021, the subject experienced feeling worst, feeling down more than up, not to motivated to go outside. On JUN-2021, the subject experienced no physical activity. On JUN-2021, the subject experienced feeling feverish. On JUN-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, diarrhea(gassy, upset stomach, running to bathroom), no physical activity, and feeling worst, feeling down more than up, not to motivated to go outside, and the outcome of feeling feverish was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Head discomfort, Headache, Injection site pain, Neck pain
Clinical narrative: PRESSURE PAIN FROM THE LEFT CROWN OF THE HEAD; SWELLING NEAR THE LEFT EYE; PRESSURE IN THE LEFT EAR CANNEL; SOFT TISSUE SWELLING AROUND THE CROWN/SOFT TISSUE LUMPS OR SWELLING/NEW BUMPS ON HEAD; PRESSURE PAIN IN THE LEFT EYE NEAR THE BROW; SINUS PRESSURE; SORENESS IN HEAD; SORENESS IN BACK OF NECK; SORENESS IN INJECTION SIRE; SORENESS IN THE LEFT ARM; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. takes blood pressure medications when necessary. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced soreness in the left arm. On 14-JUN-2021, the subject experienced soreness in injection sire. On 15-JUN-2021, the subject experienced soreness in back of neck. On 15-JUN-2021, the subject experienced soreness in head. On 17-JUN-2021, the subject experienced pressure pain from the left crown of the head. On 17-JUN-2021, the subject experienced swelling near the left eye. On 17-JUN-2021, the subject experienced pressure in the left ear cannel. On 17-JUN-2021, the subject experienced soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head. On 17-JUN-2021, the subject experienced pressure pain in the left eye near the brow. On 17-JUN-2021, the subject experienced sinus pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the left arm, and soreness in injection sire on 16-JUN-2021, and had not recovered from soreness in back of neck, pressure pain from the left crown of the head, swelling near the left eye, pressure in the left ear cannel, soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head, pressure pain in the left eye near the brow, soreness in head, and sinus pressure. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain in extremity, Paranasal sinus discomfort, Periorbital swelling, Soft tissue swelling
Clinical narrative: PRESSURE PAIN FROM THE LEFT CROWN OF THE HEAD; SWELLING NEAR THE LEFT EYE; PRESSURE IN THE LEFT EAR CANNEL; SOFT TISSUE SWELLING AROUND THE CROWN/SOFT TISSUE LUMPS OR SWELLING/NEW BUMPS ON HEAD; PRESSURE PAIN IN THE LEFT EYE NEAR THE BROW; SINUS PRESSURE; SORENESS IN HEAD; SORENESS IN BACK OF NECK; SORENESS IN INJECTION SIRE; SORENESS IN THE LEFT ARM; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. takes blood pressure medications when necessary. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced soreness in the left arm. On 14-JUN-2021, the subject experienced soreness in injection sire. On 15-JUN-2021, the subject experienced soreness in back of neck. On 15-JUN-2021, the subject experienced soreness in head. On 17-JUN-2021, the subject experienced pressure pain from the left crown of the head. On 17-JUN-2021, the subject experienced swelling near the left eye. On 17-JUN-2021, the subject experienced pressure in the left ear cannel. On 17-JUN-2021, the subject experienced soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head. On 17-JUN-2021, the subject experienced pressure pain in the left eye near the brow. On 17-JUN-2021, the subject experienced sinus pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the left arm, and soreness in injection sire on 16-JUN-2021, and had not recovered from soreness in back of neck, pressure pain from the left crown of the head, swelling near the left eye, pressure in the left ear cannel, soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head, pressure pain in the left eye near the brow, soreness in head, and sinus pressure. This report was non-serious.