chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient received a 4th dose; 3rd dose outside recommended schedule; 2nd dose outside recommended schedule; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-week-old female patient who received HBV (Engerix B) (batch number 39A3L, expiry date 23rd February 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 18th May 2022, the patient received the 4th dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 13th April 2022, the patient received the 3rd dose of Engerix B. On 31st August 2021, the patient received the 2nd dose of Engerix B. On 31st August 2021, not applicable after receiving Engerix B, Engerix B Pre-Filled Syringe Device and Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On 13th April 2022, the patient experienced drug dose administration interval too long. On 18th May 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, drug dose administration interval too long and drug dose administration interval too long 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: 18-MAY-2022 Reporter's Comment: Clinical coordinator stated that a patient received a 4th dose of Engerix-B on the day pf reporting. The patient received 1st dose on 22th July 2021.  No lot number available for 1st 3 doses that were not administered per recommended schedule as not asked prior to disconnecting the call. The reporter consented to follow-up via postal. Additional supportive information: The patient received a 4th dose of Engerix-B today (day of reporting), which led to extra dose administered.  The patient received 2nd and 3rd doses of Engerix B later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received adult dose; pediatric patient received adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix 1440 adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th May 2022, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 19th May 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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: 20-MAY-2022 Reporter's Comments: The NP (nurse practitioner) reported that an adult dose of Havrix was given to the pediatric patient. The patient were twins. The reporter consented to follow up by postal. Additional supportive information: The use of an adult dose of Havrix to pediatric patient, which led to overdose, adult product administered to child. This case is linked with case US2022081895 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081895:Same reporter
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Myalgia, Skin warm
Clinical narrative: Joint pain; Muscle pain; She felt dizzy; She felt hot to touch; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Shingrix. On 19th May 2022, less than a day after receiving Shingrix, the patient experienced dizziness and skin warm. On 20th May 2022, the patient experienced joint pain and muscle pain. On an unknown date, the outcome of the dizziness and skin warm were recovered/resolved and the outcome of the joint pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, skin warm, joint pain and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and felt dizzy and hot to the touch. On 20th May 2022, 1 day after vaccination the patient experienced joint pain and muscle pain. The symptoms felt dizzy and hot to the touch were resolved and muscle and joint pain were not resolved. The reporter did not consent to follow-up. Additional supportive information: This case has been linked with case US2022081905, reported by the same reporter. Note: Vaccination date conservatively captured as 19th May 2022, as there is a discrepancy in source document.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081905:Same Reporter
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Adult patient received Infanrix instead of Boostrix; Adult patient received Infanrix instead of Boostrix; 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 32-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 14th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 20th May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 20-MAY-2022 Reporter's Comments:  The reporter stated that an adult patient received Infanrix instead of Boostrix The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: 1st dose on 09Dec2019, and then because of COVID she delayed receiving 2nd dose until 09Mar2022.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix series on 9th December 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK receipt date: 20-May-2022 Reporter's comment: Pharmacist reported that a patient received first dose of Shingrix series and then because of Covid, she delayed receiving second dose until 9th March 2022. The patient came in to pharmacy on the date of reporting for a third dose, stating this was what her physician told her to did.   At the time of reporting, third dose was not administered. The reporter declined lot number/expiration dates of the doses or further patient information at the time of the call.  The reporter consented to follow-up. Additional Supportive Information: The patient delayed the second of Shingrix series because of Covid, which led to social problem.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) (batch number DN74H / 3G33K, expiry date 10th July 2023) for prophylaxis.   Previously administered products included shingrix (the patient received the series of Shingrix in 2019).   On 20th May 2022, the patient received the 3rd dose of Shingrix. On 20th May 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments: The reporter stated that, the patient received a 3rd dose of Shingrix. The reporter provided two different batch number as they were not sure which was the correct one, so they recorded both. The vaccine administration facility was the same as primary reporter. The reporter give consent to follow up. Additional Supportive Information: The patient received a 3rd dose of Shingrix, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Gait disturbance, Muscular weakness
Clinical narrative: Double vision; has to have a walker to be able to walk; feel like legs just fell up under; This case was reported by a pharmacist via call center representative and described the occurrence of double vision in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received Shingrix. In May 2022, less than 2 weeks after receiving Shingrix, the patient experienced double vision, walking difficulty and lower extremities weakness of. On an unknown date, the outcome of the double vision, walking difficulty and lower extremities weakness of were not recovered/not resolved.   It was unknown if the reporter considered the double vision, walking difficulty and lower extremities weakness of to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-MAY-2022 Reporter's Comment: The reporting pharmacist had a patient who received Shingrix in last week before day of reporting. The patient was experiencing double vision, he had to have a walker to be able to walk. The patient stated, his legs just felt like his legs just fell up under him. The reporter looked up some of the side effects and looks like it could be some of the symptoms. The reporter told the patient that he/she would give all this message to call them back. The reporter requested to contact patient and let him know further course of action and also to give him/her a call. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: was administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 5H42H, expiry date 19th March 2022) for prophylaxis.   On 20th May 2022, the patient received Shingrix. On 20th May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment: The reporter was the registered pharmacist. The reporter wanted to know if re-vaccination was needed if the patient was administered an expired dose of Shingrix. The number of dose given was not asked. The reporter consented to follow up. Additional Supportive Information: The patient was administered a dose of Shingrix last Friday for which the expiration date was 19th March 2022, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first "shingles vaccine" in 2020, never finished series.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date in 2020).   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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments: The reporter stated that a patient received the first shingles vaccine in 2020 but never finished the series. The reporter stated she could not hear specialist. Specialist attempted to collect information several times, but reporter stated she could not understand or hear what specialist was saying. The reporter stated she would hung up and call back, but no further information was provided. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: expired adult dose administered to pediatric patient; expired adult dose administered to pediatric patient; expired adult dose administered to pediatric patient; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-months-old male patient who received HBV (Engerix B adult) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd May 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 23rd May 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose, expired vaccine used and adult product administered to child. On an unknown date, the outcome of the overdose, expired vaccine used and adult product administered to child 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: 23-MAY-2022 Reporter's Comments: The LVN (Licensed Vocational Nurse) reported that an adult dose of Engerix B was given to the pediatric patient in the morning of day of reporting and it was already expired. The reporter consented to follow up by postal. Additional supportive information: The use of an adult dose of Engerix B to pediatric patient which was already expired on 20th May 2022, which led to overdose, adult product administered to child and expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: first dose in 2020, only first was administrated; This case was reported by a other health professional 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 23rd September 2020, no lot number and expiration date provided).   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 Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments: The pharmacist reported that the patient was late for the second dose of Shingrix. No adverse event was reported. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Engerix, patient was supposed to get meningococcal; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old male patient who received HBV (Engerix B) (batch number 53YL7, expiry date 22nd December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd May 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 23rd May 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine 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: 23-MAY-2022 Reporter's Comments: The medical assistant reported that they inadvertently administered Engerix on the day of reporting to a patient.  The reporter stated the patient did not need it and was supposed to get the unknown brand meningococcal. The reporter confirmed patient was not received the Engerix series in the past.  The reporter did not consent to follow-up. Additional Supportive Information: The patient inadvertently administered Engerix and was supposed to get the unknown brand meningococcal, which led to wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on February of 2020  did not get the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2020).   On an unknown date, the patient did not 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 Information: GSK receipt date: 23-May-2022 Reporter's comment: The patient got her first dose but did not get the second dose. Patient did not want to provide any further information The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: TDAP
Symptoms: Induration, Panniculitis
Clinical narrative: panniculitis; severe induration; This case was reported by a nurse via sales rep and described the occurrence of panniculitis in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced panniculitis (serious criteria GSK medically significant) and induration. On an unknown date, the outcome of the panniculitis and induration were unknown.   It was unknown if the reporter considered the panniculitis and induration to be related to Boostrix.  Linked case(s) involving the same patient: US2022AMR083315   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment: The reporter reported that, the patient received Boostrix and very soon after developed severe induration. She stated that, the patient later developed panniculitis. No further details were provided. The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose of Boostrix, refer case US2022AMR083315.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083315:Same reporter
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 18 YO patient received adult dose; 18 YO patient received adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number M4KE9, expiry date 29th April 2023) for prophylaxis.   On 23rd May 2022, the patient received the 1st dose of Engerix B adult. On 23rd May 2022, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 23-May-2022 Reporter's comment: The health care professional reported that a patient of 18-year-old patient was administered adult dose of Engerix B (1 month prior to the reporting). The health care professional also stated that this was the first dose of the series of Engerix B and they wanted to give the appropriate dose to the patient. Asked how we should proceed. The reporter consented to follow up. Additional Supportive Information: The patient of 18-year-old patient was administered adult dose of Engerix B, which led to overdose and inappropriate age at vaccine administration.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid component; Administered only the liquid component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA687A, expiry date 31st October 2022) for prophylaxis.   On 9th May 2022, the patient received Menveo. On 9th May 2022, 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: 23-MAY-2022 Reporter's Comments:  The nurse was called in to inquire any recommendations if patient should be revaccinated. The reporter reported they inadvertently administered only the Menveo liquid component without powder to a patient. The reporter did not consent to follow up. Additional Supportive Information: The patient inadvertently administered only the Menveo liquid component without powder, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose  2 ½ years ago and 2nd dose 2 weeks ago; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 and half year prior to the reporting date).   On 9th May 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 9th May 2022, 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 Information: GSK receipt date: 23-May-2022 Reporter's comment:  The case was reported by the patient himself. The patient reported he received his second Shingrix vaccine 2 weeks prior to the reporting date on an unknown arm. The reporter did not consent to follow-up. Additional Supportive Information:  The patient received 2nd dose later than recommended schedule, which led to lengthening of vaccination schedule.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Describes the fatigue as not being able to get out of bed; Headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 30th May 2023) for prophylaxis.   On 21st May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 21st May 2022, less than a day after receiving Shingrix, the patient experienced fatigue and headache. On 23rd May 2022, the outcome of the fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the fatigue and headache to be related to Shingrix.     Additional Information: GSK receipt date: 23-May-2022 Reporter's comment: The case was reported by the patient herself. The patient received Shingrix in unknown arm. The patient received a dose of Shingrix on the afternoon and that evening he developed a headache and fatigue. The headache and fatigue lasted about a day and a half and were now resolved.  She had nothing else to report. The reporter declined to provide email addresses but might follow-up with heath care professional. The reporter consented to follow-up. Additional Supportive Information: This case has been linked to the US2022082837 case reported by the same reporter. Note : Duration was auto calculated as per mentioned date as partial outcome date and duration of 1 and half day we won't captured.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022082837:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Received a merk diluent  that was reconstituted with the Shingrix; Received a merk diluent  that was reconstituted with the Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M39A, expiry date 28th August 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Information: GSK Receipt Date: 23-May-2022 Reporter's comments: Merck's diluent that was used to reconstitute MMR and varicella vaccines was reconstituted with the Shingrix and administered to the patient.  No reactions were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up via email. Additional Supportive Information: The Shingrix was reconstituted with Merck's diluent and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The case was linked with case US2022082843 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022082843:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Received a merk diluent  that was reconstituted with the Shingrix; Received a merk diluent  that was reconstituted with the Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M39A, expiry date 28th August 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Information: GSK Receipt Date: 23-May-2022 Reporter's comments: Merck's diluent that was used to reconstitute MMR and varicella vaccines was reconstituted with the Shingrix and administered to the patient. No reactions were reported. The consent to follow up was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The Shingrix was reconstituted with Merck's diluent and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022082842:Same Reporter
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Spinal fracture, Syncope
Clinical narrative: COLLAPSED; FRACTURED BACK; This spontaneous report received from a patient concerned a 59 year old male of unspecified ethnic origin. The patient's weight was 300 pounds, and height was not reported. The patient's concurrent conditions included: type 2 diabetes, patient was taking insulin, patient was diabetic and went to his doctor on a regular basis; high blood pressure controlled with medication and neuropathy, patient was taking pills for neuropathy and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: unknown) dose was not reported, 1 total administered at left arm on 15-MAR-2022 for prophylactic vaccination. Age at time of vaccination 59 years old. Concomitant medications included insulin for type 2 diabetes, and acetylsalicylic acid. Patient stated that he was standing to turn the TV (television) off and he collapsed on an unspecified date in MAR-2022 (4-5 days after he took the vaccine). He went to the doctor 2 days after. He fractured back, did MRI (Magnetic resonance imaging) and on an unspecified date, patient had muscle problems ever since. Patient described his muscles as weak and that tightened up. He did a spinal shot for pain. He was scheduled to start physical therapy. His doctor gave him pain pills and he still used them, His doctor never said what could have caused it, but patient thought it's because of the vaccine, because it had never happened before. He had no other side effects following the vaccine. Patient stated that he had an adverse reaction to the vaccine, it had been two months and he was still being affected by it. Patient was having muscle aches and problems with his back (back problems). Laboratory data (dates unspecified) included: MRI (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fractured back, and the outcome of collapsed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220541121-covid-19 vaccine ad26.cov2.s-Collapsed, Fractured back The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Suspected COVID-19, Taste disorder, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; COTTON MOUTH; TASTE CHANGED SIGNIFICANTLY; This spontaneous report received from a patient via a company representative concerned a 42 year old white female of unknown ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: celiac's disease, and ear infection, and concurrent conditions included: hoshimoto's thyroiditis, pcos (Polycystic ovarian syndrome), gluten allergy, and marijuana allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient was a nurse. the patient was taking other medications/products within 2 weeks of starting covid-19 treatment. The patient previously received with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total, administered on 24-JUN-2021 at 12:00 on right arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s(Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: unknown) dose was not reported, 1 total, administered on 17-NOV-2021 at 10:00 on left arm for prophylactic vaccination. Age at time of vaccination 42 years old. Concomitant medications included amoxicillin trihydrate/clavulanate potassium, and levothyroxine sodium.  On 13-MAY-2022  patient received non-company suspect drug: 3 doses of Paxlovid over 24 hours (1st morning dose 1st evening dose, 2nd morning dose) for covid19. On 07-MAY-2022, the patient experienced taste changed significantly, suspected covid-19 infection, and cotton mouth (both events in dose number series 2). On an unspecified date, the patient experienced suspected clinical vaccination failure (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from taste changed significantly, suspected covid-19 infection, and cotton mouth, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000232585.; Sender's Comments: V0: 20220545163- covid-19 vaccine ad26. cov2. s- suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 40 year old female of unspecified race and ethnicity Initial information was processed along with the additional information received on 24-MAY-2022. The patient's weight was 155 pounds, and height was 161.5 centimeters. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 25-APR-2021 12:00 to left arm for prophylactic vaccination. On 01-MAY-2021, the patient experienced itchy rash all over the body (but not at injection site), left eye became red, left eye became itchy, and hives all over the body (but not at injection site) (all events in dose number in Series 1). The patient recovered from itchy rash all over the body (but not at injection site), left eye became red, left eye became itchy, and hives all over the body (but not at injection site) on 02-MAY-2021.  The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: unknown) dose was not reported, 1 total, administered on 01-NOV-2021 for prophylactic vaccination. Age at time of vaccination 39 years old. No concomitant medications were reported.  On 18-MAY-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) positive and the patient experienced suspected clinical vaccine failure (dose number in series 2). On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210502244. This report was associated with product quality complaint: 90000232582.; Sender's Comments: V0.20220546376-covid-19 vaccine ad26.cov2.s -suspected clinical vaccine failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. 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 blood clot. The reporter stated that, "I finally know of someone who died of a blood clot from the vaccine". It was unspecified if an autopsy was performed. On an unspecified date, the patient died from blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20220547817-covid-19 vaccine ad26.cov2.s-Blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper
Clinical narrative: STOMACH PAIN; This spontaneous report received from a patient concerned an adult female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On and unspecified date, patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number and expiry: Unknown) dose, start therapy date were not reported administered 1 in total for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On and unspecified date, the patient received booster dose of non-company suspect vaccine included: tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 2) (form of admin unknown, intramuscular, batch number and expiry was not reported), dose, start therapy date were not reported for covid-19 vaccination. No concomitant medications were reported. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. On an unspecified date, the patient experienced stomach pain following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). It was unknown if patient was enrolled in covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stomach pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Haemorrhage
Clinical narrative: Bleeding; reversed effects; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) and FEELING ABNORMAL (reversed effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) and FEELING ABNORMAL (reversed effects). At the time of the report, HAEMORRHAGE (Bleeding) and FEELING ABNORMAL (reversed effects) outcome was unknown. Not Provided          CRM number was mentioned as 2348.  No concomitant medication information was provided.  It was reported that patient had bleeding and reserve effect after taking the moderna vaccine booster dose.  No treatment medication was provided.  Company comment- This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected event of Haemorrhage which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected event of Haemorrhage which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received Full Dose First booster instead of half dose; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (Received Full Dose First booster instead of half dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced ACCIDENTAL OVERDOSE (Received Full Dose First booster instead of half dose). At the time of the report, ACCIDENTAL OVERDOSE (Received Full Dose First booster instead of half dose) outcome was unknown.            Patient was not Immune compromised.         No concomitant medication were reported.   Patient  received 3 doses of Moderna COVID-19 vaccine. First full dose, 2nd full dose and Booster dose recently. Patient stated that on the vaccination card it stated that patient received a full dose.     No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised.; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Moderna ordered date was 01-Nov-2021 and 15-Nov-2021 The BUD of the vaccines was reported as 01-Dec-2021 to 15-Dec-2021. No concomitant medications information was reported.  Reporter stated that they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. They were preparing for a CDC audit and wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.   Reporter queried whether they need to take any action since they stored them in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment medications were provided.