chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: vaccinate an 18 y/o patient with Engerix B adult dose.; vaccinate an 18 y/o patient with Engerix B adult dose.; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, 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: 05th September 2022 Reporters comment:   The reporter reported that the 18 y/o patient received Engerix B adult dose The reporter consent to follow-up. Additional Supportive information: The 18 y/o patient received Engerix B adult dose which led to Overdose and inappropriate age at vaccine administration instead
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after 1st dose; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2022, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: The patient came down with Shingles one month after receiving the Shingrix vaccine.  The patient did not get the second dose of Shingrix. The reporter would like to know how long she should wait until she was able to vaccinate the patient. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Poor quality sleep
Clinical narrative: sore arm, felt like bumped into door frame; slightly restless sleep; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain in arm and sleep restless. On an unknown date, the outcome of the pain in arm and sleep restless were unknown.   It was unknown if the reporter considered the pain in arm and sleep restless to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-SEP-2022 Reporter's Comment: This case was received from consumer via interactive digital media. The patient stated that he/she would rather have an option intensely painful rash for a few weeks than a sore arm for a few days.  The reporter stated that, After the vaccine that first night was a slightly restless sleep and his/her arm felt like  bumped into a door frame.  The reporter mentioned gotta be worse than the shingles the patient would never had. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shot, got it, two weeks later got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 3-Sep-2022 Reporter's Comment: Reporter's comment: This case was reported by a patient via interactive digital media. The patients doctor said you need the shot ok patient got it two weeks later patient got shingles patient would not do anything.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Flu like symptoms; Sore arm; 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.   The patient's past medical history included shingles (The patient had shingles on face).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were unknown.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles on his/her face. So he/she was in line for vaccine.  The patient stated that, it was not painful. The patient had some flu like symptoms next day and sore arm .  The patient further stated that, If offered any protection it was certainly a win for him/her. Additional Supportive Information: the follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 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 (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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-SEP-2022. Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received a dose of Shingles vaccine and reported when he/she got vaccinated his/her arm hut like when he/she was little. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Both shots 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.     Linked case(s) involving the same patient:  US2022AMR128862   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient was sick after the shot. The patient heard shingles was a lot worse. The follow-up could not be possible as no contact details were available. Additional supportive information: The case had been linked with US2022AMR128862  reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR128862:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Illness, SARS-CoV-2 test positive
Clinical narrative: Both shots made me sick; Tested positive for covid the day after 2nd dose; 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 with an associated reaction of illness (Received first dose on an unknown date, refer case US2022AMR128850).   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 and covid-19. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness and covid-19 were unknown.   The reporter considered the sickness to be related to Shingles vaccine. It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR128850   Additional Information: GSK Receipt Date: 6-Sep-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that patient got 2nd shots of Shingles vaccine, shot  made him/her sick. The patient heard shingles was a lot worse. The patient needed 2 doses. The pharmacy had no interest in giving him/her the second shot. The patient tested positive for covid the day after getting the second shingles vaccine. The follow-up could not be possible as no contact details were available. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR128850:Same reporter.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo not reconstituted; received dose not reconstituted.; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: The reporter reported that, Menveo was given without being reconstituted.  They did not know which patient at this time received the dose that was not reconstituted. The reporter agreed to follow up from GlaxoSmithKline. Additional Supportive Information: The reporter reported that, Menveo was given without being reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st shot in 2018, 2nd shot just now in 2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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: 07-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received second dose of Shingrix vaccine in 2022. The reporter stated that the patient thought to get a second dose because the pharmacist said that the time between shots was good . Patient stated but your site said 3 to 6 months apart. Follow-up would not possible as no contact details were available. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to which led to lengthening of interval between vaccine doses.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I've been 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingrix vaccine. The reporter stated that after received Shingrix vaccine the patient had been sick from 4 days already. Follow-up would not possible as no contact details were available.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: 3rd dose 06sep2022; 1st dose 26Apr2022, 2nd 06Jun2022; This case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too long in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number kl472, expiry date 30th September 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 6th September 2022, the patient received the 3rd dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. On 6th June 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 6th June 2022, not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device and unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 6th September 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose 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: 7-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received the 2nd dose of Bexsero later than the recommended interval, which led to lengthening of vaccine schedule. The patient received an extra dose of Bexsero, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2022, the patient received the 2nd dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received Shingrix shot yesterday.  The reporter just wanted to knew if he/she could took Tylenol for soreness. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Neck pain
Clinical narrative: Long lasting myalgia; Neck pain; Flu like symptoms; This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia, neck pain and influenza-like symptoms. On an unknown date, the outcome of the myalgia, neck pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the myalgia, neck pain and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-SEP-2022  Reporter's Comment: Reported stated that patient had long lasting myalgia, neck pain and flu like symptoms for multiple weeks. Reported did not consented to follow up. Additional supportive information: This case has been linked with the case US2022AMR129917 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR129917:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Swelling
Clinical narrative: sore arm; swollen; itchy; 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 (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 pain in arm, swelling and pruritus. On an unknown date, the outcome of the pain in arm, swelling and pruritus were recovered/resolved.   It was unknown if the reporter considered the pain in arm, swelling and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient got his/her 1st vaccine and had sore arm, swollen and itchy for a couple of days but no real side effects.  The reporter did not spoke to the 2nd one yet. The patient saw a friend from work went through shingles when she was only about 23 or so.  Whatever the side effects were, had have been better than what he/she saw her endure. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Long term muscle aches; Fatigue; This case was reported by a other health professional via sales rep and described the occurrence of muscle pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain and fatigue. On an unknown date, the outcome of the muscle pain and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-SEP-2022  Reporter's Comment: The patient had complained that after post completion of Shingrix, she had long term muscle aches and fatigue for longer than 6 months. The reporter did not agreed to follow up from GSK. The consent to follow-up was denied. Additional supportive information: This case has been linked with the case US2022AMR129912 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR129912:Same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Nausea, Vertigo
Clinical narrative: feeling fatigue; headache; vertigo; nausea; 1sr dose JAN-2022, 2nd on 26-AUG-2022; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in January 2022, refer case US2022128901).   On 26th August 2022, the patient received the 2nd dose of Shingrix. On 26th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 27th August 2022, the patient experienced headache, vertigo and nausea. On an unknown date, the patient experienced fatigue. The patient was treated with paracetamol (Tylenol) and antiemetics and antinauseants (Motion Sickness Medication). On an unknown date, the outcome of the headache, vertigo, nausea and fatigue were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, vertigo, nausea and fatigue to be related to Shingrix.     Linked case(s) involving the same patient:  US2022128901   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and next day after the vaccination she experienced extreme headache, vertigo, and nausea which required her to went to the ER (emergency room visit). The patient also stated that she had also been recently feeling fatigue. The patient's concomitant medication included Tylenol, OTC motion sickness medication. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2022128901:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Fatigue; slight shivering; body aches; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced fatigue, shivering and general body pain. On an unknown date, the outcome of the fatigue, shivering and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, shivering and general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's Comment: The case was self reported by the patient. The patient received first dose of Shingrix yesterday (the day before reporting) and experienced fatigue, slight shivering, and body aches. The patient asked how long did the side effects last.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second vaccine, first dose two weeks prior; This case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 7th September 2022, the patient received the 2nd dose of Shingrix. On 7th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: The reporter stated that the patient came in 7th September 2022 and said he was there to receive his second Shingrix vaccine. The vaccine was given and afterwards they discovered that the patient had received the first dose only two weeks prior to date of reporting on 17th August 2022. Contacted the regulatory agency right away after discovering that the vaccine had been given too early. The person she spoke to informed her that the dose was invalid, and they need to give another Shingrix vaccine eight weeks from reporting date. The reported contacted the patient to let them know as well after speaking to the agency. The reporter was reported all errors to team as well. The reporter was consented to follow-up. Additional Supportive Information:  The patient received 2nd dose on 7th September 2022, 3 weeks after receiving 1st dose, which led to shortening of the recommended interval between vaccine doses. Note: As per reported information patient received 2nd dose 2 weeks after receiving 1st dose, but as per reported information interval between precise date of 2nd and 1st dose was 3 weeks, hence as per confirmation precise date 17th August 2022 was taken as vaccination date of 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Arm was sore, hurt; Felt kind of yucky; 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 (Shingles vaccine) for prophylaxis.   In August 2022, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced pain in arm and malaise. On an unknown date, the outcome of the pain in arm and malaise were recovered/resolved.   It was unknown if the reporter considered the pain in arm and malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-SEP-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient had first shot about two and half weeks prior to the reporting.  The patient arm was sore for a couple of days, it actually hurt.  The patient felt kind of yucky for a day nothing you could really pinpoint but the patient's 38 year old daughter just had shingles and the pain she was in scared the heck out of. Additional supportive information: The follow-up would not possible as no contact details were available.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Left arm swelled up; left arm swelled up into a knot for two days and was painful; Left arm swelled up into a knot; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and did fine).   On 25th August 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling, injection site lump and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were recovering/resolving and the outcome of the injection site lump was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site lump and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-Sep-2022 Reporter's comments: The patient self-reported this case. The patient volunteered 2nd dose received in left arm swelled up into a knot for two days and was painful. Patient said after two days pain and swelling subsided. The lot number and expiration date were unknown. The reporter did not agree to follow up from GSK.
Sex: U
Vaccine: MENB
Symptoms: Accidental overdose
Clinical narrative: Kid was accidentally vaccinated twice; This case was reported by a consumer via interactive digital media and described the occurrence of accidental overdose in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after receiving BEXSERO, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose 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: 8-Sept-2022 Reporter's comment: The case was received from the patient's parent via interactive digital media. The patient's parent stated that what happens if the patient was accidentally vaccinated twice with Bexsero. Additional supportive information: The patient was accidentally vaccinated twice with Bexsero, which led to accidental overdose. The follow-up could not be possible as no contact details were available. As per it was not clear whether the patient was vaccinated twice on the same time or on different time therefore in worst approach, it was considered that was vaccinated on the same time and event was coded as accidental overdose.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain
Clinical narrative: Hurt like hell; Made me real sick; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain and sickness. On an unknown date, the outcome of the pain and sickness were recovered/resolved.   It was unknown if the reporter considered the pain and sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR130483   Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received both shots and they hurt like hell and made him/her real sick for couple to three days. Additional supportive comment: Follow-up would not possible as no contact details were available.  For tolerance of 2nd dose refer case US2022AMR130483, reported by same patient.; Sender's Comments:  US-GSK-US2022AMR130483:Same reporter/ dose 2
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain
Clinical narrative: Hurt like hell; Made me real sick; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date and experienced pain, refer link case US2022AMR130481).   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 pain and sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain and sickness were recovered/resolved.   It was unknown if the reporter considered the pain and sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR130481   Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's Comments: This case was reported via interactive digital media. The patient received both shots and hurt like heck and made him/her real sick for couple to three days.; Sender's Comments:  US-GSK-US2022AMR130481:Same reporter/ dose 1
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: made arm really sore; 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 (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included alcohol use.   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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that his/her first shot made arm really sore and the last one piece of cake .  No other side effects. The patient had noticed an increase in beer consumption.  The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Influenza like illness, Malaise, Nausea
Clinical narrative: Feel so bad; Nausea; flu-like symptoms; This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 753EJ, expiry date 26th August 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell, nausea and influenza-like symptoms. On an unknown date, the outcome of the feeling unwell, nausea and influenza-like symptoms were unknown.   It was unknown if the reporter considered the feeling unwell, nausea and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's Comments: The patient reported that the patient received initial Shingrix dose. The patient feel so bad and experienced nausea, flu-like symptoms so, refused to receive second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patients outside of 2-6 month window; This case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 9-Sept-2022 Reporter's comment: The reporter submitted the report to Medical Information as an inquiry from a physician. The reporter asked that what was the protocol around the patients who had received a first dose of Shingrix and had been well past the 2-6 window. How long could a patients go between doses.  The possible duplicate was adverse event.  As reported that, medical information did not speak with the physician at any point.  The reporter consent for follow-up from safety was not provided.  Additional Supportive Information: Till the time of reporting, the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2022130646, reported by the same reporter.; Sender's Comments:  US-GSK-US2022130646:Same reporter
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Administered powder reconstituting it with non-GSK diluent; Administered powder reconstituting it with non-GSK diluent; This case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva677a, expiry date 30th April 2023) for prophylaxis.   Concurrent medical conditions included anxiety (had anxiety on 24th August 2022).   On 24th August 2022, the patient received the 1st dose of Menveo (intramuscular). On 24th August 2022, 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 Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter reported that the patient received Menveo in that administered powder reconstituting it with non-GSK diluent. The patient was revaccinated on 1st September 2022. All five potential patients were recalled for revaccination. No adverse reactions known. The reporter stated that the system was utilized from 6th September 2022. Diluent would be dispensed with the powder in this machine. Agency to check all vials for vaccines prior to administration. The reporter did consent to follow up. Additional supportive information: Menveo reconstituted with non-GSK diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was one of 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022124956:Same reporter/ original report US-GSK-US2022AMR131228:Same reporter US-GSK-US2022AMR131247:Same reporter US-GSK-US2022AMR131240:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm is still very sore a week later; 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (Patient's brother had shingles years ago). Previously administered products included Shingles vaccine with an associated reaction of limb discomfort (1st dose received on unknown date  For the tolerance of the 1st dose, refer linked case US2022AMR131245).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR131245   Additional Information: GSK Receipt Date: 10-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received second dose of Shingrix. The reporter stated that after received Shingrix vaccine the patient experienced arm sore and it was still very sore as a week later. The reporter stated patient covered not to get as his brother years ago had Shingles and it was extremely bad and painful. Follow-up would not possible as no contact details were available. Additional supportive information: For the tolerance of the 1st dose, refer linked case US2022AMR131245, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR131245:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: Arm out of commission for a couple of weeks; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's brother had shingles years ago).   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 arm discomfort. On an unknown date, the outcome of the arm discomfort was recovered/resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR131239   Additional Information: GSK Receipt Date: 10-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter though the after first shot his/her arm was pretty much out of commission for a couple of weeks but at least now hopefully patient was covered. The follow-up could not be possible as no contact details were available. The case had been linked with US2022AMR131239 reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR131239:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: bad headaches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2022, the patient received Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received shot 4 days ago (from the date of reporting) and still experienced bad headaches. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot
Clinical narrative: make work day impossible, upper arm hotter than rest of body; This case was reported by a consumer via interactive digital media and described the occurrence of extremities hot feeling of 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 extremities hot feeling of. On an unknown date, the outcome of the extremities hot feeling of was not recovered/not resolved.   It was unknown if the reporter considered the extremities hot feeling of to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that a vaccine could make a work day impossible.  The patient had at day three and my upper arm was measurably hotter than the rest of my body.  The reporter stated no reaction to vaccines. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: had an unconstituted dose be given to a pt; had an unconstituted dose be given to a pt; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 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 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: 19-JUL-2022 Reporter's comment: The reporter stated that the office used the Shingrix elastitags because they had an unconstituted dose be given to a patient so the elastitags ensured the dose was reconstituted. The reporter consented to follow-up. Additional Supportive Information: The patient received an unconstituted dose of Shingrix, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: three weeks after the vax he had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-SEP-2022 Reporters comment: This case was reported by patient's friend via interactive digital media. The patient's doctor told the patient that at his age he should get that vaccine so he would not get shingles. Three weeks after the Shingles vaccine he had shingles. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric Engerix administered to a 27y/o; Pediatric Engerix administered to a 27y/o; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 27-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 30th August 2022, the patient received the 2nd dose of Engerix B pediatric 10 mcg/mg and hepatitis B vaccine pre-filled syringe device. On 30th August 2022, unknown after receiving Engerix B pediatric and hepatitis B vaccine pre-filled syringe device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: The registered pharmacist reported that yesterday (the day before reporting) the patient received pediatric dose of Engerix B 10 mcg. No additional details were provided. The pharmacist inquired how to proceed and would this patient need an extra dose of 10 mcg. The reporter did not consent to follow up. Additional Supportive Information: The patient received a pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered liquid portion only; administered liquid portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA747A, expiry date 31st October 2023) for prophylaxis.   On 31st August 2022, the patient received Menveo. On 31st August 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: 2-Sep-2022 Reporter's Comment: Nurse reported that patient administered liquid portion only of Menveo, then administered a properly reconstituted repeat dose the same day on 31st August 2022. Adverse event contains all details provide by health care professional. Health care professional only had one lot number/expiration date available and is unsure which dose it goes to. health care professional gives permission for safety team follow up. The reporter consented to follow up. Additional Supportive Information: The patient received then administered a properly reconstituted repeat dose the same day, inappropriate preparation of medication and inappropriate dose of vaccine administered.