chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Incomplete course of vaccination
Clinical narrative: I had them, and it wasn't that bad; found the shot horrendous; I didn't go back for the second part of vaccination; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the shingles, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-Jun-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that he/she found the shingles shot horrendous and worse than shingles. The patient had shingles and stated that it was n0t that bad. The shingles shot was way worse than shingles. The patient did not go back for the second part of vaccination. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd shot of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Hypersomnia, Insomnia
Clinical narrative: headache; Chills; Fever; Nausea; Vomiting; Slept the entire 2nd day; Tingling; Itching; Horrible feeleng because Could not sleep; really hit bad/feeling horrible; 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced headache, chills, fever, nausea, vomiting, sleep excessive, tingling, pruritus, insomnia and feeling abnormal. On an unknown date, the outcome of the headache, chills, fever, nausea, vomiting, sleep excessive, insomnia and feeling abnormal were unknown and the outcome of the tingling and pruritus were recovering/resolving.   It was unknown if the reporter considered the headache, chills, fever, nausea, vomiting, sleep excessive, tingling, pruritus, insomnia and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles vaccine and this really hit bad. The patient had headache, chills, fever, nausea and vomiting. The patient slept the entire 2nd day but tingling and itching were going away. It was horrible feeling because he/she could not sleep. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Paraesthesia, Pruritus, Pyrexia, Vomiting
Clinical narrative: headache; Chills; Fever; Nausea; Vomiting; Slept the entire 2nd day; Tingling; Itching; Horrible feeleng because Could not sleep; really hit bad/feeling horrible; 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced headache, chills, fever, nausea, vomiting, sleep excessive, tingling, pruritus, insomnia and feeling abnormal. On an unknown date, the outcome of the headache, chills, fever, nausea, vomiting, sleep excessive, insomnia and feeling abnormal were unknown and the outcome of the tingling and pruritus were recovering/resolving.   It was unknown if the reporter considered the headache, chills, fever, nausea, vomiting, sleep excessive, tingling, pruritus, insomnia and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles vaccine and this really hit bad. The patient had headache, chills, fever, nausea and vomiting. The patient slept the entire 2nd day but tingling and itching were going away. It was horrible feeling because he/she could not sleep. Additional Supportive Information: The follow up would not possible as no contact details were available.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood test abnormal, Fibrin D dimer increased
Clinical narrative: D-DImer blood test extremely high, was over 1500.; This case was reported by a consumer via call center representative and described the occurrence of fibrin d dimer increased in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 2nd dose of Shingrix. On 8th June 2022, less than a week after receiving Shingrix, the patient experienced fibrin d dimer increased. On an unknown date, the outcome of the fibrin d dimer increased was unknown.   It was unknown if the reporter considered the fibrin d dimer increased to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-Jun-2022 Reporter's Comments: The patient self-reported this case. The patient had the 2nd dose of Shingrix vaccine shot 6 days before reporting and day before reporting the patient had some blood tests. One such test was called a D-Dimer test. The patient stated that normal results for him/her, that was, his/her age, should be around 710 (unit unspecified), but the results came back over 1500 (unit unspecified).  The patient asked if there was a correlation between D-Dimer results and Shingrix. The patient stated to contact him/her on the day of reporting because he/she was taking a stress test tomorrow afternoon for reporting and would not want anything bad to happen to him/her while doing that test.  The patient wondered if anyone taking the vaccine had taken the D-Dimer blood test and made any connection between the two.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Fibromyalgia, Inappropriate schedule of product administration, Nail disorder, Trichorrhexis
Clinical narrative: Fibromyalgia; Hair Broke was ruined; fingernails ruined; Joint pain in shoulders Knees; First shot. Jan- second Feb; This case was reported by a consumer via interactive digital media and described the occurrence of fibromyalgia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   In February 2022, the patient received the 2nd dose of Shingles vaccine. In February 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On 15th March 2022, the patient experienced hair breakage, nail disorder and arthralgia multiple. On an unknown date, the patient experienced fibromyalgia. On an unknown date, the outcome of the fibromyalgia, hair breakage, nail disorder, arthralgia multiple and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fibromyalgia, hair breakage, nail disorder and arthralgia multiple to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR091436   Additional Information: GSK Receipt Date: 08-Jun-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that he/she took the shots but had bad side effects from it. The reporter stated that by March 15 his/her hair broke was ruined, fingernails was ruined, had joint pain in shoulders and knees. The reporters said he/she also had fibromyalgia, would never take the shots again. The reporter said it appeared to affect all of those who got Covid or just taking the injections. On 15th March 2022, less than 2 months after receiving Shingles vaccine, the patient experienced hair breakage, nail disorder and arthralgia multiple. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced fibromyalgia. Additional supportive information: The patient received 2nd dose of Shingles vaccine earlier than the recommended interval, which led to shortening of vaccination schedule. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR091436:same report, 1st dose
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Vertigo
Clinical narrative: Vertigo; could not work almost at all; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 35-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   The patient's past medical history included ankle fracture (surgery perfomed in 2018) and deviated septum repair (surgery perfomed in 2016). Previously administered products included TDAP with an associated reaction of product prescribing error (For tolerance of TDAP dose refer case US2022AMR091741) and Flu vaccine with an associated reaction of fatigue (For tolerance of Flu vaccine dose refer case US2022AMR091740).   On 22nd April 2022, the patient received Boostrix. In April 2022, less than a day after receiving Boostrix, the patient experienced vertigo and activities of daily living impaired. The patient was treated with dramamine (nos) (Dramamine). On an unknown date, the outcome of the vertigo and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the vertigo and activities of daily living impaired to be related to Boostrix.     Additional Information: GSK receipt date: 08-June-2022 Reporter's comment: The patient received her Boostrix vaccine approximately 1.5 months ago and about 3-6 hours afterward, patient experienced extreme vertigo. Moving her head quickly or to either side or leaning it back made it much worse, but it was also very present when just sitting and looking forward to the point she could not work almost at all because of these symptoms. They would subside or lessen in severity for an hour or two intermittently, but then return for no reason. She tried dramamine which seemed to help a little bit, but she was unable to do the Epely maneuvers because the symptoms felt so severe she could not tolerate it. She stayed in a semi reclined position as much as she could for 2-3 weeks. After 3 weeks, the symptoms lessened but were still present. At the time of reporting approximately 6-7 weeks out from the vaccine and it had improved about 90 percent or so, where it had stayed. It was still present in certain situations, but notably less severe. She was hoping to get more information about this and whether there had been any other reports of this happening. The patient was also wondering if this was something that needs exploring, because she was a bit concerned about this being permanent. The patient received oral Birth control pills (BCP) and Vitamin D. No allergies was provided, and she was in good health. Additional Supportive information: Birth control pills (BCP) and Vitamin D were not coded in field as its ingredient was NOS which would cause report failure, hence it was retained in the narrative.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR091740:Same reporter US-GLAXOSMITHKLINE-US2022AMR091741:Same reporter
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Nasopharyngitis, Pain in extremity
Clinical narrative: fatigue; pain in arm; cold like symptoms; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 35-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included ankle fracture (surgery performed in 2018) and deviated septum repair (surgery performed in 2016). Previously administered products included TDAP (received on an unknown date, refer case US2022AMR091741).   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced fatigue, pain in arm and cold symptoms. On an unknown date, the outcome of the fatigue, pain in arm and cold symptoms were unknown.   The reporter considered the fatigue, pain in arm and cold symptoms to be related to Flu vaccine.     Linked case(s) involving the same patient:  US2022AMR091738, US2022AMR091741   Additional Information: GSK receipt date: 08-June-2022 Reporter's comment: The patient self-reported this case. No allergies were provided. The patient received oral Birth control pills (BCP) and Vitamin D. The patient reported that she never had a reaction to a vaccine aside from typical fatigue, arm soreness, and some cold-like symptoms from the flu shot on occasional years. she wonders if there was an excipient, preservative or something else that she not tolerant of, and if so really like to know what it was and avoid it in the future.  Additional Supportive information: Birth control pills (BCP) and Vitamin D were not coded in field as its ingredient was NOS (unspecified) which would cause report failure; hence it was retained in the narrative. For tolerance Boostrix dose refer case US2022AMR091738, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR091738:Same reporter US-GLAXOSMITHKLINE-US2022AMR091741:Same reporter
Sex: F
Vaccine: TDAP
Symptoms: Drug intolerance
Clinical narrative: didn't "tolerate it well; This case was reported by a consumer via call center representative and described the occurrence of drug intolerance in a 35-year-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced drug intolerance. On an unknown date, the outcome of the drug intolerance was unknown.   It was unknown if the reporter considered the drug intolerance to be related to DTPa vaccine.     Linked case(s) involving the same patient:  US2022AMR091738, US2022AMR091740   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comments:  The patient reported case for herself. The patient mentioned that her mother said that when she was a baby, she only got one TDAP shot because she did not tolerate it well whatever that meant, so she only received 1 of the 2 that was recommended by pediatricians at that time. The patient did not have any of those records now, of course. She wondered if there was an excipient, preservative or something else that she was not tolerant of, and if so the patient really like to know what it was and avoid it in the future. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR091740:Same reporter US-GLAXOSMITHKLINE-US2022AMR091738:Same reporter
Age: 16.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 16 yo patient was given a dose of shingrix; was given a dose of Shingrix instead of varicella vaccine; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a 16-year-old 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 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.   Additional Information: GSK Receipt Date: 09-Jun-2022 Reporter's Comments: The reporter stated that a 16 year old patient was given a dose of Shingrix instead of varicella vaccine. No other details were shared. The reporter consented to follow up. Additional Supportive Information: A 16-year-old patient was given a dose of Shingrix instead of varicella vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: 1st dose then because of Covid missed 2nd, over a year; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over a year prior to the reporting).   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: 11-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had first dose of Shingrix then because of Covid missed second dose. It was over a year asked could he/she get the second dose now. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash all over my face; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The case was self-reported by the patient via interactive digital media. The patient received dose of Shingles vaccine about three weeks ago before the day of reporting and one week later patient broke out with a rash all over face.  The patient reported that It was going into the second week and was no better.  The patient asked that could you have a shingles type reaction to the vaccine. Additional Supportive Information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: having recurring outbreaks since the 2nd dose/ suspected vaccination failure; having recurring outbreaks; had Shingrix, I'm 32, I am not immunocompromised; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles at age 16 years).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 13-JUN-2022 Reporter's comment: This case was reported by the patient via interactive digital media and described the occurrence of suspected vaccination failure. The patient was 32 years old at the time of reporting. The patient was not immunocompromised. The patient received the second dose of Shingrix 7th March (year was unknown). The patient recurring outbreaks since the 2nd dose and asked was this normal.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: horrible pain on left side; general musccle 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 (Shingles vaccine) for prophylaxis.   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 muscle soreness. On an unknown date, the outcome of the pain and muscle soreness were not recovered/not resolved.   It was unknown if the reporter considered the pain and muscle soreness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced horrible pain on left side and general muscle soreness all over. The patient stated that still above symptoms had not went away. The patient hate to thought, what the real thing felt like. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 11/3/2021. I forgot to get my second; This case was reported by a consumer via interactive digital media 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 3rd November 2021).   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: 13-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had his/her first dose, clearly he/she forgot to get second dose within 6 months. The patient asked what to do. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: antibodies response was not present; This case was reported by a consumer via other manufacturer and described the occurrence of therapy non-responder in a female patient who received HBV (Engerix B) (batch number 9232L, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 1st November 2018, the patient received the 1st dose of Engerix B 1 ml. On an unknown date, the patient received the 2nd dose of Engerix B and the 3rd dose of Engerix B. On 20th May 2022, 1296 days after receiving Engerix B and unknown after receiving Engerix B and Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.       Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: The case was reported by patient. The patient stated that she received her 1st dose from health care provider and followed proper dosing schedule as per health care provider instruction. On 20th May 2022, the patient was tested her antibodies and told to her that Hepatitis B response was not present. No other information reported, no PQC reported. Additional Supportive Information: The patient's hepatitis B antibodies were negative which led to therapy non responder.
Age: 32.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Impaired work ability, Loss of personal independence in daily activities, Vaccination failure
Clinical narrative: been having recurring outbreaks since the 2nd dose/suspected vaccination failure; shingles; missed 3 weeks of work due to the shingles outbreaks; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 32-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had shingles at age of 16).   On 7th March 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles and activities of daily living impaired were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and activities of daily living impaired to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: The patient was the reporter. The patient was not immunocompromised. The patient had her first shingles outbreak when she was age 16. She said it was on both sides of her head. Once or twice a year every since then (since age 16) she had been getting shingles outbreaks. The outbreaks were usually on the left side. The patient stated that she had the second dose of shingrix on 7th March but facing recurring outbreaks since the 2nd dose. The patient asked if it  was normal. Since getting Shingrix shots she had been getting repeated shingles outbreaks/breakouts more often (more frequently) and they last longer. The patient had missed 3 weeks of work due to the shingles outbreaks. She did not have the lot number of the Shingrix shot(s) administered to her. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of the shingles vaccine on 11/3/21; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received 1st dose on 3rd November 2021).   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: 14-June-2022 Reporter's comment: This case was reported by a consumer via Chat. The patient had my first dose and asked if it was okay to get the second dose, even though it has been longer than 6 months. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Redness spreading 3 days after vaccine; Itching spreading 3 days after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were unknown.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that the redness and itching was spreading 3 days after the Shingles vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 03-nov-21 did not get the 2nd dose, even though it has been longer than 6 months.; This case was reported by a consumer via interactive digital media 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 3rd November 2021).   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: 14-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient had my first dose shingles vaccine and asked if it was okay to get the second dose, even though it had been longer than 6 months. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Had a headache; 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.   On 14th June 2022, the patient received the 2nd dose of Shingles vaccine. On 14th June 2022, less than a day 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: 14-MAY-2022 Reporter's Comments: This case was received from the patient via interactive digital media. The patient received 2nd dose of Shingles vaccine and experienced headache. The patient wanted to know if he/she could take Tylenol for headache. Additional supportive information: The follow-up would not possible as no contact details were available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Injection site pain
Clinical narrative: Injection site pain; She developed chills; Stomachache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included acetylsalicylic acid (Aspirin) for injection site pain.   On 6th June 2022, the patient received the 2nd dose of Shingrix (intramuscular) and Aspirin at an unknown dose and frequency. On 6th June 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, chills and stomach pain. The action taken with Aspirin was unknown. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the chills and stomach pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, chills and stomach pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's comment: The reporter was the patient. She received her second Shingrix dose in arm the day prior to the reporting. She had injection site pain that resolved after she took two aspirin.  She developed chills and stomachache that had continued for about twenty-four hours. It was unknown if the reporter considered the chills and stomach pain to be related to aspirin. She had nothing else to report. The reporter might follow up with primary doctor. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: stated the second dose was not needed, DOB: 24-11-2019; stated the second dose was not needed, DOB: 24-11-2019; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the extra dose administered and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the inappropriate schedule of vaccine administered to be related to Infanrix Pre-Filled Syringe Device. 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-JUN-2022 Reporter's Comment: The patient received a second dose which was out of recommended schedule. The patient had already received a dose and the second dose was not needed, which led to overdose. Healthcare professional stated the dose was administered incorrectly then clarified it was not needed. The reporter consented to follow up. Additional Supportive Information: The patient had already received a dose and the second dose was not needed, which led to extra dose administered and inappropriate schedule of vaccine administered.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Swelling at the injection site/ the area was 4 inches long and 6 inches in width around her arm; Redness at the injection site; vaccine was given lower in arm than should have been; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2022, the patient received the 2nd dose of Shingrix. On 6th June 2022, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and vaccine administered at inappropriate site. The patient was treated with cefalexin (Cephalexin). On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-Jun-2022 and 13-JUN-2022. Reporter's Comments: The patient self-reported this case. The patient received her second dose of Shingrix in arm and that evening after vaccination she noticed some swelling and redness at the injection site. Over the following days the patient noted the swelling had grown and the patient stated at the time of the reporting the area was 4 inches long and 6 inches in width around her arm and red. The symptoms had not yet resolved, the arm was still red and swollen. The patient's doctor has prescribed Cephalexin in which reporting day was her 3rd day of treatment. The patient also stated that her physician suggested that the vaccine was given lower in her arm than should had been. The reporter did not consent to follow-up. Additional Supportive Information: The vaccine was given lower in arm than should had been, which led to vaccine administered at inappropriate site.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Gave the adjuvant portion only/ not reconstitute the adjuvant and antigen powder prior to giving the dose; Gave the adjuvant portion only/ not reconstitute the adjuvant and antigen powder prior to giving the dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number B257H, expiry date 26th June 2023) for prophylaxis.   On 9th June 2022, the patient received Shingrix. On 9th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-Jun-2022 Reporter's Comments: The reporter was a medical assistant. The reporter stated that she administered the Shingrix adjuvant portion only to a patient, she did not reconstitute the adjuvant and antigen powder prior to giving the dose. The reporter consented to follow up. Additional Supportive Information: The patient was administered Shingrix adjuvant portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Needle issue
Clinical narrative: Does not know how much, if any, the patient received; Needle malfunctioned, fell apart, spilled vaccine onto patient's arm; Spilled vaccine onto patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 4M39A, expiry date 28th August 2023) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.      Additional Information: GSK Receipt Date:10-Jun-2022 Reporter's Comments: The reporter reported that a dose of Shingrix was reconstituted and when the dose was going to be administered, the needle got malfunctioned and fell apart, spilling the vaccine onto the patient's arm. HCP stated she does not know how much vaccine had been spill.  Warm transferred to medical information for further guidance and provided reference number to agent for adverse event report. Additional Supportive information: Spilling the vaccine onto the patient's arm. HCP stated she does not know how much vaccine had been spilled, which led to incomplete dose administered, accidental exposure to product and exposure via skin contact.
Age: 35.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on March 25th 2022, 2nd dose on Jun 9th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 35-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 9th June 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 9th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.     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: 10-JUN-2022 Reporter's Comments: The pharmacist called to report that a patient received a Twinrix second dose late and now she did not know when administer the third dose. The patient received 1st dose on 25th March 2022. The reporter consented to follow up by email. Additional Supportive Information:  The patient received a Twinrix second dose late, which led to lengthening of the recommended interval between vaccine doses. This was 1 of 2 linked cases, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022089924:Same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Computerised tomogram, Headache, Injection site erythema, Injection site pain
Clinical narrative: headache; pain at the injection site; redness and swelling at injection site; redness and swelling at injection site; had pain from waist all the way down both legs; had pain from waist all the way down both legs; fever; chills; nausea; red rash all over body; This case was reported by a consumer via call center representative and described the occurrence of headache in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2022, the patient received the 1st dose of Shingrix. On 1st June 2022, less than an hour after receiving Shingrix, the patient experienced headache, injection site pain, injection site erythema, injection site swelling, pain localized and leg pain. In June 2022, the patient experienced fever, chills, nausea and red rash. The patient was treated with steroids nos (Steroids) and paracetamol (Tylenol). On an unknown date, the outcome of the headache and pain localized were not recovered/not resolved and the outcome of the injection site pain, injection site erythema, injection site swelling, leg pain, fever, chills and nausea were recovered/resolved and the outcome of the red rash was unknown.   It was unknown if the reporter considered the headache, injection site pain, injection site erythema, injection site swelling, pain localized, leg pain, fever, chills, nausea and red rash to be related to Shingrix.     Additional Information: GSK receipt date: 13-JUN-2022 Reporter's comment: The patient reports that she received dose 1 of Shingrix in left arm on 1st June 2022. She stated that within minutes she had a headache pain, redness and swelling at injection site. Hours later she had pain from waist all the way down both legs. In the middle of the night, less than a day after receiving Shigrix she woke up with fever, chills and nausea. She mentioned that less than 2 weeks after vaccination, she had a red rash all over body. She stated that she had to go to the emergency room where they did a Computerised tomogram scan and gave her steroids and Tylenol. The patient was still experiencing headaches without relief for the past 12 days. The patient would not get second dose of Shingrix within 2-6 months. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: headache; pain at the injection site; redness and swelling at injection site; redness and swelling at injection site; had pain from waist all the way down both legs; had pain from waist all the way down both legs; fever; chills; nausea; red rash all over body; This case was reported by a consumer via call center representative and described the occurrence of headache in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2022, the patient received the 1st dose of Shingrix. On 1st June 2022, less than an hour after receiving Shingrix, the patient experienced headache, injection site pain, injection site erythema, injection site swelling, pain localized and leg pain. In June 2022, the patient experienced fever, chills, nausea and red rash. The patient was treated with steroids nos (Steroids) and paracetamol (Tylenol). On an unknown date, the outcome of the headache and pain localized were not recovered/not resolved and the outcome of the injection site pain, injection site erythema, injection site swelling, leg pain, fever, chills and nausea were recovered/resolved and the outcome of the red rash was unknown.   It was unknown if the reporter considered the headache, injection site pain, injection site erythema, injection site swelling, pain localized, leg pain, fever, chills, nausea and red rash to be related to Shingrix.     Additional Information: GSK receipt date: 13-JUN-2022 Reporter's comment: The patient reports that she received dose 1 of Shingrix in left arm on 1st June 2022. She stated that within minutes she had a headache pain, redness and swelling at injection site. Hours later she had pain from waist all the way down both legs. In the middle of the night, less than a day after receiving Shigrix she woke up with fever, chills and nausea. She mentioned that less than 2 weeks after vaccination, she had a red rash all over body. She stated that she had to go to the emergency room where they did a Computerised tomogram scan and gave her steroids and Tylenol. The patient was still experiencing headaches without relief for the past 12 days. The patient would not get second dose of Shingrix within 2-6 months. The reporter did not consent to follow up.