chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: stings; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of stinging in an unspecified number of patient's who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced stinging (Verbatim: stings). The outcome of the stinging was unknown.   It was unknown if the reporter considered the stinging to be related to Arexvy.   It was unknown if the company considered the stinging to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2023 A GSK Field Representative reported that a pharmacist stated that of 169 patients that received the vaccine Arexvy at a local pharmacy, the most common comment from the patients was that the vaccine stings. The pharmacist stated that the ratio was 50/50 for male and female patients. No additional information was provided. The reporter consented to follow up. This case is for female patient's and is linked to US2023151159 for male patient's reported by same reporter.; Sender's Comments:  US-GSK-US2023151159:Male Patients case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product prescribing issue, Product use issue
Clinical narrative: Arexvy vaccine administered during pregnancy; HCP states that MD sent 36 week (3rd trimester) female to pharmacy with a prescription for Arexvy and it was administered; Inappropriate age-off label use; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In SEP-2023, the patient received Arexvy. In SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age-off label use). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy vaccine administered during pregnancy) and drug prescribing error (Verbatim: HCP states that MD sent 36 week (3rd trimester) female to pharmacy with a prescription for Arexvy and it was administered). The outcome of the vaccine exposure during pregnancy, drug prescribing error and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 01-NOV-2023 The pharmacist requested data on use of Arexvy in pregnancy.  The HCP (health care professional) stated that MD (Doctor of Medicine) sent 36-week (3rd trimester) patient to pharmacy with a prescription for Arexvy and it was administered in September 2023 (exact date unknown), which led to vaccine exposure during pregnancy and drug prescribing error. The patient received vaccine at inappropriate age, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Injection site discomfort, Injection site pain, Injection site reaction, Injection site warmth, Pain in extremity
Clinical narrative: warmth 3 to 4 inches below injection site (of injected arm); red blotches 3 to 4 inches below injection site (of injected arm); red blotches 3 to 4 inches below injection site (of injected arm); he had a little discomfort at the injection site; Tenderness (pain) 3 to 4 inches below injection site (of injected arm)/left arm hurting; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4ak57, expiry date 23-MAR-2025) for prophylaxis.   Previously administered products included TDAP with an associated reaction of no adverse event (Prior immunizations (with no problem): TDAP) and Pneumonia vaccine with an associated reaction of no adverse event (Prior immunizations (with no problem): Pneumonia). Concurrent medical conditions included type ii diabetes mellitus and blood cholesterol increased.   On 30-OCT-2023, the patient received Arexvy (intramuscular, left deltoid). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Tenderness (pain) 3 to 4 inches below injection site (of injected arm)/left arm hurting). On 31-OCT-2023, the patient experienced injection site discomfort (Verbatim: he had a little discomfort at the injection site). On an unknown date, the patient experienced skin warm (Verbatim: warmth 3 to 4 inches below injection site (of injected arm)), red blotches (Verbatim: red blotches 3 to 4 inches below injection site (of injected arm)) and erythema of extremities (Verbatim: red blotches 3 to 4 inches below injection site (of injected arm)). The outcome of the injection site discomfort, skin warm, pain in arm, red blotches and erythema of extremities were not resolved.   The reporter considered the injection site discomfort, skin warm, pain in arm, red blotches and erythema of extremities to be related to Arexvy.   The company considered the injection site discomfort, skin warm, pain in arm, red blotches and erythema of extremities to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-NOV-2023 The reporter was the patient and received Arexvy in the morning.  The day before reporting, he had a little discomfort (at the injection site). At the time of reporting, he pushed at the injection site and it was tender. While sleeping last night he noticed his left arm was hurting.  This morning he saw pinkish-red blotches three to four inches below the injection site just before his elbow.  Also the blotchy area was warm and the red blotchy area was very tender. This had not yet resolved. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Rash macular
Clinical narrative: warmth 3 to 4 inches below injection site (of injected arm); red blotches 3 to 4 inches below injection site (of injected arm); red blotches 3 to 4 inches below injection site (of injected arm); he had a little discomfort at the injection site; Tenderness (pain) 3 to 4 inches below injection site (of injected arm)/left arm hurting; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4ak57, expiry date 23-MAR-2025) for prophylaxis.   Previously administered products included TDAP with an associated reaction of no adverse event (Prior immunizations (with no problem): TDAP) and Pneumonia vaccine with an associated reaction of no adverse event (Prior immunizations (with no problem): Pneumonia). Concurrent medical conditions included type ii diabetes mellitus and blood cholesterol increased.   On 30-OCT-2023, the patient received Arexvy (intramuscular, left deltoid). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Tenderness (pain) 3 to 4 inches below injection site (of injected arm)/left arm hurting). On 31-OCT-2023, the patient experienced injection site discomfort (Verbatim: he had a little discomfort at the injection site). On an unknown date, the patient experienced skin warm (Verbatim: warmth 3 to 4 inches below injection site (of injected arm)), red blotches (Verbatim: red blotches 3 to 4 inches below injection site (of injected arm)) and erythema of extremities (Verbatim: red blotches 3 to 4 inches below injection site (of injected arm)). The outcome of the injection site discomfort, skin warm, pain in arm, red blotches and erythema of extremities were not resolved.   The reporter considered the injection site discomfort, skin warm, pain in arm, red blotches and erythema of extremities to be related to Arexvy.   The company considered the injection site discomfort, skin warm, pain in arm, red blotches and erythema of extremities to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-NOV-2023 The reporter was the patient and received Arexvy in the morning.  The day before reporting, he had a little discomfort (at the injection site). At the time of reporting, he pushed at the injection site and it was tender. While sleeping last night he noticed his left arm was hurting.  This morning he saw pinkish-red blotches three to four inches below the injection site just before his elbow.  Also the blotchy area was warm and the red blotchy area was very tender. This had not yet resolved. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Wrong technique in product usage process
Clinical narrative: Menveo reconstituted at 11 am on 31 oct 2023 and admintered at 8 am next day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 01-NOV-2023, the patient received Menveo. On 01-NOV-2023, an unknown time after receiving Menveo, the patient experienced wrong technique in drug usage process (Verbatim: Menveo reconstituted at 11 am on 31 oct 2023 and admintered at 8 am next day). The outcome of the wrong technique in drug usage process was unknown.   Additional Information: GSK receipt date: 01-NOV-2023 The health care professional reported that administration of Menveo (2-vial) that was reconstituted one day before the reporting date at 11 am and on the day of reporting, administered at 8 am, which led to wrong technique in drug usage process. The reporter consented to follow up.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Boostrix instead of Infanrix; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 97MR2, expiry date 11-OCT-2025) for prophylaxis.   On 31-OCT-2023, the patient received Boostrix. On 31-OCT-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: administered Boostrix instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 01-NOV-2023 The reporter reported that It was supposed to be the 4th dose of the Dtap series. The reporter consented to follow up. The patient received Boostrix instead of Infanrix at an inappropriate age, which led to wrong vaccine administration and inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Patient reports feeling achy and tired,; Patient reports feeling achy; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-OCT-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: Patient reports feeling achy and tired,) and pain (Verbatim: Patient reports feeling achy). The outcome of the tiredness and pain were not resolved.   It was unknown if the reporter considered the tiredness and pain to be related to Shingrix.     It was unknown if the company considered the tiredness and pain to be related to Shingrix.   Additional Information: GSK Receipt date: 01-NOV-2023 The patient seif-reported this case. Patient reported that he got the vaccine at a local pharmacy. Patient reported feeling achy and tired and that symptoms had not resolved.  Patient had called to get medical advice and inquired if he could take Tylenol for the symptoms and the patient disconnected abruptly and no additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: Nurse reports a Physician Assistant administered a dose of Shingrix to a patient that was reconstituted with a sterile diluent instead of the supplied AS01B diluent; Inappropriate age at vacciner administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 31-year-old female patient who received Herpes zoster (Shingrix) (batch number 75JT4, expiry date 30-SEP-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Nurse reports a Physician Assistant administered a dose of Shingrix to a patient that was reconstituted with a sterile diluent instead of the supplied AS01B diluent) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vacciner administration). The outcome of the wrong solution used in drug reconstitution and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The nurse reported a physician assistant administered a dose of Shingrix to a patient that was reconstituted with a sterile diluent instead of the supplied AS01B diluent. At the time of reporting, dose has not been repeated. The vaccine administration facility was the same as primary reporter. The Shingrix was reconstituted with wrong solution, which led to wrong solution used in drug reconstitution. A 31 year patient received Shingrix, which led to inappropriate age at vaccine administration. The reporter gave permission for follow-up.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Dyspnoea, Injection site rash, Injection site swelling, Rash
Clinical narrative: Swelling and rash at injection site, difficulty breathing with tightness from epiglottis to carina, cough, body rash next day
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Throat tightness
Clinical narrative: Swelling and rash at injection site, difficulty breathing with tightness from epiglottis to carina, cough, body rash next day
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given HD flu, Age 64
Age: 70.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Muscle spasms, Rash erythematous
Clinical narrative: Swelling and a red rash on left thigh (flu shot side) Pain spasms in right thigh (RSV side) which continued about twice a minute throughout the day till about 10 pm as reported by patient. Patient took Ibuprofen to help with pain.
Age: 81.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Asthenia, Mobility decreased, Nausea, Vomiting
Clinical narrative: 6 hours after receiving the vaccines the patient experienced violent vomiting, extreme weakness where he couldn't move his legs and nausea.
Age: 1.67
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Writer received notification that patient incorrectly received Kinrix (DTaP/IPV) vaccination instead of age appropriate separate DTaP, IPV vaccination based on parent preference.
Age: 73.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Arthralgia, Autoimmune disorder, Blood test abnormal, Condition aggravated, Dizziness
Clinical narrative: I had the first 3 vaccines in 2021. A 4th in May of 2022. When I went in on 11/18/22 for the Pfizer bivalent booster, I had an immediate adverse reactionI thought I was going to pass out because I stood up and the whole store was spinning. I thought I would throw up, but made myself walk a littleit lasted for about 20 minutes. Susequently, I noticed in December that my toes were looking weirdpink-ish purple, "Covid toes." By early 2023 I was very fatigued, started having joint pain, shortness of breath and dizziness when walking. My tinnitus got worse. I have seen a cardiologist, a pulmonologist, a neurologist and an ENT doctor. I now have polyneuropathy and blood tests showing  auto-immune deficiency results.
Age: 73.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Dyspnoea, Electrocardiogram, Fatigue, Immediate post-injection reaction, Nausea
Clinical narrative: I had the first 3 vaccines in 2021. A 4th in May of 2022. When I went in on 11/18/22 for the Pfizer bivalent booster, I had an immediate adverse reactionI thought I was going to pass out because I stood up and the whole store was spinning. I thought I would throw up, but made myself walk a littleit lasted for about 20 minutes. Susequently, I noticed in December that my toes were looking weirdpink-ish purple, "Covid toes." By early 2023 I was very fatigued, started having joint pain, shortness of breath and dizziness when walking. My tinnitus got worse. I have seen a cardiologist, a pulmonologist, a neurologist and an ENT doctor. I now have polyneuropathy and blood tests showing  auto-immune deficiency results.
Age: 73.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Pulmonary function test, Skin discolouration, Stress echocardiogram, Tinnitus, Vertigo
Clinical narrative: I had the first 3 vaccines in 2021. A 4th in May of 2022. When I went in on 11/18/22 for the Pfizer bivalent booster, I had an immediate adverse reactionI thought I was going to pass out because I stood up and the whole store was spinning. I thought I would throw up, but made myself walk a littleit lasted for about 20 minutes. Susequently, I noticed in December that my toes were looking weirdpink-ish purple, "Covid toes." By early 2023 I was very fatigued, started having joint pain, shortness of breath and dizziness when walking. My tinnitus got worse. I have seen a cardiologist, a pulmonologist, a neurologist and an ENT doctor. I now have polyneuropathy and blood tests showing  auto-immune deficiency results.
Sex: U
Vaccine: RV1
Symptoms: Product preparation error, Single component of a two-component product administered, Underdose
Clinical narrative: Administration of the Rotarix Diluent Alone; inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the Rotarix Diluent Alone) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152363:Different patient US-GSK-US2023152368:Different patient US-GSK-US2023152371:Different patient US-GSK-US2023152370:Different patient US-GSK-US2023152365:Different patient
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Bone pain, Myalgia, Neck pain, Pain
Clinical narrative: Pain all over the body; Neck pain; Joint pain/elbows it really hurt; Muscles pain; Bone pain; she barely stayed up due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received Arexvy (right arm). In NOV-2023, less than a day after receiving Arexvy, the patient experienced general body pain (Verbatim: Pain all over the body), neck pain (Verbatim: Neck pain), joint pain (Verbatim: Joint pain/elbows it really hurt), muscle pain (Verbatim: Muscles pain), bone pain (Verbatim: Bone pain) and weakness (Verbatim: she barely stayed up due to the pain). The outcome of the general body pain, neck pain, joint pain, muscle pain, bone pain and weakness were resolving.   It was unknown if the reporter considered the general body pain, neck pain, joint pain, muscle pain, bone pain and weakness to be related to Arexvy.     It was unknown if the company considered the general body pain, neck pain, joint pain, muscle pain, bone pain and weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter was the patient who stated that she received Arexvy yesterday in her right arm and she developed pain all over the body, specially neck, muscles, joints, bones and she barely stayed up due to the pain. The patient stated if she touch her elbows it really hurted. According to the reporter she was feeling a little bit better on the day of reporting. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Tenderness
Clinical narrative: Pain all over the body; Neck pain; Joint pain/elbows it really hurt; Muscles pain; Bone pain; she barely stayed up due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received Arexvy (right arm). In NOV-2023, less than a day after receiving Arexvy, the patient experienced general body pain (Verbatim: Pain all over the body), neck pain (Verbatim: Neck pain), joint pain (Verbatim: Joint pain/elbows it really hurt), muscle pain (Verbatim: Muscles pain), bone pain (Verbatim: Bone pain) and weakness (Verbatim: she barely stayed up due to the pain). The outcome of the general body pain, neck pain, joint pain, muscle pain, bone pain and weakness were resolving.   It was unknown if the reporter considered the general body pain, neck pain, joint pain, muscle pain, bone pain and weakness to be related to Arexvy.     It was unknown if the company considered the general body pain, neck pain, joint pain, muscle pain, bone pain and weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter was the patient who stated that she received Arexvy yesterday in her right arm and she developed pain all over the body, specially neck, muscles, joints, bones and she barely stayed up due to the pain. The patient stated if she touch her elbows it really hurted. According to the reporter she was feeling a little bit better on the day of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received her second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 07 July 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter stated that a patient received her first dose of Shingrix and never received her second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Arvexy administered to preganant patient instead of other RSV vaccine; Arvexy administered to preganant patient instead of other RSV vaccine; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arvexy administered to preganant patient instead of other RSV vaccine) and wrong vaccine administered (Verbatim: Arvexy administered to preganant patient instead of other RSV vaccine). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 2-Nov-2023 Nurse would like to know if there were any studies in pregnant ladies for Arexvy.  The reporter stated that the pregnant patient received Arexvy instead of the other RSV vaccine (did not know the name), which led to vaccine exposure during pregnancy and wrong vaccine administered. The reporter stated that the patient already called in and reported to GlaxoSmithKline but was informed her health care professional would need to call for data so this was most likely a duplicate. Note, most likely given patient was pregnant, there was a good chance this was administered under approved age indication but did not confirm on call with nurse so did not add as adverse event detail. Did not consent to follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: the administration of an expired dose of Shingrix.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 5592T, expiry date 12-OCT-2023) for prophylaxis.   On 03-NOV-2023, the patient received the 1st dose of Shingrix. On 03-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: the administration of an expired dose of Shingrix.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-NOV-2023 A LVN contacted GSK via phone to inquiring about Shingrix and what information was available about the administration of an expired dose of Shingrix.  They gave partial information about vaccine, patient and event. The vaccine administration facility was the same as primary reporter. The patient received vaccine which was expired on 12th October 2023, which led to expired vaccine used. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site cellulitis, Injection site erythema, Injection site exfoliation
Clinical narrative: cellulitis at the injection site; redness, and flaky skin at the injection site; flaky skin at the injection site; patient never received the second dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 04-FEB-2021, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site cellulitis (Verbatim: cellulitis at the injection site), injection site erythema (Verbatim: redness, and flaky skin at the injection site), injection site exfoliation (Verbatim: flaky skin at the injection site) and incomplete course of vaccination (Verbatim: patient never received the second dose of Shingrix). The outcome of the injection site cellulitis, injection site erythema and injection site exfoliation were resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site erythema and injection site exfoliation to be related to Shingrix.   It was unknown if the company considered the injection site cellulitis, injection site erythema and injection site exfoliation to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-NOV-2023 The reporter reported that one of his customers received her Shingrix. The reporter reported that the patient never received the second dose of Shingrix (Inappropriate Schedule of Vaccine).  The reporter reported that the patient experienced cellulitis, redness, and flaky skin at the injection site. (no other details were known).  Lot number was not known.  The reporter wanted to know the likelihood of this same type of above reactions to the Arexvy Vaccine. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix that expired in September 2023 was administered to a patient today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAB (Twinrix) (expiry date SEP-2023) for prophylaxis.   On 07-NOV-2023, the patient received Twinrix. On 07-NOV-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Twinrix that expired in September 2023 was administered to a patient today). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2023 The health care professional (HCP) stated to a patient today (on the day reporting) Twinrix that expired in September 2023 was administered, which led to expired vaccine used. The reporter did not consent to follow-up.
Age: 25.0
Sex: M
Vaccine: FLUC4, TD
Symptoms: Discomfort, Hypotonia, Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: Pt came in for 2 vaccinations this evening and had let us know he had previous episodes of syncope with shots and blood draws.   As we verified date of birth in the imz booth, we discussed previous times and how it had affected him.  He hadn't eaten since 12:30, so I had a technician go grab some snacks so he would have them to snack on as soon as the imz was done.  He wanted both vaccines administered in the same arm so they could be done as quickly as possible.  That was done and he did well through the immunization portion.  We talked for the first minute after the imz so I could verify how he was feeling. He began to become more pale after the 1st minute of talking so I advised him I would like him to stay sitting for a while longer until he had good color and felt much better.  We continued talking and he pinked up a bit and then color drained from his lips again (about 1 minute of talking).  At this point he said he felt very heavy so I braced my hands on his shoulder.  He was breathing deeply trying to breathe past it, I asked him how he was feeling so I could gauge his response verbally and at this point he began to go limp and was not responding verbally.  I was able to ease him toward me and brace him on my leg to lower him to the floor very gently.  I was able to get him down on the floor with no impact on his head or body, at which point a local floor associate helped me adjust his position to get his legs on a chair so they would be above his heart. He was already coming to at this point.  He was passed out for less than a minute, probably 30 seconds at the most.  At this point it was 5:55 and I was able to alert my tech staff to get a manager for assistance.   I stayed with him and he was alert and aware, he had had this happen a few times before and was cognizant of everything that had happened and was going on.  When he was feeling a bit better he called his Dad to come pick him up.  We had him laying for about 10 minutes on his back with his feet elevated till he felt well enough to sit in a chair.  At this point he felt well and I felt confident he was doing better so I had a technician sit with him and give him water and snacks will observing him.  I was able to see them the entire time and verbally checked in every 5 minutes until his Dad was able to get here and pick him up.  He was very steady on his feet and we released him with his Dad and let him know we would follow up via phone tomorrow to see how he was feeling.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Crying, Depressed mood, Depression, Nausea
Clinical narrative: I've been sad, feeling depressed, nauseous and I burst out crying for no reason at all!
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus felt 2 weeks after vaccine.  Tinnitus changes pitch when jaws are moved
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Decreased appetite, Dysphagia, Feeling cold
Clinical narrative: He got his vaccine, he did not feel the shot.  There was no pain and he started having some pain afterwards.  Around 10:00 PM his wife was in the ER and he could not see her and waited to see her, and around 7:30 he started coming home and he started having chills.  He was shaking some, and got off the freeway, came home, got inside the house and started shaking like a human vibrator and his feet was shaking like he was dancing, and was moving.  His grandson told him to sit down, and continued to shake and was cold.  He went a laid down and his family got him some blankets and they took his oxygen level and his pulse rate was 139, he had no fever, and was sweating like a pig.  He was feeling really bad, but cold at the same time.  He started feeling some chest discomfort, not pain but felt something different.  He was shaking from the cold, extreme cold, freezing cold.  He called his doctor who did not give him anything to take.  He did not take anything as he could not swallow as he was shaking so bad.  His wife is on oxygen at home, so his family put him on some oxygen and it did help some.  He is not having the chills anymore, and he has loss of appetite, but that is not unusual for him.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site pain, Tremor
Clinical narrative: He got his vaccine, he did not feel the shot.  There was no pain and he started having some pain afterwards.  Around 10:00 PM his wife was in the ER and he could not see her and waited to see her, and around 7:30 he started coming home and he started having chills.  He was shaking some, and got off the freeway, came home, got inside the house and started shaking like a human vibrator and his feet was shaking like he was dancing, and was moving.  His grandson told him to sit down, and continued to shake and was cold.  He went a laid down and his family got him some blankets and they took his oxygen level and his pulse rate was 139, he had no fever, and was sweating like a pig.  He was feeling really bad, but cold at the same time.  He started feeling some chest discomfort, not pain but felt something different.  He was shaking from the cold, extreme cold, freezing cold.  He called his doctor who did not give him anything to take.  He did not take anything as he could not swallow as he was shaking so bad.  His wife is on oxygen at home, so his family put him on some oxygen and it did help some.  He is not having the chills anymore, and he has loss of appetite, but that is not unusual for him.
Age: 66.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Injection site reaction, Pain
Clinical narrative: Patient states that she has been having an intense muscle burning pain that happens 5-8 times a day stretching from where the vaccinations were administered to approximately her elbow. She states that this feeling has never happened before and set in approximately 3 days after the vaccinations were administered. She states that this feeling is "mind numbing" and stops her in her tracks
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Oedema peripheral, Vomiting
Clinical narrative: Significant arm edema and erythema Nausea/vomiting Headache
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient has not been able to move her arm since vaccines given 10/31/2023. She says her pain and movements are better but still cause pain and they are restricted.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Chest X-ray abnormal, Cough, Rhinorrhoea
Clinical narrative: Extreme mucus from nose. Constant. Constant clearing out of air passages by coughing.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out minutes after receiving  his vaccinations
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Medical assistant administered two COVID vaccines to the patient.
Age: 88.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site pain, Neuralgia, Pain, Pain in extremity
Clinical narrative: Arm pain when at certain angles. Mentions he feels like its more "nerve pain than muscle pain" Pain started at time of injection and continues at time of reporting
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Device connection issue
Clinical narrative: This adverse event occurred because of a faulty needle attachment.  I inspected the screw on needle as I have hundreds of times before attaching it to the prefilled fluzone hd.  It must have a a hairline crack in it and then the pressure of the vaccine caused it to break because when I stuck the patient and began administering the vaccine most of it squirted out of the connection between the vaccine itself and the screw on needle.  I examined the needle once the safety was on it and the plastic had a large crack down it and at the connector.  I made sure to discard any other needles from that box.  The patient was not harmed and did not require any treatment at this time.  The only concern was lack of efficacy of the vaccine since she did not get the full dose.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Heart rate increased, Tachycardia, Vertigo
Clinical narrative: 48 hours after receiving the vaccination the patient reported experiencing tachacardia and vertigo.  The patient has also had an increase in her resting pulse rate from a usual of 60 to now a resting rat of 80.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: Pt had vaccine 11/3/23 and pts mom called 11/6/23 reporting that pt reported racing heart rate and chest pain to the middle of her chest Saturday which has since resolved. Mom did manually check pt HR which was 80-90.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Pt was seen in clinic for vaccine 11/3/23, mom called 11/6/23 to report that over the weekend pt reports that her heart was racing. This has since resolved. Mom wasn't able to state how fast pt HR was at the time.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: An extra flu vaccine was given to this patient today. He had a previous flu vaccine this season on 9/11/2023. He suffered no side effects from this extra flu vaccine
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient accidentally received two doses ph Fluzone High Dose (9/13/23 and then again 11/8/23).  Promary care physician contacted patient after 2nd dose administered, patient reported NO adverse reactions.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood urine present, Haemorrhage urinary tract, Lethargy, Peripheral swelling, Pyrexia
Clinical narrative: Vaccine site pink rash, urinary bleeding, swelling in extremities, blurry vision, lethargy and fever.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis abnormal, Vaccination site discolouration, Vaccination site rash, Vision blurred
Clinical narrative: Vaccine site pink rash, urinary bleeding, swelling in extremities, blurry vision, lethargy and fever.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Nausea, Tremor, Vomiting
Clinical narrative: Chile, sweating  , body tremble and vomiting. Patient has to call EMS to emergency room. After discharged from ER, patient has nausea on the day 3 after vaccine, which last only one day.
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: For her previous vaccinations she had prolonged reactions to the vaccines.She had the worst reaction to the bivalent vaccine.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.She had the worst reaction to the bivalent vaccine.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether the patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.She had the worst reaction to the bivalent vaccine.). At the time of the report, IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.She had the worst reaction to the bivalent vaccine.) outcome was unknown.            It was unknown whether that patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine or not. No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2023-748669, MOD-2023-748676 (Patient Link).   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: The patient received 4 Moderna Covid-19 vaccines and on September 10, 2023 the patient caught Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The patient received 4 Moderna Covid-19 vaccines and on September 10, 2023 the patient caught Covid-19) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 12-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (The patient received 4 Moderna Covid-19 vaccines and on September 10, 2023 the patient caught Covid-19). At the time of the report, COVID-19 (The patient received 4 Moderna Covid-19 vaccines and on September 10, 2023 the patient caught Covid-19) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported thatpatient had lower back pain for 4 days, and fever. The Covid-19 kicked his butt said by the patient. the worst symptoms that he had were nasal coughing sneezing runny nose, headache. Patient complains to the agent of pain that went straight to my back and he was in pain for 3 days. It was like sciatic nerve pain and was pretty miserable. It took 10 days for him to feel better.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-392112 (E2B Linked Report). This case was linked to MOD-2021-392112 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-392112:Master case
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In September 2023, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   This case referred to Patient 2 out of 4 patients.  No concomitant medications were reported.  Reporter was asking how long they should wait before they can give the Spikevax to patient who had Covid in Sep2023. HCP stated that patient had previous Moderna Covid-19 vaccines.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748266:Patient 1 out of 4
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In September 2023, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.      The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter was asking how long they should wait before they can give the Spikevax to patient who had Covid in Sep2023. HCP stated that patient had previous Moderna Covid-19 vaccines.  No treatment medications were reported.  This case referred to Patient 3 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-748266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748266:master case US-MODERNATX, INC.-MOD-2023-748266:Patient 3 out of 4