chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Eye injury, Facial paralysis, Herpes zoster, Pain
Clinical narrative: Bell's palsy; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 05-JUL-2013, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).   On 04-FEB-2014, the patient suffered debilitating injuries including an outbreak of painful shingles, facial paralysis, eye injuries, and was diagnosed with Bell's palsy. Since these initial injuries manifested, the patient still experienced facial paralysis, pain and other limitations. The patient did not recover from the event. As per the reporter, the patient sustained severe and disfiguring personal injuries, suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; second dose on 12/21/2018, third dose ofGARDASIL 9, Lot #R025725/ exp. 5/25/2021, on 2/21/2019; This spontaneous report was received from a nurse regarding to patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. The nurse described that on 23-OCT-2018, the patient was vaccinated first dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #R002344 and expiry date 16-NOV-2020, the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #R002344 and expiry date 16-NOV-2020, on 21-DEC-2018, third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, lot # R025725 and expiry date 25-MAY-2021, on 21-FEB-2019,(dose, route, were not reported)for prophylaxis (inappropriate schedule of product administration). No adverse effects  and no product quality complaint reported.
Age: 74.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Faeces discoloured, Haemoglobin decreased, Inappropriate schedule of product administration, Lymphoma, Transfusion
Clinical narrative: hemoglobin level was 10 (low); black stools; lymphoma/ spot on his right kidney and his duodenum; drug dose; This case was reported by a consumer via call center representative and described the occurrence of lymphoma in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS TOXOID (TETANUS VACCINE) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blood calcium increased (received 1st dose on 26th July 2019, refer case US2019188932). Concomitant products included apixaban (Eliquis).   On 26th August 2019, the patient received the 2nd dose of Shingrix and TETANUS VACCINE. On 26th August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 11th September 2019, the patient experienced hemoglobin decreased (serious criteria hospitalization) and black stools (serious criteria hospitalization). In September 2019, the patient experienced lymphoma (serious criteria hospitalization and GSK medically significant). The patient was treated with blood transfusion, auxiliary products (Blood Transfusion). On an unknown date, the outcome of the lymphoma was not recovered/not resolved and the outcome of the hemoglobin decreased was recovered/resolved and the outcome of the black stools and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the lymphoma, hemoglobin decreased and black stools to be related to Shingrix.  Additional details were provided as follows: The patient received a 2nd dose of Shingrix on 26th August 2019, which led to shortening of vaccination schedule. The patient went in to have some blood tests and discovered that his hemoglobin level was 10 (low) and patient had black stools.  The patient's hemoglobin then decreased to 7.5. The patient was hospitalized and received a blood transfusion which increased his hemoglobin. After the blood transfusion, the patient's hemoglobin increased to 9.5 then eventually to 10.2.  The patient stated that around this time he was diagnosed with lymphoma and has a spot on his right kidney and his duodenum.  The patient will start receiving aggressive chemotherapy in 3 weeks. The reporter consented to follow up. It was unknown if the reporter considered the lymphoma, hemoglobin decreased and black stools to be related to tetanus toxoid (tetanus vaccine).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain / pain at the injection site / area was still tender; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles this year).   On 11th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient had pain at the injection site from the first shot, like someone had punched her and the area was still tender three weeks later but had since resolved. The reporter consent to follow up. For tolerance of vaccine 2nd dose, refer case US2019188921.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Extra dose administered, Headache, Pain, Pain of skin, Pyrexia
Clinical narrative: Inadvertently received a third dose of Shingrix; Wrong vaccine administered; Skin hurting; Low grade fever; Headache; All over body aches; This case was reported by a consumer via call center representative and described the occurrence of pain of skin in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on 1st July 2019, refer case US2019189772). Concomitant products included Herpes zoster (Shingrix).   On 17th October 2019, the patient received the 3rd dose of Shingrix and PNEUMONIA VACCINE. In October 2019, less than a week after receiving Shingrix and less than a month after receiving Shingrix, the patient experienced pain of skin, fever, headache and general body pain. On 17th October 2019, the patient experienced extra dose administered and wrong vaccine administered. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain of skin, fever, headache, general body pain, extra dose administered and wrong vaccine administered were unknown.   It was unknown if the reporter considered the pain of skin, fever, headache and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix intramuscular and she also inadvertently received 3rd dose of Shingrix but was supposed to just be getting a pnuemonia vaccine. She did get the pneumonia vaccine in addition to the third Shingrix, which led to extra dose administered. She noted she was experiencing her skin hurting, low grade fever, headache and all over body aches. She noted she was taking Ibuprofen. She has not notified her physician.  The reporter did not consent to follow up. This case linked with US2019190597, reported by same reporter.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Wrong product administered
Clinical narrative: Inadvertently received a third dose of Shingrix; Wrong vaccine administered; Skin hurting; Low grade fever; Headache; All over body aches; This case was reported by a consumer via call center representative and described the occurrence of pain of skin in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on 1st July 2019, refer case US2019189772). Concomitant products included Herpes zoster (Shingrix).   On 17th October 2019, the patient received the 3rd dose of Shingrix and PNEUMONIA VACCINE. In October 2019, less than a week after receiving Shingrix and less than a month after receiving Shingrix, the patient experienced pain of skin, fever, headache and general body pain. On 17th October 2019, the patient experienced extra dose administered and wrong vaccine administered. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain of skin, fever, headache, general body pain, extra dose administered and wrong vaccine administered were unknown.   It was unknown if the reporter considered the pain of skin, fever, headache and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix intramuscular and she also inadvertently received 3rd dose of Shingrix but was supposed to just be getting a pnuemonia vaccine. She did get the pneumonia vaccine in addition to the third Shingrix, which led to extra dose administered. She noted she was experiencing her skin hurting, low grade fever, headache and all over body aches. She noted she was taking Ibuprofen. She has not notified her physician.  The reporter did not consent to follow up. This case linked with US2019190597, reported by same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Arthralgia, Dizziness, Fatigue, Impaired work ability
Clinical narrative: Injection site only feels tender / Arm still tender; Dizzy / Lightheaded; Severely nauseous; Felt ill; Severe body aches; Joint pain; Unable to go to work; Tired; Weird dreams; sleep disturbances; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2019189790). Concurrent medical conditions included ulcerative colitis.   On 16th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced tiredness, bizarre dreams, sleep disturbance and fever. On 17th October 2019, the patient experienced injection site tenderness, dizziness, nausea, malaise, general body pain, joint pain and inability to work. The patient was treated with ibuprofen and VITAMIN B NOS (VITAMIN B INJECTION). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site tenderness, fever and nausea were recovered/resolved and the outcome of the tiredness and dizziness were not recovered/not resolved and the outcome of the bizarre dreams, sleep disturbance, malaise, general body pain, joint pain and inability to work were unknown.   It was unknown if the reporter considered the injection site tenderness, tiredness, bizarre dreams, sleep disturbance, fever, dizziness, nausea, malaise, general body pain, joint pain and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she began to feel tired. She went to bed and described that she started to had weird dreams. She said that she tossed and turned during the night. The patient took her temperature and it was 103 degrees Fahrenheit. She ate some crackers and took Ibuprofen and went back to bed. The patient noted that her temperture as down to 100.1 degrees Fahrenheit. She had severe body aches, describing the she had joint pain, too. She was severely nauseous, dizzy, and lightheaded, too. She was unable to go to work that day because she felt ill. She still feels dizzy and lightheaded today but has no other symptoms other than her arm was tender. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter unable to obtain additional information. The reporter indicated that she received Vitamin B shot at the same time she received the Shingrix.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Injection site only feels tender / Arm still tender; Dizzy / Lightheaded; Severely nauseous; Felt ill; Severe body aches; Joint pain; Unable to go to work; Tired; Weird dreams; sleep disturbances; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2019189790). Concurrent medical conditions included ulcerative colitis.   On 16th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced tiredness, bizarre dreams, sleep disturbance and fever. On 17th October 2019, the patient experienced injection site tenderness, dizziness, nausea, malaise, general body pain, joint pain and inability to work. The patient was treated with ibuprofen and VITAMIN B NOS (VITAMIN B INJECTION). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site tenderness, fever and nausea were recovered/resolved and the outcome of the tiredness and dizziness were not recovered/not resolved and the outcome of the bizarre dreams, sleep disturbance, malaise, general body pain, joint pain and inability to work were unknown.   It was unknown if the reporter considered the injection site tenderness, tiredness, bizarre dreams, sleep disturbance, fever, dizziness, nausea, malaise, general body pain, joint pain and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she began to feel tired. She went to bed and described that she started to had weird dreams. She said that she tossed and turned during the night. The patient took her temperature and it was 103 degrees Fahrenheit. She ate some crackers and took Ibuprofen and went back to bed. The patient noted that her temperture as down to 100.1 degrees Fahrenheit. She had severe body aches, describing the she had joint pain, too. She was severely nauseous, dizzy, and lightheaded, too. She was unable to go to work that day because she felt ill. She still feels dizzy and lightheaded today but has no other symptoms other than her arm was tender. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter unable to obtain additional information. The reporter indicated that she received Vitamin B shot at the same time she received the Shingrix.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Injection site only feels tender / Arm still tender; Dizzy / Lightheaded; Severely nauseous; Felt ill; Severe body aches; Joint pain; Unable to go to work; Tired; Weird dreams; sleep disturbances; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2019189790). Concurrent medical conditions included ulcerative colitis.   On 16th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced tiredness, bizarre dreams, sleep disturbance and fever. On 17th October 2019, the patient experienced injection site tenderness, dizziness, nausea, malaise, general body pain, joint pain and inability to work. The patient was treated with ibuprofen and VITAMIN B NOS (VITAMIN B INJECTION). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site tenderness, fever and nausea were recovered/resolved and the outcome of the tiredness and dizziness were not recovered/not resolved and the outcome of the bizarre dreams, sleep disturbance, malaise, general body pain, joint pain and inability to work were unknown.   It was unknown if the reporter considered the injection site tenderness, tiredness, bizarre dreams, sleep disturbance, fever, dizziness, nausea, malaise, general body pain, joint pain and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she began to feel tired. She went to bed and described that she started to had weird dreams. She said that she tossed and turned during the night. The patient took her temperature and it was 103 degrees Fahrenheit. She ate some crackers and took Ibuprofen and went back to bed. The patient noted that her temperture as down to 100.1 degrees Fahrenheit. She had severe body aches, describing the she had joint pain, too. She was severely nauseous, dizzy, and lightheaded, too. She was unable to go to work that day because she felt ill. She still feels dizzy and lightheaded today but has no other symptoms other than her arm was tender. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter unable to obtain additional information. The reporter indicated that she received Vitamin B shot at the same time she received the Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Vaccine positive rechallenge
Clinical narrative: Pain under armpit; This case was reported by a nurse and described the occurrence of axillary pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles last October that presented with severe pain under armpit and rash upper left back), axillary pain and rash (rash on upper left back). Previously administered products included Shingrix with an associated reaction of axillary pain (received 1st dose on 25th July 2019, refer case US2019AMR190719), antiviral and prednisone.   On 17th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced axillary pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the axillary pain was unknown.   It was unknown if the reporter considered the axillary pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was anxious to get the Shingrix vaccine to lessen the chance of ever get Shingles.  The patient received Shingrix and experienced the pain under armpit that the patient had when she got shingles.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 96-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 98 or 97 years old at time of vaccination. The patient was diagnosed with shingles after having received two doses of Shingrix (both doses administered less than 6 months apart). The patient received the second dose of Shingrix more than 30 days before shingles diagnosis. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Redness at the site; Wrong Route of Administration; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 1st July 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received her 1st Shingrix shot as a subcutaneous injection, which led to intramuscular formulation administered by other route. The patient reported redness at the site that lasted for most of the summer. The patient did notify her physician of that dosing, but he noted it was fine to receive it subcutaneous.   The reporter did not consent to follow up. This was considered as medication error associated with the adverse event. This case linked with US2019AMR190377, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Rash
Clinical narrative: Hurt after the injection; Burned after the injection; Pattients experience rash after the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, burn and rash. On an unknown date, the outcome of the pain and burn were unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the pain, burn and rash to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. During the call, the pharmacist initially mentions that she had patients experience rash after the vaccine, But later the reporter, clarifies that she has no patient details available. The patients in general have called the pharmacy and reported it hurt and burned after the injection. Pharmacist adds she has not seen a patient develop rash afterwards.  The reporter did not consent to follow up. The pharmacist stated that she has no further details and declines follow up. This case linked with US2019AMR190427, reported by same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain
Clinical narrative: Redness on neck; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and lymph node excision (Left side lymph node removed).   On 19th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 20th August 2019, the patient experienced red neck. On 20th August 2019, the outcome of the injection site pain was recovered/resolved. On 22nd August 2019, the outcome of the red neck was recovered/resolved.   It was unknown if the reporter considered the injection site pain and red neck to be related to Shingrix.  Additional Deatils were provided as follows: The patient received dose of Shingrix in the right arm. The patient palnned to follow up with physician on an unknown date. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pain, Tongue ulceration
Clinical narrative: cluster of ulcers on her tongue and under her tongue; could not walk because her right knee was hurting; fatigue; achy; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hepatitis c.   On 14th October 2019, the patient received the 1st dose of Shingrix. On 14th October 2019, less than a day after receiving Shingrix, the patient experienced fatigue and pain. On 15th October 2019, the patient experienced tongue ulceration and knee pain. On an unknown date, the outcome of the fatigue, pain, tongue ulceration and knee pain were unknown.   It was unknown if the reporter considered the fatigue, pain, tongue ulceration and knee pain to be related to Shingrix.  Additional details were provided as follows: The patient stated that many years ago she had a diagnosis of hepatitis C for which she was treated. The patient stated that she received the first dose of the Shingrix vaccine from the doctor's office and started to feel fatigue and achy. The patient not walk because her right knee was hurting. The patient to see cluster of ulcers on her tongue and under her tongue.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Myocardial infarction
Clinical narrative: Heart Attack; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced heart attack (serious criteria death and GSK medically significant). On an unknown date, the outcome of the heart attack was fatal. The reported cause of death was heart attack.   It was unknown if the reporter considered the heart attack to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient was over 75 years. The patient received Shingrix at some point had a heart attack and died. The reporter did not give consent for follow up. This is 1 of 3 cases reported.; Reported Cause(s) of Death: Heart attack
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Vaccine Administered at Inappropriate Site; Warmth; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received Shingrix. In October 2019, less than a month after receiving Shingrix, the patient experienced injection site warmth and injection site erythema. On 19th October 2019, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site warmth, injection site erythema and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The pharmacist states that a patient received Shingrix on Saturday and thought that it was administered at an area lower than the deltoid on left arm, which led to vaccine administered at inappropriate site.  She was inquiring if there was any efficacy results if Shingrix was administered at a site other than the deltoid.  Caller also mentioned that the arm was warm and there was redness around the injected area. The reporter consented to follow up.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received Fluzone HD 3 weeks ago and he went to the doctor received another dose / no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient who had received two doses within  3 week of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and Exp. Date not reported) via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to extra dose administered.   It was reported that received Fluzone HD 3 weeks ago and he went to the doctor received another dose.  At the time of reporting, the patient had no adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand dollar; localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand dollar; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA290939 (same reporter).  This case involves a 26 years old female patient who experienced localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand dollar (inflammation) and (vaccination site reaction), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ269AB/UJ255AB, expiry date: 30-Jun-2020 via unknown route in the left deltoid.  On an unknown date, the patient experienced a non-serious localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand dollar (inflammation) and (vaccination site reaction) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Doctor visit and date 15-Oct-2019.   (Other relevant tests included no lab data.)  Final diagnosis was localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand dollar.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: a 9-year-old male received a dose of Fluzone QIV while injecting staff held the injection site in a pinch, administered the dose, did not release the site pinch and removed needle, removed the needle vaccine squirted out in her mouth and lip/No AE; a 9-year-old male received a dose of Fluzone QIV while injecting staff held the injection site in a pinch, administered the dose, did not release the site pinch and removed needle, removed the needle vaccine squirted out in her mouth and lip/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case is linked to case 2019SA295224 (same reporter).  This case involves a nine years old male patient who a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE], while injecting staff held the injection site in a pinch, administered the dose, did not release the site pinch and removed needle, removed the needle vaccine squirted out in her mouth and lip lot UJ255AA via intramuscular route in the left arm on 16-Oct-2019, expiry date not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of vaccine underdose.  It was an actual medication error due to Wrong technique in product usage process.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 15 years old female patient received a dose of Flublok Quadrivalent vaccine/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA291168 and 2019SA291169 (same reporter).  This case involves a 15 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1910, expiry date: 26-Jun-2020, via intramuscular route in the left arm on 14-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 14 years old male patient received a 0.5 ml dose of Flublok Quadrivalent/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA291128 and 2019SA291169 (same reporter).  This case involves a 14 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1910, expiry date: 26-MAY-2020 via intramuscular route in the left arm on 14-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient recieved HEPATITIS A VACCINE as concomitant medication.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 17 years old male patient received dose of Flublok Quadrivalent/ No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA291128 and 2019SA291168 (same reporter).  This case involves a 17 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1910, expiry date: 26-MAY-2020 via intramuscular route in the left arm on 14-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE).  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the Flublok Quadrivalent was accidentally administered to a 13 year old/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA295399 same reporter.  This case involves a 13 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Left arm began hurting and continued and  early evening started swelling, hot to touch and redness down arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site nodule, Myalgia, Nausea
Clinical narrative: muscle soreness - within 24 hours and still remains after 4 days, knot at injection site- within 24 hours & still remains after 4 days, headache - within 3 hours -& lasting for 3 days , neck pain - within  24 hours & lasting for 3 days , fatigue - within 24 hours & lasting 3 days, nausea - within 24 hours & lasted 1 day, itching - began on day 3 and remains on day 4.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pruritus
Clinical narrative: muscle soreness - within 24 hours and still remains after 4 days, knot at injection site- within 24 hours & still remains after 4 days, headache - within 3 hours -& lasting for 3 days , neck pain - within  24 hours & lasting for 3 days , fatigue - within 24 hours & lasting 3 days, nausea - within 24 hours & lasted 1 day, itching - began on day 3 and remains on day 4.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: The patient likely received an additional Shingrix vaccination above the recommended 2 (two) doses of the complete Zoster (Shingles) vaccination series, with the additional dose being given at her Primary Care Physician?s office. It appears that due to a problem in the connection between our computer system and the state?s vaccination registry, the patients Primary Care Physician would not have been aware that she had already completed a Shingrix vaccination series at another office.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt. called in to office to report that her entire upper arm is "still sore" 9 days after vaccine was given.  Pt. denies any redness, swelling or drainage at site.  Denies any fever or other signs/symptoms of illness.
Age: 53.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Mesenteric panniculitis
Clinical narrative: 48 hours post vaccine administration of Flublok and Shingrix, patient developed mesenteric panniculitis. Outcome unknown
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Papular red rash around the site approximately 10 days after injection
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: A quality assurance analysis has revealed that this patient likely received an additional Shingrix vaccination above the recommended 2 (two) doses of the complete Zoster (Shingles) vaccination series, with the additional doses being given at her Primary Care Physician?s office.  In a good faith effort for full disclosure, it appears that due to a problem in the connection between our computer system and the state?s vaccination registry, her Primary Care Physician would not have been aware that she had already completed a Shingrix vaccination series at another office.
Age: 19.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Injection site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: Woke up the day after being vaccinated (10/24/19) and noticed a small circle of redness with a lump at site of vaccine.  The next day (10/25/19)it got bigger.  Patient marked the area.  Patient states today (10/25/19)it is warm to the touch.  Patient says she took  benadryl the day after being vaccinated (10/24/19) but that it didn't help.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hot flush, Throat irritation, Urticaria
Clinical narrative: Hives on upper body, hot flashes, scratchy throat, questionable throat swelling
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: A quality assurance analysis has revealed that this patient likely received an additional Shingrix vaccination above the recommended 2 (two) doses of the complete Zoster (Shingles) vaccination series, with the additional dose being given at her Primary Care Physician?s office.  In a good faith effort for full disclosure, it appears that due to a problem in the connection between our computer system and the vaccination registry, her Primary Care Physician would not have been aware that she had already started a Shingrix vaccination series elsewhere.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Muscular weakness, Pain, Pyrexia, Rash
Clinical narrative: CHILLS, FEVER (UP TO 103) ACHES, WEAK LEGS, RASH ON RIGHT LEG, TOOK TYLENOL FOR FEVER, STILL ACHY BUT IMPROVING
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: I  GOT A STIFF NECK THAT EVENING THAT LED TO A SEVERE HEADACHE AND NAUSEA  WITH LITTLE ENERGY FOR  4 -5 DAYS
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: A quality assurance analysis has revealed that the patient likely received an additional Shingrix vaccination above the recommended 2 (two) doses of the complete Zoster (Shingles) vaccination series, with the additional dose being given at doctor's office.  In a good faith effort for full disclosure, it appears that due a problem in the connection between our computer system and the state?s vaccination registry,  our office would not have been aware that she had already finished her Shingrix vaccination series at her Primary Care Physician?s office.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT STATES THAT AT TIME OF VACCINATION IT HURT AND CONTINUED TO HURT AREA THEN BECAME RED HOT TO TOUCH AND VERY SORE
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms; the patient was vaccinated with expired PNEUMOVAX 23; This spontaneous report as received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-OCT-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R012713, expiration date: 03-AUG-2019 (dose and route of administration were not provided) for prophylaxis. No adverse symptoms were reported.