chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: itching at injection site; chills; fatigue; Injection site warmth; redness surrounding injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included spondylolysis. Concomitant products included phentermine, topiramate (Qsymia).   On 4th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, chills, fatigue and injection site warmth. On 8th September 2019, the patient experienced injection site itching. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site itching, chills, fatigue and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching, chills, fatigue and injection site warmth to be related to Shingrix.  Additional information received were as follows: At around noon, the patient received Shingrix. The day after vaccination, the patient experienced redness at the injection site. The day after vaccination, the patient experienced chills and fatigue. The patient reported that the redness surrounding the injection has become larger, described as about 4 by 4 inches. The site had become itchy. The patient reported that she was given Symia loading doses in May 2019 but stopped in the summer, around June with her new physician. The redness was not improved and becoming worse at time of report. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: at the injection site and below the injection site, there was redness and warmth; at the injection site and below the injection site, there was redness and warmth; soreness at injection site; fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On 14th September 2019, the patient experienced injection site warmth and injection site erythema. In September 2019, the patient experienced fatigue. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were recovering/resolving and the outcome of the fatigue was resolved with sequelae.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient stated that he developed soreness at the injection site shortly after receiving the vaccine. The patient also noticed that at the injection site and below the injection site, there was redness and warmth and experienced fatigue that lasted for 1-2 days. The patient consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site induration
Clinical narrative: Area of induration; Area of induration described as large and red; Wrong route of Administration; This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site induration, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site induration, injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site induration and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Nurse reported Shingrix was administered subcutaneously, which led to incorrect route of vaccine administration. Nurse reports an area of induration noted following dose two of Shingrix series. Area of induration described as large and red.  HCP declined to provide demographic or contact details. HCP declined to complete full report. This was a medication error with harm.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Shooting pain in arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2019, the patient received the 1st dose of Shingrix. On 5th July 2019, 2 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had experienced shooting pain in his arm since two days after the injection. The pain shoots down the patients left arm when he raises the arm. The reporter stated that the pain resolves when the arm is lowered, but returns when arm is raised again. The patient had not sought treatment from a physician as of the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: TYP
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: severe allergic reaction to TYPHOID VACCINE; Initial information received on 18-Sep-2019 regarding an unsolicited valid serious case received from Nurse via other company Merck (Non Licensed Partner) in the form of courtesy.  This case involves an unspecified patient of an unknown age who experienced severe allergic reaction to typhoid vaccine (allergy to vaccine), while he/she received vaccine TYPHOID VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect TYPHOID VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious severe allergic reaction to typhoid vaccine (allergy to vaccine) (Unknown latency) following the administration of TYPHOID VACCINE. The patient required hospitalization for this event.  (Other relevant tests included no lab data.)  Final diagnosis was severe allergic reaction to typhoid vaccine.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for severe allergic reaction to typhoid vaccine.  Information on the batch number was requested.  Documents held by sender: none.; Sender's Comments: This case concerns an unspecified patient of an unknown age who experienced allergy to TYPHOID VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: Redness to injection site of left thigh, noticed 9/18/2019.  Mild warmth to the area, tender to the area as well reported by family. Provider notes from 9/19/2019: positive erythematous lesion approximately 9 cm in diameter upper lateral region of left thigh, two small injection sites noted central of lesion approximately 1 inch apart. No induration noted, very mild warm to touch, no tenderness noted with palpation.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Ear pruritus, Headache, Nausea
Clinical narrative: Extreme chills & shaking - lasted for an hour Killer headache - lasted all night Aches in hips & knees I felt like I had to throw up, but didn't. Ears were itchy inside.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Extreme chills & shaking - lasted for an hour Killer headache - lasted all night Aches in hips & knees I felt like I had to throw up, but didn't. Ears were itchy inside.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling , redness and warmth in left arm down to the elbow
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Lethargy, Pain
Clinical narrative: Arm soreness began last night. This morning I woke up with flu like symptoms, soreness, headache, lethargy, chills.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness began last night. This morning I woke up with flu like symptoms, soreness, headache, lethargy, chills.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Injection site induration, Injection site swelling, Urticaria
Clinical narrative: Patient developed hives that resolved over the course of 36 hours without treatment. Patient developed swelling and induction at injection site on left thigh 0.5 cm x 0.5 cm. Resolved without tx.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event reported by pt, error found in facility vaccine stock indicating a probable administration of two liquid components of Menveo vaccine with no dry component mixed in.  Unable to determine which documented  pt may have received the erroneous dose.  Will re-vaccinate patient to ensure appropriate immunity.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event reported by pt.  Likely erroneous dose on menveo containing two liquid components administered from this box, unable to determine which pt received the probably erroneous dose.  All patients to be re-vaccinated to ensure appropriate immunity.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event reported by pt.  Likely erroneous dose on menveo containing two liquid components administered from this box, unable to determine which pt received the probably erroneous dose.  All patients to be re-vaccinated to ensure appropriate immunity.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia
Clinical narrative: Patient has developed insomnia
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chest pain, Chills, Headache, Nausea
Clinical narrative: headache, nausea, neck and back pain that progressed into full body pain, chills, fever of 102, chest pain for a period of roughly 30 min
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: headache, nausea, neck and back pain that progressed into full body pain, chills, fever of 102, chest pain for a period of roughly 30 min
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Influenza virus test, Pyrexia, Rash
Clinical narrative: Fever went up to 104.7 Welts /bumps all over her face Dizziness/weakness Took her to urgent care then to the hospital...she never gets a fever.  Her fever went up quickly...within a couple of hours and she got welts all over her face (I have pictures).  Urgent care had us take her to the hospital.  They tested her for a bunch of stuff which turned out negative.  They gave her IV's and released her a few hours later when her fever came down.    In the end we believe it was the HPV shot.  A few OB/GYNs tell us that they have seen this with the HPV Vaccinations.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Streptococcus test, Urticaria
Clinical narrative: Fever went up to 104.7 Welts /bumps all over her face Dizziness/weakness Took her to urgent care then to the hospital...she never gets a fever.  Her fever went up quickly...within a couple of hours and she got welts all over her face (I have pictures).  Urgent care had us take her to the hospital.  They tested her for a bunch of stuff which turned out negative.  They gave her IV's and released her a few hours later when her fever came down.    In the end we believe it was the HPV shot.  A few OB/GYNs tell us that they have seen this with the HPV Vaccinations.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This patient only at our location for Shingrix.  By phone message, states developed shingles approx 2 weeks following injection requiring antiviral treatment by his physician.  Will contact patient and ask him to contact VAERs to give more detailed personal info.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, PPV, RV1
Symptoms: Atonic seizures, Infantile spasms, Petit mal epilepsy, Retinogram
Clinical narrative: Infantile Spasms, drop head seizures, stare seizures,
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effect; administered a dose of VARIVAX today via intramuscular injection; This spontaneous report was received from a pharmacist (patient) of unknown age referring to herself. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form, intramuscularly (lot# and expiry date were not reported) for prophylaxis (Incorrect route of product administration). No adverse events were reported. No product quality complaint was involved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes simplex, Oral herpes
Clinical narrative: Eruption of Herpes Simplex; cold sores; This case was reported by a pharmacist via call center representative and described the occurrence of herpes simplex in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (are usually brought on by sun exposure or a fever).   On 22nd August 2019, the patient received Shingrix. On 26th August 2019, 4 days after receiving Shingrix, the patient experienced herpes simplex and cold sores. On an unknown date, the outcome of the herpes simplex and cold sores were unknown.   It was unknown if the reporter considered the herpes simplex and cold sores to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that the patient experienced an eruption of herpes simplex four days after Shingrix vaccine.  The reporter stated that cold sores are usually brought on by sun exposure or a fever but patient experienced followed Shingrix vaccination. The reporter consented to follow up.  Clarification has been raised for event onset date for eruption of herpes simplex whether it is 28th August 2019 or 26th August 2019.
Age: 69.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Muscle spasms, Pain, Periarthritis, Somnolence
Clinical narrative: soreness developed within 2 hours  .  Muscle spasms developed shortly after a.c. well as a frozen shoulder and severe pain.  Called pharmacist around 3:00 and suggested ibuprofen as a ice.  24 hours and sleepiness painful night spasms are less but frozen shoulder. Pain persists.
Age: 69.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Muscle spasms, Muscle twitching
Clinical narrative: soreness developed within 2 hours  .  Muscle spasms developed shortly after a.c. well as a frozen shoulder and severe pain.  Called pharmacist around 3:00 and suggested ibuprofen as a ice.  24 hours and sleepiness painful night spasms are less but frozen shoulder. Pain persists.
Age: 69.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Muscle spasms, Pain, Periarthritis, Somnolence
Clinical narrative: Patient called the pharmacy on 9/23/19, approximately 5 hours after receiving vaccinations and stated that the deltoid she received the pneumovax 23 in was experiencing pain and the deltoid muscle was twitching/in spasms.  I asked if she had any bruising or swelling at the injection site, she stated no. I asked if she was having any rashes or difficulty breathing, she said no.  I suggested using ice on the area and taking ibuprofen and informed her I would be following up with her the next day. Upon calling her the next day (9/24/19), patient informed me that the twitching/spasm stopped but the pain still persisted, so she was going to wait and additional 24 hours and if still in pain will follow up with her primary doctor. She also told me she contacted VAERS. I informed her I would follow up again with her on 9/25/19 and faxed her vaccine record to VAERS.
Age: 69.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Muscle spasms, Muscle twitching
Clinical narrative: Patient called the pharmacy on 9/23/19, approximately 5 hours after receiving vaccinations and stated that the deltoid she received the pneumovax 23 in was experiencing pain and the deltoid muscle was twitching/in spasms.  I asked if she had any bruising or swelling at the injection site, she stated no. I asked if she was having any rashes or difficulty breathing, she said no.  I suggested using ice on the area and taking ibuprofen and informed her I would be following up with her the next day. Upon calling her the next day (9/24/19), patient informed me that the twitching/spasm stopped but the pain still persisted, so she was going to wait and additional 24 hours and if still in pain will follow up with her primary doctor. She also told me she contacted VAERS. I informed her I would follow up again with her on 9/25/19 and faxed her vaccine record to VAERS.
Age: 12.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Abdominal pain, Fatigue, Headache, Hypoaesthesia, Lethargy
Clinical narrative: lethargy, nausea, blurred vision, headache, abdominal pain, throwing up, numbness/tingling/pain in legs  Injections given on 8/4/2016 and 11/23/2016.  Headache and lethargy began after first injection, but remaining symptoms began after 2nd injection.  The pain in her legs and blurred vision resolved, but the remaining symptoms persist.  We are now nearly 3 years later and she is vomiting at least 2 days each week, sometimes more.  She has frequent headaches and is tired often.  She has missed many days of school each year - enough that we get letters from the school about her attendance.
Age: 12.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Loss of personal independence in daily activities, Nausea, Paraesthesia, Vision blurred, Vomiting
Clinical narrative: lethargy, nausea, blurred vision, headache, abdominal pain, throwing up, numbness/tingling/pain in legs  Injections given on 8/4/2016 and 11/23/2016.  Headache and lethargy began after first injection, but remaining symptoms began after 2nd injection.  The pain in her legs and blurred vision resolved, but the remaining symptoms persist.  We are now nearly 3 years later and she is vomiting at least 2 days each week, sometimes more.  She has frequent headaches and is tired often.  She has missed many days of school each year - enough that we get letters from the school about her attendance.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head normal, Hallucination, Toxicologic test normal
Clinical narrative: Approximately 3 hours after receiving Gardasil vaccine, patient's mother reports patient is hallucinating.  Denies chest pains, shortness of breath, palpitations or vomiting.  Patient was taken to the nearest ED for assessment.  Patient was seen in PCP's office for follow up 2 days later.
Age: 66.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Axillary pain, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Sore arm at injection site all the way around to arm pit, still sore after 3 days,  chills, fever of 102.5, muscle aches and pains, head ache, lasted for 24 hours
Age: 66.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Sore arm at injection site all the way around to arm pit, still sore after 3 days,  chills, fever of 102.5, muscle aches and pains, head ache, lasted for 24 hours
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Dizziness, Fatigue, Mobility decreased
Clinical narrative: Within 2 hrs of injection - extreme fatigue Within 8 hrs - fever/chills/nausea/body aches/lightheadness, arm became so stiff/sore that I could barely lift it  It has been 48 hrs and the chills have stopped Treatment - Acetaminophen, drinking lots of water, bed rest (24 hrs)
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: Within 2 hrs of injection - extreme fatigue Within 8 hrs - fever/chills/nausea/body aches/lightheadness, arm became so stiff/sore that I could barely lift it  It has been 48 hrs and the chills have stopped Treatment - Acetaminophen, drinking lots of water, bed rest (24 hrs)
Age: 11.0
Sex: M
Vaccine: HPV9, MMRV, MNQ, TDAP
Symptoms: Rash, Streptococcus test negative
Clinical narrative: Parent report patient experienced a rash the evening of 9/12/19. He was given vaccines on 9/11/19. Rash was on his trunk, front and back, extending down to groin. Rash spared arms, face, buttocks and lower extremities.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Mobility decreased, Pyrexia
Clinical narrative: CHILLS, FEVER,  SHE CANNOT HOLD HER ARM UP
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Axillary pain, Contusion, Fluid retention, Headache
Clinical narrative: Fever; Flu-like symptoms (including upset stomach,, headache, muscle aches, and sore throat), Pain at injection site that radiated under arm all the way down to hand; bruising from left armpit down left side of left breast; extreme pain in armpit; "fluid pocket" between armpit and left breast; lymph node inflammation under left arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Influenza like illness, Injection site pain, Myalgia, Oropharyngeal pain
Clinical narrative: Fever; Flu-like symptoms (including upset stomach,, headache, muscle aches, and sore throat), Pain at injection site that radiated under arm all the way down to hand; bruising from left armpit down left side of left breast; extreme pain in armpit; "fluid pocket" between armpit and left breast; lymph node inflammation under left arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Flu-like symptoms (including upset stomach,, headache, muscle aches, and sore throat), Pain at injection site that radiated under arm all the way down to hand; bruising from left armpit down left side of left breast; extreme pain in armpit; "fluid pocket" between armpit and left breast; lymph node inflammation under left arm.
Age: 1.75
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot
Clinical narrative: redness and warmth
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Patient received the flu shot on 09/12/2019, and 5 hours later after getting the shot the patient experienced violent tremors over the whole body. She also experienced significant nausea without vomiting and dry heaving. Patient almost called the ambulance  but instead took 1mg of ativan. Her symptoms seemed to resolve. On the next day she was fine during the day but at night she developed a high fever.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Cough, Eye irritation, Eye swelling
Clinical narrative: Started off with a heavy chest and dry cough.  Then nausea and chills began.  Around 4pm my eyes began to swell and became extremely blood shot.  Both of my eyes still look like I have double pink eye and burn.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Ocular hyperaemia
Clinical narrative: Started off with a heavy chest and dry cough.  Then nausea and chills began.  Around 4pm my eyes began to swell and became extremely blood shot.  Both of my eyes still look like I have double pink eye and burn.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness, Ear infection viral
Clinical narrative: Patient said that night after the flu shot she started losing her hearing.  It got worse the next day.  She went to the doctor and said she now has a viral infection in the ear damaging
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Erythema of eyelid, Eyelid irritation, Pyrexia
Clinical narrative: Eyelids red and burning, fever and chills, coughing, vomiting, headache.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Eyelids red and burning, fever and chills, coughing, vomiting, headache.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity, Tendonitis
Clinical narrative: Acute pain in left elbow (tendinitis) followed by stiffness in left shoulder; joint achy/stiffness in left wrist, ankle and knee.  By morning, left arm stiff and painful
Sex: M
Vaccine: HPV4
Symptoms: Anogenital warts, Biopsy skin abnormal, Papule, Penile haemorrhage, Pruritus genital
Clinical narrative: Gardasil used for condyloma accuminata; This literature marketed report was received from the authors of a published literature article, titled as stated below, and refers to a 9-year-old male patient. On an unreported date, the previously healthy boy presented to dermatology with his mother for a lesion on his penis with a recent history of itching and bleeding. On exam, there was a 6x7 mm brown papule on the shaft of his penis surrounded by smaller papules. The area was biopsied and pathology reported condyloma accuminata positive for Human Papillomavirus (HPV) 6 and 11, and negative for HPV 16 and 18. Upon further questioning, the patient's mother reported that she was serum positive for HPV; however, she and the patient's siblings were not clinically affected. The mother was educated on routes of transmission of HPV and denied any knowledge of prior sexual abuse. Laboratory Sexually Transmitted Infection (STI) studies were ordered and the patient was returned to primary care for further care and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination.   A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HPV4
Symptoms: Skin lesion
Clinical narrative: Gardasil used for condyloma accuminata; This literature marketed report was received from the authors of a published literature article, titled as stated below, and refers to a 9-year-old male patient. On an unreported date, the previously healthy boy presented to dermatology with his mother for a lesion on his penis with a recent history of itching and bleeding. On exam, there was a 6x7 mm brown papule on the shaft of his penis surrounded by smaller papules. The area was biopsied and pathology reported condyloma accuminata positive for Human Papillomavirus (HPV) 6 and 11, and negative for HPV 16 and 18. Upon further questioning, the patient's mother reported that she was serum positive for HPV; however, she and the patient's siblings were not clinically affected. The mother was educated on routes of transmission of HPV and denied any knowledge of prior sexual abuse. Laboratory Sexually Transmitted Infection (STI) studies were ordered and the patient was returned to primary care for further care and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination.   A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: MENB, MNQ, MNQ
Symptoms: Asthenia, Blood test, Extra dose administered, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Extra dose administered; weakness; fatigue; Inappropriate Schedule of vaccine administered; This case was reported by a nurse via sales rep and described the occurrence of weakness in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Menveo (received 1st dose in 2015.). Concomitant products included Men B NVS (Bexsero).   On 15th July 2019, the patient received the 2nd dose of Menveo. On 16th August 2019, the patient received the 3rd dose of Menveo and the 2nd dose of Bexsero. On 15th July 2019, unknown after receiving Menveo, not applicable after receiving Menveo and Bexsero and an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long. In August 2019, the patient experienced weakness and fatigue. On 16th August 2019, the patient experienced extra dose administered. The patient was treated with steroids nos (Steroid Pack (Nos)). On an unknown date, the outcome of the weakness, fatigue, drug dose administration interval too long and extra dose administered were unknown.   It was unknown if the reporter considered the weakness and fatigue to be related to Menveo and Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. On 15th July 2019, the patient received 2nd dose of Menveo which led to lengthening of vaccination schedule. The patient received 3rd dose of Menveo by accident, which led to extra dose administered. The patients mom reported weakness and fatigue. The blood drawn to check for infection and gave patient steroid pack to reduce reaction to vaccines. The reporter gave permission to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site urticaria
Clinical narrative: Drug dose administration interval too long; Injection site whelp; This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose in September 2018 and experienced a slight shingles outbreak).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site wheal and drug dose administration interval too long. On an unknown date, the outcome of the injection site wheal was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix in August 2019, which led to lengthening of vaccination schedule. The patient experienced a 3 inch whelp on her arm at site of injection that has improved but not completely resolved after 3 weeks. The patient consented to follow up. This case has been linked with case US2019159147, reported by the same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Reactions at the site of Injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st September 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 6 months after receiving Boostrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had reactions at the site of injection with Boostrix. The batch number reported for Boostrix(43E47) did not exist and was updated to 43E4T, as per sales database. The reporter consented to follow up. This was one of the 6 cases, reported by the same reporter.
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Swelling; red at the injection site; flu like symptoms; This is a spontaneous report from a contactable Physician via Pfizer Sales Representative.  A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced swelling, red at the injection site and flu like symptoms. The events were non-serious with outcome of unknown.  The information on the batch number has been requested
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: You will need to contact pharmacy for vaccine information.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Electrocardiogram, Headache, Lethargy, Loss of consciousness
Clinical narrative: vomiting, passed out, extended (3-days) pain, headache, lethargic and bedridden   Could not continue clinic visit.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: vomiting, passed out, extended (3-days) pain, headache, lethargic and bedridden   Could not continue clinic visit.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: STARTED WITH SYMPTOMS ON 9/13/2019: REPORTS PULSATING B/L ARMS WITH PAIN, FATIGUE & HA'S AFTER RECEIVING VACCINE
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Immune thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: developed a petechial rash ~ 1 week after vaccines, diagnosed with Idiopathic thrombocytopenic purpura (HCC)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Pain in extremity
Clinical narrative: Patient woke up in night with arm in extreme pain when she rolled over on it. Left arm was swollen from shoulder to elbow. By the following morning she had swelling in her lymphnodes under the left arm and towards her left breast. She had no pain with movement of the arm but it was painful to touch.  She went to see her primary care provider on Monday, September 23rd. They decided to prescribe an oral steroid and as nsaid for the swelling, They determined it was a localized reaction to the vaccine. Dr has recommended patient come to office for prophylactic steroid prior to administration of second dose.
Age: 52.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Sepsis
Clinical narrative: Pt went septic.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Blood electrolytes, Blood potassium, Burning sensation, Chest pain, Ear swelling
Clinical narrative: According to my after visit summary, I received the Infuenza Quadrivalent P-Free flu shot.  At approximately 6:50 p.m., my hands started itching and burning.  Within 20 minutes, it went from 0 to 100.  I had hives from my head to my feet, swollen face, lips, ears, nose, neck and was red as a tomato.  After about 20 minutes, it affected my breathing and I started throwing up.  I went to the ER which is one block away from my home.  I was seen the ER doctor in the trauma room.  I was given epinephrine, steroids, benadryl, and a breathing treatment.  Today I pickup up prescriptions prednizone, benadryl, and two epi pens that were prescribed by ER doctor.  I am missing work today because I feel like I had a heart attack last night, not to mention I almost died.  Today suffering from chest pain, throat pain, and an awful headache.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Headache, Impaired work ability, Lip swelling, Oropharyngeal pain
Clinical narrative: According to my after visit summary, I received the Infuenza Quadrivalent P-Free flu shot.  At approximately 6:50 p.m., my hands started itching and burning.  Within 20 minutes, it went from 0 to 100.  I had hives from my head to my feet, swollen face, lips, ears, nose, neck and was red as a tomato.  After about 20 minutes, it affected my breathing and I started throwing up.  I went to the ER which is one block away from my home.  I was seen the ER doctor in the trauma room.  I was given epinephrine, steroids, benadryl, and a breathing treatment.  Today I pickup up prescriptions prednizone, benadryl, and two epi pens that were prescribed by ER doctor.  I am missing work today because I feel like I had a heart attack last night, not to mention I almost died.  Today suffering from chest pain, throat pain, and an awful headache.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Respiration abnormal, Swelling, Swelling face, Urticaria
Clinical narrative: According to my after visit summary, I received the Infuenza Quadrivalent P-Free flu shot.  At approximately 6:50 p.m., my hands started itching and burning.  Within 20 minutes, it went from 0 to 100.  I had hives from my head to my feet, swollen face, lips, ears, nose, neck and was red as a tomato.  After about 20 minutes, it affected my breathing and I started throwing up.  I went to the ER which is one block away from my home.  I was seen the ER doctor in the trauma room.  I was given epinephrine, steroids, benadryl, and a breathing treatment.  Today I pickup up prescriptions prednizone, benadryl, and two epi pens that were prescribed by ER doctor.  I am missing work today because I feel like I had a heart attack last night, not to mention I almost died.  Today suffering from chest pain, throat pain, and an awful headache.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: According to my after visit summary, I received the Infuenza Quadrivalent P-Free flu shot.  At approximately 6:50 p.m., my hands started itching and burning.  Within 20 minutes, it went from 0 to 100.  I had hives from my head to my feet, swollen face, lips, ears, nose, neck and was red as a tomato.  After about 20 minutes, it affected my breathing and I started throwing up.  I went to the ER which is one block away from my home.  I was seen the ER doctor in the trauma room.  I was given epinephrine, steroids, benadryl, and a breathing treatment.  Today I pickup up prescriptions prednizone, benadryl, and two epi pens that were prescribed by ER doctor.  I am missing work today because I feel like I had a heart attack last night, not to mention I almost died.  Today suffering from chest pain, throat pain, and an awful headache.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Dyspnoea, Foreign body sensation in eyes, Headache, Influenza
Clinical narrative: I took ibuprofen 15 minutes after the vaccine to minimize any reaction. 4 hours later my eyes started to feel like I had dirt under the eyelids. I also started to get a headache. Shortly thereafter I started to get an irritated throat and swelling at the back of my tongue. Next my sinus became so swollen that I couldn't breathe through my nose and my frontal sinuses became swollen as well. Next my lungs became involved and I started to have asthma symptoms.  I called the emergency triage nurse line for my clinic and as told to take more ibuprofen, an antihistamine and use my albuterol. If symptoms continued to get worse, I was to go to the ER. about 4-5 hours after the symptoms started, they stabilized and I was able to go to sleep. I wolk up this morning with aching muscles a headache ringing ears and a slightly swollen throat. I'm taking tylenol and ibuprofen to control the symptoms.  This is the first time I've ever reacted tot e flu vaccine. This is also the first high dose vaccine I've had. I do get serioius asthma symptoms with a cold or flu.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nasopharyngitis, Pharyngeal swelling, Swelling, Swollen tongue
Clinical narrative: I took ibuprofen 15 minutes after the vaccine to minimize any reaction. 4 hours later my eyes started to feel like I had dirt under the eyelids. I also started to get a headache. Shortly thereafter I started to get an irritated throat and swelling at the back of my tongue. Next my sinus became so swollen that I couldn't breathe through my nose and my frontal sinuses became swollen as well. Next my lungs became involved and I started to have asthma symptoms.  I called the emergency triage nurse line for my clinic and as told to take more ibuprofen, an antihistamine and use my albuterol. If symptoms continued to get worse, I was to go to the ER. about 4-5 hours after the symptoms started, they stabilized and I was able to go to sleep. I wolk up this morning with aching muscles a headache ringing ears and a slightly swollen throat. I'm taking tylenol and ibuprofen to control the symptoms.  This is the first time I've ever reacted tot e flu vaccine. This is also the first high dose vaccine I've had. I do get serioius asthma symptoms with a cold or flu.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Tinnitus
Clinical narrative: I took ibuprofen 15 minutes after the vaccine to minimize any reaction. 4 hours later my eyes started to feel like I had dirt under the eyelids. I also started to get a headache. Shortly thereafter I started to get an irritated throat and swelling at the back of my tongue. Next my sinus became so swollen that I couldn't breathe through my nose and my frontal sinuses became swollen as well. Next my lungs became involved and I started to have asthma symptoms.  I called the emergency triage nurse line for my clinic and as told to take more ibuprofen, an antihistamine and use my albuterol. If symptoms continued to get worse, I was to go to the ER. about 4-5 hours after the symptoms started, they stabilized and I was able to go to sleep. I wolk up this morning with aching muscles a headache ringing ears and a slightly swollen throat. I'm taking tylenol and ibuprofen to control the symptoms.  This is the first time I've ever reacted tot e flu vaccine. This is also the first high dose vaccine I've had. I do get serioius asthma symptoms with a cold or flu.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Fall, Loss of control of legs, Pallor, Vomiting
Clinical narrative: At daycare the day after vaccines were given, child had an episode where she vomited after becoming pale. Her knees buckled and she fell to the floor from a standing position. She did not have loss of consciousness.  She was alert.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: PATIENT REPORTS INTNESE ITCHING AND HIVE-LIKE WELTS ON AREA SURROUNDING VACCINE SITE. SYMPTOMS STARTED SEVERAL HOURS AFTER RECEIPT OF VACCINE; STATES NO CONCERNS ABOUT PROCESS OF VACCINATION. TOOK BENADRYL AND APPLIED HYDROCORTIZONE CREAM TO AFFECTED AREA. STATES SYMPTOMS RESOLVE BY MORNING AND HAVE NOT RETURNED.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Joint swelling, Peripheral swelling, Pruritus, Skin ulcer
Clinical narrative: swelling in right hand and wrist, severe itching, sores, and bruising.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Kinrix, she is only 2 years old and Kinrix is a vaccine for 4-6 years.
Age: 38.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given out of licensure age range.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Upset stomach, nausea, vomiting, diarrhea, severe headache
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Injection was very painful. Over the following several hours I experienced severe aching in my left shoulder, to the extent I could not raise my left arm. During the night I had fever and chills and continuing pain in the shoulder. The following day I suffered from fatigue, headaches and continued pain in my shoulder. I still do not have full range of motion in my left arm.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection was very painful. Over the following several hours I experienced severe aching in my left shoulder, to the extent I could not raise my left arm. During the night I had fever and chills and continuing pain in the shoulder. The following day I suffered from fatigue, headaches and continued pain in my shoulder. I still do not have full range of motion in my left arm.
Age: 21.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given out of licensure age range.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Patient got the second Shringrix shot on September 21 around 6 p.m. at our local pharmacy where we got the first one on June 21, 2019. On Sept. 22, his arm was sore, but he did not take off his Tshirt or notice if it was red at the time. On Sept. 23, he went to see a physical therapist in the morning and when she saw his arm, she told him to go to an ER immediately because it was red, hot to the touch and in a rectangular shape. She thought it was either cellulitis or MRSA. We went to the ER around 1 p.m. and the PA there, sent patient home with a cellulitis diagnosis and a prescription for Cephalexin 500 mg four times a day for seven days. Today is Tuesday, and he has taken the antibiotic five times. His upper arm is still red and warm to the touch, but the redness it seems to have faded a tiny bit. He had a low grade fever on Sunday but not now.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Staphylococcal infection
Clinical narrative: Patient got the second Shringrix shot on September 21 around 6 p.m. at our local pharmacy where we got the first one on June 21, 2019. On Sept. 22, his arm was sore, but he did not take off his Tshirt or notice if it was red at the time. On Sept. 23, he went to see a physical therapist in the morning and when she saw his arm, she told him to go to an ER immediately because it was red, hot to the touch and in a rectangular shape. She thought it was either cellulitis or MRSA. We went to the ER around 1 p.m. and the PA there, sent patient home with a cellulitis diagnosis and a prescription for Cephalexin 500 mg four times a day for seven days. Today is Tuesday, and he has taken the antibiotic five times. His upper arm is still red and warm to the touch, but the redness it seems to have faded a tiny bit. He had a low grade fever on Sunday but not now.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Flu-like symptoms +: Achy, fever, diarrhea, nausea
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling , pain and "hot" area around injection site.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Gait disturbance, Injection site erythema, Injection site warmth
Clinical narrative: Patient called in 09/24/19 that last night 09/23/19 she was having trouble walking and had to force her legs to move. Is better this morning, but is having some redness and heat on location of both vaccine sites. Patient reports using a cold pack and benadryl.