chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Underdose, Vaccination site discharge, Vaccination site haemorrhage
Clinical narrative: removed the bandage, she noticed that there was a lot of fluid leakage mixed with blood; removed the bandage, she noticed that there was a lot of fluid leakage mixed with blood; removed the bandage, she noticed that there was a lot of fluid leakage mixed with blood; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 63 years old female patient who experienced removed the bandage, she noticed that there was a lot of fluid leakage mixed with blood (Vaccination site discharge and Vaccination site haemorrhage), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2019, the patient received a 0.5 ml third dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ247AB (Expiry date 30-Jun-2020) via intramuscular route in the right deltoid.  On 26-Sep-2019, the patient developed a non-serious removed the bandage, she noticed that there was a lot of fluid leakage mixed with blood (Vaccination site discharge and vaccination site haemorrhage) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was a case of actual medication error due to vaccine underdose.   (Other relevant tests included no lab data.) Final diagnosis was Vaccination site bleeding and Vaccination site discharge.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for Vaccination site bleeding and Vaccination site discharge.  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  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Sepsis, Tremor
Clinical narrative: sepsis; fever of 100F; severe shaking; body aches; chills; Initial information and additional formation received on 03-Oct-2019 regarding an unsolicited valid serious case received from a nurse.  This case is linked to cases 2019SA276202 and 2019SA276197 (same reporter).  This case involves a 76 years old female patient who diagnosed with sepsis (Sepsis), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication   On 02-Oct-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ268AB via intramuscular route in the left deltoid.  On an unknown date, the patient was diagnosed with a serious sepsis associated with symptoms with fever of 100f (pyrexia), severe shaking (tremor), body aches (pain) and chills (chills) within 45 minutes following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant. The patient was hospitalized for these events on 02-Oct-2019 was still hospitalized at the time of reporting.  Relevant laboratory test results included: Body temperature - On an unknown date: 100 F [100]  Final diagnosis was sepsis.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.; Sender's Comments: Patient was diagnosed with sepsis with associated symptoms after vaccination with FLUZONE HIGH DOSE. Time to onset is too short to be compatible with the role of vaccine. Moreover, further information including patient's medical history, lab data suggesting the etiology for sepsis is not provided. Based on available information the role of vaccine cannot be assessed.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Shingles, right eye/forehead/scalp which started the afternoon/evening of 10/5/19 and worsened over the next 2 days.  Was evaluated and diagnosed in urgent care on 10/7/19 at 0800.  Was also seen my ophthalmology at 1045 that same morning.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Local reaction, Pain in extremity
Clinical narrative: Received a regular flu shot on 9/30. On 10/01, I noticed that there was a red, hot, somewhat itchy,  large circle surrounding the site of injection. My arm was also more sore than usual. I iced it for two days and after 4 days, it was still there. I went back to the health center on day 4 where the doctor said I have a localized reaction to the shot. I was given Triamcinolone Acetonide Ointment USP, .5%, which was to be applied until the redness and hotness disappeared.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Patient had 2 vaccines given in left upper arm, according to patient it was TDap and pneumonia and the flu was given in the right arm, according to pharmacy the flu and pneumonia were given in left arm and tdap in the right.  The injections in the left arm were given very low in the left upper arm, not appropriate anatomic position for IM injections, the patient has redness, warmth, swelling, and ecchymosis noted to the top injection site.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Erythema, Headache, Pruritus, Urticaria
Clinical narrative: Two days after I received the shot I had a headache and cold chills.  Then I started to notice red blots on my stomach and my neck was itchy.  Over the course of the next week, I now have several hives on my neck, a few on my lower back and about 20 from my stomach up to my armpits. Most of them are on or around my breasts.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Eye irritation, Heart rate increased, Ocular hyperaemia, Pharyngeal swelling
Clinical narrative: I received the flu shot, though not sure of the exact strain.  I selected a strain above, but am not sure if it is the correct one or not.  3 hours after receiving the shot, I felt a slight swelling and itching in my throat, making it a little more difficult to breathe.  My eyes became red and irritated, and heart rate was slightly increased.  These symptoms came on suddenly, and remained until I woke up in the morning.  HR remained increased during the night, about 6-7 BPM higher than normal. (I wear a pedometer and track my HR during sleep)
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: I received the flu shot, though not sure of the exact strain.  I selected a strain above, but am not sure if it is the correct one or not.  3 hours after receiving the shot, I felt a slight swelling and itching in my throat, making it a little more difficult to breathe.  My eyes became red and irritated, and heart rate was slightly increased.  These symptoms came on suddenly, and remained until I woke up in the morning.  HR remained increased during the night, about 6-7 BPM higher than normal. (I wear a pedometer and track my HR during sleep)
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Tremor
Clinical narrative: Patient stated he had violent shaking (asked him to check blood sugars and stated he was at 119)- for 7 hours after vaccine, told him to go to urgent care to be check out
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Neuralgia
Clinical narrative: Patient reported extreme pain at the time of injection followed by lasting nerve pain in her arm for over one week.
Age: 96.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Back pain, Chest pain, Dyspnoea, Laboratory test normal
Clinical narrative: SOB, back pain and chest pain 1-2 minutes after administration. called 911 and sent the patient to the hospital to get it checked out.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Monoplegia, Muscular weakness
Clinical narrative: Patient reported complete paralysis in his arm following the flu shot, lasting for about one day and then continued weakness in the arm for several days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Myalgia, Nausea, Peripheral swelling
Clinical narrative: Pt had immunization on Monday/ was ill with nausea and muscle aches & pains on Tuesday & arm red, swollen & tender to touch (RUE)/came to clinic on Wednesday
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Pt had immunization on Monday/ was ill with nausea and muscle aches & pains on Tuesday & arm red, swollen & tender to touch (RUE)/came to clinic on Wednesday
Age: 27.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Eye movement disorder, Syncope
Clinical narrative: After receiving the vaccines, the patient asked for some water. Writer was about to get water when the patient's eyes rolled back and she fainted. Patient was sitting in a chair - patient did not fall or hit her head. Writer stayed near patient to make sure she did not slide out of the chair and called for help. Patient came to less than a minute after fainting. Once able, staff assisted patient to a lying position. Patient stayed in the office for approximately 25-30 minutes to ensure she was stable and steady.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Drug screen negative, Dysarthria, Feeling drunk, Gait disturbance, Laboratory test normal
Clinical narrative: 1-2 hours post vaccination client began with symptoms of staggering, slurred speech, bizarre thoughts, stupor. Client's mom describes it "as if she were drunk".
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Stupor, Thinking abnormal
Clinical narrative: 1-2 hours post vaccination client began with symptoms of staggering, slurred speech, bizarre thoughts, stupor. Client's mom describes it "as if she were drunk".
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: pt reports sharp pain/pulling in shoulder from injection site
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness, Pyrexia
Clinical narrative: Headache, flu like symptoms, temp of 100.5 over 24 hour period.  Fever finally broke.   Just feel weak  now.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Pyrexia
Clinical narrative: Patient reports receiving the vaccine at a pharmacy other than mine. She states that night she had 2 asthma attacks and carried a low grade fever for 48 hours
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Influenza like illness, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Experienced flu like symptoms approx 4 hours after injection .  Symptoms included aching muscles , sore throat, itchy eyes and nausea.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Antinuclear antibody negative, Blindness unilateral, Borrelia test negative, Colour blindness, Laboratory test normal
Clinical narrative: Blurry vision in  October and November 2018.  Loss of vision in right eye Dec 12, 2018.  Optic neuritis diagnosed.  Loss of vision permanent in right eye with colorblindness.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Magnetic resonance imaging brain normal, Optic neuritis, Treponema test negative, Vision blurred
Clinical narrative: Blurry vision in  October and November 2018.  Loss of vision in right eye Dec 12, 2018.  Optic neuritis diagnosed.  Loss of vision permanent in right eye with colorblindness.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Erythema, Swelling
Clinical narrative: patient stated she had swelling near injection site, redness, dizziness, and chills
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Discomfort, Irritability, Vomiting
Clinical narrative: mom called the on call doctor at 8:14 pm as the baby had vomiting and diarrhea for the past couple hours - was to go to ER if symptoms not resolved within 4-6 hours - vomiting stopped within 4 hours, baby was pale - diarrhea stopped a few hours after the vomiting- the next morning the baby had 1 stool and then no further vomiting or diarrhea - gave Tylenol for discomfort and fussiness day of vaccines and the next day  baby was not seen as symptoms resolved
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint swelling, Pruritus
Clinical narrative: Was given flu shot.  She went home and spot became itchy.  Her wrist swelled up and started feeling sharp and shooting pains down to her wrist.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Computerised tomogram thorax normal, Dyspnoea, Palpitations, Swollen tongue
Clinical narrative: Patient here for flu shot at approximately 11:30 AM on 10/9/19. Around 2pm she started feeling short of breath, chest felt constricted. Went to E.R. Tongue felt slightly enlarged. CT chest done came back negative, having palpitations E.R. doctor determined not due to flu shot
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head, Hypoaesthesia, Hypoaesthesia oral, Swollen tongue
Clinical narrative: Patient received flu shot approx. 3:00PM. Left facility. Returned to facility at 4:08PM with c/o facial numbness and c/o tongue swelling 408 was given Epi 0.3ml 1:1000 I.M. 410pm Gave Benadryl 25mg BP 160/80 at 415/ BP 150/74 No swelling visible in throat or tongue 433/pm BP 126/70 450pm Friend have to take to E.R.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Eczema, Infantile spitting up
Clinical narrative: Eczema appeared over legs, more frequent spitting up.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: After receiving flu shot at 3:15 pm on 10/9, patient woke up in the morning on 10/10 experiencing a ringing in his ears which is not something he usually has so he feels this is an adverse effect of his vaccine
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: Vertigo that won?t go away
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Peripheral swelling
Clinical narrative: entire arm swelling/bruised exceeding 1 week
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Intervertebral disc degeneration, Musculoskeletal pain, Neck pain, Osteoarthritis, Pain in extremity
Clinical narrative: 9/23/2019 left neck, shoulder. arm and hand pain and tingling 9/28/2019 seen at Urgent Care- xray done  DX with degererative arthritis C5-C6- treated w prednisone and flexeril x 2 weeks 10/10/2019  no releief of symptoms
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Spinal X-ray abnormal
Clinical narrative: 9/23/2019 left neck, shoulder. arm and hand pain and tingling 9/28/2019 seen at Urgent Care- xray done  DX with degererative arthritis C5-C6- treated w prednisone and flexeril x 2 weeks 10/10/2019  no releief of symptoms
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness and hotness and swelling the size of the palm of the mom's hand to her finger tips-  She gave Benadryl and Tylenol
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Around 11pm patient had a fever of 103.  Right arm was extremely sore Rash is now on right arm
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, FLU4, VARCEL
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Received varivax and fluzone in right arm, small amount of swelling and redness noticed for a few days after, started to go away and then returned and worsened on 10 /4/19 with induration of 0.5x2cm and 1x3cm erythema nontender. Warm to touch. Started on a course of Keflex X 10 days
Age: 24.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Cardiac stress test normal, Chest discomfort, Dyspnoea, Echocardiogram normal, Ejection fraction normal
Clinical narrative: palpitations and elevated troponins. History of palpitations in past. Presented with thumping discomfort in front of chest. SOB.  Pt lost to follow up.  Symptoms: PALPITATIONS(R002).
Age: 24.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Electrocardiogram ambulatory abnormal, Palpitations, Sinus tachycardia, Troponin increased
Clinical narrative: palpitations and elevated troponins. History of palpitations in past. Presented with thumping discomfort in front of chest. SOB.  Pt lost to follow up.  Symptoms: PALPITATIONS(R002).
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Injection site, redness, swelling, and it was warm to touch. I had hives on hand, feet, back, and abd.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Patient presented to the pharmacy with a red, tender to touch and hot to touch left arm. She had already been to her doctor and he prescribed keflex and prednisone for her to take.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: Redness/edema/warmth
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chest discomfort, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Parent came in and reported fever, body aches, chest tightness, headache, and fatigue.  No localized redness/swelling at injection site.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Hyperhidrosis, Influenza virus test, Muscular weakness
Clinical narrative: Fever, headache, chills, sweats, nausea, tachycardia, sensitivity to light, muscle soreness and weakness
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Photophobia, Pyrexia, Tachycardia
Clinical narrative: Fever, headache, chills, sweats, nausea, tachycardia, sensitivity to light, muscle soreness and weakness
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Lip pruritus, Pruritus, Rash
Clinical narrative: Itching and rash approx. 20 min after receiving vaccination  Lips itching
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Chest X-ray abnormal, Full blood count, Pneumonia
Clinical narrative: Pneumonia, diagnoses by chest xray and CBC. Required 2 shots of Rocephin administered on 9/26/2017 and 9/27/2017 followed by 10 days of Cefdinir.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: REDNESS, ITCHING, HIVES AND SPREAD UP AND DOWN LEFT ARM, FACE AND NECK AREA approx. 20 min after receiving vaccine
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased
Clinical narrative: temp  39C
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertantly administered a dose of Proquad instead of MMRII; no adverse effect; This spontaneous report was received from a nurse regarding a 16-year-old patient gender was not reported. The patient's medical history, concurrent condition and concomitant medications were not reported. The nurse described that two siblings, both sixteen years old, were inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), therapy type rha, lot # S002496 and expiry date 23-JUL-2020, (strength, dose, route were not reported) for prophylaxis, instead of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (wrong product administered). No adverse effects reported.   This is one of several reports received from the same reporter.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Limb discomfort
Clinical narrative: developed soreness and redness across the entire width of her arm from the injection site down her elbow; developed soreness and redness across the entire width of her arm from the injection site down her elbow; developed soreness and redness across the entire width of her arm from the injection site down her elbow; developed soreness and redness across the entire width of her arm from the injection site down her elbow; swelling; This spontaneous report was received from a pharmacist regarding a 77 year old female patient. The patient did not have any medical history or drug reactions or allergies. The patient's concomitant medications and concurrent conditions were not reported. On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R012976, expiration date: 25-JAN-2020 , 0.5 milliliter once intramuscularly as routine vaccination. On the same day, the patient was vaccinated with  influenza virus whole virion 3v vaccine inactivated (FLUZONE) (flu shot) on the same arm. On an unknown date in September 2019, also reported as, with in 24 hours after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient developed soreness and redness across the entire width of her arm from the injection site down to her elbow. The patient reported that the swelling started to go down on 30-SEP-2019. No treatment was given for the events and no laboratory tests were done. There was no intervention to prevent seriousness criteria. The outcome of events was reported as recovering. The relatedness between the events and suspect products was not reported. No product quality complaints were involved.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA002594: US-009507513-1910USA002818: US-009507513-1910USA002328:
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: inadvertantly administered a dose of Proquad instead of MMRII; no adverse effect; This spontaneous report was received from a nurse regarding a 16-year-old patient gender was not reported. The patient's medical history, concurrent condition and concomitant medications were not reported. The nurse described that two siblings, both sixteen years old, were inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), therapy type rHa, lot # S002496 and expiry date 23-JUL-2020, (strength, dose, route were not reported) for prophylaxis, instead of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (wrong product administered). No adverse effects reported.   This is one of several reports received from the same reporter.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: High fever; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 12-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number H47PB, expiry date unknown) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 3 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter reported that, the patient patient had high fever of 104 degree F after vaccination with dose of Fluarix Quadrivalent 2019-2020 season. The reporter consent to follow up. This case has been linked with case US2019AMR178819, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Terrible Arthralgia; This case was reported by a consumer via sales rep and described the occurrence of arthralgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was recovered/resolved.   It was unknown if the reporter considered the arthralgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient had terrible arthralgia. The reporter stated that, artralgia resolved after a couple days. The reporter did not consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: shingles on torso, under the right breast and on the thighs / lack of drug effect; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ramsay-hunt syndrome.   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2019, 1 days after receiving Shingrix, the patient experienced shingles and pain in arm. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and pain in arm were unknown.   It was unknown if the reporter considered the shingles and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The next day, after vaccination the patient's arm was sore.  The patient also reported shingles that developed on her torso, under the right breast and on the thighs.  The patient was seen by her physician for the diagnosis and was prescribed acyclovir. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: Pain at injection site; Headache; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On 11th April 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and muscle pain. In April 2019, the outcome of the injection site pain, headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient's husband The patient received vaccine in left arm. The patient experienced the symptoms on the same day when she received the 1st dose of vaccine. The injection site pain was lasted 3-4 days. The muscle aches and headache resolved within 2 days. The phone number or address was not available. The reporter consented to follow up. This case had been linked to the case US2019177121, reported for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash / rash on the side of the body and on stomach; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient experienced rash on the side of the body and on the stomach after a Shingrix injection. No other details were known at time of report. The reporter was very busy and could not continue with report.  The reporter was reporting what the patient said. The reporter consented to follow up.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Fatigue; Body aches; This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   On 19th August 2019, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever, fatigue and general body pain. On an unknown date, the outcome of the fever, fatigue and general body pain were unknown.   It was unknown if the reporter considered the fever, fatigue and general body pain to be related to Shingrix.  Additional case details were reported as follows: The patient experienced fever, fatigue, and body aches following a dose of Shingrix. No details related to start date or end dates of events was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate vaccine schedule; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th September 2018 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not reported. The patient did not return within the 6 months time frame to receive the second dose, which led to incomplete course of vaccination. The reporter did not consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: Shingles; Feel tingly in a small area on her buttocks; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 2 episodes in 2019).   On 21st September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced shingles and tingling. On an unknown date, the outcome of the shingles and tingling were unknown.   It was unknown if the reporter considered the shingles and tingling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient after receiving vaccine started to feel tingly in a small area on her buttocks and the patient's physician diagnosed her with having shingles. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Drooling, Lip swelling, Peripheral swelling, Pruritus, Swelling face
Clinical narrative: Swelling of the [lips, face], tongue; Swelling of the [lips], face, [tongue]; Swelling of the lips, [face, tongue]; Arm swelling; Small amount of itching; A few 'whelps'; This is a spontaneous case initially received from other health professional (nurse) via Communications (reference number: SEQ19-03769) on 02-Oct-2019, concerning a 60-year-old, female patient.   The patient's current medical condition included egg, beef and shellfish allergy.   The patient's concomitant medications were not provided.  On 02-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscularly, batch number and expiration date: not provided] for an influenza prophylaxis.  On the same day, two hours after vaccination (reported at 6 pm), the patient experienced a small amount of itching and a few whelps' (as reported). The patient took a cold shower.  On 03-Oct-2019, at 12:30 am, the patient woke up with drooling and arm swelling. The patient also experienced swelling of the lips, face and tongue. Due to tongue swelling, the patient bit her tongue badly. The patient did not have any breathing or swallowing problems.   At the time of initial reporting, all events were resolving.    The case was assessed as serious and reporter did not provide causality assessment.; Sender's Comments: The patient experienced swollen tongue, swelling face, lip swelling, urticaria, peripheral swelling and pruritus after administration of the suspect product Flucelvax QIV. Chronology is plausible. Medical history of multiple food allergies may have contributed to development of the events. No concomitant medications were reported. Based on provided information, causal role of the suspect product is assessed as related for the events.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Swollen tongue, Tongue biting, Urticaria
Clinical narrative: Swelling of the [lips, face], tongue; Swelling of the [lips], face, [tongue]; Swelling of the lips, [face, tongue]; Arm swelling; Small amount of itching; A few 'whelps'; This is a spontaneous case initially received from other health professional (nurse) via Communications (reference number: SEQ19-03769) on 02-Oct-2019, concerning a 60-year-old, female patient.   The patient's current medical condition included egg, beef and shellfish allergy.   The patient's concomitant medications were not provided.  On 02-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscularly, batch number and expiration date: not provided] for an influenza prophylaxis.  On the same day, two hours after vaccination (reported at 6 pm), the patient experienced a small amount of itching and a few whelps' (as reported). The patient took a cold shower.  On 03-Oct-2019, at 12:30 am, the patient woke up with drooling and arm swelling. The patient also experienced swelling of the lips, face and tongue. Due to tongue swelling, the patient bit her tongue badly. The patient did not have any breathing or swallowing problems.   At the time of initial reporting, all events were resolving.    The case was assessed as serious and reporter did not provide causality assessment.; Sender's Comments: The patient experienced swollen tongue, swelling face, lip swelling, urticaria, peripheral swelling and pruritus after administration of the suspect product Flucelvax QIV. Chronology is plausible. Medical history of multiple food allergies may have contributed to development of the events. No concomitant medications were reported. Based on provided information, causal role of the suspect product is assessed as related for the events.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Placenta praevia
Clinical narrative: Low-lying placenta; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 03-Oct-2019, concerning a 36-year-old, female pregnant subject of body weight: 127 lbs, height: 61.5 inches and body mass index (BMI): 23.6, enrolled in a prospective observational safety study.   The subject's past medical history included urinary tract infection.  The subject's relevant medical history included Herpes Simplex I, seasonal allergies, acne, left breast fibroadenoma. The subject's obstetrical history included two previous pregnancies in which there was one preterm live birth and one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The concomitant medications of the subject included Prenatal vitamins (minerals nos, vitamins nos) for pregnancy, clindamycin for acne and Baby aspirin (acetylsalicylic acid) for prophylaxis. The subject had a risk factor of an advanced maternal age.   The subject's last menstrual period (LMP) date was 10-Apr-2019. The subject's estimated date of delivery (EDD) was reported as 15-Jan-2020 and corrected estimated date of delivery (CEDD) was reported as 20-Jan-2020. The type of pregnancy was singleton.  On 03-Jun-2019 and 01-Jul-2019, the subject underwent ultrasound and no MCM was noted.   0n 29-Jul-2019, the subject underwent maternal serum alpha-fetoprotein (MSAFP) screening and no MCM was noted.   On 26-Aug-2019, the subject underwent ultrasound and no MCM was noted.   On 23-Sep-2019, at gestational age of approximately 23 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL [Influenza Vaccine, batch number: P1001185562 dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunization.  On an unspecified date, after vaccination, when pregnancy status was collected it was noted that the subject had a low-lying placenta.   At the time of initial reporting, the outcome of low-lying placenta was not reported.; Sender's Comments: The subject experienced placenta praevia associated with the suspect product Flu Vaccine Egg Split QIV CSL. Reportedly, vaccination occurred during pregnancy at gestational age of approximately 23 weeks. Temporal relationship is implausible because the placenta is fully formed by 18 to 20 weeks. Advanced maternal age may have contributed to development of the event. Causality was confounded by use of concomitant drugs, clindamycin and aspirin. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. Causal relationship between the suspect product and the event placenta praevia is assessed as not related.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Blood follicle stimulating hormone increased, Premature menopause
Clinical narrative: Amenorrhea and Premature Ovarian Failure, 4 years later. I was on birth control for those 4 years so those would have masked the symptoms (amenorrhea) had I developed POF before it was diagnosed in 2018.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: pt stated her whole arm swelled up and she had a fever of 104F for 36hrs. She was very sick and tired for 2 weeks
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Haematochezia, Occult blood negative
Clinical narrative: 1 month later at the allergy/GER f/u appt when pt 3 months old, mom said that 3 days after the vaccine, she had frank blood in the stool that "took a while" to be gone; she had that appt had submitted stool tests for blood (1 month after vaccine, on 10/4/16) and they were neg
Age: 99.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: On  10/3 - patient noted to have a red, raised/inflamed , firm, warm area at injection site (R deltoid) as well as bruise.  At the date of this report (10/10/2019) patient still remains with area
Age: 99.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: On  10/3 - patient noted to have a red, raised/inflamed , firm, warm area at injection site (R deltoid) as well as bruise.  At the date of this report (10/10/2019) patient still remains with area
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture negative, Blood lactic acid normal, Chest X-ray normal, Detoxification, Eczema
Clinical narrative: Widespread eczema developed 6 days after vaccinations. Food sensitivities to: dairy, grains, gluten, eggs and sugar developed in the week following vaccination. Tonic-clonic seizures developed on 7/08/2019. She continued to have tonic-clonic type seizures every 3 weeks (date of seizures: 7/8/2019, 7/29/2019, 8/20/2019). No "known" causes can be found, only seeing relief in seizure activity after starting heavy metals detoxification.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Electroencephalogram normal, Food allergy, Full blood count normal, Generalised tonic-clonic seizure, Magnetic resonance imaging brain normal
Clinical narrative: Widespread eczema developed 6 days after vaccinations. Food sensitivities to: dairy, grains, gluten, eggs and sugar developed in the week following vaccination. Tonic-clonic seizures developed on 7/08/2019. She continued to have tonic-clonic type seizures every 3 weeks (date of seizures: 7/8/2019, 7/29/2019, 8/20/2019). No "known" causes can be found, only seeing relief in seizure activity after starting heavy metals detoxification.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Metabolic function test, Metabolic function test normal, Milk allergy, Urine analysis normal
Clinical narrative: Widespread eczema developed 6 days after vaccinations. Food sensitivities to: dairy, grains, gluten, eggs and sugar developed in the week following vaccination. Tonic-clonic seizures developed on 7/08/2019. She continued to have tonic-clonic type seizures every 3 weeks (date of seizures: 7/8/2019, 7/29/2019, 8/20/2019). No "known" causes can be found, only seeing relief in seizure activity after starting heavy metals detoxification.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Pruritus, Urticaria, Wheezing
Clinical narrative: Employee started itching and hives 45minutes after dose administerd. Took benadryl. started with wheezing and coughing.  GIven nebulizer, pepcid, prednisone, epi pen
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Full blood count normal, Headache, Hepatitis B surface antigen negative, Injection site swelling
Clinical narrative: Fever 101.9, headache, dizziness, swelling while warm to touch at injection site right deltoid.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site warmth, Laboratory test, Pyrexia
Clinical narrative: Fever 101.9, headache, dizziness, swelling while warm to touch at injection site right deltoid.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reports swelling and redness of the left upper arm that spread from shoulder to elbow. Patient said the redness developed the next day and continued for about a week. She claims benadryl OTC 25mg helped the redness drastically. She reports never having this reaction.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Severe shivers for approximately one hour.  Overall body aches for 1 1/2 - 2 days
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Pain
Clinical narrative: PATIENT HAD SORENESS THE SAME DAY OF VACCINATION (10/7/19), THREE DAYS LATER THE PATIENT WOKE UP AT 0600 WITH A RASH EXTENDING DOWN HIS LEFT UPPER ARM FROM INJECTION SITE. THE RASH WAS RED AND WARM TO TOUCH. PATIENT COMPLAINED OF PAIN AT SITE OF RASH
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Red hot round 1? raised then within an hour 3? raised round and very hot to touch and tender.  Used hot and cold compress then doctors office said to take Benadryl.
Age: 82.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cough, Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: NAUSEA, GENERALIZED ACHING, HEADACHE, FATIGUE, RED ITCHING RASH UPPER BODY, MILD COUGH, MALAISE, ITCHING SORENESS AND SWELLING IN ADMINISTRATION SITE.  ITCH FINALLY GONE AS OF 10/9.  STARTED FEELING BETTER 10/01/ 2019. NOT TOTALLY GONE UNTIL 10/ 5-6 EXCEPT FOR RASH
Age: 82.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site swelling, Malaise, Nausea, Pain, Rash erythematous
Clinical narrative: NAUSEA, GENERALIZED ACHING, HEADACHE, FATIGUE, RED ITCHING RASH UPPER BODY, MILD COUGH, MALAISE, ITCHING SORENESS AND SWELLING IN ADMINISTRATION SITE.  ITCH FINALLY GONE AS OF 10/9.  STARTED FEELING BETTER 10/01/ 2019. NOT TOTALLY GONE UNTIL 10/ 5-6 EXCEPT FOR RASH
Age: 82.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Rash pruritic
Clinical narrative: NAUSEA, GENERALIZED ACHING, HEADACHE, FATIGUE, RED ITCHING RASH UPPER BODY, MILD COUGH, MALAISE, ITCHING SORENESS AND SWELLING IN ADMINISTRATION SITE.  ITCH FINALLY GONE AS OF 10/9.  STARTED FEELING BETTER 10/01/ 2019. NOT TOTALLY GONE UNTIL 10/ 5-6 EXCEPT FOR RASH
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site pain, Injection site warmth, Lip swelling
Clinical narrative: She was given Flu vaccine Afluria by her CN at 2230. She experienced tightening of her throat, had some soup, brush her teeth thinking her mouth is dry and noted tonque start to feel swollen. She took 50mg. Benadryl p.o. took a nap during her lunch break at 3am. when she woke up her face, lips were numb swollen and her arm where vaccine was administered was sore , hot to touch but no redness. She was taken to ER for medical evaluation at 5:30AM. She was given Pepcid, Atarax and Prednisone. She was observed for a couple hours and discharged home after at around 7AM with rx for Atarax and Pepcid
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Swollen tongue, Throat tightness
Clinical narrative: She was given Flu vaccine Afluria by her CN at 2230. She experienced tightening of her throat, had some soup, brush her teeth thinking her mouth is dry and noted tonque start to feel swollen. She took 50mg. Benadryl p.o. took a nap during her lunch break at 3am. when she woke up her face, lips were numb swollen and her arm where vaccine was administered was sore , hot to touch but no redness. She was taken to ER for medical evaluation at 5:30AM. She was given Pepcid, Atarax and Prednisone. She was observed for a couple hours and discharged home after at around 7AM with rx for Atarax and Pepcid
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; improperly stored vaccine administered; This spontaneous report was received from a medical assistant regarding a 4 year old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. The reporter stated that on 26-SEP-2019, the patient was vaccinated improperly stored hepatitis a vaccine, inactivated (VAQTA) (product storage error), lot # S007770 and expiry date 24-JUL-2020, (strength, dose, route were not reported) for prophylaxis. No adverse event reported. It was reported the product was stored at below 36-degree Fahrenheit/2 degree Celsius for 10 minutes. There was no previous temperature excursion and no data logger.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one dose of VARIVAX was administered to a patient after improper storage, stored in 40 Fahrenheit degrees; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 04-OCT-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, dose reported as per CDC guidelines, route of administration reported as: one injection, lot # S015460 and expiry date: 20-MAY-2021 (anatomical location was not provided) for immunization. The vaccine was stored in temperature of 40 Fahrenheit degrees for 24 hours. Sterile diluent used for reconstitution was properly stored. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.