chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pain in extremity
Clinical narrative: Patient states her started hurting in am of 10/7/2017, when she looked at her arm it was red, warm with a lump at the site. Patient came in the office 10/11/17 and showed the provider.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash 3 inches below injection site on arm. Pt stated that its a faint rash and doesnt itch and is not hot to touch. Pt instructed to keep an eye on the rash and if it gets any worse to make a dr appointment to be checked out. Pt is calling pharmacy with update in a day or 2. THIS REPORT REPLACES THE ONE THAT WAS FILED UNDER THE WRONG PATIENT INFORMATION. PLEASE DELETE THE REPORT.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient called pharmacy on 10/7/17 said that her arm was extremely red, swollen, and hot, she was advised if it didn't get better after a cool compress to see a Dr, patient called back on 10/8/2017 and said that she had went to an urgent care and they told her she had cellulitis and prescribed her doxycycline. I called patient on 10/9/7 to check on her and she stated I had not worn gloves during administration of  vaccinations, I explained to her that I had wore gloves, and they were more for my protecion. I also used inject safe bandaids for the injections, she got upset and hung up on me and I have not been able to contact her to get more information. She said that the arm started swelling and hurting about 4 hours after it was given. I did ask her if it was worse on the front or back side of her arm and she stated it was worse towards the back and there was a knot she could feel under the skin, I gave the PNEUMOVAX 23 towards the back of the arm and the FLUARIX QUAD towards the front. She did say that it was getting better after starting the antiobiotics. I do not have the information for the Dr. she saw.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Impaired work ability, Injection site pain
Clinical narrative: Rash on neck and soreness and burning at site, acetaminophen cleared up symptoms (first day), left work early. Day 2, evening, soreness under right arm, took more acetaminophen. Day 3, morning, upset stomach, diarrhea, chills, swelling under right arm and extending toward breast, took prescription anti-inflammatory (all week). Unable to work.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site swelling, Rash
Clinical narrative: Rash on neck and soreness and burning at site, acetaminophen cleared up symptoms (first day), left work early. Day 2, evening, soreness under right arm, took more acetaminophen. Day 3, morning, upset stomach, diarrhea, chills, swelling under right arm and extending toward breast, took prescription anti-inflammatory (all week). Unable to work.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Blepharospasm, Pyrexia, Vaccination complication, Weight decreased
Clinical narrative: My son got the MMR vaccine and 5 other vaccines then had eye spasms and the doctor lied and sead he was looking for something on the ceiling!? He was having a reaction to the vaccines  then lost waght had high fever.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 21-MAR-2017 the patient was vaccinated with GARDASIL 9, first dose, (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis. Subsequently, on 21-JUN-2017 patient received GARDASIL, lot # K016966 (expiration date: 10-MAY-2017; exact dose and route of administration were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from two nurses refers to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 25-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL 9 (dose and route of administration were not provided; lot # L019287, expiration date: 14-SEP-2017). No adverse events were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 49 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-OCT-2017, the patient was inadvertently administered an expired dose of ZOSTAVAX lot # M032141, expiration date on 02-OCT-2017, subcutaneously for prophylaxis. No adverse effects were reported in the patient.
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient). A 50 year-old female patient of an unspecified race and ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced shoulder pain. Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report from a contactable nurse via a Company representative reported for two patients. This report is the second of two. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm got swollen and it was sore, excessive itching. The outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Headache, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for two patients. This is the first of two patients. This report was received via a sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, 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. The patient experienced nausea, headache, sore arm and temperature of 101 all on an unspecified date with outcome of unknown. The patient actually went to the emergency room.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Flushing, Nausea, Respiratory distress, Wheezing
Clinical narrative: Developed coughing, wheezing, respiratory distress, nausea, facial flushing after Flu vaccine was given. Patient received EPIPEN JR IM approximately 1 hr 15 mins after Flu vaccine was given and then was sent to ER.
Age: 83.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient states 30 days after vaccine she is still experiencing pain and difficulty raising arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Patient's spouse stated that her whole left arm (down to her wrist) was swollen for a week after both immunizations were administered. Patient contacted her primary care doctor, but they never responded.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain, Swelling
Clinical narrative: Pain and swelling that was reported to be the worst on the day of the vaccine and decreasing in the 2 days post vaccination. Patient reported on pain on 10/11/17, but reported some swelling at the injection site still.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Myalgia, Vaccination site swelling
Clinical narrative: Patient reported major swelling, redness and itching in area of vaccine. Also reported were muscle aches in pains in her entire body including her muscles in her legs.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Electrocardiogram, Flushing, Full blood count, Hypoaesthesia
Clinical narrative: Employee was walking up the stairs after receiving the flu shot when she experienced sudden dizziness, palpitations, flushing, numbness in hands and feet. Was diagnosed with Near syncope in the ER.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Laboratory test, Palpitations, Presyncope
Clinical narrative: Employee was walking up the stairs after receiving the flu shot when she experienced sudden dizziness, palpitations, flushing, numbness in hands and feet. Was diagnosed with Near syncope in the ER.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood thyroid stimulating hormone, Chest pain, Dizziness, Drug screen, Dyspnoea
Clinical narrative: Employee was walking up the stairs after receiving the flu shot when she experienced sudden dizziness, palpitations, flushing, numbness in hands and feet. Was diagnosed with Near syncope in the ER.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Presyncope, Tachycardia
Clinical narrative: Employee was walking up the stairs after receiving the flu shot when she experienced sudden dizziness, palpitations, flushing, numbness in hands and feet. Was diagnosed with Near syncope in the ER.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Thyroxine
Clinical narrative: Employee was walking up the stairs after receiving the flu shot when she experienced sudden dizziness, palpitations, flushing, numbness in hands and feet. Was diagnosed with Near syncope in the ER.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging, Seizure, Specialist consultation
Clinical narrative: Patient suffered seizures after the vaccination was administered.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Entire upper arm swollen, red, hot to touch.
Age: 61.0
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: The vaccine was expired on 10/07/2017 but it was given to the patient on 10/08/2017 without checking expiration date. The patient was okay and had no adverse event was observed.
Sex: F
Vaccine: TDAP
Symptoms: Arthritis infective
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of joint infection in a adult female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced joint infection (serious criteria GSK medically significant). On an unknown date, the outcome of the joint infection was unknown. It was unknown if the reporter considered the joint infection to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. In 2015, the patient received the BOOSTRIX. The patient reported as result of the vaccine being administered intramuscular, she developed an infection in her shoulder. The pharmacist wanted information about the BOOSTRIX vaccine. The patient was transferred to medical information (MI).
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest pain, Seizure
Clinical narrative: Patient received PREVNAR 13 and FLUZONE HI DOSE on 9-18-17. Pt has egg allergy. Patient admitted to hospital on 9-26-17 with chest pain. Over the first night patient had seizure activity. Patient discharged 10-4-17.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor, Urinary incontinence, Vaccination complication
Clinical narrative: Fever, unspecified fever cause. Urinary incontinence, unspecified type. Adverse effect of influenza vaccine "I do suspect that the high fever last night and associated shaking (chills) and possibly the urinary incontinence was an adverse reaction to being given the high dose flu vaccine. Reassured mom that at this present time, patient physically appears ok"
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: 1 day later patient reported complaining of arm pain. Referred to Doctor.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Pain in extremity, Swelling
Clinical narrative: Increased pain in left arm beyond expected beginning evening of 10/4/17. Redness and swelling noted on 10/5/17 and continued pain. On 10/6/17 redness & swelling had increased/spread & warmth had developed. Saw Occ Health nurse, called primary care provider that day as well and began applying cold compresses. Borders outlined on 10/6. The following morning (10/7) the redness extended slightly beyond the  drawn border & swelling remained the same. By the evening of 10/7 both redness & swelling had reduced. 10/8 redness gone & swelling minimal & no longer warm. All symptoms resolved by the evening of 10/8/17.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort
Clinical narrative: Upset Stomach.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given the combo ProQuad which is only recommended for 2 years to 12 years. Parents were notified by the physician. No further action was required.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort
Clinical narrative: Upset Stomach.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram head normal, Dyskinesia, Eyelid function disorder, Facial paralysis, Hypoaesthesia
Clinical narrative: Awoke 10/5/17 morning after flu vaccine and unable to blink left eye,or raise left eyebrow, numbness tingling left side of face. Unable to open mouth fully. Has left sided facial palsy that involves the forehead.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Scan with contrast normal
Clinical narrative: Awoke 10/5/17 morning after flu vaccine and unable to blink left eye,or raise left eyebrow, numbness tingling left side of face. Unable to open mouth fully. Has left sided facial palsy that involves the forehead.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given the combo ProQuad which is only recommended for 2 years to 12 years. Parents were notified by the physician. No further action was required.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Pt describes as "light nausea/vomiting/diarrhea."  Pt reports self-resolving, starting this morning (10/11/17).  Awaiting call back from prescriber to notify them of reported reaction.
Age: 33.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Pt. states that after he received the vaccine to his left deltoid on Monday his left deltoid felt sore for the first 2 days and was not unusual for him since he has had similar symptoms after a flu shot in the past and symptoms seemed to improve by Thursday but then on Saturday noticed pain when moving his left  arm and shoulder a certain way (brushing his hair or lifting up his left arm to shoulder height). Pain is felt in the left deltoid area and is described as mild. Pt. denies any bruising, swelling, redness, rashes or warmth at the flu shot site after the vaccine. Denies left extremity weakness, numbness or tingling, loss of sensation. Denies any tenderness at the left deltoid and only feels it when he raises his arm. Denies decrease in mobility or crepitus. Has not tried to self treat. Denies recent injury or fall. Does work out daily but the last time he did was last Friday (chest press, rope pull, dead lifts) and has not since. Pt. not sure if this is related to the flu vaccine but wanted to report and come in for evaluation. Pt. evaluated in clinic. Active mild pain with motion only of left arm in the deltoid region and with otherwise full ROM. Left deltoid muscle non-tender with no palpable hematoma or visible ecchymosis, no edema, warmth, rashes or shoulder joint tenderness. Skin intact. Strength 5/5 in upper extremities b/l. Hand grips equal and strong b/l. Neurovascular intact. Advised to try ice, Aleve 1 tab PO BID with food for a week and activity as tolerated but avoid left arm/shoulder strain and activities that cause pain or overuse. Maintain ROM. Follow up scheduled for next week.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Erythematous papules developed the next day on bilateral thighs were immunizations were given, not in distribution of bandaid but rather in a 2-3cm area around site of vaccine. Rash worse on right than left. Non-pruritic, non-painful. Seen in clinic 2 days after immunization.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site oedema, Injection site pain, Injection site reaction, Purulence, Pyrexia
Clinical narrative: Patient had tenderness and edema under the arm and surrounding the injection site. Robust take - purulence and edema approximately 24 mm, thickness of approximately 1 mm. Patient reported fever of 101 degrees approximately 6 days following the injection. Patient did not have a fever at the time of reporting, vital signs were normal. Patient denied pericarditis symptoms.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: In 2016 she had a reaction to the FLUZONE flu vaccine. This year the office ordered preservative free vaccine for her and she had a reaction to it also. Within a few minutes her arm was starting to swell and itch. Within 2 hours her reaction site was about a 4" x 6" area, raised, red, hard and very hot to touch. She was given BENADRYL and Ibuprofen routinely for the weekend. This was severe until Sunday at that time she said it didn't hurt as bad. Prior to that she c/o itching, pain and throbbing. She also had a rough feeling petechiae rash that was approx. 1" x 2" around injection site. It is not completely well, but almost completely well. She was taken back to Health Center within 1 hour of injection for Doctor to look at it. She advised BENADRYL, ibuprofen, cool compress.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Petechiae, Pruritus
Clinical narrative: In 2016 she had a reaction to the FLUZONE flu vaccine. This year the office ordered preservative free vaccine for her and she had a reaction to it also. Within a few minutes her arm was starting to swell and itch. Within 2 hours her reaction site was about a 4" x 6" area, raised, red, hard and very hot to touch. She was given BENADRYL and Ibuprofen routinely for the weekend. This was severe until Sunday at that time she said it didn't hurt as bad. Prior to that she c/o itching, pain and throbbing. She also had a rough feeling petechiae rash that was approx. 1" x 2" around injection site. It is not completely well, but almost completely well. She was taken back to Health Center within 1 hour of injection for Doctor to look at it. She advised BENADRYL, ibuprofen, cool compress.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: I developed a fever, muscle aches, and chills beginning in the evening of 10/09/2017 and continuing until the morning of 10/11/2017.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Irritability, Rash
Clinical narrative: Developing rash on the trunk, fussiness, temperature up to 100.9 degrees Ferenheit.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Varicella zoster virus infection
Clinical narrative: This spontaneous report was received from a nurse and refers to a 5 year old female patient. No information regarding medical history, concurrent conditions and concomitant therapies was provided. The patient was vaccinated on 03-JUN-2013 (first dose) and on 23-SEP-2013 (second dose), with VARIVAX injection, 1 DF (reported as one dose) (route of administration, lot numbers and expiration dates were not reported) for prophylaxis (reported as routine vaccination). Other suspect therapies included sterile diluent (MERCK), used to reconstitute the suspected vaccines (dose, route of administration, lot number and expiration date were not provided). On an unknown date, the patient was vaccinated with first dose of M-M-R II injection, (dose, frequency, route of administration, lot # and expiration date were unspecified) for prophylaxis. On unknown date in September 2017, the patient came to county health department for kindergarten shots. Before the vaccines were administered, the mother of the patient asked about the rash on patient's leg. It was reported that the symptoms started on 10-SEP-2017 (reported as 10-SEP-2017 or 11-SEP-2017). The patient was referred to medical office and was diagnosed with varicella (also reported as chicken pox) by her primary care physician (name unspecified) on 13-SEP-2017. The patient's mother wanted the patient to get the second dose of measles, mumps and rubella vaccine. The reporter wanted to verify time frame to give another live vaccine with recent varicella infection. The outcome of varicella was reported as not recovered. The relatedness between chicken pox and VARIVAX, sterile diluent (MERCK) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was reported as unknown. On 20-SEP-2017, the patient's mom called and wanted patient to get second measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine. The reporter wanted to verify time frame to give another live vaccine with a recent varicella infection. The patient sought for medical attention (reported as physician appointment). No information regarding given treatment was provided. No Product Quality Concern (PQC) was involved. No additional information was available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Pain
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 14-year-old female patient. The patient had citrus allergy. The patient had no concomitant medications. On 25-NOV-2014, the patient received the first shot of GARDASIL (lot number K006191; expiration date was not reported) and on 02-FEB-2015 she received second shot (lot number K006191; expiration date was not reported), both intramuscularly for human papillomavirus prevention. The patient had never received a third dose of GARDASIL. On an unspecified date in March 2017, reported also as after receiving GARDASIL, the patient experienced pain and generalized bruising. The patient sought a medical attention by seeing the physician due to the adverse effects. She was not given any medical treatment for the events but was referred to unspecified rheumatologist for her symptoms. The outcome and causality assessment of the events to GARDASIL were not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA010353.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's concurrent conditions included "sulfa" (unspecified) allergy. There was no information about the patient' s concomitant therapies or medical history provided. On 19-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N012492, expiry date 17-MAR-2018 (exact dose and route of administration were not reported) for prophylaxis. Other suspect therapies included sterile diluent lot# reported as N0079321, expiry date 06-MAY-2018. On 21-SEP-2017, the patient came to the pharmacy and she had a lump at the injection site, redness, itching, warmth and pain. The pharmacist called the patient on 22-SEP-2017 and lump and pain had decreased but the redness had gotten larger, the size of a softball, and was very itchy. No treatment was given for the events. The outcome of the events was reported as not recovered. Causality assessment was not provided by the reporter.
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 69 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On 11-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, 0.5 ml, lot # N011305, expiry date 20-JAN-2019 (route of administration was not reported) for prevention of pneumococcal disease. On the same day, the patient developed cellulitis at the injection site on his upper right deltoid. The physician reported that the patient went to an unspecified emergency room where he received unspecified intravenous (I.V.) antibiotics for an unspecified length of time for the event. The patient was not hospitalized. The outcome of the event was reported as recovered on an unknown date in September 2017. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: Abdominal discomfort, Abdominal pain upper
Clinical narrative: This spontaneous report was received from a consumer, the patient's mother who referred to a 2-month-old patient of unknown gender. The patient had sensitivity to dairy, soy, possibly wheat and eggs. No information regarding the patient's pertinent medical history and concomitant medications was provided. On 06-OCT-2017, the patient was vaccinated with the first dose of ROTATEQ orally (lot# and expiration date were not reported). On the same day, a few hours after vaccination, the patient experienced nonspecific gastrointestinal (GI) discomfort and stomach pain. The patient did not seek medical attention or hospitalization. The outcome of nonspecific GI discomfort and stomach pain was reported as recovered. No causality assessment was provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 09-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 18-AUG-2014, at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. On or about the dates of 14-JUL-2016, 20-SEP-2016 and 08-NOV-2016, the patient sought subsequent treatment from her physician for ongoing and worsening outbreaks of shingles and excruciating accompanying pain. The patient was been prescribed VALTREX for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 06-OCT-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 07-APR-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-AUG-2016, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as herpes zoster, or shingles. The patient has been prescribed continued dosages of valacyclovir for management of her painful condition. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus, Wrong technique in product usage process
Clinical narrative: Initial unsolicited case received from a consumer on 27 Sep 2017. This case involves 90-year-old male patient who was vaccinated with 0.5 ml one dose of FLUZONE HD (Batch number, expiry date, dose in series were not reported) intramuscularly at the very top of the arm at the shoulder on 23 Sep 2017. Patient medical history was not reported. The patient had never had a vaccine related reactions in the past. Concomitant medications were not reported. On 23 Sep 2017 in the afternoon, few hours after the vaccination, the patient developed itching and redness with swelling to 2 times the arm size. It was also a case of actual medication error due to Wrong injection technique. Relevant lab tests and corrective treatment were not reported. The outcome of the events were reported as not recovered. 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 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.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dyspnoea, Lower respiratory tract infection bacterial, Pain, Vomiting
Clinical narrative: Initial unsolicited report received from consumer on 02 Oct 2017. This case involves a 53-year-old female patient who was vaccinated with first dose of Flu Shot and Pneumonia Shot (frequency once, batch number, expiration date, dose, route was not reported) in arm on 25 Sep 2017. The patient's medical history includes COPD (Chronic Obstructive Pulmonary Disease). Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed body aches and pain, shortness of breath, vomiting (ongoing). It was reported that, patient saw a pulmonologist on 02 Oct 2017, which stated she developed a bacterial infection in lungs on an unspecified date post vaccination. Lab data was not reported. The patient received corrective treatment with steroid injection to open up the lungs, unspecified antibiotics and a breathing machine to use 2x/day. The patient had not recovered from the event vomiting (reported as ongoing) and patient was recovering from other events. This case was considered as serious due to medically significant events. List of documents held by sender: none.; Sender's Comments: Patient had bacterial infection in lungs with General body pain, shortness of breath and vomiting following FLUZONE QUADRIVALENT vaccine and PNEUMOCOCCAL VACCINE (unknown manufactuer). Time to onset is compatible, but additional information regarding patient medical history, like any lung infection, past vaccination history and its tolerance needed to further assess case. As two vaccines are administered at same time hence role of each component cannot be assessed.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Pain
Clinical narrative: Pt came in on 10/11/2017. She said about 2 days after getting the shot, the pain moved from the immunization site in her arm to her joint. She said she does not have the same range of motion, and when she goes to move her arm in a certain way, it hurts. She is following up with her md tomorrow.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Laboratory test, Nausea, Vertigo, Vomiting
Clinical narrative: Onset of nausea, vomiting and vertigo 1 hour after administration of flu shot. Given at 0930 and onset at 1030. Went home from work at 1200. Symptoms worsened over the next few days (started on Thursday 05 Oct ) and he went to ER on Sunday 08 Oct 2017. As of 11 Oct 2017, patient is still taking medication for nausea and vertigo.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: Localized reaction at site of injection with fever, lots of pain, and swelling around the area. Happened later that night a few hours after vaccination.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Same day bruising and pain around injection site. Then at night time developed a large, red, hot spot below injection site (about an inch and half away from injection site). Also inlammed a little.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient has red, hard, very warm bump on right deltoid. She states it has progressively worsened over the past 5 days. I recommended cool/cold compress and ibuprofen, which she has already been doing.  I then recommended seeing a doctor (patient does not currently have a PCP).
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: ERYTHEMA, SWELLING  PAIN AROUND INJECTIONS SITE AND UPPER ARM. ALSO PT. REPORTED FEVER/CHILLS FOR 48HRS POST VACCINATION. TREATED WITH IBUPROFEN AND ICE.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Tinnitus
Clinical narrative: Within 10 minutes of administration, I started feeling chest tightness with shortness of breath. Pulse was 99 and BP 127/80. Within 30 minutes from onset of symptoms, I took 25mg of  Benadryl. The chest tightness and shortness of breath lasted approximately 1 hour and started improving about 20 minutes after the Benadryl. No erythema at the injection site. Left ear-ringing started once the shortness of breath resolved and has continued for the last 30 minutes.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient was given flu vaccine at primary care office earlier in day then seen in the emergency department for injection side redness, swelling, hardness and pain. Patient given Prednisolone, BENADRYL and TRIMOX in ER. Patient was discharged and mother instructed to follow up with primary care.
Age: 36.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Chills, Injection site pain, Pyrexia
Clinical narrative: FEVER, CHILLS, ARTHRALGIA AND PAIN AROUND INJECTION SITE. SYMPTOMS LASTED APPROX. 24HRS.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: REDNESS AND SWELLING AROUND INJECTION SITE. ARM PAIN. FEVER AND BODY ACHES LASTING 48HRS +.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Patient reported redness at the site of vaccination about 2 inch in diameter, warm to touch. Patient was instructed to see her primary care provider.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site swelling, Nausea, Swelling, Vision blurred
Clinical narrative: Swelling of upper left arm through the should and neck. Headache, blurred vision and left eye visual disturbances for 48 hours. Nausea and vomiting as well. I am a nurse, so I treated as home. I nearly went to ED for management of the headache and N/V. Pain was 10/10 for two days.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Visual impairment, Vomiting
Clinical narrative: Swelling of upper left arm through the should and neck. Headache, blurred vision and left eye visual disturbances for 48 hours. Nausea and vomiting as well. I am a nurse, so I treated as home. I nearly went to ED for management of the headache and N/V. Pain was 10/10 for two days.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Fall, Immediate post-injection reaction, Syncope
Clinical narrative: I administered four shots to patient at about 3:00pm on 10/10/17. The first three (MCV, Tdap and Flu) went well. I administered MCV and Tdap to into the left arm and Flu and HPV into the right arm. Right after administering the fourth shot (HPV/Gardasil 9) the pt fainted, falling backwards. I caught the pt and laid her down on the exam bed as she was sitting on the bed during shot administration. I called code blue immediately, followed by Dr. calling code blue into the hallway. The pt woke up almost immediately after falling backwards. She tried to sit up but I instructed her to stay laying. I used my pulse ox to find that pt's oxygen was 98 and her pulse was 70. She was coherent, knew where she was and what she was doing. I asked nurse, who had responded to the code blue to retrieve a cold pack and she did so. I placed the cold pack under the pt's neck. Dr. advised the other medical assistants that everything was under control and they could go back to work. Dr. and I stayed with patient for 10 minutes, monitoring her pulse and oxygen and making sure she was doing okay. Dr. and I checked on the pt two more times in five minute intervals. We gave the pt juice. After twenty minutes the pt was feeling fine and pulse was checked at 78 and oxygen saturation still at 98%. We instructed the pt to slowly stand up . She did so and was feeling fine so Dr. discharged the pt. Dr. instructed the pt to take it slow and have something to eat when she got home.
Age: 81.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Erythema, Peripheral swelling, Rash pruritic
Clinical narrative: Left arm became swollen and red, itchy rash developed and persisted for 7 days.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Injection site erythema, Vaccination site swelling
Clinical narrative: Severe redness and swelling in the area of vaccination. Then the redness started to move down the arm and the back. Appeared like the patient got hit in the arm, black and blue brusing.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Pt presented 2 days after vaccine administration with swelling and redness at PCV vaccine injection site with some fatigue, but no fever or other constitutional symptoms. Cold compresses and PO ibuprofen for symptomatic treatment. Was asked to call or return for an appointment if symptoms worsen.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient had no reaction on day of vaccination - delayed onset. Woke up the following day and noticed pain, redness and swelling near the injection site.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site reaction, Malaise, Pain, Paraesthesia
Clinical narrative: Patient reported that evening not feeling well and the following day her arm of injection was warm, tingling, and swollen with additional patches of rashes. Two days post reaction the patient presented in the office and was examined by PCP. Findings from exam: Temp 100.3F, 8 cm x 6 cm erythematous rash of right upper arm near recent injection site. Warm and tender to touch. Full ROM but painful. Alternating therapy of TYLENOL and Ibuprofen were instructed for patient and warm/cool compresses.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Patient reported that evening not feeling well and the following day her arm of injection was warm, tingling, and swollen with additional patches of rashes. Two days post reaction the patient presented in the office and was examined by PCP. Findings from exam: Temp 100.3F, 8 cm x 6 cm erythematous rash of right upper arm near recent injection site. Warm and tender to touch. Full ROM but painful. Alternating therapy of TYLENOL and Ibuprofen were instructed for patient and warm/cool compresses.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Patient came to pharmacy today at 1:45 pm with red arm you could see the injection mark from the shot then you could see the irritation from the shot to about her elbow. She went to the doctor who prescribed BENADRYL and triamcinolone cream. Patient stated it did not hurt just looks bad.
Sex: F
Vaccine: HEP
Symptoms: Autonomic nervous system imbalance, Enteritis infectious, General physical health deterioration, Infertility female, Systemic lupus erythematosus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a adolescent female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced systemic lupus erythematosus (serious criteria GSL medically significant), ill-defined intestinal infections (serious criteria GSK medically significant), dysautonomia, female infertility, loss of teeth and general physical health deterioration. On an unknown date, the outcome of the systemic lupus erythematosus, ill-defined intestinal infections, dysautonomia, female infertility, loss of teeth and general physical health deterioration were unknown. The reporter considered the systemic lupus erythematosus, ill-defined intestinal infections, dysautonomia, female infertility and loss of teeth to be related to Hepatitis B vaccine. It was unknown if the reporter considered the general physical health deterioration to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported by the patient's father. The patient was 34 years old at the time of reporting. The age at vaccination was not reported. The patient received Hepatitis B vaccine in her teenage as a requirement to attend the school. The patient was getting worse, her teeth were falling out, experienced dysautonomia, the lupus was diagnosed 6 months ago from reporting date  in 2017, severe intestinal infection and she could not get pregnant due to the drugs she was taking for these issues. The reporter stated that the Centers  for  Disease  Control  (CDC) told him that they know the dysautonomia was a side effect of the vaccine. The reporter was not able to share the brand name of the vaccine in question, but was certain it was a GSK product. The patient denied permission to contact their physician. The patient's father declined to provide any further information.
Sex: F
Vaccine: HEP
Symptoms: Tooth loss
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a adolescent female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced systemic lupus erythematosus (serious criteria GSL medically significant), ill-defined intestinal infections (serious criteria GSK medically significant), dysautonomia, female infertility, loss of teeth and general physical health deterioration. On an unknown date, the outcome of the systemic lupus erythematosus, ill-defined intestinal infections, dysautonomia, female infertility, loss of teeth and general physical health deterioration were unknown. The reporter considered the systemic lupus erythematosus, ill-defined intestinal infections, dysautonomia, female infertility and loss of teeth to be related to Hepatitis B vaccine. It was unknown if the reporter considered the general physical health deterioration to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported by the patient's father. The patient was 34 years old at the time of reporting. The age at vaccination was not reported. The patient received Hepatitis B vaccine in her teenage as a requirement to attend the school. The patient was getting worse, her teeth were falling out, experienced dysautonomia, the lupus was diagnosed 6 months ago from reporting date  in 2017, severe intestinal infection and she could not get pregnant due to the drugs she was taking for these issues. The reporter stated that the Centers  for  Disease  Control  (CDC) told him that they know the dysautonomia was a side effect of the vaccine. The reporter was not able to share the brand name of the vaccine in question, but was certain it was a GSK product. The patient denied permission to contact their physician. The patient's father declined to provide any further information.
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Chills, Headache, Hyperaesthesia, Malaise
Clinical narrative: Information was received on 28-SEP-2017 from a female consumer who is the mother of the patient, a 33 year old female with rheumatoid arthritis, autoimmune issues and asthma "since she was born" and the grandmother of the child who was vaccinated. The patient's child (age and gender unknown) was vaccinated with a dose of VARIVAX (lot, expiration, site and dose not reported) "10 days ago". Following the child's vaccination, the female patient (the child's mother) developed "a mild headache for four days" and was "lying in bed all day yesterday and last night got very sick with high fever and chills all night" last night. The patient's skin presently feels "raw and sensitive and burns as if her nerves are inflamed". She currently has 8 chickenpox lesions on her chest and neck. The reporter believes that the vaccine virus was transmitted through saliva as the recipient of the vaccine (the child) does not have a rash. The reporter stated that her state requires mandatory vaccination even though the vaccine recipient's parent has an autoimmune disorder. The reporter is contemplating legal action. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information was received on 28-SEP-2017 from a female consumer who is the mother of the patient, a 33 year old female with rheumatoid arthritis, autoimmune issues and asthma "since she was born" and the grandmother of the child who was vaccinated. The patient's child (age and gender unknown) was vaccinated with a dose of VARIVAX (lot, expiration, site and dose not reported) "10 days ago". Following the child's vaccination, the female patient (the child's mother) developed "a mild headache for four days" and was "lying in bed all day yesterday and last night got very sick with high fever and chills all night" last night. The patient's skin presently feels "raw and sensitive and burns as if her nerves are inflamed". She currently has 8 chickenpox lesions on her chest and neck. The reporter believes that the vaccine virus was transmitted through saliva as the recipient of the vaccine (the child) does not have a rash. The reporter stated that her state requires mandatory vaccination even though the vaccine recipient's parent has an autoimmune disorder. The reporter is contemplating legal action. Additional information has been requested.