chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site pain, Injection site rash, Injection site reaction, Musculoskeletal pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX (batch number G72ZD, expiry date unknown) for prophylaxis. On 31st January 2019, the patient received the 1st dose of SHINGRIX. On 31st January 2019, 1 day after receiving SHINGRIX, the patient experienced injection site pain, shoulder pain, fever, injection site rash, itchy rash and injection site discharge. On an unknown date, the outcome of the injection site pain, shoulder pain, fever, injection site rash, itchy rash and injection site discharge were unknown. It was unknown if the reporter considered the injection site pain, shoulder pain, fever, injection site rash, itchy rash and injection site discharge to be related to SHINGRIX. Additional details were provided as follows: The case was reported via chat. The patient subsequently experienced pain at the injection site, shoulder pain, low grade fever, and lesions around the injection site. It was reported that per conversation with patient, the symptoms developed about 24 hours after injection. The lesions started as itchy bumps and as on the reporting date a few have opened with a small clearish discharge. The lesions only surrounded the injection site. The reporter only expected the patient to experience the pain at the injection site, shoulder pain, and low grade fever. The patient received vaccine at the patient's pharmacy and not at the clinic where the reporter worked.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash pruritic, Skin lesion
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX (batch number G72ZD, expiry date unknown) for prophylaxis. On 31st January 2019, the patient received the 1st dose of SHINGRIX. On 31st January 2019, 1 day after receiving SHINGRIX, the patient experienced injection site pain, shoulder pain, fever, injection site rash, itchy rash and injection site discharge. On an unknown date, the outcome of the injection site pain, shoulder pain, fever, injection site rash, itchy rash and injection site discharge were unknown. It was unknown if the reporter considered the injection site pain, shoulder pain, fever, injection site rash, itchy rash and injection site discharge to be related to SHINGRIX. Additional details were provided as follows: The case was reported via chat. The patient subsequently experienced pain at the injection site, shoulder pain, low grade fever, and lesions around the injection site. It was reported that per conversation with patient, the symptoms developed about 24 hours after injection. The lesions started as itchy bumps and as on the reporting date a few have opened with a small clearish discharge. The lesions only surrounded the injection site. The reporter only expected the patient to experience the pain at the injection site, shoulder pain, and low grade fever. The patient received vaccine at the patient's pharmacy and not at the clinic where the reporter worked.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose in September 2018, for tolerance of 1st dose refer case US2019GSK023600.). In January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, nausea, fatigue and injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, nausea, fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, nausea, fatigue and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was one of the 6 cases reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE vaccine for prophylaxis. On 27th September 2018, the patient received the 1st dose of SHINGRIX 50 µg and FLUZONE vaccine. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's wife. The patient received the vaccines one in each arm. The patient experienced soreness in both arms with both the vaccines. For tolerance of dose 2 refer case US2019GSK027918.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age group was not reported but was selected adult as per vaccine indication. The age at vaccination was not applicable for this report. The reporter also said there was currently a class action lawsuit against GlaxoSmithKline with the amount of patients that have had a bad reaction. The reporter asked whether the safety department was aware of this. The reporter did not have any additional information. This was a potential legal case. This case has been linked to case US2019021239, reported by same reporter.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination, Serology abnormal, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 25-year-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included ENGERIX B ADULT for prophylaxis. Previously administered products included ENGERIX-B (1st dose received in August 2018). On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and the 2nd dose of ENGERIX B ADULT. On an unknown date, not applicable after receiving Hepatitis B vaccine and unknown after receiving ENGERIX B ADULT, the patient experienced incomplete course of vaccination and therapeutic response decreased. On an unknown date, the outcome of the incomplete course of vaccination and therapeutic response decreased were unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine and ENGERIX B ADULT. Additional details were provided as follows: This case was reported by the patient mother. The batch number and expiry date was not reported. The reporter stated that the patient received the "full series as a child" but due to the patient's program of study a titre was completed. The patient was found to had levels under the target, which resulted in requiring additional immunization which led to decreased therapeutic response. The agent unable to confirm if the series administered in the patient's childhood was ENGERIX or another brand for the Hep B series. The patient had not yet received the series. This led to incomplete course of vaccination. Second or third dose to complete the. The reporter provided responsible prescriber name and phone number but did not have address available. Lab Comments: On unknown date, serology test was performed.
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chest burning in a male patient who received SHINGRIX for prophylaxis. On 14th August 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chest burning. On an unknown date, the outcome of the chest burning was recovered/resolved. It was unknown if the reporter considered the chest burning to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that her husband had the shot with SHINGRIX and later one he told her that he experienced a burning chest. The reporter would not provide initials nor additional details on her husband. This case was 2 of the 2 cases, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (on right buttock once monthly) and genital herpes. Previously administered products included valacyclovir. On 29th December 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were provided as follows: The patient noted her history of shingles had been monthly every month for 4 years now. The patient received SHINGRIX in the left upper arm. The patient needed to see a new dermatologist, as her previous one left and she also needs a new prescription for the valacyclovir. The patient was not relating the events to SHINGRIX but did not it occurred after the shots, so this report being filed. She noted her history of shingles has been monthly every month for 4 years now.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. SHINGRIX was discontinued. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient's age was in 60's at the time of reporting. The patient acquired shingles after getting the vaccine. The nurse practitioner had treated the patient approximately 2 to 3 weeks before the date of reporting and then the patient left for vacation. The patient would not be getting her second dose of SHINGRIX. No additional details were provided by the healthcare professional. The reporter had consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. While caller was reporting side effects to 2nd dose of SHINGRIX, stated he heard a lot of people have experienced issues with the 2nd dose. No other information was provided.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Gait inability, Guillain-Barre syndrome, Hemiparesis
Clinical narrative: GBS/CIDP diagnosed 2/23/18 by Dr. Unable to walk, pick things up, weakness of right side.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Lumbar puncture, Musculoskeletal disorder, Nuclear magnetic resonance imaging
Clinical narrative: GBS/CIDP diagnosed 2/23/18 by Dr. Unable to walk, pick things up, weakness of right side.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Micturition urgency, Syncope
Clinical narrative: Syncope after getting out of bed the morning after injection. Sweating followed by chills and urge to void. Stable after an additional hour. First time ever reaction or event of this kind. No other signs or symptoms noted.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Hyperhidrosis, Tremor
Clinical narrative: About 12 hours after the injection @11:30pm 02/14/2019, I started to feel very tired and cold. I started to shake as I was undressing. I felt like I could not warm up. The shaking continued until I added a tee shirt and socks and stocking cap. Then the shaking subsided and I slept. I woke up about 4:00am sweating. I removed the extra clothing I was wearing and the extra blanket on the bed. As I cooled down I started to feel better. By 10am 02/15/2019 I felt normal again and had a good appetite.
Age: 0.33
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Abdominal pain, Cyanosis, Diarrhoea, Gastric disorder, Grunting
Clinical narrative: Paper says she received DTaP, Hib, Hepatitis B, polio, PCV13 and a rotavirus vaccine. A day later she was running fever of 100.7. TYLENOL brought it down next day fever hit 104.1 and went to emergency room because she was shaking uncontrollably, blue lips and hands, and then very sleepy even though she just napped two almost three hours. TYLENOL brought it down. Her stomach is also tore up and causing issues. Screaming in pain and grunting to pass loose stool (diarrhea) it's day three and she's no better.
Age: 0.33
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, Screaming, Somnolence
Clinical narrative: Paper says she received DTaP, Hib, Hepatitis B, polio, PCV13 and a rotavirus vaccine. A day later she was running fever of 100.7. TYLENOL brought it down next day fever hit 104.1 and went to emergency room because she was shaking uncontrollably, blue lips and hands, and then very sleepy even though she just napped two almost three hours. TYLENOL brought it down. Her stomach is also tore up and causing issues. Screaming in pain and grunting to pass loose stool (diarrhea) it's day three and she's no better.
Age: 0.33
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Tremor
Clinical narrative: Paper says she received DTaP, Hib, Hepatitis B, polio, PCV13 and a rotavirus vaccine. A day later she was running fever of 100.7. TYLENOL brought it down next day fever hit 104.1 and went to emergency room because she was shaking uncontrollably, blue lips and hands, and then very sleepy even though she just napped two almost three hours. TYLENOL brought it down. Her stomach is also tore up and causing issues. Screaming in pain and grunting to pass loose stool (diarrhea) it's day three and she's no better.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Body temperature increased, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: 3-4mm diffuse macular, blanching rash on the trunk. Myalgia, fatigue, Tmax 100.5F, sore throat, headache.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Pallor, Rash, Rash macular
Clinical narrative: 3-4mm diffuse macular, blanching rash on the trunk. Myalgia, fatigue, Tmax 100.5F, sore throat, headache.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Herpes zoster, Myalgia, Pain in extremity, Weight bearing difficulty
Clinical narrative: Shingles vaccine received January 2019. Next morning, unable to weight bear on legs without great pain. Muscle and bone pain. Lasted 24 hours. One month later broke out with actual case of shingles 2/15/19.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient got her immunizations on 2/12/19 and started to have some reactions on 2/13/19 PM. Mother said that patient started to get redness at injection sights and was complaining of pain at injection sights. She states there was heat to the touch as well as some swelling. Mother called the office and was advised to give patient Ibuprofen and ice the sights. It helped with the reaction on the right leg but the left leg reaction is still present. They came in the office for an appointment and was advised by Dr. to continue with Ibuprofen and ice and she told mother she could give patient BENADRYL. The reaction on the left leg was 3 cm and the right leg was less than a quarter.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from an office manager regarding to a current 16 year old patient (gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 05-JUL-2018, the patient was vaccinated with a dose of PROQUAD (lot number and expiration date not reported), subcutaneous for prophylaxis. On 16-JAN-2019, the patient received another dose of PROQUAD (lot number and expiration date not reported), subcutaneous for prophylaxis. No known adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In November 2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On an unknown date, the patient was treated at a hospital emergency room for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, 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.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Death, Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and the spouse of a deceased male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 31-DEC-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately early 2017 [reported as "shortly after" receiving the ZOSTAVAX vaccine], the patient suffered congestive heart failure and shingles which required hospitalization. The patient's ultimate cause of death was congestive heart failure. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 12-FEB-2017. As a direct and proximate result of the ZOSTAVAX, the patient suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient suffered congestive heart failure and shingles, and untimely died a wrongful death on 12-FEB-2017. It is unknown if an autopsy was performed. Upon internal review, congestive heart failure was determined to be medically significant. Congestive heart failure and shingles were considered to be disabling. Additional information has been requested. Reported Cause(s) of Death: Congestive heart failure.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced product storage error.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Breast pain, Nightmare, Pain in extremity, Tension
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On 5th February 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, breast pain, feeling anxious, bad dreams and tension. On an unknown date, the outcome of the pain in arm, breast pain, feeling anxious, bad dreams and tension were unknown. It was unknown if the reporter considered the pain in arm, breast pain, feeling anxious, bad dreams and tension to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX 2 days before the date of reporting. The patient's arm was sore and so was the under arm into breast area. The patient was in anxious feeling, had horrible bad dreams and very uptight. The patient asked if this happened to anyone else.
Sex: U
Vaccine: MENB
Symptoms: Laboratory test, Meningococcal infection
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of meningococcal infection in a adolescent patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 2 years after receiving BEXSERO, the patient experienced meningococcal infection (serious criteria GSK medically significant). On an unknown date, the outcome of the meningococcal infection was unknown. It was unknown if the reporter considered the meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1 dose of BEXSERO 2 years before disease onset. The genetic testing of strain showed to expect coverage from BEXSERO. This case was one of 4 case reported by the same reporter. Lab Comments: On an unknown date, the patient's genetic testing of strain resulted in expect coverage from BEXSREO.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster oticus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes zoster otitis externa in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in late August or early September 2018 without adverse events). In December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In January 2019, less than a month after receiving SHINGRIX, the patient experienced herpes zoster otitis externa (serious criteria GSK medically significant). On an unknown date, the outcome of the herpes zoster otitis externa was unknown. It was unknown if the reporter considered the herpes zoster otitis externa to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 88 or 89 years. The patient received 2nd dose of SHINGRIX on left arm sometime in late December 2018. In early January 2019, the patient developed shingles on and around the left ear. She was seen by her physician and was being treated. The reporter gave consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Drug hypersensitivity, Hypersensitivity, Pruritus, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of drug allergy in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included BENADRYL for an unknown indication, ZYRTEC for an unknown indication, ALEVE for an unknown indication, ambiguous medication, CLARITIN for an unknown indication and EXCEDRIN MIGRAINE unknown for migraine. Previously experienced adverse reactions included back pain and multiple allergies. Concurrent medical conditions included migraine. Concomitant products included SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the patient started BENADRYL at an unknown dose and frequency, ZYRTEC at an unknown dose and frequency, ALEVE at an unknown dose and frequency, CLARITIN at an unknown dose and frequency and EXCEDRIN MIGRAINE at an unknown dose and frequency. In August 2018, less than a year after receiving SHINGRIX, EXCEDRIN MIGRAINE, the patient experienced drug allergy, allergy aggravated, burning sensation, vesicular rash, skin swelling and itchy skin. The patient was treated with Prednisone Cream. On an unknown date, the outcome of the drug allergy, allergy aggravated, burning sensation, vesicular rash, skin swelling and itchy skin were recovering/resolving. The reporter considered the drug allergy and allergy aggravated to be related to SHINGRIX. It was unknown if the reporter considered the burning sensation, vesicular rash, skin swelling and itchy skin to be related to SHINGRIX and EXCEDRIN MIGRAINE. It was unknown if the reporter considered the drug allergy and allergy aggravated to be related to EXCEDRIN MIGRAINE. Additional details were provided as follows: The age at vaccination was not reported. In August the patient started noticing that she was getting worse and having a bad reaction anytime that she took some over the counter medication. The patient had visited various physicians, dermatologists, allergists and all her symptoms have gotten worse when they have recommended taking one of the medications that she mentioned as being allergic to. The patient did not take anything orally. The patient clarified that the only event that was new after having SHINGRIX vaccines was that she was allergic to medications she had not been allergic to before.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of drug allergy in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included BENADRYL for an unknown indication, ZYRTEC for an unknown indication, ALEVE for an unknown indication, ambiguous medication, CLARITIN for an unknown indication and EXCEDRIN MIGRAINE unknown for migraine. Previously experienced adverse reactions included back pain and multiple allergies. Concurrent medical conditions included migraine. Concomitant products included SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the patient started BENADRYL at an unknown dose and frequency, ZYRTEC at an unknown dose and frequency, ALEVE at an unknown dose and frequency, CLARITIN at an unknown dose and frequency and EXCEDRIN MIGRAINE at an unknown dose and frequency. In August 2018, less than a year after receiving SHINGRIX, EXCEDRIN MIGRAINE, the patient experienced drug allergy, allergy aggravated, burning sensation, vesicular rash, skin swelling and itchy skin. The patient was treated with Prednisone Cream. On an unknown date, the outcome of the drug allergy, allergy aggravated, burning sensation, vesicular rash, skin swelling and itchy skin were recovering/resolving. The reporter considered the drug allergy and allergy aggravated to be related to SHINGRIX. It was unknown if the reporter considered the burning sensation, vesicular rash, skin swelling and itchy skin to be related to SHINGRIX and EXCEDRIN MIGRAINE. It was unknown if the reporter considered the drug allergy and allergy aggravated to be related to EXCEDRIN MIGRAINE. Additional details were provided as follows: The age at vaccination was not reported. In August the patient started noticing that she was getting worse and having a bad reaction anytime that she took some over the counter medication. The patient had visited various physicians, dermatologists, allergists and all her symptoms have gotten worse when they have recommended taking one of the medications that she mentioned as being allergic to. The patient did not take anything orally. The patient clarified that the only event that was new after having SHINGRIX vaccines was that she was allergic to medications she had not been allergic to before.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Fear, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX. On 15th August 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On 16th August 2018, the patient experienced chest burning and tingling. On 18th August 2018, the patient experienced numbness of upper extremities and fear. On an unknown date, the outcome of the pain in arm, chest burning, tingling, numbness of upper extremities and fear were recovered/resolved. It was unknown if the reporter considered the pain in arm, chest burning, tingling, numbness of upper extremities and fear to be related to SHINGRIX. Additional details were provided as follows: 2 days after vaccination, the patient experienced chest burning and tingling. On 17th August 2018, the patient was ok with no symptoms. On 18th August 2018, 4 days after vaccination, the patient experienced numbness of upper extremities, fear and went to emergency room. The patient did not want to provide her full name nor any details for the report. The reporter did not give consent to follow up. Customer declined to providing last name nor initials. This case was 1 of the 2 cases, reported by the same reporter.
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female patient of unknown age who was feeling ill, after she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (also reported as Fluzone) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient was feeling ill within 2 hours following the administration of INFLUENZA VACCINE. Patient was ill for two days and had to stay home. No lab test was reported. Final diagnosis was feeling ill. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovering for feeling ill.
Age: 27.0
Sex: F
Vaccine: MMRV
Symptoms: Fatigue, Hyperhidrosis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection 2.12.19 to right posterior arm; Began to sweat around 10 am; Swelling, redness, hot to touch with induration to right posterior arm around 1400. Swelling continued with fever 100.1 on 2. 13.19. Fatigue, increased swelling to arm to 6 x 9 inches in a somewhat oval shape; 2.14.19 notifed MD suggested warm compresses; 2.15.19 continued fatigue, swelling, warmth, no larger at this time in size.
Age: 27.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Injection 2.12.19 to right posterior arm; Began to sweat around 10 am; Swelling, redness, hot to touch with induration to right posterior arm around 1400. Swelling continued with fever 100.1 on 2. 13.19. Fatigue, increased swelling to arm to 6 x 9 inches in a somewhat oval shape; 2.14.19 notifed MD suggested warm compresses; 2.15.19 continued fatigue, swelling, warmth, no larger at this time in size.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Myalgia, Vomiting
Clinical narrative: Patient reports vomiting, diarrhea, muscle aches, fatigue within 12 hours of vaccination.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Injection arm very sore 3 hours after shot. Then at 8:00 Pm (8 hours after shot) Severe chills, headache, fever, all over achiness all night long and into the next day.
Age: 54.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Burning sensation, Injection site pain, Injection site reaction, Pain in extremity, Pruritus
Clinical narrative: Patient is a 54-year-old female who presents for evaluation of right arm injection site. Patient reports she had the influenza and hepatitis A vaccination injections on 10/3/18. Patient states and proximal right upper extremity near injection site, she noticed a small "dot". States she has used rubbing alcohol on the area. Rates pain 1/10. In patient's proximal left upper extremity she reports some pain, which she describes as itching and burning. Patient denies noticing any lesions in her proximal left upper extremity. Denies any drainage or erythema of either arm. Denies any fever, sweats, chills. Denies being on any antibiotics. Follow-up PRN.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Patient had a fever of 101F and had severe shaking/chills. She couldn't hold onto anything without shaking. She took ibuprofen 400mg and acetaminophen 1000mg at 1:30am on 2-15-19. At 3:00am on 2-15-19, her symptoms resolved and have not recurred (as of 3:00 pm on 3-15-19).
Age: 43.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: Patient's wife called to clinic, states he has been in the hospital for two days and is moving to the ICU, they suspect Guillain-Barre syndrome.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Lymph node pain, Lymphadenopathy, Pruritus, Rash, Rash erythematous
Clinical narrative: Started noticing a red, raised pinpoint rash on my chest on Tuesday, 2/5/2019. By Thursday, 2/7/19, the rash was itching and had spread to my arms, face and back and multiple large painful lymph nodes swelled all over the back of my head and behind my ears. Went to a clinic on Friday, 2/8/2019, where the doctor confirmed it was due to the MMR and prescribed Hydroxyzine HCl medication for it. By Monday, 2/11/19,  the rash and itch had mostly faded, but the lymph nodes remained swollen and painful. Friday, 2/15/19, rash gone but intermittent itching returned and lymph node sites, some are gone and a few are tender to touch.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: Started noticing a red, raised pinpoint rash on my chest on Tuesday, 2/5/2019. By Thursday, 2/7/19, the rash was itching and had spread to my arms, face and back and multiple large painful lymph nodes swelled all over the back of my head and behind my ears. Went to a clinic on Friday, 2/8/2019, where the doctor confirmed it was due to the MMR and prescribed Hydroxyzine HCl medication for it. By Monday, 2/11/19,  the rash and itch had mostly faded, but the lymph nodes remained swollen and painful. Friday, 2/15/19, rash gone but intermittent itching returned and lymph node sites, some are gone and a few are tender to touch.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Fatigue
Clinical narrative: Patient describes symptoms as follows: Shortly after dose administration, he experienced pain going down his arm to his wrist. After that, the pain started to expand to his shoulder and up his back. As the evening progressed, he started to feel weaker and weaker. At 2 am (the morning after dose administration) he woke up with chills, muscle and joint pain, and burning skin. All of these symptoms were felt mostly in the upper body. Patient mentions that the burning skin was felt on his face and scalp. Unfortunately, the next day, the symptoms continued, but progressed to general malaise to the point that he said that he could not stay awake. This fatigue lasted all day. The adverse effects lasted about 48 hours in their entirety according to the patient. The patient has since improved and returned to baseline.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Musculoskeletal pain, Myalgia, Pain in extremity, Skin burning sensation
Clinical narrative: Patient describes symptoms as follows: Shortly after dose administration, he experienced pain going down his arm to his wrist. After that, the pain started to expand to his shoulder and up his back. As the evening progressed, he started to feel weaker and weaker. At 2 am (the morning after dose administration) he woke up with chills, muscle and joint pain, and burning skin. All of these symptoms were felt mostly in the upper body. Patient mentions that the burning skin was felt on his face and scalp. Unfortunately, the next day, the symptoms continued, but progressed to general malaise to the point that he said that he could not stay awake. This fatigue lasted all day. The adverse effects lasted about 48 hours in their entirety according to the patient. The patient has since improved and returned to baseline.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Patient describes symptoms as follows: Shortly after dose administration, he experienced pain going down his arm to his wrist. After that, the pain started to expand to his shoulder and up his back. As the evening progressed, he started to feel weaker and weaker. At 2 am (the morning after dose administration) he woke up with chills, muscle and joint pain, and burning skin. All of these symptoms were felt mostly in the upper body. Patient mentions that the burning skin was felt on his face and scalp. Unfortunately, the next day, the symptoms continued, but progressed to general malaise to the point that he said that he could not stay awake. This fatigue lasted all day. The adverse effects lasted about 48 hours in their entirety according to the patient. The patient has since improved and returned to baseline.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Foreign travel, Varicella post vaccine
Clinical narrative: Patient received two Varicella vaccine in 1999 and 2009. Recently went out of country, exposed to Chicken pox and was diagnosed this week with them.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Pt was administered with a TWINRIX vaccine that was expired. Expiration date was 09/27/2018.
Age: 35.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Body temperature increased
Clinical narrative: Pt reported message that he had a temperature of 104 the day after the vaccines and was admitted into the hospital for "possible adverse reaction to vaccines". No other information is available at this time.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Loss of consciousness, Nausea, Pallor, Syncope
Clinical narrative: About 1 minute after vaccine administration the patient fainted. She lost consciousness for 15 to 30 minutes. After coming to, she was pale, felt sick to her stomach, and just "not right." She sat in the store for about 10 minutes when her husband decided it was an ok to try and move her to take her to the ER.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram head, Electroencephalogram, Encephalitis, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient with a meningoencephalitis of unknown etiology. She had a 3 day hospitalization at a local facility in and was transferred to hospital where she was hospitalized for an additional 5 days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal
Clinical narrative: Patient with a meningoencephalitis of unknown etiology. She had a 3 day hospitalization at a local facility in and was transferred to hospital where she was hospitalized for an additional 5 days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Amnesia, Dizziness, Encephalitis, Headache, Loss of consciousness
Clinical narrative: Patient with a meningoencephalitis of unknown etiology. She had a 3 day hospitalization at a local facility in and was transferred to hospital where she was hospitalized for an additional 5 days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Prosopagnosia, Stress, Vaccination complication, Visual impairment
Clinical narrative: Patient with a meningoencephalitis of unknown etiology. She had a 3 day hospitalization at a local facility in and was transferred to hospital where she was hospitalized for an additional 5 days.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Erythema multiforme, Inflammation, Skin warm, Swelling
Clinical narrative: Erythema Multiform and red, inflamed, warm bump.
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Mother brought child to clinic due to apparent local reaction following vaccination. Large, circular, erythematous area noted to side of left thigh. Area of reaction approximate diameter of grapefruit, non-raised, warm to touch. Child non-febrile and in no apparent distress. Child was observed by APN. APN advised mother to give BENADRYL and if redness widens, call pediatrician. Mother marked area with marker. APN reviewed ER precautions with mother. Also advised cold compresses to area as needed.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Dizziness, Fall, Fatigue, Headache
Clinical narrative: Two hours after the MENACTRA and Men B vaccines she felt tired. After 6 to 7 hours after the vaccines she got dizziness, headache and passed out for a brief period of time, possibly less than 1 to 2 minutes and fell down to the ground. Mother came to her immediately and found her pale and weak to stand. Mother gave her Juice and make her sit for some time and had improved. She saw tiny spots before she became dizzy and has mild headache today. No fever. No rash, no swelling of mucosa, no swelling of injection site. Has soreness of injection site, no redness. Vital signs are within normal range and no physical abnormality today.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site pain, Loss of consciousness, Pallor
Clinical narrative: Two hours after the MENACTRA and Men B vaccines she felt tired. After 6 to 7 hours after the vaccines she got dizziness, headache and passed out for a brief period of time, possibly less than 1 to 2 minutes and fell down to the ground. Mother came to her immediately and found her pale and weak to stand. Mother gave her Juice and make her sit for some time and had improved. She saw tiny spots before she became dizzy and has mild headache today. No fever. No rash, no swelling of mucosa, no swelling of injection site. Has soreness of injection site, no redness. Vital signs are within normal range and no physical abnormality today.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with M-M-R II, via intramuscular route (incorrect route of product administration)(strength, dose, frequency, route, lot#  and expiry were not reported) for prophylaxis and no adverse symptoms reported. Product quality control issue was not involved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, 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 SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on Monday and still having fever (101 degree F).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (on right buttock once monthly) and genital herpes. Previously administered products included valacyclovir and SHINGRIX (1st dose received on 29th December 2018 on left arm). On 1st February 2019, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX in right upper arm. The patient had event occur after her 2nd SHINGRIX shot. The patient needs to see a new dermatologist, as her previous one left and she also needs a new prescription for the valacyclovir. The patient was not relating the events to SHINGRIX but did not it occurred after the shots, so this report being filed. The patient noted history of shingles had been monthly every month for 4 years now. This case has been linked to the US2019023101, reported for the dose 1 of the same patient.