chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Constipation, Inappropriate schedule of product administration
Clinical narrative: Abdominal pain; Constipation; Inappropriate schedule of vaccine; This case was reported by a physician via call center representative and described the occurrence of abdominal pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 30th January 2018. Please refer the case US2019GSK089658.).   On 10th May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 10th May 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 14th May 2019, the patient experienced abdominal pain and constipation. On an unknown date, the outcome of the abdominal pain and constipation were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the abdominal pain and constipation to be related to Shingrix.  Additional details were provided as follows: This case was reported by the physician for his wife. The patient received the 2nd dose of the Shingrix vaccine past the recommended six months on 10th May 2019 at 2:00pm, which led to lengthening of the vaccination schedule On 14th May 2019, she began to experience abdominal pains and constipation.  At the time of this call the representative was unable to obtain additional information, because the call was disconnected. Hence the representative called back and left message. The physician did not give consent to follow up. This case has been linked to the US2019GSK089658, reported for the dose 1 of the same patient by the same reporter. There is a discrepancy in the outcome of the event abdominal pains and constipation. In the structured field it is reported as not recovered/not resolved, but the outcome reported in the source document is recovering/ resolving, however outcome is retain as per fields.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: Body aches; Chills; Headache; Tiredness; Muscle pain all over body; Flu Like Symptoms; torso not comfortable; Torso not comfortable; sore arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGLES VACCINE with an associated reaction of herpes zoster (received in 2007 and experienced Shingles and neuralgia outbreaks).   On 14th May 2019 13:00, the patient received the 1st dose of Shingrix (intramuscular). On 14th May 2019, 2 hrs after receiving Shingrix, the patient experienced pain in arm. On 14th May 2019 23:00, the patient experienced general body pain, chills, headache, tiredness, generalized muscle aches, influenza-like symptoms, chest discomfort and abdominal discomfort. On an unknown date, the outcome of the general body pain, chills, headache, tiredness, generalized muscle aches, influenza-like symptoms, chest discomfort, abdominal discomfort and pain in arm were recovering/resolving.   It was unknown if the reporter considered the general body pain, chills, headache, tiredness, generalized muscle aches, influenza-like symptoms, chest discomfort, abdominal discomfort and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 14th May 2019 at 1 PM pacific time, the patient received Shingrix vaccine in left deltoid. About 10 hours later at 11 PM at night he started experiencing body aches, chills, headache, flu like symptoms, tiredness, muscle pain all over the body and mostly his torso was not comfortable. About 2 to 3 hours post vaccination he experienced a sore arm.  All the side effects had subsided a little bit. This case has been linked with case US2019AMR088872, US2019AMR088911 and US2019AMR088873 reported by the same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pain, Pain in extremity
Clinical narrative: Body aches; Chills; Headache; Tiredness; Muscle pain all over body; Flu Like Symptoms; torso not comfortable; Torso not comfortable; sore arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGLES VACCINE with an associated reaction of herpes zoster (received in 2007 and experienced Shingles and neuralgia outbreaks).   On 14th May 2019 13:00, the patient received the 1st dose of Shingrix (intramuscular). On 14th May 2019, 2 hrs after receiving Shingrix, the patient experienced pain in arm. On 14th May 2019 23:00, the patient experienced general body pain, chills, headache, tiredness, generalized muscle aches, influenza-like symptoms, chest discomfort and abdominal discomfort. On an unknown date, the outcome of the general body pain, chills, headache, tiredness, generalized muscle aches, influenza-like symptoms, chest discomfort, abdominal discomfort and pain in arm were recovering/resolving.   It was unknown if the reporter considered the general body pain, chills, headache, tiredness, generalized muscle aches, influenza-like symptoms, chest discomfort, abdominal discomfort and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 14th May 2019 at 1 PM pacific time, the patient received Shingrix vaccine in left deltoid. About 10 hours later at 11 PM at night he started experiencing body aches, chills, headache, flu like symptoms, tiredness, muscle pain all over the body and mostly his torso was not comfortable. About 2 to 3 hours post vaccination he experienced a sore arm.  All the side effects had subsided a little bit. This case has been linked with case US2019AMR088872, US2019AMR088911 and US2019AMR088873 reported by the same reporter
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: injection site swelling; injection site redness; injection site warmth; injection site itching; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2019, the patient received Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the left deltoid. The patient reported to the pharmacist that all week long, she had swelling the size of half dollar at the injection site and redness. Now, the swelling was half the length of her upper arm and it was 4 to 5 inches wide. The area was also warm and itching.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Headache, Influenza like illness
Clinical narrative: Flu Like Symptoms; Fever; Chills; Vomiting; Nausea; Loss of appetite; Diarrhea; Headache; Painful arm; Blisters in mouth; She could not move or do anything and was in bed; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired. The patient was treated with ibuprofen and emetrol (nos) (Emetrol). In May 2019, the outcome of the influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm and at that night she woke up with flu like symptoms, fever, chills, vomiting, nausea, loss of appetite, diarrhea, headache, painful arm and blisters in mouth. The patient could not move or do anything and was in bed. She missed 3 days of work.  The patient mentioned the first three days were worse. The patient took Emetrol and Ibuprofen. Vomiting and nausea were resolved after lasting for 3 days. Influenza-like symptoms, fever, chills, appetite lost, diarrhea, headache, pain in arm and blistering of mouth were resolved after lasting for 5 days. No further details were provided. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Oral mucosal blistering, Pain in extremity, Pyrexia
Clinical narrative: Flu Like Symptoms; Fever; Chills; Vomiting; Nausea; Loss of appetite; Diarrhea; Headache; Painful arm; Blisters in mouth; She could not move or do anything and was in bed; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired. The patient was treated with ibuprofen and emetrol (nos) (Emetrol). In May 2019, the outcome of the influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm and at that night she woke up with flu like symptoms, fever, chills, vomiting, nausea, loss of appetite, diarrhea, headache, painful arm and blisters in mouth. The patient could not move or do anything and was in bed. She missed 3 days of work.  The patient mentioned the first three days were worse. The patient took Emetrol and Ibuprofen. Vomiting and nausea were resolved after lasting for 3 days. Influenza-like symptoms, fever, chills, appetite lost, diarrhea, headache, pain in arm and blistering of mouth were resolved after lasting for 5 days. No further details were provided. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Flu Like Symptoms; Fever; Chills; Vomiting; Nausea; Loss of appetite; Diarrhea; Headache; Painful arm; Blisters in mouth; She could not move or do anything and was in bed; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired. The patient was treated with ibuprofen and emetrol (nos) (Emetrol). In May 2019, the outcome of the influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm and at that night she woke up with flu like symptoms, fever, chills, vomiting, nausea, loss of appetite, diarrhea, headache, painful arm and blisters in mouth. The patient could not move or do anything and was in bed. She missed 3 days of work.  The patient mentioned the first three days were worse. The patient took Emetrol and Ibuprofen. Vomiting and nausea were resolved after lasting for 3 days. Influenza-like symptoms, fever, chills, appetite lost, diarrhea, headache, pain in arm and blistering of mouth were resolved after lasting for 5 days. No further details were provided. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Electrocardiogram, Fall, Head injury, Heart rate decreased
Clinical narrative: Awoke the next morning feeling dizzy and sore. Went into bathroom to get pain reliever. Syncope and hit head upon falling down.  Felt hearing was off and felt dizzy.  Mother put him to bed and called us. Had got him up and sent him to school - in school he had worsening dizziness and his speech was off and went to Emergency Room in afternoon.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Hypoacusis, Pain, Speech disorder, Syncope
Clinical narrative: Awoke the next morning feeling dizzy and sore. Went into bathroom to get pain reliever. Syncope and hit head upon falling down.  Felt hearing was off and felt dizzy.  Mother put him to bed and called us. Had got him up and sent him to school - in school he had worsening dizziness and his speech was off and went to Emergency Room in afternoon.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blood glucose, Blood test, Borrelia test, Diplopia
Clinical narrative: NET DAY BAD LOWER BACK PAIN AND EXTREME FATIGUE...... THREE WEEKS LATER I WOKE UP WITH DOUBLE VISION.  IT'S BEEN LIKE THIS FOR 11 WEEKS SO FAR. STARTING THE 12TH WEEK IT SEEMS TO BE GETTING BETTER. ALL 6 DOCTORS I HAVE SEEN SAID I HAD A SIXTH NERVE PALSY OF MY EYE.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Inflammatory marker test, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: NET DAY BAD LOWER BACK PAIN AND EXTREME FATIGUE...... THREE WEEKS LATER I WOKE UP WITH DOUBLE VISION.  IT'S BEEN LIKE THIS FOR 11 WEEKS SO FAR. STARTING THE 12TH WEEK IT SEEMS TO BE GETTING BETTER. ALL 6 DOCTORS I HAVE SEEN SAID I HAD A SIXTH NERVE PALSY OF MY EYE.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: VIth nerve paralysis
Clinical narrative: NET DAY BAD LOWER BACK PAIN AND EXTREME FATIGUE...... THREE WEEKS LATER I WOKE UP WITH DOUBLE VISION.  IT'S BEEN LIKE THIS FOR 11 WEEKS SO FAR. STARTING THE 12TH WEEK IT SEEMS TO BE GETTING BETTER. ALL 6 DOCTORS I HAVE SEEN SAID I HAD A SIXTH NERVE PALSY OF MY EYE.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Pyrexia, Rash, Swelling
Clinical narrative: Fever, SkinRash & SWOLLEN KNOT PREDNISONE 20 MG BID 20MG PO BID
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Arthralgia, Bone pain, Fatigue, Headache, Influenza like illness
Clinical narrative: Patient reports symptoms started about 4 hours after vaccine. States he feels like he has the flu, bones/joint aches (not limited to shoulder), headache, vomiting, congestion, feeling very tired. Will monitor symptoms and provide supportive care. Patient instructed to call if symptoms worsen or if he starts to develop s/sx of allergic reaction.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Respiratory tract congestion
Clinical narrative: Patient reports symptoms started about 4 hours after vaccine. States he feels like he has the flu, bones/joint aches (not limited to shoulder), headache, vomiting, congestion, feeling very tired. Will monitor symptoms and provide supportive care. Patient instructed to call if symptoms worsen or if he starts to develop s/sx of allergic reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt was administered second dose of shingrix shot on 04/30/2019. After getting the shot, she started having muscle ache at the site of injection. After few days , the muscle pain went away but she started having itchiness and redness at the site of injection. She started pcp office on or about 05/16/2019 and MD suggested betamethasone oint and follow up with dermatologist, since MD classified it as an adverse rcn. She visited dermatologist after her PCP apt and Dermatologist said it was not an allergix rcn or adverse event. Patient called today ( 05/24/2019) concerned about her itchiness and redness. I suggested her Benadryl tablets and calamine lotion at the site of itchiness and redness .
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Musculoskeletal disorder, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: extreme pain from shoulder down to wrist, clavicle. neck, collar bone.  unable to use arm at all.  tiniest movement causes severe pain.  running temp 101*.  pain relievers such as ibuprofen, excedrin and even old hydrocodone i had on hand, didn't touch the pain.  this happened with my first injection also, but no where near what it is like this time.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Endotracheal intubation, Herpes zoster meningoencephalitis, Hypotension, Intensive care, Polymerase chain reaction positive
Clinical narrative: Patient presented with vesicular rash and after being admitted to hospital became hypotensive and with concern for seizure activity, ultimately leading to being transferred to pediatric intensive care unit and intubated. It was later identified that patient's CSF PCR was positive for VZV. Now being managed for VZV encephalitis. Patient is usually followed by our pediatric nephrology service.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella virus test positive
Clinical narrative: Patient presented with vesicular rash and after being admitted to hospital became hypotensive and with concern for seizure activity, ultimately leading to being transferred to pediatric intensive care unit and intubated. It was later identified that patient's CSF PCR was positive for VZV. Now being managed for VZV encephalitis. Patient is usually followed by our pediatric nephrology service.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache, achy feeling, felt chills but no documented fever
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Scab, Varicella post vaccine
Clinical narrative: Chickenpox; This solicited report was received from a medical assistant and refers to a currently 4 years old female patient. The patient's pertinent medical history, allergies and concomitant drugs were unknown by the reporter. The patient's concurrent conditions were not provided.  On 13-MAY-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously for routine vaccination (dose, frequency and strength were not reported. Lot number R026547 with expiration date on 17-SEP-2020). The vaccine was reconstituted with properly stored sterile diluent.  On 15-MAY-2019, the primary reporter stated that patient's mother noticed bumps on the patient's skin. It got worse the next day, so the patient sought medical attention and was diagnosed with chickenpox. The physician referred the patient to an ophthalmologist as there was a bump near the patient's eye. No treatment was given for the adverse event. None laboratories diagnostics or other studies were performed. At the moment of this report the patient had not recovered from chickenpox.   The relatedness between the event occurrence and varicella virus vaccine live (Oka/Merck) (VARIVAX) administration was not reported.  Follow up information has been received from medical assistant on 17-MAY-2019.  Medical assistant called to ask if it was okay to remove a scab from patient and place it in sterile urine cup until the ship it out. Instructions from the varicella zoster virus identification program (VZVIP) were reviewed with the medical assistant.  Follow up information  has been received from medical assistant on 21-MAY-2019.  A callback was received from medical assistant, who confirmed that vesicular sample was obtained from the patient's right wrist.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Neuralgia, Post herpetic neuralgia, Skin lesion
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 2011, the pt was vaccinated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (strength, dosage schedule, route, lot number and expiration date were not provided). On an unspecified date, a few months after vaccination, the pt developed terrible skin lesions across her buttocks and backside and the lesions spread into her groin region. She also developed chronic shingles episodes, severe neuropathic pain into her hips, groin, feet, and toes. The pain was so severe that she was unable to wear socks or close-toe shoes of any kind or remain seated in a car or on a plane. As a direct and proximate result of ZOSTAVAX vaccine, the pt suffered serious injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt also suffered incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of the report, the pt had permanent nerve damage and ever-present neuropathic pain (not recovered). The reporter considered herpes zoster and postherpetic neuralgia to be related to ZOSTAVAX. Upon internal review, the events herpes zoster and postherpetic neuralgia were considered disabling due to sustained, severe and permanent personal injuries. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Colitis, Injection site erythema, Injection site pain, Injection site rash, Irritable bowel syndrome
Clinical narrative: pain at injection site; redness at injection site; splotchy rash at injection site; splotchy rash at injection site; spastic colon; colitis; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site rash, macular rash, spastic colon and colitis. In May 2019, the outcome of the injection site pain, injection site erythema and injection site rash were recovered/resolved. On an unknown date, the outcome of the macular rash was recovered/resolved and the outcome of the spastic colon and colitis were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site rash, macular rash, spastic colon and colitis to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left deltoid. One week after vaccination, the patient experienced what felt like spastic colon and colitis that had not resolved. Injection site pain, injection site erythema and injection site splotchy rash were lasted for 4 days. The patient had not seen the physician regarding this issue. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: pain at injection site; redness at injection site; splotchy rash at injection site; splotchy rash at injection site; spastic colon; colitis; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site rash, macular rash, spastic colon and colitis. In May 2019, the outcome of the injection site pain, injection site erythema and injection site rash were recovered/resolved. On an unknown date, the outcome of the macular rash was recovered/resolved and the outcome of the spastic colon and colitis were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site rash, macular rash, spastic colon and colitis to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left deltoid. One week after vaccination, the patient experienced what felt like spastic colon and colitis that had not resolved. Injection site pain, injection site erythema and injection site splotchy rash were lasted for 4 days. The patient had not seen the physician regarding this issue. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Feel Like Passing Out; Fast Heartbeat; Weight Loss; Fever; Body Aches/aching; Chills; Stomach Discomfort; Diarrhea; Loss of Appetite; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th April 2019, 2 days after receiving Shingrix, the patient experienced fever, general body pain, chills, stomach discomfort, diarrhea, appetite lost, fatigue and weight loss. On 30th April 2019, the patient experienced feeling bad and heartbeats increased. The patient was treated with ibuprofen (Advil). On 29th April 2019, the outcome of the fever and chills were recovered/resolved. On 1st May 2019, the outcome of the general body pain was recovered/resolved. On 2nd May 2019, the outcome of the stomach discomfort, diarrhea and fatigue were recovered/resolved. In May 2019, the outcome of the appetite lost was recovered/resolved. On an unknown date, the outcome of the feeling bad, heartbeats increased and weight loss were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain, chills, stomach discomfort, diarrhea, appetite lost, fatigue, feeling bad, heartbeats increased and weight loss to be related to Shingrix.  Additional details were provided as follows: The patient experienced fever (101 degree farenheit), general body pain, chills, stomach discomfort, diarrhea, appetite lost, fatigue, feeling bad, heartbeats increased and weight loss. Fever was relived after treatment with advil.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Heart rate increased, Pain, Pyrexia, Weight decreased
Clinical narrative: Feel Like Passing Out; Fast Heartbeat; Weight Loss; Fever; Body Aches/aching; Chills; Stomach Discomfort; Diarrhea; Loss of Appetite; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th April 2019, 2 days after receiving Shingrix, the patient experienced fever, general body pain, chills, stomach discomfort, diarrhea, appetite lost, fatigue and weight loss. On 30th April 2019, the patient experienced feeling bad and heartbeats increased. The patient was treated with ibuprofen (Advil). On 29th April 2019, the outcome of the fever and chills were recovered/resolved. On 1st May 2019, the outcome of the general body pain was recovered/resolved. On 2nd May 2019, the outcome of the stomach discomfort, diarrhea and fatigue were recovered/resolved. In May 2019, the outcome of the appetite lost was recovered/resolved. On an unknown date, the outcome of the feeling bad, heartbeats increased and weight loss were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain, chills, stomach discomfort, diarrhea, appetite lost, fatigue, feeling bad, heartbeats increased and weight loss to be related to Shingrix.  Additional details were provided as follows: The patient experienced fever (101 degree farenheit), general body pain, chills, stomach discomfort, diarrhea, appetite lost, fatigue, feeling bad, heartbeats increased and weight loss. Fever was relived after treatment with advil.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Face injury, Fall, Lip injury, Musculoskeletal stiffness, Pallor
Clinical narrative: Patient had syncopal event 3-5 minutes following administration of the HPV vaccine. He was standing at the time. Mom reports he began to look pale, and he fell on his face. He appeared to stiffen. In the floor. When I examined him, he was noted to be pale. He was sitting up in a chair. There was a superficial mucosal laceration to lower lip and an abrasion to mucosa of top lip. He responded to questions appropriately. His vitals were stable. Several minutes later, he became pale again and vomited several times. HR was in the 40?s prior to vomiting, but rebounded after the episode. He recovered after 30 minutes and tolerated a pedialyte popsicle.  He was observed in clinic for around 1 hour following syncopal event.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Skin abrasion, Syncope, Vomiting
Clinical narrative: Patient had syncopal event 3-5 minutes following administration of the HPV vaccine. He was standing at the time. Mom reports he began to look pale, and he fell on his face. He appeared to stiffen. In the floor. When I examined him, he was noted to be pale. He was sitting up in a chair. There was a superficial mucosal laceration to lower lip and an abrasion to mucosa of top lip. He responded to questions appropriately. His vitals were stable. Several minutes later, he became pale again and vomited several times. HR was in the 40?s prior to vomiting, but rebounded after the episode. He recovered after 30 minutes and tolerated a pedialyte popsicle.  He was observed in clinic for around 1 hour following syncopal event.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Perioral dermatitis
Clinical narrative: I developed a rash around my mouth which has not gone away in over 3 weeks now !
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: Patient described a migraine she had the evening after the vaccine was administered. It did not go away. Her doctor prescribed ibuprofen 800mg three times daily and the migraine went away after a couple of days.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Hyperaesthesia, Insomnia, Pyrexia, Skin burning sensation
Clinical narrative: Between 9-10p on 5/23/2019, client started feeling feverish, but T-99, had difficulty sleeping, due to feeling like skin was on fire. In the morning noticed face slightly swollen, felt lightheaded, skin feels like on fire (coming in waves), skin sensitive to touch, skin hot to touch, feels sluggish,. Coworker noticed face more swollen at work. No difficulty breathing. First rabies dose 5/16/19, had some lower back pain(lasted about a day) and headache(lasted about a day).
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Skin warm, Sluggishness, Swelling face
Clinical narrative: Between 9-10p on 5/23/2019, client started feeling feverish, but T-99, had difficulty sleeping, due to feeling like skin was on fire. In the morning noticed face slightly swollen, felt lightheaded, skin feels like on fire (coming in waves), skin sensitive to touch, skin hot to touch, feels sluggish,. Coworker noticed face more swollen at work. No difficulty breathing. First rabies dose 5/16/19, had some lower back pain(lasted about a day) and headache(lasted about a day).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Gastrointestinal disorder
Clinical narrative: Headache, chills, nausea, aching all over, dizzy, gastrointestinal problems, no appetite, fatigue, redness and pain at injection site Headache started around 3:30 pm, all other symptoms began around 9:30 pm on day of injection (I am reporting this the next day)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: Headache, chills, nausea, aching all over, dizzy, gastrointestinal problems, no appetite, fatigue, redness and pain at injection site Headache started around 3:30 pm, all other symptoms began around 9:30 pm on day of injection (I am reporting this the next day)
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Abnormal behaviour, Dehydration, Diarrhoea, Lethargy
Clinical narrative: Patient began projectile vomiting and having severe diarrhea a few hours post vaccine. He became lethargic and almost unresponsive that night and into the following day and was severely dehydrated. He could not keep breast milk down. We took him back to Doctor's office on 3/20/19 and they gave him pedialyte which was all he kept down for the next 12 hours. The next day he continued to vomit and have severe diarrhea and only had 3-4 wet diaper in 48 hours. We took him to the ER at Hospital on 3/21 where they did X-rays and ultrasounds to rule out intussusception. He was given fluids and sent home to rest and we were instructed to keep up the pedialyte until he began producing more wet diapers and then slowly introduce breast milk again.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Ultrasound abdomen normal, Urine output decreased, Vomiting, X-ray normal
Clinical narrative: Patient began projectile vomiting and having severe diarrhea a few hours post vaccine. He became lethargic and almost unresponsive that night and into the following day and was severely dehydrated. He could not keep breast milk down. We took him back to Doctor's office on 3/20/19 and they gave him pedialyte which was all he kept down for the next 12 hours. The next day he continued to vomit and have severe diarrhea and only had 3-4 wet diaper in 48 hours. We took him to the ER at Hospital on 3/21 where they did X-rays and ultrasounds to rule out intussusception. He was given fluids and sent home to rest and we were instructed to keep up the pedialyte until he began producing more wet diapers and then slowly introduce breast milk again.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Eczema, Food allergy, Rash generalised
Clinical narrative: On 4/20, patient consumed eggs and had rash breakout on trunk of body going down her arms and legs. Patient has eaten egg prior but not reacted.  Mother was treating it as a heat rash--keeping patient cool, dry, and applying lotion. On 4/22 during doctor visit for older sibling and doctor observed the patient's rash and confirmed it was an allergy. Doctor recommended use of Benadryl in case it did not go away on its own--did not need to use any. Rash disappeared 2 days after seeing the doctor. It turned into an eczema rash.  Rash has healed,now and patient is exclusively breastfeeding. However, rash flairs up if mother eats eggs.  Using Eucerin and Aquaphor as needed for breakouts.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fatigue, Fever, Chills, Muscle pain for 24 hours.  Ibuprofen and bedrest. Resolved by next morning.  Site pain persisted 2 more days.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a physician via call center representative and described the occurrence of adverse event in an unspecified number of the adult patients who received Herpes zoster (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 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 reported. The age group was not reported but it was selected as adult as per the vaccine indication. The physician reported that the many patients have side effects after 1st dose of Shingrix and were reluctant to take the 2nd dose of Shingrix. Additional details regarding type of side effects or other information were not provided in the inquiry.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: achey; This case was reported by a other health professional via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received Shingrix at different facility. The patient felt better after taking tylenol. The reporter decline to provide more information. The reporter did not consent to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Patient states that she woke up on 5/24/19 and was experiencing all over body aches and nausea.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Posture abnormal, Vomiting
Clinical narrative: One day after vaccine- vomiting and Excruciating stomach pains similar to cramping from diarrhea or a stomach virus. Unable to stand up straight, could only be somewhat relieved by staying bent over.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: Patient received vaccine 04//30/2019 and called in 05/07/2019 stating that  05/06/2019 she had noticed a sore bump at injection site the size of a quarter.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Pt. reported after 1.5 weeks from Shingrix 1 st dose, pt. developed rash at left side of abdomen that was erythematous, blistering, itchy, burning,   As of today, 5/24/19, rash are gone but sill feels some tenderness around the area where she had rashes.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: Pt. reported after 1.5 weeks from Shingrix 1 st dose, pt. developed rash at left side of abdomen that was erythematous, blistering, itchy, burning,   As of today, 5/24/19, rash are gone but sill feels some tenderness around the area where she had rashes.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MMR, TD, VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Mother calls health department on 05/24/2019 to report that patient'r left arm is red and swollen.  Swelling extends up the left arm and into left side of her neck.  Mother reports that she has had a fever off and on since vaccination also.  Patient also has pain in left arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pain
Clinical narrative: pt felt dizzy right after shingrix #1. She said this happens sometimes which is why she was prepared and brought an electrolyte drink with her. She said she could "feel the liquid of the injection going into her arm and that it stung". After about 15 minutes and a cold pack and drinking her electrolytes she said she felt better and left the store on her own.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: no anitbodies for measles; received vaccination before she was 1 years old; This spontaneous report was received from a patient's husband and refers to a currently 65-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, before the patient was 1-year-old, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient got her "titers pulled" and it showed no anitbodies for measles. The outcome of the event was unknown. The causality assessment between the event and the suspect vaccine was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Herpes zoster, Pneumonia, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 31-MAY-2016, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, dose# and route not specified) at a pharmacy for the prevention of shingle. In approximately 2016 (reported as shortly after the vaccination), pt suffered and was later diagnosed with shingles on the left side of her upper back area. Pt also suffered and was diagnosed with dry eye syndrome and pneumonia. The pt claimed that the vaccine did not prevent shingles, but rather caused contract persistent strain of herpes zoster, dry eye syndrome and pneumonia. As a direct and proximate result of defective vaccine, pt suffered painful injuries and damages, and required extensive medical care and treatment. Pt sustained severe and permanent personal injuries. Further, pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of pneumonia, herpes zoster, vaccination failure and dry eye syndrome was unknown. The reporter considered all events to be related to ZOSTAVAX. The events pneumonia, herpes zoster, vaccination failure and dry eye syndrome were considered to be disability. Upon internal review, pneumonia was determined to be medically significant. The event of pneumonia, herpes zoster, vaccination failure and dry eye were considered disabling. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect; patient was administered the M-M-R II intramuscularly; This spontaneous report was received from a pharmacy intern referred to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N032747 and expiry date 20-NOV-2019, route of administration via intramuscular for an unknown indication(incorrect route of product administration) and no adverse effects reported (no adverse event). Action taken with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was discontinued on 10-MAY-2019. No PQC found.
Sex: U
Vaccine: HEP, HEP, HEP, HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: no seroconversion; Therapy non-responder; Therapy non-responder; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   Previously administered products included Zostavax (received Zostavax when he was 48years old).   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, Hepatitis B vaccine at an unknown dose, Hepatitis B vaccine at an unknown dose and Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder, therapy non-responder and therapy non-responder. On an unknown date, the outcome of the therapy non-responder, therapy non-responder and therapy non-responder were unknown.   It was unknown if the reporter considered the therapy non-responder, therapy non-responder and therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. It was unknown if the reporter considered the therapy non-responder and therapy non-responder to be related to Hepatitis B vaccine. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine and Hepatitis B vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was nor reported. The patient received 6 hepatitis B vaccine over the last 20 years. The patient received Zostavax when he was 48 years old and Merk included him in a study for Zostavax because of his condition of not converting Hepatitis B vaccines. The patient believed his hepatitis B vaccination was also Merk's and that was why they wanted to include him in a study, but could not confirm that all of the 6 vaccines received were Merk's. The patient stated he got the initial series (3 doses) of Hepatitis B vaccine and then through his profession had a titre drawn and given a booster dose. Then found again after booster dose to not be protected and received two additional doses, again with no conversation. The patient had no other reactions and no problems converting any other vaccines. For tolerance of Shingrix, refer linked case US2019088015.      Lab Comments: On an unknown date, the lab tests were performed.