chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Ascites, Biliary tract disorder, Carbohydrate antigen 19-9 increased, Hepatic cirrhosis, Hepatitis acute
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hepatic cirrhosis in a 56-year-old female patient who received SHINGRIX for prophylaxis.  In July 2018, the patient received SHINGRIX. In July 2018, less than a month after receiving SHINGRIX, the patient experienced rash. On 1st August 2018, the patient experienced lab test abnormal. On 9th August 2018, less than a year after receiving SHINGRIX, the patient experienced cancer antigen 19-9 increased. In August 2018, the patient experienced hepatic cirrhosis (serious criteria GSK medically significant), ascites (serious criteria GSK medically significant), biliary tract disorder and raised liver function tests. On an unknown date, the outcome of the hepatic cirrhosis, ascites, rash, biliary tract disorder and lab test abnormal were unknown and the outcome of the raised liver function tests was recovering/resolving and the outcome of the cancer antigen 19-9 increased was not recovered/not resolved. It was unknown if the reporter considered the hepatic cirrhosis, ascites, rash, biliary tract disorder, raised liver function tests, lab test abnormal and cancer antigen 19-9 increased to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX in early July and developed a rash sometime in July. In early August the patient developed elevated liver function tests (LFT's), acute hepatitis with ascites and bile duct dilation and evidence of cirrhosis based on imaging. Since August the patient's cancer antigen 19-9 increased (CA 19-9), has been steadily increasing (this was a pancreatic cancer marker). On 9th August 2018 the CA 19-9 was 429, and on 10th October 2018 it was 1281. The healthcare professional did not have information on the SHINGRIX as it was given elsewhere. The healthcare professional stated that the patient's liver lab values have been improving but not the CA 19-9. They were questioning whether the SHINGRIX might have caused a false positive in this marker.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Liver function test increased, Nuclear magnetic resonance imaging abnormal, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hepatic cirrhosis in a 56-year-old female patient who received SHINGRIX for prophylaxis.  In July 2018, the patient received SHINGRIX. In July 2018, less than a month after receiving SHINGRIX, the patient experienced rash. On 1st August 2018, the patient experienced lab test abnormal. On 9th August 2018, less than a year after receiving SHINGRIX, the patient experienced cancer antigen 19-9 increased. In August 2018, the patient experienced hepatic cirrhosis (serious criteria GSK medically significant), ascites (serious criteria GSK medically significant), biliary tract disorder and raised liver function tests. On an unknown date, the outcome of the hepatic cirrhosis, ascites, rash, biliary tract disorder and lab test abnormal were unknown and the outcome of the raised liver function tests was recovering/resolving and the outcome of the cancer antigen 19-9 increased was not recovered/not resolved. It was unknown if the reporter considered the hepatic cirrhosis, ascites, rash, biliary tract disorder, raised liver function tests, lab test abnormal and cancer antigen 19-9 increased to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX in early July and developed a rash sometime in July. In early August the patient developed elevated liver function tests (LFT's), acute hepatitis with ascites and bile duct dilation and evidence of cirrhosis based on imaging. Since August the patient's cancer antigen 19-9 increased (CA 19-9), has been steadily increasing (this was a pancreatic cancer marker). On 9th August 2018 the CA 19-9 was 429, and on 10th October 2018 it was 1281. The healthcare professional did not have information on the SHINGRIX as it was given elsewhere. The healthcare professional stated that the patient's liver lab values have been improving but not the CA 19-9. They were questioning whether the SHINGRIX might have caused a false positive in this marker.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Dizziness, Loss of consciousness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of lost consciousness in a 70-year-old female patient who received SHINGRIX (batch number M224F, expiry date 8th February 2021) for prophylaxis. The patient's past medical history included low blood pressure. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 1 day after receiving SHINGRIX, the patient experienced lost consciousness (serious criteria GSK medically significant) and dizzy spells. On an unknown date, the patient experienced double vision. On an unknown date, the outcome of the lost consciousness and dizzy spells were recovered/resolved and the outcome of the double vision was unknown. It was unknown if the reporter considered the lost consciousness, dizzy spells and double vision to be related to SHINGRIX. Additional details were received as follows: This case was previously reported to the physician. The patient received SHINGRIX vaccine in left arm. On the day of reporting, the patient came into the pharmacy for 2nd dose, however, pharmacist advised patient to follow up with primary care provider before getting the 2nd dose of SHINGRIX. The reporter stated that the next morning after receiving the vaccine, the patient experienced a dizzy spell and lost consciousness. Caller states that the patient went to the emergency room. However, the cause of the symptoms were unknown. Upon call transfer, the reporter additionally stated that the next morning after receiving SHINGRIX, the patient was seeing double, then blacked out.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Dizziness, Erythema, Fatigue, Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, pain in arm, nausea, light headedness, tiredness and discomfort. On an unknown date, the outcome of the swelling arm, erythema of extremities, pain in arm, nausea, light headedness, tiredness and discomfort were unknown.  It was unknown if the reporter considered the swelling arm, erythema of extremities, pain in arm, nausea, light headedness, tiredness and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of the shingles vaccine and she believed that she had a reaction that her arm was very red swollen and very sore. The day after the patient felt nauseas light headed and very tired. The patient asked that is there anything that she could do to elevate the soreness swelling and discomfort. The patient also asked about if she would have the same reaction after the 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, pain in arm, nausea, light headedness, tiredness and discomfort. On an unknown date, the outcome of the swelling arm, erythema of extremities, pain in arm, nausea, light headedness, tiredness and discomfort were unknown.  It was unknown if the reporter considered the swelling arm, erythema of extremities, pain in arm, nausea, light headedness, tiredness and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of the shingles vaccine and she believed that she had a reaction that her arm was very red swollen and very sore. The day after the patient felt nauseas light headed and very tired. The patient asked that is there anything that she could do to elevate the soreness swelling and discomfort. The patient also asked about if she would have the same reaction after the 2nd dose of SHINGRIX.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Was seen in office on 8/30/18 with well-circumscribed, erythematous, edematous wheals over the buttocks and bilateral lower extremities noted. Patient did have fever on 8/29/18, but resolved before appointment on 8/30/18. On 8/21/18, patient received 12 month vaccines and ROCEPHIN.  This was followed by a prescription of OMNICEF for 10 days.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister
Clinical narrative: Blisters on face.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site pain
Clinical narrative: Blisters on face.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Face oedema
Clinical narrative: Patient was given vaccines in office on 8/23/18. He was then seen in Urgent Care on 8/29/18 for right eye edema and hives and swelling noted to bilateral cheeks, feet, legs and arms. Nasal congestion and discharge also present on exam in urgent care. Oral benadryl and IM Epinephrine given in urgent care for worsening hives. Sent home with Benadryl prescription to be used every 6-8 hours PRN.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Hypoaesthesia, Impaired work ability
Clinical narrative: Patient developed arm numbness, swelling and redness on the left arm, report feeling nausea and vomiting, and diarrhea after the injection. Patient felt extremely drowsy and fatigue, as a result, patient was absent from work for 3 days. Patient was advised to do warm compress, take IBU and go to emergency for evaluation.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Peripheral swelling, Somnolence, Vomiting
Clinical narrative: Patient developed arm numbness, swelling and redness on the left arm, report feeling nausea and vomiting, and diarrhea after the injection. Patient felt extremely drowsy and fatigue, as a result, patient was absent from work for 3 days. Patient was advised to do warm compress, take IBU and go to emergency for evaluation.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Hypertension, Skin warm
Clinical narrative: 3 minutes after admini, patient exhibited redness and warmth at face, arms, chest. Blood pressure measured at 1:45pm was 145/69 pulse 82. Patient reports having normal/low usual BP.  1:49pm BP 123/62 pulse 68. 1:54pm BP 123/68 pulse 67. Paramedics came to assess patient at 1:56pm.  Paramedics cleared and released patient at 2:05pm.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Pain in extremity
Clinical narrative: Pt claims that after the shot she received she experienced extreme pain in her arm and she had flushing for 2 days as if she was feverish.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Gait inability, Lethargy, Vertigo
Clinical narrative: Patient woke up in the middle of that night around 1 or 2 am very dizzy and lethargic, patient said that he felt like the ceiling was spinning and he could not walk at all, he was like crawling to reach his destination.
Age: 26.0
Sex: M
Vaccine: FLU4, HEP, HEPA
Symptoms: Haemorrhage, Pain in extremity
Clinical narrative: Patient came back up to the counter stating the bandage fell off because of the blood and that his arm hurt. I activated an instant ice pack and applied it to the right arm to ensure pressure and cold was being applied. We continued to apply the ice pack for 15 minutes checking periodically for additional swelling etc. After the 15 minutes the patient said the arm still hurt but the bleeding stopped and no additional adverse reaction was seen.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Tingling in lip 1 hour after vaccine. Lip swelling the next day.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, and diarrhea.
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: 12 months 7 days male, here for his 1 year vaccines. I mistakenly administer patient Tdap (BOOSTRIX) instead of his 4th Dtap. Patient tolerated vaccines well, patient kept for 10 to 15 minutes after administration of vaccines for observation of any allergic reactions or side effects. Patient discharged with father awake and alert.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Infection, Peripheral swelling
Clinical narrative: Red, swollen, infection traveling down arm. Given antibiotics by doctor.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient's family members said that patient is experiencing shoulder pain. She cannot raise her arm at all without pain. Pain is a 10 on the pain scale. There is no redness/swelling at the injection site and pain is under her arm (armpit area rather than injection area). She has taken Excedrin (at 5pm) and put ice on the arm. Pain started approximately 3 hrs after injection. I instructed family to seek medical attention if pain gets worse, or does not get better. There is no numbness or tingling. She can move her elbow, hand and fingers.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: FLUAD reaction: Per patient in right arm, started with pain in shoulder more severe on Tuesday. On Wednesday (today)  he experienced elbow pain but shoulder pain was gone. He couldn't left a coffee cup without pain. Pain was worse on Wednesday. He could raise his arm.
Age: 60.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt came into pharmacy to notify us of her reaction. After ADACEL, her arm was extremely painful. She thought this was normal and waited about a week before consulting with md. The pain had not subsided and she was unable to sleep well or use her arm. Md stated immunization was not given in correct area of arm. Her arm would be fine and the pain would subside but it would take time. When pt came into pharmacy (1mos later), it was better but still painful.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Allergy to vaccine, Erythema, Hypersensitivity, Joint swelling, Purulent discharge
Clinical narrative: Patient presented to me on Saturday, September 29, 2018 with red and swollen elbow and a pocket of pus on the bottom or upper arm. I recommeded that she see nurse practitioner immediately at Clinic.  Given antibiotic. She called me on Monday and said that she had gone to Dr. to follow-up.. He d/c antibiotic, started steroid and stated that he thought she had had an (allergic) reaction to the PNEUMOVAX vaccine. I saw her today (10/10/2018) and she is much better.. Some minor swelling in left elbow, but otherwise better.
Age: 46.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Cellulitis at injection site, confirmed by PCP and given antibiotics for treatment. Pain, swelling, redness, fever, malaise.
Age: 46.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Cellulitis at injection site, confirmed by PCP and given antibiotics for treatment. Pain, swelling, redness, fever, malaise.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: "I got a flu shot about 8-9 days ago and had bad pain in my arm for several days. I also experienced mild pain/tingling in two fingers on my right hand (shot was in the right shoulder). Today, my shoulder still hurts but the fingers are more numb than in pain. I had a similar reaction, but without the fingers pain, a couple years back".
Age: 56.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Pain in extremity
Clinical narrative: PT HUSBAND STOP BY THE PHARMACY TODAY AND SAID THAT AFTER 3 MONTHS SINCE THE VACINATION, PT ARM IS STILL SORE/PAIN. PT IS TAKING ASPIRIN FOR THE SORENESS BUT THE SYMPTOM DOES NOT GO AWAY.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Pt said he felt like he had been hit by a truck- fever and severe muslce aches all over.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Excessive Fatigue, intermittent nausea, intermittent headache, painful enlarged (3-inch in diameter) red and warm to touch lymph node under left arm. Initially was one inch in diameter, grew over two days to 3 inches since today. Painful enough to awaken me during sleep.    Ibuprofen used to control pain and headache. It eased but did not relieve pain. I have never had an allergic reaction to the flu vaccine except a little soreness at the injection site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Poor quality sleep, Skin warm
Clinical narrative: Excessive Fatigue, intermittent nausea, intermittent headache, painful enlarged (3-inch in diameter) red and warm to touch lymph node under left arm. Initially was one inch in diameter, grew over two days to 3 inches since today. Painful enough to awaken me during sleep.    Ibuprofen used to control pain and headache. It eased but did not relieve pain. I have never had an allergic reaction to the flu vaccine except a little soreness at the injection site.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Throat tightness
Clinical narrative: Felt throat closing. Went to urgent car and received benadryl and prednisone prescription. Symptoms resolved within a few hours after.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: 10 minutes after receiving the vaccination patient started to become itchy all over her body. Per patient had hives on legs and back. Her tips of ears were also itching. Patient stated that she has an Epipien with her and if difficulty breathing or throat/lip swelling didoccur that she was going to use it. I advised her to call an ambulance if difficulty breathing occurs. Patient was advised to take benadryl and patient did take benadryl and her symptoms improved to the point where she did not feel an ER visit was necessary. Patient still has residual itchiness but symptoms have improved. I advised patient to take benadryl again before bed if symptoms are still there.
Age: 34.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Fever, fatigue, malaise, general unwell feeling.
Age: 25.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Dyspnoea, Syncope
Clinical narrative: Patient was having decreased breathing, and started fainting.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Received shot at 8:45pm felt okay, got home and within the hour felt nauseated, dizzy, quivering, instant headache and fever, severe pain in arm, legs felt like they were on fire, feet were ice cold.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Pyrexia, Tremor
Clinical narrative: Received shot at 8:45pm felt okay, got home and within the hour felt nauseated, dizzy, quivering, instant headache and fever, severe pain in arm, legs felt like they were on fire, feet were ice cold.
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: Back pain, Neck pain, Pruritus generalised, Pyrexia, Renal pain
Clinical narrative: Severe back and neck pain, fever, kidney pain, little-to-mild itching all over body, small amount of hives.
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: Severe back and neck pain, fever, kidney pain, little-to-mild itching all over body, small amount of hives.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Paraesthesia, Pyrexia, Rash papular
Clinical narrative: Pt reported a fever of 99.9 for the 3-4 days following admin. Pt reported raised bumps on her eyelids, a "pinching" feeling all over her body, a red patch (2x4) at injection site and a headache starting the day of vaccination and continuing for 3 weeks.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Fatigue, Flushing, Inflammation
Clinical narrative: Then experienced incredible all over body pain/inflammation, nausea, flushed, and fatigue from about 1600 hours Monday through about 2100 Tuesday evening. Only slight fever (99.6) that night. Pain continued through today with upper body joint pain/inflammation / chest pain in deep breathing with decreasing fatigue. Currently continue with site induration of 4 inch by 2 inch, overall raised about 1/4 inch above regular surface. Only telling you b/c I am reporting my adverse effects on website for "vaccine adverse effect reporting" and if website is actually organized enough to contact my PCP (highly doubtful) you should know from me first. Thanks.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Nausea, Pain, Pyrexia
Clinical narrative: Then experienced incredible all over body pain/inflammation, nausea, flushed, and fatigue from about 1600 hours Monday through about 2100 Tuesday evening. Only slight fever (99.6) that night. Pain continued through today with upper body joint pain/inflammation / chest pain in deep breathing with decreasing fatigue. Currently continue with site induration of 4 inch by 2 inch, overall raised about 1/4 inch above regular surface. Only telling you b/c I am reporting my adverse effects on website for "vaccine adverse effect reporting" and if website is actually organized enough to contact my PCP (highly doubtful) you should know from me first. Thanks.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Per the patient, states that a few hours after vaccine began to get hives on different areas of her body (counted about 8 in total). States there are no hives at area of administration. Has treated with BENADRYL with some relief. No reports of any anyphylaxis. Patient also states she has received vaccine in previous years with no reaction. I recommended also reaching out to her doctor so they are aware of possible allergic reaction.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Localized warm red rash.
Age: 79.0
Sex: F
Vaccine: FLUR4
Symptoms: Mobility decreased, Myalgia, Nodule
Clinical narrative: PATIENT HAS BEEN EXPERIENCING QUITE A BIT OF MUSCLE PAIN SINCE RECEIVING SHOT. SHE FEELS LIKE SHE CAN HARDLY MOVE THE ARM (EVEN WITH ROUTINE DAILY EVENTS LIKE DRESSING OR LIFTING OBJECTS). SHE STATES SHE FEELS A KNOT IN HER ARM.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Swelling
Clinical narrative: Patient is experiencing redness out side of injection site (shoulder and lower arm). She mentioned she also had very bad muscle pain throughout the whole body on the date she received the  vaccination which is quite common. Pain is much better today but the swelling and redness made patient concerned.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives lasting over one week; treated with antihistamines.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt arm is swollen with red patches. Pt was advised to take BENADRYL and if redness travels further down the arm or BENADRYL does not work to call their doctor.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient presented back to the pharmacy on 10/10/2018 in the evening and her left arm was warm to touch and slightly swollen. Appeared a light pink color. Patient said last year with the high dose vaccine her arm hurt and was a little red, this year seems to be worse. She took some naproxen to decrease inflammation and also put ice on the arm. I did tell her she can take some BENADRYL which she was to do this evening. Told her if symptoms worsen to be seen by Dr. in the office.
Age: 38.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Loss of consciousness, Malaise, Syncope
Clinical narrative: Within 2 minutes of getting the vaccinations, the patient said he was not feeling well repeatedly.  He was sitting down in the pharmacy waiting area when the next thing you know he passed out completely and fainted, with his head slumped down into his chest. Myself and a customer who happened to be there lifted him out of the chair and laid him on the ground, and elevated his legs.  He did hit his head slightly when we laid him on the carpet, but there was no lasting bump or contusion. Within about two minutes, he came back to full conciousness and was feeling much better, and by that time EMS had arrived.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient reported getting flu shot last month on 9-15-18 and is still experiencing pain in his arm. Patient advised on 10-10-18 date of reported to contact is PCP.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient complains of having sore and swollen arm at and below injection site. Arm is warm to the touch.
Age: 69.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: Pt got rash on his both arms and it last more than 2 weeks.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Fall
Clinical narrative: Patient requested for flu shot in the pharmacy, patient has history of high dose flu shot on 9/22/17. Patient questionnaire was asked/translated by pharmacist. Vaccination administration time between 3:40-3:49pm. After administration of the vaccine, patient was advised that the flu shot may take 2 weeks to be fully effective, she might experience injection site pain, and possible fever. Patient left seating area, walked out of the store, then promptly walked back into the store and fell face first by the doorway. An off duty doctor, first assisted the patient. After pharmacist was paged to the front, the doctor requested assistance to turn patient on her back to see if patient was conscious. Patient was asked if her back, neck, or head hurt, she said no. Patient was asked to squeeze both hands, to which she did so with strength. Patient was asked to provide family member contact info, to which she was able to do so. Pharmacist contact patient son while the doctor stayed with the patient. Paramedics arrived, checked her vitals & motor function.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 03-Oct-2018, concerns an adult, female patient of unspecified age. The patient's current condition included diabetes. On 27-Sep-2018, the patient was administered AFLURIA (QIV) [dose: 0.5 ml, route of administration: intramuscular, batch number: YF37706 and expiry date: 11-Jun-2019, anatomical location: not reported]. On an unspecified date in Sep-2018, 48 hours after the administration of the vaccine, the patient's sugar level was 200 (unit and normal range unspecified) and on unspecified date in Oct-2018, 96 hours later it was 400 (unit and normal range unspecified). At the time of this report, the outcome of the event was not reported.
Age: 47.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Dyspnoea, Pruritus, Rash, Rash generalised
Clinical narrative: Flu shot in (L) arm at 11:00 on 10/1/18 to employee health received MMR in (R) arm about 13:00. Broke out with rash over body on 10/3/18 rash progressed facial rash, itching difficulty breathing.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal, Injection site erythema, Injection site swelling
Clinical narrative: At 1500 on 10/4/2018 patient presented w/shortness of breath, chest tightness, and swelling of the left anterior and posterior upper arm extending to the left antecubital and anterior chest wall at the pectoral muscle. SOLU-MEDROL IM 125mg, BENADRYL 50mg IM given. EKG completed was normal. Patient was monitored for 2 hours after injections. At time of discharge anterior/posterior swelling in the (L) arm was subsiding, and patient was no longer short of breath. Patient was scheduled a follow up appt on 10/5/18. On 10/5/18 all symptoms were resolved except for redness and swelling of the left upper arm which is continuing to improve/subside.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: At 1500 on 10/4/2018 patient presented w/shortness of breath, chest tightness, and swelling of the left anterior and posterior upper arm extending to the left antecubital and anterior chest wall at the pectoral muscle. SOLU-MEDROL IM 125mg, BENADRYL 50mg IM given. EKG completed was normal. Patient was monitored for 2 hours after injections. At time of discharge anterior/posterior swelling in the (L) arm was subsiding, and patient was no longer short of breath. Patient was scheduled a follow up appt on 10/5/18. On 10/5/18 all symptoms were resolved except for redness and swelling of the left upper arm which is continuing to improve/subside.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Swelling to upper left arm.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Injection site pain, Paraesthesia
Clinical narrative: Pain at injection site. Tingling of fingers. Pt taking APAP. Pt went to MD -> dx hematoma.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a 12 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown by the reporter. On an unspecified date in 2009, the patient was vaccinated with GARDASIL for prophylaxis (strength, dose, dosage schedule, route, anatomical location, lot # and expiry date were not provided). The physician reported that a patient's acquaitance told of about a family member that received GARDASIL and died from unknown causes on an unspecified date (death). It was unknow if an autopsy was performed. Further information regarding the patient's death was not provided. The reporter's causality assessment between GARDASIL with death was not reported.; Reported Cause(s) of Death: Unspecified causes.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On 05-SEP-2010 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2010 the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. On or about 14-DEC-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by a physician for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-AUG-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), 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 condition of herpes zoster or shingles. On or about 24-AUG-2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative 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 (1st dose, refer case US2018GSK182303). On 2nd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced fever, general body pain, headache, shivering and dizziness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, general body pain, headache, shivering and dizziness were unknown. It was unknown if the reporter considered the fever, general body pain, headache, shivering and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced achy all over, fever, headache, shivering and dizziness. The patient reported that it has already been over 24 hours and the event were present at the time of reporting. The reporter wanted GlaxoSmithKline to know about the events.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative 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 (1st dose, refer case US2018GSK182303). On 2nd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced fever, general body pain, headache, shivering and dizziness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, general body pain, headache, shivering and dizziness were unknown. It was unknown if the reporter considered the fever, general body pain, headache, shivering and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced achy all over, fever, headache, shivering and dizziness. The patient reported that it has already been over 24 hours and the event were present at the time of reporting. The reporter wanted GlaxoSmithKline to know about the events.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative 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 (1st dose, refer case US2018GSK182303). On 2nd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced fever, general body pain, headache, shivering and dizziness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, general body pain, headache, shivering and dizziness were unknown. It was unknown if the reporter considered the fever, general body pain, headache, shivering and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced achy all over, fever, headache, shivering and dizziness. The patient reported that it has already been over 24 hours and the event were present at the time of reporting. The reporter wanted GlaxoSmithKline to know about the events.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative 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 (1st dose, refer case US2018GSK182303). On 2nd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced fever, general body pain, headache, shivering and dizziness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, general body pain, headache, shivering and dizziness were unknown. It was unknown if the reporter considered the fever, general body pain, headache, shivering and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced achy all over, fever, headache, shivering and dizziness. The patient reported that it has already been over 24 hours and the event were present at the time of reporting. The reporter wanted GlaxoSmithKline to know about the events.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, general body pain, headache and shivering. On an unknown date, the outcome of the fever, general body pain, headache and shivering were recovered/resolved. It was unknown if the reporter considered the fever, general body pain, headache and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a reaction to the 1st SHINGRIX and reported it to the Center for disease control and prevention (CDC). The patient experienced achy all over. This case has been linked to the case US2018GSK183618, reporter by same reporter and for same patient.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, general body pain, headache and shivering. On an unknown date, the outcome of the fever, general body pain, headache and shivering were recovered/resolved. It was unknown if the reporter considered the fever, general body pain, headache and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a reaction to the 1st SHINGRIX and reported it to the Center for disease control and prevention (CDC). The patient experienced achy all over. This case has been linked to the case US2018GSK183618, reporter by same reporter and for same patient.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, general body pain, headache and shivering. On an unknown date, the outcome of the fever, general body pain, headache and shivering were recovered/resolved. It was unknown if the reporter considered the fever, general body pain, headache and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a reaction to the 1st SHINGRIX and reported it to the Center for disease control and prevention (CDC). The patient experienced achy all over. This case has been linked to the case US2018GSK183618, reporter by same reporter and for same patient.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, general body pain, headache and shivering. On an unknown date, the outcome of the fever, general body pain, headache and shivering were recovered/resolved. It was unknown if the reporter considered the fever, general body pain, headache and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a reaction to the 1st SHINGRIX and reported it to the Center for disease control and prevention (CDC). The patient experienced achy all over. This case has been linked to the case US2018GSK183618, reporter by same reporter and for same patient.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Emotional distress, Fatigue, Gait disturbance, Injection site erythema
Clinical narrative: SHINGRIX vaccine 0.5ml IM Localized hot red 3 inches diameter for 5 days. General malaise, achy symptoms. Most significant effect was Pain/muscle spasms in left lower back required treatment.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms
Clinical narrative: SHINGRIX vaccine 0.5ml IM Localized hot red 3 inches diameter for 5 days. General malaise, achy symptoms. Most significant effect was Pain/muscle spasms in left lower back required treatment.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Erythema, Feeling hot, Malaise, Muscle spasms
Clinical narrative: SHINGRIX vaccine 0.5ml IM Localized hot red 3 inches diameter for 5 days. General malaise, achy symptoms. Most significant effect was Pain/muscle spasms in left lower back required treatment.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: SHINGRIX vaccine 0.5ml IM Localized hot red 3 inches diameter for 5 days. General malaise, achy symptoms. Most significant effect was Pain/muscle spasms in left lower back required treatment.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chills, Fatigue, Gait disturbance, Gait inability
Clinical narrative: Achy flu like symptoms onset 24 hours after injection 09/03/2018 at 11:30 PM Onset of Severe lower left back and left leg pain crippling and unable to walk. Call and visit to MD,  several prescriptions ordered with little relief e.g. Cyclobenzaprine and Naproxen and Pantoprazole  MD prescribed Physical Therapy and acupuncture - treatment on going as I am not back to baseline activity and still experiencing difficulty with walking and discomfort in left gluteus. Limited ability to perform normal activities of daily living and normal walking distance.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Insomnia, Muscle spasms, Walking aid user
Clinical narrative: Achy flu like symptoms onset 24 hours after injection 09/03/2018 at 11:30 PM Onset of Severe lower left back and left leg pain crippling and unable to walk. Call and visit to MD,  several prescriptions ordered with little relief e.g. Cyclobenzaprine and Naproxen and Pantoprazole  MD prescribed Physical Therapy and acupuncture - treatment on going as I am not back to baseline activity and still experiencing difficulty with walking and discomfort in left gluteus. Limited ability to perform normal activities of daily living and normal walking distance.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Gait inability, Influenza like illness, Loss of personal independence in daily activities, Musculoskeletal discomfort
Clinical narrative: Achy flu like symptoms onset 24 hours after injection 09/03/2018 at 11:30 PM Onset of Severe lower left back and left leg pain crippling and unable to walk. Call and visit to MD,  several prescriptions ordered with little relief e.g. Cyclobenzaprine and Naproxen and Pantoprazole  MD prescribed Physical Therapy and acupuncture - treatment on going as I am not back to baseline activity and still experiencing difficulty with walking and discomfort in left gluteus. Limited ability to perform normal activities of daily living and normal walking distance.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Achy flu like symptoms onset 24 hours after injection 09/03/2018 at 11:30 PM Onset of Severe lower left back and left leg pain crippling and unable to walk. Call and visit to MD,  several prescriptions ordered with little relief e.g. Cyclobenzaprine and Naproxen and Pantoprazole  MD prescribed Physical Therapy and acupuncture - treatment on going as I am not back to baseline activity and still experiencing difficulty with walking and discomfort in left gluteus. Limited ability to perform normal activities of daily living and normal walking distance.