chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased
Clinical narrative: Change in range of motion. Swelling and redness at the injections site.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue
Clinical narrative: Debilitating fatigue.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Feeling cold, Myalgia
Clinical narrative: All over muscle aches. Body so cold I could not get warm or comfortable. May have been running a fever. Needed to sleep. Everything seemed to resolve late that evening.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills, fever 100.9, headache, severe joint and muscle pain, extreme fatigue. (Difficulty getting out of bed).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever 100.9, headache, severe joint and muscle pain, extreme fatigue. (Difficulty getting out of bed).
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient stated that she developed a fever, extreme back/arm pain, swelling in her arm and shoulder/back area, redness down arm and into the shoulder/back area, and vomiting.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Vomiting
Clinical narrative: Patient stated that she developed a fever, extreme back/arm pain, swelling in her arm and shoulder/back area, redness down arm and into the shoulder/back area, and vomiting.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Feeling cold
Clinical narrative: NIGHT OF DIARRHEA AFTER VACCINE (4 TIMES). SHIVERING COLD IN THE MIDDLE OF THE NIGHT. WOKE UP THE NEXT MORNING WITH NO SYMPTOMS.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site swelling, Migraine, Pain
Clinical narrative: Per pt 3 hours after shot on Monday 5/21/18 patient noticed symptoms of migraine, soreness, and back pain centered around the spine. As the day progressed to the next day the symptoms only got worse. She also developed fever, redness, and swelling around the injection site. As of today 5/23/18 she is only sore now.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Per pt 3 hours after shot on Monday 5/21/18 patient noticed symptoms of migraine, soreness, and back pain centered around the spine. As the day progressed to the next day the symptoms only got worse. She also developed fever, redness, and swelling around the injection site. As of today 5/23/18 she is only sore now.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Eczema, Full blood count normal, Metabolic function test normal, Pruritus
Clinical narrative: Patient developed a generalized, vesicular rash that was similar in appearance to a primary varicella infection.  Skin biopsy showed a spongiotic dermatitis with eosinophils. The patient had pruritis, but was not clinically ill. (We have photographs if you or the manufacturer would like them.)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Patient developed a generalized, vesicular rash that was similar in appearance to a primary varicella infection.  Skin biopsy showed a spongiotic dermatitis with eosinophils. The patient had pruritis, but was not clinically ill. (We have photographs if you or the manufacturer would like them.)
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood test abnormal, Condition aggravated, Gait disturbance, Musculoskeletal stiffness
Clinical narrative: CHRONIC JOINT PAIN. HYPERPIGMENTATION AND THIGHTENING OF THE SKIN. SWELLING ON HANDS AND FEET. BAD BLOOD CIRCULATION. WALKING DIFFICULTY AND STIFFNESS.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Poor peripheral circulation, Raynaud's phenomenon, Scleroderma, Skin hyperpigmentation
Clinical narrative: CHRONIC JOINT PAIN. HYPERPIGMENTATION AND THIGHTENING OF THE SKIN. SWELLING ON HANDS AND FEET. BAD BLOOD CIRCULATION. WALKING DIFFICULTY AND STIFFNESS.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Skin tightness
Clinical narrative: CHRONIC JOINT PAIN. HYPERPIGMENTATION AND THIGHTENING OF THE SKIN. SWELLING ON HANDS AND FEET. BAD BLOOD CIRCULATION. WALKING DIFFICULTY AND STIFFNESS.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: After receiving vaccination on 5/14/18 the patient was diagnosed with cellulitis and received antibiotic treatment on 5/18/18.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Patient asked for me to look at her right arm. There was a slightly raised, red area about 2 inches wide and 4 inches long with irregular borders. It was warm to the touch. She received a SHINGRIX vaccine on 5/18/18 and was concerned about the reaction she was still having from the vaccination. She did report that her arm was sore and she felt ill and tired the next day, but that went away the next day. She wanted to know if she should have the area looked at; "she wasn't dying or anything". We discussed what she should do. I recommended that if she was really concerned to have it checked out. However, I recommended she keep an eye on the area. If it got worse or spread, to seek treatment. I also recommended icing or cold compresses if the heat bothered her. Patient agreed with the recommendation and will follow up with her provider if needed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Vaccination complication
Clinical narrative: Patient asked for me to look at her right arm. There was a slightly raised, red area about 2 inches wide and 4 inches long with irregular borders. It was warm to the touch. She received a SHINGRIX vaccine on 5/18/18 and was concerned about the reaction she was still having from the vaccination. She did report that her arm was sore and she felt ill and tired the next day, but that went away the next day. She wanted to know if she should have the area looked at; "she wasn't dying or anything". We discussed what she should do. I recommended that if she was really concerned to have it checked out. However, I recommended she keep an eye on the area. If it got worse or spread, to seek treatment. I also recommended icing or cold compresses if the heat bothered her. Patient agreed with the recommendation and will follow up with her provider if needed.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Lethargy, Rash, Respiration abnormal, Somnolence, Urticaria
Clinical narrative: Extreme lethargy to the point I couldn't get him to wake up to feed. Hives/rash on chest, neck, face and upper arms, breathing abnormally, kept taking a deep breath and holding it for a very long period of time, inconsistent breaths etc.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Skin warm
Clinical narrative: Patient's arm was red area slightly larger than golf  ball, tender to touch and warm to touch. Patient also had slight fever 2 days after injection and aches which resolved after 1 day. Checked with patient four days after vaccine today she said swelling, soreness, and heat to touch was resolved and only thing remaining was red itchy spot. Used ice, BENADRYL and ibuprofen for symptoms.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Patient's arm was red area slightly larger than golf  ball, tender to touch and warm to touch. Patient also had slight fever 2 days after injection and aches which resolved after 1 day. Checked with patient four days after vaccine today she said swelling, soreness, and heat to touch was resolved and only thing remaining was red itchy spot. Used ice, BENADRYL and ibuprofen for symptoms.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 56-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). On 17th April 2018 13:25, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain, feeling unwell, swelling arm and fever. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain, feeling unwell, swelling arm and fever. On an unknown date, the outcome of the pain, feeling unwell, swelling arm and fever were recovered/resolved. The reporter considered the pain, feeling unwell, swelling arm and fever to be almost certainly related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, the patient experienced big swelling in a large area that took up most of his upper arm part. The patient experienced achy, feverish and crappy feeling after receiving SHINGRIX. The healthcare professional is not sure when the symptoms had begun but when the patient came in a couple of days later to pick up other prescriptions, they were resolved, there was no swelling visible. No other vaccines were concomitantly administered to the patient. This was linked to case US2018084304, reported by the same reporter.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Herpes zoster
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of worn out in a 79-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, FLOMAX, glucosamine, Vitamin D3, triamcinolone, MIRALAX, XALATAN, CARDURA, fish oil, Ketoconazole Topical Shampoo, metoprolol and TYLENOL. On 5th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 5th May 2018, less than a day after receiving SHINGRIX, the patient experienced worn out. On 6th May 2018, the patient experienced vesicles and shingles. On an unknown date, the outcome of the worn out and shingles were unknown and the outcome of the vesicles was not recovered/not resolved. The reporter considered the worn out an vesicles to be related to SHINGRIX. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The nurse reported about one of their patients. The patient did not receive the SHINGRIX vaccine at their facility but received at a local pharmacy. The reporter provided name of the pharmacy but could not provided contact information. The patient felt completely wiped out on the day of vaccination. On the very next day, the patient experienced vesicles on skin on the inner left thigh and sacrum. The patient was seen by the physician assistant (PA) in their office and PA concluded that, the vesicles look like active shingles infection.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Pain in jaw, Poor quality sleep, Trismus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of temporal headache in a 68-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 8th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th may 2018, several hours after receiving SHINGRIX, the patient experienced temporal headache, poor quality sleep, ear pain and jaw pain. In May 2018, the patient experienced lockjaw. On 10th May 2018, the outcome of the temporal headache was recovered/resolved. On 11th May 2018, the outcome of the poor quality sleep, ear pain, jaw pain and lockjaw were recovered/resolved. It was unknown if the reporter considered the temporal headache, poor quality sleep, ear pain, jaw pain and lockjaw to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Office Manager. At approximately 9:15 am, the patient received SHINGRIX in the left deltoid. In the evening, the patient experienced a stabbing pain in the left temple, pain in the ear, and pain in the jaw. In the night, the patient did not sleep good. On 9th May 2018, at around 4 AM, 18 hours 45 minutes after vaccination, the patient tried to take TYLENOL for the pain, and realized her jaw was locked. The patient's symptoms began to improve the next day. Until 10th May 2018, the patient continued to have a dull headache, and the patient's symptoms were resolved at the time of the report. No emergency room or doctor's visit was required. The patient's symptoms were not considered life threatening or disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain, feeling unwell and fever. On an unknown date, the outcome of the pain, feeling unwell and fever were recovering/resolving. The reporter considered the pain and fever to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient was a physician. The age at vaccination was not reported. The patient received the vaccine about 2 weeks ago on an unknown arm. Afterwards the patient felt achy and feverish and just did not feel well. The reporter said the patient was getting better.
Age: 63.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Dry throat, Dysphonia, Malaise, Renal pain
Clinical narrative: LT knee pain, Pain in kidney area, Hoarse, dry throat, General malaise. F/Up 5/23/18 Pt reports symptoms are abating. To contact MD.
Sex: U
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: This case was reported by a nurse and described the occurrence of dizziness in a patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 1 ml. On an unknown date, unknown after receiving HAVRIX 1440, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to HAVRIX 1440. Additional details were provided as follows: The age at vaccination was not reported. The patients had adverse reaction to medication. The customer also stated she contacted the vendor. The customer had been notified in writing that their complaint was forwarded to GlaxoSmithKline vaccines for investigation and said that to respond directly to the complainant in this matter and copy Health Office at provided address. This case is 1 of the 4 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site hypersensitivity, Injection site rash, Injection site urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site allergic reaction in a adult patient who received SHINGRIX. On 4th May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site allergic reaction, injection site rash and injection site hives. On an unknown date, the outcome of the injection site allergic reaction, injection site rash and injection site hives were unknown. It was unknown if the reporter considered the injection site allergic reaction, injection site rash and injection site hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Medical Assistant. The age at vaccination was not reported. The patient developed a rash near injection site, explained as a hive like rash. The patient would like to know if this would be a problem when she would get her second injection as far allergic reaction being worse. The patient was asking if anyone else has experienced this type of reaction. The patient was asking for help to find the answers to these questions.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia, Peripheral swelling, Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling of legs in a 67-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). Concomitant products included CARTIA, RESTASIS, SEROQUEL, triamcinolone, WELLBUTRIN, RANEXA, clonazepam, Nitroglycerin patch and YUVAFEM. On 2nd May 2018 17:46, the patient received the 2nd dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced swelling of legs, facial swelling, tingling sensation and burning sensation. On an unknown date, the outcome of the swelling of legs, facial swelling, tingling sensation and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the swelling of legs, facial swelling, tingling sensation and burning sensation to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included PROAIR. The patient came to the pharmacy last night on 9th May 2018 with swelling in both legs and her face. She also had a burning or tingling sensation all over her body. Since last night 9th May 2018 the patient had not seen her doctor, but the pharmacist advised her to do so and she was supposed to contact the doctor today. The patient did not state when the swelling had started, just that it was after she received SHINGRIX. The patient came into the pharmacy riding a motorized cart, but she had done so in the past as well. The pharmacist said he left a message on the line last night, but I did not yet find a record in 360.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a 56-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). On 4th May 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash and injection site hives. The patient was treated with BENADRYL (nos). On an unknown date, the outcome of the injection site rash and injection site hives were not recovered/not resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. The reporter considered the injection site hives to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient developed a rash and hives close to the injection site a few days after receiving the SHINGRIX vaccine. The patient contacted pharmacist who recommended BENADRYL cream.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was reported that 3 days post vaccination with SHINGRIX patient broke out in shingles rash on left pectoral muscle and under arm.
Age: 79.0
Sex: M
Vaccine: PNC10, VARZOS
Symptoms: Chills, Feeling cold, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 79-year-old male patient who received SHINGRIX. Co-suspect products included Pneumococcal Vaccine. On 8th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and Pneumococcal Vaccine. On 8th May 2018, several hours after receiving SHINGRIX and not applicable after receiving Pneumococcal Vaccine, the patient experienced shivering, feeling cold, touch sensitivity increased and injection site pain. In May 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the shivering and feeling cold were unknown and the outcome of the injection site erythema, touch sensitivity increased and injection site pain were not recovered/not resolved. The reporter considered the shivering, feeling cold, injection site erythema, touch sensitivity increased and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's spouse. The patient was an optometrist. On Tuesday around 9:30 am, the patient received 1st dose of SHINGRIX vaccine on the left arm. On the same day, the patient received Pneumococcal vaccine of unknown manufacturer in the opposing right arm. On the same day, at night, the patient experienced shivering and felt cold with chills. There was still a red area oblong about 4 inches by 6 inches on the left arm where the vaccine had been administered which is currently sensitive to being touched. The reporter called to inquire if this could be an allergic reaction or adverse reaction and whether or not her husband should receive the second dose in the series which was already scheduled. The product packet insert (PI) was discussed during the call, and her specific inquiry was referred to the responsible healthcare professional. The patient's injection site got a little pink on the right arm described as hardly being any reaction at all in comparison to the other left arm's red area where the SHINGRIX vaccine had been administered. The pink area on the right arm injection site was improved. The reporter indicated she had no further time to discuss and then needed to end the call. It was okay to contact the reporter via letter with further questions. The reporter said she tried to contact GSK a day before the date of reporting, to discuss but only got a message that the GRC was in a meeting and was unable to speak with anyone. However, no service request (SR) for this reporter was found. Due to time constraints, it was unknown if the patient grants permission to contact his responsible healthcare professional or not. No further information was available beyond what was documented above, due to time constraints. It was unknown, if the reporter considered the shivering, feeling cold, injection site erythema, touch sensitivity increased and injection site pain to be related to SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a69-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (10 years ago). Concomitant products included Levothyroxine. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced burning sensation skin. On an unknown date, the outcome of the burning sensation skin was recovered/resolved. It was unknown if the reporter considered the burning sensation skin to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the dose of SHINGRIX in late March 2018 or early April 2018. The patient reported that she developed a burning sensation, but no rash along the same nerve pathway where had a Shingles infection 10 years ago. The patient reported that this burning sensation ran from her back to left side to under left breast area that lasted for about 3 weeks and resolved on its own.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain. On an unknown date, the outcome of the influenza-like symptoms and pain were unknown. It was unknown if the reporter considered the influenza-like symptoms and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms. The reporter did not agree to be followed up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, visual, Immediate post-injection reaction, Memory impairment
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hallucination in a 83-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th May 2018, immediately after receiving SHINGRIX, the patient experienced hallucination and memory disturbance. On 5th May 2018, the outcome of the hallucination and memory disturbance were recovered/resolved. The reporter considered the hallucination and memory disturbance to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported on behalf of the patient. At 16:10, the patient received SHINGRIX on the left arm. Immediately after receiving SHINGRIX, the patient experienced hallucinations. The patient stated, during this hallucination she imagined that she drove her car through her neighborhood and could visualize the street signs. She could not remember where she parked her car and that there was a time period of 20 minutes where she had no recollection of what happened. The patient believed that this event was caused by the vaccine. However, the pharmacist did not believe this event was caused by the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On 4th May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching and injection site wheal. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site wheal were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site wheal to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient received SHINGRIX on an unspecified arm. A large red itchy welt developed on the same arm in which the injection was given and had not gone away. Materials suggested side effects would last on 2-3 days but the patient was now on day 7. The patient asked whether this was normal.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX. On 9th May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who is a physician. The patient stated that, his arm was sore and had no other symptoms and spent the evening (from 6:30 to 10 pm) emcee'ing a benefit event (not otherwise specified).
Sex: U
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: This case was reported by a nurse and described the occurrence of dizziness in patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 1 ml. On an unknown date, unknown after receiving HAVRIX 1440, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to HAVRIX 1440. Additional details were provided as follows: The age at vaccination was not reported. The patients had adverse reaction to medication. The customer had been notified in writing that their complaint was forwarded to GlaxoSmithKline vaccines for investigation and said that to respond directly to the complainant in this matter and copy Agency at provided address. This case is 1 of the 4 cases reported by the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: This case was reported by a nurse and described the occurrence of dizziness in a patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 1 ml. On an unknown date, unknown after receiving HAVRIX 1440, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to HAVRIX 1440. Additional details were provided as follows: The age at vaccination was not reported. The patients had adverse reaction to medication. The customer had been notified in writing that their complaint was forwarded to GlaxoSmithKline vaccines for investigation and said that to respond directly to the complainant in this matter and copy Agency at provided address. This case is 1 of the 4 cases reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 80-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Concomitant products included triamcinolone. On 1st May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site erythema was recovering/resolving. The reporter considered the injection site erythema to be almost certainly related to SHINGRIX. Additional details were reported as follows: The health care professional reported that the patient got dose of SHINGRIX and 8 days later called to report the adverse event. The health care professional advised the patient to take TYLENOL and BENADRYL at the time of her call.
Age: 8.0
Sex: F
Vaccine: MMRV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Mother reports patient had increased redness and swelling to the injection site on the left thigh. This was first noticed early morning on 05/18/18. Seen in ER 05/19/18 BACTRIM and KEFLEX started orally. Patient was then seen here in clinic on 05/21/18. Affected area remained red with mild induration. Border was outside of outlined area at that time. BACTRIM and KEFLEX discontinued. Clindamycin 300mg PO TID for 10 days initiated. Patient seen 05/23/18 for f/u redness and swelling have improved. Patient does not have a history of cellulitis in the past. Referral to Allergist done to look for further into possible allergies. Patient did not have fever at any time during this episode. ED diagnosed patient with Cellulitis.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Joint swelling, Urticaria, Vaccination site rash
Clinical narrative: Patient developed hives and swelling of multiple joints the day after receiving her vaccinations. The site of the MenB vaccine had a rash around it. The site of the MENACTRA was normal, no rash or swelling.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Fatigue, headache, malaise, chills, myalgia, pain at injection site, few hours after vaccine administration until the following day.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Myalgia
Clinical narrative: Fatigue, headache, malaise, chills, myalgia, pain at injection site, few hours after vaccine administration until the following day.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site itching, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site itching, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient was presented for consult stating she had been given SHINGRIX at another pharmacy about a week before the date of reporting. The patient was given SHINGRIX subcutaneously in her left arm below her triceps, which led to inappropriate route of vaccination. The pharmacist noted that the area was red and itching and advised warm compress and BENADRYL. The pharmacist called asking about the product as he was unfamiliar with it. The pharmacist did not have any additional information.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020). On 9th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several months after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: Within a few months after receiving SHINGRIX, the patient developed Shingles. No additional information was provided.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 84-year-old female patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020). Concomitant products included Insulin. On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site itching and injection site erythema. On 2nd May 2018, the outcome of the extensive swelling of vaccinated limb, injection site itching and injection site erythema were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left deltoid. The registered pharmacist reported that the patient experienced swelling, redness, and itching at her injection site, from her shoulder to her elbow, that occurred on an unknown date and lasted for two weeks.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Migraine, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 53-year-old female patient who received SHINGRIX. Concomitant products included PREVACID, WELLBUTRIN, fluticasone propionate, ADVAIR, ADDERALL, Albuterol, estradiol, Glaucoma Eye Drops, KLONOPIN, metoprolol, topiramate and TRINTELLIX. On 9th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, migraine and nausea. On an unknown date, the outcome of the injection site swelling, injection site erythema, migraine and nausea were not recovered/not resolved. The reporter considered the injection site swelling, injection site erythema, migraine and nausea to be related to SHINGRIX. Additional details were reported as follows: The reporter was very kind and understanding and informed, not like he could do much about my migraines. The patient's concomitant medication included FLEXERIL. The patient received SHINGRIX on left arm. The patient experienced migraine, redness and swelling at injection site and nausea. The reporter just wanted to make sure that was not and did not need to go to the hospital or anything like that, that I was not having an overreaction. So the patient was very good.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was not recovered/not resolved. The reporter considered the injection site burning to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. The pharmacist reported that the patient called her today stating he continued to have burning in his arm above the bicep on his left arm where he had his vaccine. The pharmacist stated that she did instruct him to report the events to his physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th May 2018, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In morning patient experienced rash on her thighs and her stomach and later in the afternoon she experienced rash across her back. The patient's symptoms were still unchanged. The patient wanted to follow up with their health care provider for further information.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: Redness/line at injection site and rash covering a large area of lower back. Patient just notified. The pharmacy of reaction on 5/23/18.
Age: 1.0
Sex: U
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Irritability, Papule, Rash, Rash generalised
Clinical narrative: Rash appeared 5-20-18 itchy and spreading but on trunk only. Had MMR, Varicella and PCV13 on 5-3-18. No cough, congestion or runny nose. No fever, slightly fussy. Initially had a little redness at shot site office visit 5-23-18. Skin-multiple erythematous macules with small papule on top on the chest, 1 lesion on the back. Discussed suspect viral rash however cannot exclude atypical chicken pox. Patient is a 12 m.o. female who is here with mother for a chief complain of Rash, all over body x5days., here with mom.
Age: 1.0
Sex: U
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash macular, Rash pruritic, Viral rash
Clinical narrative: Rash appeared 5-20-18 itchy and spreading but on trunk only. Had MMR, Varicella and PCV13 on 5-3-18. No cough, congestion or runny nose. No fever, slightly fussy. Initially had a little redness at shot site office visit 5-23-18. Skin-multiple erythematous macules with small papule on top on the chest, 1 lesion on the back. Discussed suspect viral rash however cannot exclude atypical chicken pox. Patient is a 12 m.o. female who is here with mother for a chief complain of Rash, all over body x5days., here with mom.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site inflammation in a female patient who received SHINGRIX. 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 injection site inflammation, injection site swelling, injection site warmth, pain, tiredness, feeling unwell and influenza-like symptoms. On an unknown date, the outcome of the injection site inflammation, injection site swelling, injection site warmth, pain, tiredness, feeling unwell and influenza-like symptoms were recovered/resolved. The reporter considered the injection site inflammation, injection site swelling, injeqction site warmth, pain and tiredness to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no concomitant medications available to provide during the call. In 2018, the patient received SHINGRIX in the unknown arm. The reporter did not know exactly what date the patient received the first dose in the series of SHINGRIX or exact dosing details for the administration which occurred at an unknown pharmacy location. The reporter also did not know how soon after receiving the vaccination that the symptoms started. The patient called the reporter on 7th May 2018, and told her that the symptoms started 2 weeks prior to the telephone call and that the symptoms had lasted for five to ten days. The patient reported that the injection site reaction was described as the injection site area of the unknown arm's being inflamed, swollen, and warm to the touch. The patient also did not feel good, described as having had flu-like symptoms of being tired and achy. The call was transferred to the GSK Medical Information regarding her inquiry of whether or not this patient should have a second dose in the series, no further doses, or perhaps a half of a dose. The reporter was the responsible physician and grants permission to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site inflammation in a female patient who received SHINGRIX. 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 injection site inflammation, injection site swelling, injection site warmth, pain, tiredness, feeling unwell and influenza-like symptoms. On an unknown date, the outcome of the injection site inflammation, injection site swelling, injection site warmth, pain, tiredness, feeling unwell and influenza-like symptoms were recovered/resolved. The reporter considered the injection site inflammation, injection site swelling, injeqction site warmth, pain and tiredness to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no concomitant medications available to provide during the call. In 2018, the patient received SHINGRIX in the unknown arm. The reporter did not know exactly what date the patient received the first dose in the series of SHINGRIX or exact dosing details for the administration which occurred at an unknown pharmacy location. The reporter also did not know how soon after receiving the vaccination that the symptoms started. The patient called the reporter on 7th May 2018, and told her that the symptoms started 2 weeks prior to the telephone call and that the symptoms had lasted for five to ten days. The patient reported that the injection site reaction was described as the injection site area of the unknown arm's being inflamed, swollen, and warm to the touch. The patient also did not feel good, described as having had flu-like symptoms of being tired and achy. The call was transferred to the GSK Medical Information regarding her inquiry of whether or not this patient should have a second dose in the series, no further doses, or perhaps a half of a dose. The reporter was the responsible physician and grants permission to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue and general body pain. On an unknown date, the outcome of the fatigue and general body pain were unknown. It was unknown if the reporter considered the fatigue and general body pain to be related to SHINGRIX. Additional details were reported as follows: The case was reported by a certified medical assistant. The age at vaccination was not reported. The patient experienced achy feeling all over her body. This was 1 of 3 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness at injection site which was similar to a ring. The patient's husband called to the practice to tell the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported potential local injection site reactions with SHINGRIX which described as redness, pain, and swelling. The reporter was unable to clarify if the patient was involved or not and was unsure of any patient or product information.