chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Burning sensation, Pain, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of burning sensation in a female patient who received ENGERIX B (batch number 94S22, expiry date 4th September 2020). This case was associated with a product complaint. On an unknown date, the patient received ENGERIX B. On an unknown date, 14 days after receiving ENGERIX B, the patient experienced burning sensation and pain. On an unknown date, the outcome of the burning sensation and pain were unknown. It was unknown if the reporter considered the burning sensation and pain to be related to ENGERIX B. Additional information was received as follows: The reporter stated that the patient in the same day received an ENGERIX B injection, it was unspecified if it was for adult or pediatric. The patient experienced burning and soreness two weeks after the injection. The reporter noted this had never happened before. The patient had denied permission to contact their physician. The caller was the nurse practitioner but did not wish any contact. The reporter tried explaining the importance of full information. This was all the information she would give. The nurse practitioner reported that she the batch of ENGERIX-B may had caused the adverse event. The reporter did not wish to provide other specifics, nor wished to be contacted about this report. There was no product to return. This case was linked with case US2018079546, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of palpitation in a adult female patient who received SHINGRIX. On 3rd May 2018, the patient received SHINGRIX. In May 2018, 3 days after receiving SHINGRIX, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown. The reporter considered the palpitation to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, 3 to 4 days after receiving SHINGRIX, she experienced palpitations. On 6th May 2018, Sunday, the patient had to bouts and had to go to the emergency room (ER). The patient's doctor thought that, the palpitations are related to the SHINGRIX, but she was not so sure. The patient's doctor thought the patient should still get the 2nd shot, even if the palpitations are related to the SHINGRIX.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash, Rash pustular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX. Concomitant products included Lisinopril. On 14th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several days after receiving SHINGRIX, the patient experienced rash, pustule and blister. On 28th April 2018, the patient experienced shingles, sensory disturbance and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the sensory disturbance and pain were recovering/resolving and the outcome of the rash, pustule and blister were not recovered/not resolved. It was unknown if the reporter considered the  shingles, rash, pustule and blister to be related to SHINGRIX. The reporter considered the sensory disturbance and pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's son. Fourteen days after receiving SHINGRIX, the patient first experienced sensitivity on the lower right side of her back, pain and shingles. A few days later a rash appeared with pustule blisters. She sought medical treatment and her doctor diagnosed it as shingles. There was still evidence of the rash at the date of reporting.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensory disturbance
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX. Concomitant products included Lisinopril. On 14th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several days after receiving SHINGRIX, the patient experienced rash, pustule and blister. On 28th April 2018, the patient experienced shingles, sensory disturbance and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the sensory disturbance and pain were recovering/resolving and the outcome of the rash, pustule and blister were not recovered/not resolved. It was unknown if the reporter considered the  shingles, rash, pustule and blister to be related to SHINGRIX. The reporter considered the sensory disturbance and pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's son. Fourteen days after receiving SHINGRIX, the patient first experienced sensitivity on the lower right side of her back, pain and shingles. A few days later a rash appeared with pustule blisters. She sought medical treatment and her doctor diagnosed it as shingles. There was still evidence of the rash at the date of reporting.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX. concomitant products included atenolol, BUMEX, JANUVIA, KLONOPIN, lisinopril and SINEQUAN. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and less than a day after vaccination, the patient experienced fatigue, muscle pain and headache. The patient was treated with TYLENOL and (NOS) BENADRYL. SHINGRIX was discontinued. In May 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the fatigue, muscle pain and headache were not recovered/not resolved. The reporter considered the injection site pain, fatigue, muscle pain and headache to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient received SHINGRIX on the left arm. Immediately after receiving SHINGRIX, the patient experienced injection site pain which lasted 2 to 3 days and then it diminished. The patient went back in to the pharmacy where he received the vaccine and the pharmacists recommended him to take TYLENOL and BENADRYL to help with the symptoms. The patient stated that, he does not think he would be getting the 2nd dose of the vaccine. The patient denied permission to contact his physician.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Impetigo, Rash pruritic, Scab
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 69-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). On 7th April 2018, 10:35, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, itchy rash, impetigo, blister and scab. On an unknown date, the outcome of the erythema and impetigo were not recovered/not resolved and the outcome of the itchy rash, blister and scab were recovering/resolving. The reporter considered the erythema and itchy rash to be related to SHINGRIX. It was unknown if the reporter considered the impetigo, blister and scab to be related to SHINGRIX. Additional details were provided as follows: The patient developed a large redden areas on underside of abdomen and it almost looked like impetigo. It was about a foot long and 1/2 foot wide. The patient also developed a blistery scab like itchy rash on his head and several other parts of his body. The rash was improving and the reddened area was still visible as of past Friday of the date of reporting.
Age: 97.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema multiforme
Clinical narrative: ErythemaMultiform.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Pt reported to the ED on 4/8/17 with rash after taking diphenhydramine without benefit.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a elderly 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 fever, general body pain and chills. On an unknown date, the outcome of the fever, general body pain and chills were recovered/resolved. It was unknown if the reporter considered the fever, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The patient had a febrile reaction with chills and body aches lasting 2.5 days. The healthcare professional had declined to provide any contact information.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Product quality issue, Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 15-month-old male patient who received INFANRIX (batch number Y5475, expiry date unknown). This case was associated with a product complaint. On 23rd April 2018, the patient received INFANRIX. In April 2018, less than a month after receiving INFANRIX, the patient experienced injection site rash, generalized rash and injection site erythema. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site rash and pharmaceutical product complaint were unknown and the outcome of the generalized rash and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site rash, generalized rash and injection site erythema to be related to INFANRIX. Additional information was received as follows: The nurse reported that the patient experienced a red rash at injection site that was larger than usual and a systemic rash (rash over body). In total 13 patients received INFANRIX with the same lot number but only 3 patients including this patient experienced reactions. The vaccine was administered at the 15 - 18 month visit. According to the treating physician, the adverse events reported were not due to the INFANRIX but thought it was a normal reaction to DTap. The nurse reported that they had 40 more doses from this lot number and she was not sure if they should use so she had sat them aside in the refrigerator until she hears from GlaxoSmithKline (GSK). The nurse was informed that there had not been a recall on this lot but that investigation would be carried out. The reporter had return one vial from the lot for investigation. This case is link with case US2018GSK080192 and US2018GSK080194, reported by the same reporter. The reported agreed to contact on follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Blood cholesterol decreased, Erythema, Glycosylated haemoglobin increased, Monocyte count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX. On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, less than an hour after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On 1st May 2018, the patient experienced ALT high, hemoglobin A1C increased, cholesterol low and monocyte count increased. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved and the outcome of the ALT high, hemoglobin A1C increased, cholesterol low and monocyte count increases were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities, ALT high, cholesterol low and monocyte count increased to be related to SHINGRIX. The reporter considered the hemoglobin A1C increased to be unrelated to SHINGRIX. Additional details were provided as follows: Within an hour and a half to two hours after receiving the SHINGRIX vaccination, the patient experienced tenderness and redness that extended from his shoulder ultimately down to his elbow after approximately two days. On 1st May 2018, eleven days after receiving vaccination, the patient had laboratory work and his monocytes, HA1C (Glycosylated haemoglobin), ALTs (Alanine aminotransferase) were high, and cholesterol was low. The patient felt that he was responsible for most of the numbers being off but was concerned that the SHINGRIX vaccine might have affected the monocytes. The patient had denied permission to contact their physician. The reporter wanted to end the call and would not provide additional information. The reporter referred to health care professional.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX. On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, less than an hour after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On 1st May 2018, the patient experienced ALT high, hemoglobin A1C increased, cholesterol low and monocyte count increased. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved and the outcome of the ALT high, hemoglobin A1C increased, cholesterol low and monocyte count increases were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities, ALT high, cholesterol low and monocyte count increased to be related to SHINGRIX. The reporter considered the hemoglobin A1C increased to be unrelated to SHINGRIX. Additional details were provided as follows: Within an hour and a half to two hours after receiving the SHINGRIX vaccination, the patient experienced tenderness and redness that extended from his shoulder ultimately down to his elbow after approximately two days. On 1st May 2018, eleven days after receiving vaccination, the patient had laboratory work and his monocytes, HA1C (Glycosylated haemoglobin), ALTs (Alanine aminotransferase) were high, and cholesterol was low. The patient felt that he was responsible for most of the numbers being off but was concerned that the SHINGRIX vaccine might have affected the monocytes. The patient had denied permission to contact their physician. The reporter wanted to end the call and would not provide additional information. The reporter referred to health care professional.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Erythema multiforme, Fatigue, Influenza like illness, Pain
Clinical narrative: Patient reported his body felt run down, like he had the flu, and his temperature rose to 100F 1 day after, followed by 99F 48 hours after.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Patient reported his body felt run down, like he had the flu, and his temperature rose to 100F 1 day after, followed by 99F 48 hours after.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received SHINGRIX. On 25th April 2018 12:00, the patient received the 1st dose of SHINGRIX. On 25th April 2018 17:00, 5 hrs after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient who is reporter is also a nurse. The patient experienced pain in the left arm a few hours following the vaccination, which was intensified through the night. It lasted over a week and although it was resolving, the arm still aches. The patient gave consent to contact physician.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received SHINGRIX. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unlikely related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The vaccination date (2nd May 2018) was an estimate. The reporter thought it was just a coincidence that the patient developed shingles rash on her torso two days after getting vaccinated and thought the patient might have already been getting shingles. The sales rep consulted with his medical science liaison (MSL), who advised him to report it.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Cold sweat, Pyrexia, Syncope
Clinical narrative: Patient experienced fever, chills, cold sweats and chest pain in the evening after receiving SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Muscle fatigue, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a adult female 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 fever, muscle fatigue, pain in arm and feeling unwell. On an unknown date, the outcome of the fever, muscle fatigue, pain in arm and feeling unwell were unknown. It was unknown if the reporter considered the fever, muscle fatigue, pain in arm and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: From the time of vaccination the patient was feeling very sick. The patient wanted to speak to someone. The patient felt worse. The patient experienced muscles tiredness, fever for 1 week. The chiropractor did massage and the patient experienced more pain in the left arm. The patient was not feeling better. No consent given for drug safety to follow up with the patient's health care professional.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Impaired driving ability, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of nausea in a adult male patient who received SHINGRIX. On 3rd May 2018, the patient received SHINGRIX. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced nausea. On 4th May 2018, the patient experienced injection site swelling, injection site erythema and dizziness. On an unknown date, the outcome of the nausea, injection site swelling, injection site erythema and dizziness were unknown. It was unknown if the reporter considered the nausea, injection site swelling, injection site erythema and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccination on Thursday and on Friday 1 day after receiving SHINGRIX, the patient felt nauseous and so dizzy, he had to stop driving. He also developed a large red swelling at the site of injection. The patient was still feeling dizzy on Saturday.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml. On 4th May 2018, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The caller said they failed to report an incident that was relayed to them on Friday, 4th May 2018. The nurse reported that her husband got SHINGRIX vaccine and experience adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in a adult patient who received SHINGRIX. On 5th May 2018, the patient received SHINGRIX. On 6th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain, feeling bad, influenza like illness, shivers and gastrointestinal upset. On an unknown date, the outcome of the pain, feeling bad, influenza like illness, shivers and gastrointestinal upset were not recovered/not resolved. It was unknown if the reporter considered the pain, feeling bad, influenza like illness, shivers and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX a day before the reporting day and felt horrible on the day of reporting. The patient felt the patient was getting the flu. Ache, shivers and gastrointestinal upset all were present. The patient wanted to know that someone could tell how long the events would last.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Pain
Clinical narrative: This case was reported by a dentist via call center representative and described the occurrence of back pain in a 78-year-old male patient who received SHINGRIX. Concomitant products included simvastatin, vitamin D and lisinopril. On 1st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 3rd May 2018, 2 days after receiving SHINGRIX, the patient experienced back pain and pain localized. On an unknown date, the outcome of the back pain and pain localized were not recovered/not resolved. The reporter considered the back pain to be related to SHINGRIX. It was unknown if the reporter considered the pain localized to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient is a dentist and received the SHINGRIX vaccine on the right arm. On Thursday, the patient experienced back pain described as along his waistline and around to the front as well. The patient stated, the pain was better when he was prone, and hurts more when he sit up or stood up. The patient would see his physician on the date of reporting. The patient was unable to provide full demographic details of his physician.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Skin haemorrhage, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a adult female patient who received SHINGRIX. On 4th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced hives, pruritus, pain in arm and skin bleeding. In May 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the hives, pruritus and skin bleeding were unknown. It was unknown if the reporter considered the hives, pruritus, pain in arm and skin bleeding to be related to SHINGRIX. Additional details were provided as follows: The patient received her SHINGRIX vaccine on Thursday of that week and by the next she started itching, on her head, ankles, calves, forearms, fingers to the point of bleeding and basically all over. Besides, the sore arm for the last 3 days. The vaccine costs her 179 dollars from the local pharmacy that night and she was scheduled for her second SHINGRIX on or around May 4th two months later for another cost of 179 dollars at pharmacy. The patient wanted to know how much longer would the hives last and should she take BENADRYL. The patient would prefer a call.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a female patient who received SHINGRIX. Previously experienced adverse reactions included fever blister. 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 fever blister. On an unknown date, the outcome of the fever blister was unknown. It was unknown if the reporter considered the fever blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient with history of fever blisters and again developed fever blisters after receiving a dose of SHINGRIX. No further information was available at the time of report.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Pyrexia, Rash
Clinical narrative: Shot given on Sunday. On Tuesday Rash, swelling in morning- evening- fever, chills- diarrhea. Wed. lost of energy- Shot given May 6th.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Shot given on Sunday. On Tuesday Rash, swelling in morning- evening- fever, chills- diarrhea. Wed. lost of energy- Shot given May 6th.
Age: 4.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting x 2 days, diarrhea x 1 day.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Angiogram, Anxiety, Nervousness, Nuclear magnetic resonance imaging brain, Speech disorder
Clinical narrative: Speech difficulty, nervous/anxious 3 to 4 hrs after vaccine was given. Admitted to hospital for neuro eval.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Patient had SHINGRIX shot on 5/7/18. She came into the store on 5/16/18 to show us severe arthus reaction on her arm. She used topical steroid ointment and is resolving by 5/17/18. Pt does not feel need to see Dr.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain and swelling at inj. site for approx. 12-14 hours after vaccine. Body aches into next day.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness
Clinical narrative: Child received Hep A #2 in office. When mom was checking out at front desk child passed out.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Mobility decreased, Pain in extremity
Clinical narrative: Arm is sore enough that I cannot lift it above my head. Headache, Very achy flu like symptoms from waist down. Chilled. Able to work today however.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2019). Previously administered products included Flu vaccine (with no issues). Concurrent medical conditions included penicillin allergy. On 7th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On 13th March 2018, 6 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient contracted a mild case of shingles after receiving Shingles vaccine. The patient previously reported the event to VAERS.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Chest X-ray, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: Patient complained of throat swelling, chest tightness, and dry mouth within 10 minutes. Had pt sit down, called 911. Gave a dose of 25mg BENADRYL. Ambulance arrived where care was continued and sent to Hospital.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pharyngeal oedema, Swelling face, Throat tightness, Troponin
Clinical narrative: Patient complained of throat swelling, chest tightness, and dry mouth within 10 minutes. Had pt sit down, called 911. Gave a dose of 25mg BENADRYL. Ambulance arrived where care was continued and sent to Hospital.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Dry mouth, Pharyngeal oedema
Clinical narrative: Patient complained of throat swelling, chest tightness, and dry mouth within 10 minutes. Had pt sit down, called 911. Gave a dose of 25mg BENADRYL. Ambulance arrived where care was continued and sent to Hospital.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Arthritis, Burning sensation, C-reactive protein
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX. Concurrent medical conditions included migraine. Concomitant products included triamterene and zolpidem. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th April 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, injection site erythema, blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar. On an unknown date, the outcome of the shingles and injection site erythema were recovered/resolved and the outcome of the blistery rash and rash hemorrhagic were recovering/resolving and the outcome of the injection site induration, injection site warmth and scab were not reported and the outcome of the scar was not recovered/not resolved. The reporter considered the shingles and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the date of vaccination, the patient got some redness next to the injection site. In them morning of 5th April 2018, the patient noticed she had a rash underneath her right breast, running in a line along her ribcage, that was blistered and bleeding. When she looked at the bra she was wearing the day before, so noticed some blood on it, so thinks the rash must have started the day she received the vaccine as well. The redness next to the injection site continued to grow over several days until it covered all the skin on the outside of her upper left arm. It was hard and hot to the touch. After one week she took a picture and contacted her physician's office and she was told to come in. The rash under her breast was diagnosed as shingles. At this point the redness and shingles have resolved, except she still had some scarring under her breast where the blisters had scabbed over.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Depressed level of consciousness, Dizziness, Dyspnoea, Erythema, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX. Concurrent medical conditions included migraine. Concomitant products included triamterene and zolpidem. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th April 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, injection site erythema, blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar. On an unknown date, the outcome of the shingles and injection site erythema were recovered/resolved and the outcome of the blistery rash and rash hemorrhagic were recovering/resolving and the outcome of the injection site induration, injection site warmth and scab were not reported and the outcome of the scar was not recovered/not resolved. The reporter considered the shingles and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the date of vaccination, the patient got some redness next to the injection site. In them morning of 5th April 2018, the patient noticed she had a rash underneath her right breast, running in a line along her ribcage, that was blistered and bleeding. When she looked at the bra she was wearing the day before, so noticed some blood on it, so thinks the rash must have started the day she received the vaccine as well. The redness next to the injection site continued to grow over several days until it covered all the skin on the outside of her upper left arm. It was hard and hot to the touch. After one week she took a picture and contacted her physician's office and she was told to come in. The rash under her breast was diagnosed as shingles. At this point the redness and shingles have resolved, except she still had some scarring under her breast where the blisters had scabbed over.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Full blood count, Haemorrhage, Induration, Injection site swelling, Joint injection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX. Concurrent medical conditions included migraine. Concomitant products included triamterene and zolpidem. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th April 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, injection site erythema, blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar. On an unknown date, the outcome of the shingles and injection site erythema were recovered/resolved and the outcome of the blistery rash and rash hemorrhagic were recovering/resolving and the outcome of the injection site induration, injection site warmth and scab were not reported and the outcome of the scar was not recovered/not resolved. The reporter considered the shingles and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the date of vaccination, the patient got some redness next to the injection site. In them morning of 5th April 2018, the patient noticed she had a rash underneath her right breast, running in a line along her ribcage, that was blistered and bleeding. When she looked at the bra she was wearing the day before, so noticed some blood on it, so thinks the rash must have started the day she received the vaccine as well. The redness next to the injection site continued to grow over several days until it covered all the skin on the outside of her upper left arm. It was hard and hot to the touch. After one week she took a picture and contacted her physician's office and she was told to come in. The rash under her breast was diagnosed as shingles. At this point the redness and shingles have resolved, except she still had some scarring under her breast where the blisters had scabbed over.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint swelling, Myalgia, Pain, Rash erythematous, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX. Concurrent medical conditions included migraine. Concomitant products included triamterene and zolpidem. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th April 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, injection site erythema, blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar. On an unknown date, the outcome of the shingles and injection site erythema were recovered/resolved and the outcome of the blistery rash and rash hemorrhagic were recovering/resolving and the outcome of the injection site induration, injection site warmth and scab were not reported and the outcome of the scar was not recovered/not resolved. The reporter considered the shingles and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the date of vaccination, the patient got some redness next to the injection site. In them morning of 5th April 2018, the patient noticed she had a rash underneath her right breast, running in a line along her ribcage, that was blistered and bleeding. When she looked at the bra she was wearing the day before, so noticed some blood on it, so thinks the rash must have started the day she received the vaccine as well. The redness next to the injection site continued to grow over several days until it covered all the skin on the outside of her upper left arm. It was hard and hot to the touch. After one week she took a picture and contacted her physician's office and she was told to come in. The rash under her breast was diagnosed as shingles. At this point the redness and shingles have resolved, except she still had some scarring under her breast where the blisters had scabbed over.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Skin exfoliation, Skin warm, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX. Concurrent medical conditions included migraine. Concomitant products included triamterene and zolpidem. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th April 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, injection site erythema, blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar. On an unknown date, the outcome of the shingles and injection site erythema were recovered/resolved and the outcome of the blistery rash and rash hemorrhagic were recovering/resolving and the outcome of the injection site induration, injection site warmth and scab were not reported and the outcome of the scar was not recovered/not resolved. The reporter considered the shingles and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the date of vaccination, the patient got some redness next to the injection site. In them morning of 5th April 2018, the patient noticed she had a rash underneath her right breast, running in a line along her ribcage, that was blistered and bleeding. When she looked at the bra she was wearing the day before, so noticed some blood on it, so thinks the rash must have started the day she received the vaccine as well. The redness next to the injection site continued to grow over several days until it covered all the skin on the outside of her upper left arm. It was hard and hot to the touch. After one week she took a picture and contacted her physician's office and she was told to come in. The rash under her breast was diagnosed as shingles. At this point the redness and shingles have resolved, except she still had some scarring under her breast where the blisters had scabbed over.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site induration, Injection site warmth, Purpura
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX. Concurrent medical conditions included migraine. Concomitant products included triamterene and zolpidem. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th April 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, injection site erythema, blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar. On an unknown date, the outcome of the shingles and injection site erythema were recovered/resolved and the outcome of the blistery rash and rash hemorrhagic were recovering/resolving and the outcome of the injection site induration, injection site warmth and scab were not reported and the outcome of the scar was not recovered/not resolved. The reporter considered the shingles and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the date of vaccination, the patient got some redness next to the injection site. In them morning of 5th April 2018, the patient noticed she had a rash underneath her right breast, running in a line along her ribcage, that was blistered and bleeding. When she looked at the bra she was wearing the day before, so noticed some blood on it, so thinks the rash must have started the day she received the vaccine as well. The redness next to the injection site continued to grow over several days until it covered all the skin on the outside of her upper left arm. It was hard and hot to the touch. After one week she took a picture and contacted her physician's office and she was told to come in. The rash under her breast was diagnosed as shingles. At this point the redness and shingles have resolved, except she still had some scarring under her breast where the blisters had scabbed over.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Scab, Scar
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX. Concurrent medical conditions included migraine. Concomitant products included triamterene and zolpidem. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th April 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, injection site erythema, blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar. On an unknown date, the outcome of the shingles and injection site erythema were recovered/resolved and the outcome of the blistery rash and rash hemorrhagic were recovering/resolving and the outcome of the injection site induration, injection site warmth and scab were not reported and the outcome of the scar was not recovered/not resolved. The reporter considered the shingles and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the blistery rash, rash hemorrhagic, injection site induration, injection site warmth, scab and scar to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the date of vaccination, the patient got some redness next to the injection site. In them morning of 5th April 2018, the patient noticed she had a rash underneath her right breast, running in a line along her ribcage, that was blistered and bleeding. When she looked at the bra she was wearing the day before, so noticed some blood on it, so thinks the rash must have started the day she received the vaccine as well. The redness next to the injection site continued to grow over several days until it covered all the skin on the outside of her upper left arm. It was hard and hot to the touch. After one week she took a picture and contacted her physician's office and she was told to come in. The rash under her breast was diagnosed as shingles. At this point the redness and shingles have resolved, except she still had some scarring under her breast where the blisters had scabbed over.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX. The patient's past medical history included diabetes. Concurrent medical conditions included blood pressure high and heart disorder. On 2nd May 2018 11:00, the patient received the 1st dose of SHINGIRX. In May 2018, 14 hrs after receiving SHINGRIX, the patient experienced fever, tremor limb, low blood pressure, tongue thick, fatigue, chills, eye swelling, fall, feeling cold and jerkiness. The patient was treated with methylprednisolone. On 5th May 2018, the outcome of the fever was recovered/resolved. On 6th May 2018, the outcome of the tremor limb, tongue thick, chills, eye swelling and jerkiness were recovered/resolved. In May 2018, the outcome of the low blood pressure was recovered/resolved. On an unknown date, the outcome of the fatigue was recovering/resolving and the outcome of the fall and feeling cold were unknown. The reporter considered the fever, tremor limb, low blood pressure, tongue thick, fatigue chills, eye swelling and feeling cold to be related to SHINGRIX. It was unknown if the reporter considered the fall and jerkiness to be related to SHINGRIX. Additional details were provided as follows: At 11:00, the patient received SHINGRIX on left arm without discussing it with his doctor. He received some information from the pharmacist, but he did not think it was enough of warning of possible side effects. The patient stated that when he woke up the tremors in his arms and legs were so bad that he thought he might be having a seizure. The patient said the chills made him feel like he was freezing and could not get warm. About an hour and a half after he got up at 1:00 am, he tried to go to the bathroom and fell. The patient was so cold he said that he had a sheet, an electric blanket and a comforter on top of him in the bed to try to get warm. The patient could get an appointment to see his doctor on Thursday, 3rd May 2018. The doctor was not familiar with the vaccine and did not know what to do. When they took his blood pressure at the office it was 101 by 63 and was told that was very low. The patient was told that if his pressure had gotten any lower, it could be a potential stroke. The doctor did give the patient a prescription for Methylprednisolone, a steroid to help with the side effects. The most side effects were resolved by Saturday afternoon. The jerking and shaking did not stop until Sunday. The patient said that on the reporting date he still felt fatigued. He wanted the company to have the feedback and awareness. He did mention that the pharmacist had reported this case to the FDA a week before the reporting date.