chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Allergy to vaccine, Chills, Fatigue, Flatulence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergy to vaccine in a 77-year-old female patient who received SHINGRIX. Concurrent medical conditions included breast cancer. On 24th April 2018, the patient received SHINGRIX (intramuscular). On 25th April 2018, 1 days after receiving SHINGRIX, the patient experienced allergy to vaccine, nausea, tiredness, shivering and influenza-like symptoms. On 8th May 2018, the patient experienced gas and abdominal distension. SHINGRIX was discontinued. On an unknown date, the outcome of the allergy to vaccine was unknown and the outcome of the nausea, gas, abdominal distension, tiredness, shivering and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the allergy to vaccine and abdominal distension to be related to SHINGRIX. The reporter considered the nausea, gas, tiredness, shivering and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient felt nauseated every afternoon after receiving SHINGRIX and she said that they were halting her physical activity. In 2018, fourteen days after receiving SHINGRIX, the patient's tummy was extended and she had a lot of gas. The patient's physician told her to not have her second dose of SHINGRIX because physician thought she was allergic to the vaccine. The patient said that she was not going to have her second dose of SHINGRIX.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergy to vaccine in a 77-year-old female patient who received SHINGRIX. Concurrent medical conditions included breast cancer. On 24th April 2018, the patient received SHINGRIX (intramuscular). On 25th April 2018, 1 days after receiving SHINGRIX, the patient experienced allergy to vaccine, nausea, tiredness, shivering and influenza-like symptoms. On 8th May 2018, the patient experienced gas and abdominal distension. SHINGRIX was discontinued. On an unknown date, the outcome of the allergy to vaccine was unknown and the outcome of the nausea, gas, abdominal distension, tiredness, shivering and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the allergy to vaccine and abdominal distension to be related to SHINGRIX. The reporter considered the nausea, gas, tiredness, shivering and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient felt nauseated every afternoon after receiving SHINGRIX and she said that they were halting her physical activity. In 2018, fourteen days after receiving SHINGRIX, the patient's tummy was extended and she had a lot of gas. The patient's physician told her to not have her second dose of SHINGRIX because physician thought she was allergic to the vaccine. The patient said that she was not going to have her second dose of SHINGRIX.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes virus infection, Oral herpes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpetiform lesion in a 75-year-old male patient who received SHINGRIX. The patient's past medical history included herpes virus infection. Previously administered products included shingles vaccine with an associated reaction of herpes zoster (1st dose received over 4 to 5 years before the date of reporting and experienced shingles a couple of years before the date of reporting). On 16th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced herpetiform lesion. On an unknown date, the outcome of the herpetiform lesion was recovered/resolved. The reporter considered the herpetiform lesion to be related to SHINGRIX. Additional details were provided as follows: The patient had not had a herpes lesion on his lip for over one year prior to the SHINGRIX vaccine. The patient's concomitant medication included, blood pressure medication and vitamins. The patient received the vaccine at approximately 2:00 to 3:00 PM and he experienced the worst case of herpes on his lips in two different spots. The lesions took about three weeks to resolve and the reporter described the lesions as one that was big and then on a separate area of his lip, the other lesion was smaller. The lesions were bigger than the patient ever had. The reporter was supposed to be getting the SHINGRIX vaccine but she kind of was hesitating she would even go for it.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red injection site warm to touch.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site nodule, Lethargy, Mobility decreased
Clinical narrative: Systemic side effect started next day, fever, myalgia, ache all over the body, chills, couldn't get out bed, weak, lethargic. Had a kind of knot at the site of injection, Started improving after 2 days
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Systemic side effect started next day, fever, myalgia, ache all over the body, chills, couldn't get out bed, weak, lethargic. Had a kind of knot at the site of injection, Started improving after 2 days
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Left thigh erythematous with urticarial rash. Rx: prednisolone x 3 days.
Sex: U
Vaccine: ANTH
Symptoms: Dental caries, Tooth fracture
Clinical narrative: Decaying and rotting teeth early upon coming back from country 2009. Teeth started breaking and rot spread 2010-present.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Received flu vaccine to left deltoid on 2/21/18. Pt. states at approx. 3 PM on 2/21/18, area of injection became swollen, painful to touch, knot to center. Pt. has received no treatment. Pt. reported incident on 5/11/18 at approx. 1 PM.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Rash macular
Clinical narrative: Red blotches, gave BENADRYL at 10:55.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old male patient who received SHINGRIX. Concurrent medical conditions included chronic obstructive pulmonary disease (was taking BREO to treat). Concomitant products included Atorvastatin, fluticasone furoate, BREO ELLIPTA, ALEVE and trazodone. On 7th May 2018, the patient received the 1st dose of SHINGRIX. On 7th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were recovered/resolved. The reporter considered the injection site pain and influenza-like symptoms to be probably related to SHINGRIX. Additional details were provided as follows: The patient was the caller's husband. The patient experienced injection site pain immediately after the vaccination and developed flu like symptoms. The patient was fine at the time of reporting.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swollen tongue in a 60-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). Concomitant products included Lisinopril/Hydrochlorothiazide. On 6th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th March 2018, 3 days after receiving SHINGRIX, the patient experienced swollen tongue and difficulty breathing. On an unknown date, the outcome of the swollen tongue and difficulty breathing were recovered/resolved. It was unknown if the reporter considered the swollen tongue and difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: This case was reported by registered pharmacist. The patient received SHINGRIX vaccine in the left deltoid. The patient required emergency room visit. The reporter reported that the patient followed-up with his physician.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Swelling
Clinical narrative: The evening she received the vaccine, she developed about a 4 in red rash that was flower shaped. It was slightly puffy. She also reported that she felt feverish. The next day the redness continued to spread and pt stayed in bed all day. The following day (day 3) it was a little better. She came to pharmacy day 4. Rash was still present but was resolving.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling 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. In May 2018, less than a year after receiving SHINGRIX, the patient experienced fatigue, general body pain, chills and fever. On an unknown date, the patient experienced injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, fatigue, general body pain, chills and fever were recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, fatigue, general body pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: This case was also reported by a medical assistant. The patient was administered SHINGRIX in the right arm. The patient reported adverse events to physician on 4th May 2018, and sent a picture and description of the following symptoms. The patient had never had a reaction to a vaccine before so did not know if this was significant. The patient felt very tired and achy, with chills (like fever), Wednesday night and most of the day before reporting. The patient felt better so far on the day of reporting. The patient provided the photo of his arm captured on the day before reporting. The swelling had gone down some, but it was redder, whereas in photo it looked more pink. It was still very sore. Website seems to say this was a normal reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling 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. In May 2018, less than a year after receiving SHINGRIX, the patient experienced fatigue, general body pain, chills and fever. On an unknown date, the patient experienced injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, fatigue, general body pain, chills and fever were recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, fatigue, general body pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: This case was also reported by a medical assistant. The patient was administered SHINGRIX in the right arm. The patient reported adverse events to physician on 4th May 2018, and sent a picture and description of the following symptoms. The patient had never had a reaction to a vaccine before so did not know if this was significant. The patient felt very tired and achy, with chills (like fever), Wednesday night and most of the day before reporting. The patient felt better so far on the day of reporting. The patient provided the photo of his arm captured on the day before reporting. The swelling had gone down some, but it was redder, whereas in photo it looked more pink. It was still very sore. Website seems to say this was a normal reaction.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Abdominal discomfort, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling for vaccinated limb in a adult female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included splenectomy and idiopathic thrombocytopenic purpura. Concomitant products included TYLENOL. On an unknown date, the patient received Influenza vaccine Quadrivalent (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach to be related to Influenza vaccine Quadrivalent. Additional details reported as follows: The age at vaccination was not reported. The reporter approximates that within the past five years there were three yearly occasions in which the symptoms occurred within a few hours after receiving a flu vaccine of unknown name and manufacturer. The patient always had the vaccines administered into her left arm muscle, as she was right-handed. The patient cannot recall exact dosing details. The left arm would be swollen and red around the site of injection, and the area would be 4 inches or greater in diameter. That arm area was painful and could feel hot like it had a fever. The symptoms would last for another day and then resolve. In addition to the left arm symptoms, she also fell sick to her stomach described as feeling like she was getting the flu on one of the three occasions. That symptom diminished the next day after receiving the vaccine. The patient went to the doctor the day after receiving the vaccine when she had the stomach upset. The doctor told her that symptom was likely to have been caused by food poisoning instead of the flu. Once she changed and started getting her annual flu shot at a different retail pharmacy location, she did not have these symptoms and was told that the previous symptoms which had followed her previous flu vaccinations had been due to the preservatives in the vaccine products she had previously received which were no longer now included in the vaccine provided at the retail location. The patient thought the symptoms were due to the preservatives in those past flu vaccine products.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Abdominal discomfort, Extensive swelling of vaccinated limb, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling for vaccinated limb in a adult female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included splenectomy and idiopathic thrombocytopenic purpura. Concomitant products included TYLENOL. On an unknown date, the patient received Influenza vaccine Quadrivalent (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach to be related to Influenza vaccine Quadrivalent. Additional details reported as follows: The age at vaccination was not reported. The reporter approximates that within the past five years there were three yearly occasions in which the symptoms occurred within a few hours after receiving a flu vaccine of unknown name and manufacturer. The patient always had the vaccines administered into her left arm muscle, as she was right-handed. The patient cannot recall exact dosing details. The left arm would be swollen and red around the site of injection, and the area would be 4 inches or greater in diameter. That arm area was painful and could feel hot like it had a fever. The symptoms would last for another day and then resolve. In addition to the left arm symptoms, she also fell sick to her stomach described as feeling like she was getting the flu on one of the three occasions. That symptom diminished the next day after receiving the vaccine. The patient went to the doctor the day after receiving the vaccine when she had the stomach upset. The doctor told her that symptom was likely to have been caused by food poisoning instead of the flu. Once she changed and started getting her annual flu shot at a different retail pharmacy location, she did not have these symptoms and was told that the previous symptoms which had followed her previous flu vaccinations had been due to the preservatives in the vaccine products she had previously received which were no longer now included in the vaccine provided at the retail location. The patient thought the symptoms were due to the preservatives in those past flu vaccine products.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling for vaccinated limb in a adult female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included splenectomy and idiopathic thrombocytopenic purpura. Concomitant products included TYLENOL. On an unknown date, the patient received Influenza vaccine Quadrivalent (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach to be related to Influenza vaccine Quadrivalent. Additional details reported as follows: The age at vaccination was not reported. The reporter approximates that within the past five years there were three yearly occasions in which the symptoms occurred within a few hours after receiving a flu vaccine of unknown name and manufacturer. The patient always had the vaccines administered into her left arm muscle, as she was right-handed. The patient cannot recall exact dosing details. The left arm would be swollen and red around the site of injection, and the area would be 4 inches or greater in diameter. That arm area was painful and could feel hot like it had a fever. The symptoms would last for another day and then resolve. In addition to the left arm symptoms, she also fell sick to her stomach described as feeling like she was getting the flu on one of the three occasions. That symptom diminished the next day after receiving the vaccine. The patient went to the doctor the day after receiving the vaccine when she had the stomach upset. The doctor told her that symptom was likely to have been caused by food poisoning instead of the flu. Once she changed and started getting her annual flu shot at a different retail pharmacy location, she did not have these symptoms and was told that the previous symptoms which had followed her previous flu vaccinations had been due to the preservatives in the vaccine products she had previously received which were no longer now included in the vaccine provided at the retail location. The patient thought the symptoms were due to the preservatives in those past flu vaccine products.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of ankle swelling in a female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 3rd May 2018, the patient received SHINGRIX. On 5th May 2018, 2 days after receiving SHINGRIX, the patient experienced ankle swelling. In May 2018, the patient experienced joint tightness and pain ankle. On an unknown date, the outcome of the ankle swelling was not recovered/not resolved and the outcome of the joint tightness and pain ankle were unknown. The reporter considered the ankle swelling to be probably related to SHINGRIX. It was unknown if the reporter considered the joint tightness and pain ankle to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced swelling of the ankle the reporter was not sure which ankle. The patient also stated that there was pain and tightness of the ankle. No additional information was provided.
Sex: M
Vaccine: RAB, TYP
Symptoms: Headache, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of malaise in a adult male patient who received RABAVERT. Concomitant products included Typhoid vaccine, live oral. On an unknown date, the patient received the 1st dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, the patient experienced malaise and headache. On an unknown date, the outcome of the malaise and headache were recovered/resolved. The reporter considered the malaise and headache to be probably related to RABAVERT. Additional details were provided as follows: This case was reported by a physician assistant. The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced malaise and a mild headache for 24 hours after dose of pre-exposure RABAVERT. The HCP did not have vaccine lot number or expiry date information with her at the time of reporting. This case was linked with US2018GSK089078, reported by the same reporter for the 2nd dose of SHINGRIX.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX. Concurrent medical conditions included ear infection (the patient was taking an antibiotic to treat the ear infection). Concomitant products included LUNESTA, Nature Thyroid and Progestin. On 7th May 2018, the patient received the 1st dose of SHINGRIX. On 7th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and influenza-like symptoms. On 8th May 2018, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, influenza-like symptoms and injection site erythema were unknown and the outcome of the injection site swelling was not recovered/not resolved. The reporter considered the injection site pain, injection site swelling, influenza-like symptoms and injection site erythema to be probably related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX on the left arm. The patient experienced injection site pain immediately. Less than a day after receiving vaccination, the patient had flu-like symptoms. One day after receiving vaccination, the patient had a big round red circle of swelling and pain at the injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Feeling cold, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 51-year-old female patient who received SHINGRIX. On 2nd May 2018, the patient received SHINGRIX. On 9th May 2018, 7 days after receiving SHINGRIX, the patient experienced feeling cold, shivering, pain, headache, upset stomach, diarrhea, nausea, tremor and influenza-like symptoms. On an unknown date, the outcome of the feeling cold, shivering, pain, headache, upset stomach, diarrhea, nausea, tremor and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the feeling cold, shivering, pain, headache, upset stomach, diarrhea, nausea, tremor and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine last week before the reporting date. She woke up in the morning on the date of reporting, was feeling cold and shaky, shivering and overall achiness. The main symptoms that bothered her were shivering and achiness. The patient had denied permission to contact their physician.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 51-year-old female patient who received SHINGRIX. On 2nd May 2018, the patient received SHINGRIX. On 9th May 2018, 7 days after receiving SHINGRIX, the patient experienced feeling cold, shivering, pain, headache, upset stomach, diarrhea, nausea, tremor and influenza-like symptoms. On an unknown date, the outcome of the feeling cold, shivering, pain, headache, upset stomach, diarrhea, nausea, tremor and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the feeling cold, shivering, pain, headache, upset stomach, diarrhea, nausea, tremor and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine last week before the reporting date. She woke up in the morning on the date of reporting, was feeling cold and shaky, shivering and overall achiness. The main symptoms that bothered her were shivering and achiness. The patient had denied permission to contact their physician.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old male patient who received SHINGRIX. Previously administered products included acyclovir. On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th May 2018, 11 days after receiving SHINGRIX, the patient experienced shingles and local swelling. On an unknown date, the outcome of the shingles and local swelling were not recovered/not resolved. It was unknown if the reporter considered the shingles and local swelling to be related to SHINGRIX. Additional details were reported as follows: The patient got an outbreak of bumps which he identified as an outbreak of shingles. The patient said that he had been struggling with shingles for the past 20 years and he constantly needed acyclovir treatment to combat his shingles. He said that this outbreak looked like any other outbreak that he had before. It did not look any different.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site mass in a adult female patient who received SHINGRIX. On 6th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site mass, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site mass and injection site erythema were unknown and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site mass, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The reporter was an occupational health nurse at GSK and reported the case on behalf of the patient. The age at vaccination was not reported. At 14:00, the patient received SHINGRIX on left arm. The patient experienced a bump at injection site. The reporter stated that the bump was now a 3 inch rounded red circle around the injection site. The patient reported (1/10) pain at the injection site that seemed to be improving. The patient reported this event to reporter on the day of reporting.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Myalgia, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain localized in a 59-year-old male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020). On 8th May 2018 09:15, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the dose was an unknown dose. On 8th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain localized, body temperature increased and headache. On 9th May 2018, the patient experienced fatigue and tenderness. In May 2018, the patient experienced myalgia. In May 2018, the outcome of the body temperature increased, fatigue and headache were recovered/resolved. On an unknown date, the outcome of the pain localized, myalgia and tenderness were recovering/resolving. The reporter considered the pain localized, myalgia, body temperature increased, fatigue, headache and tenderness to be probably related to SHINGRIX. Additional information was received as follows: The reporter himself was the patient. The patient received the vaccine in the left deltoid. The SHINGRIX adjuvant vial had lot number A4X57 and expiry date 13th July 2020. The patient had 10% localized pain, 10% myalgia and 30% tenderness pain on pressure. The patient noticed a slight rise in his temperature but he did not take his temperature for confirmation. At the reporting time, the patient felt good and he was happy. The patient had no unusual side effects. The reporter stated that nurse practitioner administered the SHINGRIX to him. No further details was provided.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain localized in a 59-year-old male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020). On 8th May 2018 09:15, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the dose was an unknown dose. On 8th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain localized, body temperature increased and headache. On 9th May 2018, the patient experienced fatigue and tenderness. In May 2018, the patient experienced myalgia. In May 2018, the outcome of the body temperature increased, fatigue and headache were recovered/resolved. On an unknown date, the outcome of the pain localized, myalgia and tenderness were recovering/resolving. The reporter considered the pain localized, myalgia, body temperature increased, fatigue, headache and tenderness to be probably related to SHINGRIX. Additional information was received as follows: The reporter himself was the patient. The patient received the vaccine in the left deltoid. The SHINGRIX adjuvant vial had lot number A4X57 and expiry date 13th July 2020. The patient had 10% localized pain, 10% myalgia and 30% tenderness pain on pressure. The patient noticed a slight rise in his temperature but he did not take his temperature for confirmation. At the reporting time, the patient felt good and he was happy. The patient had no unusual side effects. The reporter stated that nurse practitioner administered the SHINGRIX to him. No further details was provided.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX. On 5th May 2018, the patient received SHINGRIX. On 5th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 6th May 2018, the patient experienced injection site erythema and injection site swelling. On 9th May 2018, the patient experienced discomfort. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site erythema and injection site swelling were recovering/resolving and the outcome of the discomfort was unknown. The reporter considered the injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated in the early afternoon and reported pain at injection site on Saturday. By the next day (1 day after vaccination) the area had swelling and showed redness. The pain resolved to more of discomfort (4 days after vaccination) on the date of reporting. The reporter ended the call and said that he was done and had other things to do.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX. Concomitant products included CALTRATE, Fish Oil + Vitamin E, Vitamin C and Multivitamin. On 8th May 2018, the patient received SHINGRIX. On 8th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and contusion. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema and injection site swelling were unchanged and the outcome of the contusion was unknown. The reporter considered the injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injection site erythema, injection site swelling and contusion to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she received the SHINGRIX vaccine 10:00 a.m on left arm and it hurt during injection which surprised her because she usually had a high tolerance for pain and the pharmacist put a Band Aid on the site and she took the Band Aid off and there was a two inch red circle all around and the area was swollen. She claimed that the area was painful and felt like a bruise when touched but she had no pain if she does not touch the area. She noticed the swelling and redness after approximately eight hours after the injection. Staff failed to obtain the pharmacy information because of an IT issue during the phone call.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema, swelling of (R) upper arm, up to about 4 1/2 x 3 inches.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th May 2018, 2 days after receiving SHINGRIX, the patient experienced pain in arm and fever. On 6th May 2018, the patient experienced rash and shingles. In May 2018, the patient experienced shoulder pain. On 6th May 2018, the outcome of the pain in arm and fever were recovered/resolved. On an unknown date, the outcome of the rash and shingles were recovering/resolving and the outcome of the shoulder pain was unknown. The reporter considered the pain in arm, fever and rash to be related to SHINGRIX. It was unknown if the reporter considered the shoulder pain and shingles to be related to SHINGRIX. Additional information was received as follows: At 9:00, the patient received SHINGRIX, in the right deltoid. The patient experienced normal side effects such as sore arm and low grade fever which lasted 24 hours. Less than week after receiving SHINGRIX, the patient's soreness in arm went into the shoulder. Three days after receiving SHINGRIX, the patient experienced the rash that was widespread on his face and resembled shingles. The patient did not experience any of the other symptoms which go with shingles. The reporter confirmed proper preparation of the vaccine which appeared to have no abnormalities when reconstituted. The vaccine was placed in the refrigerator for 30 minutes prior to administration. The physician had pictures available. The physician was transferred to Medical Information (MI) for additional assistance. The physician did not have the lot number and expiry date available at the time of the call.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Throat irritation
Clinical narrative: Pt recv'd vaccines at 2pm., went to mall; while out at mall-child stated throat itchy, face turned red; dad brought her back to office Sat's were 94% HR132 administered EPIPEN 0.15mg with BENADRYL 10mL per Dr. EMS transported her to hospital at 310pm due to little improvement.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5 1/2 cm area of redness and warmth at (L) deltoid injection site, temp 99.2.
Age: 1.75
Sex: F
Vaccine: MMRV
Symptoms: Dyspnoea, Lymphadenopathy, Parotitis, Pharyngeal oedema
Clinical narrative: She was hospitalized many times for this only after MMR vaccine. I'm fuzzy on a lot of info. I wanted to make sure it was reported since I was never told about vaers until recently. This happened a while back but lasted until she was a pre teen. She would swell up for no reason and wasn't able to breathe. Official diagnosis of parotitis.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: Fever, malaise 2 days; arm pain at site of injection --continues at time of report May 19, 2018.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: THE LADY THAT GAVE ME THE INJECTION TOLD ME THAT THE SHOT WOULD BE PAINFUL GOING INTO MY SHOULDER/ARM, BUT SHE DID NOT SAY HOW LONG THE PAIN WOULD PERSIST. AFTER SIX MONTHS I AM STILL EXPERIENCING PAIN FROM THE SAME LOCATION. IT BOTHERS ME SOME DURING THE DAY AND NIGHT. I HAVE HAD TO INHIBIT OR STOP SOME OF MY REGULAR ROUTINES OR JUST ENDURE THE AGGRAVATION THAT EXIST. IT AWAKENS ME AT NIGHT AND I TRY TO FIND A POSITION WITH LESS DISCOMFORT. I JUST WANT TO GET RID OF THIS AGGRAVATION  SO I CAN GET BACK TO BEING MYSELF.  MAYBE MORE RESEARCH SHOULD HAVE BEEN  DONE BEFORE THIS DRUG WAS APPROVED OR AM I IN THE PART OF YOUR STUDY THAT DOES NOT MATTER; IF SO THEN SHAME ON YOU.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Recieved expired vaccine. Event previously reported by phone to MERK (case# 00820160). it was determined the vaccine was considred potent a viable based on return email I recieved from MERK.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Insomnia, Musculoskeletal disorder
Clinical narrative: A few hours after vaccine was given, my entire left arm ached, especially at the joint areas (elbow and wrist); I could barely use that arm. That night, my entire body ached and I developed a bad and consistent headache that lasted throughout the night. I also experienced chills and a fever and was unable to sleep. I took TYLENOL over two days and symptoms eventually went away.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: A few hours after vaccine was given, my entire left arm ached, especially at the joint areas (elbow and wrist); I could barely use that arm. That night, my entire body ached and I developed a bad and consistent headache that lasted throughout the night. I also experienced chills and a fever and was unable to sleep. I took TYLENOL over two days and symptoms eventually went away.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Vertigo
Clinical narrative: Patient describes dizziness or vertigo beginning 2 weeks after each vaccination. Symptoms lasted 3-4 days and were identical in nature. Dizziness severe enough to cause fall.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Large weal rash to left arm, monitored size, saw pediatrician.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Influenza like illness, Pain in extremity
Clinical narrative: Patient reports shivers and flu-like symptoms beginning in the evening, several hours after vaccination. She attributes the symptoms to the PNEUMOVAX as the pain was central to her right arm. Patient reports these symptoms continued for about 4 hours and were gone by the following day, though her right arm still hurt at the time of her call (after noon).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Immediate post-injection reaction
Clinical narrative: Patient experienced sudden, crushing sensation in center of chest intermittently for about a half hour at 9:00 PM. Each following morning, she experienced less severe, intermittent chest pain for about 15 minutes.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Bruxism, Cold sweat, Discomfort, Erythema
Clinical narrative: After about 3 minutes of the vaccine administration, the patient stated he didn't feel well and then began to faint. His head dropped forward first as he was losing consciousness and he began to turn red in color and start to sweat. We called code white in the pharmacy. When we lifted him upward his head tilted back and his pupils were both completely dilated. He then began to lose the color in face and became very pale including white lips. His body then started to tighten/seize with his arms in a straight forward position. While his upper body was seizing, his lower body was still slumping and sliding down the chair as we attempted to keep him sitting upright. His mouth/jaw appeared to be clenching and the pharmacist thought for a second he almost started foaming at the mouth. Within only about 20 seconds, the patient regained consciousness and stated he just went out of it for a minute. It was confirmed that he did not remember actually having the reaction, so he blacked out for the entirety of the incident. After regaining consciousness and body control, we kept the patient upright and brought him water and ice packs. His skin was still pale and hands were cold and clammy. We monitored the patient for the next 45 minutes. He regained normal skin color and the general feelings of weakness subsided. We took the patient's BP and it was 117/77 with pulse 66. We took it again later and it remained normal. The patient was offered additional medical assistance (911 or EMS) and declined. We continued to monitor and discuss the patient's history in further detail. It was exposed that the patient had history of general anxiety, albeit no history of any seizure or otherwise CNS issues. He had been weaned off anxiety medication and was not currently on any. The patient works night shift and expressed that they had just woken up and he had not eaten any food in the last 12-16 hours. He also confirmed that his current schedule and sleep quality is low. Per his request, the patient got up after 30 minutes and was escorted to and from the bathroom by our AP associate (large enough build to support the patient in height and weight). He finished his water and then confirmed he would go to the grocery side of the store to get food. All symptoms had subsided and vitals were normal after 45 minutes, but the patient did mention having a general "heaviness" in the mouth and felt it was kind of hard to speak or "slow." Given this later symptom, we referred the patient to go to the ER for extended monitoring to rule out any stroke or general CNS issues that could not be seen by the naked eye. The patient's wife was in accompaniment throughout the entirety of the incidence and was fully capable of taking the patient out of the pharmacy with proper follow-up plans.