chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.83
Sex: F
Vaccine: HEP
Symptoms: Genital rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythematous rash in a 10-month-old female patient who received ENGERIX B pediatric (batch number 97Y27, expiry date 5th February 2021) for prophylaxis. On 30th May 2018 14:00, the patient received ENGERIX B pediatric (intramuscular) .5 ml. On 2nd June 2018, 3 days after receiving ENGERIX B pediatric, the patient experienced erythematous rash. On 9th June 2018, the patient experienced genital rash. The patient was treated with antibiotics nos. On 8th June 2018, the outcome of the erythematous rash was recovered/resolved. On an unknown date, the outcome of the genital rash was unknown. The reporter considered the erythematous rash and genital rash to be possibly related to ENGERIX B pediatric. Additional details were provided as follows: The patient received either 2nd or 3rd dose of ENGERIX B. The patient developed rash on face that consisted of red bumps. By Sunday, the rash was on her back. On Tuesday, the reporter took patient to the pediatrician and she was prescribed a steroid cream. The reporter was only able to apply cream to the patient's back. By Friday, the rash was started to resolve. The redness was going away but the bumps were still there. On Saturday, the reporter was started to break out again although her face had never fully resolved, but at the time of reporting the patient was started rash appearing on her hairline, chest, stomach, extending down into pubic area. The patient's back was almost all clear, had only two bumps left. The reporter took the patient back to her pediatrician and was prescribed a new antibiotic and was referred to a dermatologist. The reporter gave permission for the patient's physician to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a bizarre feeling in the muscle of the arm in which she received the SHINGRIX. The pharmacist did not have details readily available as the pharmacist reported from home and vaccine was administered at the pharmacy. The pharmacist has not seen the patient since the vaccine was administered.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Hypoaesthesia, Influenza like illness, Mobility decreased, Nasopharyngitis
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 for prophylaxis. On 8th June 2018, the patient received the 1st dose of Shingrix .5 ml. On 9th June 2018, 1 days after receiving Shingrix, the patient experienced fever, energy decreased, cold, general body pain, influenza-like symptoms and nausea. On 10th June 2018, the patient experienced numbness and mobility decreased. On 10th June 2018, the outcome of the fever, energy decreased, cold, numbness, general body pain, influenza-like symptoms, nausea and mobility decreased were recovered/resolved. The reporter considered the fever, energy decreased, cold, numbness, general body pain, influenza-like symptoms and nausea to be almost certainly related to Shingrix. It was unknown if the reporter considered the mobility decreased to be related to Shingrix. Additional details were provided as follows: This case was previosuly reported to the physician. At 16:30, on 8th June 2018 (Friday), the patient received Shingrix. The next day, the patient woke up with cold, aching all over his body and no energy. The patient felt nauseous when he would eat and had high fever which was resolved by 8:00 pm. The patient woke up on 10th June 2018 (Sunday) and could not bend with aching and also felt numbness all over this body. On same day (Sunday) at night, all symptoms were resolved. The patient had thick accent and the sender could not understand the name of the patient doctor and the patient could not spell it. The patient reported these symptoms to his doctor. This is 1 of 2 cases, reported by the same reporter.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
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 for prophylaxis. On 8th June 2018, the patient received the 1st dose of Shingrix .5 ml. On 9th June 2018, 1 days after receiving Shingrix, the patient experienced fever, energy decreased, cold, general body pain, influenza-like symptoms and nausea. On 10th June 2018, the patient experienced numbness and mobility decreased. On 10th June 2018, the outcome of the fever, energy decreased, cold, numbness, general body pain, influenza-like symptoms, nausea and mobility decreased were recovered/resolved. The reporter considered the fever, energy decreased, cold, numbness, general body pain, influenza-like symptoms and nausea to be almost certainly related to Shingrix. It was unknown if the reporter considered the mobility decreased to be related to Shingrix. Additional details were provided as follows: This case was previosuly reported to the physician. At 16:30, on 8th June 2018 (Friday), the patient received Shingrix. The next day, the patient woke up with cold, aching all over his body and no energy. The patient felt nauseous when he would eat and had high fever which was resolved by 8:00 pm. The patient woke up on 10th June 2018 (Sunday) and could not bend with aching and also felt numbness all over this body. On same day (Sunday) at night, all symptoms were resolved. The patient had thick accent and the sender could not understand the name of the patient doctor and the patient could not spell it. The patient reported these symptoms to his doctor. This is 1 of 2 cases, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Rash, Rash pustular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a male patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received the 2nd dose of SHINGRIX. On 20th May 2018, less than a day after receiving SHINGRIX, the patient experienced muscle soreness. On 21st May 2018, the patient experienced lethargic. On 22nd May 2018, the patient experienced pustular rash. On an unknown date, the outcome of the muscle soreness and lethargic were recovered/resolved and the outcome of the pustular rash was recovering/resolving. The reporter considered the muscle soreness and lethargic to be related to SHINGRIX. The reporter considered the pustular rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 21st May 2018, 1 day after receiving SHINGRIX, the patient was lethargic. On 22nd May 2018, 2 days after receiving SHINGRIX, the patient developed chest rash with pustules that look like shingles. In 2018, the muscle soreness and lethargy had resolved. The patient reported that, the rash had improved some but it was present at the time of reporting. The patient declined to provide his address or physician information. The patient provided address to pharmacy only. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 8th June 2018, the patient received SHINGRIX. On 8th June 2018, less than a day after receiving SHINGRIX, the patient experienced sleepiness. In June 2018, the patient experienced fever, injection site pain and injection site erythema. On an unknown date, the outcome of the fever, injection site pain, sleepiness and injection site erythema were unknown. It was unknown if the reporter considered the fever, injection site pain, sleepiness and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient indicated that she received the SHINGRIX vaccine last Friday and less than a week after receiving SHINGRIX, the experienced a fever, a red mark at the injection site, and soreness at the injection site. The patient also stated that after the vaccination she went home and slept for the rest of the day. The reporter did not want to provide any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of flu like symptoms in a female patient who received SHINGRIX for prophylaxis. On 12th June 2018, the patient received SHINGRIX. On 12th June 2018, less than a day after receiving SHINGRIX, the patient experienced flu like symptoms. On an unknown date, the outcome of the flu like symptoms was unknown. It was unknown if the reporter considered the flu like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient also reported that she was a GSK employee, via after hours voice mail (AHVM).
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Pain, Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of tingling of extremity in a 17-year-old female patient who received BEXSERO (batch number 16D401, expiry date 9th February 2019) for prophylaxis. Co-suspect products included FLULAVAL QUADRIVALENT 2017-2018 season) (batch number 5LR3F, expiry date 30th June 2018) for prophylaxis. On 17th November 2017, the patient received BEXSERO (intramuscular) .5 ml and FLULAVAL QUADRIVALENT 2017-2018 season (intramuscular) .5 ml. On 17th November 2017, less than a day after receiving BEXSERO and FLULAVAL QUADRIVALENT 2017-2018 season, the patient experienced tingling of extremity and pain. On an unknown date, the outcome of the tingling of extremity and pain were recovered/resolved. It was unknown if the reporter considered the tingling of extremity and pain to be related to BEXSERO and FLULAVAL QUADRIVALENT 2017-2018 season. Additional details were reported as follows: The patient received BEXSERO on the right arm and FLULAVAL QUADRIVALENT 2017-2018 season on the left arm. The physician reported that the patient went to the emergency room and was discharged home.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received SHINGRIX (intramuscular). On 12th June 2018, 1 days 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 recovering/resolving. The reporter considered the fever, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: The patient reported of receiving the SHINGRIX vaccine on Monday. The patient started having symptoms on the day before reporting. The patient had a fever of 101 degrees, chills and body aches and was feeling better on the day of reporting. The patient had denied permission to contact their physician.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypothyroidism and blood cholesterol increased. Concomitant products included SYNTHROID and ZOCOR. On 4th June 2018, the patient received SHINGRIX. On 13th June 2018, 9 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site rash and injection site warmth. On 14th June 2018, the patient experienced swelling arm. In June 2018, the patient experienced pain in arm. In June 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site erythema and swelling arm were not recovered/not resolved and the outcome of the injection site rash and injection site warmth were recovering/resolving. The reporter considered the pain in arm, injection site erythema, injection site rash, injection site warmth and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of breakouts from mosquitoes. The patient received the SHINGRIX (left arm) in the late afternoon around 4:00 pm on and her arm was sore for three days and then resolved on the 4th day after the injection. In the evening before the reporting date, around 8:00 pm (9 days and 4 hours after vaccination) her arm started to bother her and the area got a bright red and hot rash around the injection site. In the morning of reporting date, the rash subsided a lot but it was still red and the top part of her arm was swollen. The contact details of the healthcare professional was provided.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypothyroidism and blood cholesterol increased. Concomitant products included SYNTHROID and ZOCOR. On 4th June 2018, the patient received SHINGRIX. On 13th June 2018, 9 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site rash and injection site warmth. On 14th June 2018, the patient experienced swelling arm. In June 2018, the patient experienced pain in arm. In June 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site erythema and swelling arm were not recovered/not resolved and the outcome of the injection site rash and injection site warmth were recovering/resolving. The reporter considered the pain in arm, injection site erythema, injection site rash, injection site warmth and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of breakouts from mosquitoes. The patient received the SHINGRIX (left arm) in the late afternoon around 4:00 pm on and her arm was sore for three days and then resolved on the 4th day after the injection. In the evening before the reporting date, around 8:00 pm (9 days and 4 hours after vaccination) her arm started to bother her and the area got a bright red and hot rash around the injection site. In the morning of reporting date, the rash subsided a lot but it was still red and the top part of her arm was swollen. The contact details of the healthcare professional was provided.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypothyroidism and blood cholesterol increased. Concomitant products included SYNTHROID and ZOCOR. On 4th June 2018, the patient received SHINGRIX. On 13th June 2018, 9 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site rash and injection site warmth. On 14th June 2018, the patient experienced swelling arm. In June 2018, the patient experienced pain in arm. In June 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site erythema and swelling arm were not recovered/not resolved and the outcome of the injection site rash and injection site warmth were recovering/resolving. The reporter considered the pain in arm, injection site erythema, injection site rash, injection site warmth and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of breakouts from mosquitoes. The patient received the SHINGRIX (left arm) in the late afternoon around 4:00 pm on and her arm was sore for three days and then resolved on the 4th day after the injection. In the evening before the reporting date, around 8:00 pm (9 days and 4 hours after vaccination) her arm started to bother her and the area got a bright red and hot rash around the injection site. In the morning of reporting date, the rash subsided a lot but it was still red and the top part of her arm was swollen. The contact details of the healthcare professional was provided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 12th June 2018 14:15, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and itchy rash. The patient was treated with hydrocortisone and BENADRYL. On an unknown date, the outcome of the injection site pain and itchy rash were recovering/resolving. The reporter considered the injection site pain to be probably related to SHINGRIX. The reporter considered the itchy rash to be unrelated to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right deltoid. The health care professional reported that the patient developed an itchy rash on the abdomen, under the bra area, and groin area the day after receiving the SHINGRIX vaccine. The patient also experienced soreness at the injection site. The health care professional does not believe rash was caused by the SHINGRIX. The health care professional recommended the patient to use hydrocortisone cream and BENADRYL on the rash.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 56-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, 9 days after receiving SHINGRIX, the patient experienced chills (serious criteria disability), nausea (serious criteria disability), myalgia (serious criteria disability), malaise (serious criteria disability), fever (serious criteria disability) and shaking (serious criteria disability). In June 2018, the outcome of the chills, myalgia, malaise and shaking were recovered/resolved. On an unknown date, the outcome of the nausea was not recovered/not resolved and the outcome of the fever was unknown. It was unknown if the reporter considered the chills, nausea, myalgia, malaise, fever and shaking to be related to SHINGRIX. Additional information was received as follows: The patient developed a sudden onset of events. In June 2018, the patient's body temperature was recorded as 102.5 degree F. The healthcare professional stated that the fever was disabling for the patient (because it was 102.5 F). Also, the patient went to the emergency room and then also went to the physician's office.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 56-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, 9 days after receiving SHINGRIX, the patient experienced chills (serious criteria disability), nausea (serious criteria disability), myalgia (serious criteria disability), malaise (serious criteria disability), fever (serious criteria disability) and shaking (serious criteria disability). In June 2018, the outcome of the chills, myalgia, malaise and shaking were recovered/resolved. On an unknown date, the outcome of the nausea was not recovered/not resolved and the outcome of the fever was unknown. It was unknown if the reporter considered the chills, nausea, myalgia, malaise, fever and shaking to be related to SHINGRIX. Additional information was received as follows: The patient developed a sudden onset of events. In June 2018, the patient's body temperature was recorded as 102.5 degree F. The healthcare professional stated that the fever was disabling for the patient (because it was 102.5 F). Also, the patient went to the emergency room and then also went to the physician's office.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 61-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020) for prophylaxis. Concomitant products included Losartan and BYETTA. On 26th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced joint pain, general body pain and activities of daily living impaired. On an unknown date, the outcome of the joint pain, general body pain and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the joint pain, general body pain and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included unspecified thyroid medication. The patient received SHINGRIX vaccine on an unknown deltoid. The healthcare professional (HCP) reported that, the patient experienced joint pain and generalized body aches following the 1st dose of SHINGRIX. The patient's activities of daily living were limited for a few days. The HCP stated that the patient did not contact the pharmacy at the time of the reaction and only mentioned her experience when she was contacted to schedule the 2nd dose of SHINGRIX. Therefore, the HCP did not have specifics regarding onset times and durations.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 17th February 2018, the patient received the 1st dose of SHINGRIX. On 18th February 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and shivering. On 19th February 2018, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in left arm. The patient stated that he received his SHINGRIX dose in February 2018 and the next day he experienced flu-like symptoms and shivering. The patient stated that these symptoms resolved after 1 day. The patient was not comfortable in providing address and had denied permission to contact their physician.
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: This case was reported by a non-health professional and described the occurrence of dizziness in a female patient who received ENGERIX B for prophylaxis. Concurrent medical conditions included anemia and blood pressure high. On 19th April 2018, the patient received the 1st dose of ENGERIX B. On an unknown date, less than a year after receiving ENGERIX B, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to ENERGIX B. Additional details were provided as follows: The age at the vaccination was not reported. The patient developed dizziness sometime after the injection. On 9th May2018, the patient was therefore advised not to receive the next dose in the series. The reporter was not the patient. The reporter advised the patient to contact the GlaxoSmithKline as she was questioning possible side effects as well as drug interactions. The reporter had no other information and did not have the patient's contact details for follow up. The reporter also did not know if the patient contacted the GlaxoSmithKline for more information.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of generalized pruritus in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown. It was unknown if the reporter considered the generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: On an unknown date, two weeks ago the patient received a dose experienced Itching over entire body. The patient was itching till the date of reporting. He did not know if it was for sure linked to SHINGRIX but happened after she received dose.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced very sore arm for a month and a half following the vaccination and finally subsided. The nurse said patient had a history of fibromyalgia so she was not sure if her fibromyalgia contributed to the pain. The patient just went in for their 2nd dose of SHINGRIX and had got it on the other arm.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported for the patients who had warned the reporter regarding the vaccine. The age at vaccination was not reported. After receiving vaccine, the patients experienced flu like symptoms. This is 1 of 2 cases, reported by the same reporter.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Horrific rash.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Malaise
Clinical narrative: Fatigue, shivering, pain at injection site, general feeling of malaise.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Approx 5 in area of erythema developed next to site of DTaP/IPV injection. No itching/pain. No sign of systemic reaction.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On 19 June she received PNEUMOVAX 23 and within hours noted localized swelling at vaccination site which has progressively spread in dependent fashion over the past 24 hours to affect her right upper arm. She notes warmth and tenderness of affected area. She denies generalized cutaneous symptoms and rash. She denies laryngeal, pulmonary, GI, CV, and neurologic symptoms. She denies fever/chills, arthralgias/myalgias, and malaise.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: FLU-LIKE SYMPTOMS SUCH AS ACHES AND PAIN AND TIREDNESS.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Retching
Clinical narrative: Flu like symptoms night of the vaccination - body aches, dry heaving and chills. Arm pain for the following 3 days finally starting to progress.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site oedema, Injection site warmth
Clinical narrative: 4 hrs after vaccination, pt reported high temp of 103-104 and "hard knot" where injection was given in left deltoid. Next morning his left arm was red, hot, edematous from his shoulder to his elbow. Seen in clinic 4 days after vaccination. Treated with Celphelaxin 500mg  4 times daily x 7 days. F/U 6/21/18 showed all symptoms resolved except there remains a small firm round area at the site of the injection.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: 4 hrs after vaccination, pt reported high temp of 103-104 and "hard knot" where injection was given in left deltoid. Next morning his left arm was red, hot, edematous from his shoulder to his elbow. Seen in clinic 4 days after vaccination. Treated with Celphelaxin 500mg  4 times daily x 7 days. F/U 6/21/18 showed all symptoms resolved except there remains a small firm round area at the site of the injection.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Immediate post-injection reaction, Musculoskeletal pain, Product administered at inappropriate site
Clinical narrative: The nurse administered the shot too high on my left shoulder. I experienced immediate pain in the shoulder that progressively worsened over the next few weeks. After a few weeks of trying to control the symptoms with OTC medications, I sought medical treatment. I was ultimately diagnosed with subacromial bursitis.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5 hours after vaccines given, left thigh was red and swollen, warm to touch. Able to move leg freely. No fever. Recommended cool compress and TYLENOL PRN. To call back if worsens or new s/s develop.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: Complain of dizziness, headache, weakness, joint pains, chills s/p getting SHINGRIX injection this morning. Patient was feeling fine yesterday, painful at the injection at left arm.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Complain of dizziness, headache, weakness, joint pains, chills s/p getting SHINGRIX injection this morning. Patient was feeling fine yesterday, painful at the injection at left arm.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Weight bearing difficulty
Clinical narrative: Pt's mother reports the 3-4 hours after the injection pt's leg was red and swollen, pt would not put weight on the leg. Pt had a fever that reached 102.5, she reported the event to us and was told to monitor the pt's sx, she called again on 6/21 and said sx have improved but were not completely resolved, she was told that if pt worsens to bring her into the clinic to be checked.
Age: 25.0
Sex: M
Vaccine: HEPA, HEPA, TDAP
Symptoms: Immunisation, Underdose
Clinical narrative: Patient was given a pediatric dose of Hepatitis A. This was discovered during the visit and the Adult dose was given.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red area, warm to touch at the site on the back of the left arm was noted. 2- 5/8 inches by 1- 1/4 inches, warm and soft.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal stiffness, Photophobia
Clinical narrative: Sensitive to light for 48 hours. My left arm hurts at the elbow and my back and legs are stiff after I have at for over 30 minutes.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site joint pain, Injection site joint swelling
Clinical narrative: Patient began complaining of right shoulder joint pain and presented to the clinic with right shoulder joint swelling and pain 5/8, the morning after the injection. The swelling subsided within 7 days after the injection was given. Continues to have pain in the joint.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Injection site erythema, Pain
Clinical narrative: Pain immediately after shot with soreness continuing through 21 June (today). Redness at shot site, cleared by 20 Jun 2018. New outbreak of Shingles occured the evening of 17 June 2018 and is continuing to get worse. This is my third outbreak in same location (left flank).
Age: 49.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling, Neck pain, Pyrexia, Skin warm
Clinical narrative: Swelling and pain at injection site, pain extended through shoulder and neck, fever (not recorded temp., feels hot according to wife).
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, Injection site swelling, Pyrexia, Wrong drug administered
Clinical narrative: Patient was given PEDARIX and Polio vaccines when he needed Dtap and Polio only. He got an extra dose of Hep B and extras dose of Polio. Mother stated that he got a fever the next day and has a small bump on his right arm. She gave him TYLENOL for the fever and it went away. The bump is still there and will use hot compress on the arm.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Muscle twitching, Neck pain, Pain in extremity, Swelling
Clinical narrative: Severe pain in my right arm that moves from my arm to my neck, swelling and redness of area, causing my nerves to twitch.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperchlorhydria, Influenza like illness, Injection site pain
Clinical narrative: Muscle aches similar to the flu, headache, fatigue, sour stomach, arm soreness where the shot was administered. Treating symptoms with ibuprofen.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches similar to the flu, headache, fatigue, sour stomach, arm soreness where the shot was administered. Treating symptoms with ibuprofen.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Pain, Tremor
Clinical narrative: Patient experienced shakes, was achy all over, and was freezing cold. The symptoms started about 6.5 hours after having the vaccine.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Redness (3 cm) and pain at injection site, dizziness, fever (subjective the next day; documented the 3rd day).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient told that her arm at injection site was sore, red, warm and painful and got celulitis. Currently her MD has prescribed KEFLEX.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Influenza like illness, Vaccination complication
Clinical narrative: Patient came to pharmacy complaining that she had a reaction to the the 2nd dose of SHINGRIX. She stated that the first dose was fine, the 2nd one caused her flu like symptoms and upset stomach for about 12 hours. She felt fine after approximately 12 hours.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Decreased appetite, Haematochezia, Hypersomnia, Pain, Rash generalised
Clinical narrative: Screaming in pain 24/7, paused breathing for weeks afterwards, not eating, head to toe severe rash that never went away. Blood in stool, projectile vomiting, slept for weeks.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Respiration abnormal, Screaming, Vomiting projectile
Clinical narrative: Screaming in pain 24/7, paused breathing for weeks afterwards, not eating, head to toe severe rash that never went away. Blood in stool, projectile vomiting, slept for weeks.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Per patient "nausea, diarrhea, body aches, headaches" x 24 hours, unclear if related, but thought it was reportable regardless.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Employee received her 3rd hepatitis shot in right deltoid experienced hives on anterior right shoulder, pain, and redness. Employee took 25mg of BENADRYL at the time of adverse event and drank Gatorade. She began to have difficulty breathing and took a puff of her PRO-AIR inhaler.  She has been advised to seek medical attention from the nearest ER. Currently stable.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Head injury, Headache, Loss of consciousness, Pain in extremity
Clinical narrative: The patient blacked out on the bathroom floor. He hit his head and has a sore arm, headache, and fever. He feels exhausted.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The patient blacked out on the bathroom floor. He hit his head and has a sore arm, headache, and fever. He feels exhausted.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash erythematous
Clinical narrative: Patient was given a SHINGRIX IMZ on 6-19-18 at 2:57. She came back on 6-21-18. She showed me her arm. It was red (about the size of an oblong orange) and had some darker red spots which she said were painful. I told her to place a cold compress on her arm and take some ibuprofen or Aleve. She stated she cannot take NSAIDs because she is on a blood thinner. She stated the redness started the night I administered the immunization. I drew a marker around the area and told her to keep on eye on it to make sure the area was not getting larger. I also told her to call her doctor she he has record of the adverse reaction. I tried phoning the patient a few times throughout the day and again tonight (8:20pm) but I could only leave a message.
Age: 80.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Right arm swollen, and painful.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash erythematous, Rash generalised, Red blood cell sedimentation rate
Clinical narrative: Generalized skin eruption red rash patches trunk/arms - started after shot, progressively worse until today 6/21/18 (expected Tx, Rx Prednisone).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Contusion, Haemoglobin normal, Platelet count normal, White blood cell count normal
Clinical narrative: Pt seen the day after MMR/varicella vaccines were given for new onset bruising of torso and lower extremities/face. No known trauma. Pt. had a few days of red spots on body previously, before vaccines, thought to be heat rash. The pt. was afebrile and acting like himself.
Sex: M
Vaccine: FLU3
Symptoms: Food allergy
Clinical narrative: This non-serious spontaneous case, initially received from consumer on 08-Jan-2018 and concerns a male patient of an unspecified age. The patient had no history of allergies. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient was administered with AFLURIA (TIV) (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after the vaccination, the patient had developed peanut allergy. It was reported that, patient refused to provide any other information. At the time of this report, the outcome of the event was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Fatigue, Feeling hot
Clinical narrative: This is a spontaneous case, initially received on 20-Dec-2017 reported by a pharmacist concerning a male patient of unspecified age. It was reported that, the patient had never experienced any reactions to his past influenza vaccines. The patient's concomitant medication included: Naproxen, AMBIEN, Lorazepam, Lisinopril, Bupropion and Duloxetine for an unknown indication. On an unspecified date, the patient was administered with AFLURIA (TIV) (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF30029, expiry date: not reported). On an unspecified date, after the administration of vaccine, the patient felt hot, confused and tired. At the time of this report, the outcome of the events was not reported. The reporter assessed this case as non-serious. Significant case correction was received on IRD 20-Dec-2017: The causality of the events (tiredness, confused and feeling hot) was changed from unassessable to related. No changes were done in narrative.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from pharmacist on 11-Dec-2017, concerning a patient of unspecified age and gender. The patient's medical history was not reported. On 09-Dec-2017 (09-Dec-2017 before 11-Dec-2017), the patient was administered with AFLURIA (TIV) (batch number: 14449211A, expiry date: 30-Jun-2018, dose, anatomical location and route of administration: not reported) after first excursion. It was reported that, the patient administered the product which was stored at 56.3 degrees F due to power outage of 7 hours. On an unspecified date, the patient was revaccinated and no adverse effects were noted. The reporter assessed the event as non-serious. Follow-up received from pharmacist on 12-Jan-2018: The report type was changed from invalid to spontaneous, as the pharmacist confirmed that only one patient received the flu-vaccine. It was reported that on an unspecified date, the patient was revaccinated and no adverse effects were noted. Narrative amended accordingly. Non-significant case correction received with IRD 12-Jan-2018: The event verbatim '2 patients administered after excursion 09DEC17 before 11DEC17' was replaced. Non-significant case correction received with IRD 12-Jan-2018: Narrative was corrected. 'The patient did not had any adverse effect' was changed to 'the patient did not experience any adverse effect'. 'On 09-Dec-2017 (09-Dec-2017 between 11-Dec-2017)' was changed to 'On 09-Dec-2017 (09-Dec-2017 before 11-Dec-2017)'.
Sex: F
Vaccine: FLU3
Symptoms: Contraindication to vaccination
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional on 25-Jan-2018, concerning a female patient of unspecified age. The patient had allergy to neomycin since an unspecified date. Historical drug included AFLURIA for an unknown indication (dates not reported). On an unspecified date (reported as past 2 season), the patient was vaccinated with AFLURIA (dose, route of administration, anatomical location, batch no and expiry date: not reported) with no reaction which was explicitly coded as contraindicated product administered. Reportedly, the consumer wanted to know if the AFLURIA contains neomycin and she did not received the vaccine this year. The reporter did not provide the seriousness assessment.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Liquid product physical issue
Clinical narrative: This is a non-serious spontaneous case, initially received on 14-Mar-2018, was reported by a pharmacist and concerns a 59-year-old, adult, female patient. On 07-Feb-2018, the patient was administered with AFLURIA in which foreign particles floating in syringe (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT33908, expiry date: 30-Jun-2018) (explicitly coded as particle present in liquid product and drug administration error). The PTC number was PR485504. It was reported that, the patient did not experience any adverse events after the administration of vaccine. Follow-up report received on 16-Apr-2018: Vaccination date and adverse events after the administration of vaccine. Follow-up report received on 16-Apr-2018: Vaccination date and event onset was changed from 05-Feb-2018 to 07-Feb-2018. Amended narrative accordingly. Significant case correction received 14-Mar-2018: LLT for the event 'pharmacist wants to know if it is normal to have particles in the AFLURIA pre-filled syringe' was changed from 'product contamination particulate matter' to particle present in liquid product'. Amended narrative accordingly.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 15-Mar-2018, was reported by a other health professional and concerns a 31-year-old adult female patient. The patient's concomitant medication included Pneumococcal vaccine (administered on 18-Jan-2017). On an unspecified date first temperature excursion of the vaccine occurred. On 18-Jan-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, anatomical location: left arm, batch number XT59906, expiry date: 06-Jun-2018, route of administration: not reported) stored out of range. On an unspecified date, the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines. Non-significant case correction received with IRD 15-Mar-2018: Narrative was corrected (word 'date' was added in sentence). Amended narrative accordingly.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Vaccination complication
Clinical narrative: This non-serious spontaneous case, initially received on 11-Feb-2018, was reported by other non-health professional and concerns a 64-year-old female patient. The patient's current condition included diabetics and allergy to seafood. The patient never had an allergic reaction to a vaccine in the past. On 19-Jan-2018, the patient was administered with AFLURIA (TIV) (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date in Jan-2018, the patient developed pain in the vaccinated arm, for which she took self-medication with 2 doses of PANADOL and lidocaine cream. On an unknown date, the patient's arm had swollen (described as a medium size ball in forearm appears to be like a chopped bee) and a red spot near that swollen area. The patient had to visit emergency room. The reaction occurred in the forearm, far away from the site of vaccination. The physician stated, that the event was an adverse reaction to the vaccine and had not suggested any other tests. The outcome of the events was not reported.