chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Abnormal behaviour, Anger, Electroencephalogram, Learning disorder, Mental disorder
Clinical narrative: Shortly after he developed high fevers and screaming. Followed by full body rash. My son has never been the same. He is currently in weekly private OT, speech, and PT. He is in a multi disability kindergarten. There he receives the same services. He mentally acts like a 3 year old. Is unable to function like other children his own age. He is given life skills and sign language classes.  Days after the vaccination he lost all capability for learned things. He was completely unintelligible and became angry and enraged over every little thing.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Mental impairment, Neuropsychological test, Pyrexia, Rash generalised, Screaming
Clinical narrative: Shortly after he developed high fevers and screaming. Followed by full body rash. My son has never been the same. He is currently in weekly private OT, speech, and PT. He is in a multi disability kindergarten. There he receives the same services. He mentally acts like a 3 year old. Is unable to function like other children his own age. He is given life skills and sign language classes.  Days after the vaccination he lost all capability for learned things. He was completely unintelligible and became angry and enraged over every little thing.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had the expected site reaction - pain, redness and swelling. Yesterday, 5-3-18, the reaction shifted up her arm to the bicep area. The site is much better. The redness and swelling is significant and worried patient since it migrated.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX. On 20th April 2018, the patient received SHINGRIX. On 21st April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injection site warmth and injection site itching were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site warmth and injection site itching to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient experienced hot feeling at injection site.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Colostomy, Dermatomyositis, Dysstasia, Gait disturbance
Clinical narrative: On 10-13-14, I was diagnosed with dermatomyositis. Dr. advised me "to get the flu vaccine since my immune system was already compromised." I was able to walk with a 4 prong cane at this time. My health declined rapidly after the flu vaccine. On 12-24-14, I was hospitalized with internal bleeding. My overall strength was rapidly declining. I was so weak, I could only lift my arm 3 inches off the mattress. I had multiple surgeries for the internal bleeding. I was given a colostomy which was reversed to an ileostomy in May 2016 (I think). That surgery took 7 1/2 hours. I spent 32 months in 2 nursing homes. I am home as of Aug. 4, 2017. I am still weak, and can only walk 50 ft. with a walker. I took methotrexate prescribed on 10-13-14. I took 20 mg. once a week. I did not take it prior to 10-13-14. I will have the ileostomy the rest of my life. I can stand for about a duration of 3 minutes with a walker to support me. I was able to climb two steps on a full stepladder. I was painting my kitchen. Now I am confined to a wheelchair and housebound.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: General physical health deterioration, Housebound, Ileostomy, Internal haemorrhage, Mobility decreased
Clinical narrative: On 10-13-14, I was diagnosed with dermatomyositis. Dr. advised me "to get the flu vaccine since my immune system was already compromised." I was able to walk with a 4 prong cane at this time. My health declined rapidly after the flu vaccine. On 12-24-14, I was hospitalized with internal bleeding. My overall strength was rapidly declining. I was so weak, I could only lift my arm 3 inches off the mattress. I had multiple surgeries for the internal bleeding. I was given a colostomy which was reversed to an ileostomy in May 2016 (I think). That surgery took 7 1/2 hours. I spent 32 months in 2 nursing homes. I am home as of Aug. 4, 2017. I am still weak, and can only walk 50 ft. with a walker. I took methotrexate prescribed on 10-13-14. I took 20 mg. once a week. I did not take it prior to 10-13-14. I will have the ileostomy the rest of my life. I can stand for about a duration of 3 minutes with a walker to support me. I was able to climb two steps on a full stepladder. I was painting my kitchen. Now I am confined to a wheelchair and housebound.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Surgery, Walking aid user, Wheelchair user
Clinical narrative: On 10-13-14, I was diagnosed with dermatomyositis. Dr. advised me "to get the flu vaccine since my immune system was already compromised." I was able to walk with a 4 prong cane at this time. My health declined rapidly after the flu vaccine. On 12-24-14, I was hospitalized with internal bleeding. My overall strength was rapidly declining. I was so weak, I could only lift my arm 3 inches off the mattress. I had multiple surgeries for the internal bleeding. I was given a colostomy which was reversed to an ileostomy in May 2016 (I think). That surgery took 7 1/2 hours. I spent 32 months in 2 nursing homes. I am home as of Aug. 4, 2017. I am still weak, and can only walk 50 ft. with a walker. I took methotrexate prescribed on 10-13-14. I took 20 mg. once a week. I did not take it prior to 10-13-14. I will have the ileostomy the rest of my life. I can stand for about a duration of 3 minutes with a walker to support me. I was able to climb two steps on a full stepladder. I was painting my kitchen. Now I am confined to a wheelchair and housebound.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 2 female patients of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB injection, (lot number N002202, expiration date: 04-NOV-2019) (exact dose, route of administration were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with M-M-R II (expiration date 29-MAR-2018, subcutaneous) (formulation, strength, dose, frequency, route of administration, indication, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with expired dose of with M-M-R II. The outcome of the event was unknown. The outcome of the event was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: Information was received from a healthcare worker via a company representative referring to a 14 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions, and allergies were not reported. In approximately 2017 (reported as about a year ago), the patient was vaccinated with first dose of GARDASIL 9 for prophylaxis (route of administration, lot number, and expiration date were not reported). On an unspecified date, the patient developed a wart on an unspecified location; the outcome of the wart was unknown. The relatedness between the event and GARDASIL 9 was not reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 02-MAY-2018, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot number M038744, expiry date 26-APR-2018) (exact dose was not reported) for prophylaxis. No adverse effects were reported.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 85-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date July 2020) and (batch number DA34Z, expiry date July 2020). On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis (serious criteria GSK medically significant), injection site rash, injection site warmth, injection site erythema, injection site swelling and allergic reaction. On an unknown date, the outcome of the injection site cellulitis, injection site rash, injection site warmth, injection site erythema and allergic reaction were not recovered/not resolved and the outcome of the injection site swelling was unknown. The reporter considered the injection site cellulitis, injection site rash, injection site warmth, injection site erythema, injection site swelling and allergic reaction to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. As per the sales data sheet the batch number changed to ZY3X4, DA34Z instead of 243XY, DA3YZ respectively. The pharmacist reported that patient received SHINGRIX vaccine about a week before the time of reporting and at the time of reporting the patient came into pharmacy with red raised warm area at the injection site. The pharmacist reported that an allergic reaction that looked like cellulitis, and when asked to describe, the pharmacist described all the adverse events. The patient reported that the area was higher above the injection site, but had moved down lower of the injection site. The pharmacist stated that was 3 to 4 inches in length by 2 to 2.5 inches in width in an oval shape. The patient was told to take CLARITIN by her physician. The pharmacist believed by discussion with the patient the physician wanted to start her on an antibiotic but the patient did not want to. No antibiotic had been ordered at time of reporting.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 85-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date July 2020) and (batch number DA34Z, expiry date July 2020). On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis (serious criteria GSK medically significant), injection site rash, injection site warmth, injection site erythema, injection site swelling and allergic reaction. On an unknown date, the outcome of the injection site cellulitis, injection site rash, injection site warmth, injection site erythema and allergic reaction were not recovered/not resolved and the outcome of the injection site swelling was unknown. The reporter considered the injection site cellulitis, injection site rash, injection site warmth, injection site erythema, injection site swelling and allergic reaction to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. As per the sales data sheet the batch number changed to ZY3X4, DA34Z instead of 243XY, DA3YZ respectively. The pharmacist reported that patient received SHINGRIX vaccine about a week before the time of reporting and at the time of reporting the patient came into pharmacy with red raised warm area at the injection site. The pharmacist reported that an allergic reaction that looked like cellulitis, and when asked to describe, the pharmacist described all the adverse events. The patient reported that the area was higher above the injection site, but had moved down lower of the injection site. The pharmacist stated that was 3 to 4 inches in length by 2 to 2.5 inches in width in an oval shape. The patient was told to take CLARITIN by her physician. The pharmacist believed by discussion with the patient the physician wanted to start her on an antibiotic but the patient did not want to. No antibiotic had been ordered at time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX .5m l. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient was administered SHINGRIX on arm approximately about 12 days before the time of reporting. The patient experienced intense pain at the site of injection on the day of vaccination which woke her up. At the time of reporting the patient was experiencing pain at the site of injection. The reporter did not have the patient's health care provider information. All questions were asked.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of leg pain in a 35-year-old male patient who received BOOSTRIX (batch number 9PD92, expiry date 30th May 2020). On 22nd April 2018 14:45, the patient received the 1st dose of BOOSTRIX .5 ml. On 23rd April 2018, 1 days after receiving BOOSTRIX, the patient experienced leg pain and back pain. On an unknown date, the outcome of the leg pain and back pain were not recovered/not resolved. The reporter considered the leg pain and pain to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in right deltoid. The pharmacist reported that the patient called today (on the date of reporting) and reported that he awoke with body aches in his back and legs yesterday morning after receiving BOOSTRIX vaccine on 22nd April 2018. The reporter did text to MIS for duration of events.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Discomfort, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 76-year-old female patient who received SHINGRIX. Concurrent medical conditions included blind (glaucoma diagnosed years ago and she was going blind), glaucoma (left eye glaucoma diagnosed 2 years ago), cancer surgery (twice) and brain operation. Concomitant products included Metformin, Ranitidine, Baby Aspirin, vitamin D, JANUVIA, SYNTHROID and TRAVATAN. On 20th April 2018 14:00, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced discomfort. On 20th April 2018, the patient experienced general body pain and bone pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the general body pain and bone pain were recovering/resolving and the outcome of the discomfort was unknown. It was unknown if the reporter considered the general body pain, bone pain and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. Within 2 hours after vaccination, the patient experienced pain starting in her arm and in her collar bone which got worse and then the pain was from her waist up. If she had the slightest movement, the pain was outrageous. Within 3 hours after vaccination, the patient experienced extreme pain throughout her body and it took her a couple of days to recover. On the following day, 21st April 2018, the patient contacted her physician and he advised her to take Ibuprofen 600 mg immediately and then 200 mg every two hours. The pain started to ease but she carried a residual feeling of being uncomfortable. The patient reported that he collar bone, chest and arm killed her. The patient had no mark or bleeding at the injection site. The patient had no reaction at the injection site. The patient claimed that the pain was resolving at the time of reporting.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th June 2020). Concurrent medical conditions included blood pressure abnormal. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In April 2018, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be almost certainly related to SHINGRIX. Additional details were reported as follows: The patient was takin medication for blood pressure issues. The pharmacist who administered the injection called and reported that the patient experienced pain and soreness immediately after the injection in the right upper arm. No additional information was available at the time of the call. This case was linked to case US2018071876, as reported by the same reporter. The reporter gave permission to contact her and would like to received follow-up in relation to this adverse event.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hypertension, Immediate post-injection reaction, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a adult male patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several hours after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site warmth, injection site pain, injection site rash, headache and blood pressure high. The patient was treated with Blood Pressure Medicine (Unknown). In April 2018, the outcome of the injection site induration, injection site erythema, injection site warmth, injection site pain, injection site rash and headache were recovered/resolved. On an unknown date, the outcome of the blood pressure high was unknown. It was unknown if the reporter considered the injection site induration, injection site erythema, injection site warmth, injection site pain, injection site rash, headache and blood pressure high to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On approximately 12th April 2018, about ten to twelve days before the date of reporting, the patient received SHINGRIX in unknown arm. With the pass of the hours, the injection site place got harder and the area got much more reddish. The reddishness started to expand and create a larger and larger reddish area which was hot, painful, and was burning. Immediately after the vaccination, he had a headache. With the passing of the hours and the days, that reddishness disappeared, the rash disappeared, and the headache disappeared. On the day of reporting, his arm showed no evidence where anyone could see or recognize that in that place had been such a reaction and when he touched his arm, he did not feel the symptoms either. These symptoms were described as occurring within the first five days after having the vaccination. On Saturday night about nine or ten days approximately after having the vaccine, he had a headache again. On Sunday, the headache became stronger and stronger. He took his blood pressure which was described as being very, very high (latency less than a month). The patient notified his doctor and was prescribed blood pressure medicine and a full and complete lab test was ordered. The patient had the shingles vaccination. No information beyond what was already documented could be gained during the call, as the reporter decline to answer any reporting questions. He was referred to his healthcare professional during the call.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a adult male patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several hours after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site warmth, injection site pain, injection site rash, headache and blood pressure high. The patient was treated with Blood Pressure Medicine (Unknown). In April 2018, the outcome of the injection site induration, injection site erythema, injection site warmth, injection site pain, injection site rash and headache were recovered/resolved. On an unknown date, the outcome of the blood pressure high was unknown. It was unknown if the reporter considered the injection site induration, injection site erythema, injection site warmth, injection site pain, injection site rash, headache and blood pressure high to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On approximately 12th April 2018, about ten to twelve days before the date of reporting, the patient received SHINGRIX in unknown arm. With the pass of the hours, the injection site place got harder and the area got much more reddish. The reddishness started to expand and create a larger and larger reddish area which was hot, painful, and was burning. Immediately after the vaccination, he had a headache. With the passing of the hours and the days, that reddishness disappeared, the rash disappeared, and the headache disappeared. On the day of reporting, his arm showed no evidence where anyone could see or recognize that in that place had been such a reaction and when he touched his arm, he did not feel the symptoms either. These symptoms were described as occurring within the first five days after having the vaccination. On Saturday night about nine or ten days approximately after having the vaccine, he had a headache again. On Sunday, the headache became stronger and stronger. He took his blood pressure which was described as being very, very high (latency less than a month). The patient notified his doctor and was prescribed blood pressure medicine and a full and complete lab test was ordered. The patient had the shingles vaccination. No information beyond what was already documented could be gained during the call, as the reporter decline to answer any reporting questions. He was referred to his healthcare professional during the call.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash morbilliform, Scab
Clinical narrative: Mom reported a rash, reddened and raised "measles like" developed w/I 24hrs of immunization. Started at hairline and behind ears. Mom then called later to say she believes it was bug bites and attached pictures to an email (72 hrs after rash developed); 4 dry, crusty raised areas noted in pictures; with slightly reddened area around "crust".
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Itching all over (head to feet) Start: 4/23/18 7pm Stop: 4/24/18 8am.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient contacted me on 4-25-18 to inform me that his arm was red, hurting, and hot to touch. I told her to see her doctor.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Flushing, Local reaction, Skin warm, Swelling
Clinical narrative: Injection given (Ll deltoid). Local reaction red, swelling, warm to touch from side up to top of shoulder. Red flushing of face no SOB but tingling at site. Ice packs and steroids Prednisone 20 mg 2 tabs daily for 5 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (L) mid thigh-red, warm. Treatment-ibuprofen, BENADRYL, cold compress.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Body aches, headache, chills, nausea, low fever, fatigue, all on the day after the vaccine and all being gone by the following day.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Body aches, headache, chills, nausea, low fever, fatigue, all on the day after the vaccine and all being gone by the following day.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: It started with a bruise that slowly got bigger. When he came to our office on 04/20/18 the bruise was 4 cm in size with significant tenderness throughout his deltoid. He experienced an ache in his arm that increased over time to the point where he could not raise his arm due to soreness. The pain finally resolved around the beginning of May.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Severe body aches, pain at injection site, fatigue.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Eyelid oedema
Clinical narrative: Initially left eyelid swelling, w/mild right eyelid swelling. Pt tx'd w/BENADRYL 50 mg q 4-6 hours. Presented to clinic for eval day 4 of sx's, at which time her right eyelid was no longer swollen. Left eyelid swollen w/secondary cellulitis.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye infection, Eyelid oedema, Ocular hyperaemia
Clinical narrative: Initially left eyelid swelling, w/mild right eyelid swelling. Pt tx'd w/BENADRYL 50 mg q 4-6 hours. Presented to clinic for eval day 4 of sx's, at which time her right eyelid was no longer swollen. Left eyelid swollen w/secondary cellulitis.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: NO ADVERSE EVENT AT THE TIME OF THIS REPORT; GAVE FIRST ROTATEQ VACCINATION TO THE PATIENT THAT WAS 16 WEEKS OLD, ONE WEEK PAST THE  RECOMMENDED AGE LIMIT OF 15 WEEKS.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth, Rash pustular
Clinical narrative: Client presented to clinic on 5/4/18 with rash spread in clusters along thigh. Rash with pustules was red and warm to touch. Client's mother denies any ointment or treatment put on prior to coming in. Referred to Urgent Care for evaluation.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash, Injection site urticaria
Clinical narrative: Rash hives from just below injection site to elbow. Also bruise just below injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Blood glucose increased, Condition aggravated, Feeding disorder, Headache
Clinical narrative: Patient reports severe headache and body aches. She also reports severe stomach upset and nausea, near vomiting. She is unable to eat due to the nausea. She has diabetes and since receiving the immunization her blood sugar has increased from normal range to between 200-300. This morning her fasting was elevated at 201. Increase has been resistant to multiple insulin doses and she is still unable to eat.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Patient reports severe headache and body aches. She also reports severe stomach upset and nausea, near vomiting. She is unable to eat due to the nausea. She has diabetes and since receiving the immunization her blood sugar has increased from normal range to between 200-300. This morning her fasting was elevated at 201. Increase has been resistant to multiple insulin doses and she is still unable to eat.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood glucose increased, Bone pain, Decreased appetite, Feeding disorder, Headache
Clinical narrative: Patient reports severe headache and body aches. She also reports severe stomach upset and nausea, near vomiting. She is unable to eat due to the nausea. She has diabetes and since receiving the immunization her blood sugar has increased from normal range to between 200-300. This morning her fasting was elevated at 201. Increase has been resistant to multiple insulin doses and she is still unable to eat.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza, Pain
Clinical narrative: Patient reports severe headache and body aches. She also reports severe stomach upset and nausea, near vomiting. She is unable to eat due to the nausea. She has diabetes and since receiving the immunization her blood sugar has increased from normal range to between 200-300. This morning her fasting was elevated at 201. Increase has been resistant to multiple insulin doses and she is still unable to eat.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dry mouth, Fatigue, Injection site erythema, Pain
Clinical narrative: Patient arrives at the Pharmacy to notify that after administering the vaccine he had felt pain tiredness and dryness in the mouth beside the area of administration is red.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient arrives at the Pharmacy to notify that after administering the vaccine he had felt pain tiredness and dryness in the mouth beside the area of administration is red.
Age: 28.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Burning sensation, Rash, Rash pruritic, Scratch, Skin haemorrhage
Clinical narrative: Shortly after 3rd shot in 2004, began to break out in itchy/burning rash, started on ankles and spread up legs, trunk to neck and down arms. Could not be subdued by creams, ointments, steroids, or ingestion of medication. Received 4th shot in series in 2008 condition got worse and continued to spread. Rash was observed by a doctor while being treated for eye injury. Rash consisted of spots that were intense in itching and burning. Scratching would lead to lesions, ruptures, bleeding. Was given various remedies but none would cease the pain. Rash still comes and goes to this day.
Age: 28.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Skin lesion
Clinical narrative: Shortly after 3rd shot in 2004, began to break out in itchy/burning rash, started on ankles and spread up legs, trunk to neck and down arms. Could not be subdued by creams, ointments, steroids, or ingestion of medication. Received 4th shot in series in 2008 condition got worse and continued to spread. Rash was observed by a doctor while being treated for eye injury. Rash consisted of spots that were intense in itching and burning. Scratching would lead to lesions, ruptures, bleeding. Was given various remedies but none would cease the pain. Rash still comes and goes to this day.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: Patient's wife called patient support this morning that early this morning he began experiencing shortness of breath. At the time of the call symptoms had resolved. Advised to go to ER if symptoms begin again.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given extra vaccine in error. Another nurse present in room for assist, LPN. Patient was not due for vaccines today. No symptoms. FNP made aware of incident on 5/4/2018 at 0900. Patient guardian (Grandmother) contacted and made aware. Patient has no complaints today and acting normal.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Large (about 3-4 inches) round, swollen, warm area around injection site. Patient states that she noticed symptoms the next morning after vaccination. She denies fever, increased blood pressure, and general malaise. Patient is going to ice area and take BENADRYL to reduce swelling. Patient is not going to taking NSAID due to high blood pressure. No outcome has been reported from patient. We will follow up with patient tomorrow 5/5/18.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: Beginning about 12hrs after injection, and for next 12hrs, headache, nauseous, body ached all over, extremely tired and stayed in bed for those 12hours except for trips to bathroom, and to get ibuprofen(2) half way through the 12-miserable-hours. This was unusual because I've never before had an adverse reaction to any vaccination (including the "old" shingles vaccine, and years of influenza, etc).
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Swelling, Urticaria
Clinical narrative: Large area of induration, erythema, swelling. Local hives.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Wrong patient received medication
Clinical narrative: Multiple vaccines given in error. Total of 3 children in room at time of injections. LPN present to assist  RN with injections. Patient was due for only Hepatitis A today and she did receive that injection but also received Four others that she was not due for this date of 5/3/2018. FNP made aware of error on 5/4/2018. Patient Guardian contacted (Grandmother) and notified, made of aware of incident. Negative injury to patient. Grandmother denies any complaints from child, only some redness to right thigh where 2 injections were given.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient developed welt at injection site. Grew double in size (from quarter size).
Age: 41.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Pain in extremity
Clinical narrative: On 4/25/18 the client called the clinic complaining of pain to R arm, denied any redness or swelling. I told her to ice and apply warm compresses to her arm and follow up with her doctor if not better in the next couple of days. On 5/3/18 she left a voicemail at the clinic and it was received on 5/4/18 regarding still having sharp pain to R arm, that was keeping her up at night. I then referred the message to Dr., our clinic's medical director, who then returned the client's phone call. When he spoke with her on 5/4/18 at approximately 9:30 AM she stated she had been seen at Medical Center by Dr., and was given Prednisone for her R arm pain which is helping. She told him as of today her R arm is feeling better and still denies any redness or swelling to that arm. Dr. did tell her she may be allergic to the Pertussis part of the Tdap vaccine and recommended getting Td vaccine from now on, however it is impossible for us to know for sure which vaccine caused the R arm pain, as she received two vaccines in that arm.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Flushing, Myalgia, Rash
Clinical narrative: Severe chills began at 2:00am about 12 hours after injection. Lasted for about 6 hours. Severe muscle aching lasting about 12 hours began at 2 am as well. The main issues and reactions which as of the posting of this report are still very much active are: Feeling of a "pit in my stomach" which was present for about 24 hours after the FIRST injection (1/28/2018) after the second injection returned at about 2 am and continues to this day. An odd rash appeared on 04/07/2018 in two places: on my right forearm and my right calf. Raised and red and itchy. They are still present at this reporting. The itchiness tends to travel down the forearm to the hand and all up and down the right calf. When heated while exercising a red flushing appears on my forearm and travels down to my right hand. In fact there has been an overall worsening of generalized urticaria.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Severe chills began at 2:00am about 12 hours after injection. Lasted for about 6 hours. Severe muscle aching lasting about 12 hours began at 2 am as well. The main issues and reactions which as of the posting of this report are still very much active are: Feeling of a "pit in my stomach" which was present for about 24 hours after the FIRST injection (1/28/2018) after the second injection returned at about 2 am and continues to this day. An odd rash appeared on 04/07/2018 in two places: on my right forearm and my right calf. Raised and red and itchy. They are still present at this reporting. The itchiness tends to travel down the forearm to the hand and all up and down the right calf. When heated while exercising a red flushing appears on my forearm and travels down to my right hand. In fact there has been an overall worsening of generalized urticaria.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This non valid spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history, drug reactions or allergies. Concomitant therapies included sterile diluent concomitant therapies were not reported. On 30-APR-2018, the patient was vaccinated with a properly stored expired dose of M-M-R II (lot number M004305 and expiration date of 25-JAN-2018) (dose, dose number, route and anatomical place of vaccination were not provided), for prophylaxis, which was reconstituted with sterile diluent which had a lot number of N013282 and expiration date of 23-AUG-2019. No adverse effects were reported.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Dysphagia, Incomplete course of vaccination, Phobia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of phobia in a 22-year-old female patient who received RABAVERT. Co-suspect products included RABAVERT. Previously administered products included Tdap with an associated reaction of dizziness (see linked case US2018GSK078834). Concomitant products included Meclizine. On 26th September 2011, the patient received the 1st dose of RABAVERT (intramuscular) 1 ml. On an unknown date, the patient received the 5th dose of RABAVERT. On 26th September 2011, less than a day after receiving RABAVERT and not applicable after receiving RABAVERT, the patient experienced phobia, swallowing difficult and anxiety. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the phobia, swallowing difficult, anxiety and incomplete course of vaccination were unknown. It was unknown if the reporter considered the phobia, swallowing difficult and anxiety to be related to RABAVERT. Additional details were provided as follows: The patient reported that she had another possible exposure to an animal that had rabies and had her first injection of the series on 23rd April 2018 (the patient had another series at a different time from another rabies exposure on 26th September 2011). The patient required emergency room visit. The reporter also had questions about how much coverage she would have as when she has the vaccine years ago, she had 4 of the 5 series of doses (she did not complete the series). Thus, leading incomplete course of vaccination. No other information available. It was previously reported to manufacturer. This case has been linked with US2018GSK078833 and US2018GSK078834, reported by the same reporter for the same patient.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Injection site erythema, Insomnia
Clinical narrative: This case was reported by a consumer and described the occurrence of general body pain in a 62-year-old male patient who received SHINGRIX. On 17th April 2018, the patient received the 1st dose of SHINGRIX. On 17th April 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping. On 18th April, the patient experienced general body pain, chills, joint pain and muscle pain. On 20th April 2018, the patient experienced dizziness. On 19th April 2018, the outcome of the general body pain, difficulty sleeping, chills, joint pain and muscle pain were recovered/resolved. On an unknown date, the outcome of the dizziness was recovering/resolving. The reporter considered the general body pain, dizziness, difficulty sleeping and chills to be related to SHINGRIX. It was unknown if the reporter considered the  joint pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in the left arm. On 17th April 2018, in the  morning the patient received SHINGRIX and had trouble sleeping that night. The following morning the patient felt body aches from head to toe. The patient's muscles and joints ached and also had chills. These symptoms resolved after the second day. On the third day following the vaccination, the patient dizziness was still slightly present but resolving at the time of reporting. The patient give consent to contact there physician for the further follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of general body pain in a 62-year-old male patient who received SHINGRIX. On 17th April 2018, the patient received the 1st dose of SHINGRIX. On 17th April 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping. On 18th April, the patient experienced general body pain, chills, joint pain and muscle pain. On 20th April 2018, the patient experienced dizziness. On 19th April 2018, the outcome of the general body pain, difficulty sleeping, chills, joint pain and muscle pain were recovered/resolved. On an unknown date, the outcome of the dizziness was recovering/resolving. The reporter considered the general body pain, dizziness, difficulty sleeping and chills to be related to SHINGRIX. It was unknown if the reporter considered the  joint pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in the left arm. On 17th April 2018, in the  morning the patient received SHINGRIX and had trouble sleeping that night. The following morning the patient felt body aches from head to toe. The patient's muscles and joints ached and also had chills. These symptoms resolved after the second day. On the third day following the vaccination, the patient dizziness was still slightly present but resolving at the time of reporting. The patient give consent to contact there physician for the further follow up.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash broke out next day. This may have been a coincidence.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Dry mouth, Dyspnoea, Hot flush, Hypoacusis, Hypoaesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hard of hearing in a 28-year-old female patient who received RABAVERT. Previously administered products included Tdap with an associated reaction of dizziness (see linked case US2018GSK078834) and RABAVERT with an associated reaction of phobia (1st dose received on 26th September 2011 (see linked case US2018074027)). Concomitant products included Meclizine. On 23rd April 2018, the patient received the 2nd dose of RABAVERT (intramuscular) 1 ml. In April 2018, less than a week after receiving RABAVERT, the patient experienced numbness in leg and twitching facial. On 23rd April 2018, the patient experienced hard of hearing, difficulty breathing, hot flashes, insomnia, dry mouth, injection site burning and vaccine administered at inappropriate site. On an unknown date, the outcome of the hard of hearing, difficulty breathing, hot flashes, insomnia, dry mouth, injection site burning, numbness in leg, twitching facial and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the hard of hearing, difficulty breathing, hot flashes, insomnia, dry mouth, injection site burning, numbness in leg and twitching facial to be related to RABAVERT. Additional details were provided as follows: The patient reported that she had another possible exposure to an animal that had rabies and her first injection of the series on 23rd April 2018 (the patient had another series at a different time from another rabies exposure on 26th September 2011). The patient had another exposure to Rabies and received the vaccine on Monday on 23rd April 2018 and had to get another one on day of reporting on 26th April 2018. The patient was having adverse reactions to the one that she received Monday on 23rd April 2018, her legs were numb and when she smiles her face twitches really bad. Before the patient was able to probe, she disconnected from the call. The caller also had questions about how much coverage she would have as when she had the vaccine years ago, she had 4 of the 5 series of doses (she did not complete the series). No other information available. The patient required emergency room visit. This case has been linked with US2018074037 and US2018GSK078834, reported by the same reporter for the same patient).