chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Traumatic lung injury, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Influenza vaccine Quadrivalent for prophylaxis. Co-suspect products included ADVAIR HFA inhaler (batch number 8ZP0313, expiry date 30th September 2019) for chronic obstructive pulmonary disease and TAMIFLU (batch number UNKNOWN, expiry date unknown) for an unknown indication. In October 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, the patient started ADVAIR HFA (inhaled) 1 puff(s) twice daily (2 puff(s) daily). On an unknown date, the dose was changed to an unknown dose and frequency. In March 2018, the patient started TAMIFLU at an unknown dose and frequency. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season and not applicable after starting ADVAIR HFA, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza (serious criteria hospitalization), collapse of lung (serious criteria hospitalization and GSK medically significant), lung injury (serious criteria hospitalization), diminished lung sounds (serious criteria hospitalization), cough (serious criteria hospitalization) and oxygen consumption decreased (serious criteria hospitalization). ADVAIR HFA was continued with no change. On an unknown date, the outcome of the vaccination failure, influenza, collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased were unknown. It was unknown if the reporter considered the vaccination failure, influenza, collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased to be related to Influenza vaccine Quadrivalent 2017-2018 season. It was unknown if the reporter considered the influenza, collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased to be related to ADVAIR HFA. Additional details were provided as follows: This case was reported by the patient's wife. The patient received flu shot in his left arm. In March 2018, the patient was diagnosed with the flu and started on TAMIFLU. Five days after receiving TAMIFLU, he had a coughing spell and he heard his left lung pop. The patient was diagnosed with a collapsed lung. He went to the hospital. In an effort to inflate his lung, a breathing tube was inserted but it blew two small holes in his lung. He was in the hospital for eight weeks. The reporter indicated that the patient had been on 24 hour oxygen since being discharged from the hospital. It was unknown if the reporter considered the collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased to be related to TAMIFLU as well. The reporter was unable to provide any additional details related to the TAMIFLU because he no longer had the container. The reporter gave permission for his physician to be contacted.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of myalgia upper extremities in a 74-year-old male patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th August 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia upper extremities. On 31st August 2018, the outcome of the myalgia upper extremities was recovered/resolved. It was unknown if the reporter considered the myalgia upper extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced muscle pain from site down to elbow the same day as his injection. It was noted to be a muscle pain. The pain lasted for 4 days and then resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of rash in a elderly male patient who received SHINGRIX (batch number Z9RR4, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported this case through chat. The age at the vaccination was not reported. The patient developed a severe rash on the arm which he received a dose of SHINGRIX. The rash started 5 to 6 days after receiving the vaccine, which went all the way around the patient's arm from his shoulder to the elbow. The patient had no signs of anaphylaxis. The reporter did not have expiry date of the vaccine as it was given at a pharmacy and not at his office.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received KINRIX for prophylaxis. On 5th September 2018, the patient received KINRIX. On 5th September 2018, unknown after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The 2 month old patient inadvertently received a dose of KINRIX, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema 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 year after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported redness following SHINGRIX.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (when she was younger). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that her nurse at the physician's office told her that one of her friends had shingles after getting the SHINGRIX vaccine. However, the shingles that the patient experienced after getting the SHINGRIX vaccine was a mild case of shingles. The reporter did not have additional information. This case was considered as suspected vaccination failure case as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Crohn's disease, Drug ineffective, Herpes zoster, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (when she was younger). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that her nurse at the physician's office told her that one of her friends had shingles after getting the SHINGRIX vaccine. However, the shingles that the patient experienced after getting the SHINGRIX vaccine was a mild case of shingles. The reporter did not have additional information. This case was considered as suspected vaccination failure case as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (when she was younger). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that her nurse at the physician's office told her that one of her friends had shingles after getting the SHINGRIX vaccine. However, the shingles that the patient experienced after getting the SHINGRIX vaccine was a mild case of shingles. The reporter did not have additional information. This case was considered as suspected vaccination failure case as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown. It was unknown if the reporter considered the fever and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced fever and a headache. No additional information was provided. The pharmacist left the chat without providing adverse event details.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Erythema, Pain, Porokeratosis, Skin irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of porokeratosis in a 78-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included porokeratosis (since 1988 and the condition has been stable for the most part for years). On 29th May 2018, the patient received the 1st dose of SHINGRIX. On 30th May 2018, 1 days after receiving SHINGRIX, the patient experienced porokeratosis (serious criteria GSK medically significant), condition aggravated, swelling, pain and skin red. In June 2018, the patient experienced skin irritation. On an unknown date, the outcome of the porokeratosis, condition aggravated and skin irritation were not recovered/not resolved and the outcome of the swelling, pain and skin red were recovered/resolved. It was unknown if the reporter considered the porokeratosis, condition aggravated, skin irritation, swelling, pain and skin red to be related to SHINGRIX. This case was reported by the patient for himself. The patient received SHINGRIX in the left deltoid. The patient stated that his porokeratosis symptoms worsened a couple of weeks after getting the SHINGRIX vaccination. His skin was redder with more irritation on his legs, arms, chest and back.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of porokeratosis in a 78-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included porokeratosis (since 1988 and the condition has been stable for the most part for years). On 29th May 2018, the patient received the 1st dose of SHINGRIX. On 30th May 2018, 1 days after receiving SHINGRIX, the patient experienced porokeratosis (serious criteria GSK medically significant), condition aggravated, swelling, pain and skin red. In June 2018, the patient experienced skin irritation. On an unknown date, the outcome of the porokeratosis, condition aggravated and skin irritation were not recovered/not resolved and the outcome of the swelling, pain and skin red were recovered/resolved. It was unknown if the reporter considered the porokeratosis, condition aggravated, skin irritation, swelling, pain and skin red to be related to SHINGRIX. This case was reported by the patient for himself. The patient received SHINGRIX in the left deltoid. The patient stated that his porokeratosis symptoms worsened a couple of weeks after getting the SHINGRIX vaccination. His skin was redder with more irritation on his legs, arms, chest and back.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Product supply issue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, injection site pain and product supply issue. On an unknown date, the outcome of the fever, influenza-like symptoms, injection site pain and product supply issue were unknown. It was unknown if the reporter considered the fever, influenza-like symptoms and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever and bad flu-like symptoms and was in bed for 3 days. The patient also experienced an extremely sore arm at the area of the injection. The patient mentioned that there was a shortage of SHINGRIX and time was running out for his 2nd dose. Because of the adverse events experienced after 1st dose, the patient did not want to have the shot three times (if the patient miss the 2nd dose within the 6 month window). The patient was asking if there was any way possible to make sure that people who had gotten the 1st dose (especially the ones who had a reaction) were at the top of the list for the 2nd dose and if there was any way to assure the patient could get the 2nd dose before the end of September. The patient stated there must be many people in this situation.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Cheilitis, Erythema, Exposure via skin contact, Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult female patient who was administering the vaccine received SHINGRIX. In August 2018, the patient received SHINGRIX. In August 2018, unknown after receiving SHINGRIX, the patient experienced inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via skin contact were unknown. Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but was captured as adult as per the vaccine indication. The staff nurse (patient) was reconstituting SHINGRIX, when drawing the reconstituted SHINGRIX from the vial, the SHINGRIX leaked from the needle hub and got on the nurse's hand and skin in the last week of August 2018, which led to inadvertent exposure to vaccine and exposure via skin contact. The outcome of the event was unknown. Follow up received from other healthcare professional on 5th September 2018: The patient details were updated. Within a day after the skin exposure of the SHINGRIX, the patient experienced local adverse reactions of redness and irritation, by the later part of last week after the receiving, either On 29th August 2018 or 30th August 2018, less than a week after receiving the SHINGRIX she experienced some small bumps on her nose and upper lip. The patient was evaluated by the physician on 31th August 2018 and based on the bumps on her nose and lip, and her skin exposure to SHINGRIX, she was diagnosed with shingles. The patient was planned to see an ophthalmologist in the week of reporting to see if there was any eye involvement.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Rash, Skin irritation
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult female patient who was administering the vaccine received SHINGRIX. In August 2018, the patient received SHINGRIX. In August 2018, unknown after receiving SHINGRIX, the patient experienced inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via skin contact were unknown. Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but was captured as adult as per the vaccine indication. The staff nurse (patient) was reconstituting SHINGRIX, when drawing the reconstituted SHINGRIX from the vial, the SHINGRIX leaked from the needle hub and got on the nurse's hand and skin in the last week of August 2018, which led to inadvertent exposure to vaccine and exposure via skin contact. The outcome of the event was unknown. Follow up received from other healthcare professional on 5th September 2018: The patient details were updated. Within a day after the skin exposure of the SHINGRIX, the patient experienced local adverse reactions of redness and irritation, by the later part of last week after the receiving, either On 29th August 2018 or 30th August 2018, less than a week after receiving the SHINGRIX she experienced some small bumps on her nose and upper lip. The patient was evaluated by the physician on 31th August 2018 and based on the bumps on her nose and lip, and her skin exposure to SHINGRIX, she was diagnosed with shingles. The patient was planned to see an ophthalmologist in the week of reporting to see if there was any eye involvement.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain localized in a adult 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 year after receiving SHINGRIX, the patient experienced pain localized. On an unknown date, the outcome of the pain localized was recovered/resolved. It was unknown if the reporter considered the pain localized to be related to SHINGRIX. Additional details were reported as follows: The field reporter contacted GlaxoSmithKline adverse event line. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient experienced local pain lasted for 5 to 7 days. The reporter did not provide any additional information as this report was already submitted the occurrences directly. The reporter did not agree to be followed up by GSK. This was one of four cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of dizziness (1st dose received on an unknown date, for tolerance see case US2018160836). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and dizziness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site reaction and dizziness were recovered/resolved. It was unknown if the reporter considered the injection site reaction and dizziness to be related to SHINGRIX. Additional details were provided as follows: The caller was cousin of patient who received both doses of SHINGRIX. The age at vaccination was not reported. The caller reported that after receiving a dose of SHINGRIX the patient experienced dizziness that lasted for 4 to 5 hours as well as injection site reaction and all events were resolved. The lot number, pharmacy information and physician information were not available. The patient had denied permission to contact their physician.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling cold, Headache, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 75-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on 18th June 2018, for tolerance see case US2018139571). On 18th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever were unknown. It was unknown if the reporter considered the shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever (similar but milder reaction as that of 1st dose). The patient did not see physician or anyone else for events after 1st dose.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 75-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on 18th June 2018, for tolerance see case US2018139571). On 18th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever were unknown. It was unknown if the reporter considered the shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever (similar but milder reaction as that of 1st dose). The patient did not see physician or anyone else for events after 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of joint pain in a adult 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 year after receiving SHINGRIX, the patient experienced joint pain and fever. On an unknown date, the outcome of the joint pain and fever were unknown. It was unknown if the reporter considered the joint pain and fever to be related to SHINGRIX. Additional details were reported as follows: The field reporter contacted GlaxoSmithKline adverse event line. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient experienced joint soreness and fever for 2 days. The reporter did not provide any additional information as this report was already submitted the occurrences directly. The reporter did not agree to follow up to GSK. This was one of four cases reported by the same reporter.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Alopecia, Blood test normal, Madarosis
Clinical narrative: Hair loss starting about 48 hrs after vaccine administration. Patient seen about 7 days after hair starting to come off. Basic blood work normal. Patient seen 4 days after that 1st visit. More hair loss including eyebrow and eyelashes. Some of body hair was coming off too. Patient seen by dermatology who are treating her with topical steroids.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area to left thigh injection site is red and hard. Area may have been warm to touch but unable to tell as ice was applied upon reaction.
Age: 26.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, C-reactive protein normal, Chest X-ray normal, Chest pain
Clinical narrative: Onset of retrosternal, nonradiating chest pain on 11 Dec 2017 (5 days after primary smallpox vaccine). Patient sought evaluation at local ER where ECG, labs, and exam essentially normal. Treated with GI cocktail (no impact on pain) and naproxen initiated, which did decrease chest pain. No accompanying symptoms. Pain remained substernal, worse when lying down improved with sitting up, and improved with taking Naprosyn.
Age: 26.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Electrocardiogram abnormal, Fibrin D dimer normal, Sinus bradycardia, Troponin I normal
Clinical narrative: Onset of retrosternal, nonradiating chest pain on 11 Dec 2017 (5 days after primary smallpox vaccine). Patient sought evaluation at local ER where ECG, labs, and exam essentially normal. Treated with GI cocktail (no impact on pain) and naproxen initiated, which did decrease chest pain. No accompanying symptoms. Pain remained substernal, worse when lying down improved with sitting up, and improved with taking Naprosyn.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Two red, round, slightly raised areas approximately 2 inches in diameter distal to the injection site. One is on the anterior portion of the bicep and one is more lateral between the tricep and bicep.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Induration, Injection site hypoaesthesia
Clinical narrative: 5cm area of induration. Numbness in the lt. arm extending from shoulder to fingers.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient was seen today on 09/13/18. Rash to stomach and back area. Was diagnosed as Urticaria. Treatment was diphenhydramine 12.5mg, 5ml every 6 hr PRN x12 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: Patient came back to the pharmacy on 9/5/18 to report her adverse events following vaccine administration on 8/30/18. Patient reports a fever of 102F on the first day, which she took TYLENOL and ibuprofen for. On days 2-6, she experienced redness and swelling in the left arm without any itching. She said the swelling was very noticeable and there was swelling to her left armpit as well. On day 7, the swelling resolved. Also on day 7, the injection site is itchy but the itchiness is tolerable.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Pt. called stating the SHINGRIX vaccine had made her sick. Severe arm pain hot red severe swelling. Sick in bed x 3 days with a fever of 101. She also had nausea.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Pt. called stating the SHINGRIX vaccine had made her sick. Severe arm pain hot red severe swelling. Sick in bed x 3 days with a fever of 101. She also had nausea.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fall, Head injury, Hypotension, Loss of consciousness
Clinical narrative: 5 minutes after vaccine pt. fainted, bumped head moderately on fridge, and had 3-4 second seizure called 911, within 10 min. they arrived. Pt regained conscious within 8-10 seconds after fall. Nausea/light headed, low BP for 1.5-2 hours. Walked away under own power after 2 hours with wife when she arrived. Injuries suffered were minimally bit tongue on tip. No head/neck/spine injuries-EMT cleared patient to leave on own terms.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Seizure, Syncope, Tongue biting
Clinical narrative: 5 minutes after vaccine pt. fainted, bumped head moderately on fridge, and had 3-4 second seizure called 911, within 10 min. they arrived. Pt regained conscious within 8-10 seconds after fall. Nausea/light headed, low BP for 1.5-2 hours. Walked away under own power after 2 hours with wife when she arrived. Injuries suffered were minimally bit tongue on tip. No head/neck/spine injuries-EMT cleared patient to leave on own terms.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT HAD RED, SWOLLEN ARM AND SITE OF INJECTION, PATIENT TOOK SOME BENADRYL AND APPLIED CORTISONE.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Pt developed a rash on the injection site and it spread down right side of arm and right leg and eventually to left lower leg.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Nausea, Paraesthesia
Clinical narrative: Patient C/O severe pain during administration with nausea and near syncope within minutes after the injection. Pt had complaint of pain ongoing after the injection with decreased ROM in right arm along with tingling sensation in fingers of right arm and continued nausea and mild headache for several days. Now, 7 days after vaccine administration, patient still C/O mild headache.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Presyncope
Clinical narrative: Patient C/O severe pain during administration with nausea and near syncope within minutes after the injection. Pt had complaint of pain ongoing after the injection with decreased ROM in right arm along with tingling sensation in fingers of right arm and continued nausea and mild headache for several days. Now, 7 days after vaccine administration, patient still C/O mild headache.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Answered a couple of questions incorrectly -received shingles shot from Pharmacy. Dr. is my interist not the doctor that administer the shot. Having pain in left arm where I received the shot. Nothing the first week but last two weeks it is getting worse. Throbbing mainly after use, like golf, tennis or working out at gym.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Crying, Mental disorder, Opisthotonus, Pain, Screaming
Clinical narrative: Psychological episode, non stop screaming and crying as if she was in severe pain, arching of body. Turning red and purple. Took her to the ER was giving 5ml ibuprofen 5ml acetaminophen.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Skin discolouration
Clinical narrative: Psychological episode, non stop screaming and crying as if she was in severe pain, arching of body. Turning red and purple. Took her to the ER was giving 5ml ibuprofen 5ml acetaminophen.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to 3 teenage patients 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 patients were vaccinated with RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, all patients had recent labs showing no antibodies. The outcome of the event was reported as not recovered. The relatedness between the event and RECOMBIVAX HB was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2017, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella zoster pneumonia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-NOV-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a hospital (did not specify whether admitted; therefore, considered Emergency Room visit until follow-up is received) for the onset of varicella pneumonia which is caused by the varicella zoster virus. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, varicella pneumonia was considered to be a medically significant event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-AUG-2017, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2017, the patient was treated at a hospital (not specified whether he was admitted; therefore, considered an Emergency Room visit until follow-up is received) for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at an urgent care for the onset of a vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On 16-JUL-2009 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a hospital. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On 22-APR-2016 the patient was treated by a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case was linked with 2018SA251660, 2018SA251703 and 2018SA251618 (Same reporter). This case involves a six-year-old patient (gender not reported) who received 0.5 ml of FLUZONE QUADRIVALENT batch number: UI997AA on 31-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is actual medication error case due to product storage error (received FLUZONE QUAD 0.5 mL and 0.25 mL syringes after the 48 hours shipping, MA said it was still cool). No other vaccine was given to patient. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case was linked with 2018SA251660, 2018SA251703 and 2018SA251366 (Same reporter). This case involves an eight years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT. The patients medical history and concomitant medications were not reported. On 31-Aug-2018, the patient received 0.5 ml dose of FLUZONE QUADRIVALENT (batch number UI997AA) (expiration date, route and site of administration was not reported). It was reported that, the product was shipped Tuesday and delivered after the 48 hours shipping. It was an actual medication error due to product storage error. It was reported that, the MA who administered these vaccines said they were still cool. No other vaccine was given to patient. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.