chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Myalgia, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: S/O Note Written @ 19 Mar 2018 1243 EDT Chief complaint: The Chief Complaint is: Hx AE after IIV. History of present illness. The Patient is a 54 year old male. The patient is a 54 yo male with a history of adverse effects after receipt of IIV characterized by fever, chills, malaise, arthralgias & myalgias of 5-7 duration. POC was to trial FLUCELVAX, which is a different manufacturing process and premedicating with ibuprofen 800 and continuing for 2-3 days to decrease immune response symptoms. He received vaccine on 27 FEB 2018, and writer telephoned him on 01 MAR, at which time he reported malaise, headache, nausea, and rhinorrhea and missed several days of work. Today I telephoned to review POC. He reports symptoms fully resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: Pt. was given PROQUAD SQ in the right arm and KINRIX and Hep A IM in the left arm on 4-16-17 pm. On 4-17-18 Pt. dad noticed swelling on the right arm about the size of a 50 cent piece. On 4-18-18 dad bought the pt in to be seen for a knot, warmth and redness at the injection site.and the pt. was seen by the provider DNP, CNM, FNP-C at Health Department. Employee prescribed the pt. Cetrizine HCL 5 ml daily and Prednisolone 10 ml daily and to come back on 4-20-18 to be rechecked by the nurse. Employee dx. the pt. with Adverse Effects of Other Viral Vaccines Initial Encounter.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Pronounced local reaction to injection site - swelling (5x 5 &1/2cm), redness, itching, pain beginning in pm of 4/17/18 with increasing sx on 4/18/18. Tx recommended: ice, ibuprofen, hydrocortisone cream, Benadryl. If increases in next 24, antibiotics would be recommended.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm (serious criteria disability) and mobility decreased (serious criteria disability). On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved. The reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. This was one of the 4 patients involving both male and female over the age of 65 years old. After receiving SHINGRIX vaccine, the patient experienced intense pain after the shot. The reporter stated that patient complained of whole arm pain with the shoulder and had decreased mobility of the arm. The reporter stated that after a couple of days the pain was better, but it was very intense for 24 hours and then it started to decline. The reporter reviewed her technique and stated that she was using a new 25g needle to give the injection after removing the needle that was used to puncture the vial stoppers. The reporter noted it was disabling to them because he/she was limited in mobility of that arm. The reporter didn't have specifics of the patient at the time of this report, but would be able to get that information.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm (serious criteria disability) and mobility decreased (serious criteria disability). On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved. The reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. This was one of the 4 patients involving both male and female over the age of 65 years old. After receiving SHINGRIX vaccine, the patient experienced intense pain after the shot. The reporter stated that patient complained of whole arm pain with the shoulder and had decreased mobility of the arm. The patient went to emergency room for the pain and received medication but were not admitted. The reporter stated that after a couple of days the pain was better, but it was very intense for 24 hours and then it started to decline. The reporter reviewed her technique and stated that she was using a new 25g needle to give the injection after removing the needle that was used to puncture the vial stoppers. The reporter noted it was disabling to them because he/she was limited in mobility of that arm. The reporter didn't have specifics of the patient at the time of this report, but would be able to get that information.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Alopecia, Asthenia, Back pain, Balance disorder, Blood test
Clinical narrative: Weakness in arms, legs, body, pain all over, headaches, severe back pain, no control of body at times, unable to walk at times, hair loss, blurry eyes, balance off.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Computerised tomogram, Dyskinesia, Gait inability, Headache, Laboratory test
Clinical narrative: Weakness in arms, legs, body, pain all over, headaches, severe back pain, no control of body at times, unable to walk at times, hair loss, blurry eyes, balance off.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Pain, Vision blurred
Clinical narrative: Weakness in arms, legs, body, pain all over, headaches, severe back pain, no control of body at times, unable to walk at times, hair loss, blurry eyes, balance off.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Fatigue, Full blood count normal, Immediate post-injection reaction
Clinical narrative: Patient had immediate swelling and redness on her arm. Patient also had fatigue, fever, chills, myalgia on 03/27/18. Patient experienced right axillary lymph node which was swollen, tender with palpation.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Metabolic function test normal, Myalgia, Peripheral swelling
Clinical narrative: Patient had immediate swelling and redness on her arm. Patient also had fatigue, fever, chills, myalgia on 03/27/18. Patient experienced right axillary lymph node which was swollen, tender with palpation.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Patient had immediate swelling and redness on her arm. Patient also had fatigue, fever, chills, myalgia on 03/27/18. Patient experienced right axillary lymph node which was swollen, tender with palpation.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: Patient had immediate swelling and redness on her arm. Patient also had fatigue, fever, chills, myalgia on 03/27/18. Patient experienced right axillary lymph node which was swollen, tender with palpation.
Age: 53.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Fatigue, Full blood count normal, Immediate post-injection reaction
Clinical narrative: Swollen Arm, Golf ball sized swelling under Arm (lymph node) Fever. Right Bicep swelling. (4/12/18) Per Doctor office.
Age: 53.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Metabolic function test normal, Myalgia, Peripheral swelling
Clinical narrative: Swollen Arm, Golf ball sized swelling under Arm (lymph node) Fever. Right Bicep swelling. (4/12/18) Per Doctor office.
Age: 53.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Swollen Arm, Golf ball sized swelling under Arm (lymph node) Fever. Right Bicep swelling. (4/12/18) Per Doctor office.
Age: 53.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: Swollen Arm, Golf ball sized swelling under Arm (lymph node) Fever. Right Bicep swelling. (4/12/18) Per Doctor office.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Patient reports that starting approximately 6 hours after her injection she experienced fever, chills, body aches that lasted through the night and a headache on the 2nd day. The fever was measured at 101 degrees fahrenheit. the fever/chills/body aches from the night were gone by the morning and the patient reported feeling better but had a headache.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Patient reported she got HPV-9 vaccine on 4/12/2018 Thursday, she had abd pain and vomited x 2 on 4/13/2018 Friday.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: I received the vaccine on 3/29/2018. Within 8 hours I had a headache, fever and chills that lasted for approximately 36 hours. The injection site was sore, but no redness or swelling. Approximately 72 hours (4/1/2018) after the vaccine I developed a maculopapular rash on the right buttock that was extremely pruritic; the blisters weeped for approximately one week. The rash continued to spread to my lower abdomen, hips, left left, the tops of both of my feet and both shoulders. The rash persists to this date (4/18/2018). I went to urgent care on 4/8/2018 because the rash continued to spread. I was given acycolvir 800 mg for 7 days (I completed the meds). I returned to my primary care on 4/11/2018 because the rash continued to spread. I continue to apply calamine and take claritin or benadryl.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: I received the vaccine on 3/29/2018. Within 8 hours I had a headache, fever and chills that lasted for approximately 36 hours. The injection site was sore, but no redness or swelling. Approximately 72 hours (4/1/2018) after the vaccine I developed a maculopapular rash on the right buttock that was extremely pruritic; the blisters weeped for approximately one week. The rash continued to spread to my lower abdomen, hips, left left, the tops of both of my feet and both shoulders. The rash persists to this date (4/18/2018). I went to urgent care on 4/8/2018 because the rash continued to spread. I was given acycolvir 800 mg for 7 days (I completed the meds). I returned to my primary care on 4/11/2018 because the rash continued to spread. I continue to apply calamine and take claritin or benadryl.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm (serious criteria disability) and mobility decreased (serious criteria disability). On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved. The reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. This was one of the 4 patients involving both male and female over the age of 65 years old. After receiving SHINGRIX vaccine, the patient experienced intense pain after the shot. The reporter stated that patient complained of whole arm pain with the shoulder and had decreased mobility of the arm. The patient went to emergency room for the pain and received medication but were not admitted. The reported stated that after a couple of days the pain was better, but it was very intense for 24 hours and then it started to decline. The reporter reviewed her technique and stated that she was using a new 25g needle to give the injection after removing the needle that was used to puncture the vial stoppers. The reporter noted it was disabling to them because he/she was limited in mobility of that arm. The reporter didn't have specifics of the patient at the time of this report, but would be able to get that information.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm (serious criteria disability) and mobility decreased (serious criteria disability). On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved. The reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. This was one of the 4 patients involving both male and female over the age of 65 years old. After receiving SHINGRIX vaccine, the patient experienced intense pain after the shot. The reporter stated that patient complained of whole arm pain with the shoulder and had decreased mobility of the arm. The reporter stated that after a couple of days the pain was better, but it was very intense for 24 hours and then it started to decline. The reporter reviewed her technique and stated that she was using a new 25g needle to give the injection after removing the needle that was used to puncture the vial stoppers. The reporter noted it was disabling to them because he/she was limited in mobility of that arm. The reporter didn't have specifics of the patient at the time of this report, but would be able to get that information.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a male patient of an unknown age referring to himself. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On an unknown date, the patient's physician recommended that he received a booster dose of RECOMBIVAX HB injection, for prophylaxis (exact dose, frequency, route of administration, lot# and expiration date were unknown).
Sex: U
Vaccine: HEPA
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 06-APR-2018, the patient was vaccinated with a dose of VAQTA injection (dose, route of administration, lot number and expiration date were not reported). The patient might have not gotten full dose of VAQTA because they moved. No adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 14-NOV-2017 the patient was vaccinated with first dose of GARDASIL 9 (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prophylaxis (also reported as treatment). On 06-APR-2018 the patient was vaccinated with second dose of GARDASIL 9 (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prophylaxis (inappropriate schedule of drug administration). No adverse effects were reported. There was no product quality compliant reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ (strength, dosing regimen and frequency unknown) (lot # N024294 expiry date: 26-FEB-2019) for prophylaxis (product storage error). The vaccine was stored at a temperature of 32 degrees Fahrenheit (F) up to 35 F (32.3 F) for 1 hour 45 minutes and 30.2 F for 37 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This case is linked to case number 1804USA005778 and 1804USA005184 via same reporter link.; Sender's Comments: US-009507513-1804USA005778: US-009507513-1804USA005184:
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster, Herpes zoster oticus, Pain, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2012, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster and complications involving facial nerve paralysis. During 2016, the patient was treated at a hospital for a severe vesicular rash accompanied and pain, which was diagnosed as herpes zoster, and the secondary complications of Ramsey Hunt Syndrome and Bell's Palsy involving the partial paralysis of facial muscles. As a direct and proximate result of the ZOSTAVAX, 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, pain and suffering and other damages. Upon internal review, Ramsey Hunt Syndrome and Bell's Palsy involving the partial paralysis of facial muscles were determined to be medically significant. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from an office manager refers to a 6 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date the patient was vaccinated with a dose of VAQTA 25/0.5 (units unspecified) (dosing regimen and frequency unknown) (lot number and expiry date unknown) intramuscularly instead of a dose of influenza virus vaccine (unspecified)(manufacturer unknown) (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prophylaxis (wrong drug administered). No adverse events were reported. There was no product quality compliant reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, body aches, stomach pain, nausea and vomiting. Started approximately 3.5 hours after receiving SHINGRIX. Pt took two 81 mg aspirin at onset of symptoms, then 2 more about 4.5 hours later. Returned to clinic about 20 hours later with continued symptoms. Prescribed Ondansetron for the nausea/vomiting and advised to take OTC ibuprofen for the fever and body aches.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 82-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 5th April 2018 15:00, the patient received SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site rash and erythematous rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site erythema, injection site rash and erythematous rash were recovering/resolving. The reporter considered the injection site erythema, injection site rash and erythematous rash to be possibly related to SHINGRIX. Additional information was received as follows: The patient received the vaccine in the left deltoid. The health care professional reported that the patient developed a red rash at the injection site, on the trunk and on the face after receiving SHINGRIX. The reporter did not know how long after the SHINGRIX, the reactions started. The patient took BENADRYL which seemed to help.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 55-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). On 23rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd March 2018, immediately after receiving SHINGRIX, the patient experienced injection site lump, injection site itching, injection site discoloration, injection site erythema and swelling. On an unknown date, the outcome of the injection site lump, injection site itching and swelling were recovered/resolved and the outcome of the injection site discoloration and injection site erythema were not recovered/not resolved. The reporter considered the injection site lump, injection site itching, injection site discoloration, injection site erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The reporter was the pharmacist who administered the product. The patient called to notify her that almost immediately after having been administered the vaccine, she had a red lump at the site of the injection which was raised about one half inch and was itching. It was described as a localized reaction on her right upper arm at the injection site which was a little smaller than the size of the palm of her hand. The itching and lump lasted about 10 to 12 days and had resolved at the time of reporting, but there was a discoloration in the area where the lump had been. Within a couple of days after receiving the SHINGRIX, the patient went to an urgent clinic care and was given BENADRYL and told that it would make the reaction resolve. The call was transferred to the GlaxoSmithKline regarding the reporters inquiry as to whether or not this patient should receive a 2nd future dose in the series. When asked twice what dose was administered of the SHINGRIX vaccine, she responded twice 50 mcg. The patient granted permission to be contacted with further related questions. The reporter was called back, and she clarified that the dose administered was 0.5 mL.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headache, fatigue.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Cerebral disorder, Electroencephalogram abnormal, Immediate post-injection reaction, Seizure
Clinical narrative: I am unsure which vaccines were given. Whatever is normal for her age at the time. The next day, it was noticed that patient was having a seizure in her sleep. This was witnessed for 25 minutes by the paramedics, despite the use of rectal VALIUM. Since then patient has continued to have more seizures.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Diarrhoea
Clinical narrative: Patient suffered severe diarrhea and blood sugar level 27 mg/dL. Patient required overnight hospitalizations.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Left Arm/Shoulder/Bicep/Tricep/Front and Rear Delt, Neck and Trap no mobility without severe pain. Went to Doctor 3/29/18 very concerned deep down in pain. Gave Steroids and MRI. Joint pain is very deep.
Age: 59.0
Sex: F
Vaccine: HEPA
Symptoms: Needle issue, Pain in extremity, X-ray normal
Clinical narrative: Patient complains of Left arm pain since the day she received the Hep A vaccine. She stated the nurse told her the needle broke in her arm and then repeated the test in the same location.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Borrelia test negative, Facial paralysis
Clinical narrative: Vaccines administered 4/4/18; Bell's Palsy of right side of face: symptoms started 4/6/18; seen in office 4/10/18, sent to ER; Lyme titers returned from 4/10: negative; 4/18/18 f/u in office: symptoms improving. if persistent facial weakness will send to neurology for f/u.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of injected limb mobility decreased in a 77-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st march 2020) and (batch number 5523C, expiry date 28th April 2020). On 10th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 10th April 2018, 3 hrs after receiving SHINGRIX, the patient experienced injected limb mobility decreased and injection site pain. On an unknown date, the outcome of the injected limb mobility decreased and injection site pain were not recovered/not resolved. The reporter considered the injected limb mobility decreased and injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient spoke to the pharmacist 3 hours after the vaccination to report the events. The patient experienced pain at the site of injection and difficulty in raising arm. The lot number from the box was not available but the lot number from the antigen was T5242 with expiration date of 31st March 2020 and the lot number of adjuvant was 5223C with expiration date of 28th April 2020. The caller was provided the phone number to medical information for additional assistance as the reporter was unable to transfer the call.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX. On 26th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain and injection site tingling. On an unknown date, the outcome of the injection site pain and injection site tingling were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site tingling to be related to SHINGRIX. Additional details were provided as follows: The reporter was the dispensing pharmacist. The patient was still complaining about the symptoms. The pharmacist did not have the lot number or further details available during the time of call. Due to time constraints, she declined to continue answering specific form questions and was contacted to the GlaxoSmithKline team to first discuss her inquiry of whether or not how long the symptoms were expected to last. The call was transferred to the GlaxoSmithKline team upon request. The reporter granted permission to be contacted; due to time constraints no other information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown. It was unknown if the reporter considered the erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient mentioned that she had the usual redness and swelling with the SHINGRIX however she was at work and could not take the time to provide additional information.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Pain, Pain in extremity
Clinical narrative: Headache for 2 to 3 days and extreme body aches for 2 days. Arm very sore for 4 days. Missed work.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RV1
Symptoms: Constipation, Crying, Diarrhoea, Hypersomnia, Laboratory test
Clinical narrative: By the evening that day, my son had a 3 hour screaming episode. Nothing would calm him and he nonstop screamed/cried. That night, he slept for about 15 hours straight. Then, in the months following developed chronic constipation and diarrhea. One week he would have constipation, the next he would have diarrhea. His diet was consistent and healthy. He continued to have screaming fits that were so abnormal for him. He also developed splenomegaly in the months following these vaccines and the ones given in May, July & August.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RV1
Symptoms: Screaming, Splenomegaly, Ultrasound scan
Clinical narrative: By the evening that day, my son had a 3 hour screaming episode. Nothing would calm him and he nonstop screamed/cried. That night, he slept for about 15 hours straight. Then, in the months following developed chronic constipation and diarrhea. One week he would have constipation, the next he would have diarrhea. His diet was consistent and healthy. He continued to have screaming fits that were so abnormal for him. He also developed splenomegaly in the months following these vaccines and the ones given in May, July & August.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Patient developed severe diarrhea. No time course provided.
Sex: U
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a patient who received FLUARIX TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to FLUARIX TETRA. Additional information was reported as follows: The age at vaccination was not reported. The reporter stated that the patient had a Guillain-Barre reaction to a flu shot. Flu shot was from unknown manufacturer.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, pain and swelling. On an unknown date, the outcome of the erythema, pain and swelling were unchanged. The reporter considered the erythema, pain and swelling to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced redness, swelling and pain after receiving SHINGRIX. The reporter called to find out appropriate treatment for this event(s). The patient has denied permission to contact their physician. The reporter was in hurry and provided limited information about this case.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site swelling, Injection site warmth, Nausea, Neck pain
Clinical narrative: Patient reported experiencing pain in left arm, swelling of entire left arm, pain radiating to neck beginning 2-3 hours after injection. Continued with swelling in the upper left arm, warmth to touch, numbness in tingling in the left arm, headache, and intermittent nausea at time of evaluation by Dr on 4/17/18
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Patient reported experiencing pain in left arm, swelling of entire left arm, pain radiating to neck beginning 2-3 hours after injection. Continued with swelling in the upper left arm, warmth to touch, numbness in tingling in the left arm, headache, and intermittent nausea at time of evaluation by Dr on 4/17/18
Sex: M
Vaccine: PPV
Symptoms: CD4 lymphocytes, Cellulitis, Systemic infection
Clinical narrative: This spontaneous report was received from a physician assistant concerning a 39 year old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. The patient's concomitant medications included an unspecified "antiretroviral". On 06-APR-2018, a HIV positive patient was vaccinated with a dose of PNEUMOVAX 23 lot # N029303 (expiry date: 21-APR-2019), subcutaneous in the left upper arm. "HIV positive patient" was also reported as a indication of the PNEUMOVAX 23. The physician assistant reported that on 07-APR-2018, the patient developed "a reaction" described as a "cellulitis infection that went systemic". On an unknown date in April 2018, CD4 lab test was performed. The patient's lab result on "above 1000 (units not provided)". In addition, the physician assistant reported that the patient sought medical attention in the physician's office on 09-APR-2018 and 12-APR-2018, in which the patient was prescribed and given KEFLEX and BACTRIM antibiotics as a treatment of the adverse event. At the time of the reporting, the patient's outcome was reported as not recovered. The reporter considered the adverse event as a significant disability or incapacity. Upon internal review, Cellulitis was considered to be an important medical event.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 27-OCT-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-JUN-2017, the patient was treated by a physician, for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 25-JUN-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center, for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. Later in 2016, the patient sought further treatment at a medical facility for ongoing and worsening symptoms of 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. 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. A female patient, age unspecified, was inoculated with ZOSTAVAX on 22-SEP-2011 at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain condition of herpes zoster also known as shingles. On or about 14-MAY-2016 the patient was treated at a medical center for a blistering vesicular outbreak which was then diagnosed as herpes zoster, 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: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX. In December 2017, the patient received the 1st dose of SHINGRIX. In December 2017, 1 day after receiving SHINGRIX, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were recovered/resolved. The reporter considered the fever and myalgia to be probably related to SHINGRIX. Additional information was reported as follows: This case was reported by the medical assistance for her hair dresser. The age at vaccination was not reported and it could be 59 or 60 years. The reporter believed that, the patient received SHINGRIX on an unknown day after she received SHINGRIX and the symptoms were lasted for 3 days due to which she was unable to go to work. Till the time of this reporting, the patient did not received her second dose. The reporter did not have any further patient or product details like initials, date of birth, lot and expiration.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site swelling
Clinical narrative: (L) arm swollen to injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash, Rash erythematous
Clinical narrative: Pt states received SHINGRIX at Pharmacy 3/30/18. Had 3 days of intense muscle pain at site and red rash on both hands. Initially thought to be a reaction to MOBIC. See by PCP and questions reaction to SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site paraesthesia
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 March 2018, the patient received SHINGRIX. In March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site tingling. On an unknown date, the outcome of the injection site pain and injection site tingling were recovering/resolving. The reporter considered the injection site pain and injection site tingling to be probably related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported, but the patient was over 60 years of age. The patient received SHINGRIX two weeks before the reporting date and had been experiencing injection site area pain and tingling since administration. The healthcare professional did not have full patient demographics or vaccine information at the time of the reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX. On 12th April 2018, the patient received the 1st dose of SHINGRIX. On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were unknown. The reporter considered the extensive swelling of vaccinated limb and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist was calling from a physician's office. One of their physicians saw a patient that just got her first SHINGRIX injection at the local pharmacy today. The patient experienced extensive swelling of vaccinated limb (a 4 inches by 5 inches swelling) at the injection site that is hot to the touch. The reporter did not know the details of the patient. She did not had the patient's information. The reporter said that it required a visit to the doctor but not hospitalization.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling at and around injection site, hardened area.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site erythema, Pain in extremity, Tenderness
Clinical narrative: Tender to the touch soreness in arm for two days red mark at site of injection. Acute stomach distress, headache.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Patient took acetominophen(tylenol) as she cannot take advil or motrin per md instructions.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient express no contraindications prior to receiving the vaccination. She had severe lightheaded effects from an unknown vaccination in the 1970s, but had been given blood tests, flu vaccinations, and other shots since then without any problem. Post vaccination, the patient reported a lightheaded/dizzy feeling and thought she may need to "lay down". I talked with her to make sure breathing, speech were still ok. The lady she was with and I helped her remain calm and awake so she did not fall out of the chair. Over the course of the next 20- 30 minutes, I stayed with the patient to make sure she did not faint. She requested some water and chocolate which did make her feel better. I took her blood pressure which was normal but below her normal numbers. She eventually felt better and I had my tech walk her outside just in case.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt has redness, swelling and tenderness to injection site. Pt went to ER the day after administration, dx with cellulitis, given ABX, seen here the following day (2 days later).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Abdominal pain, Aggression, Agitation, Antinuclear antibody negative, Arthralgia
Clinical narrative: 4/5/18- pt c/o headache, hip pain, knee pain, leg pain, abdominal pain, decreased appetite, lethargy. 4/6/18- Low grade fever (100.5), nausea and vomiting. Reported symptoms along regressive behavior and agitation continued through 4/10/18. Pt had 3 day course of orapred beginning on 4/11/18. Caregiver reported pt back to self by 4/11/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: C-reactive protein normal, Decreased appetite, Full blood count normal, Headache, Lethargy
Clinical narrative: 4/5/18- pt c/o headache, hip pain, knee pain, leg pain, abdominal pain, decreased appetite, lethargy. 4/6/18- Low grade fever (100.5), nausea and vomiting. Reported symptoms along regressive behavior and agitation continued through 4/10/18. Pt had 3 day course of orapred beginning on 4/11/18. Caregiver reported pt back to self by 4/11/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Metabolic function test normal, Nausea, Pain in extremity, Platelet count increased, Pyrexia
Clinical narrative: 4/5/18- pt c/o headache, hip pain, knee pain, leg pain, abdominal pain, decreased appetite, lethargy. 4/6/18- Low grade fever (100.5), nausea and vomiting. Reported symptoms along regressive behavior and agitation continued through 4/10/18. Pt had 3 day course of orapred beginning on 4/11/18. Caregiver reported pt back to self by 4/11/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: 4/5/18- pt c/o headache, hip pain, knee pain, leg pain, abdominal pain, decreased appetite, lethargy. 4/6/18- Low grade fever (100.5), nausea and vomiting. Reported symptoms along regressive behavior and agitation continued through 4/10/18. Pt had 3 day course of orapred beginning on 4/11/18. Caregiver reported pt back to self by 4/11/18.
Age: 16.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Administration site swelling, Administration site warmth, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Patient received MENVEO and IPOL on the left arm on April 16, 2018 at clinic. Patient requested both vaccines on same arm. Patient had received 3 prior doses of IPOL, but she had never received a dose of MENVEO. Patient reports some pain with injection but no other symptoms. On April 17, 2018, the patient showed a family member where she got her shots, and they noticed that the administration site was reddened and swollen and warm to the touch. She checked it through the evening, and it continued to stay that way. On April 18, 2018, a family member brought in the patient at 2:00 pm for a check. Upon assessment, the left upper arm is reddened and swollen.  There is a defined place on the upper arm that is almost round in shape. The patient also complains of being tired. The patient denies any other complaints. Advised the patient to treat with cool compresses at the site as needed. Advised the patient to use Benadryl, per package instructions, as needed for allergic reaction. Advised the patient's family member that if condition worsens or patient has any trouble breathing to take patient to PCP, Urgent Care or ER. Patient and family member voiced understanding and had no further questions.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received shot on thursday by the following Monday. On side of left bicep/tricep an area  had swelled and was red.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe Urticaria all over significant portions of patient's body. Severe itching associated with it.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Redness, swelling, fever up to 101, headache, fatigue, arm pain.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Redness, swelling, fever up to 101, headache, fatigue, arm pain.