chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: Felt awful; Inappropriate Schedule of Vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of feels awful in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 27J4P, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA) for prophylaxis.   On 2nd November 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix and AFLURIA at an unknown dose. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced feels awful and incomplete course of vaccination. On an unknown date, the outcome of the feels awful was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were received as follows: After 1st dose, the patient felt awful after receiving Shingrix and Afluria did not come back for second dose but now would like to receive their second dose. This led to incomplete course of vaccination. The patient received Shingrix in one arm and Afluria in the another. The reporter consented to follow up. No true expiration date available since system only puts in a year expiration date (system states 02NOV2019) as expiration. RPh couldn't further clarify "felt awful"
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: stinging @ L Deltoid injection site @ time of injection followed by soreness/aching in L deltoid region which has not resolved. Movement does not aggravate. no weakness, numbness or tingling. no radiation of pain. no better, no worse - no mass, redness or swelling. no shock type pain
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Headache, Injection site erythema, Injection site irritation
Clinical narrative: Initially,day 1:injection site irritation,then swelling and erythema, later that evening headache, nausea, neck and vertebra aching and fever (100.3). The arm remained painful, swollen and red for approx 5-7 days days. Day 2: Malaise, cont arm pain, low grade fever.  Day 3: head started itching, and with erthyema of  face with swelling of eye lids and lips, diarrhea.  About day 6: later I had a macular rash on hands, forearms, upper chest, and on the areas of both thighs and knees. Sand paper typer skin on cheeks. Face remained red, head itchy, and swollen eye lids and rash for 10-12 days. Treatment: Prednisone 40 mg daily x 5 days, zyrtec 10 mg bid, zantac 150 mg bid. started on 10/23/2019
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lip swelling, Malaise, Nausea, Neck pain
Clinical narrative: Initially,day 1:injection site irritation,then swelling and erythema, later that evening headache, nausea, neck and vertebra aching and fever (100.3). The arm remained painful, swollen and red for approx 5-7 days days. Day 2: Malaise, cont arm pain, low grade fever.  Day 3: head started itching, and with erthyema of  face with swelling of eye lids and lips, diarrhea.  About day 6: later I had a macular rash on hands, forearms, upper chest, and on the areas of both thighs and knees. Sand paper typer skin on cheeks. Face remained red, head itchy, and swollen eye lids and rash for 10-12 days. Treatment: Prednisone 40 mg daily x 5 days, zyrtec 10 mg bid, zantac 150 mg bid. started on 10/23/2019
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Rash macular
Clinical narrative: Initially,day 1:injection site irritation,then swelling and erythema, later that evening headache, nausea, neck and vertebra aching and fever (100.3). The arm remained painful, swollen and red for approx 5-7 days days. Day 2: Malaise, cont arm pain, low grade fever.  Day 3: head started itching, and with erthyema of  face with swelling of eye lids and lips, diarrhea.  About day 6: later I had a macular rash on hands, forearms, upper chest, and on the areas of both thighs and knees. Sand paper typer skin on cheeks. Face remained red, head itchy, and swollen eye lids and rash for 10-12 days. Treatment: Prednisone 40 mg daily x 5 days, zyrtec 10 mg bid, zantac 150 mg bid. started on 10/23/2019
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: Initially,day 1:injection site irritation,then swelling and erythema, later that evening headache, nausea, neck and vertebra aching and fever (100.3). The arm remained painful, swollen and red for approx 5-7 days days. Day 2: Malaise, cont arm pain, low grade fever.  Day 3: head started itching, and with erthyema of  face with swelling of eye lids and lips, diarrhea.  About day 6: later I had a macular rash on hands, forearms, upper chest, and on the areas of both thighs and knees. Sand paper typer skin on cheeks. Face remained red, head itchy, and swollen eye lids and rash for 10-12 days. Treatment: Prednisone 40 mg daily x 5 days, zyrtec 10 mg bid, zantac 150 mg bid. started on 10/23/2019
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Increased upper airway secretion, Nausea, Palpitations, Paraesthesia
Clinical narrative: Sudden congestion in throat, racing heart, nausea, feeling of something stuck in throat, floating feeling, mental fog, fingers tingling
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Sensation of foreign body
Clinical narrative: Sudden congestion in throat, racing heart, nausea, feeling of something stuck in throat, floating feeling, mental fog, fingers tingling
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Haematochezia
Clinical narrative: Hematochezia x1
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received flublok which wasn't intended for her age. It is FDA approved for 18 years and older.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Coccydynia, Pain in extremity, Pruritus, Rash
Clinical narrative: On Tuesday, October 1, 2019 at approximately 7:00p, I experienced  mild itching. The following morning, I noticed swelling in my face & hives on my arms, belly, back &  ankle area. Late afternoon, around 1:00p on Wednesday, October 2nd, the swelling went away without treatment. By 3:00p Wednesday, I started to feel excruciating lower back/tailbone pain. The rashes/hives was treated with Benadryl on Wednesday evening but was not resolved until Friday afternoon on October 14th. On Thursday, October 10,  I reported the incident to my employee health worker & was prescribed Naproxen for 5 days.  I took the Naproxen as prescribed & it did not help. As of today, I am still experiencing lower back/tailbone pain that radiates down both legs intermittently. I am being followed by an employee health physician.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Urticaria
Clinical narrative: On Tuesday, October 1, 2019 at approximately 7:00p, I experienced  mild itching. The following morning, I noticed swelling in my face & hives on my arms, belly, back &  ankle area. Late afternoon, around 1:00p on Wednesday, October 2nd, the swelling went away without treatment. By 3:00p Wednesday, I started to feel excruciating lower back/tailbone pain. The rashes/hives was treated with Benadryl on Wednesday evening but was not resolved until Friday afternoon on October 14th. On Thursday, October 10,  I reported the incident to my employee health worker & was prescribed Naproxen for 5 days.  I took the Naproxen as prescribed & it did not help. As of today, I am still experiencing lower back/tailbone pain that radiates down both legs intermittently. I am being followed by an employee health physician.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Headache, Lip swelling, Pruritus
Clinical narrative: Swollen lips, swelling L  eye, itchy all over, headache
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted a couple of minutes after receiving immunization, patient regained consciousness immediately, stayed for another 20 minutes under observation and was feeling fine after 10 minutes. No treatment was needed or given.
Age: 7.0
Sex: F
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Syncope
Clinical narrative: Patients mother returned to clinic the following week and stated that the child fainted 1 hour after they left clinic and was taken to the emergency room for evaluation.  The vaccines were administered at 11:43 AM.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Hot flush, Immediate post-injection reaction, Lip swelling
Clinical narrative: right after getting the injection I developed hives on arms, legs , back, neck, my tongue turned bright red and lips swelled. My throat was raw and very irritated also tight, extreme hot flashing felt like I was on fire. All of this occurred with in the first 5-15 minutes after the shot. The hives were immediate. I had taken 25 mg benadryl  1 hour before the shot because I always have a slight dizziness when I take the flu shot, but NEVER like this, I made sure the shot did not contain eggs because I have an intolerance to eggs.  After developing the hives and the other symptoms occurring especially tongue and mouth I took another 25 mg benedryl,. I reported to Occupational Health where I was monitored and needed more help, can't take pepcid (allergic), Dr. ordered a Jr. does of Epinephrine which with drinking a large amount of water my tongue started to reduce and become less red. I was released from the clinic and went home took another 25 gm benedryl and later that night before bed I took and additional 25mg benedryl was extremely itchy the entire afternoon and evening.  the next day about 28hr after the vaccination I had more itching and took benedryl. I have had headaches since the injection and hives at various times since the injeciton like today, Unsure of what has triggered them.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Throat irritation, Tongue erythema, Urticaria
Clinical narrative: right after getting the injection I developed hives on arms, legs , back, neck, my tongue turned bright red and lips swelled. My throat was raw and very irritated also tight, extreme hot flashing felt like I was on fire. All of this occurred with in the first 5-15 minutes after the shot. The hives were immediate. I had taken 25 mg benadryl  1 hour before the shot because I always have a slight dizziness when I take the flu shot, but NEVER like this, I made sure the shot did not contain eggs because I have an intolerance to eggs.  After developing the hives and the other symptoms occurring especially tongue and mouth I took another 25 mg benedryl,. I reported to Occupational Health where I was monitored and needed more help, can't take pepcid (allergic), Dr. ordered a Jr. does of Epinephrine which with drinking a large amount of water my tongue started to reduce and become less red. I was released from the clinic and went home took another 25 gm benedryl and later that night before bed I took and additional 25mg benedryl was extremely itchy the entire afternoon and evening.  the next day about 28hr after the vaccination I had more itching and took benedryl. I have had headaches since the injection and hives at various times since the injeciton like today, Unsure of what has triggered them.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Eye pain, Eye swelling, Herpes zoster, Hypoaesthesia
Clinical narrative: I am currently at home with a shingles flareup. I think this time it was early Horner's syndrome and possible early zoster (shingles) meningitis, but not sure about the Horner?s and headed to PCP in a few regarding the bodyaches and rash on chest...to determine if I need to go to hospital to be evaluated for early meningitis from recurrent zoster.  I went to eye doctor last Friday for acute onset, right-sided eyeball pain and swelling....on same side of my face from my last flareup. He started me on acyclovir and prednisone eye drops. Then. Got better for about a day or two. Now I have a painful shingles rash on my right chest, and I am achy all over and my left thigh and stomach are hurting like I got punched. If a rash appears there, I am going to hospital right away. Going to see PCP at 430. I got the shingrix vaccination due to recurrent shingles flareup prior to that. But they were mild and not so frequent. After both injections last year, for Shingrix, I was out of work sick with flu-like symptoms. Then earlier this year I was out of work for about 2 weeks due to flareup on my face that happened. I?ve had 3 minor flareups in a spot on the back of my leg that come and go. Now the problems I mentioned at the beginning of this paragraph are current as of today. I am on  800mg acyclovir which was restarted by my ophthalmologist for my right eye. I have completed the  prednisone drops. But face is still numb and right chest wall has small painful  rash.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Pain, Pain in extremity, Rash
Clinical narrative: I am currently at home with a shingles flareup. I think this time it was early Horner's syndrome and possible early zoster (shingles) meningitis, but not sure about the Horner?s and headed to PCP in a few regarding the bodyaches and rash on chest...to determine if I need to go to hospital to be evaluated for early meningitis from recurrent zoster.  I went to eye doctor last Friday for acute onset, right-sided eyeball pain and swelling....on same side of my face from my last flareup. He started me on acyclovir and prednisone eye drops. Then. Got better for about a day or two. Now I have a painful shingles rash on my right chest, and I am achy all over and my left thigh and stomach are hurting like I got punched. If a rash appears there, I am going to hospital right away. Going to see PCP at 430. I got the shingrix vaccination due to recurrent shingles flareup prior to that. But they were mild and not so frequent. After both injections last year, for Shingrix, I was out of work sick with flu-like symptoms. Then earlier this year I was out of work for about 2 weeks due to flareup on my face that happened. I?ve had 3 minor flareups in a spot on the back of my leg that come and go. Now the problems I mentioned at the beginning of this paragraph are current as of today. I am on  800mg acyclovir which was restarted by my ophthalmologist for my right eye. I have completed the  prednisone drops. But face is still numb and right chest wall has small painful  rash.
Age: 54.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: Patient claims that after the flu shot in his left arm he had sudden shooting  pain sensation down his arm starting almost immediately after his shot. Also has started a rash on his back only on the left side as well by where the arm is. Patient was instructed to go see primary care physician to determine the cause of the rash and the pain in the arm.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: mom came in for patient's next scheduled well visit, at 4 months on 10/14/19, and reported to the doctor that the patient was crying inconsolably after receiving her 2 month old vaccines on 8/15/19. mom never called the office to report the event as it was happening or shortly after.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called reporting that her arm is hurting her. She has to physically pick up her arm to reach things and it is just causing her pain.
Age: 55.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Erythema, Headache, Injection site erythema, Pyrexia
Clinical narrative: Injection via percutaenous at unknown location. Pt arrived to Immunizations clinic approx 9 days after vaccination with redness/swellin at vaccination site, redness radiating up left arm on to chest. Pt was referred to family health provider and treated for cellulitis. Pt stated 13 days after vaccination pt started having headaches and fevers and was seen at another hospital. Pt was admitted to the hospital for 24 hours. Pt states she had a rash on her back. I am unsure if she said it was before she was admitted or during. She states it might have been caused from medications given during hospital visit.
Age: 55.0
Sex: F
Vaccine: SMALL
Symptoms: Rash, Vaccination site swelling
Clinical narrative: Injection via percutaenous at unknown location. Pt arrived to Immunizations clinic approx 9 days after vaccination with redness/swellin at vaccination site, redness radiating up left arm on to chest. Pt was referred to family health provider and treated for cellulitis. Pt stated 13 days after vaccination pt started having headaches and fevers and was seen at another hospital. Pt was admitted to the hospital for 24 hours. Pt states she had a rash on her back. I am unsure if she said it was before she was admitted or during. She states it might have been caused from medications given during hospital visit.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Pain
Clinical narrative: PT REPORTED 3-3.5 HOURS OF SEVERE CHILLS TO THE POINT THAT SHE FELT SHE COULDN'T STOP TREMORING. TEMP OF 101.4 FOR 12 HOURS, SEVEVE HEADACHE BEHIND THE EYES. OVERALL BODY ACHES AND FATIGUE FOR MORE THAN 24 HOURS
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: PT REPORTED 3-3.5 HOURS OF SEVERE CHILLS TO THE POINT THAT SHE FELT SHE COULDN'T STOP TREMORING. TEMP OF 101.4 FOR 12 HOURS, SEVEVE HEADACHE BEHIND THE EYES. OVERALL BODY ACHES AND FATIGUE FOR MORE THAN 24 HOURS
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash
Clinical narrative: One day later employee broke out in a rash that spread throughout her whole body.  She stated that the rash caused extreme itching. She had to take Benadryl.  Employee will make an appointment to see her doctor. Do not know of the outcome as of now.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient felt light headed; sat on table and then passed out for approx. 30 seconds to one minute.  She was given ice packs to place on her neck and head. Also ammonia inhalant was used to help arouse patient. She gradually sat up and vital signs were checked. Vital signs were normal and patient was able to stand and rest until she had her friend pick her up. She was told if feeling light headed again to go to ED.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient given flu vaccine SQ instead of IM at the right triceps. She had erythema, tenderness, warmth, swelling at site of injection. She developed a cellulitis and was treated with Keflex and APAP for pain control. Cellulitis resolved.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Pain
Clinical narrative: Patient given flu vaccine SQ instead of IM at the right triceps. She had erythema, tenderness, warmth, swelling at site of injection. She developed a cellulitis and was treated with Keflex and APAP for pain control. Cellulitis resolved.
Age: 77.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Herpes zoster, Injection site pain, Insomnia, Pain
Clinical narrative: Recieved vaccines on Monday Oct. 7th  afternoon at the pharmacy. On Wednesday the 9th,developed a red painful rash on her right lower rib area . Presented to the clinic to see DR on Wednesday afternoon, suspecting shingles. DR started her on Valtrex regimen. Shingles continued to spread around her right side towards her back throughout the weekend. She was unable to sleep on Friday night and Saturday night due to the pain. She did sleep Sunday night due to taking Tylenol PM and an over the counter cream called Shingles cream.  The pain started radiating to her right shoulder and right hip to her ankle. She actually thought she may be developing shingles in her right ankle, as well, as it was that painful.  She came into see Dr today 10-15-19 and was started on gabapentin three times a day.
Age: 77.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Recieved vaccines on Monday Oct. 7th  afternoon at the pharmacy. On Wednesday the 9th,developed a red painful rash on her right lower rib area . Presented to the clinic to see DR on Wednesday afternoon, suspecting shingles. DR started her on Valtrex regimen. Shingles continued to spread around her right side towards her back throughout the weekend. She was unable to sleep on Friday night and Saturday night due to the pain. She did sleep Sunday night due to taking Tylenol PM and an over the counter cream called Shingles cream.  The pain started radiating to her right shoulder and right hip to her ankle. She actually thought she may be developing shingles in her right ankle, as well, as it was that painful.  She came into see Dr today 10-15-19 and was started on gabapentin three times a day.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Itching & rash (hives) began within the next 24 hours.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Large red welt on right arm not at injection site but close to it.  Was not there the night of the injection.  Was very visibly noticeable the next morning.  As of 10/15/19 it is still visible but fading
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: None, parent notified, no concerns
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Inappropriate schedule of product administration
Clinical narrative: the third dose of ROTATEQ was delayed due to the patient experiencing a fever with the administration of the second dose of ROTATEQ; patient is currently experiencing diarrhea; patient experiencing a fever with the administration of the second dose of ROTATEQ at 4 months of age; This spontaneous report was received from a nurse referring to a 4 month old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On approximately March 2019, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), for prophylaxis, along with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) and diphtheria toxoid, hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL). With this administration, the patient experienced fever. Then, on 19-SEP-2019 (conflicting information also reported as "09/19/219"), the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # and expiration date reported as S010564 on 17-JAN-2021, at 12 months of age. This third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was delayed due to the previous fever experienced.  Approximately in September 2019, also reported as "currently", the patient was experiencing diarrhea and was not recovered from it.  No treatment was given for the adverse experiences neither laboratory studies were performed and they called to the office for medical attention.   At the reporting time, the outcome of pyrexia was unknown. The causality assessment was not provided.
Age: 50.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported.; a 50 years old patien received a dose of GARDASIL 9 recently; This spontaneous report has been received from a pharmacist refers to a 50-year-old patient of unknown gender. The patient´s concurrent conditions, medical history and concomitant medications was not reported.   On an unspecified day in July 2019, the patient was recently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, dose, route of administration, anatomical location of vaccine were not reported) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored dose; This spontaneous report was received from nurse refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent. On 21-JUN-2019, the patient was vaccinated with an improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and frequency were not reported) (lot # S002874 and expiration date: 29-JAN-2021) for prophylaxis. It was reported that the sterile diluent used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. The temperature excursion was noted at 7.64 fahrenheit for 20 minutes. No previous temperature excursion was noted. This call was because of digital data logger. No adverse effects were reported. Product quality complaint was not involved.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: sore shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shoulder soreness. On an unknown date, the outcome of the shoulder soreness was recovered/resolved.   It was unknown if the reporter considered the shoulder soreness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's partner. The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient experienced sore shoulder after receiving Shingrix. The patient received 2nd dose and experienced same adverse event, refer case US2019AMR184142. Also, this case has been linked to US2019169168 and US2019AMR176794, reported by the same reporter.
Sex: U
Vaccine: UNK
Symptoms: Culture positive, Haemophilus infection, Haemophilus test positive, Viral infection
Clinical narrative: Haemophilus influenzae type b (HIB) infection; Virus infection; This case was reported in a literature article and described the occurrence of hemophilus influenza infection in a child patient who received Haemophilus influenzae type b vaccine for prophylaxis.  On an unknown date, the patient received the 1st dose of Haemophilus influenzae type b vaccine. On an unknown date, unknown after receiving Haemophilus influenzae type b vaccine, the patient experienced hemophilus influenza infection (serious criteria hospitalization and GSK medically significant) and viral infection. On an unknown date, the outcome of the hemophilus influenza infection and viral infection were unknown.   The reporter considered the hemophilus influenza infection to be related to Haemophilus influenzae type b vaccine. It was unknown if the reporter considered the viral infection to be related to Haemophilus influenzae type b vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of Haemophilus influenzae type B (HIB) infection in a child aged less than 5 years of unspecified gender, who was vaccinated with unspecified Haemophilus influenzae type b (HIB) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of retrospective study that aimed to describe the cases of all hospitalized patients with culture-proven invasive Haemophilus influenzae infections at Hospital, between 2009 and 2018. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received only 1 dose of unspecified Haemophilus influenzae type b (HIB) vaccine (administration route and site unspecified, batch number not provided). The age of vaccination was not provided. On an unspecified date between 2009 and 2018, an unknown period after the vaccination, the patient's blood culture or cerebrospinal fluid (CSF) culture or both blood and CSF culture showed Haemophilus influenzae type B (HIB). Subsequently, the patient was hospitalised and diagnosed with culture-proven invasive Haemophilus influenzae type B infection at Hospital. The patient had virus coinfection.  This case has been considered as serious due to hospitalization. Treatment was unknown. The outcome of the event was not reported. The author did not comment on the relationship between the event of Haemophilus influenzae type B (HIB) infection and unspecified Haemophilus influenzae type b (HIB) vaccine. The authors concluded, "Invasive H. influenzae infections were associated with substantial morbidity and a 2% case-fatality rate." This article corresponding to this case is not available for regulatory submission due to copyright restriction.      Lab Comments: On an unspecified date between 2009 and 2018, the patient's blood culture or cerebrospinal fluid (CSF) culture or both blood and CSF culture showed Haemophilus influenzae type B (HIB).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Musculoskeletal pain, Pain in extremity, Rash
Clinical narrative: arm pain; patches that looks like shingles; pain migrated across their back; shoulder pain; rash burning area; itching rash; burning at the site of the rash area; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number K9DX5, expiry date 8th August 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 92M54, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMOVAX) for prophylaxis.   On 15th April 2019, the patient received Boostrix (intramuscular). On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th April 2019, the patient received PNEUMOVAX. On an unknown date, less than a month after receiving Boostrix and Shingrix, the patient experienced pain in arm, vesicular rash, back pain, shoulder pain, burning sensation, itchy rash and rash. On an unknown date, the outcome of the pain in arm, vesicular rash, back pain, shoulder pain, burning sensation, itchy rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, vesicular rash, back pain, shoulder pain, burning sensation, itchy rash and rash to be related to Boostrix and Shingrix.  Additional details were provided as follows: The patient received Boostrix and Pneumovax spaced one inch apart in the right deltoid and the patient received Shingrix two days later in the same arm. The patient's pain began in their right arm, and it has since migrated across their back and to their left arm. Symptoms were still present at time of call. After transfer of call to second line agent, the reporting pharmacist also reported that the patient having patches that looks like shingles, burning at the site of the rash area, and was burning and itching. Did not consent to follow up. Postal follow up declined. Phone call would be okay. The number was provided by Governance, risk and compliance Quoted text from second line. The MI agent who reported new symptom to the patient after transfer. Repeat Shingrix in suspect vaccines was due to case not being able to upload to system if no GSK suspect was listed according to management. Only one dose of Shingrix was administered, and the reporter was not able to find Pneumovax in search for suspect vaccines.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: arm pain; patches that looks like shingles; pain migrated across their back; shoulder pain; rash burning area; itching rash; burning at the site of the rash area; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number K9DX5, expiry date 8th August 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 92M54, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMOVAX) for prophylaxis.   On 15th April 2019, the patient received Boostrix (intramuscular). On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th April 2019, the patient received PNEUMOVAX. On an unknown date, less than a month after receiving Boostrix and Shingrix, the patient experienced pain in arm, vesicular rash, back pain, shoulder pain, burning sensation, itchy rash and rash. On an unknown date, the outcome of the pain in arm, vesicular rash, back pain, shoulder pain, burning sensation, itchy rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, vesicular rash, back pain, shoulder pain, burning sensation, itchy rash and rash to be related to Boostrix and Shingrix.  Additional details were provided as follows: The patient received Boostrix and Pneumovax spaced one inch apart in the right deltoid and the patient received Shingrix two days later in the same arm. The patient's pain began in their right arm, and it has since migrated across their back and to their left arm. Symptoms were still present at time of call. After transfer of call to second line agent, the reporting pharmacist also reported that the patient having patches that looks like shingles, burning at the site of the rash area, and was burning and itching. Did not consent to follow up. Postal follow up declined. Phone call would be okay. The number was provided by Governance, risk and compliance Quoted text from second line. The MI agent who reported new symptom to the patient after transfer. Repeat Shingrix in suspect vaccines was due to case not being able to upload to system if no GSK suspect was listed according to management. Only one dose of Shingrix was administered, and the reporter was not able to find Pneumovax in search for suspect vaccines.
Sex: F
Vaccine: VARZOS
Symptoms: Bladder cancer
Clinical narrative: Bladder cancer; This case was reported by a pharmacist via call center representative and described the occurrence of bladder cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced bladder cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the bladder cancer was unknown.   It was unknown if the reporter considered the bladder cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient would be receiving chemotherapy for bladder cancer in November 2019. It was unclear whether the patient was diagnosed with bladder cancer before or after receiving the Shingrix. The pharmacist stated he was receiving the information second hand and limited details were available. The reporter did not consent for follow up.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: alot of swelling, pain, itching, a popeye arm.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage subcutaneous, Local reaction
Clinical narrative: Pt had localized reaction. Pt on blood thinner and developed a pocket of blood betweenskin and muscle layers. I asked staff and a nurse from the clinic next door for assistance. They applied gauze and pressure for about 5 minutes. They then wrapped it tightly and told pt to apply ice whe she returned home. Pt showed no other signs of distress or other symptoms. I helped pt to her vehicle, she walked out under her own power. I informed her husband what happened and what staff had said to do when she gets home.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Erythema, Hypersensitivity, Induration, Pyrexia
Clinical narrative: Patient walked into clinic complaining of: Redness in the left arm goes all the way under arm;  Redness on each side of the face;  Low grade temp since Saturday; and Swollen Arm, hard and hot to touch.   Physician directed RN to send patient to Urgent care where she was diagnosed with severe allergic reaction, treated with steroids and antibiotics and sent home with prescriptions for both.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient walked into clinic complaining of: Redness in the left arm goes all the way under arm;  Redness on each side of the face;  Low grade temp since Saturday; and Swollen Arm, hard and hot to touch.   Physician directed RN to send patient to Urgent care where she was diagnosed with severe allergic reaction, treated with steroids and antibiotics and sent home with prescriptions for both.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient returned to clinic 1 day after vaccine with redness and swelling a the sit eof injection measuring 4cmx4cm. Patient also reports tenderness.
Age: 50.0
Sex: M
Vaccine: TD
Symptoms: Electromyogram, Impaired work ability, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Severe pain for a few weeks as expected at injection location of my right arm at the top.  I didnt do any psychical activity due to the pain and the stitches in my left thumb. After pain subsided I had limited movement in the right shoulder and shoulder blade area the injection was administered. I have seen my physician who referred me to a neurologist who ordered an MRI and performed in office test. The neurologists suggests the vaccine attacked the healthy proteins in my shoulder nerve endings and I now need physical therapy. I have 50% use of my right arm when lifted straight out and half way up. Once at approximately 75% raised I have about 10% strength and am unable to perform the duties I need to on a regular basis and at work.
Age: 50.0
Sex: M
Vaccine: TD
Symptoms: Magnetic resonance imaging, Muscular weakness, Nerve conduction studies
Clinical narrative: Severe pain for a few weeks as expected at injection location of my right arm at the top.  I didnt do any psychical activity due to the pain and the stitches in my left thumb. After pain subsided I had limited movement in the right shoulder and shoulder blade area the injection was administered. I have seen my physician who referred me to a neurologist who ordered an MRI and performed in office test. The neurologists suggests the vaccine attacked the healthy proteins in my shoulder nerve endings and I now need physical therapy. I have 50% use of my right arm when lifted straight out and half way up. Once at approximately 75% raised I have about 10% strength and am unable to perform the duties I need to on a regular basis and at work.
Age: 0.33
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13, RV1
Symptoms: Constipation, Crying, Decreased appetite, Immediate post-injection reaction, Vomiting
Clinical narrative: The vaccine records we have did not specify the mfg or type just the name (DTap, Hib etc). So the company/type may not be correct.  When we brought patient in for her well visit we discussed with the doctor that patient was exclusively breastfed and had 3 bowel movements (or more) every day. We had not introduced her to solids. Immediately following the vaccines, patient's digestive tract stopped working correctly and she was unable to have a bowel movement. After days of not being able to go, the doctor recommended , prunes, water and white grape juice which did not help.   Patient started throwing up every time she nursed  and she lost her appetite.  She would cry in pain. After 6 days (18+ bowel movements missed) the doctor said we could give  her a suppository and were assured this would help her go within 1 hour.  It took 14 hours for the suppository to work. She was not able to have a bowel movement again after the suppository and we waited days  before having to administer another suppository. She was put on magnesium to help her go. This went on for months. She was still exclusively breastfed and nothing had changed except that she was not able to go to the bathroom on her own after receiving her vaccinations. She never went back to having 3 or more bowel movements a day. She began solids around 6 months.
Age: 1.5
Sex: M
Vaccine: UNK
Symptoms: Eyelid function disorder, Facial paralysis
Clinical narrative: Patient developed Bell's palsy 3-4 days after receiving the Hep A vaccination.  I do not know the name of the manufacturer or the details of the Hep A vaccination.  I do know it was his first dose of Hep A.  We were referred to a neurologist immediately when our pediatrician suspected patient has Bell's palsy.  We were seen later that day.  (I think it was July 2, 2018.)  The neurologist confirmed the pediatrician's diagnosis and prescribed steroids.  We were also required to put eye drops in patient's eye and have him wear an eye patch since he wasn't able to close his eye completely.  After about a week on medication, patient began to show signs of improvement.  We were told to follow up with our pediatrician which we did.  No further treatment was given since he was improving.  He appears to have made a complete recovery from Bell's palsy.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Pt was treated at County Health Department on 10-15-19 for contact to an STD. She was given Metronidazole (4 tablets) and Hepatitis A vaccine around 9:50am. Pt was released for checkout by RN at 10:00. At around 10:15, a nurse was paged to the front lobby where pt was found to be in distress. EMS was called by clerk. She was complaining of shortness of breath and heart racing. Pt was moved to a exam room and transferred to bed. 1st set of vitals (10:18) : BP-110/70; HR-94, SpO2-98%  RA; Resp: 22 bpm. EMS arrived at 10:20 and 2nd set of vitals: BP-103/57; HR-98; SpO2-95% RA; Resp: 22bpm. 3rd set of vitals taken at 10:34am: BP-98/60; HR-98; SpO2:97% RA; Resp:18 bpm. Pt was calming down, and breathing normal. Informed pt that it would be best if she would consider going to the ER for evaluation for her safety. After thinking about it, pt decided to go. Pt walked to stretcher and was transported by EMS EMTs out of clinic at 10:40am to  ER of patient's choice.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Cold sweat, Malaise
Clinical narrative: Patient received the Fluzone HD vaccination, however he had requested the shingles vaccination. He had already received the Flu Shot prior to the offsite clinic. Patient reported the following adverse reactions: chills, cold sweats and "not feeling well." These are normal adverse reactions from the flu vaccination.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Anaemia, Antinuclear antibody positive, Arthralgia, Bone pain, Computerised tomogram abnormal
Clinical narrative: Pain and golf ball sized knot immediately developed in arm which did not recede for 90+ days. Dizziness & flu like symptoms began within 48 hours. Was seen by civilian doctor on numerous visits due to flu like symptoms with negative tests between 2009 and 2019. Numbness and tingling in legs began in 2009. Chronic widespread pain began in 2013, joint pain level 5+ more than 50% of the time.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction, Influenza like illness, Intervertebral disc degeneration
Clinical narrative: Pain and golf ball sized knot immediately developed in arm which did not recede for 90+ days. Dizziness & flu like symptoms began within 48 hours. Was seen by civilian doctor on numerous visits due to flu like symptoms with negative tests between 2009 and 2019. Numbness and tingling in legs began in 2009. Chronic widespread pain began in 2013, joint pain level 5+ more than 50% of the time.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Magnetic resonance imaging abnormal, Nodule, Osteoarthritis, Pain in extremity, Paraesthesia
Clinical narrative: Pain and golf ball sized knot immediately developed in arm which did not recede for 90+ days. Dizziness & flu like symptoms began within 48 hours. Was seen by civilian doctor on numerous visits due to flu like symptoms with negative tests between 2009 and 2019. Numbness and tingling in legs began in 2009. Chronic widespread pain began in 2013, joint pain level 5+ more than 50% of the time.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Vitamin D deficiency, X-ray abnormal
Clinical narrative: Pain and golf ball sized knot immediately developed in arm which did not recede for 90+ days. Dizziness & flu like symptoms began within 48 hours. Was seen by civilian doctor on numerous visits due to flu like symptoms with negative tests between 2009 and 2019. Numbness and tingling in legs began in 2009. Chronic widespread pain began in 2013, joint pain level 5+ more than 50% of the time.
Age: 1.0
Sex: M
Vaccine: FLU4, HIBV, MMR, PNC13
Symptoms: Albumin globulin ratio normal, Blood alkaline phosphatase increased, Blood creatinine normal, Computerised tomogram head normal, Seizure
Clinical narrative: patient had possible seizure approx. 24 hrs post vaccine administration. Was evaluated at local ED and  no fever noted.
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Bilateral lower extremity edema and paresthesia in feet with pain when walking or standing. Pt advised to elevate legs, compression sleeve given for left extremity ( right leg/ankle had improved by time of visit). Pt advised to take Tylenol for pain, started on HCTZ 12.5mg  for edema.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Shortness of breath, chest pain, headache, severe body aches, dizziness, visual disturbance, weakness, fatigue. I have not sought treatment as I'm hoping that it will pass in another day or so.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Pain, Visual impairment
Clinical narrative: Shortness of breath, chest pain, headache, severe body aches, dizziness, visual disturbance, weakness, fatigue. I have not sought treatment as I'm hoping that it will pass in another day or so.
Age: 76.0
Sex: F
Vaccine: FLUR4
Symptoms: Culture negative, Rash
Clinical narrative: patient reported topical rash around her navel
Age: 63.0
Sex: F
Vaccine: UNK, UNK, VARZOS
Symptoms: Discomfort, Dizziness, Feeling hot, Loss of consciousness, Nausea
Clinical narrative: I got up to use the bathroom at around midnight and because very dizzy and faint. I was able to get back into bed without falling. At about 3:30, I awoke and was extremely hot and uncomfortable. Both arms were sore, the right one was very swollen. I got up to have a drink of water, felt dizzy and began to knee down on the floor. I awoke some time later, on the floor, feeling extremely dizzy, hot and nauseous. I vomited several times. I was unable to get up for quite a while but my husband brought me some ibuprofen and water and after a time, I felt well enough to get up and use the bathroom. After that, I was still dizzy, but made it back to bed. When I awoke around 9am, I felt better than I had the previous night and sat up in bed for several minutes but became dizzy and nauseous and lay down again. By noon, I was able to get up for the bathroom and felt lightheaded but not as much as before. I continue to feel lightheaded, slightly nauseous, and my right arm is still painful and swollen.