chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No adverse symptoms reported; inadvertently administered an expired dose of GARDASIL 9; GARDASIL 9 used in a 4 week old patient; This spontaneous report was received from a licensed practical nurse and refers to a 4 week old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 03-FEB-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, vaccination site and dose number were not reported), lot # N010497, expiration date 15-JAN-2020, for prophylaxis.
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea
Clinical narrative: diarrhea; Information has been received from the patient's mother via an employee referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.     On an unknown date in February 1988 (reported as 32 years ago), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status unknown, (subcutaneous; strength, frequency, lot number and expiration date unknown) for prophylaxis.   On unknown date in 1988 (reported as shortly afterwards, 32 years ago), the patient developed severe diarrhea. The patient was seen by an unknown physician who prescribed an unknown treatment. It was unknown if any lab diagnostics or studies were performed for the event. On an unknown date, the patient recovered from the event. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On 31-JAN-2014, the pt was inoculated with zoster vaccine live(ZOSTAVAX)(lot number, dosage, and route of administration not provided), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation,  pt was treated by a healthcare provider for shingles. As a direct and proximate result of  zoster vaccine live(ZOSTAVAX),  pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased 1isk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Irritable bowel syndrome
Clinical narrative: Irritable bowel syndrome with loose stools sometimes or watery stools at other times; Spontaneous report received on 13DEC2019.  A female consumer who is a physician reported that she had "irritable bowel syndrome (IBS) with loose stools sometimes or watery stools at other times" (PT: Irritable bowel syndrome), after administration of oral Vivotif for typhoid fever prophylaxis. On an unknown date in 2015, the consumer took the course of Vivotif. Then, after 2 weeks, she developed IBS. She had no abdominal pain but had different stool consistency, such as having loose stools sometimes or watery stools at other times. She stated that she usually pooped every day. She did not take any treatment for IBS. She was eating healthy. Action taken with Vivotif with respect to reported event was not applicable. After a few months, she was recovered from the event.  Consumer's medical history included inflammatory mass in colon so her descending colon was removed in 2011.  Reporter considered the event of "irritable bowel syndrome (IBS) with loose stools sometimes or watery stools at other times" related to Vivotif as she did not have a history of IBS.  Company Comment: A consumer completed Vivotif course, and after 2 weeks had irritable bowel syndrome with loose stools sometimes or watery stools at other times. The event resolved after a few months with out any treatment. Consumer had a history of descending colon removal for an inflammatory mass in colon a few years prior to taking Vivotif. Considering the potential of Vivotif to cause diarrhea, and the case information, the role of Vivotif cannot be ruled out, and the causality of the event is assessed as possible with Vivotif.; Sender's Comments: A consumer completed Vivotif course, and after 2 weeks had irritable bowel syndrome with loose stools sometimes or watery stools at other times. The event resolved after a few months with out any treatment. Consumer had a history of descending colon removal for an inflammatory mass in colon a few years prior to taking Vivotif. Considering the potential of Vivotif to cause diarrhea, and the case information, the role of Vivotif cannot be ruled out, and the causality of the event is assessed as possible with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Nausea
Clinical narrative: Nausea; Spontaneous report received on 13DEC2019.  A nurse reported that a female consumer had nausea (PT: Nausea), following immunization with Vivotif. On an unknown date about 2 years ago, the consumer took Vivotif but missed her last dose due to nausea. Action taken with Vivotif with respect to reported event was vaccine discontinued. At the time of report, the event had resolved.  Company Comment: A consumer who started taking Vivotif doses had nausea and did not take her last dose of Vivotif, and the event nausea resolved.The consumer was not certain if she had nausea prior to the start of Vivotif or not. Considering the potential of Vivotif to cause nausea, and the positive dechallenge, the causality of the event nausea is assessed as possible with Vivotif.; Sender's Comments: A consumer who started taking Vivotif doses had nausea and did not take her last dose of Vivotif, and the event nausea resolved.The consumer was not certain if she had nausea prior to the start of Vivotif or not. Considering the potential of Vivotif to cause nausea, and the positive dechallenge, the causality of the event nausea is assessed as possible with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; Spontaneous report received on 13DEC2019.  A pharmacist reported that a female consumer developed urinary tract infection (UTI) (PT: Urinary tract infection), following immunization with Vivotif. On an unknown date, the consumer started taking Vivotif. It was reported that she developed UTI while she was taking Vivotif. The consumer completed Vivotif four day before reporting and was prescribed with Macrobid (nitrofurantoin; 100 mg; 1 capsule twice daily for 5 days) for UTI which has not been started yet. Action taken with Vivotif with respect to reported event was dosage maintained. At the time of report, she was not recovered from the event.   Reporter considered the event urinary tract infection not related to Vivotif.  Company Comment: A consumer developed urinary tract infection while being on Vivotif. She was prescribed with nitrofurantoin for treating the event. A follow-up query was requested to know after how many days of completing Vivotif course she has started nitrofurantoin. The causality of the event is assessed as not related to Vivotif due to the infectious pathogenesis of the event, urinary tract infection.; Sender's Comments: A consumer developed urinary tract infection while being on Vivotif. She was prescribed with nitrofurantoin for treating the event. A follow-up query was requested to know after how many days of completing Vivotif course she has started nitrofurantoin. The causality of the event is assessed as not related to Vivotif due to the infectious pathogenesis of the event, urinary tract infection.
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Vomited the first dose of Vivotif; Spontaneous report received on 16DEC2019.  A nurse reported that a 16-year-old female consumer "vomited the first dose of Vivotif" (PT: Vomiting), following immunisation with Vivotif (lot number: 3003297). On 12DEC219, the consumer took first dose of Vivotif that had been thrown up. It was reported that the nurse had given another dose from a new pack of Vivotif so that she could complete four doses. She had not vomited again after the first dose. Action taken with Vivotif with respect to reported event was none. On 12DEC2019, the event was resolved.  Company Comment: A consumer vomited the first dose of Vivotif (Vomiting). In response to the event, the consumer took another dose from a new pack of Vivotif so that she could complete four doses. The consumer did not vomit after taking the dose from a new pack. The causality of the event is assessed as possible due to the potential of Vivotif to cause vomiting.; Sender's Comments: A consumer vomited the first dose of Vivotif (Vomiting). In response to the event, the consumer took another dose from a new pack of Vivotif so that she could complete four doses. The consumer did not vomit after taking the dose from a new pack. The causality of the event is assessed as possible due to the potential of Vivotif to cause vomiting.
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Rash
Clinical narrative: Small raised bumps on the stomach, shoulder, back and the forearm; Scratching the bumps; Spontaneous report received on 17DEC2019.  A nurse reported that a female consumer had small raised bumps on the stomach, shoulder, back and the forearm (PT: Skin reaction) and she was scratching the bumps (PT: Pruritus), while being on oral Vivotif for typhoid fever prophylaxis. On 01DEC2019, the consumer started Vivotif and a week after completing Vivotif course she developed small raised bumps on the stomach, shoulder, back and the forearm. She started scratching the bumps that made it worse. She did not have such experience in the past. On 16DEC2019, she took one dose of Benadryl (diphenhydramine) for treatment that helped with itching and subsided some bumps. She did not eat new foods and not use any new detergent. Action taken with Vivotif with respect to the reported events was not applicable. She was recovering from the reported events at the time of report.  Medical history included eczema on her hands.  Allergy included reactions to vaccines where the reactions "were not visible but she could feel it in her body".  Company Comment: A consumer completed Vivotif course and after a week had had small raised bumps on the stomach, shoulder, back and the forearm (generalized skin reaction) with itching. The events were resolving with Benadryl treatment. Considering the potential of Vivotif to cause pruritus and skin reactions, the causality of both the events is assessed as possible with Vivotif.; Sender's Comments: A consumer completed Vivotif course and after a week had had small raised bumps on the stomach, shoulder, back and the forearm (generalized skin reaction) with itching. The events were resolving with Benadryl treatment. Considering the potential of Vivotif to cause pruritus and skin reactions, the causality of both the events is assessed as possible with Vivotif.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Ill-defined disorder, Inappropriate schedule of product administration
Clinical narrative: I became Ill; All the minute clinics were out of the shot; This case was reported by a consumer via call center representative and described the occurrence of illness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 31st January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced illness and product supply issue. On an unknown date, the outcome of the illness and product supply issue were unknown.   It was unknown if the reporter considered the illness to be related to Shingrix.  Additional details were received as follows: The patient was a reporter. The age at vaccination was not reported. The patient got the shingles vaccination when it was only a 1 dose requirement. Then patient went for the first of the 2 shot vaccination at the end of July 2019. All the clinics were out of the shot but patient was fortunate enough to find a location that had it. They told patient they would call when it was time for the 2nd shot. The patient didn't hear from anyone and assumed they were still very low in stock. The patient managed to speak to the main number for clinic. He told me to call him the da, the patent was going to get the shot and he would be able to tell me where the patient could get one. The patient became Ill in December 2019 and the patient am just feeling better now. I would like to got that 2nd shot today. The patient was asking, if it still ok to get it a few days past the 6th month mark and how do know who had it.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Influenza like illness
Clinical narrative: She is past the 6 month window; experienced flu-like symptoms; made her very tired; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, tiredness and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms and tiredness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix experienced flu-like symptoms, mainly it made her very tired.   She was past the 6-month window and till the time of reporting, did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. She did not want to provide her MD contact information. This case is 1 of 2 cases reported by the same reporter.
Age: 22.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: upper arm injection site area was swollen; upper arm injection site area was dark red; upper arm injection site area was itchy; patient was under age 50; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 22-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's (Diagnosed with Crohns in 2018, about 1.5 to 2 years prior to date of reporting).   On 9th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th July 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and itchy upper limbs were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix at an age of 22 years, which led to inappropriate age at vaccine administration. The patient experienced his whole upper arm injection site area was dark red, swollen, and itchy for quite a few days then resolved. The patient was past the 6-month window and has not received the 2nd dose of the series at the time of reporting. The reporter did not want to provide her son's MD contact information.   This case is 1 of 2 cases reported by the same reporter.
Age: 22.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Pruritus
Clinical narrative: upper arm injection site area was swollen; upper arm injection site area was dark red; upper arm injection site area was itchy; patient was under age 50; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 22-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's (Diagnosed with Crohns in 2018, about 1.5 to 2 years prior to date of reporting).   On 9th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th July 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and itchy upper limbs were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix at an age of 22 years, which led to inappropriate age at vaccine administration. The patient experienced his whole upper arm injection site area was dark red, swollen, and itchy for quite a few days then resolved. The patient was past the 6-month window and has not received the 2nd dose of the series at the time of reporting. The reporter did not want to provide her son's MD contact information.   This case is 1 of 2 cases reported by the same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Mother refers she applied vicks to the injection site and pt started scratching the area. Next day the injection site became warm and slight edema.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Discomfort
Clinical narrative: Uncomfortable day after getting immunizations. No fever, redness or site soreness. Just seems uncomfortable.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Blood uric acid increased, Bursitis, Cellulitis, Injected limb mobility decreased, Injection site erythema
Clinical narrative: STANDARD TITLE: DISCHARGE SUMMARY                                   DICT DATE: JAN 17, 2020@11:55     ENTRY DATE: JAN 17, 2020@11:55:10        DICTATED BY:                 ATTENDING:                  PRINCIPAL DIAGNOSIS: (REQUIRED ITEM)  Right Upper extremity Cellulitis after  immunizations SECONDARY DIAGNOSIS:  Right olecranon bursitis due to cellulitis Hx of Gouty arthritis Hyperlipidemia Hypertension CKD Asthma OSA on CPAP PTSD ATTENDING: MD CHIEF COMPLAINT: Right arm pain, swelling with stiffness for past few days.  HISTORY OF PRESENT ILLNESS:   Pt is a 63 y/o male with pmhx OSA on CPAP, HTN, CKD stage 3, HLP, GERD and  Gout presents with right elbow pain and swelling. Patient received pneumonia  immunization on 1/7/20. Patient reports initially noted right elbow stiffness on  1/8/20. He then noted upper arm erythema and went to see his PCP on 1/9/20.  Symptoms were thought to be related to immunization reaction thus he was advised  to take Benadryl, NSAIDs and heat/cold. On the 11th, erythema progressed toward  elbow with associated inability to bend elbow and pain. He sought care at his  PCP office and was advised to come to the ED for further management.   In the ED, he was treated with colchicine, ketorolac and vancomycin. He is being  admitted for RUE cellulitis and right olecranon bursitis.  HOSPITAL COURSE:   Pt was admitted to 4M, vitals stable, he was afebrile. He was alert, oriented,  not toxic appearing. Physical exam significant for right arm swelling, pain and  redness extending to right elbow, some bogginess but no collection. He was  empirically started on IV vancomycin, pain control, prednisone and allopurinol  for elevated uric acid level and prior h/o gout. He continued to improve and ROM  improved. UA levels returned to normal. He improved and redness/swelling  improving. Vancomycin was changed to doxycycline. Pt was encouraged mobility, to  avoid stiffening. MRI was obtained revealed mild tendonosis, triceps tearing and  mild bursitis. OT was consulted to recommend exercises. He was stable for  discharge. If no improvement, consider referral to ortho. He was provided  topical diclofenac for pain.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site joint movement impairment, Injection site pain, Injection site reaction, Injection site swelling, Joint stiffness
Clinical narrative: STANDARD TITLE: DISCHARGE SUMMARY                                   DICT DATE: JAN 17, 2020@11:55     ENTRY DATE: JAN 17, 2020@11:55:10        DICTATED BY:                 ATTENDING:                  PRINCIPAL DIAGNOSIS: (REQUIRED ITEM)  Right Upper extremity Cellulitis after  immunizations SECONDARY DIAGNOSIS:  Right olecranon bursitis due to cellulitis Hx of Gouty arthritis Hyperlipidemia Hypertension CKD Asthma OSA on CPAP PTSD ATTENDING: MD CHIEF COMPLAINT: Right arm pain, swelling with stiffness for past few days.  HISTORY OF PRESENT ILLNESS:   Pt is a 63 y/o male with pmhx OSA on CPAP, HTN, CKD stage 3, HLP, GERD and  Gout presents with right elbow pain and swelling. Patient received pneumonia  immunization on 1/7/20. Patient reports initially noted right elbow stiffness on  1/8/20. He then noted upper arm erythema and went to see his PCP on 1/9/20.  Symptoms were thought to be related to immunization reaction thus he was advised  to take Benadryl, NSAIDs and heat/cold. On the 11th, erythema progressed toward  elbow with associated inability to bend elbow and pain. He sought care at his  PCP office and was advised to come to the ED for further management.   In the ED, he was treated with colchicine, ketorolac and vancomycin. He is being  admitted for RUE cellulitis and right olecranon bursitis.  HOSPITAL COURSE:   Pt was admitted to 4M, vitals stable, he was afebrile. He was alert, oriented,  not toxic appearing. Physical exam significant for right arm swelling, pain and  redness extending to right elbow, some bogginess but no collection. He was  empirically started on IV vancomycin, pain control, prednisone and allopurinol  for elevated uric acid level and prior h/o gout. He continued to improve and ROM  improved. UA levels returned to normal. He improved and redness/swelling  improving. Vancomycin was changed to doxycycline. Pt was encouraged mobility, to  avoid stiffening. MRI was obtained revealed mild tendonosis, triceps tearing and  mild bursitis. OT was consulted to recommend exercises. He was stable for  discharge. If no improvement, consider referral to ortho. He was provided  topical diclofenac for pain.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Magnetic resonance imaging abnormal, Muscle strain, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: STANDARD TITLE: DISCHARGE SUMMARY                                   DICT DATE: JAN 17, 2020@11:55     ENTRY DATE: JAN 17, 2020@11:55:10        DICTATED BY:                 ATTENDING:                  PRINCIPAL DIAGNOSIS: (REQUIRED ITEM)  Right Upper extremity Cellulitis after  immunizations SECONDARY DIAGNOSIS:  Right olecranon bursitis due to cellulitis Hx of Gouty arthritis Hyperlipidemia Hypertension CKD Asthma OSA on CPAP PTSD ATTENDING: MD CHIEF COMPLAINT: Right arm pain, swelling with stiffness for past few days.  HISTORY OF PRESENT ILLNESS:   Pt is a 63 y/o male with pmhx OSA on CPAP, HTN, CKD stage 3, HLP, GERD and  Gout presents with right elbow pain and swelling. Patient received pneumonia  immunization on 1/7/20. Patient reports initially noted right elbow stiffness on  1/8/20. He then noted upper arm erythema and went to see his PCP on 1/9/20.  Symptoms were thought to be related to immunization reaction thus he was advised  to take Benadryl, NSAIDs and heat/cold. On the 11th, erythema progressed toward  elbow with associated inability to bend elbow and pain. He sought care at his  PCP office and was advised to come to the ED for further management.   In the ED, he was treated with colchicine, ketorolac and vancomycin. He is being  admitted for RUE cellulitis and right olecranon bursitis.  HOSPITAL COURSE:   Pt was admitted to 4M, vitals stable, he was afebrile. He was alert, oriented,  not toxic appearing. Physical exam significant for right arm swelling, pain and  redness extending to right elbow, some bogginess but no collection. He was  empirically started on IV vancomycin, pain control, prednisone and allopurinol  for elevated uric acid level and prior h/o gout. He continued to improve and ROM  improved. UA levels returned to normal. He improved and redness/swelling  improving. Vancomycin was changed to doxycycline. Pt was encouraged mobility, to  avoid stiffening. MRI was obtained revealed mild tendonosis, triceps tearing and  mild bursitis. OT was consulted to recommend exercises. He was stable for  discharge. If no improvement, consider referral to ortho. He was provided  topical diclofenac for pain.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Tendon disorder, X-ray limb
Clinical narrative: STANDARD TITLE: DISCHARGE SUMMARY                                   DICT DATE: JAN 17, 2020@11:55     ENTRY DATE: JAN 17, 2020@11:55:10        DICTATED BY:                 ATTENDING:                  PRINCIPAL DIAGNOSIS: (REQUIRED ITEM)  Right Upper extremity Cellulitis after  immunizations SECONDARY DIAGNOSIS:  Right olecranon bursitis due to cellulitis Hx of Gouty arthritis Hyperlipidemia Hypertension CKD Asthma OSA on CPAP PTSD ATTENDING: MD CHIEF COMPLAINT: Right arm pain, swelling with stiffness for past few days.  HISTORY OF PRESENT ILLNESS:   Pt is a 63 y/o male with pmhx OSA on CPAP, HTN, CKD stage 3, HLP, GERD and  Gout presents with right elbow pain and swelling. Patient received pneumonia  immunization on 1/7/20. Patient reports initially noted right elbow stiffness on  1/8/20. He then noted upper arm erythema and went to see his PCP on 1/9/20.  Symptoms were thought to be related to immunization reaction thus he was advised  to take Benadryl, NSAIDs and heat/cold. On the 11th, erythema progressed toward  elbow with associated inability to bend elbow and pain. He sought care at his  PCP office and was advised to come to the ED for further management.   In the ED, he was treated with colchicine, ketorolac and vancomycin. He is being  admitted for RUE cellulitis and right olecranon bursitis.  HOSPITAL COURSE:   Pt was admitted to 4M, vitals stable, he was afebrile. He was alert, oriented,  not toxic appearing. Physical exam significant for right arm swelling, pain and  redness extending to right elbow, some bogginess but no collection. He was  empirically started on IV vancomycin, pain control, prednisone and allopurinol  for elevated uric acid level and prior h/o gout. He continued to improve and ROM  improved. UA levels returned to normal. He improved and redness/swelling  improving. Vancomycin was changed to doxycycline. Pt was encouraged mobility, to  avoid stiffening. MRI was obtained revealed mild tendonosis, triceps tearing and  mild bursitis. OT was consulted to recommend exercises. He was stable for  discharge. If no improvement, consider referral to ortho. He was provided  topical diclofenac for pain.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms being reported; patient inadverently received a dose of Pneumovax 23 on 13-JAN-2020 and also received a dose of PNEMOVAX 23 on 12-DEC-2019 at another pharmacy; This spontaneous report was received from a nurse and refers to a 66-year-old female patient. The patient's concurrent conditions included migraines. There was no information about the patient's allergies, drug reactions or medical history provided. Concomitant therapies included topiramate (TOPAMAX), atorvastatin calcium (LIPITOR), zolpidem tartrate (AMBIEN), sertraline hydrochloride (ZOLOFT), vitamins (unspecified), amoxicillin (AMOXICILLIN) and acetaminophen (+) aspirin (+) caffeine(EXCEDRIN). On 12-DEC-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (at Pharmacy) (dose, dose number, lot #, expiration date and route of administration were not reported) for prophylaxis, one month later, on 13-JAN-2020, the patient inadvertently received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (lot # S006777, expiration date: 28-NOV-2020) (dose, dose number were not reported) for pneumococcal prevention. No adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt sick for a 5-7 days after receiving each of the two injections; This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient felt sick for a 5 to 7 days after receiving injection. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020AMR019499.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: felt sick for a 5-7 days after receiving each of the two injections; This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (On an unknown date received 1st dose of vaccine, refer case US2020AMR019016).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient felt sick for a 5 to 7 days after receiving injection. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Malaise, Rash
Clinical narrative: shingles outbreak (rash); horribly sick; flu-like symptoms; Rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles, sickness, influenza-like symptoms and rash. On an unknown date, the outcome of the shingles, sickness, influenza-like symptoms and rash were unknown.   It was unknown if the reporter considered the shingles, sickness, influenza-like symptoms and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the same of vaccination, the patient was horribly sick with flu like symptoms. The patient also had shingles outbreak with rash. The reporter informed that as per all the information had been seen so far, it denies that this could happen.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash erythematous, Swelling
Clinical narrative: Red Bumps all over her cheeks.; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2020, the patient received the 1st dose of Shingrix. On 29th January 2020, 3 days after receiving Shingrix, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown.   It was unknown if the reporter considered the localized erythema and local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but may be 60 or 61 years. The patient received Shingrix vaccine on sunday and on wednesday woke up with red bumps all over her cheeks. No further details were provided. The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a flu shot about 10 years before the time of reporting (name of flu shot formulation unknown) and she experienced flu like symptoms for 2 days.   No further information was available. The reporter did not consent to follow-up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness; Tickling / Paraesthecia in the right arm and in the half part of face; This case was reported by a physician via call center representative and described the occurrence of paresthesia in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2020, the patient received Shingrix. On 31st January 2020, 1 days after receiving Shingrix, the patient experienced paresthesia. On an unknown date, the patient experienced numbness. On an unknown date, the outcome of the paresthesia and numbness were unknown.   It was unknown if the reporter considered the paresthesia and numbness to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced a tickling, numbness and paraesthecia in the right arm and in the half part of her face. Reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling
Clinical narrative: wrist pain; wrist swelling; This case was reported by a pharmacist via call center representative and described the occurrence of wrist pain in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number P9733, expiry date 12th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (on an unknown date the patient received 1st dose with no events.).   On 20th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd January 2020, 2 days after receiving Shingrix, the patient experienced wrist pain and swelling of wrists. On an unknown date, the outcome of the wrist pain and swelling of wrists were recovering/resolving.   It was unknown if the reporter considered the wrist pain and swelling of wrists to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left arm. The pain was alternate between left and right wrist. There were some improvement with events, at time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Needle issue
Clinical narrative: Needle leaked while patient was being administered Shingrix.; This case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix. On 24th January 2020, unknown after receiving Shingrix, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The needle leaked while patient was being administered Shingrix which led to accidental overdose and needle issue. Consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site vesicles
Clinical narrative: large red area at the injection site; small vesicles at the injection site; welt at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number JC453, expiry date 15th February 2022) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th January 2020, 3 days after receiving Shingrix, the patient experienced injection site wheal. On 31st January 2020, the patient experienced injection site erythema and injection site vesicles. On an unknown date, the outcome of the injection site wheal was recovered/resolved and the outcome of the injection site erythema and injection site vesicles were not recovered/not resolved.   It was unknown if the reporter considered the injection site wheal, injection site erythema and injection site vesicles to be related to Shingrix.   Additional details were reported as follows: The patient received a dose of Shingrix on the left arm. On Monday, the patient devloped a welt at the injection site. At the time of reporting, the patient came into the pharmacy and she had a large red area at the injection site and small vesicles at the injection site. The area containing the vesicles is approximately 2 inches in diameter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: experienced shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient experienced shingles. The reporter did not provide outcome or date of the adverse event The reporter requested information about the administration of the 2nd dose after the adverse event.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Sore in the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male 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 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Three months before the time of reporting, the patient received Shingrix and still experienced sore in the injection site. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: her leg was itching; a rash was developing on her knee; This case was reported by a nurse via call center representative and described the occurrence of itchy legs in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number T2CS3, expiry date 1st December 2021) for prophylaxis.   On 31st January 2020 11:00, the patient received the 1st dose of Shingrix. On 31st January 2020 15:00, 4 hrs after receiving Shingrix, the patient experienced itchy legs and rash. On an unknown date, the outcome of the itchy legs and rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy legs and rash to be related to Shingrix.  Additional details were provided as follows: The patient was having an adverse reaction after receiving the first dose of Shingrix. The patient experienced that her leg was itching, and a rash was developing on her knee. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell Palsy again after first dose of Shingrix, ended up in hospital; This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy (had history of bell's palsy).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced bell's palsy (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The batch number and expiry date of Shingrix was not provided. The patient developed Bell's palsy again after shingrix vaccination and ended up in hospital. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Fontanelle bulging, Pyrexia
Clinical narrative: Mother reported child presenting with a bulging fontanelle Saturday the 8th.  She stated it was the size of a goose egg with child presenting with fever of 100.1.  She telephoned the child's provider to discuss concerns.  Child still presenting with bulging fontanelle on Sunday with no fever at last report that day.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue
Clinical narrative: chills, elevated temperature (99.9 deg f), fatigue
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram abnormal, Lymph node pain, Lymph node rupture, Lymphadenopathy, Positron emission tomogram abnormal
Clinical narrative: Approximately 10 days after the vaccination. the lymph node in the armpit enlarged to size of an apple, but CT shows it as 1.9cm Nov 10 2019. Several days later, the water broke from that lymph node, it was leaking 2-3 days and later subdued in size and pain. Reduced to size 0.9 cm PET scan 12/26/2019.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Tenderness
Clinical narrative: Pt noticed development of about 4 splotches approx. a nickel size to 2 inches across in size. She first noticed them approximately 48 hours prior to vaccination. Pt says they're slightly tender but do not itch and are not warm to the touch.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site cellulitis, Injection site erythema, Injection site infection, Injection site pain, Injection site pruritus
Clinical narrative: Within 48-72 hours following vaccine receipt, patient noted swelling, redness, itching, warmth, and tenderness surrounding anthrax vaccination site.  She tried applying ice to the area to reduce pain and swelling, but felt it was not effective. The area affected went from her vaccination site to her elbow and was almost encircling her whole upper arm.  By 3 Sep, there was no significant improvement at her vaccination site, so she sought evaluation. Patient denied hives, fever, sore throat, cough, difficulty breathing, hoarseness, lump in throat, enlarged lymph nodes, headache, chest pain, abdominal pain, nausea, vomiting, diarrhea, difficulty with urination, and joint pain. On exam, the skin was described as: Warm and dry. Normal color. No rash. Normal turgor, small area of erythema with tenderness and warmth to right arm. No swelling or lymphangitis.  She was diagnosed with normal reaction to anthrax vaccine.  Acetaminophen or Motrin were recommended. On 5 Sep 2019, patient returned for medical evaluation after there was no significant improvement of her RUE. She reported redness, warmth, itching and tenderness affecting vaccination site on RUE. She denied fever, chills, headache, sore throat, skin rash, enlarged lymph nodes, abdominal pain, nausea, vomiting, and diarrhea. On exam, description of extremities noted:  Upper extremity signs of infection present (Right deltoid (faint erythema), No purulent drainage, serous drainage, lymphangitis, or fluctuance. No axillary adenopathy. Upper extremity capillary refill no prolonged.  She was diagnosed with right deltoid/bicep cellulitis, and was prescribed Keflex, Motrin and Benadryl.  Patient does not recall when RUE returned to normal, but it was by the end of the second week in Sep 2019. Patient denies significant restriction or limitations of ADLs and work-related duties due to vaccine reaction.