chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Blotch on Arm; Nose Rash/ Back Rash/ thigh rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th April 2019, 3 days after receiving Shingrix, the patient experienced rash. On 6th June 2019, the patient experienced blotchy rash. On 6th June 2019, the outcome of the blotchy rash was recovered/resolved. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash and blotchy rash to be related to Shingrix.  Additional details were provided as follows: The patient's husband called on her behalf to report the adverse events. Reporter stated that, approximately on 10th April 2019, they both received 1st dose of Shingrix vaccine and he was fine. However, approximately 3 days after vaccine, the patient broke out on her nose for about a month.  On 6th June 2019, at morning, the patient for the first time broke out with a large blotch on each arm. About 75 percent of her back was rashed out and she had a rash on her thighs.  The blotch and rashes resolved in approximately 1 hour. The reporter gave medical disclaimer and offered to contact health care professional and to the primary investigator (PI). Their 2nd dose of Shingrix was scheduled for 10th June 2019.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Gave it under the shoulder blade instead of the shoulder; Hurt when they gave her the injection/ still having a lot of pain; Couldn't raise her arm/ raise her arm a little; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration under the shoulder blade on 04Jun2019 at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was recommended by her doctor to get the pneumococcal 13-val conj vac (dipht crm197 protein) injection so she got it on 04Jun2019 and they gave it under the shoulder blade instead of the shoulder and it hurt when they gave her the injection. She couldn't raise her arm at all on 04Jun2019 and was still having a lot of pain and can only raise her arm a little. She was concerned about it because she didn't think it was given in the right spot. The outcome of the events was unknown.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: DNA antibody, Measles antibody, Morbillivirus test positive, Rash, Varicella virus test negative
Clinical narrative: Pt developed facial rash on 6/2/19.  Was seen in ER on 6/3/19 and diagnosed with questionable varicella.  On 6/6/19 she was seen in clinic and case was discussed with infectious disease and they suspected attenuate form of measles secondary to recent vaccination.  Varicella Igm, Measles Igm, and Rubeola Ab was drawn.  Measles and varicella were negative, but measles nasal swab was positive.  Pt currently has DNA typing pending.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient was seated for adverse reactions and stood up to get out of the immunization booth and passed out.  Patient landed on the booth wall as pharmacist and mother caught the patient.  He was laid out on the floor with feel elevated and was given water.  Stayed down for about 5 more minutes just to make sure and then was helped into the chair.  We made sure that he was alright and after another 5-10 minutes him and his mother agreed he was ok and the left to get lunch.  Patient was instructed to let us know if they have any other issues.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: injection site swelling which lasted almost a full day  then patient said that there was  tenderness around the injection site and it is very warm and red till this moment
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMRV
Symptoms: Dermatitis, Rash macular, Rash pruritic, Viral infection
Clinical narrative: On 6/12/19 pt developed itchy macular rash.  Seen at local ER and diagnosed with Acute viral syndrome and Dermatitis.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccine on 6/13/2019 but the vaccine expired in May 2019. No adverse reaction.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on chest and back arms legs and face.  flat, no allergic reaction otherwise,
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Day after injection noted pinkish/reddish area covering entire back from neck to waist, red splotches noted on chest and shoulders, itching on chest and shoulders. This lasted for 3 days. Used Benadryl tablets and cream.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Arthritis, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: Severe pain in hands, elbows, ankles,  ankles inflammations, muscles pain and stiffness on both sides. I was taken Ibuprofen and diclofenac  sodium.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Swelling and redness to the eye. over a period of 5 days.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram abnormal, Local reaction, Myocarditis, Nuclear magnetic resonance imaging, Pericarditis
Clinical narrative: Pericarditis; Myocarditis; Localized reaction at the site of administration; This spontaneous report was received on 03JUN2019 from a physician. A 24 years old male patient presented with a reaction from ACAM2000. He experienced myocarditis, pericarditis and localized reaction at the site of vaccination following the administration of ACAM2000 (smallpox vaccine).  Ten days ago on an unknown date (??-MAY-2019), the patient was administered ACAM2000 (lot, dose and route unknown) in the right arm.  The patient was transferred from an unknown emergency room to their emergency room for a higher level of care. The patient had a localized reaction at the site of administration, developed myocarditis and pericarditis. On 31MAY2019, an electrocardiogram(EKG) showed pericarditis and patient was hospitalized. MRI result was still pending. He was treated with colchicine and ibuprofen orally with events improving. The patient was still in hospital at the time of the report.  Medical history: None reported.  There was no known allergies.  The event was considered to be serious (life threatening, hospitalization).  Company Medical Assessment:  The Company considered that there was temporal relationship to ACAM2000 vaccination and because myocarditis and pericarditis are known complication phenomenon of ACAM2000. Because there is not enough information, the Company assessed these events as "suspected" or possible related. The vaccination reaction is considered "definitely" related as it is a common mild vaccination and local complication. The Company does not consider that the AEs were "Life threatened" as they do not meet the seriousness criterion of Life threatening.    It appears that this case is the same case as 19000138SP. The company is waiting for more information.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination site reaction
Clinical narrative: Pericarditis; Myocarditis; Localized reaction at the site of administration; This spontaneous report was received on 03JUN2019 from a physician. A 24 years old male patient presented with a reaction from ACAM2000. He experienced myocarditis, pericarditis and localized reaction at the site of vaccination following the administration of ACAM2000 (smallpox vaccine).  Ten days ago on an unknown date (??-MAY-2019), the patient was administered ACAM2000 (lot, dose and route unknown) in the right arm.  The patient was transferred from an unknown emergency room to their emergency room for a higher level of care. The patient had a localized reaction at the site of administration, developed myocarditis and pericarditis. On 31MAY2019, an electrocardiogram(EKG) showed pericarditis and patient was hospitalized. MRI result was still pending. He was treated with colchicine and ibuprofen orally with events improving. The patient was still in hospital at the time of the report.  Medical history: None reported.  There was no known allergies.  The event was considered to be serious (life threatening, hospitalization).  Company Medical Assessment:  The Company considered that there was temporal relationship to ACAM2000 vaccination and because myocarditis and pericarditis are known complication phenomenon of ACAM2000. Because there is not enough information, the Company assessed these events as "suspected" or possible related. The vaccination reaction is considered "definitely" related as it is a common mild vaccination and local complication. The Company does not consider that the AEs were "Life threatened" as they do not meet the seriousness criterion of Life threatening.    It appears that this case is the same case as 19000138SP. The company is waiting for more information.
Sex: U
Vaccine: MENB
Symptoms: Autoimmune disorder, Encephalitis, Seizure
Clinical narrative: Encephalitis; Seizure; Chronic autoimmune issues; This case was reported by a consumer via interactive digital media and described the occurrence of encephalitis in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced encephalitis (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant) and autoimmune disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis, seizure and autoimmune disorder were unknown.   It was unknown if the reporter considered the encephalitis, seizure and autoimmune disorder to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero in 2002. It was reported that this was one of the four vaccinations that the patient received for work in 2002 (it was not FDA approved until 2005, so patients were used as test subjects) and the patient experienced encephalitis and seizures. The patient also experienced chronic autoimmune issues. The patient visited the emergency room for the events. The patient had not experienced the events within 15minutes of receiving Bexsero, that the reporter could not record it as such and ended up in the data used for adverse reaction reports during the testing phase. This case has been linked with case US2019GSK107338 reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: redness; itching; fever; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old 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 a year after receiving Shingrix, the patient experienced injection site erythema, injection site itching, fever, shivering and headache. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown and the outcome of the fever, shivering and headache were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, fever, shivering and headache to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix two and half month ago from the time of report. The patient experienced fever, shivering and headache which lasted for 24 hours. The patient also experienced mild redness and itching at the injection site. This is one of 3 cases reported.
Sex: M
Vaccine: MENB
Symptoms: Autoimmune disorder, Encephalitis, Seizure
Clinical narrative: Encephalitis; Seizure; Chronic autoimmune issues; This case was reported by a consumer via interactive digital media and described the occurrence of encephalitis in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced encephalitis (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant) and autoimmune disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis, seizure and autoimmune disorder were unknown.   It was unknown if the reporter considered the encephalitis, seizure and autoimmune disorder to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero in 2002. It was reported that this was one of the four vaccinations that the patient received for work in 2002 (it was not FDA approved until 2005, so the patients were used as test subjects) and the patient experienced encephalitis and seizures. The patient also experienced chronic autoimmune issues. The patient visited the emergency room for the events. The patient had not experienced the events within 15 minutes of receiving Bexsero, that the reporter could not record it as such and ended up in the data used for adverse reaction reports during the testing phase.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Skin warm
Clinical narrative: injection site swelling; injection site redness; injection site heat/ heat to touch from shoulder to elbow; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number Z9E99, expiry date 2nd June 2021) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema and skin warm were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient continued to experience overall redness, swelling and heat to touch from shoulder to elbow after vaccination with Shingrix almost one month ago, from the date of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever; headache; body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, headache and general body pain. On an unknown date, the outcome of the fever, headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, headache and general body pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced adverse events for 24 hours included fever, headache and pain. The patient was unable to get off the couch for a day due to the adverse events. This is one of 3 cases reported.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Myalgia, Rash, Swelling
Clinical narrative: Muscle Pain; Swelling; Rash/spreading to arm; rash around injection site; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd June 2019, 5 hrs after receiving Shingrix, the patient experienced muscle pain, swelling, rash and injection site rash. On an unknown date, the outcome of the muscle pain, swelling, rash and injection site rash were unknown.   It was unknown if the reporter considered the muscle pain, swelling, rash and injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. About 5 to 6 hours post vaccination she experienced muscle pain, swelling, and a rash.  The rash started out as 2 inches all around the injection site, expanded to 4 to 5 inches and  spreading to the patient's arm. the patient had recovered from the swelling, and the muscle pain had dropped from 7 to 3 on a scale of 1 to 10. The patient had not went urgent care.  The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were unknown.   It was unknown if the reporter considered the nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix between 5 pm and 6 pm, and approximately 8 hours later around 2 am developed nausea and vomiting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphatic disorder, Pain
Clinical narrative: terrible pain; lymph system overwhelmed; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer.   On 2nd February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain and lymphatic disorder. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the lymphatic disorder was unknown.   It was unknown if the reporter considered the pain and lymphatic disorder to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient had lymph nodes removed when she had breast cancer. The patient had the 1st dose of Shingrix and her lymph system became overwhelmed. The patient had the shot in her good arm, the patient had terrible pain for several weeks. Patient would like information on whether or not to receive the 2nd dose of Shingrix. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Incorrect route of product administration
Clinical narrative: cellulitis; incorrect route of vaccine administration; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant) and intramuscular formulation administered by other route. On an unknown date, the outcome of the cellulitis was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The patient stated that she had a side effect of cellulitis. The patient did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Cellulitis; Vaccine Administered at Inappropriate Site; Wrong Route of Administration; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 2nd dose of Shingrix (subcutaneous) .5 ml. On 6th June 2019, less than a day after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), vaccine administered at inappropriate site and intramuscular formulation administered by other route. On an unknown date, the outcome of the cellulitis was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   The reporter considered the cellulitis to be related to Shingrix.  Additional details were provided as follows: The patient reported that her 2nd dose of Shingrix was administered subcutaneously in her fatty tissue, which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route.  The patient developed cellulitis and wanted to know if that dose was effective or if she would be needing an additional dose.  It was reported that efficacy of Shingrix was studied with deltoid muscle as the injection site.  Medical Advise disclaimer was given.  The reporter had consented to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bacterial test negative, Diarrhoea, Frequent bowel movements, Helicobacter test negative, Mucous stools
Clinical narrative: 6/6/19 2 month Well Child check with immunizations On Simethicone drops since 5/7 Approximately 6/8-9/19 Develops frequent small loose stools with subjective straining mucous Seen 6/11/19 good hydration & gaining weight, staring episodes stool bacterial DNA screen negative for shigella shiga toxin genes, campylobacter NDA, Salmonella DNA Seen 6/14/19 6 stools since MIV-Maintaining W+
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rectal tenesmus, Salmonella test negative, Staring
Clinical narrative: 6/6/19 2 month Well Child check with immunizations On Simethicone drops since 5/7 Approximately 6/8-9/19 Develops frequent small loose stools with subjective straining mucous Seen 6/11/19 good hydration & gaining weight, staring episodes stool bacterial DNA screen negative for shigella shiga toxin genes, campylobacter NDA, Salmonella DNA Seen 6/14/19 6 stools since MIV-Maintaining W+
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pyrexia
Clinical narrative: Fever and headache started the evening  that the vaccine was given. Fever got up to  102-103. Symptoms lasted about a week.  Seen in clinic 2 days after vaccine - had a  normal exam.
Age: 39.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Condition aggravated, Hepatitis
Clinical narrative: Pt was already Being treated for Hepatitis of unknown origin - AST & ALT were improving and down to AST-75, ALT 86. Vaccine given - then 11/12/2018 AST-1173, ALT-1334
Age: 39.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Autoimmune hepatitis
Clinical narrative: Pt was already Being treated for Hepatitis of unknown origin - AST & ALT were improving and down to AST-75, ALT 86. Vaccine given - then 11/12/2018 AST-1173, ALT-1334
Age: 44.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Condition aggravated, Hepatitis
Clinical narrative: AST - 170, ALT - 257 (Vaccine given prior to Lab Draw same Day) Vaccine 10:01 AM, LABS 10:27 AM -AST + ALT continue Elevated since then Patient now Diagnosed with Autoimmune Hepatitis.  Pt since Vaccine TDAP (8/13/18) has been Diagnosed with Autoimmune Hepatitis
Age: 44.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Autoimmune hepatitis
Clinical narrative: AST - 170, ALT - 257 (Vaccine given prior to Lab Draw same Day) Vaccine 10:01 AM, LABS 10:27 AM -AST + ALT continue Elevated since then Patient now Diagnosed with Autoimmune Hepatitis.  Pt since Vaccine TDAP (8/13/18) has been Diagnosed with Autoimmune Hepatitis
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: First time diagnosis of genital herpes.  Husband negative. Patient did not have any other sexual encounters.  Thought to be an activation of a dormant virus. Patient monogomous 30 years.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Abnormal dreams, Confusional state, Delirium, Headache
Clinical narrative: per patient notes- "Was in pain, delirious and confused.  Severe stomach,head ache, and body ache. Wild dreams."
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: per patient notes- "Was in pain, delirious and confused.  Severe stomach,head ache, and body ache. Wild dreams."
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: FOURTEEN DAYS AFTER RECEIVEING PROQUAD DEVELOPED FEVER UP TO 103.0 AND A BUMPY, BLISTERY RASH ON HIS FACE, CHEST, BACK AND ARMS.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Patient contracted shingles after one dose of varicella. She has never had chicken pox. Shingles was a result of her varicella vaccine. I am a healthcare provider (FNP) and her mother.  She still acts like her left thigh hurts where the shingles occurred.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: Full body hives a day after the 4th dose.  1st dose was taken 8/9/17 or 8/10/17 after getting the Yellow Fever Vaccine (injection).  I didn't have any reaction until after the 4th dose of the typhoid vaccine.  It started off with itching of my legs and head.  I took a Bendaryl that night and it helped, but the hives just moved to a different location.  I took another bendaryl the next morning and went to the doctors in the afternoon.  Hives were on my legs and stomach.   My doctor prescribed steroids and allergy medication to control it.  All of the hives went away slowly after 1.5 weeks.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Bursitis like pain left arm, hurts to move, redness, swelling, was feverish but that is  better.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt received her second doses of Pediatrix, Hib, and Prevnar 13 too early, but she did not have any adverse effects/symptoms. Pt received her second doses only 15 days after the first doses.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash generalised
Clinical narrative: Rash appeared on my neck, chin and face two days after the shot and began to increase and spread.  I went to the Dr on the third day of the rash and Predisone 10 MG and Valacyclovir HCL 1 Gram were prescribed. The rash lessened quickly and then started to decrease and disappear in a few days.  I have been taking the medication for 5 days and the rash is almost gone.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness up to left shoulder by evening on day vaccine was given.  Was warm to touch and painful. Applied ice, took oral Benadryl. Had decreased swelling and pain 24 hours after treating
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Slight swelling, warmth and redness in right thigh noticed evening of 6/13/19. Swelling continued to spread down to knee and Pt having trouble with ambulation. Seen 6/14/19 in Physician's office, exam is c/w local reaction to vaccine vs cellulitis. Suspect local reaction is more likely so will tx with ibuprofen and benadryl every 6 hrs as needed and monitor for improvement. If swelling/blotchy redness improves after ibuprofen/benadryl given in office, it is ok to continue ibuprofen and benadryl every 6 hrs as needed until reaction has resolved. If redness/swelling worsens, then go ahead and start antibiotic as directed for a possible cellulitis.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Patient called and reported hives on left arm and part of right arm about an hour after vaccination, reported no trouble breathing/other discomfort; I advised to keep an eye on spread of hives go to drif continues to sprae/cause further side effects, i.e/ trouble breathing and to take Benadryl and ibuprofen for a few doses till next day to help  hives to subside
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Has had shoulder pain and decreased range of motion since vaccine administered
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills, muscle aches, fever lasting 48 hours.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Muscular weakness, Peripheral swelling
Clinical narrative: patient expressed that her arm was swollen after administration of vaccine. and that her arm has been week since she got the prevnar shot.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Patient states she has a rash all over and is itchy. On exam there is no rash visible
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Dizziness, Dyskinesia, Fall, Feeling abnormal
Clinical narrative: At approximately 1600 on 6/14/19, nurse administered three vaccinations to patient: Menveo, Bexsero, and Gardasil-9. The last vaccine administered was Gardasil-9. Upon receiving the third vaccine (Gardasil-9), patient describes immediately becoming dizzy and then "blanking out." Her mom describes her then slumping forward while sitting, and continuing to fall forward off of the exam table. This was witnessed by patient's mother and nurse. She was partially caught during her fall, but her nose did hit the floor leading to a hematoma. Mom describes 2 or 3 upper body "jerks" immediately after falling. Within several seconds, patient regained consciousness and tried to stand up very quickly, at which time she hit her head on the exam table affixed to the wall. At this time, myself (patient's pediatrician), and other ancillary staff arrived in the room. Patient's SBP blood pressure was initially 70s. Upon examination, she had a regular heart rate in the 60s, She was conversing well, c/o mild dizziness, and had pallor and diaphoresis. She was given juice and upon feeling able, she was assisted back to the exam table and layed supine with legs elevated. Her blood pressure was cycled every several minutes and within 20-30 minutes of observation BP was back to baseline 119/80s. Patient describes a feeling of "feeling odd and dizzy" before losing consciousness. Upon coming to, she felt dizzy and had soreness of her nasal bridge. She was given 800mg of ibuprofen and an ice pack for a hematoma and swelling of her nasal bridge. She was observed closely for 1 hour after the adverse event, at which time patient denied headache, dizziness, lethargy, or fatigue. She continues to endorse nasal pain and swelling. Patient will be referred to ENT to evaluate her nasal trauma. I will be in contact with her mother over the next few days. She ambulated with her mom out of the office without incident. All questions were answered.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Haematoma, Head injury, Hyperhidrosis, Loss of consciousness, Nasal injury
Clinical narrative: At approximately 1600 on 6/14/19, nurse administered three vaccinations to patient: Menveo, Bexsero, and Gardasil-9. The last vaccine administered was Gardasil-9. Upon receiving the third vaccine (Gardasil-9), patient describes immediately becoming dizzy and then "blanking out." Her mom describes her then slumping forward while sitting, and continuing to fall forward off of the exam table. This was witnessed by patient's mother and nurse. She was partially caught during her fall, but her nose did hit the floor leading to a hematoma. Mom describes 2 or 3 upper body "jerks" immediately after falling. Within several seconds, patient regained consciousness and tried to stand up very quickly, at which time she hit her head on the exam table affixed to the wall. At this time, myself (patient's pediatrician), and other ancillary staff arrived in the room. Patient's SBP blood pressure was initially 70s. Upon examination, she had a regular heart rate in the 60s, She was conversing well, c/o mild dizziness, and had pallor and diaphoresis. She was given juice and upon feeling able, she was assisted back to the exam table and layed supine with legs elevated. Her blood pressure was cycled every several minutes and within 20-30 minutes of observation BP was back to baseline 119/80s. Patient describes a feeling of "feeling odd and dizzy" before losing consciousness. Upon coming to, she felt dizzy and had soreness of her nasal bridge. She was given 800mg of ibuprofen and an ice pack for a hematoma and swelling of her nasal bridge. She was observed closely for 1 hour after the adverse event, at which time patient denied headache, dizziness, lethargy, or fatigue. She continues to endorse nasal pain and swelling. Patient will be referred to ENT to evaluate her nasal trauma. I will be in contact with her mother over the next few days. She ambulated with her mom out of the office without incident. All questions were answered.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Nasal oedema, Pallor, Rhinalgia
Clinical narrative: At approximately 1600 on 6/14/19, nurse administered three vaccinations to patient: Menveo, Bexsero, and Gardasil-9. The last vaccine administered was Gardasil-9. Upon receiving the third vaccine (Gardasil-9), patient describes immediately becoming dizzy and then "blanking out." Her mom describes her then slumping forward while sitting, and continuing to fall forward off of the exam table. This was witnessed by patient's mother and nurse. She was partially caught during her fall, but her nose did hit the floor leading to a hematoma. Mom describes 2 or 3 upper body "jerks" immediately after falling. Within several seconds, patient regained consciousness and tried to stand up very quickly, at which time she hit her head on the exam table affixed to the wall. At this time, myself (patient's pediatrician), and other ancillary staff arrived in the room. Patient's SBP blood pressure was initially 70s. Upon examination, she had a regular heart rate in the 60s, She was conversing well, c/o mild dizziness, and had pallor and diaphoresis. She was given juice and upon feeling able, she was assisted back to the exam table and layed supine with legs elevated. Her blood pressure was cycled every several minutes and within 20-30 minutes of observation BP was back to baseline 119/80s. Patient describes a feeling of "feeling odd and dizzy" before losing consciousness. Upon coming to, she felt dizzy and had soreness of her nasal bridge. She was given 800mg of ibuprofen and an ice pack for a hematoma and swelling of her nasal bridge. She was observed closely for 1 hour after the adverse event, at which time patient denied headache, dizziness, lethargy, or fatigue. She continues to endorse nasal pain and swelling. Patient will be referred to ENT to evaluate her nasal trauma. I will be in contact with her mother over the next few days. She ambulated with her mom out of the office without incident. All questions were answered.
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine passed the minimum age. So immunization error.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: PAIN AND KNOT AT VACCINATION SITE BECOMING INCREASING INTENSITY  UP TO SHOULDER AND DOWN ARM. THIS PAIN IS INTERMITENT AND OCCURS WITHOUT WARNING MOSTLY DURING SLEEPING HOURS. IT IS AN INTENSE PAIN WHICH AWAKENS PATIENT FROM DEEP SLEEP ANDVCAN LAST SEVERAL HOURS. PATIENT STATES IT IS THE WORST PAIN HE HAS EVER HAS HAD AND  CONTINUES TO PRESENT DATE.  THIS WAS REPORTED TO NURSE WHO GAVE VACCINATION AND TO DR. SEVERAL TIMES FOLLOWING INJECTION  AND DR DID NOT THINK VACCINE WAS RESPONSIBLE UNTIL LAST REPORTED ON 4/29/2019 AT WHICH TIME HE CONCURRED WITH FILING THIS REPORT.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient stated she started to develop a rash around possibly 6-8-19 (unsure because she did not pay attention) but noticed more on 6-9-19 that there was a rash (unsure of size) and then notice on 6-10-19 that it was getting larger (about the size of a baseball) around the injection site.  The rash was not hot on 6-10-19 but said it was before then (unsure of when and time frame).  There was a little itching at first (again unsure of time frame) but there is no itching as of 6-10-19.  Tried calling pt on 6-11-19 to follow up but no answer.  Reached patient on 6-13-19 and she stated that she is all better and there is no redness.  Unclear as to when the redness had gone away.  Patient never had a fever, chills, or any other side effects.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Anaemia, Arthralgia, Blood thyroid stimulating hormone normal, Borrelia test negative, Feeling abnormal
Clinical narrative: Patient developed a rash on the legs and arms 24 hours after the second dose of the oral typhoid vaccine.  She took Benadryl which helped.  She then took the third dose and then developed generalized malaise, arthralgias (especially in the hands and knees) without joint effusion or redness, and myalgias.  After the third dose the vaccine was discontinued.  She felt poorly for 3 days and then symptoms began to improve.  She felt better by June 10.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Full blood count normal, Haemoglobin decreased, Malaise, Metabolic function test, Myalgia
Clinical narrative: Patient developed a rash on the legs and arms 24 hours after the second dose of the oral typhoid vaccine.  She took Benadryl which helped.  She then took the third dose and then developed generalized malaise, arthralgias (especially in the hands and knees) without joint effusion or redness, and myalgias.  After the third dose the vaccine was discontinued.  She felt poorly for 3 days and then symptoms began to improve.  She felt better by June 10.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Patient developed a rash on the legs and arms 24 hours after the second dose of the oral typhoid vaccine.  She took Benadryl which helped.  She then took the third dose and then developed generalized malaise, arthralgias (especially in the hands and knees) without joint effusion or redness, and myalgias.  After the third dose the vaccine was discontinued.  She felt poorly for 3 days and then symptoms began to improve.  She felt better by June 10.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: later that evening arm became tender and started to swell below injection site
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient given shingrix vaccination Tuesday around 11:30 am. He returned late Thursday night with slight redness/warm at injection site as well as red, circular rash down right arm from injection site to wrist. patient stated some off/on itching. Stated that around 1 am he experienced shivering/shaking and feeling cold but that it went away by Thursday night. I followed-up with Glaxo Smith Klien and the patient Friday morning.  Patient stated rash appears to have "almost went away now".  Patient primary care physician was unavailable to discuss/ inform of the side effects but will follow-up Monday.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Tremor
Clinical narrative: Patient given shingrix vaccination Tuesday around 11:30 am. He returned late Thursday night with slight redness/warm at injection site as well as red, circular rash down right arm from injection site to wrist. patient stated some off/on itching. Stated that around 1 am he experienced shivering/shaking and feeling cold but that it went away by Thursday night. I followed-up with Glaxo Smith Klien and the patient Friday morning.  Patient stated rash appears to have "almost went away now".  Patient primary care physician was unavailable to discuss/ inform of the side effects but will follow-up Monday.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Patient not secure for vaccine administration and moved during vaccination. Causing patient to only receive half of the vaccine dose
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose decreased, Blood pressure fluctuation, Fall, Oxygen saturation normal, Syncope
Clinical narrative: Patient got his vaccine and when he stood up and fell- had a syncopal episode, BP was 123/51 Sats:  were normal  100 % on RA.  Blood Sugar 69mg/dl . exam was normal, we had him lie down for about 35 mins and recheck he did well BP repeat 119/79- lying 112/74 standing, . Was sent home.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: One hour after the Shingrix injection I experienced a succession of triangular connected floaters which looked like wavy lines and briefly  affected my vision although I could still see and read print without difficulty.  Initially both eyes were affected and then gradually over several minutes the triangular floaters shifted to the right periphery of my vision and then faded and disappeared.   There was no pain with this occurrence and my vision returned to normal.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration and redness in area of injection (lateral aspect) of approximately 6X6 cm
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Disturbance in attention, Fatigue, Impaired driving ability, Malaise, Vision blurred
Clinical narrative: Patient received vaccine at 10:30 am and waited for approximately 15 minutes before leaving pharmacy.  He reports he felt well at this time.  At 2pm, he started to feel unwell and by 5pm, it "hit him hard."  He complains of fatigue, feeling unwell, unable to concentrate and blurred vision with a white haze around it.  It says he considered going to the emergency room but could not drive in his condition.  By noon the next day, he surprisingly felt better and returned to work.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Injection site discomfort, Musculoskeletal discomfort
Clinical narrative: Pain across lower back, not sore or painful to touch, not spine Woke up with the pain and it lased through out the day, sitting was more uncomfortable than standing Tender on right side of neck and at the injection sight
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Rash erythematous, Rash vesicular, Similar reaction on previous exposure to drug
Clinical narrative: When patient was in to receive her second dose of Shingrix vaccine, she noted that after the first dose, she experienced a leg rash on both legs similar to what shingles looks like. She still received the second dose and I asked her to let us know if she had the same reaction this time around, which she did. No severe pain or irritation noticed, just a rad patchy rash on both of her legs. It has since resolved.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Patient called the pharmacy at 7:00pm to inquire about the possible side effects of the Shingrix and Boostrix vaccines. She reported that since waking up that morning around 8:00am, she had extreme lethargy, a fever of 100.4 degrees Fahrenheit, moderate pain in arm where vaccines were administered, body aches and chills, headache, and a "tingly" sensation throughout her body. Patient stated that she felt "worn down" and compared it to a severe case of the Flu, Mono, or Strep Throat and had been home in bed all day.  Patient said she took "a few" Tylenol ER 650mg tablets to help with the fever. She said she was going to take Benadryl for the "tingly" sensation after she got off the phone but it is unknown whether patient took medication.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Lethargy, Pain, Paraesthesia, Pyrexia
Clinical narrative: Patient called the pharmacy at 7:00pm to inquire about the possible side effects of the Shingrix and Boostrix vaccines. She reported that since waking up that morning around 8:00am, she had extreme lethargy, a fever of 100.4 degrees Fahrenheit, moderate pain in arm where vaccines were administered, body aches and chills, headache, and a "tingly" sensation throughout her body. Patient stated that she felt "worn down" and compared it to a severe case of the Flu, Mono, or Strep Throat and had been home in bed all day.  Patient said she took "a few" Tylenol ER 650mg tablets to help with the fever. She said she was going to take Benadryl for the "tingly" sensation after she got off the phone but it is unknown whether patient took medication.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm was swollen, red and hot to touch. Pharmacist counselled patient to buy Over The Counter Ibuprofen 200mg and Take 1 tablet three times per day for three days and to apply cold ice packs on swollen arm as many times a day as possible and then let pharmacy know how it goes.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: The lot numbers are at PCP office Dr. Client came to the ER.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Balance disorder, Blood glucose normal, Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: Pt had Vaccines administered at 2:10 pm. At 2:30 pm pt. had labs drawn. As pt. was walking out of office at 2:35 pm pt. told nurse that he felt hot and sick. Nurse took pt. back to lab and had him sit w/ice pack on neck and sip water for 5 minutes. Pt still felt dizzy so nurse and mother walked pt to room to lay down. On the way to room, pt. got wobbly and passed out. Pt. was carried to room and immediately woke. Vitals and blood sugar were recorded. Pt monitored by physician for 15 mins. and released w/mother.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Malaise
Clinical narrative: Pt had Vaccines administered at 2:10 pm. At 2:30 pm pt. had labs drawn. As pt. was walking out of office at 2:35 pm pt. told nurse that he felt hot and sick. Nurse took pt. back to lab and had him sit w/ice pack on neck and sip water for 5 minutes. Pt still felt dizzy so nurse and mother walked pt to room to lay down. On the way to room, pt. got wobbly and passed out. Pt. was carried to room and immediately woke. Vitals and blood sugar were recorded. Pt monitored by physician for 15 mins. and released w/mother.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash erythematous, Rash morbilliform
Clinical narrative: Erythematous, Measle-Like Rash on face, Behind ears, and trunk, 101' Fever.