chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; patient received expired dose of PNEUMOVAX 23; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 23-APR-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) lot # N024717, expiration date: 06-APR-2019 (dose, frequency and route not provided)  for prophylaxis (expired product administered). No adverse effects reported.
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Vaccination failure
Clinical narrative: Initial vaccination failure in inflammatory bowel disease patients; 149 patients with inadequate baseline titers; Overall, 58.4% (n = 87/149) of patients received 1 or 2 sequential HBV revaccination doses within a 6- month time period, and 41.6% (n = 62/149) of patients received 3 sequential revaccination doses during a 12-month time period; Information was received from the authors in a published literature article titled as stated below. The aim of this article was to analyze the association between additional vaccination doses and HBsAb seroconversion in infIammatory bowel disease (IBD) patients. This case concerns 149 unspecified patients of unknown genders and age. This retrospective cohort study of patients seen in a large tertiary care facility from 2000-2014. Inclusion criteria: age >=18, diagnosis of Crohn's disease (CD) / ulcerative colitis (UC), prior vaccination history/presence of >= 1 +HBsAb level <10 IU/l, follow up HBsAb level after re vaccination. Patients were separated into study arms based on the number of additional vaccine doses received: 1 and 2 (within 6 months) or 3 (within 12months). Follow-up serum HBsAb, demographic info and IBD medications received in the 6 months prior to titer measurements were reported. Seroprotection was defined as HBsAb >= 10 IU/l.   On unknown dates, the patients were vaccinated with hepatitis b vaccine (manufacturer unknown), lot number, expiration date, dose and route were not reported, for prophylaxis. On unknown date, the patients showed inadequate baseline titers (vacination failure): 63 then received 1 dose, 25 received 2 doses, 61 received 3 doses. Following 1, 2 and 3 doses, average follow-up titers were 122.8, 55.1 and 263.8 IU/l, respectively. Following 1, 2 and 3 doses, 41.3, 40 and 62.3%, respectively, developed HBsAb 10 . Patients exposed to immunosuppressive therapy within 6 months of titer measurement were significantly less likely to seroconvert after any number of additional vaccinations.  Follow up information was received on 25-APR-2019 to this previously non-valid case, from the authors in a published literature article titled as stated below, regarding 68 male patients from 149 patients in study cohort.  It was also reported that unspecified number of male patients (of a total of 87 out of 149 patients, previously reported as 88) received 1 or 2 sequential HBV revaccination doses within a 6-month time period, and unspecified number of male patients (of a total of 62 out of 149 patients, previously reported as 61) received 3 sequential revaccination doses during a 12-month time period.    This is one of several reports received from the same reporter.  Sender's Comments:  US-009507513-1710USA010440:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced guillain barre syndrome after receiving flu vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blindness in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced blindness (serious criteria GSK medically significant). On an unknown date, the outcome of the blindness was unknown. It was unknown if the reporter considered the blindness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced blindness after receiving SHINGRIX vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hypotension, Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included shingles and cardiac syncope (narrow cardiogenic syncope). On 10th April 2019, the patient received the 1st dose of SHINGRIX. On 10th April 2019, 1 sec after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), injection site pain, pain in arm, nausea, chills, weakness, low blood pressure, feeling unwell and looked pale. On 11th April 2019, the patient experienced local swelling and enlargement of lymph nodes. On an unknown date, the outcome of the fainting, injection site pain, pain in arm, chills, weakness and low blood pressure were recovered/resolved and the outcome of the nausea and local swelling were not recovered/not resolved and the outcome of the enlargement of lymph nodes, feeling unwell and looked pale were unknown. It was unknown if the reporter considered the fainting, injection site pain, pain in arm, nausea, chills, weakness, low blood pressure, local swelling, enlargement of lymph nodes, feeling unwell and looked pale to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. It was reported that right away(1 second) after receiving SHINGRIX the patient fainted, experienced injection site pain and a few minutes after receiving SHINGRIX the patient felt sick and looked pale. The pharmacist monitored the patient for about 20 minutes after receiving SHINGRIX. The patient experienced nausea. The evening, 2 minutes after receiving SHINGRIX, the patient reported experienced chills, that lasted for 7 hours and 7 hours after receiving SHINGRIX the patient felt weak and experienced low blood pressure. One day after receiving SHINGRIX, the patient's armpit was also swollen. She suspected that she experienced swollen lymph nodes under her left arm, which was the side where she received SHINGRIX. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Malaise, Nausea, Pain in extremity, Pallor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included shingles and cardiac syncope (narrow cardiogenic syncope). On 10th April 2019, the patient received the 1st dose of SHINGRIX. On 10th April 2019, 1 sec after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), injection site pain, pain in arm, nausea, chills, weakness, low blood pressure, feeling unwell and looked pale. On 11th April 2019, the patient experienced local swelling and enlargement of lymph nodes. On an unknown date, the outcome of the fainting, injection site pain, pain in arm, chills, weakness and low blood pressure were recovered/resolved and the outcome of the nausea and local swelling were not recovered/not resolved and the outcome of the enlargement of lymph nodes, feeling unwell and looked pale were unknown. It was unknown if the reporter considered the fainting, injection site pain, pain in arm, nausea, chills, weakness, low blood pressure, local swelling, enlargement of lymph nodes, feeling unwell and looked pale to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. It was reported that right away(1 second) after receiving SHINGRIX the patient fainted, experienced injection site pain and a few minutes after receiving SHINGRIX the patient felt sick and looked pale. The pharmacist monitored the patient for about 20 minutes after receiving SHINGRIX. The patient experienced nausea. The evening, 2 minutes after receiving SHINGRIX, the patient reported experienced chills, that lasted for 7 hours and 7 hours after receiving SHINGRIX the patient felt weak and experienced low blood pressure. One day after receiving SHINGRIX, the patient's armpit was also swollen. She suspected that she experienced swollen lymph nodes under her left arm, which was the side where she received SHINGRIX. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included shingles and cardiac syncope (narrow cardiogenic syncope). On 10th April 2019, the patient received the 1st dose of SHINGRIX. On 10th April 2019, 1 sec after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), injection site pain, pain in arm, nausea, chills, weakness, low blood pressure, feeling unwell and looked pale. On 11th April 2019, the patient experienced local swelling and enlargement of lymph nodes. On an unknown date, the outcome of the fainting, injection site pain, pain in arm, chills, weakness and low blood pressure were recovered/resolved and the outcome of the nausea and local swelling were not recovered/not resolved and the outcome of the enlargement of lymph nodes, feeling unwell and looked pale were unknown. It was unknown if the reporter considered the fainting, injection site pain, pain in arm, nausea, chills, weakness, low blood pressure, local swelling, enlargement of lymph nodes, feeling unwell and looked pale to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. It was reported that right away(1 second) after receiving SHINGRIX the patient fainted, experienced injection site pain and a few minutes after receiving SHINGRIX the patient felt sick and looked pale. The pharmacist monitored the patient for about 20 minutes after receiving SHINGRIX. The patient experienced nausea. The evening, 2 minutes after receiving SHINGRIX, the patient reported experienced chills, that lasted for 7 hours and 7 hours after receiving SHINGRIX the patient felt weak and experienced low blood pressure. One day after receiving SHINGRIX, the patient's armpit was also swollen. She suspected that she experienced swollen lymph nodes under her left arm, which was the side where she received SHINGRIX. The reporter did not consent to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Caesarean section, Foetal exposure during pregnancy, Foetal growth restriction, Intensive care, Premature baby
Clinical narrative: This is a serious spontaneous case reporter by other health professional and initially received on 18-Apr-2019, concerning a neonate patient of an unspecified gender. This was the patient's mother's first pregnancy. The father did not receive any medications prior to conception. There was no paternal or maternal history with major congenital malformation. The patient's mother didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The patient's mother did not use any other concomitant medications. The patient's mother's last menstrual period date was 07-Mar-2018. The type of pregnancy was singleton. On 20-Jun-2018, the patient's mother underwent nuchal translucency and no major congenital malformation was noted. On the same day, the patient's mother underwent first trimester screening and no major congenital malformation was noted. On 04-Sep-2018, the patient's mother underwent targeted ultrasound and no major congenital malformation was noted. On 05-Oct-2018, the patient's mother's underwent growth ultrasound, and intrauterine Growth restriction (IUGR) of the foetus was noted. On 10-Oct-2018, approximately 28 weeks gestational age, the mother received AFLURIA QUADRIVALENT (batch number: YF40208, route of administration, dose, anatomical location and expiry date: not reported) for an unknown indication. Days after vaccination, the mother delivered the infant at 30 weeks of gestation via emergency caesarean section due to IUGR and 2/8 BPP (as reported). The patient was admitted in neonatal intensive-care unit (NICU) and was doing well after stay in NICU. The patient's mother's estimated date of delivery was reported as 29-Dec-2018. This case was linked to 201805226, the corresponding maternal pregnancy report. Reporter's Comments: A neonate of unknown gender and underlying intrauterine Growth restriction (IUGR) was considered as premature baby, days after administration of AFLURIA QUADRIVALENT vaccine given at 28 weeks of gestation age. Despite the plausible temporal relationship between vaccination and reported event, there is no evidence for a biological mechanism that could cause the event and reported intrauterine Growth restriction (IUGR) of the foetus on ultrasound 5 days prior to vaccination appears to be more likely cause and therefore the event was assessed as not related to the vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 77.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Peripheral swelling, Rash
Clinical narrative: 10/12/18 when contacted because patient had not gotten second dose, caregiver reported arm was swollen and was not going to get another dose. No time course details were reported.  4/29/19 caregiver declined second dose during exam; reported rash after getting first dose. No time course details were reported. No evidence of any care for this response. No reports of symptom to clinic until several months later.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, chills, muscle aches and fever for about 28 hours. Highest fever recorded was 101.5 F
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Rash macular, Screaming
Clinical narrative: Around 12pm, we get home and, after a bath, I put her clothes back on and she starts screaming. I take her clothes off and her left leg is beet red, somewhat swollen and her torso and right leg are blotchy. She screamed for about thirty minutes and I gave her Motrin and 1/2 tsp Benedryl
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: She stated that she went to the Emergency room on friday 4/19/19 because she received the Pneumococcal 23 at our clinic and then a few hours later her arm was swollen around injection site and tender to touch. Patient stated that she also got a fever. Patient stated she was home all weekend not feeling well and wanted her provider to know. Patientalso stated that she is very susceptible to having reactions to things.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Glossodynia, Injection site pain, Myalgia, Night sweats
Clinical narrative: 6 PM, shooting pain (sting) under tongue, lasted thru night 7 PM, lower back pain, diruppted sleep, took ibuprophen next morning, got better almost immediately night sweats, that night Swollen left tonsil, lasted week General myalgia, lasted 2 days sore injection site, lasted 7 days
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Sleep disorder, Tonsillar hypertrophy
Clinical narrative: 6 PM, shooting pain (sting) under tongue, lasted thru night 7 PM, lower back pain, diruppted sleep, took ibuprophen next morning, got better almost immediately night sweats, that night Swollen left tonsil, lasted week General myalgia, lasted 2 days sore injection site, lasted 7 days
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: Received shot in late afternoon, and before bedtime began feeling sick.  Symptoms overnight progressed to chills, fever, bad headache, sore left arm, muscle aches like the flu, very achy and tired, felt so bad not able to sleep.   Symptoms lasted about 24 hours, but took about 2 days to finally feel back to normal.    The first dose of vaccine made me feel achy from first evening for 24 hours like coming down with flu but not severe as second dose.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Malaise, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Received shot in late afternoon, and before bedtime began feeling sick.  Symptoms overnight progressed to chills, fever, bad headache, sore left arm, muscle aches like the flu, very achy and tired, felt so bad not able to sleep.   Symptoms lasted about 24 hours, but took about 2 days to finally feel back to normal.    The first dose of vaccine made me feel achy from first evening for 24 hours like coming down with flu but not severe as second dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm red and slightly swollen about 1/2 dollar coin size.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache
Clinical narrative: Headache, dizzy, lightheaded for over 60 minutes
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Papule
Clinical narrative: Erythematous papules
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Papule
Clinical narrative: erythematous papules
Age: 52.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Injection site cellulitis, Injection site induration
Clinical narrative: Areas of induration and cellulitis at both injection sites. Worse on (R) arm. Temp of 99. Sx began 2 days after injection. No issues in past w/imms. Tx with Keflex 500 mg 3x7days. RTC for reevaluation.
Sex: F
Vaccine: MENB
Symptoms: Heart rate increased, Immediate post-injection reaction, Sinus tachycardia, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 18-year-old female patient who received BEXSERO for prophylaxis. In April 2019, the patient received the 1st dose of BEXSERO. In April 2019, 5 min after receiving BEXSERO, the patient experienced fainting (serious criteria GSK medically significant) and sinus tachycardia. On an unknown date, the outcome of the fainting and sinus tachycardia were unknown. It was unknown if the reporter considered the fainting and sinus tachycardia to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient received BEXSERO and experienced a blood draw and fainted and had since had 10 new episodes of sinus tachycardia with heart rates up to 198 lasting around 20 minutes. The patient had been in the emergency room twice for this and they were unable to figure out why this presented immediately after the vaccination. The reporter asked any information on this as a possible side effect of the BEXSERO.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: shivers; tired; belly pain; diarrhea; pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix. On 10th April 2019, 3 hrs 30 min after receiving Shingrix, the patient experienced pain in arm. On 11th April 2019, the patient experienced shivers, tiredness, abdominal pain and diarrhea. On 12th April 2019, the outcome of the shivers was recovered/resolved. On an unknown date, the outcome of the pain in arm, tiredness, abdominal pain and diarrhea were unknown.   It was unknown if the reporter considered the pain in arm, shivers, tiredness, abdominal pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: On Wednesday at 1:30 pm, the patient received Shingrix and at 5:00 pm experienced pain in arm. On Thursday, the patient experienced Shivers till noon of the day of reporting. Since Thursday afternoon, the patient was very tired and had belly pain. On the day of reporting, the patient experienced diarrhea. The reporter asked how long would these side effects last. The patient was very energetic person and could not stand this tired and other side effects. The patient would like to know if it likely to get side effects from the 2nd dose also.
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis; This case was reported by a physician via sales rep and described the occurrence of cellulitis in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, 2 days after receiving Kinrix, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant). The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis was unknown.   It was unknown if the reporter considered the cellulitis to be related to Kinrix.  Additional details were reported as follows: The age at vaccination was not reported however the patient was atleast 4 years old. The patient received KInrix and 48 hours later, the patient came back to physician's office with cellulitis. The patient was hospitalized for 2-3 days and treated with unspecified antibiotics.
Age: 49.0
Sex: F
Vaccine: JEV1
Symptoms: Diarrhoea, Fatigue, Pruritus, Rash
Clinical narrative: JE 3# 1 in February with no problems. JE vaccine # 2 received on 26 Apr.  She stated the following day she noticed a fine rash on her upper torso to include neck and few areas on face. Later that PM she had several episodes of diarrhea.  She reported fatigue but denied nausea, vomiting, and fever. No respiratory symptoms or angioedema. Rash described as bumps with minimal itching, and does not come and go. Never had anything like this before or problems with previous immunizations. No one else at home with rash or diarrhea. Was able to return to normal diet on 28th, and rash is going away. Currently is feeling well but skin is still bumpy.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Started with rash and fever on 3 days after receiving the MMR/Varivax, fever of 101  Patient seen in the office ( 4-30-19 ) rash is slowly starting to get better
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and mild induration right hip near injection site, non-tender.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: This vaccine was administered subcutaneously, not intrmuscular
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site swelling
Clinical narrative: This vaccine was administered subcutaneously, not intrmuscular
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Pt's left arm at injection site was red, warm, and swollen to half the size of a softball per mother. No drainage, no fever. Mother reported pt "did not feel well" and was "dizzy in the shower." RN triage advised pt to mother to apply cold packs to the arm for 20 minutes at a time, and may take ibuprofen for pain/swelling. Advised mother to draw a circle around the swelling and to call back if it continued to get worse. Mother verb. understanding, and did call back the next day 3/29 to report that the "rash was getting worse" and "spreading across the arm" with red dots also. Report forwarded to pediatric MD available who advised mother to take the pt to the ED for evaluation. Family has not returned calls regarding this incident.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pyrexia, Rash, Rash erythematous, Viral pharyngitis
Clinical narrative: Pt's left arm at injection site was red, warm, and swollen to half the size of a softball per mother. No drainage, no fever. Mother reported pt "did not feel well" and was "dizzy in the shower." RN triage advised pt to mother to apply cold packs to the arm for 20 minutes at a time, and may take ibuprofen for pain/swelling. Advised mother to draw a circle around the swelling and to call back if it continued to get worse. Mother verb. understanding, and did call back the next day 3/29 to report that the "rash was getting worse" and "spreading across the arm" with red dots also. Report forwarded to pediatric MD available who advised mother to take the pt to the ED for evaluation. Family has not returned calls regarding this incident.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Feeling abnormal, Lymphadenopathy, Pyrexia
Clinical narrative: parent reported fever of 102-103 on the evening of 4/27/19 and some atypical behavior of child, possibly hallucinating, appeared dazed per parent report, possibly seizure like activity. He was not evaluated on the evening of 4/27 but was seen in Urgent care on 4/28 and exam documented was of an alert, playful child with anterior cervical adenopathy but otherwise non focal
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Gave Kinrix instead of Boostrix vaccination. No adverse reactions noted
Age: 22.0
Sex: M
Vaccine: YF
Symptoms: Chills, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: fever 5 days after the vaccine to 102, resolved with ibuprofen. achy muscles. chills, no appetite, no nausea, no vomiting. no change in urine
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Myalgia, Pain in extremity, Rhinorrhoea
Clinical narrative: Patient refuses to move left upper arm or shoulder on arrival in emergency room, no clavicle tenderness, elbow, forearm or wrist pain or tenderness.  Left radial pulse intact.  Patient with pinpoint area of erythema three finger breadths below acromion where vaccine was given, no surrounding erythema, edema or warmth.  No discharge noted.  Has  arm pain, myalgias, rhinorrhea.  Rx with oral NSAIDS and warm compress.  After treatment left arm pain with full ROM after medications, no numbness, tingling or signs of infection
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urine analysis
Clinical narrative: Patient refuses to move left upper arm or shoulder on arrival in emergency room, no clavicle tenderness, elbow, forearm or wrist pain or tenderness.  Left radial pulse intact.  Patient with pinpoint area of erythema three finger breadths below acromion where vaccine was given, no surrounding erythema, edema or warmth.  No discharge noted.  Has  arm pain, myalgias, rhinorrhea.  Rx with oral NSAIDS and warm compress.  After treatment left arm pain with full ROM after medications, no numbness, tingling or signs of infection
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: the night and next morning patient experienced sore arm.  she said the vaccinator hit a muscle due to quickly giving her the vaccine.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Facial paralysis
Clinical narrative: pt presented with bells palsy 6 days later sent to the hospital had CT scan negative for CVA and was given prednisone and valtrex
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: bump around injection site, looks like hives
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Influenza like illness, Lethargy, Nausea
Clinical narrative: About 6 hours after the vaccination, I began to experience flu like symptoms. I had a slight fever but did not check until the next morning. At that time, it was 100.0. At the onset, I had severe ringing in my ears. As of today (4/30/19 at 1 PM), I still have a lot of ringing in my ears. I pretty much felt lethargic until approximately 6:30 PM on 4/27. I had no energy and felt like a dead body. I also felt nauseous at times and a bit dizzy, but the dizzy part could have been due to the fever.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tinnitus
Clinical narrative: About 6 hours after the vaccination, I began to experience flu like symptoms. I had a slight fever but did not check until the next morning. At that time, it was 100.0. At the onset, I had severe ringing in my ears. As of today (4/30/19 at 1 PM), I still have a lot of ringing in my ears. I pretty much felt lethargic until approximately 6:30 PM on 4/27. I had no energy and felt like a dead body. I also felt nauseous at times and a bit dizzy, but the dizzy part could have been due to the fever.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: Patient received her first dose of shingrix on 04/28/19. She called the pharmacy on 04/30/19 complaining of rash on torso and under breast and that it had gotten worse overnight. She had called the cdc and fda prior to calling the pharmacy and they told her its an allergic reaction and to go to her doctor. I also told the patient to go to the doctor and monitor for signs of anaphylaxis and worsening reaction. Patient reported to her doctor who told her it was an allergic reaction and to take allegra every day and for 5 days after symptoms resolve.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Imm given. N/A
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Fatigue, Nausea
Clinical narrative: NAUSEA VOMITING DIARRHEA FATIGUE STOMACH PAIN BACK PAIN
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: NAUSEA VOMITING DIARRHEA FATIGUE STOMACH PAIN BACK PAIN
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: red, swollen, painfull arm tx: ibuprofen, ice and clindamycin
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 02-AUG-2018 first dose, 12-APR-2019 second dose; Information has been received from a medical assistant concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 02-AUG-2018, the patient was vaccinated with dose 1 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Lot No. R029117, exp. date 24-SEP-2020), intramuscular for prophylaxis. On 12-APR-2019,  the patient was vaccinated with dose 2 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Lot no. R029117, exp. date 10-JUL-2021) (inappropriate schedule of product administration), intramuscular for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Inappropriate route of vaccination; No adverse effect reported; This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's historical conditions, concurrent condition, and drug reactions/ allergies were not reported.  On an unknown date, the patient was inadvertently vaccinated by intramuscular route (incorrect route of product administration) with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, lot number, and expiration date were not provided), for prophylaxis. No adverse effect reported.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Multiple sclerosis, Off label use, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of multiple sclerosis in a 45-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced multiple sclerosis (serious criteria GSK medically significant), shingles, off label use and inappropriate age at vaccine administration. On an unknown date, the outcome of the multiple sclerosis, shingles, off label use and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the multiple sclerosis and shingles to be related to SHINGRIX. Additional details were reported as follows: A 45-years-old patient might potentially receive a dose of SHINGRIX based on the recommendation from her physician which led to off label use. The patient had multiple sclerosis and experienced an episode of Shingles about six weeks ago from the time of report. No additional information was provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Myalgia, Restlessness
Clinical narrative: At 9:00 pm on the evening of the shot, I experienced sever joint & muscle pain.  I could not get comfortable in bed, tossed & turned for several hours.  Finally, at 2:00 am, I just got up, trying to sit or recline to get comfortable.  Most of the entire day I was very uncomfortable, I tried taking Tylenol with no success.  I did sleep better the next evening., but was feeling pain and discomfort all the day.  It was 2 days following the shot before I felt reasonable.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Blood bicarbonate decreased, Blood glucose decreased, Drooling, Eye movement disorder, Generalised tonic-clonic seizure
Clinical narrative: Mother reporting pt. "started drooling and eyes rolled back in her head" while at the Mall approx. 1/2 hr after receiving the MMR vaccine.  Episode lasted approx. 2 min.  Pt. then acting lethargic and laying in Mother's arms. Mom called 9-1-1 and Paramedics evaluated pt. and then left as pt's eye were open and they felt she simply "passed out". Mom spoke with this Pediatric office who recommended pt. be seen at  Hospital. Mom called the Paramedics back who transported pt. to the ER where she was evaluated. Upon evaluation pt. was dx with probable post tonic-clonic seizure. To f/u with Neurology and schedule EEG.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Loss of consciousness, Metabolic function test normal
Clinical narrative: Mother reporting pt. "started drooling and eyes rolled back in her head" while at the Mall approx. 1/2 hr after receiving the MMR vaccine.  Episode lasted approx. 2 min.  Pt. then acting lethargic and laying in Mother's arms. Mom called 9-1-1 and Paramedics evaluated pt. and then left as pt's eye were open and they felt she simply "passed out". Mom spoke with this Pediatric office who recommended pt. be seen at  Hospital. Mom called the Paramedics back who transported pt. to the ER where she was evaluated. Upon evaluation pt. was dx with probable post tonic-clonic seizure. To f/u with Neurology and schedule EEG.
Age: 57.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Blood glucose, C-reactive protein, Cardiac telemetry, Computerised tomogram head, Computerised tomogram spine
Clinical narrative: loss of consciousness (not witnessed, unknown duration), "grogginess", amnesia of event, dizziness and nausea upon awakening, husband had to shake her and call her name to arouse her. This occurred within 24 hours of the immunizations. Presented to the ER 3 hours later.
Age: 57.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dizziness, Electrocardiogram, Fibrin D dimer, Full blood count, Loss of consciousness
Clinical narrative: loss of consciousness (not witnessed, unknown duration), "grogginess", amnesia of event, dizziness and nausea upon awakening, husband had to shake her and call her name to arouse her. This occurred within 24 hours of the immunizations. Presented to the ER 3 hours later.
Age: 57.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Metabolic function test, Nausea, Somnolence, Troponin, Urine analysis
Clinical narrative: loss of consciousness (not witnessed, unknown duration), "grogginess", amnesia of event, dizziness and nausea upon awakening, husband had to shake her and call her name to arouse her. This occurred within 24 hours of the immunizations. Presented to the ER 3 hours later.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: She had soreness the day after the shot.  A day or two later, she developed swelling and a rash going from site of administration to inside of the arm.  She denied being outside for having a bug bite.  There is redness about 5 inches around the injection site, and it is swollen with some blistering.  She did not have hives, but the rash itched and was sore to the touch.  She was counselled to hydrate and use cold compresses to reduce the swelling.  She was told to report to us on 4/29/19 if it had not improved.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic
Clinical narrative: She had soreness the day after the shot.  A day or two later, she developed swelling and a rash going from site of administration to inside of the arm.  She denied being outside for having a bug bite.  There is redness about 5 inches around the injection site, and it is swollen with some blistering.  She did not have hives, but the rash itched and was sore to the touch.  She was counselled to hydrate and use cold compresses to reduce the swelling.  She was told to report to us on 4/29/19 if it had not improved.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Chest X-ray, Condition aggravated, Cough, Pneumonia
Clinical narrative: Cough, congestion, asthma, pneumonia
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory tract congestion
Clinical narrative: Cough, congestion, asthma, pneumonia
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Cardiomyopathy, Myocarditis
Clinical narrative: Hospitalization for myocarditis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Impaired work ability, Influenza virus test negative
Clinical narrative: Fever of up to 104.3 for 7 days, home visit for fever and headache, 2 ER visits to Medical Center, 3 days in hospital on IV fluids, morphine, antibiotics (Azithromycin, SEPTRA and CEFDINIR,  KENALOG cream for rash, TYLENOL and ibuprofen. I had a constant severe headache, fever, chills, severe night sweats, muscle aches, rash on stomach and back, and pneumonia. I felt like I was poisoned. I have never been so sick in my life. I was healthy prior to the vaccine. My new rheumatology RN did not consider my immune compromised status. I should never have been prescribed this shot. I missed 9 days of work and feel like I will not bounce back from this.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Night sweats, Pneumonia, Pyrexia
Clinical narrative: Fever of up to 104.3 for 7 days, home visit for fever and headache, 2 ER visits to Medical Center, 3 days in hospital on IV fluids, morphine, antibiotics (Azithromycin, SEPTRA and CEFDINIR,  KENALOG cream for rash, TYLENOL and ibuprofen. I had a constant severe headache, fever, chills, severe night sweats, muscle aches, rash on stomach and back, and pneumonia. I felt like I was poisoned. I have never been so sick in my life. I was healthy prior to the vaccine. My new rheumatology RN did not consider my immune compromised status. I should never have been prescribed this shot. I missed 9 days of work and feel like I will not bounce back from this.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Fever of up to 104.3 for 7 days, home visit for fever and headache, 2 ER visits to Medical Center, 3 days in hospital on IV fluids, morphine, antibiotics (Azithromycin, SEPTRA and CEFDINIR,  KENALOG cream for rash, TYLENOL and ibuprofen. I had a constant severe headache, fever, chills, severe night sweats, muscle aches, rash on stomach and back, and pneumonia. I felt like I was poisoned. I have never been so sick in my life. I was healthy prior to the vaccine. My new rheumatology RN did not consider my immune compromised status. I should never have been prescribed this shot. I missed 9 days of work and feel like I will not bounce back from this.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMRV, PNC13
Symptoms: Pallor, Rash erythematous, Rash papular
Clinical narrative: 4/30/19: The patient's mother noted a red rash which developed the morning of the visit on his face and body.  The rash is blanchable, ~.5cm, erythematous papules, scattered distribution, no palm or sole involvement, no oral lesions. No fever, no cough, no conjunctivitis.  Afebrile today.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness and pain at injection site 1 week after injection
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Pt noted warmth / redness at the injectionsite the morning after the vaccine was administered. The following day, pt was seen by a HCP on 4/29 who stated patient had cellulitis and was prescribed cephalexin.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Aphasia, Autism spectrum disorder, Decreased eye contact
Clinical narrative: Loss of eye contact, loss of speech, Autism. Caused by two doses of MMR vaccine on 02/02/2018 & 08/03/2018.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Paraesthesia oral, Rash
Clinical narrative: patient reports she experienced headache, tingling tongue, rash
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pyrexia
Clinical narrative: FEVER ; TEMP OF 105 DEGREE FAHRENHEIT ( TEMPORAL ARTERY THERMOMETER )
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Paraesthesia oral
Clinical narrative: patient reports that she had earache, headache, and tongue felt funny after the second dose.  (also had reaction to first dose but did not tell anyone until my last visit with her in April 2019).  she wanted me to report this.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Joint range of motion decreased, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA -impaired shoulder motion, weakness since 1-2 days after vaccine administration
Age: 1.83
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Child needed several vaccines- DTAP/Polio, Hep A, Hep B, PCV. Kinrix inadvertently given by mistake.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: urticarial rash on left arm and chest- itchy and red. treated with antihistamine and monitoring
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain
Clinical narrative: Achy, hurt all over, pain in joints
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: Minor seizures movement  and chills  Dizziness  High fever  Tiredness  Soreness
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Seizure like phenomena
Clinical narrative: Minor seizures movement  and chills  Dizziness  High fever  Tiredness  Soreness
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm was hot, swollen and red
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Chills, Dizziness, Injection site erythema, Musculoskeletal stiffness
Clinical narrative: Around four hours after getting the shot I became very lightheaded and had to sit for a long period of time. My left arm (where i go the injection) became stiff and my elbow, wrist, and finger joints were all on fire. I then got the chills and stated vomiting non stop until about 3 am.  At 12 pm I noticed red circles about 2 inches in diameter beginning to appear around my injection site.  I then called the pharmacy that gave me the injection to ask questions. I ended up going back to the clinic at 4 pm the next day. I had one of the staff look at my arm and talked  him through my symptoms. He said it was more than likely my body reacted very strongly to the vaccine.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Around four hours after getting the shot I became very lightheaded and had to sit for a long period of time. My left arm (where i go the injection) became stiff and my elbow, wrist, and finger joints were all on fire. I then got the chills and stated vomiting non stop until about 3 am.  At 12 pm I noticed red circles about 2 inches in diameter beginning to appear around my injection site.  I then called the pharmacy that gave me the injection to ask questions. I ended up going back to the clinic at 4 pm the next day. I had one of the staff look at my arm and talked  him through my symptoms. He said it was more than likely my body reacted very strongly to the vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Day 1 - Developed rash in a concentrated cluster around the diaper strap on his right hip. Day 2 - Fever of 102 and a few pox on the trunk in addition to the clustered area. Day 3 - Continued fever of 101 and pox all over trunk, face, and neck with sporadic pox on the legs and arms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth
Clinical narrative: CHILLS, INJECTION SITE RED AND WARM TO TOUCH
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Swelling
Clinical narrative: pt shoulder was swollen and painful
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling cold, Feeling of body temperature change, Injected limb mobility decreased, Injection site pain
Clinical narrative: Constant pain in area of shot.   Tuesday started being cold, Wednesday went from cold to shivers then fever of 102.2 Thursday off and on cold to being hot.  Friday woke up with sniffles and  extreme pain in inner arm just below armpit, later in evening a huge rash on upper left arm.  Friday woke up with pain in upper arm; was very hard to lift arm.  Saturday the rash left and begun a runny nose with sneezing.  Talked with Drs. office on Thursday 04/25/2019 described what was going on, she was to leave Dr. a message.