chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Sensitive skin
Clinical narrative: ?Sunburn? sensation on skin of torso and thighs, body  aches, shivers, stomach discomfort, low-grade fever (100.2), fatigue .  The skin sensitivity began within 20 of injection and remaining symptoms were present upon awakening 12 hours later.  Low-moderate pain at site of injection and skin sensitivity continues 36 hours later.  No fever 36 hours later
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Dyspepsia, Facial neuralgia, Fatigue, Pyrexia
Clinical narrative: Digestive discomfort, lack of appetite, tired and feverish (100.7 Farenheit 24 hours after vaccination, 99.4 F 48 hours after vaccination, ), Facial neuralgia  28-40 hours after vaccination.  Fully recovered after 72 hours.  Treated with acetominophen, 2 doses(fever) and ibuprofen, 1 dose (neuralgia)
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Confusional state
Clinical narrative: Approximately 45 minutes after receiving the injection, coworkers said she was acting "strange" and "confused" Could spell her husband's name but couldn't say it.  Was very nervous prior to getting the vaccine..trying to distract her and asked what she had for lunch and she responded 'tobasco' but she commented that 'tobasco' didn't sound right and maybe she had a brownie.  Took her BP and it was 150/90.  EMS called.
Age: 58.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Headache, Injection site discomfort, Injection site erythema, Limb discomfort, Pain
Clinical narrative: Soreness and red mark on right arm at injection site Soreness in left arm Slight fever (99.8 F), general achiness and headache
Age: 58.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness and red mark on right arm at injection site Soreness in left arm Slight fever (99.8 F), general achiness and headache
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction, Pain
Clinical narrative: NO TREATMENT TAKEN, HEADACHE AND ARM REACTION, LASTED A FEW DAYS AND, BODY PAIN LASTED 24 HOURS
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Peripheral swelling, Sensory loss
Clinical narrative: Patient given HepA pedi dose at school clinic and approx 10 mins later she stated she had no sensation in her left arm or fingers below the injection site. She was unable to squeeze fingers or pick anything up. Ice applied until parent picked her up and then student was taken to doctor's office.  Student was seen by her PCP a few hours later.  RN who administered vaccine at clinic spoke with mom at 1:00pm and they were still at MD's office. MD did not think it was vaccine related and could be a stress induced reaction.   Nurse followed up with mom the next day and she statied her arm was getting better, had increased sensation but fingers were still a little swollen and she would follow up with doctor if needed.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea on may 7-9
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Skin lesion
Clinical narrative: Red annular rash with central clearing, slightly raised borders for some lesions, without pruritus, appearing 6 days after vaccinations on the lower extremities, near where he had his injections.
Age: 15.0
Sex: F
Vaccine: HPV9, PNC13
Symptoms: Blindness, Cold sweat, Hyperhidrosis, Peripheral coldness, Skin discolouration
Clinical narrative: Shots were given around 1020 and symptoms started around 1025. Pt stated that she could not see. Pt had a blank stare and was cool, clammy, and diaphoretic. Pt was given 2L oxygen via nasal cannula, ice pack on back of neck, and a lolly pop. Vital signs recorded at 1025 O2 sat: 98%, BP: 91/59, P: 105-20. @ 1030: O2 sat: 100- 2L, P: 94-20. @ 1035 BP: 101/69, P: 94-18, O2 sat: 100-2L. Pts skin color returned to normal and was conversational.
Age: 15.0
Sex: F
Vaccine: HPV9, PNC13
Symptoms: Staring
Clinical narrative: Shots were given around 1020 and symptoms started around 1025. Pt stated that she could not see. Pt had a blank stare and was cool, clammy, and diaphoretic. Pt was given 2L oxygen via nasal cannula, ice pack on back of neck, and a lolly pop. Vital signs recorded at 1025 O2 sat: 98%, BP: 91/59, P: 105-20. @ 1030: O2 sat: 100- 2L, P: 94-20. @ 1035 BP: 101/69, P: 94-18, O2 sat: 100-2L. Pts skin color returned to normal and was conversational.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother called Public Health Clinic 2 days after child received vaccine stating "child's left leg is red and swollen" started last night, mom didn't have an exact time as to when symptoms started. Mom couldn't describe the size of the swelling but stated "its just really swollen"
Age: 12.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Measles antibody negative
Clinical narrative: she subsequently has negative measles titers; she subsequently has negative measles titers; This spontaneous report was received from a physician, who was a female patient, currently 61-year-old, reporting on herself. She had no concomitant medication nor pertinent medical history but being allergic to sulfamethoxazole (+) trimethoprim (SEPTRA).  On an unspecified date in June 1970, when she was 12 years old, the patient was vaccinated with a dose of measles virus vaccine live (unspecified)(dose, route of administration, injection site, lot # and expiration date were not reported) for immunity.  On 06-APR-1991, she received another dose of measles virus vaccine live (unspecified) On 28-JUN-1996, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status unknown) (M-M-R II) (exact dose, route of administration, injection site, lot # and expiration date were not provided) for immunity and on 30-AUG-2018, with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Subsequently after all vaccinations, her measles titers were negative (onset date unspecified). She sought medical attention by consulting an unspecified healthcare professional, however no treatment was given. The patient had multiple unspecified measles immunoglobulin (IGG) tests performed (dates and results were not reported).  On 26-SEP-2018, she had her last negative IGG titer. At the reporting time, she was not recovered from negative measles titers.  The causality assessment was not provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: CSF virus identified, Facial paralysis, Gait inability, Guillain-Barre syndrome, Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 22-JUL-2013, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 24-FEB-2015, the patient was diagnosed with Transverse Myelitis. On approximately 2015, a lumbar puncture was performed, and spinal fluid confirmed the presence of herpes zoster/shingles infection. Thereafter, the patient was diagnosed with Bell's Palsy and Transverse Myelitis/Guillain-Barre Syndrome, and at the reporting time was unable to walk. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Further, as a direct and proximate result of the Company's conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The reporter considered the events to be related to ZOSTAVAX. Transverse Myelitis/Guillain-Barre Syndrome, Bell's Palsy and herpes zoster/shingles infection were considered to be disabling. Upon internal review, the events Bell's Palsy and Transverse Myelitis/Guillain-Barre Syndrome were determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 22-JUL-2013, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 24-FEB-2015, the patient was diagnosed with Transverse Myelitis. On approximately 2015, a lumbar puncture was performed, and spinal fluid confirmed the presence of herpes zoster/shingles infection. Thereafter, the patient was diagnosed with Bell's Palsy and Transverse Myelitis/Guillain-Barre Syndrome, and at the reporting time was unable to walk. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Further, as a direct and proximate result of the Company's conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The reporter considered the events to be related to ZOSTAVAX. Transverse Myelitis/Guillain-Barre Syndrome, Bell's Palsy and herpes zoster/shingles infection were considered to be disabling. Upon internal review, the events Bell's Palsy and Transverse Myelitis/Guillain-Barre Syndrome were determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; An adult patient received a dose of PROQUAD; This spontaneous report was received from a Licensed Practical Nurse refers to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 10-MAY-2019, the patient was vaccinated with a dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) (lot # S002496, expiration date: 23-JUL-2020) (strength, dose and anatomical location not reported) subcutaneously as prophylaxis (product administered to patient of inappropriate age). The patient did not have any known adverse effects.  Product quality complaint not involved.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Urticaria; This case was reported by a physician via sales rep and described the occurrence of urticaria in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced urticaria. On an unknown date, the outcome of the urticaria was unknown.   It was unknown if the reporter considered the urticaria to be related to Shingrix.  Additional details were provided as follows:  On 15th April 2019, the patient alerted that, she experienced urticaria. The physician was unsure if the event related to vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Vaccine positive rechallenge
Clinical narrative: felt bad; This case was reported by a nurse via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine. Previously administered products included Shingrix with an associated reaction of myalgia (1st dose received in March 2019, refer case US2019080731).   In May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The nurse reported these adverse events experienced by herself. The age at vaccination was not reported. Due to bad experience from 1st Shingrix dose, the patient was very hesitant to get 2nd dose, but followed through with receiving it as she was a registered nurse and recognized the importance of completing the series.   After receiving 2nd dose, the patient felt so bad as like first that she had to take a day off of work. The patient also commented that pharmacist really needs to highlight the horrible side effects of the vaccine.  The patient also asked that, did there was any case of Irritable bowel syndrome (ISB) or Small intestine bacterial overgrowth (SIBO) after receiving this vaccine since the patient developed ISB after her 1st dose. No other details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported for the pharmacist's mother. The patient experienced arm pain for a couple of months. The reporter did not consent to follow up. This case was linked with case US2019080686 (reporter's case) reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspepsia, Flatulence, Vaccine positive rechallenge
Clinical narrative: heart burn; chest pain; Gaseousness; This case was reported by a consumer via call center representative and described the occurrence of heartburn in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chest pain (1st dose received in November 2018 and experienced heartburn, gaseousness, refer case US2019GSK083554).   On 17th April 2019, the patient received the 2nd dose of Shingrix. On 18th April 2019, 1 days after receiving Shingrix, the patient experienced heartburn, chest pain and gaseousness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the heartburn, chest pain and gaseousness were not recovered/not resolved.   It was unknown if the reporter considered the heartburn, chest pain and gaseousness to be related to Shingrix.  Additional details were provided as follows: On the date of reporting the patient said experienced the same symptoms(pain, heartburn, chest pain and gaseousness) as experienced after receiving 1st dose of Shingrix. The reporter did not consent to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea
Clinical narrative: abdominal pain; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received the 1st dose of Shingrix .5 ml. On 5th May 2019, 5 days after receiving Shingrix, the patient experienced abdominal pain and diarrhea. On an unknown date, the outcome of the abdominal pain and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the abdominal pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the left arm. The pain was described as dull cramps low in the patient's stomach. The reporter gave consent to follow up.
Age: 74.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Pain, redness, soreness, swelling at site and down arm  Day 1 and 2 Headache, muscle aches, fever, shivering, fatigue Temp. Days 2 and 3 and 4 Felt Faint - Day 4 Arthritic type aches continued for the duration of 18 days - took Aleve or arthritis pain formula which helped
Age: 74.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Pain, redness, soreness, swelling at site and down arm  Day 1 and 2 Headache, muscle aches, fever, shivering, fatigue Temp. Days 2 and 3 and 4 Felt Faint - Day 4 Arthritic type aches continued for the duration of 18 days - took Aleve or arthritis pain formula which helped
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Scab, Vaccination site reaction, Vaccination site vesicles
Clinical narrative: Patient woke 5/16/2019 and noticed pink rash about size of orange under vaccine site. The rash was flush with skin and had small blister/crusty area
Age: 0.58
Sex: M
Vaccine: DTAPIPV, HEP, HIBV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: none
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Pt. has experienced itching all over his body, starting 2-3 days after receiving Shingrix. Still going on curently
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site movement impairment, Injection site pain, Musculoskeletal stiffness, X-ray normal
Clinical narrative: The patient reports that shortly after receiving the Influenza vaccine, her (L) upper arm (at injection site) became  sore and progressed to stiffness and  decreased range of motion.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: fever, fatigue, headache, sweating, they lasted about 1 day. The patient started feeling better the next day
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever, Body aches, Headaches, Joint pain, Sore throat, rash to  all over body
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Fever, Body aches, Headaches, Joint pain, Sore throat, rash to  all over body
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: The Menveo vaccine that this patient received may not have been mixed properly. During inventory at the end of the month there was only 1 vial of diluent left in the box suggesting that an improper diluent might have been used to administer the vaccine, rendering the vaccine invalid. We are unsure what patient may have received the improper solution, so we notified all patient seen in August, and suggested revaccination. No adverse events were noted by the patient and she was revaccinated with a properly  mixed menveo dose and our state registry was updated to reflect the subpotent dose.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Dyspnoea, Electrocardiogram abnormal, Palpitations
Clinical narrative: Patient developed palpitations, racing heart, and shortness of breath 4 hours after receiving Shingrix vaccine. Symptoms persisted and she presented to office for evaluation.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Axillary pain, Body temperature fluctuation, Body temperature increased, Chills, Decreased appetite
Clinical narrative: 5-6-19. Awoke with sore/swollen under right arm. Went to school. Complained of feeling cold/shivery at school. Temp 101.7 PM. 5-7-19: Am temp 101.5. Headache, sore/swollen under right arm, fatigue, no appetite. Temp fluctuating between 101.5-103.5. 5-8-19: AM temp 102.3. Headache, sore/swollen under right arm, fatigue, no appetite. Temp fluctuating between 102-103.8 5-9-19: AM temp 102.7. Headache, sore/swollen under right arm, fatigue, no appetite. Awoke with red rash all over body, mostly on trunk.Temp fluctuating between 102-102.8 5-10-19:AM temp 101.7. Headache, sore/swollen under right arm, fatigue, no appetite. Red rash covering entire body. Temp between 101.5-102.8 5-11-19: Am temp 100.5. Headache less intense, sore/swollen right arm, appetite beginning to increase a little. Fatigue continues. Rash still present.PM temp 102. 5-12-19: AM temp 99.9. Slight headache, sore/swollen under right arm. Appetite increasing, Less fatigue. Rash still present. PM temp 99.7 5-13-19: AM temp 99.0 No headache. sore swollen under right arm. Appetite increasing, Fatigue in afternoon, evening. Rash still present, but staring to fade. PM temp 98.7. 5-14-19: AM temp 98.5. No headache. Arm is till swollen, mush less sore. Fatigue in evening. Rash present but fading more. 5-15-19: Temp normal. appetite almost back to normal. Arm swollen, not sore. Fatigue in evening. Rash is fading more. 5-16-19: Temp normal. Appetite almost back to normal. Arm still swollen, not sore. Rash very faint. 5-14-19: AM temp 98.4. No headache 5-12-19
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Feeling cold, Headache, Peripheral swelling, Rash erythematous
Clinical narrative: 5-6-19. Awoke with sore/swollen under right arm. Went to school. Complained of feeling cold/shivery at school. Temp 101.7 PM. 5-7-19: Am temp 101.5. Headache, sore/swollen under right arm, fatigue, no appetite. Temp fluctuating between 101.5-103.5. 5-8-19: AM temp 102.3. Headache, sore/swollen under right arm, fatigue, no appetite. Temp fluctuating between 102-103.8 5-9-19: AM temp 102.7. Headache, sore/swollen under right arm, fatigue, no appetite. Awoke with red rash all over body, mostly on trunk.Temp fluctuating between 102-102.8 5-10-19:AM temp 101.7. Headache, sore/swollen under right arm, fatigue, no appetite. Red rash covering entire body. Temp between 101.5-102.8 5-11-19: Am temp 100.5. Headache less intense, sore/swollen right arm, appetite beginning to increase a little. Fatigue continues. Rash still present.PM temp 102. 5-12-19: AM temp 99.9. Slight headache, sore/swollen under right arm. Appetite increasing, Less fatigue. Rash still present. PM temp 99.7 5-13-19: AM temp 99.0 No headache. sore swollen under right arm. Appetite increasing, Fatigue in afternoon, evening. Rash still present, but staring to fade. PM temp 98.7. 5-14-19: AM temp 98.5. No headache. Arm is till swollen, mush less sore. Fatigue in evening. Rash present but fading more. 5-15-19: Temp normal. appetite almost back to normal. Arm swollen, not sore. Fatigue in evening. Rash is fading more. 5-16-19: Temp normal. Appetite almost back to normal. Arm still swollen, not sore. Rash very faint. 5-14-19: AM temp 98.4. No headache 5-12-19
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised, Swelling
Clinical narrative: 5-6-19. Awoke with sore/swollen under right arm. Went to school. Complained of feeling cold/shivery at school. Temp 101.7 PM. 5-7-19: Am temp 101.5. Headache, sore/swollen under right arm, fatigue, no appetite. Temp fluctuating between 101.5-103.5. 5-8-19: AM temp 102.3. Headache, sore/swollen under right arm, fatigue, no appetite. Temp fluctuating between 102-103.8 5-9-19: AM temp 102.7. Headache, sore/swollen under right arm, fatigue, no appetite. Awoke with red rash all over body, mostly on trunk.Temp fluctuating between 102-102.8 5-10-19:AM temp 101.7. Headache, sore/swollen under right arm, fatigue, no appetite. Red rash covering entire body. Temp between 101.5-102.8 5-11-19: Am temp 100.5. Headache less intense, sore/swollen right arm, appetite beginning to increase a little. Fatigue continues. Rash still present.PM temp 102. 5-12-19: AM temp 99.9. Slight headache, sore/swollen under right arm. Appetite increasing, Less fatigue. Rash still present. PM temp 99.7 5-13-19: AM temp 99.0 No headache. sore swollen under right arm. Appetite increasing, Fatigue in afternoon, evening. Rash still present, but staring to fade. PM temp 98.7. 5-14-19: AM temp 98.5. No headache. Arm is till swollen, mush less sore. Fatigue in evening. Rash present but fading more. 5-15-19: Temp normal. appetite almost back to normal. Arm swollen, not sore. Fatigue in evening. Rash is fading more. 5-16-19: Temp normal. Appetite almost back to normal. Arm still swollen, not sore. Rash very faint. 5-14-19: AM temp 98.4. No headache 5-12-19
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Emotional distress, Irritability, Rash generalised, Screaming
Clinical narrative: PER CONVERSATION WITH PATIENTS MOTHER, "NO FEVER, BUT INCONSOLABLE FOR LONG PERIODS OF TIME, CRYING/SCREAMING, IRRITABLE, RASH STARTED ON FACE AND NOW SPREAD TO BODY, DECREASED PO BUT STILL VOIDING PLENTY, INTERMITTENT SCREAMING."
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient became dizzy, lightheaded, and passed out less than 2 minutes. States he does this every time he receives any injections of any kind or has blood drawn. Aroused easily and was able to ambulate with no distress stayed in clinic until 1330. Provider notified, and patient allowed to leave clinic.
Age: 79.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness and warmth to the back of left upper arm that radiates to below elbow.  Patient states it started about 7 hrs after PPV23 injection.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site paraesthesia
Clinical narrative: 2 days post intramuscular vaccine pt. returned to clinic with +. swollen red, hard lt. deltiod. Associated with + pain, +paresthesias, +itching, no discharge or pus visible. puncture marks with peripheral bruising at area oblong 8*2.5x 5.5 inches. increase compare lt. in circumference of arm by 2 inches.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: 2 days post intramuscular vaccine pt. returned to clinic with +. swollen red, hard lt. deltiod. Associated with + pain, +paresthesias, +itching, no discharge or pus visible. puncture marks with peripheral bruising at area oblong 8*2.5x 5.5 inches. increase compare lt. in circumference of arm by 2 inches.
Age: 39.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event happened.
Age: 12.0
Sex: M
Vaccine: HEP, HPV9, MNQ, TDAP
Symptoms: Product preparation error
Clinical narrative: The Menveo vaccine that this patient received may not have been mixed properly. During inventory at the end of the month there was only 1 vial of diluent left in the box suggesting that an improper diluent might have been used to administer the vaccine, rendering the vaccine invalid. We are unsure what patient may have received the improper solution, so we notified all patient seen in August, and suggested revaccination. Our state registry was updated to reflect the subpotent dose.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Patient reported that he experienced myalgia, fatigue, shivering, a fever, and a headache.  This occurred twelve hours after the administration of the vaccine.  All symptoms have subsided in 12 hours since they began except for his headache which he is taking ibuprofen to relieve.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody increased, C-reactive protein increased, Joint swelling, Red blood cell sedimentation rate increased, Rheumatoid arthritis
Clinical narrative: Swollen joints in hands, elbow and knee. Have not had any auto immune issues in 20 years. Not being treated for the last 20 years. After 84 hours all systoms of RA came on suddenly.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient had redness, itching  and swelling of the left arm that appeared to be warm to the touch in patients medial distal upper arm.  Patient was advised to use an over the counter antihistamine Benadryl and over the counter hydrocortisone cream for the itching  and ice for the swelling.  Patient was advised to follow up with provider in 24-48 hours or sooner if redness and swelling exceeded the marked parameters.
Sex: U
Vaccine: RV5, RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: was administered a dose of ROTATEQ and vomited once after administration; vomited once after administration resulting in a possible incomplete dose; This spontaneous report was received from a nurse practitioner referring to a 2-month-old infant patient. Information on patient's medical history, concurrent conditions and concomitant therapies was not reported. On 09-MAY-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency were not reported, lot # R033253 and expiration date 19-JUL-2019) via unknown route for prophylaxis. On 09-MAY-2019 the patient vomited (vomiting) once after administration of the vaccine resulting in a possible incomplete dose (accidental underdose). The outcome of vomiting was unknown.   Action taken with the suspect therapy was not applicable. Causality assessment was not reported. There was no involvement of product quality complaint (PQC).  Lot number R033253 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect dose administered, Vomiting
Clinical narrative: was administered a dose of ROTATEQ and vomited once after administration; vomited once after administration resulting in a possible incomplete dose; This spontaneous report was received from a nurse practitioner referring to a 2-month-old infant patient. Information on patient's medical history, concurrent conditions and concomitant therapies was not reported. On 09-MAY-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency were not reported, lot # R033253 and expiration date 19-JUL-2019) via unknown route for prophylaxis. On 09-MAY-2019 the patient vomited (vomiting) once after administration of the vaccine resulting in a possible incomplete dose (accidental underdose). The outcome of vomiting was unknown.   Action taken with the suspect therapy was not applicable. Causality assessment was not reported. There was no involvement of product quality complaint (PQC).  Lot number R033253 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent.
Sex: M
Vaccine: RV5
Symptoms: Breath holding, Cyanosis
Clinical narrative: Held their breath and turned blue; Held their breath and turned blue; This spontaneous report was received from a physician via company representative referring to multiple male infant patients of an unknown age. The patient's concurrent condition included rotavirus immunization. The patient's medical history, historical drugs, drug allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, oral for prophylaxis and rotavirus immunization. On an unknown date, infant patients held their breath (breath holding) and turned blue (cyanosis) during administration of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Physician reported that, this issue spontaneously resolved after administration was completed and also reported to field employee that this issue occurred more often in unspecified male infants, though it was clarified that both unspecified male infants and unspecified female infants may have been involved. Physician no longer administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to any patients due to the issue, and instead administered ROTARIX (manufactured by GlaxoSmithKline), and reported that no patients have experienced the same issue with ROTARIX. It was not clarified if this meant any patients who experienced the issue with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) completed their rotavirus vaccination series with ROTARIX. The outcome of breath holding, and cyanosis was reported as recovered. The causality of the events was related with respect to suspect therapy rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored doses of vaccine administered; no adverse effect; This spontaneous report was received from a nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. Nurse reported that on an unknown date,  the patient was administered an improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dosing details, route of administration unknown) lot # R004439 and expiry date 12-AUG-2019 for prophylaxis(product storage error).  Other concomitant therapy included sterile diluent which was properly stored. No adverse effect reported(no adverse event). There was no previous temperature excursion. The temperature was 26 degree Celsius or warmer and the time frame was 24 hours.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Inflammation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Dry, red itchy rash on face, chest and 1 leg.  Very red and inflamed. Treated with oral diphenhydramine. Will call MD tomorrow if still present because that will be past the 48 hour mark since symptoms started.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mild/moderate swelling, redness, tenderness at site and 3 inches below since a few hours from vaccine.  Doesn't seem any worse since yesterday.
Age: 1.58
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Erythema infectiosum, Immunisation reaction, Pyrexia, Rash macular
Clinical narrative: Varicella-Mom reports varicella like rash and fever. Diagnosed in office with Post Immunization Reaction- crusted lesions from Varicella vaccination. Suspected Fifths Disease, viral type syndrome. History of slapped cheeks and now blotchy erythema.  Hep A- Mom self reports fever, rash. Patient was not seen in office.
Age: 1.58
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash vesicular, Scab, Viral infection
Clinical narrative: Varicella-Mom reports varicella like rash and fever. Diagnosed in office with Post Immunization Reaction- crusted lesions from Varicella vaccination. Suspected Fifths Disease, viral type syndrome. History of slapped cheeks and now blotchy erythema.  Hep A- Mom self reports fever, rash. Patient was not seen in office.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Product preparation issue
Clinical narrative: The Menveo vaccine that this patient received may not have been mixed properly. During inventory at the end of the month there was only 1 vial of powder component left in the box suggesting that only the diluent component might have been administered. We are unsure what patient may have received only the diluent and not the powder component, so we notified all patients seen in August, and suggested revaccination if interested. Our state registry was updated to reflect the subpotent dose.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: CSF protein increased, Guillain-Barre syndrome, Immunoglobulin therapy, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Exactly 2 weeks after receiving the PREVNAR 13 vaccine I started with symptoms of tingling in my hands and feet which within days became acute Guillain Barre syndrome. I spent almost 1 week in the Neurology Ward of Hospital receiving IVIG treatment and then almost 2 weeks in the Rehab Hospital receiving PT, OT and SLP therapy.
Age: 16.0
Sex: F
Vaccine: HEP, MENB, MNQ
Symptoms: Electromyogram, Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: unable to lift left arm above shoulder pain in left arm
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: right shoulder became swollen, reddened, warm and itchy within 12 hours of administration.  Reaction continued x 48 hours.
Age: 58.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Chills, Fatigue, Malaise
Clinical narrative: Chills, malaise, fatigue
Age: 57.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Chills, Fatigue, Malaise
Clinical narrative: CHILLS, MALAISE, FATIGUE
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient reported injection site pain, throbbing, redness for 2 days. No fever. Family doctor indicated possible skin infection, was treated with antibiotics and ibuprofen. 4 days later reports no symptoms.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Papule, Rash vesicular, Scab
Clinical narrative: Patient presented for follow-up a few weeks later and mother reports that he had vesicular rash, now crusted and papules with umbilicated center. ? varicella like rash from vaccine
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Eye irritation, Eye pruritus, Malaise, Pruritus
Clinical narrative: Approx one hour after MMR given in Occ Health patient developed itchy face, itchy and irritated eyes and feeling unwell. She went directly to the Emergency Dept here at the Clinic. RN who gave vaccine had patient wait in clinic 10 minutes after giving it.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site. Mother reports pt began having redness and swelling within one hour of injection. When pt came in for appointment today, mother reported reaction. There was still redness and swelling noted to the injection site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Brain natriuretic peptide increased, C-reactive protein increased, Chest pain, Electrocardiogram ST segment depression, Exercise electrocardiogram
Clinical narrative: Patient developed swelling and pain at injection site. Later in week (4 days) later patient developed palpitations and chest pain which she attributed to her injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Exercise electrocardiogram normal, Injection site pain, Injection site swelling, Palpitations, Red blood cell sedimentation rate increased
Clinical narrative: Patient developed swelling and pain at injection site. Later in week (4 days) later patient developed palpitations and chest pain which she attributed to her injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Patient developed swelling and pain at injection site. Later in week (4 days) later patient developed palpitations and chest pain which she attributed to her injection.
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, Pain
Clinical narrative: drug is supposed to be SQ, i gave IM, that is the event i'm reporting. pt reports to be a little sore.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: Patient experienced redness, warmth, bump, and rash that spread under her arm. She noticed the reaction the next day and the rash has spread over her arm
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: imz is supposed to be SQ, i administered IM, that is what i'm reporting. pt reports no adverse effects.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin irritation, Skin warm, Swelling, Urticaria
Clinical narrative: Patient was given a pneumovax vaccine today at her visit. She noticed slight irritation this morning, and it has progressed. Now she has a round swollen area about the size of a tennis ball, redness/warmth and 2 hives have appeared on the red area. Patient states she did take 2 tylenol 500mg to see if that would help and has been icing it off and on. Patient is wondering what to do. She has never had a reaction like this previously with any vaccination.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: SWELLING, TENDER TO TOUCH, REDDISH PURPLE COLOR, PAIN WITH MOVEMENT
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: imz is supposed to be SQ, i administered IM, that is what i'm reporting. i tried to call pt to notify but she didn't pick up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Injection site swelled to larger than golf ball size.  Area was red and painful.  Chills, lethargy experienced next day for approximately 24 hours
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: Tissue surrounding injection site became itchy and inflamed starting 2 days after injection.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Provider at local ER states that the patient has suffered a seizure.  Patient is not currently being treated for seizures and has no history of seizures noted.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pruritus
Clinical narrative: Redness and soreness next day, lump in  deltoid about 2-3 inches away from injection site. Lump is about 3 inches in diameter. Experiences similar  adverse effect after 1st dose and each year after flu shot but the size of lump , itchiness, and redness a lot more . Reaction lasted for more than 2 weeks and got better without treatment. Itching still on as at today
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Patient arm has knot and is red and itchly, looks like typical injection site reaction but patient did want reaction reported. No issues with movement and slight pain if touched. Reaction (redness and itching) is gradually improving.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin tightness, Skin warm, Swelling
Clinical narrative: red swollen circle, 2 inches in diameter, body aches, hot and tight, slightly off center of deltoid; no treatment yet
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Rash at injection site and very sore arm
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Sacral blistering rash 48 hours after immunization with SHINGRIX
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Pain
Clinical narrative: Irregular urticarial reaction left deltoid noted with largest patch in region of injection and a linear series of welts going around anteromedially. Benadryl and tylenol for pain
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Irritability, Occult blood, Ultrasound abdomen normal
Clinical narrative: Patient developed irritability and passed a grossly bloody stool.  Was sent to ER and intussusception was ruled out with ultrasound.  Patient was seen in my office today and is doing better.  Still having mild diarrhea but non bloody and irritability is gone.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site paraesthesia, Pain, Paraesthesia, Pyrexia
Clinical narrative: Patient reports no pain at time of administration. At approximately 10:30 pm the same evening as the vaccine was administered, patient reports noticing a painful red (not raised) rash developing underneath the arm near the left armpit. Patient also reports fever (temperature unknown), severe throbbing pain at and around injection site, and tingling sensation from left shoulder to left wrist. Timeframe of fever/pain development is unclear from patient report. Patient reports rash had spread from underneath arm to left breast. Rash was not causing pain today (5/16/19) and fever no longer present per patient report. Patient denied shortness of breath and throat/lip swelling/tingling. No treatment given, patient advised to follow up with primary care physician.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient reports no pain at time of administration. At approximately 10:30 pm the same evening as the vaccine was administered, patient reports noticing a painful red (not raised) rash developing underneath the arm near the left armpit. Patient also reports fever (temperature unknown), severe throbbing pain at and around injection site, and tingling sensation from left shoulder to left wrist. Timeframe of fever/pain development is unclear from patient report. Patient reports rash had spread from underneath arm to left breast. Rash was not causing pain today (5/16/19) and fever no longer present per patient report. Patient denied shortness of breath and throat/lip swelling/tingling. No treatment given, patient advised to follow up with primary care physician.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Headache, body aches, nausea, chills, painful right arm, swelling of right arm, red mark on right arm began around 10:00pm on day of injection and lasted 2 days
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Headache, body aches, nausea, chills, painful right arm, swelling of right arm, red mark on right arm began around 10:00pm on day of injection and lasted 2 days
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Pain at injection site at rest.  Fatigue and myalgia with interference activity.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Apnoea, Cyanosis, Electrocardiogram, Electroencephalogram, Resuscitation
Clinical narrative: Pt had seizure followed by cyanosis. FOC gave rescue breaths and called 911. Pt had 3-4 apneic events in ambulance lasting less than 10 seconds. Pt admitted overnight - observation - EEG/ECG.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Seizure
Clinical narrative: Pt had seizure followed by cyanosis. FOC gave rescue breaths and called 911. Pt had 3-4 apneic events in ambulance lasting less than 10 seconds. Pt admitted overnight - observation - EEG/ECG.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Respiratory arrest, Resuscitation, Seizure
Clinical narrative: Pt had seizure followed by cyanosis. FOC gave rescue breaths and called 911. Pt had 3-4 apneic events in ambulance lasting less than 10 seconds. Pt admitted overnight - observation - EEG/ECG.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia, Respiratory arrest, Resuscitation, Seizure
Clinical narrative: Pt had seizure followed by cyanosis. FOC gave rescue breaths and called 911. Pt had 3-4 apneic events in ambulance lasting less than 10 seconds. Pt admitted overnight - observation - EEG/ECG.