chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to two unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M033905, expiration date 20-JUL-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit (-9 to 8 degrees Celsius) for 8 hours. Data logger was involved. Previous excursion of 6 to 14 degrees Fahrenheit / -14 to -10 degrees Celsius for 2 hours was also reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, reported as six days after vaccination, the patient experienced shingles. No treatment was given for the adverse event. The outcome of shingles was unknown. The relatedness between the event of shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, site of administration and lot number not reported). On an unknown date, a year after the vaccination, the patient developed a mild case of shingles. The outcome of the event was unknown. The relationship between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 23-FEB-2017, the patient was vaccinated with an improperly store dose of VARIVAX, subcutaneously, lot number M038225 with expiration date 07-SEP-2018 (dose and anatomical location were not reported). The vaccine was exposed to temperatures between 6 F (Fahrenheit) (-14 C (Celsius)) to 14F (-10C) during 6 hours. There was no previous temperature excursion. Data logger was filled. No adverse effects were noted for the patient. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012499: US-009507513-1703USA003697:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 27-FEB-2017, the patient was vaccinated with an improperly store dose of VARIVAX, subcutaneously, lot number M033212 with expiration date 13-SEP-2018 (dose and anatomical location were not reported). The vaccine was exposed to temperatures between 6 F (Fahrenheit) (-14 C (Celsius)) to 14F (-10C) during 6 hours. There was no previous temperature excursion. Data logger was filled. No adverse effects were noted for the patient. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA003697: US-009507513-1703USA012498:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient might have been vaccinated with improperly stored PNEUMOVAX23 injection, lot # M043424, expiration date: 06-JUN-2018 (dose and route of administration were not reported). Temperature excursion ranged from 47 to 77 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. Digital data logger was used. No adverse effect was reported. No product quality complaint was involved. This is one of three reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009340: US-009507513-1703USA012509:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient might have been vaccinated with improperly stored ROTATEQ orally, lot # M038847, expiration date: 27-APR-2018 (dose was not reported). Temperature excursion ranged from 47 to 77 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. Digital data logger was used. No adverse effect was reported. No product quality complaint was involved. This one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012508: US-009507513-1703USA009340.
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on23Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a female patient (daughter) of unknown age and race received TRUMENBA on unknown date at single dose for immunization. Medical history and concomitant medication were unknown. On unknown date the patient experienced headache and body ache. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Local swelling, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable office manager calling on behalf of a physician. The office manager reported similar events for 3 patients. This is the 2nd of 3 reports. A female patient of an unspecified age received PREVNAR 13 (LOT R19477; expiration Jan2018) via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced local swelling and arm pain. The outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017129381 same reporter/drug, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Influenza like illness, Myalgia, Swelling
Clinical narrative: This is a spontaneous report from a contactable office manager calling on behalf of a physician. The office manager reported similar events for 3 patients. This is the 3rd of 3 reports. A female patient of an unspecified age received PREVNAR 13 (LOT R19477; expiration Jan2018) via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced flu like symptoms, swelling, myalgia, fatigue. The outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017129381 same reporter/drug, different patient.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant (patient' father) via Pfizer sales representative. A 16-year-old male patient received the first or maybe the second dose of TRUMENBA, on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after receiving the vaccine, the patient experienced swelling, pain at the injection site and red streaking on his arm. Pain and swelling went away after a couple of days. Outcome of red streaking was unknown.
Sex: U
Vaccine: MEN, MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable Physician. A child  patient of unspecified age ethnicity and gender received TRUMENBA at single dose on an unspecified date for immunisation, and MENINGOCOCCAL VACCINE at an unspecified dose, both via an unspecified route of administration for immunisation. The patient medical history and concomitant medications were not reported. The patient had a headache like a hour and a half later after receiving TRUMENBA and MCV on an unspecified date with outcome of unknown.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse and medical assistant reporting on behalf of the nurse. An 18-year-old female patient received TRUMENBA (Lot number R56655, Expiry Date 23Mar2017, NDC number 00050100010), intramuscular at single dose in the left deltoid on 27Feb2017 16:35 for immunisation. The patient medical history was not reported. Concomitant medication included FLONASE 50 mcg nasal spray suspension. The patient previously took GARDASIL intramuscular in right deltoid on 21Nov2016 for immunisation. On an unspecified date, the patient experienced innervated area like a raised hard area underneath her skin where the immunization was given one month ago, redness, swelling. Therapeutic measures were taken as a result of the events included Ibuprofen 400 mg, 3 times a day. The outcome was unknown.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis left upper extremity. Given Bactrim.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, and vomiting for 2 days with redness, swelling of upper right extremity. Diagnosis of cellulitis. Treated with cephalexin.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Fever, chills, and vomiting for 2 days with redness, swelling of upper right extremity. Diagnosis of cellulitis. Treated with cephalexin.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blister, Erythema, Injection site erythema, Injection site reaction, Rash erythematous
Clinical narrative: Patient was noted to have a dermal lesion on the lower arm that measured approximately 1.5 cm in diameter.  This lesion was made up of four or five 2mm in diameter vesicular lesions in close proximity to one another (cluster).  The area around the lesion was erythematous, but did not appear to be pruritic. Vesicles were intact.  A second, perhaps older, lesion was subsequently noted on the thigh. This second lesion was approximately the same size and was also erythematous, non pruritic. Clusters of about 2mm raised lesions made up the lesion, but these clusters were not apparent visually and could only be deciphered by palpation.  Two of the 2mm bumps had evidence of thin dark red scabbing on the surface measuring about 1mm in diameter.  This cluster looked like it was recently vesicular, but had ruptured.  Parent making this report was not present at vaccination, but believes that patient was vaccinated  intramuscularly on the thigh.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Scab, Skin lesion
Clinical narrative: Patient was noted to have a dermal lesion on the lower arm that measured approximately 1.5 cm in diameter.  This lesion was made up of four or five 2mm in diameter vesicular lesions in close proximity to one another (cluster).  The area around the lesion was erythematous, but did not appear to be pruritic. Vesicles were intact.  A second, perhaps older, lesion was subsequently noted on the thigh. This second lesion was approximately the same size and was also erythematous, non pruritic. Clusters of about 2mm raised lesions made up the lesion, but these clusters were not apparent visually and could only be deciphered by palpation.  Two of the 2mm bumps had evidence of thin dark red scabbing on the surface measuring about 1mm in diameter.  This cluster looked like it was recently vesicular, but had ruptured.  Parent making this report was not present at vaccination, but believes that patient was vaccinated  intramuscularly on the thigh.
Sex: U
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The nurse reported that, on 07-MAR-2017, the patient received an improperly stored dose of VARIVAX subcutaneously, lot number: M037643, expiration date: 01-SEP-2018 (strength, dose, frequency, and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 10 Fahrenheit (F) (between 6F to 14F), for 40 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report was received from a licensed practical nurse, regarding a female patient of unknown age. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 21-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, and route was not provided) lot number: N003993; expiration date: 20-OCT-2018, for prophylaxis. On the same date, after receiving the injection, the patient developed a "red, hot, and hard lump at the injection site". The patient sought medical attention by calling a physician's office and no intervention was performed to prevent serious criteria. She was prescribed MEDROL DOSEPACK and an unspecified antibiotic by her physician to treat the events. At the time of reporting, the outcome of the events was unknown. The reporter did not provide a causality assessment between the suspect vaccine and the events: injection site reaction, injection site warmth, injection site erythema, and injection site induration. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-00950513-1703USA012535.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report was received from a licensed practical nurse, regarding a male patient of unknown age. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 21-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dose, and route was not provided) lot number: N003993; expiration date: 20-OCT-2018, for prophylaxis. On the same date, after receiving the injection, the patient developed a "red, hot, and hard lump at the injection site". The patient sought medical attention by calling a physician's office but no intervention to prevent serious criteria was performed. He was prescribed methylprednisolone (MEDROL DOSEPACK) and an unspecified antibiotic by his physician to treat the events. At the time of reporting, the outcome of the events was unknown. The reporter did not provide a causality assessment between the suspect vaccine and the events: injection site reaction, injection site warmth, injection site erythema, and injection site induration. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA011244:
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Given extra Hep B vaccine. No symptoms.
Age: 53.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: 1cm soft, flat mobile lesion at MMR administration site; no skin changes.
Age: 27.0
Sex: M
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Malaise, Pruritus, Pyrexia, Skin lesion, Varicella zoster virus infection
Clinical narrative: TWO WEEKS AFTER RECEIVING VACCINES PT. REPORTS FEVER, MALAISE, AND VARIOUS PRURITUS LESIONS ON HIS TRUNK AND BACK. PT WENT TO PCP AND AS DIAGNOSED WITH VZV, ANTIVIRAL MEDICATION PRESCRIBED. LESIONS AND SYMPTOMS DISSIPATED ONE WEEK LATER.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chest pain, Chills, Dizziness, Feeling abnormal
Clinical narrative: Pt received  pneumococcal vaccine in L arm on Wednesday 3/22 at 3pm, started feeling bad and lightheaded within an hour, pt continued to feel bad throughout the night, then developed a fever on Thursday AM and her L arm was swollen with shooting pain. Thursday night she was bedridden with the chills, shakes, N/V, and severe headache. The shooting pain by then  spread to the whole left side accompanied with chest pain.  Pt called the appointment line on Friday early morning and was told to call 911.  Pt was then taken to the ER by a friend within 30 min.  Her BP was fond to be low and WBC was very elevated.  Pt was diagnosed with cellulitis and sepsis.  Pt is returned home on 3/27.  At the time of phone call on 3/28, pt still has shooting pain in the L arm and neck. The injection site is still very tender to touch.  Pt was discharged with antibiotics and pain meds. she continues to rotate percocet w/ ibuprofen every 6 hrs as instructed.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hypotension, Injection site pain, Nausea, Neck pain
Clinical narrative: Pt received  pneumococcal vaccine in L arm on Wednesday 3/22 at 3pm, started feeling bad and lightheaded within an hour, pt continued to feel bad throughout the night, then developed a fever on Thursday AM and her L arm was swollen with shooting pain. Thursday night she was bedridden with the chills, shakes, N/V, and severe headache. The shooting pain by then  spread to the whole left side accompanied with chest pain.  Pt called the appointment line on Friday early morning and was told to call 911.  Pt was then taken to the ER by a friend within 30 min.  Her BP was fond to be low and WBC was very elevated.  Pt was diagnosed with cellulitis and sepsis.  Pt is returned home on 3/27.  At the time of phone call on 3/28, pt still has shooting pain in the L arm and neck. The injection site is still very tender to touch.  Pt was discharged with antibiotics and pain meds. she continues to rotate percocet w/ ibuprofen every 6 hrs as instructed.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Sepsis
Clinical narrative: Pt received  pneumococcal vaccine in L arm on Wednesday 3/22 at 3pm, started feeling bad and lightheaded within an hour, pt continued to feel bad throughout the night, then developed a fever on Thursday AM and her L arm was swollen with shooting pain. Thursday night she was bedridden with the chills, shakes, N/V, and severe headache. The shooting pain by then  spread to the whole left side accompanied with chest pain.  Pt called the appointment line on Friday early morning and was told to call 911.  Pt was then taken to the ER by a friend within 30 min.  Her BP was fond to be low and WBC was very elevated.  Pt was diagnosed with cellulitis and sepsis.  Pt is returned home on 3/27.  At the time of phone call on 3/28, pt still has shooting pain in the L arm and neck. The injection site is still very tender to touch.  Pt was discharged with antibiotics and pain meds. she continues to rotate percocet w/ ibuprofen every 6 hrs as instructed.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Tremor, Vomiting, White blood cell count increased
Clinical narrative: Pt received  pneumococcal vaccine in L arm on Wednesday 3/22 at 3pm, started feeling bad and lightheaded within an hour, pt continued to feel bad throughout the night, then developed a fever on Thursday AM and her L arm was swollen with shooting pain. Thursday night she was bedridden with the chills, shakes, N/V, and severe headache. The shooting pain by then  spread to the whole left side accompanied with chest pain.  Pt called the appointment line on Friday early morning and was told to call 911.  Pt was then taken to the ER by a friend within 30 min.  Her BP was fond to be low and WBC was very elevated.  Pt was diagnosed with cellulitis and sepsis.  Pt is returned home on 3/27.  At the time of phone call on 3/28, pt still has shooting pain in the L arm and neck. The injection site is still very tender to touch.  Pt was discharged with antibiotics and pain meds. she continues to rotate percocet w/ ibuprofen every 6 hrs as instructed.
Age: 45.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Bone pain, Pain, Rash macular
Clinical narrative: Patient complained of macular rash signs on both posterior upper arms (left and right deltoids) and symptoms of body aches and soreness all over her body to the Triage Nurse (in person) on 11/17/2016. Patient was encouraged to take Motrin 600mg every 6 hours with food as needed for pain, and Benadryl 25mg as needed for her rash on 11/17/2016. On 11/21/2016, the patient reported no rash and reduced bone pain.
Sex: U
Vaccine: HEPA, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other healthcare worker and refers to three patients of unknown age or gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown dates, one unspecified patient was vaccinated with a dose of improperly stored ROTATEQ, lot # M018958, expiration date: 03-MAR-2018 and two unspecified patients were vaccinated with improperly stored doses of VAQTA, lot # M032492, expiration date: 02-MAR-2018 (dose and route were unknown) for prophylaxis.  No adverse effects reported. The temperature for the vaccines stored was 0 degrees Celsius to 1 degree Celsius, with 5 hours time frame. Previous temperature excursion was not reported. Data logger was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Chest pain, Post herpetic neuralgia, Rash
Clinical narrative: Information was received on 13-MAR-2017 from an elderly male patient. Medical history/concurrent conditions included hypothyroidism, overactive bladder, and allergy to unspecified medication for overactive bladder. Concomitant medications were reported as unspecified thyroid medication. The patient reported that back in 1996, he developed a "severe case of the shingles". Then in 2007, he received the ZOSTAVAX vaccine, which is other then indicated in the prescribing information. On an unspecified date, the patient developed a rash and a spike in his temperature. He then started to develop severe chest and back pain and would be woken from deep sleep because of the pains. He was prescribes various medications that did not help him. When asked if he sought medical attention- he replayed "yes: talked with physician."The patient has suffered with these adverse events from about 20-21 months, however the patient stated that the past 2-3 months, the pain has been worse. He also stated that he was recently diagnosed with post-neuralgia. The patient's current status is not recovered. No further adverse event information was provided.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Information was received on 13-MAR-2017 from an elderly male patient. Medical history/concurrent conditions included hypothyroidism, overactive bladder, and allergy to unspecified medication for overactive bladder. Concomitant medications were reported as unspecified thyroid medication. The patient reported that back in 1996, he developed a "severe case of the shingles". Then in 2007, he received the ZOSTAVAX vaccine, which is other then indicated in the prescribing information. On an unspecified date, the patient developed a rash and a spike in his temperature. He then started to develop severe chest and back pain and would be woken from deep sleep because of the pains. He was prescribes various medications that did not help him. When asked if he sought medical attention- he replayed "yes: talked with physician."The patient has suffered with these adverse events from about 20-21 months, however the patient stated that the past 2-3 months, the pain has been worse. He also stated that he was recently diagnosed with post-neuralgia. The patient's current status is not recovered. No further adverse event information was provided.  Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal discomfort, Diarrhoea, Erythema, Skin warm
Clinical narrative: Employee stated he had urgent need to use the restroom. Stated he had 2 episodes of diarrhea. Employee informed possible allergic reaction. Was questioned if body had any itching stated none. S/S employee had was redness not at vaccine site bilateral ears and stomach discomfort no urge to vomit and loose stool X2 within the last 30 minutes.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash started the night after injection covering whole body.  Slightly itchy.  Benadryl was given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Pt had localized swelling, redness and bruising at the site.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient wife reported that patient had itching at injection site, localized tenderness, erythema at injection site, and swelling at injection site. Said this occurred earlier but reported to us at 8:50PM.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt. fainted, became unconscious. Pt. regained consciousness after a minute or two.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: Pt received PPSV23 at 10:30AM during normal well visit. Feeling well. In the afternoon she reports she began to feel dizzy, arm (L) was heavy with red, swollen, tender spot at injection site. She denies fever. Used Ibuprofen, ice, BENADRYL-resolved next day.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pruritus generalised, Urticaria, Vaccination site pain, Vaccination site swelling
Clinical narrative: Generalized itching and hives. Patient also had redness, tenderness and swelling at vaccination site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient specifies that she received the vaccine on 03/21/2017, pain on the left arm in the afternoon and on Wednesday it was red and warm to touch. It looks warm to touch and a little red.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site erythema, Pain in extremity
Clinical narrative: Pain under arm. Red strip from vax site to under arm. Arm was red and sore. Still have to this day a 2 inch wide faint strip but pain has gotten better. Pain lasted for about 3 days. Has never received this vaccine before. Checked with pharmacist on 3/19.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, VARCEL, MMR
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, VARCEL, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Rash all over body.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain lower, Administration site odour, Biopsy skin, Hyperhidrosis, Injection site pain
Clinical narrative: Noticed on informative paper printed and given to me GSK is mentioned in bottom corner in regards to this vaccination. A different Mfr. was given to me by a staff member. Sunday morning following vaccine on Friday afternoon, a bump rather large on my nose, dirty looking particle on biopsy in appearance, discharge on urinating. Still have some signs of menstruation and some lower abdominal cramps. Also, soreness in area where injection was given - took off band aid this day. No signs of more bleeding, just a point from previous entry that was not covered by the cotton part of the band aid. It was covered by the sticky part near the box of cotton. Much aches and pains all over, especially in back, legs, and ankles. The manufacturer that was mentioned as the provider for this vaccine is Sanofi Pasteur. However, on the information paper given to me with info about the vaccine has the (GSK) mentioned at the bottom of page. In previous forms this is a manufacturer - GlaxoSmithKline. On the info paper, only the symbol with initials are legible. The print after it is too foggy to comprehend. Today's food intake is: Coffee - regular, caffeinated, instant in the AM and at lunchtime with 3 small tsp. sugar and some whole milk. Breakfast for me and dog was scrambled eggs (4) between the 2 of us. A snack was butter cookies. Another snack is island pineapple yellow jello. Saturday night was a bowl of chili and some saltine crackers. With PM meds was a bowl of island pineapple flavored jello. This AM a glass of grape juice. Yesterday in the morning was a bowl of cereal and whole milk. Friday night was a can of beef raviolis. Friday a bag of eggs - white chocolate coat and peanut butter fill - whole bag. Several snacks with a sweet taste craved - maybe menstrual cycle related or related to a diet or blood need that is insufficient or not being filled. Sunday following vaccine, there is an odor. Sunday morning call to nurse line mentioned on back of health insurance card to ask if okay to remove band aid and mention any symptoms. Sunday afternoon some sweats break out after having coffee.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Menstruation normal, Pain, Rash, Urine abnormality
Clinical narrative: Noticed on informative paper printed and given to me GSK is mentioned in bottom corner in regards to this vaccination. A different Mfr. was given to me by a staff member. Sunday morning following vaccine on Friday afternoon, a bump rather large on my nose, dirty looking particle on biopsy in appearance, discharge on urinating. Still have some signs of menstruation and some lower abdominal cramps. Also, soreness in area where injection was given - took off band aid this day. No signs of more bleeding, just a point from previous entry that was not covered by the cotton part of the band aid. It was covered by the sticky part near the box of cotton. Much aches and pains all over, especially in back, legs, and ankles. The manufacturer that was mentioned as the provider for this vaccine is Sanofi Pasteur. However, on the information paper given to me with info about the vaccine has the (GSK) mentioned at the bottom of page. In previous forms this is a manufacturer - GlaxoSmithKline. On the info paper, only the symbol with initials are legible. The print after it is too foggy to comprehend. Today's food intake is: Coffee - regular, caffeinated, instant in the AM and at lunchtime with 3 small tsp. sugar and some whole milk. Breakfast for me and dog was scrambled eggs (4) between the 2 of us. A snack was butter cookies. Another snack is island pineapple yellow jello. Saturday night was a bowl of chili and some saltine crackers. With PM meds was a bowl of island pineapple flavored jello. This AM a glass of grape juice. Yesterday in the morning was a bowl of cereal and whole milk. Friday night was a can of beef raviolis. Friday a bag of eggs - white chocolate coat and peanut butter fill - whole bag. Several snacks with a sweet taste craved - maybe menstrual cycle related or related to a diet or blood need that is insufficient or not being filled. Sunday following vaccine, there is an odor. Sunday morning call to nurse line mentioned on back of health insurance card to ask if okay to remove band aid and mention any symptoms. Sunday afternoon some sweats break out after having coffee.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Headache
Clinical narrative: That same day of receiving them he had a bad headache. The next day he had BAD gut aches and diarrhea that is still happening to this day. His gut aches have subsided some. (3/23/17) Still has stomach cramps and diarrhea.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Redness to insertion site. Sore muscles of L arm. Fever. Nausea and 1 episode of vomiting.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Two weeks after vaccine, (R) arm shoulder with moderate soreness and severe when arm raised, the next day left arm shoulder with same pain, unable to raise arms. 4 days later both arms still sore with numb/tingle in hand, jaw soreness 4th day.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Pain in jaw, Paraesthesia
Clinical narrative: Two weeks after vaccine, (R) arm shoulder with moderate soreness and severe when arm raised, the next day left arm shoulder with same pain, unable to raise arms. 4 days later both arms still sore with numb/tingle in hand, jaw soreness 4th day.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Pyrexia, Rash, Swelling
Clinical narrative: Fever, itchy red swelling and rash, after work. I took BENADRYL Allergy, an TYLENOL Plus.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Systemic itchy rash - bumps. Gradual onset approximately 2 weeks after vaccine; continues to progress.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain at site redness that progress in size around insertion site to tennis ball sized area that resolved after 3 days with hardness to area.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Mom presents w/child to clinic ER. Rash on chest and back several hours after immunization. No fever or other Sx. BENADRYL dispensed.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt reports to clinic for f/u appointment with provider. Reports to RN and this nurse that the area where she got vaccine is swollen, warm to touch and hurts. Area is swollen upon inspection, measures 55 cm wide, pt denies any fever. Pt evaluated by provider, advise on BENADRYL and cold compress and to D/C vaccine series. Per nurse provider to consult for further management.
Age: 33.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Incontinence, Loss of consciousness, Seizure
Clinical narrative: Pt lost consciousness and became incontinent -wife reported pt had a seizure but I was not present at the onset of symptoms within minutes of administration.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Eye pain, Eye pruritus, Fatigue
Clinical narrative: Swelling and sore - 5 days with sore, itchy eyes. Fever 6 hr. Headache 3 days. Fatigue - 5 days. Nausea - 15 days and Thirsty - 2 days. Dizzy - when move - 3 days worth, then another week and short of breath. I could not do 1 flight of stairs when usually do 10 flights or more.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Swelling and sore - 5 days with sore, itchy eyes. Fever 6 hr. Headache 3 days. Fatigue - 5 days. Nausea - 15 days and Thirsty - 2 days. Dizzy - when move - 3 days worth, then another week and short of breath. I could not do 1 flight of stairs when usually do 10 flights or more.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Thirst
Clinical narrative: Swelling and sore - 5 days with sore, itchy eyes. Fever 6 hr. Headache 3 days. Fatigue - 5 days. Nausea - 15 days and Thirsty - 2 days. Dizzy - when move - 3 days worth, then another week and short of breath. I could not do 1 flight of stairs when usually do 10 flights or more.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Crying, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Hot, reddened, painful injection site (right upper arm). Severe arm pain (continues at present). Severely limited arm movement (continues at present). Fatigue, bouts of crying, chills (continues at present). Irritability. Hot soaks applied and heating pad as TX. Some SX's persist at present.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Irritability, Mobility decreased, Pain in extremity
Clinical narrative: Hot, reddened, painful injection site (right upper arm). Severe arm pain (continues at present). Severely limited arm movement (continues at present). Fatigue, bouts of crying, chills (continues at present). Irritability. Hot soaks applied and heating pad as TX. Some SX's persist at present.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Limb mass, Skin discolouration
Clinical narrative: Swelling at site with redness and itching initially. Currently small lump in (L) arm and slight discoloration. Marked improvement. No s/sx of anaphylactic allergy.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: On 3/24/17 in the AM, patient experienced a red, itchy rash approximately 5 inches in diameter at the administration site. Patient also reported a slight fever (not measured).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient generalized swelling on left upper arm from shoulder to elbow. Applied cold packs and took BENARDYL. Took approximately 1 week for reaction to subside.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: IIV4 received 11/6/2017. UTD 2016-2017 flu season Client vaccinated on 3/17/17 with IIV4 dose #2 non-valid dose received.
Age: 29.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Onset swelling same evening in (R) arm. Itching, reddened. Notes she had mild itching with prior varicella vaccine 1 month ago.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Fear of injection, Immediate post-injection reaction, Tremor
Clinical narrative: Patient began to shake and tremble after needle withdrew from administration site. Patient stated he was afraid of needles. 5 minutes later patient was back to normal. VS normal.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash and swelling at site. Small, red spot became 3.5 inches in diameter. Itching at site.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Acute localized cellulitis reaction to MMRV site.
Age: 68.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain
Clinical narrative: Muscle pain in upper right arm since receiving it on Oct. 1, 2015.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event
Clinical narrative: None.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site inflammation
Clinical narrative: Large inflammatory skin reaction surrounding injection site 24 hours after receiving influenza vaccine, temp 101.
Age: 7.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, HEPA, MMRV, UNK
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Pt's. left arm has 6 cm x 6.5 cm raised reddened area. Pt. C/O soreness to touch.
Age: 7.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, HEPA, MMRV, UNK
Symptoms: Vaccination complication
Clinical narrative: Pt's. left arm has 6 cm x 6.5 cm raised reddened area. Pt. C/O soreness to touch.
Age: 43.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Fatigue, Headache, Pain, Rash, Rash erythematous
Clinical narrative: The night of the vaccine I woke up at approximately 1am with a very bad headache. I took ADVIL and drank water. The headache continued the next day and I have been experiencing them just about everyday since. I have felt very fatigued and have had frequent body aches that come and go. I have been resting, taking ADVIL and drinking a lot of water. I noticed small red spots on my trunk today, 15Mar2017, and immediately contacted my Supervisor.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Feeling cold, Headache, Hyperhidrosis, Tremor
Clinical narrative: Shaking, cold, clammy, sweaty, headache. Gave BENADRYL and KENALOG in office to try to help. It didn't.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Mobility decreased, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Sore muscles and lack of movement. Could not get off floor. Paralysis in extremities.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Paralysis
Clinical narrative: Sore muscles and lack of movement. Could not get off floor. Paralysis in extremities.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Gait disturbance, Irritability, Local reaction, Petechiae, Serum sickness-like reaction
Clinical narrative: Initial unsolicited report received from a physician on 14-MAR-2017. This case involves a 24-months old female patient who was vaccinated with a fourth dose of DAPTACEL (batch number: C5148AA, expiry date: 09-FEB-2019, dose and dose in series were not reported) in the right leg (right thigh) on 01-MAR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination was reported as none. Any other vaccinations within four weeks of vaccinations were also not reported. Concomitant medications were not reported. On 02-MAR-2017, one day following the vaccination, the patient had developed a myocitis which was symptomatized by a 9 cm raised red area with heat, swelling and pain and also experience pain when walking. It was also reported that the area was measured and found to be 10 cm still raised red and painful on the last week. The patient was previously vaccinated with three doses of DAPTACEL on an unknown date. The patient required emergency room (ER)/ doctor visit on an unknown date. Laboratory investigations were reported as Labs being done today. Corrective treatment was not reported. The outcome of event was reported as not recovered (showing little improvement with treatments). List of documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Erythema, Local swelling, Myositis, Pain, Skin warm
Clinical narrative: Initial unsolicited report received from a physician on 14-MAR-2017. This case involves a 24-months old female patient who was vaccinated with a fourth dose of DAPTACEL (batch number: C5148AA, expiry date: 09-FEB-2019, dose and dose in series were not reported) in the right leg (right thigh) on 01-MAR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination was reported as none. Any other vaccinations within four weeks of vaccinations were also not reported. Concomitant medications were not reported. On 02-MAR-2017, one day following the vaccination, the patient had developed a myocitis which was symptomatized by a 9 cm raised red area with heat, swelling and pain and also experience pain when walking. It was also reported that the area was measured and found to be 10 cm still raised red and painful on the last week. The patient was previously vaccinated with three doses of DAPTACEL on an unknown date. The patient required emergency room (ER)/ doctor visit on an unknown date. Laboratory investigations were reported as Labs being done today. Corrective treatment was not reported. The outcome of event was reported as not recovered (showing little improvement with treatments). List of documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Crying, Culture urine, Differential white blood cell count, Dizziness, Fall
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13-year-old female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 23-MAR-2017, the patient was vaccinated with the third dose of properly stored GARDASIL 9 injection, lot # M017983 with expiry date on 30-MAY-2018 (dose and route of administration were not reported). On the same day, approximately 3 minutes after administration of the vaccine, the patient was seated in a chair and observed by her mother and the reporting medical assistant. The patient was sitting upright and rigid in the chair with her arms bent at the elbow, hands drawn up to her shoulders and her head "back". The medical assistant stated that the patient appeared unresponsive for about a minute and then became responsive and "seemed completely all right after that." At that time, the patient was examined by a physician, who recommended a further examination at the local emergency department. The physician, reporting medical assistant and the mother of the patient continued to observe the patient for following 17 minutes and the family of the patient and the physician felt comfortable enough to allow the patient to be transported via the family's car to the emergency department. It was reported that the patient sought a medical attention. The outcome of the event was considered as recovered/resolved on 23-MAR-2017. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of appearing unresponsive was considered to be medically significant. Additional information is not expected because there was no consent to contact the physician.