chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician assistant referring to a 60 year old male patient. The patient had no pertinent medical history and no drug reactions/allergies. On 30-JUN-2015 the patient was vaccinated with ZOSTAVA vial (dose, frequency and route were not provided). The patient had no concomitant medication. On 30-JUN-2015, the patient developed pain at the injection site shortly after the administration on the same day. On 01-JUL-2015 ("yesterday"), the patient also began to experience erythema about 12cm by 6 to 8cm in size, warmth and tenderness at the injection site. No rash presented. On 02-JUL-2015 ("today"), the patient then came to the emergency department because he was concerned with the reaction. No lab diagnostics studies were performed. No treatment was given to the patient and he was discharged without being admitted to the hospital. The outcome of the events was reported as not recovered. Causality was not provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Information has been received from a physician assistant referring to a 60 year old male patient. The patient had no pertinent medical history and no drug reactions/allergies. On 30-JUN-2015 the patient was vaccinated with ZOSTAVA vial (dose, frequency and route were not provided). The patient had no concomitant medication. On 30-JUN-2015, the patient developed pain at the injection site shortly after the administration on the same day. On 01-JUL-2015 ("yesterday"), the patient also began to experience erythema about 12cm by 6 to 8cm in size, warmth and tenderness at the injection site. No rash presented. On 02-JUL-2015 ("today"), the patient then came to the emergency department because he was concerned with the reaction. No lab diagnostics studies were performed. No treatment was given to the patient and he was discharged without being admitted to the hospital. The outcome of the events was reported as not recovered. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored  GARDASIL which were exposed to 1.0 C for 5 hours, (Dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported). On an unknown date, the patient experienced shingles. The outcome of shingles was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt administered PROQUAD 0.5ml SQ x 1 (L) arm.
Age: 1.2
Sex: F
Vaccine: DTAP, HEPA, MMRV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever, rash (widespread). Alternate TYLENOL and ibuprofen; BENADRYL; epinephrine injection; ZANTAC; ORAPRED.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Headache, myalgia and fatigue, body aches, chills, temp=101, sweats and headache.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Pain
Clinical narrative: Headache, myalgia and fatigue, body aches, chills, temp=101, sweats and headache.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot # J006236 and expiry date: 25-FEB-2015) which was improperly stored. No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to multiple patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, multiple unspecified patients were vaccinated with improperly stored GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 08-JUL-2015 the patient was vaccinated with ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K016314 with expiration date: 15-JUN-2016) which was improperly stored. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: Blood creatine phosphokinase increased, Catheterisation cardiac normal, Fatigue, Intensive care, Myocardial infarction
Clinical narrative: 4 days after vaccine patient developed fever, nausea, vomiting, fatigue. He went to ER, was placed in ICU with concern for MI! Cath of heart was normal. Viral myocarditis was suspected. He was treated with IV antibiotics, d/ced after hospital d/c.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Troponin increased, Viral myocarditis, Vomiting
Clinical narrative: 4 days after vaccine patient developed fever, nausea, vomiting, fatigue. He went to ER, was placed in ICU with concern for MI! Cath of heart was normal. Viral myocarditis was suspected. He was treated with IV antibiotics, d/ced after hospital d/c.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: White blood cell count increased
Clinical narrative: 4 days after vaccine patient developed fever, nausea, vomiting, fatigue. He went to ER, was placed in ICU with concern for MI! Cath of heart was normal. Viral myocarditis was suspected. He was treated with IV antibiotics, d/ced after hospital d/c.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 04-MAY-2015 was vaccinated with a dose of oral ROTATEQ (lot # K015816, expiration date not reported) (dose and route not reported) that was 63 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administration were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 06-APR-2015 was vaccinated with an unknown dose of oral, ROTATEQ (lot # K011663) (route defaulted as oral) that was 12 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death, Pyrexia
Clinical narrative: Slight fever on Thursday night. Friday put to sleep on stomach for 2 hours and mother found him deceased.
Age: 33.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patient of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On an unspecified day, the unspecified number of patients received improperly stored (Oka/Merck) VARIVAX (dose, frequency, lot#, expiration date, route of administration and indication were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administration were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 07-APR-2015 was vaccinated with an unknown dose of ROTATEQ (lot # K011663) (route defaulted as oral) that was 12 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning an adult patient of unknown age and gender who on 13-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 103 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient says that her arm started itching a little the night of 7/15/2015. By morning on 7/16/2015, her injection site had a red, swollen, painful rash that had spread almost to her elbow.  She used Tylenol and Caladryl for relief.  I saw the rash on Sunday (7/19/15) and on Monday (7/20/15) and it had improved. I am unable to determine whether this was a reaction to something in the vaccine or a very mild shingles rash.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Balance disorder, Fall
Clinical narrative: Patient received 3 vaccines: 2nd dose Menveo, 2nd dose Hepatitis A, and First dose of Gardasil. After vaccines were given, patient stood up to walk toward our waiting room for wait time after receiving vaccines. Patient was going to wait in waiting where his mother was sitting. At the time he reached the waiting room door, he lost balance, physically turned around twice and ran 5 steps into a wall and fell to the floor.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized redness, swelling, and itching spread from the injection site almost completely down the patient's bicep before stopping. As of 7/19/15, the redness had not shrank significantly, but there is some improvement.
Age: 40.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Chills, Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: Red swollen, tender arm, body aches, chills, headache.
Age: 40.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Tenderness
Clinical narrative: Red swollen, tender arm, body aches, chills, headache.
Age: 40.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Chills, Erythema, Headache, Pain, Rash
Clinical narrative: Red swollen, tender arm, body aches, chills, headache.
Age: 40.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Chills, Dry skin, Erythema, Headache, Peripheral swelling
Clinical narrative: Red swollen, tender arm, body aches, chills, headache.
Age: 40.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: Red swollen, tender arm, body aches, chills, headache.
Age: 0.34
Sex: F
Vaccine: DTAP
Symptoms: Crying, Diet refusal, Irritability, Pain
Clinical narrative: Infant was extremely fussy the day of and after the vaccine, and she was never fussy before. The next day after the vaccination (DTaP) she refused to nurse and would intermittantly cry like she was in pain. She continued to refuse to nurse for three weeks (forced to pump to make sure she was getting enough nutrition). She continues to only nurse when almost sleeping, and refuses to when awake and alert. The only thing that was different/changed was the vaccine.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope, Visual impairment
Clinical narrative: Syncope. Palness, sweating, dizziness, visual disturbnaces. Treated with cold compress.
Age: 11.0
Sex: M
Vaccine: MNQ, TD, VARCEL
Symptoms: Cold sweat, Dizziness, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Within 10 minutes of receiving vaccines he became clammy in waiting room and felt lightheaded and heavy arms. Was better within 30 minutes and went home with mother. Later that morning, mother called Dr. because patient also started having headache, nausea and fever of 99.8F.  Also c/o throat feeling little funny.  Dr. informed her to take patient to ER if any other complaints or increased concerns. Took Ibuprofen at 11am and then alternated every 3-4 hours when awake with Acetaminophen over weekend. Nausea and funny throat feeling went away after Headache left after 1st dose of Acetaminophen.  H/A was full feeling and hurt worse when bent over and with other movement of body. Fever got up to 101 that Friday evening and up to 102F over weekend (possibly Saturday) and was down to 99.8F Monday am (7/20/15).  States has red area today and arm itches where Varicella vaccine given in left arm.
Age: 11.0
Sex: M
Vaccine: MNQ, TD, VARCEL
Symptoms: Limb discomfort, Nausea, Pain, Pyrexia, Throat irritation
Clinical narrative: Within 10 minutes of receiving vaccines he became clammy in waiting room and felt lightheaded and heavy arms. Was better within 30 minutes and went home with mother. Later that morning, mother called Dr. because patient also started having headache, nausea and fever of 99.8F.  Also c/o throat feeling little funny.  Dr. informed her to take patient to ER if any other complaints or increased concerns. Took Ibuprofen at 11am and then alternated every 3-4 hours when awake with Acetaminophen over weekend. Nausea and funny throat feeling went away after Headache left after 1st dose of Acetaminophen.  H/A was full feeling and hurt worse when bent over and with other movement of body. Fever got up to 101 that Friday evening and up to 102F over weekend (possibly Saturday) and was down to 99.8F Monday am (7/20/15).  States has red area today and arm itches where Varicella vaccine given in left arm.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, PPV, TDAPIPV, VARCEL
Symptoms: Fatigue, Herpes zoster, Pyrexia, Rash
Clinical narrative: Patient developed shingles after receiving the chicken pox vaccine. I noticed the bumps on the 15th but did not think it was shingles. Shingles were diagnosed on July 20, 2015. She has had fever, severe rash on the back of her neck, and fatigue.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose increased, Dizziness, Injection site rash, Syncope
Clinical narrative: Pt experienced dizziness/faintness and developed a rash under injection site 36 hours post vaccination. Pt may visit Dr to be evaluated if dizziness/faintness unresolved. Fasting bg was 126 the am of 7/20 and bp was unknown.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Cold sweat, Dizziness, Nausea, Pallor
Clinical narrative: After receiving vaccines: Hepatitis A, MCV4 #2.  Client became very pale, clammy, c/o nausea and dizziness. Time:  12:07 PM  B/P 110/70. Cool pack applied to clients neck, soft drink and foods were given to client to eat.
Age: 0.18
Sex: M
Vaccine: PNC13
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Rash in all body including face, trunk and extremities, sparing palms and diaper area. Maculo-papular.  Not evaluated by same physician as currently making report, description as per mom.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Abasia, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Fatigue, seizure, low fever, inability to walk that day.  Headaches, high fever site pain and swelling persisting for several days after.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Pyrexia, Seizure
Clinical narrative: Fatigue, seizure, low fever, inability to walk that day.  Headaches, high fever site pain and swelling persisting for several days after.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Blood glucose normal, Eye movement disorder, Fall, Fatigue, Head injury
Clinical narrative: She was standing and fell straight backwards, she hit the floor with her head and her eyes rolled up and remained open as she began to convulse for about 12 seconds. She stayed still for a second with her eyes open and then appeared to come back, she did not know what happened to her. For the next 3 days she had a fever 100-102, and has been very tired.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Metabolic function test, Pyrexia, Seizure
Clinical narrative: She was standing and fell straight backwards, she hit the floor with her head and her eyes rolled up and remained open as she began to convulse for about 12 seconds. She stayed still for a second with her eyes open and then appeared to come back, she did not know what happened to her. For the next 3 days she had a fever 100-102, and has been very tired.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: At the time of examination on 07/19/2015 in the PM, of note was 12cm of well-circumscribed flat erythema to lateral/anterior left thigh. Warm to touch. No fluctuance or abscess formation. No drainage. Right thigh immunizations site unremarkable.  Area was marked and patient was given sulfamethoxazole-trimethoprim to take twice a day for 10 days.  Patient did return to ER on 7/20/2015 for further treatment.  No additional treatment known as of yet.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Pain
Clinical narrative: HEADACHE, GENERAL BODYACHES NO FEVER.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Slow response to stimuli
Clinical narrative: Severe pain in right hand after injection in right arm.  Throat tightening 2 hours post-vaccine.  Headache, dizziness, fatigue, slow mental response time x 48 hours after the vaccine was given (ongoing).  Facial swelling 60 hours post-vaccine.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Swelling face, Throat tightness
Clinical narrative: Severe pain in right hand after injection in right arm.  Throat tightening 2 hours post-vaccine.  Headache, dizziness, fatigue, slow mental response time x 48 hours after the vaccine was given (ongoing).  Facial swelling 60 hours post-vaccine.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Malaise, Nausea, Pyrexia
Clinical narrative: Patient reports intermittent dizziness, nausea, generalized malaise, low grade fever.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Blood test, Headache, Lymphadenopathy, Pruritus generalised
Clinical narrative: It started off with severe fever throughout 27th night. I had a breaking headache along with it. On the following day (06/28), the fever subsided and the headache was less painful. When I went to Urgent Care on the following day (06/28), my body temperature was 99.5 F. I had itchy feeling all over the body. I also had blisters all over my body. The doctor also noted that "lymph node around neck was swollen", and subsequently ordered blood test to get CBC count. The headache was moderate for the following 4 days after which my head started to feel normal. A second vaccine was given on 07/13/2015. The itching started again, after 2 to 3 days of vaccination. It still continues to itch. I'm currently waiting to see if the itch will subside anytime soon. Wondering how long it will take for it to stop.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: It started off with severe fever throughout 27th night. I had a breaking headache along with it. On the following day (06/28), the fever subsided and the headache was less painful. When I went to Urgent Care on the following day (06/28), my body temperature was 99.5 F. I had itchy feeling all over the body. I also had blisters all over my body. The doctor also noted that "lymph node around neck was swollen", and subsequently ordered blood test to get CBC count. The headache was moderate for the following 4 days after which my head started to feel normal. A second vaccine was given on 07/13/2015. The itching started again, after 2 to 3 days of vaccination. It still continues to itch. I'm currently waiting to see if the itch will subside anytime soon. Wondering how long it will take for it to stop.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Eye pruritus, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Patient called Health Center on 7/18/15 at 9:00 am to report that her right arm was "swollen down to the elbow" after receiving a Pneumovax injection the previous day during the routine physical exam. The patient was advised to come to the Health Center ASAP for evaluation. Also c/o itchy eyes, facial swelling, and right arm pain. Upon examination, patient had erythema and urticaria to the right upper arm, increased warmth, tenderness, +1 non-pitting edema and induration. Affected area was 5.75 inches x 7.5 inches in diameter. Right upper arm circumference measured approx 1 inch larger than the left upper arm circumference. Patient was treated with OTC PO Benadryl and Prednisone 20mg PO BID x3 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth, Pain in extremity, Swelling face
Clinical narrative: Patient called Health Center on 7/18/15 at 9:00 am to report that her right arm was "swollen down to the elbow" after receiving a Pneumovax injection the previous day during the routine physical exam. The patient was advised to come to the Health Center ASAP for evaluation. Also c/o itchy eyes, facial swelling, and right arm pain. Upon examination, patient had erythema and urticaria to the right upper arm, increased warmth, tenderness, +1 non-pitting edema and induration. Affected area was 5.75 inches x 7.5 inches in diameter. Right upper arm circumference measured approx 1 inch larger than the left upper arm circumference. Patient was treated with OTC PO Benadryl and Prednisone 20mg PO BID x3 days.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainting.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Breast pain, Breast tenderness, Erythema, Lymphadenopathy
Clinical narrative: Red spot in axilla with significant swelling of lymph nodes throughout right breast tissue; extremely sensitive and sore for one week, resolved itself.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Signs: rash on arm of vaccination taken.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Expired product administered
Clinical narrative: Pt received a HPV vaccine that expired 5-31-15.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Pruritus, Rash
Clinical narrative: Itchings, rash, dry skin, MD gave BENADRYL cream and BENADRYL capsule itching --> after going home.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Pain in extremity
Clinical narrative: 57 y/o female w/ a complaint of left arm pain. She received a PCV13 vaccination 5 days ago, the day after she felt induration at the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Wound infection
Clinical narrative: Pt. came to pharmacy showing the site of injection (ZOSTAVAX) has swollen red looks like infected with a dime size wound-she said it is painful and sore. She noticed it on 7-19-15 and reported it on 7-20-15 at 12.12PM.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Dtap given on 7/18/15, on 7-19-15 dad noticed red, swollen area were vaccine given, and returned to office for visit on 7-20-15.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Pt received vaccine on 7/14/15. She came into the pharmacy 7/20/15 with a large red, itchy area 7 in x 5 in, she went to her doctor and received some steroid cream and an antihistamine. She will go back to the doctor if not improving. Will also ice the area.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red, itching, swollen, "like a half an egg " size. Started about 4 days later. Internal swelling like a ball under skin. Ice and TYLENOL. No temperature reported.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash on trunk and scalp.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning an adult patient of unknown age and gender who on 12-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 103 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV9
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to three unspecified patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were unspecified. On 24-JUN-2015 the three patients were vaccinated with an unspecified dose of GARDASIL 9 (dose, dose number, route, anatomical location, lot number and expiration date were not reported). Concomitant medications were unspecified. The three patients reported that, on the same day, they experienced a tingling sensation in their arm as the vaccine was being administered. The three patients also stated that the arm that received the injection felt numb and also experienced soreness at the injection site following the administration of GARDASIL 9 on 24-JUN-2015. The three patients were called by the physician's office on 25-JUN-2015 and stated that they no longer experienced the injection site hypoaesthesia and paraesthesia, only the injection site pain. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected as the reporter did not wish further contact.
Age: 1.03
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 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 01-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.02
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 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 03-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. In approximately 2013 (reported as 'about two years ago'), the patient received her first dose of GARDASIL (dose, route, lot# and expiration date were not provided) and on 15-JUL-2015, she received her second dose of GARDASIL (dose, route, lot# and expiration date were not provided). No adverse effects reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal distension, Chest X-ray normal, Chest discomfort, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse and physician refers to a 18 year old male patient with no allergies. The patient had no pertinent medical history. On 04-JUN-2015, the patient was vaccinated with the first dose of GARDASIL lot # K014191 (expiration date and dose were not provided), intramuscular. There were no concomitant medications. In June 2015, the patient experienced chronic fullness and discomfort on the left side of his chest. The patient felt fuller and bloated after eating a minimal amount, like he had just eaten a three-course meal. The discomfort was limited to the chest area and not the abdomen. The patient visited physician and as treatment, the patient was prescribed an unspecified muscle relaxer which did not help his symptoms. On 02-JUL-2015, the patient had a chest x-ray which was negative for any abnormalities. On 02-JUL-2015, the patient was vaccinated with the second dose of GARDASIL lot # K016966 (expiration date and dose were not provided), intramuscular, which is less than the 2-month interval between the first and second doses of GARDASIL. The outcome of chest discomfort was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning an adult patient of unknown age and gender who on 12-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 103 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning an Adult patient of unknown age and gender who on 14-MAY-2015 was vaccinated with a dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 103 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/ allergies of these patients were vaccinated with improperly stored GARDASIL (strength, dose/frequency, lot # unspecified). Concomitant medications were not reported. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated for doses of oral, ROTATEQ lot # K010221, I011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 06-APR--2015 was vaccinated with an unknown dose of ROTATEQ (lot # K011663) (route defaulted as oral) that was 12 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning an Adult patient of unknown age and gender who on 12-MAY-2015 was vaccinated with a dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 103 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, unspecified number of patients were vaccinated with improperly stored VAQTA injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Pt. rec'ed PCV13 on 7-1-15-she returned to clinic 7-8-15 to ask if this was a reaction. Lt deltoid was red and warm to touch-c/o itching to area-Dr examined the arm-it was a local reaction.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patient of unknown demographics. Medical history, concurrent conditions and drug reactions/ allergies of these patients were not reported. On unspecified dates, these patients were inadvertently vaccinated with improperly stored GARDASIL (it was confirmed that the suspect product was not GARDASIL 9). Concomitant medication was not reported. No adverse effects were reported. This is one of the five reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 year old female patient. The patient's concurrent conditions included reactions/allergy to penicillin and cephalosporins (unspecified). On 07-SEP-2006, the patient received a dose of VARIVAX (Merck) subcutaneously (dose, lot# and expiration date were not provided). On 01-SEP-2009, the patient received a dose of PROQUAD (Merck) subcutaneously (lot# reported as 0845Y, dose and expiration date were not provided). On 11-JUL-2015, the patient developed a 'low-grade fever (temperature unspecified). On 15-JUL-2015, the patient developed a 'varicella-like rash on the trunk area and down her right leg'. The patient sought medical attention - she went to see a physician. No treatment was given for the events. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and VARIVAX (Merck) and PROQUAD (Merck) was not provided. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 year old female patient. The patient's concurrent conditions included reactions/allergy to penicillin and cephalosporins (unspecified). On 07-SEP-2006, the patient received a dose of VARIVAX (Merck) subcutaneously (dose, lot# and expiration date were not provided). On 01-SEP-2009, the patient received a dose of PROQUAD (Merck) subcutaneously (lot# reported as 0845Y, dose and expiration date were not provided). On 11-JUL-2015, the patient developed a 'low-grade fever (temperature unspecified). On 15-JUL-2015, the patient developed a 'varicella-like rash on the trunk area and down her right leg'. The patient sought medical attention - she went to see a physician. No treatment was given for the events. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and VARIVAX (Merck) and PROQUAD (Merck) was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On an unspecified day, the unspecified number of patients received improperly stored PROQUAD (Merck) (lot # L002419, expiration date 23-JUL-2016; lot # reported as L007248, expiration date 03-SEP-2016 (dose, frequency , route of administration and indication were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Lot number L007248 is an invalid lot number of PROQUAD (Merck). Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 2 month old patient (gender unknown). No concurrent condition, medical history or allergy/drug reactions were reported. On 07-JUL-2015, the patient was inadvertently vaccinated with a dose (the only dose this patient has received) of GARDASIL injection (lot #  K023432, expiry date 18-JUN-2016) (strength and dose unspecified) intramuscular (inappropriate schedule of drug administration). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Age: 4.0
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 4 year old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 05-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 03-APR-2015 was vaccinated with an unknown dose of ROTATEQ (lot # K011663) (route identified as oral) that was 12 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 23-JUN-2015 the patient was vaccinated with ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K013661 with expiration date 26-MAY-2016) which was improperly stored. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number patient of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unspecified dates, these patients were inadvertently vaccinated with improperly stored VAQTA (strength, dose/frequency, lot # unspecified). Concomitant medication was not reported. No adverse effects were reported. This is one of five reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration date, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender who on 06-APR-2015 was vaccinated with an unknown dose of ROTATEQ (lot # K011663) (route defaulted as oral) that was 12 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.