chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Lip blister, Pruritus, Rash
Clinical narrative: After receiving vaccine, pt reported rash on both legs and burning itching sensation on back. Blister underneath upper lip. Went to see MD  a few days after incident.
Age: 0.85
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: C/O high fever per mom of 105.0 at home. Mom took child to ER on 10/14/15 when the fever occurred. Mom didn't follow-up with our office till today on the child's one year old health check appt.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Epstein-Barr virus test negative, Fatigue, Herpes simplex serology negative, Mycoplasma test, Rash
Clinical narrative: Patient is a 13-year-old female with no significant past medical history who presents to the Health Agency-Immunization. Healthcare Office further evaluation and management of an adverse event following immunizations. Patient is accompanied to the clinic by her mother who provides most of the history. Patient was in her normal state of health on 13 October when she received school-mandated meningococcal vaccine. She did well until approximately 2 weeks later (27 Oct 15) when she began to develop a rash. The lesions initially developed on the back of the arms but then spread towards her trunk and then moved to her upper extremities, lower extremities, abdomen, neck, and face and minimally on her lower back. Lesions on her extremities tend to be more densely distributed around the elbows and knees. She denies any pruritus associated with these lesions but has noticed some pain occasionally, though currently denies any. She also endorses feeling fatigued but denies any other symptoms such as arthralgias, myalgias, fevers, chills, night sweats. She denies any mucosal involvement of her mouth, vagina or anus. She denies any other systemic symptoms. Patient denies any other known adverse events following immunizations. Patient denies any medication use recently. Patient denies any previous h/o herpes labialis or cold sores. Patient treated supportively with antihistamines and topical steroids with resolution of all symptoms in about 6 weeks.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Sickle cell trait, Skin lesion
Clinical narrative: Patient is a 13-year-old female with no significant past medical history who presents to the Health Agency-Immunization. Healthcare Office further evaluation and management of an adverse event following immunizations. Patient is accompanied to the clinic by her mother who provides most of the history. Patient was in her normal state of health on 13 October when she received school-mandated meningococcal vaccine. She did well until approximately 2 weeks later (27 Oct 15) when she began to develop a rash. The lesions initially developed on the back of the arms but then spread towards her trunk and then moved to her upper extremities, lower extremities, abdomen, neck, and face and minimally on her lower back. Lesions on her extremities tend to be more densely distributed around the elbows and knees. She denies any pruritus associated with these lesions but has noticed some pain occasionally, though currently denies any. She also endorses feeling fatigued but denies any other symptoms such as arthralgias, myalgias, fevers, chills, night sweats. She denies any mucosal involvement of her mouth, vagina or anus. She denies any other systemic symptoms. Patient denies any other known adverse events following immunizations. Patient denies any medication use recently. Patient denies any previous h/o herpes labialis or cold sores. Patient treated supportively with antihistamines and topical steroids with resolution of all symptoms in about 6 weeks.
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a male patient who received FLULAVAL (batch number MJ7A9, expiry date June 2015). On 23rd January 2015, the patient received FLULAVAL. In 2015, an unknown time after receiving FLULAVAL, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to FLULAVAL. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The patient experienced an adverse reaction (unspecified) after the vaccination with FLULAVAL. The reported batch number (MJ749) for FLULAVAL did not exist and was updated to MJ7A9 as per the sales database.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # K005958 and expiry date of 09-FEB-2017 or lot # L018499 and expiry date of 25-FEB-2017 (unknown route, strength and dose). No adverse effects were reported. This is one of the 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 (also reported as medical assistant) refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ Lot # K008140 with expiry date of 03-MAR-2016 or L009119 with expiry date of 17-DEC2016 (orally, unknown strength and dose). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K012874 and expiry date of 09-JUN-2016 or lot # K014190 and expiry date of 24-OCT-2016 or lot # J007946 and expiry date of 24-MAR-2016 or lot # K006682 and expiry date of 17-DEC-2015 (unknown route, strength and dose). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: No signs of sxs of adverse effects, patient tolerated well. Patient was given the HPV 4 types as second dose 1st dose he was given the 9 types, I was unaware of there being a new HPV vaccine out.
Age: 51.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Drug administered at inappropriate site
Clinical narrative: Pain in left shoulder, arm, back. Limited ability to move and use arm.
Age: 51.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in left shoulder, arm, back. Limited ability to move and use arm.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain where shot was administered, and loss of mobility of arm.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site swelling, Pyrexia, Rash erythematous
Clinical narrative: Fever 101 F degrees. Big red rash on upper right arm and swollen. Patient has been taking aspirin 325 mg every 4 hrs. It seemed to help with fever and redness and swollen last 8-9 days.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients might have been vaccinated with doses of improperly stored ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Age: 1.81
Sex: F
Vaccine: DTAP, FLU3, HEPA, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: Influenza 6-35 months 0.25 cc was ordered by physician. Influenza 0.5cc was given by nurse.
Age: 63.0
Sex: M
Vaccine: FLUC3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Painful 8-10 mm, red and raised area on left deltoid within two hour after receiving the vaccine. EPIPEN 0.3mg given in right outer thigh. Dull headache for several hour.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Mobility decreased, Pain, Pyrexia
Clinical narrative: Patient is extremely sore, can not lift arm. Pain at level 10. Persistent fever and headache.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint pain, Injection site pain, Pain in extremity
Clinical narrative: Pain in left upper arm began on evening of 11-20-15. Continues to have pain in arm and shoulder joint. Occasionally, pain radiates to elbow. Taking ibuprofen. Recommend physician evaluation.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL Lot # K006124 and expiry date of 02-FEB-2017 (unknown route, strength and dose). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to the patients of unknown age and gender with no medical history reported. Since 12-MAY-2015, an unspecified number of patients had been vaccinated with doses of improperly stored GARDASIL 9 lot number: K004205, expiry date: 12-JAN-2017 (route of administration and dose were not reported). Further information was provided that approximately 10 patients had been vaccinated with doses of another improperly stored GARDASIL 9 lot number: L014415, expiry date: 25-JUL-2017 (route of administration and dose were not reported). No concomitant medications were reported. No adverse events were reported. Product quality complaint (PQC) was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash outbreak on inside of L arm.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: I received the flu shot in my left upper arm and since that day I have had significant pain when moving my arm certain ways. I cannot lift my arm more than approximately 45 degrees, reach forward or across my body to buckle my seatbelt or take my shirt off without severe pain in my arm.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Pruritus generalised
Clinical narrative: Given at approximately 8:45 am; 11:30 AM employee experiencing generalized itching and face flushed. Refused Epi. Refused EM5CK. Denied difficulty breathing, chest tightness or chest pain. No swelling of throat, no wheezing or shortness of breath. Had family member bring her an anti-histamine (Zyrtec); took 2 tablets at 1:30 pm. 11/16/15 denied further effects.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Injection site reaction, Neuralgia, Paraesthesia
Clinical narrative: Nerve pain at injection site, upper right arm.  Weakness and tingling extend to fingers. Continues to date, 12/9/2105.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 63 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received form the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Apparent death, Body temperature increased, Feeling abnormal, Hypotension, Loss of consciousness
Clinical narrative: Initial unsolicited report received from a consumer on 25 November 2015. This case involves a 69-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI477AA, expiration date: 20 May 2015, dose, dose number, route and site of administration were not reported) on 15 October 2015. The patient did not have known drug allergy. Concomitant medication was not reported. On 15 October 2015, few hours following the vaccination, the patient was feeling very bad, lost consciousness, severe shaking, vomiting and elevated temperature. On 15 October 2015, the patient's neighbor took her to the hospital. The patient required ER or doctor visit. It was reported that in hospital patient continued to have shaking, vomiting, elevated temperature, times in which lost consciousness, low blood pressure and she felt almost died. Laboratory investigations and corrective treatment were reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 25 November 2015. This case involves a 69-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI477AA, expiration date: 20 May 2015, dose, dose number, route and site of administration were not reported) on 15 October 2015. The patient did not have known drug allergy. Concomitant medication was not reported. On 15 October 2015, few hours following the vaccination, the patient was feeling very bad, lost consciousness, severe shaking, vomiting and elevated temperature. On 15 October 2015, the patient's neighbor took her to the hospital. The patient required ER or doctor visit. It was reported that in hospital patient continued to have shaking, vomiting, elevated temperature, times in which lost consciousness, low blood pressure and she felt almost died. Laboratory investigations and corrective treatment were reported. The outcome of the event was unknown. List of documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 04-DEC-2015 the patient was vaccinated with expired GARDASIL injection 120 Y lot # H021861, expiration date 09-OCT-2015. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Prenatal screening test
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a currently 19 year old female patient. The patient's concurrent conditions and medical history were none. There was no history of drug allergies and reactions. On 02-OCT-2015, the patient was vaccinated with VARIVAX (Merck) (lot # 013825; and expiry date of 21-APR-2017) unknown strength, dose and route while she was pregnant. Concomitant medications were none. The patient was unaware that at the time of administration, that she was pregnant. The last month period date is approximately 20-AUG-2015 and estimated date of delivery is 26-MAY-2016. The patient's gestation age was reported to be 14 weeks and 6 days. The patient underwent a routine prenatal lab work on an unknown date in 2015. No treatment was received in response to the event. The patient sought medical attention and spoke to a doctor. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.) and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 25-NOV-2015, the patient was accidentally vaccinated with an expired dose of RECOMBIVAX HB (lot # K004989, expiration date 14-NOV-2015; dose and route of administration were not reported). Concomitant therapy was not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB (strength, dose, frequency and route were not reported) lot # L012835 with an expiry date of 11-MAR-2018. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 25-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (lot number K010211 and expiration date 17-JAN-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 22-JUL-2015, the patient was vaccinated with an improperly stored doses of PROQUAD (Merck) (lot number L010142 with expiration date 24-SEP-2016 and lot number J013436 with expiration date 24-APR-2015) dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.96
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 1 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 20-JUL-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number K010211 and expiration date 17-JAN-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, lot # K011948, expiration date 07-JUN-2016, dose not reported). There was no adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (lot number K010211 and expiration date 17-JAN-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored Oral, ROTATEQ (strength, dose, frequency and route were not reported) lot # K011947 with an expiry date of 06-JUL-2016. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, lot # K008410, expiry date 26-FEB-2016, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of five reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 3 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 27-JUL-205, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number K010211 and expiration date 17-JAN-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (Lot #, exp. date, strength, anatomical location and dose were not provided). There was no concomitant medication reported. On an unknown date, the patient developed seizures after receiving unspecified doses of GARDASIL. At the reporting time, the outcome of seizures was not reported. The causal assessment of seizures to GARDASIL was not reported. Upon internal review the event of seizures was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 5 unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB (strength, dose, frequency and route were not reported) lot # K026532 with an expiry date of 07-AUG-2017. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction, Pruritus generalised
Clinical narrative: 12-2-15 4:30 pm Wife called to report that patient was in a staff meeting and he was starting to itch all over. He did not have any rash yet, but the itch seemed to be worse around the injection site. Patient has a history of severe allergic reactions to various insects and foods and has been instructed that he should call an ambulance whenever there are symptoms of a reaction. The wife was advised to go to town to give patient some BENADRYL., his epi-pens and to call an ambulance. The prescribing physician nurse was made aware of the situation. 12-4-15 10:30 am (Friday) The itching has totally resolved, but there is a local reaction that has redness about the size of a baseball and slight puffiness. The pharmacy advised the patient to call back and report the reaction on Monday and a mew Rx for epi pens were obtained. 12/3/15 - 9 am Spoke to wife - she reported that the reaction was itching in arm, head and neck no rash was seen, site of injection was red and puffy. No ambulance or hospital visit was needed. Patient had left for work and left her a note that the itching has resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. On 03-DEC-2015 the patient was vaccinated with ZOSTAVAX (dose and route not reported, lot # L021610, expired date: 10-SEP-2016) which was an improperly stored vaccine. No adverse effect reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site erythema, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: According to pt's note from the ED visit patient c/o redness, swelling and pain on the site of vaccine. Has had associated nausea and vomiting x1. Started antibiotics on 12/05 during visit at the ED with no improvement. Seen by PCP on 12/07 who started pt on BENADRYL and prednisone taper. Pt to be evaluated again on 12/09/15.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: According to pt's note from the ED visit patient c/o redness, swelling and pain on the site of vaccine. Has had associated nausea and vomiting x1. Started antibiotics on 12/05 during visit at the ED with no improvement. Seen by PCP on 12/07 who started pt on BENADRYL and prednisone taper. Pt to be evaluated again on 12/09/15.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in arm received vaccination.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Skin warm
Clinical narrative: 11/21/15 (morning) - hard to sleep on. Hot to the touch. Painful around sight. 11/22/15 (morning) - at 12:50 am noticed spot was red. The red spot was the size of a tennis ball (circumference) - at 8 a.m. spot has gotten a little wide and more painful.
Age: 1.02
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site induration
Clinical narrative: Pt presented to office today with 2 inch in diameter reddened, firm area at immunization site on (R) thigh; Received PREVNAR 11/30/15; Reddened area began 12/21/15 and low grade temp 1130/15 x 24 hours, none since.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Pt received a PREVNAR immunization and within 2 days developed a rash at the site of injection which got diagnosed as cellulitis. Patient received antibiotic treatment and is recovering without further complications.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56 year old female patient (a pharmacy technician at the pharmacy) with unknown reaction or allergies to morphine. There was no patient's pertinent medical history and concomitant medications reported. On 02-NOV-2015, the patient was vaccinated with ZOSTAVAX injection (lot# reported as L032399, expiration date 26-NOV-2016) single dose, subcutaneously in the left upper arm. On 03-NOV-2015, the patient experienced a large area of redness and warmth at the injection site. The area of reaction was also slightly itchy. The patient was treated with unspecified antihistamines. On 12-NOV-2015, the patient recovered from the events. The patient sought medical attention and spoke with the pharmacist. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected, as there was no consent for follow up.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: OUTER ARM RED, SWOLLEN, HOT, ITCHY, AND VERY TENDER. AREA ENLARGED OVER 12/05 AND BEGAN TO IMPROVE IN AFTERNOON OF 12/06.
Age: 0.47
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Flu vaccine was given 12 days early to the patient. No adverse event.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Sustained fever that responded poorly to TYLENOL and lasted greater than 24 hours.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # K020216, expiry date 17-SEP-2016; lot # L016427, expiry date 13-APR-2017, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of five 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 was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL, lot # K010215, expiry date 05-MAY-2017, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of five 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 was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, lot # K024700, expiry date 30-JUL-2016, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot # L000459, expiry date 06-JAN-2017, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug ineffective, Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL (lot # K011562, exp. 08-APR-2017). No concomitant therapy was reported. No adverse effect was reported. The outcome of the events was unknown. No product quality issue was involved. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medications were not reported. The reporter stated, that 5 doses of improperly stored PNEUMOVAX23 lot # L013428, expiration date: 03-FEB-2017 (dose, route of administration and anatomical location were not provided) were administered to multiple unspecified patients on multiple unspecified dates. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K009105, exp. 21-JAN-2016). No concomitant therapy was reported. No adverse effect was reported. The outcome of the events was unknown. No product quality issue was involved. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 69 year old male patient. There was no information about historical medication. Patient had no drug reactions or allergies. On 01-DEC-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L014420, Expiration Date- 23-FEB-2017, 0.5 ml, intramuscular. No concomitant medication was reported. On 01-DEC-2015, the patient developed redness, swelling and warmth at the injection site. No treatment was given for the redness, swelling and warm at the injection site. Patient contacted pharmacist to sought medical attention. No laboratory diagnostic studies were performed. The outcome of redness, swelling and warmth at the injection site was reported as not resolved. Causality between redness, swelling and warmth at the injection site and PNEUMOVAX 23 was unknown. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of sore throat in a adult female patient who received Influenza vaccine. Co-suspect products included VENTOLIN HFA unknown (batch number 9T3A, expiry date 6th August 2016) for shortness of breath. Concurrent medical conditions included shortness of breath. Concomitant products included ADVAIR. In 2015, the patient received Influenza vaccine. On an unknown date, the patient started VENTOLIN HFA at an unknown dose and frequency. On an unknown date, an unknown time after receiving Influenza vaccine and VENTOLIN HFA, the patient experienced sore throat. On an unknown date, the outcome of the sore throat was unknown. It was unknown if the reporter considered the sore throat to be related to Influenza vaccine and VENTOLIN HFA. Additional details were received as follows: This case was received from the healthcare provider via the vaccine patient assistance program. The patient stated that, she had been receiving VENTOLIN and experienced sore throat after using it. The patient recently received a Flu vaccine and so she was not sure whether the sore throat was from VENTOLIN HFA or from Flu vaccine. The patient also received ADVAIR but did not mention that the adverse event with ADVAIR. The patient started that medication couple of years ago but did not know the exact date.
Sex: F
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Malaise
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of sickness in a adult female patient who received Seasonal Influenza vaccine. Co-suspect products included BREO ELLIPTA inhalation powder (batch number R740011, expiry date June 2017) for chronic obstructive airways disease exacerbated. Concurrent medical conditions included chronic obstructive airways disease exacerbated. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. In 2014, the patient started BREO ELLIPTA 100/25 ug at an unknown dose and frequency. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine and BREO ELLIPTA, the patient experienced sickness (serious criteria hospitalization). The action taken with BREO ELLIPTA was unknown. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Seasonal Influenza vaccine and BREO ELLIPTA. Additional details were provided as follows: This case was received from the healthcare provider via GSK Access program for BREO ELLIPTA. The patient could not provide the exact date of when she started with BREO. She thought that it could be end of 2014 or might be in early 2015. The patient stated that she was not feeling well after getting a flu shot and became sick and had to be hospitalized for 2 to 3 days. She did not recall how long she was in the hospital and stated that she thought she was hospitalized in October 2015. Since she was in hospital she had been on oxygen.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-NOV-2015, the patient was inadvertently administered an expired dose of VAQTA 25/0.5 (units not provided) lot # K008984, expiration date 21-OCT-2015 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Age: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Culture negative, Encephalopathy, Seizure, Viral test negative
Clinical narrative: Pt developed encephalopathy/seizures 5 days after vaccination. No infectious etiology isolated.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient was given PNEUMOVAX 12/4 and presented in office 12/7/15 with 4 x 3" erythema at injection site with warmth. Treatment with cold packs and ibuprofen as directed.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified Medical Assistant referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 23-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (Lot # K024036, expiration date 26-NOV-2016) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received form the same source. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema
Clinical narrative: Large red area several inches wide from injection site down to elbow of left arm, no discomfort, area has not gotten worse or better after 7 days post vaccination.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Patient presents extense red and hot area in right arm. MD gave LEVAQUIN 750mg per 7 days. Patient is well (follow up call 11/30/15). The symptoms persist for 7 days. She finish today 11/30/15 the antibiotic and the arm is normal.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Dizziness, wobbly legs 24 hours after vaccination.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Swelling hives itching - sent to ER. 1 HR after receiving vaccine symptoms began - f/u 11-23-15.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Injection site pruritus
Clinical narrative: Pt received FLUVIRIN vaccine and within 10 min pt walked into clinic stating she felt it was harder to breathe/swallow. Pt alert and oriented. She stated she also had severe itching at the site of her injection. NP administered EPIPEN 0.3 mg at 1300 pm and had store management call EMS. Pt stated 1 minute later she was feeling better and easier to breathe after EPIPEN administered. VS -> HR 70s and O2 sat on RA=100%. EMA arrived w/in 5-10 min after EPI-PEN and took over care. They took her to nearby hospital to be observed. Pt walked out of clinic on her own with EMS at her side.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt. received vaccine at 9:30 am. By noon, pt. noticed redness, swelling, and warm to the touch around area of vaccine down to elbow. That same night pt. felt she was running a fever and had chills. Pt. advised to take TYLENOL or ibuprofen and alternate cool and warm.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Inflammation, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Got pneumonia 13 shot 11-30. Today he noted a 10cm circle on his upper left arm, some redness and itchiness but no other sxs, no SOB, no sore throat, no swelling of tongue etc. States that area was swollen welt earlier, looks better now. This is a normal inflammatory response to a foreign substnace and not a true allergy. Diphenhydramine unknown.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Got pneumonia 13 shot 11-30. Today he noted a 10cm circle on his upper left arm, some redness and itchiness but no other sxs, no SOB, no sore throat, no swelling of tongue etc. States that area was swollen welt earlier, looks better now. This is a normal inflammatory response to a foreign substnace and not a true allergy. Diphenhydramine unknown.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Acoustic stimulation tests abnormal, Depressed mood, Depression, Dizziness, Electronystagmogram
Clinical narrative: I woke up with vertigo, and my left ear was ringing, my hearing became extremely sensitive (cannot tolerate even the slightest of sound), dizzy, and eyes were moving involuntary. Had to sleep it off for it to go away.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Eye movement disorder, Hyperacusis, Nuclear magnetic resonance imaging normal, Tinnitus, Vertigo
Clinical narrative: I woke up with vertigo, and my left ear was ringing, my hearing became extremely sensitive (cannot tolerate even the slightest of sound), dizzy, and eyes were moving involuntary. Had to sleep it off for it to go away.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse (also reported as from a medical assistant) referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unknown dates, the patients were administered improperly stored doses of PEDVAXHIB injection (lot # K026532 with expiration date 07-AUG-2017, lot# L012837 with expiration date 11-MAR-2018, Lot # L030869 with expiration date 068-JUN-2018; dose and route were not provided). No adverse effects were reported. It was unknown of the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.