chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB, HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 3 month old exam. Brought in for first vaccination and congestion. Foster mother had no with immunization records. IIS was checked no records found ordered the following combination vaccines. PENTACEL, KINRIX and Hib computer did not display any warning. Immunization given. Informed doctor with her mother.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, X-ray limb
Clinical narrative: Persistent pain on (L) deltoid area.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Erythema infectiosum, Pharyngeal erythema, Pruritus, Pyrexia, Rash
Clinical narrative: Shots given 9-4-15 mom states child started running high fever 103, with rash to trunk of body, arms, and legs, itching, and red throat on 9-21-15. Inst. to go to doctor. Child had red swollen tonsils with pus on visual exam. Mom brought child to doctor. Doctor said Fifth disease and started on antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Rash pustular, Tonsillar hypertrophy
Clinical narrative: Shots given 9-4-15 mom states child started running high fever 103, with rash to trunk of body, arms, and legs, itching, and red throat on 9-21-15. Inst. to go to doctor. Child had red swollen tonsils with pus on visual exam. Mom brought child to doctor. Doctor said Fifth disease and started on antibiotics.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Several hours after the injection, my arm had a swollen, itchy, red circle of 2 1/2 inches in diameter around the site. It spread to 4 inches on my upper arm with a fever of 100 degrees. I took TYLENOL for 5 days and used ice. It is slowly disappearing.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin burning sensation, Upper extremity mass
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. Pertinent medical history and drug reactions/allergies were not reported. Approximately in 2012 (reported as about 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) to treat shingles (product use issue). Concomitant drug was not reported. It was reported that the patient experienced burning and itching in her scalp and developed lumps under her arms while on ZOSTAVAX (in approximately 2012). On an unknown date, the patient had been seen by her physician. The outcome of the events "burning and itching in her scalp as well as lumps under her arms" was reported as recovering. The causality of the events "burning and itching in her scalp as well as lumps under her arms" with ZOSTAVAX was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site pain
Clinical narrative: Burning feeling when injected, pain in arm from shoulder to elbow, bruise at injection site.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Oka-Merck) injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site reaction, Rash, Rash maculo-papular
Clinical narrative: 9 days from MMR patient developed a maculopapular rash abd, back, legs. Per dad rash lasted approximately 48 hours. No fever. Some area of rash coalescing to one red maculopapular area.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 12 month old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 16-SEP-2015 the patient inadvertently received a dose of PROQUADD (lot# K006218 with expiration date of 29-OCT-2015; strength, dosage, frequency and route unspecified) and a dose of (Oka/Merck) VARIVAX (lot# J012150 with expiration date of 28-SEP-2015; strength, dosage, frequency and route unspecified). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 9 patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. Between May 2015 to September 2015 the patients were vaccinated with improperly stored (Merck) VARIVAX lot # L002214, expiration date: 21-JAN-2017, lot # L011082, expiration date 01-APR-2017/07-NOV-2017 (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of (Merck) VARIVAX (lot # L010144 exp date 24-MAR-2017) (dose and route not reported) that were improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a several anonymous patients of unknown age. On an unknown date, several patients were vaccinated with (Merck) VARIVAX (lot# L020002 and expiry date: 02-JUN-2017), post temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 18 year old (also reported as 19) male patient. Medical history and concurrent conditions were none. Illness at the time of vaccination was none. On 24-AUG-2015 at 09:555 am, the patient was vaccinated with a fourth dose of improperly stored GARDASIL (lot # K011562, expiry date: 08-APR-2017) intramuscular in the left arm. No adverse effect was reported. No concomitant therapy was reported. This is one of the six reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a male physician of unknown age referring to himself. Information about medical history and concurrent conditions were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown). Concomitant medications were unspecified. On an unknown date, three years after receiving ZOSTAVAX, the patient experienced a mild case of shingles. The patient stated that he "self-treated" with unspecified treatment and the event was resolved on an unspecified date. The causality between the event and ZOSTAVAX was unspecified. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Presents to clinic on 8/4/15 for doctor ordered tetanus/dip and pneumococcal shots. Daughter calls on 9/28/15 and says that mother's Lt arm (where Td given) began to swell 1 week after injection to quarter size. Daughter says that mother never sought medical evaluation and now Lt. deltoid (arm) is 4 inches in diameter for a rash/swelling. Recommended that patient seek evaluation by personal physician as soon as possible. Note - no reported fever or other symptoms.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL 9 lot # L007560, expiry date 15-JUN-2017. No adverse effects reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 0.87
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse referring to a 10 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reaction described. The reporter stated that on 29-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533., with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse referring to a 3 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reaction described. The reporter stated that on 16-JUL-2015, the chills was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.82
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This report was received from a licensed practitioner nurse referring to a 21 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 17-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: Pt had c/o pain to (L) deltoid. Hematoma measured 1 1/2" x 1 1/2" purple and red in color. Redness below hematoma 2 1/2" x 2 1/2" square shaped.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Felt a little weak and tired - lasted 1 1/2 days. Also, slight dizziness.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: 9 days after MMR patient developed maculopapular rash on face, neck, abd, back and legs. Pt also had fever 2 days prior - patient given MMR at another physician's office and was traveling.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Patient given IM doses of PENTACEL and PREVNAR 13, oral ROTATEQ, fol. well at exam. Three hours later developed diffuse and signif urticaria. No other significant symptoms, no vomit, no fever, no resp. sx.
Age: 1.3
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse referring to a 15 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 17-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: 10 days after 1 year old vaccine. Parents noted pt with rash, itchy, macular papular rash on abd, back, neck and arms.Within first 24 hours.  4 days prior pt had fever Tm 101 approximately 24 hours. MMR given (another physician office).
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse referring to a 15 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 23-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Inflammation, Mobility decreased, Pain in extremity
Clinical narrative: Patient reported soreness/inflammation of arm. Could not move arm at all yesterday, now able to move slightly.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients might have been vaccinated with improperly stored doses of ZOSTAVAX lot # L012475, expiration date 10-JUL-2016 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same source. 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 licensed practitioner nurse referring to a 1 day-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 28-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.27
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse referring to a 15 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 16-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.37
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse referring to a 4 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 29-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose , frequency and route were not reported). No adverse effects were reported. IT was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. 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 licensed visiting nurse, referring to multiple unspecified patients of unknown age and gender. The medical history and concurrent conditions of the patients were not reported. On multiple unspecified dates, the multiple unspecified patients were vaccinated with improperly stored doses of GARDASIL lot # J011272, expiration date 21-APR-2016 and lot # K006117, expiration date 14-JAN-2017 (dose, route and frequency were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of two cases received from the same reporter (linked case MARRS # 1509USA012606). Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse referring to a 15 month old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 30-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. 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 licensed visiting nurse, referring to multiple unspecified patients of unknown age and gender. The medical history and concurrent conditions of the patients were not reported. On multiple unspecified dates, the multiple unspecified patients were vaccinated with improperly stored doses of ROTATEQ by oral route (lot # K01022, expiration date 12-MAY-2016 and lot # K023534, expiration date 22-MAY-2016) (dose and frequency were not reported). No concomitant medication were reported. No adverse effect was reported. No product quality complaint was involved. This is one of two cases received from the same reporter (MARRS # 1509USA013325). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions of the patients were not reported. On unspecified dates between 10-SEP-2015 and 18 SEP-2015, the patients were vaccinated with 7 improperly stored doses of (Merck) VARIVAX lot # L013827, expiration date 21-APR-2017 (dose, route and frequency were not reported). No concomitant medications were reported. No adverse symptoms were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a female patient of unknown age and refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneously. On an unknown date, the following day, patient experienced redness on her skin, where the vaccine was administered. The outcome of the event was reported as not recovered/not resolved. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Product contamination with body fluid
Clinical narrative: This unconfirmed, spontaneous report was received from a scientist via a company representative referring to unspecified patients. The company representative heard a news story on television channel. Suspect therapies included GARDASIL or GARDASIL 9 (dose, frequency, indication and route of vaccination were not reported). Reporting scientist claimed to have conducted independent testing of the suspect vaccines and noted there were traces of human blood DNA in formulation of the vaccine which interacted with the aluminum in the vaccine and could cause adverse events. The outcome of the event was unknown. Causality assessment was not provided. This is one of several reports received from the same reporter. Additional information is not expected, because contact details were not provided.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Started on 9/27/15 with left forearm swelling. Had mild fever. Calor and rubor of left forearm. Did improve 9/28/15. Seen in office 9/28/15.
Age: 1.28
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Gait disturbance, Irritability, Myalgia, Weight bearing difficulty
Clinical narrative: Pt. seen in office 9/22/15 for 15 mo WCE and immunizations. Per mom, pt became fussy and began refusing to bear wt/walk next eve. No fever. Seen at pediatric office 9/24/15 -> no edema, redness at hip/knee joints - or - vaccine site. Likely secondary to muscle soreness. Rec -> ibuprofen and observation at time of report.
Age: 31.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 31 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown date, while the patient was still 26 years of age or under, the patient was vaccinated with first two doses of GARDASIL (lot number, expiration date, dose and route of administration were not reported). On 31-AUG-2015, the patient was in the office to receive their third dose of GARDASIL (lot number: L004014, expiration date: 04-MAR-2017, dose and route of administration were not reported) at 31 years of age. No adverse effects was reported. There was no product quality complaint. The outcome of the event was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Local reaction, Vaccination complication
Clinical narrative: This spontaneous report was received from a registered nurse (also reported as a licensed practical nurse) and refers to a 60 year old female patient with allergy to SULFA. There was no patient's pertinent medical history reported. On 21-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot# L024999, expiration date 06-OCT-2016) 0.65 ml, frequency reported as once, subcutaneously in the left arm. Concomitant therapies included CITRACAL. On 22-SEP-2015, reported as on the "next morning", the patient experienced mild burning and redness at the injection site, which developed into a rash that had traveled down her left arm and was 6 inches by 2 inches. On 25-SEP-2015, the patient sought medical attention and was diagnosed to have a local reaction to the vaccine by unspecified physician. No treatment was given and no lab diagnostic studies were performed. The patient not recovered from the events. The relatedness between the events and ZOSTAVAX was not reported. Lot number L024999 had been verified to be a valid number for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 22-SEP-2015, the patient was vaccinated with an expired dose of PNEUMOVAX23, lot # K007773 and expiration date 01-MAY-2015 (dose, route of administration and anatomical location were not reported). There were not concomitant medications provided. There were no adverse effects reported and no product quality issue was involved.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 year old female patient. No pertinent medical history was reported. On an unknown date in 2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). On 14-SEP-2015, the patient was inadvertently vaccinated with another dose of PNEUMOVAX 23 (lot # K020214 and expiration date 25-MAR-2016) (dose and route were not reported). Concomitant therapies included FLONASE, WELLBUTRIN, pravastatin, meloxicam, cyclobenzaprine, loratadine and vitamin B12 injection. On 15-SEP-2015, the patient arm was red and swollen. Patient sought medical attention, saw pharmacist. No treatment was given to the patient. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was reported as recovering/resolving. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Extra dose administered, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 year old female patient. No pertinent medical history was reported. On an unknown date in 2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). On 14-SEP-2015, the patient was inadvertently vaccinated with another dose of PNEUMOVAX 23 (lot # K020214 and expiration date 25-MAR-2016) (dose and route were not reported). Concomitant therapies included FLONASE, WELLBUTRIN, pravastatin, meloxicam, cyclobenzaprine, loratadine and vitamin B12 injection. On 15-SEP-2015, the patient arm was red and swollen. Patient sought medical attention, saw pharmacist. No treatment was given to the patient. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was reported as recovering/resolving. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Musculoskeletal disorder, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: I was administered the flu vaccine at walk in flu clinic time and immediately felt pain and stiffness in my upper arm after shot was given.  I could barely use my upper arm for many months and still have residual soreness in my upper arm.  I believe the vaccine was administered improperly.  I am hoping that is the case as I need to get another flu vaccine soon.  I hope it was not the fluid itself.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on elbows and forearms, no difficulty breathing, patient took Benadryl to control rash.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Ear pain, Myalgia, Nausea
Clinical narrative: Sore throat, nausea, fever hoarse, coughing, sore muscles, ear pain x 4 days.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, nausea, fever hoarse, coughing, sore muscles, ear pain x 4 days.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Lymphadenopathy, Swelling
Clinical narrative: Swelling and redness, lymphadenopathy in axilla of affected side.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Breast cancer female, Chemotherapy, Hepatitis B surface antibody negative, Radiotherapy
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an approximately 55 year old female patient. It was reported that the patient had no drug reactions/allergies. No information regarding the patient's medical history and concomitant therapies was reported. On unspecified dates in 1989, the patient received a complete series of unspecified Hepatitis B vaccine (manufacturer unknown) (exact doses, route of administration and schedule of vaccination were not provided). On an unspecified date in 2014, the patient was diagnosed with breast cancer and began chemotherapy and radiation treatment. It was reported, that on unspecified dates, the patient began treatment with tamoxifen for breast cancer and promethazine for unknown reason. On an unknown date, unspecified bloodwork revealed low Hepatitis B antibody titers. The outcome of breast cancer and low Hepatitis B antibody titers was unknown. The relatedness between the events and unspecified Hepatitis B vaccine (manufacturer unknown) was not reported. Upon internal review, breast cancer was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Post vaccination syndrome, Vaccination complication
Clinical narrative: Information has been received from a consumer who was also an author of an article on a newspaper, referring to her granddaughter, a female patient of unknown age. The information of concurrent conditions, medical history and concomitant medications was not provided. On an unknown date, the patient was vaccinated with GARDASIL (lot#, dose, frequency and route were not provided). On the same date, the patient had a severe and frightening reaction within 30 seconds of receiving the GARDASIL in the doctor's office. The patient survived but had lived through a post-vaccination period that had negatively affected her health and included several emergency room visits. The outcome of the events was unknown. The reporter considered the event severe and frightening reaction within 30 seconds of receiving the vaccine to be life-threatening. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site inflammation, Injection site pain, Injection site rash, Swelling
Clinical narrative: Large rash at injection site with inflammation, and mild pain and discomfort. Patient was seen by the nurse practitioner on site here at pharmacy. Who mark the rash to see if it grew any large. I contact the patient on (9/30/2015) and she stated that she was feeling better and that the sweeling had gone down.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat came first, followed by fatigue and a low grade (99.5) fever. The sore throat still hurts as of 9/30/15. Fever is gone, fatigue still present.
Age: 86.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Malaise, Respiratory tract congestion
Clinical narrative: PATIENT HAS FILLED SOME ANTIBIOTICS SINCE VACCINATION FOR "CHEST STUFF". HE SAID HE THINKS IT WAS THE PREVNAR THAT CAUSED HIM TO GET SICK BECAUSE HE HAS BEEN SICK SINCE HE WAS GIVEN MEDICATION.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: At 1700 the day of the vaccination, hives developed on the forearms and upper extremities on both the right and left arms. At 1800, a fever of 100 degrees developed with a headache.  No shortness of breath, no difficulty breathing, no abominal pain.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Felt nausea on drive home between 5:30 and 6:00pm. Diarrhea at 6:00pm, vomiting at 6:15pm. Rehydrated with small glass of water, few ounces of gatorade, and a few crackers. Vomited violently 4 more times and diarrhea five more times.   Took 1 dose of Zofran at 9:30pm and slowly rehydrated with water and gatorade. Vomiting and diarrhea stopped after administering of zofran.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Immediate post-injection reaction, Injection site urticaria, Mass
Clinical narrative: After the vaccine, I got a lump (silver dollar sized) and immediately started to bruise and redden. It was warm to the touch, not hot though, until Sunday night. On Friday afternoon I started to get hives that lasted until Sunday afternoon too. They were quarter sized, warm, and spread from the shot site to the elbow, not above the shot site though. It was on the sides of my upper left arm but not underneath or near my armpit either. Today just a small bruise and slight redness remains.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Urticaria
Clinical narrative: After the vaccine, I got a lump (silver dollar sized) and immediately started to bruise and redden. It was warm to the touch, not hot though, until Sunday night. On Friday afternoon I started to get hives that lasted until Sunday afternoon too. They were quarter sized, warm, and spread from the shot site to the elbow, not above the shot site though. It was on the sides of my upper left arm but not underneath or near my armpit either. Today just a small bruise and slight redness remains.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient experienced redness at injection site and extending down arm towards elbow and extreme pain in deltoid upon awakening the morning after shot. Patient saw doctor and was given prednisone 40mg daily for 6 days and diphenhydramine 25mg-50mg every 4-6 hours as needed.
Age: 21.0
Sex: F
Vaccine: FLU4, HEPA, YF
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Pt developed welt on forearm, redness and tenderness at the site.  It lasted for about 30 mins and no other symptoms.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mother called to clinic to report her daughter called from school to report that here left arm near the injection was very itching and was red and swollen.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: REDNESS IN LEFT ARM; WARM TO TOUCH; SORE.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Swelling, redness, severe pain at site of injection; severe fatigue and not feeling well.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Passed out for <1 minute after 3rd injection. Tdap first, Menveo second, and HPV given third.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Peripheral swelling, Rash
Clinical narrative: This is a spontaneous report from the non-clinical study program from a contactable pharmacist. A 78-year-old female patient of unspecified ethnicity received PREVNAR 13, intramuscular in the arm, on an unspecified date, at 0.5 ml single, and FLUZONE, intramuscular, on an unspecified date, at 0.5 ml. Relevant medical history and concomitant medications were not reported. Within hours after vaccination rash and swelling near her elbow appeared. The patient went to her doctor where it was diagnosed as cellulitis. The site was not cultured by the doctor. Outcome was unknown.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Fatigue, Migraine, Pain
Clinical narrative: Shot on 9/10. Tired 9/11 and 12-migraine-aches and pains. ER on 9/14-shots. ER on 9/16-I.V.-ER on 9/21-I.V.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Shot on 9/10. Tired 9/11 and 12-migraine-aches and pains. ER on 9/14-shots. ER on 9/16-I.V.-ER on 9/21-I.V.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Chest pain, Musculoskeletal pain
Clinical narrative: Patient said she had shoulder pain for 2 days then she had chest pain. She went to her doctor and he had an X-ray done then prescribed a ZPAK.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site redness in a elderly female patient who received Flu vaccine. Previously administered products included Flu vaccine with an associated reaction of injection site pruritus (received each year) and flu vaccine with an associated reaction of injection site erythema. Concurrent medical conditions included drug allergy (allergic to several drugs). On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced injection site redness, injection site itching and feeling unwell. On an unknown date, the outcome of the injection site redness and injection site itching were unknown and the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the injection site redness, injection site itching and feeling unwell to be related to Flu vaccine. Additional details were received as follows: The patient stated that, each year after receiving flu vaccine, she experienced redness and itching on and around injection site. Sometimes these reactions reached to her elbow. On an unknown date, last year, after receiving Flu vaccine the patient also felt very ill, which recovered after 12 hours. The patient was asking whether to continue with the vaccines. The patient's husband did not experienced any adverse events after receiving Flu vaccine. Also, he was having compromised immune system and decided not to receive further flu vaccine doses. The patient stated that she her husband were 73 and 75 years old.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site warmth
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of injection site infection in a female patient who received FLUARIX TRIVALENT. On 9th September 2015, the patient received FLUARIX TRIVALENT. On an unknown date, less than a week after receiving FLUARIX TRIVALENT, the patient experienced injection site infection, injection site redness and injection site warmth. The patient was treated with antibiotics nos (Drug Name Unknown). On an unknown date, the outcome of the injection site infection, injection site redness and injection site warmth were unknown. It was unknown if the reporter considered the injection site, injection site redness and injection site warmth to be related to FLUARIX TRIVALENT. Additional details were received as follows: In September 2015, the patient developed injection site redness and injections site warmth. On 11th September 2015, the patient visited her physician, who stated that she had a secondary injection site infection. She was prescribed unspecified antibiotics to resolved the problem.
Age: 12.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Student c/o feeling like wanted to vomit, feeling faint, pale. Mom reports student has not eaten she has had this reaction 1 year ago cold pack, pretzels and water.
Age: 14.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Pallor, Seizure, Tension
Clinical narrative: After given 4th vaccine, he became pale and laid head on arm-passed out and then immediately tensed/convulsed about 3 seconds. Mom reported (via translator) symptoms usual after vaccines-always happens and not new symptoms. Reported after vaccines given. Cold pack applied to back, head down between knees. Vitals checked, monitored, snack and water. 1035 BP-110/80 HR-76 R-16 T-97%.
Age: 9.0
Sex: F
Vaccine: FLU3, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Cold sweat, Feeling abnormal, Pallor
Clinical narrative: Client became clammy and pale. States that she felt "weird" after her shots. Denies headaches, blurred vision but stomach ache per she states that she did not eat today and has been here since 7 am. Ice pack given, snacks. VS complete. Resolved s/s at discharge.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Urticaria
Clinical narrative: Hives, no respiratory distress w/in 5 mins after vaccine was given; BENADRYL 1 tsp PO x 2 dose then Q 6 hours sent to the ER, spreading to front and (L) leg thigh pains-where he got his shot.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: States noted redness, lump and warmth at site within 24 hours. Persisted x 5 days. Also pain at site.
Sex: U
Vaccine: FLUX, PER, VARZOS
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Information was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot# and route unknown), influenza virus vaccine (manufacturer unknown) (dose, lot# and route unknown) and pertussis vaccine (manufacturer unknown) (dose, lot# and route unknown). Concomitant therapy was not reported. Four to five days after the vaccination, the patient developed fever, chills, redness at injection site on an unknown date. The patient sought medical attention by contacting the pharmacist. The outcome of the events was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Patient had local site reaction to vaccine. Redness and pain around injection sites for each vaccine.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema, Differential white blood cell count, Drooling, Dysphagia, Dyspnoea
Clinical narrative: Patient reported approximated 2 hrs after receiving flu shot shortness of breath, increased warmness and itchy throat. Later that evening symptoms worsened accompanied by facial swelling and dysphagia and drooling. She went to the ER for evaluation.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Full blood count, Metabolic function test, Swelling face, Throat irritation
Clinical narrative: Patient reported approximated 2 hrs after receiving flu shot shortness of breath, increased warmness and itchy throat. Later that evening symptoms worsened accompanied by facial swelling and dysphagia and drooling. She went to the ER for evaluation.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: The injection site turned red, warm to touch and spread around various centimeters.  I also feel itchiness.
Age: 34.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema
Clinical narrative: RED ZONE AT INJECTION SITE.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mouth ulceration, Oral pruritus, Pruritus, Rash
Clinical narrative: Patient developed itching of face and mouth on the evening of 9/23, also complains of development of rash and mouth ulcers which she noticed on 9/24/15. She has received the flu vaccine in prior years with no allergic reaction reported. She denies any egg allergy.  She is not experiencing any skin reaction near the injection site.  She also reported eating out at a restaurant immediately following vaccination at the pharmacy. It is  possible that the symptoms she is experiencing were a result of some food type allergy, although she is not aware of any food allergies at this time.    Patient is currently managing symptoms with over the counter Benadryl. I instructed patient to contact her PCP is her symptoms worsen or do not resolve for further treatment.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye discharge, Musculoskeletal pain, Neck pain, Ocular hyperaemia
Clinical narrative: Started with cough which increased in frequency, felt that throat opening was tightening, aches in shoulders and neck, went to bed by 8:30 PM. Wondered if my throat would close completely in the night. Got up during the night with very red, oozing eyes and swollen pockets on my face. No cough or throat tightness in the morning but eyes were still red, face still swollen.  Dizzy during the day. All issues resolved by Tuesday evening except some aches in shoulders and neck.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face, Throat tightness
Clinical narrative: Started with cough which increased in frequency, felt that throat opening was tightening, aches in shoulders and neck, went to bed by 8:30 PM. Wondered if my throat would close completely in the night. Got up during the night with very red, oozing eyes and swollen pockets on my face. No cough or throat tightness in the morning but eyes were still red, face still swollen.  Dizzy during the day. All issues resolved by Tuesday evening except some aches in shoulders and neck.
Age: 4.0
Sex: M
Vaccine: FLUN4, MMRV
Symptoms: Cold sweat, Hyperhidrosis, Irritability, Pyrexia
Clinical narrative: Excessive sweating (fever), clammy to the touch, and irritability.
Age: 80.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Patient states arm swollen. At first thought it normal side effect, but can't lift above shoulder. It is worsening he states today.
Age: 1.14
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: 9/5 left arm swollen and warm to touch. 9/4 area was itchy and swollen. May use loratadine and BENADRYL at bedtime.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Lethargy, Loss of consciousness, Tremor
Clinical narrative: 2 hours after HIGH-DOSE flu shot, pt experienced drop in BP from 125/75 -> 90/50. Chills, uncontrollable shaking. Almost passed out, very lethargic and several hours.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: As soon as needle was taken out of her arm, she bled alot and the injection site swelled into a hard lump.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None known at this time, vaccine was given today, supervisor/doctor/parent notified of error.