chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Meningism, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional and from a contactable pediatrician via a Pfizer sales representative. A 16-year-old female patient of unspecified ethnicity received TRUMENBA (lot number M37314, expiry date 17Apr2016) at 0.5 ml single and MENACTRA (lot number M15066 and expiry date 30Sep2016) at an unknown dose both via an unspecified route of administration, on unknown date for meningitis-like reaction. Relevant medical history and concomitant medications were not reported. The patient previously received two doses of MENACTRA at the age of 11 and 12 year-old respectively, without problem. the patient experienced syndrome of meningeal irritation on unknown date which required hospitalization with symptoms of stiff neck and fever. The outcome of the event was unknown.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Meningism, Musculoskeletal stiffness, Pyrexia, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional and from a contactable pediatrician via a Pfizer sales representative. A 16-year-old female patient of unspecified ethnicity received TRUMENBA (lot number M37314, expiry date 17Apr2016) at 0.5 ml single and MENACTRA (lot number M15066 and expiry date 30Sep2016) at an unknown dose both via an unspecified route of administration, on unknown date for meningitis-like reaction. Relevant medical history and concomitant medications were not reported. The patient previously received two doses of MENACTRA at the age of 11 and 12 year-old respectively, without problem. the patient experienced syndrome of meningeal irritation on unknown date which required hospitalization with symptoms of stiff neck and fever. The outcome of the event was unknown.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # L031459 with expiry date: 30-APR-2017; strength, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion of 70 degree Fahrenheit during 1 month. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with the improperly stored doses of PROQUAD (Merck) lot #: L031601, expiration date on 18-FEB-2017, lot #: L034931, expiration date on 03-MAR-2017 and lot#: L041629, expiration date on 22-APR-2017 (dose number, strength and anatomical location were not provided). The vaccines were stored in a temperature of 6F during 72 hours. Previous temperature excursion was 40.1F for 50 minutes. No adverse events were reported. No product quality issue was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Local swelling, Musculoskeletal chest pain, Peripheral swelling
Clinical narrative: Here for fasting labs as f/u from recent physical. He also is here for left arm swelling. 4/13/16 received Tdap vaccine in left. arm. 2 days later got a pain in left axilla/lateral chest wall, had some swelling in same area. Area has remained about the same. No erythema, no warmth. No arm swelling, no numbness, tingling or pain otherwise. No recent injury, trauma, no fever, no NVD. No other aggravating or relieving factors. No other complaint.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Grip strength decreased, Herpes zoster, Immediate post-injection reaction, Injection site vesicles
Clinical narrative: The vaccination hurt very badly, immediately, on the 7th day after vax blisters began to develop on site of injection. On 9th day thumb and hand felt like on fire and lots of itchiness. Took ADVIL as needed for pain. On 4/2 went to weekend care office below and was seen by Dr. Dr diagnosed shingles and provided the following medications gabapentin 100 hydrocodone - acetaminophen, ganciclovir 500 mg. Redness followed nerve down arm. Medication helped, noticed relief within 48 hours. On 4/5 went to regular doctor for follow-up. Seen by Dr at 10 am. Confirmed shingles. Still having problems to pick up something - still dropping it.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: The vaccination hurt very badly, immediately, on the 7th day after vax blisters began to develop on site of injection. On 9th day thumb and hand felt like on fire and lots of itchiness. Took ADVIL as needed for pain. On 4/2 went to weekend care office below and was seen by Dr. Dr diagnosed shingles and provided the following medications gabapentin 100 hydrocodone - acetaminophen, ganciclovir 500 mg. Redness followed nerve down arm. Medication helped, noticed relief within 48 hours. On 4/5 went to regular doctor for follow-up. Seen by Dr at 10 am. Confirmed shingles. Still having problems to pick up something - still dropping it.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 18-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # L031459 with expiry date: 30-APR-2017; strength, dose, route and site of administration were unspecified). The administered vaccine underwent  the temperature excursion at 70 degree Fahrenheit during 1 month. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report was received from a consumer on an online article regarding his son, a male patient of unknown age. Medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with a dose of MMR vaccine (manufacturer unknown) (lot# and expiry were not provided). On an unknown date the patient experienced autism. The outcome of autism was unknown. The causality assessment was not provided. Additional information is not expected as reporter contact details were not provided.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Mobility decreased, Pain, Skin warm
Clinical narrative: Pt received PNEUMOVAX in clinic on 3/10/16 at 1100. Pt called clinic on 3/11/16 complaining of swollen deltoid and shoulder. arm red and warm to touch, painful and difficult to lift arm. Clinic recommended placing ice 15 minutes and 15 minutes off, and going to ED if symptoms worsen. Pt presented to ED 3/11/16 complaining of same symptoms, began 5 hrs post vaccine administration. In ED, given ketorolac 60mg IM, methylprednisolone NA succ 80 mg IM, diphenhydramine 50 mg PO. On discharge from ED, prescribed methylprednisolone 4mg dosepak, diphenhydramine OTC as needed, ice packs as needed, home med diclofenac as needed. Follow up call 3/14/16, pt tolerating medications and swelling in shoulder improved.
Sex: M
Vaccine: HEPAB
Symptoms: Antibody test negative, Incomplete course of vaccination, No therapeutic response, Serology test
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 65-year-old male patient who received TWINRIX adult. Co-suspect products included TWINRIX adult, TWINRIX adult and TWINRIX adult. On an unknown date, the patient received the 1st dose of TWINRIX adult 1 ml, the 2nd dose of TWINRIX adult, the 3rd dose of TWINRIX adult and the 4th dose of TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, TWINRIX adult and TWINRIX adult and not applicable after receiving TWINRIX adult, the patient experienced therapy non-responder and incomplete course of vaccination. On an unknown date, the outcome of the therapy non-responder and incomplete course of vaccination were unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX adult, TWINRIX adult and TWINRIX adult. Additional details provided were as follows: On unspecified dates, the patient received 3 doses of TWINRIX adult vaccine as per accelerated vaccination schedule and never came back to receive the booster dose schedule after a year of receiving the 3rd dose. This led to an incomplete course of vaccination. On an unknown date, the patient underwent serology test and was tested non-reactive for the titres as recommended by the health care professional. The reporter wanted to know, whether they need to repeat the vaccination with TWINRIX or only with the Hepatitis B vaccine. No side effects were reported. Age at vaccination was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient of unknown age (who was also a pharmacist) and refers to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-APR-2016, the patient was subcutaneously vaccinated with ZOSTAVAX (dose, lot # and expiration date were not reported). On 12-APR-2016 (also reported as 12-APR-2106), the patient experienced redness and swelling "about the size of her palm" around the injection site. This area was also warm to the touch. The patient did not seek medical attention. No treatment was given for the adverse events. The outcome of the events was reported as not recovered, at the time of the report, the area was still red, swollen and warm to the touch. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Erythema, Oral mucosal blistering, Pain, Wound secretion
Clinical narrative: Patient receive a dose of HPV4 on 10/26/12 and he was fine. He received HPV9 for his 2nd dose along with Peds/Adol Hep A 2nd dose. He has received a dose of Peds/Adol before on 10/26/12 and was fine. Patient has really bad blisters that are raised located inside and outside of his mouth. They are weeping and red. Patient states that they are painful. He also has these blisters located on his penis, soles of his feet, injection site of HPV9 vaccine and his hands. Patient did go to the Emergency Department because his condition got worse and mom was very concerned.
Age: 24.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Pain in extremity, Upper extremity mass
Clinical narrative: Client received immunizations on 3/2/2016. She stated that her arm has been painful since the injection. When she arrived at the office on 4/20/2016 there was a visible lump in her arm about 20mm in diameter. She scheduled an appointment with her PCP.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Eosinophil count increased, Erythema, Impaired work ability, Joint swelling, Lymphocyte count increased
Clinical narrative: Redness and swelling of left deltoid to elbow and neck as well as warmth of arm.  Pt reports she could not even move her arm due to pain.  Generalized body aches.  pain at 4/5 to touch on left upper arm.  Upper body tenderness that prevents her from wearing a bra.  Pt unable to work for two days now.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain, Pain in extremity, Platelet count increased, Skin warm
Clinical narrative: Redness and swelling of left deltoid to elbow and neck as well as warmth of arm.  Pt reports she could not even move her arm due to pain.  Generalized body aches.  pain at 4/5 to touch on left upper arm.  Upper body tenderness that prevents her from wearing a bra.  Pt unable to work for two days now.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: Redness and swelling of left deltoid to elbow and neck as well as warmth of arm.  Pt reports she could not even move her arm due to pain.  Generalized body aches.  pain at 4/5 to touch on left upper arm.  Upper body tenderness that prevents her from wearing a bra.  Pt unable to work for two days now.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria pruritus. Betamethasone sufficient amount BID, Loratadine 10 mg every day.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain upper, Chest pain, Hypoaesthesia, Insomnia, Nausea
Clinical narrative: Mom called on 4-20-16 stating that patient couldn't sleep last night 4-19-16 due to having fever (100.1), stomach ache, nausea, headache, chest pain and numbing on left arm. No treatment was required per Dr. pt was seen in office today 4-20-16.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: Mom called on 4-20-16 stating that patient couldn't sleep last night 4-19-16 due to having fever (100.1), stomach ache, nausea, headache, chest pain and numbing on left arm. No treatment was required per Dr. pt was seen in office today 4-20-16.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Large reddened area around site, painful, warm to touch per patient; body aches and fever.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Large reddened area around site, painful, warm to touch per patient; body aches and fever.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 17-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # L031459 with expiry date: 30-APR-2017; strength, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion of 70 degree Fahrenheit during 1 month. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Injection site was completely red and the (L) deltoid area was red as well. Skin was slightly warm and arm was very sore. Pt given Triamcinolone cream and to call office if symptoms worsen.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Measles antibody negative, Viral titre decreased
Clinical narrative: Information has been received from a licensed nurse practitioner referring to a 24 year old female patient. There were no drug reactions/allergies reported. The patient's medical history and concurrent conditions were not provided. On 18-APR-2016, the patient was vaccinated with MMR II, intramuscular (dose, frequency, lot number and indication not provided). There were no concomitant medications reported. On an unknown date in April 2016, the patient was found to have low rebeola titers. She also had blood test and result was not reported. The outcome of viral titre decreased was unknown. There was no product quality issue (PQC) involved. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEPAB
Symptoms: Ocular hyperaemia
Clinical narrative: Experienced redness in left eye for more than 24 hours. Patient said he would seek medical attention.
Age: 68.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Rash, Rash morbilliform, Rash pruritic
Clinical narrative: Pruritic morbilliform rash, mostly on extremities with little truncal involvement.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Computerised tomogram normal, Dizziness, Fall, Head injury, Syncope
Clinical narrative: Patient recvd HPV (2nd dose) at 8:30am. Patient stated to his mother that he felt light-headed while walking out of the clinic shortly after 8:40am. While attempting to get into the car, patient fainted and fell backwards, hitting the back of his head on the pavement.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Crying
Clinical narrative: Child cried much of the time from the afternoon of 4/15/16 until the eve of 4/17/16. Mom stated child would seem fine and then just start crying.
Age: 43.0
Sex: F
Vaccine: HEPA, JEV1
Symptoms: Injected limb mobility decreased
Clinical narrative: Per Client approximately an hour after administration of vaccine in R Deltoid she experienced limited range of motion in R arm.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Swelling, redness, heat pain from elbow to shoulder. Worse 24 hours later. Swelling now below elbow. Redness also on underside of upper arm. I went to the ED and recommended treatment was NSAIDS and cold compress. Symptoms unresolved and worsened, waiting for call back from provider.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: The shot was very painful and the pain got worse with every passing minute. Had many Dr. and PT apt and saw a surgeon. Am still in PT and still have pain.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Acne, Injection site rash, Injection site reaction, Injection site scab, Irritability
Clinical narrative: Circular rash @ 2cm diameter on anterolateral right thigh with small scab. Initially pimple like but clear per family. History of fever and fussiness. No other lesions or symptoms.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Pyrexia
Clinical narrative: Circular rash @ 2cm diameter on anterolateral right thigh with small scab. Initially pimple like but clear per family. History of fever and fussiness. No other lesions or symptoms.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient reported that the day after receiving vaccine that her family member noticed that patient's was having tremors to her right arm.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Dysphagia, Headache, Throat tightness
Clinical narrative: Intense headache, chest pain, tight throat with difficulty swallowing.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Gianotti-Crosti syndrome, Rash
Clinical narrative: Diarrhea and rash (diagnosed as Gianotti Crosti on 4/19/16).
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Apnoea
Clinical narrative: Apnea.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Swelling, mild itchiness, and pain to area.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Feeling hot, Hyperhidrosis, Injection site erythema, Injection site warmth, Irritability
Clinical narrative: STARTED TO FEEL CRANKY AND JUST FEELING SORE, IRRITATED.  FELT WARM AND SWEATY.  NEXT DAY STILL FEELING THE SAME.  WHEN SHE WENT TO THE DR AT 1 PM, A RED SPOT WAS NOTICED APPROX 1 1/2" AWAY FROM THE INJECTION SITE, WITH A SMALL HEAD, THE SPOT IS WARM AND RAISED.  NO LOCALIZED REDNESS OR IRRITATION NOTED AT THE INJECTION SITES.  AT THE DR OFFICE TODAY AT 1 PM, AN ANTIBIOTIC OMNICEF WAS GIVEN.  THE DR. OFFICE STATES THE RED RAISED AREAS COULD HAVE BEEN A BACTERIA IRRITATION FROM THE INJECTION OF THE VACCINE.  GRANDMA STATES THE 2 MONTH SHOTS WERE GIVEN AND PATIENT WAS ADMITTED TO HOSPITAL FOR ABX DUE TO FEVER.  BUT THEY DID NOT CONSIDER IT A VACCINE REACTION.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pain
Clinical narrative: STARTED TO FEEL CRANKY AND JUST FEELING SORE, IRRITATED.  FELT WARM AND SWEATY.  NEXT DAY STILL FEELING THE SAME.  WHEN SHE WENT TO THE DR AT 1 PM, A RED SPOT WAS NOTICED APPROX 1 1/2" AWAY FROM THE INJECTION SITE, WITH A SMALL HEAD, THE SPOT IS WARM AND RAISED.  NO LOCALIZED REDNESS OR IRRITATION NOTED AT THE INJECTION SITES.  AT THE DR OFFICE TODAY AT 1 PM, AN ANTIBIOTIC OMNICEF WAS GIVEN.  THE DR. OFFICE STATES THE RED RAISED AREAS COULD HAVE BEEN A BACTERIA IRRITATION FROM THE INJECTION OF THE VACCINE.  GRANDMA STATES THE 2 MONTH SHOTS WERE GIVEN AND PATIENT WAS ADMITTED TO HOSPITAL FOR ABX DUE TO FEVER.  BUT THEY DID NOT CONSIDER IT A VACCINE REACTION.
Age: 23.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Blood culture negative, Injection site cellulitis
Clinical narrative: Patient developed cellulitis in her deltoid after receiving the MMR and Pneumococcal vaccine in the same arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: Localized swelling to site of injection, red area of diameter of half-dollar coin. Pt denies pain associated with it.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received double dose of hepatitis B instead of a hepatitis B and a Hib vaccine.  No subsequent adverse event noted.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dermatitis allergic
Clinical narrative: Allergic rash self resolved with time and Benadryl.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 25-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Henoch-Schonlein purpura
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with GARDASIL injection (strength, dose, frequency, anatomical location were not provided). Concomitant or co-suspect therapies were not provided. On an unspecified date, the patient developed Henoch-Schonlein purpura. The outcome of Henoch-Schonlein purpura was not reported. The relatedness between GARDASIL and Henoch-Schonlein purpura was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 26-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Loss of consciousness, Presyncope
Clinical narrative: One day after HPV9 given on 4/18/16 pt said she got dizzy, lightheaded and passed out at school. Dr examined pt. and stated she had vasovagal attack and possible reaction to vaccine just had headache on AM of 4/20/16.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Rash, fever. Rash at site initially - then rash on arms/legs.
Age: 57.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Pain
Clinical narrative: Pt has complained today of pain and has gotten tx and rehab the past 6 months, -> frozen shoulder?
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Left deltoid hives, pain, swelling.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Bloody stool (streaks) x 2 today. No vomiting no abdominal distension and no acute distress.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right upper arm 1 day after receiving ZOSTAVAX, increasing pain (redness), swelling after. Temp. 102.3 2 days after vaccine given. ER evaluation 4-10-16, given antibiotic for cellulitis. Evaluation at our office 4-14-16, improved pain, swelling.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Redness, swelling to L deltoid, ? cellulitis vs local tissue reaction. Redness/pain to touch/4/06.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Heat, induration , pain, whole of left upper arm. Tx with pain medication and antihistamine.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received on 4-18-16. That evening he c/o redness, warm, swelling (L) deltoid. Pt did c/o discomfort to the injection site at that time. Was f/u by phone and then was seen on 4/20/16.
Age: 20.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Discomfort, Erythema, Immediate post-injection reaction, Pain, Ultrasound scan
Clinical narrative: Patient reported immediate pain. Had "heaviness/achiness". Patient woke up with redness on 03/27/16.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 17-APR-2016, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot #: L018001, expiration date on 19-MAY-2017 (dose, route and anatomical location were not reported). Concomitant therapies were not provided. The vaccine was stored in a temperature of 43F during 68 hours. No previous temperature excursion was reported. No adverse events were reported. Additional information is not expected, since no consent to contact the reporter was provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 20-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 08-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 12-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 24-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 28-DEC-2015, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 13-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 30-DEC-2015, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccines were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reaction or allergies were not reported. On 05-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017, (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Registered nurse concerning to a patient (age and gender not reported) who on 13-APR-2016, was vaccinated with dose 1 (reported as "this is the only dose of PROQUAD this patient has ever been administered) of PROQUAD (lot No. K013867) subsequently. The nurse noticed that the patient was inadvertently vaccinated with an expired dose. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Body temperature increased, Erythema
Clinical narrative: This spontaneous report has been received from a physician via Pfizer (company # 2016170053) referring to a patient of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. On an unknown date in 200 the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration, lot #, expiration date were not provided). Concomitant therapies were not reported. It was reported that patient had a reaction to PNEUMOVAX 23 in 2000 with temperature of 100F and redness. At the time of reporting the outcome of events were unknown. However, no causal relationship was reported between the events of temperature of 100F and redness and vaccination with the PNEUMOVAX 23. The event of vaccine adverse reaction was considered to be related to suspect therapy. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from an adult female consumer, who was referring to herself, a patient of unknown age. The patient's current conditions, drug reactions or allergies were not reported. On 30-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (dose number, strength, route of administration, lot # and expiry date were not provided). Concomitant medications were not reported. After vaccination, the patient experienced pain at the injection site. Additionally, at the time of reporting, the injection site was still painful and the patient could barely move her arm. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 12-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes an d18.2 f for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 10-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 18-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 15 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Skin reaction
Clinical narrative: Information has been received from a physician via field representative referring to a 26 year old female patient. There was no concurrent condition or medical history reported. In 2014 (two years ago) the patient was vaccinated with second dose of GARDASIL (dosage, strength, lot# and route unknown) by a different doctor. There was no concomitant medication reported. After she got her second dose of GARDASIL, she experienced a dermatological reaction to the vaccination. The patient did fully recover from the event within2 weeks of the patient getting her second GARDASIL shot. The patient also thought that she might have developed pederosis and rosacea. The patient went to see her primary care physician. On 18-APR-2016 (today) the patient was scheduled to get her third dose of GARDASIL. The outcome of pederosis and rosacea was unknown. The reporter considered dermatological reaction to be related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning a patient of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of PROQUAD (Merck) (lot # L046509, Expiration Date 17-MAY-2017, strength, dose and route were not provided). The PROQUAD (Merck) was improperly stored at 24.6 F for 60 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 12-APR-2016 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # J001836, expiration date: 01-FEB-2015) (dose and route unspecified). No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling of injection site - size of softball, warm to touch.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness around site. Went to ER and was given Ibuprofen and warm compress.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 18-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine 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.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 27-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 f for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccines were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning a patient of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose with VARIVAX (Merck) (lot # L028276, Expiration Date 28-JUL-2017 or reported as L019994, Expiration Date 02-DEC-2016, strength, dose and route were not provided) with M-M-R II (lot #, strength, dose and route were not provided). The VARIVAX (Merck) was improperly stored at 24.6 F for 60 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects reported. The M-M-R II did not undergo any excursion. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report concerning a male patient of unknown age, was received from the patient's mother who is a medical assistant. The patient's concurrent conditions and pertinent medical history were not reported. On 12-APR-2016, the patient was vaccinated with M-M-R II and VARIVAX (Merck), (lot #, expiration date, strength, and dose were  not provided for both of them), both were administered via the intramuscular route rather than the subcutaneous route (incorrect route of drug administered). Additionally, it was also reported that the vaccines were administered in the back of the child's thigh rather than the side (drug administered at inappropriate site). There was no concomitant therapy reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 12-APR-2016 the patient was vaccinated with an expired dose of PROQUAD (Merck) (lot # K018143, expiration date: 10-APR-2016) (dose and route unspecified). No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Decreased appetite, Nausea
Clinical narrative: Nausea, dizziness, redness 4 weeks or 5 adverse effects.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Dizziness, Erythema, Nausea
Clinical narrative: Nausea, dizziness, redness 4 weeks or 5 adverse effects.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pain. Onset 1 day ago. The problem is worsening. Location: upper arm. The pain is aching. Trauma type: injection, 1 day ago on 04/13/2016. The pain is aggravated by movement. Associated symptoms include swelling and tenderness. Pertinent negatives include fevers, chills, chest pain and dyspnea.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain. Onset 1 day ago. The problem is worsening. Location: upper arm. The pain is aching. Trauma type: injection, 1 day ago on 04/13/2016. The pain is aggravated by movement. Associated symptoms include swelling and tenderness. Pertinent negatives include fevers, chills, chest pain and dyspnea.