chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On an unspecified date in March 2016 the patient was vaccinated with first dose of expired M-M-R II (expired product administered) (lot # K000997, expiry date 22-JAN-2016) 0.5 ml, intramuscularly (incorrect route of drug administration). No concomitant medications were reported. On an unknown date in March 2016 the patient was vaccinated with second dose of expired M-M-R II (expired product administered)(lot # K000997, expiry date 22-JA-2016) 0.5 ml, intramuscularly (incorrect route of drug administration). No adverse effects were reported. The action taken with the therapy with M-M-R II was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 09-NOV-2015, ROTATEQ was stored under 32 F for 39.5 hours. Then on 03-DEC-2015 the patient was vaccinated with the improperly stored dose of ROTATEQ (lot # k007246, expiration date 17-MAR-2016, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of "data logger". This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 1 or 2 unspecified patients of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (route and dose were not reported) (lot # L030587, expiration date: 10-FEB-2017). The PROQUAD was stored in -10 Celsius degrees for 12 hours. There was no previous temperature excursion and the call as because of a data logger. This is one of two reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I was providing IPV and Influenza vaccinations to forming recruits.  When giving one patient their 2nd vaccination, I noticed and hair and threw the vaccination in the sharps container.  I had assumed that I had thrown away the IPV vaccination, so I grabbed another IPV and provided it to the patient.  After the patient walked away, I looked in the sharps container and found a full influenza vaccination at the top of the pile.  This confirmed the patient received 2 IPV vaccinations in the left arm.  The patient then received his influenza vaccination.  The patient has not had any side effects or treatment from this.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Neuralgia, Pain in extremity
Clinical narrative: When I woke I had severe pain in my feet and the bottoms were red. Nerve pain continues in my left foot today.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 08-NOV-2015, RECOMBIVAX HB was stored under 32 F for 39.5 hours. Then on 11-DEC-2015 the patient wsa vaccinated with the improperly stored dose of RECOMBIVAX HB (lot # L018501, expiration date 22-JUN-2007, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". This is  one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 67 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX23, dose regiment unspecified (lot # L029306, expiry date 23-JUN-2016). On an unknown date the patient experienced redness and swelling localized at the injection site. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovering/resolving. The causality assessment was not provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 69 years old male patient. On an unknown date the patient was vaccinated with PNEUMOVAX23, dosing regiment unspecified (lot # L029306, expiry date 23-JUN-2016). On an unknown date the patient experienced redness and swelling localized at the injection site. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovering/resolving. The causality assessment was not provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 04-APR-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 25/0.5 Y (lot # K007825, expiry date 13-JAN-2016) dosing details and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No concurrent condition, medical history or concomitant therapy was reported. On 13-APR-2016 the patient was vaccinated with expired PNEUMOVAX 23 (lot # K008409 with expiration date 04-MAR-2016, dose and route unknown) (expired product administered). The PNEUMOVAX 23 did not have any temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: Flu-like symptoms with erythema to proximal arm of injection. ZYRTEC 10mg daily.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner via filed representative refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The patient was not a pregnant. On unspecified dates, the patient was vaccinated with complete schedule of doses for GARDASIL 9 at a dose of 0.5 ml. On an unspecified date, the patient was given an additional dose of GARDASIL 9 for an unspecified reason. No adverse effect was reported. Therapy with GARDASIL 9 was continued. The outcome o f the events was not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse via a company representative referring to a male patient under 2 years of age. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot#, dose, dose# and route unknown) (inappropriate schedule of drug administration). No adverse event was reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a 78 year old female patient regarding herself. The patient had a history of shingles. The patient's pertinent medical history included type 2 diabetes mellitus. The patient had drug reaction or allergies to Penicillin (manufacturer unknown) and Mycins (manufacturer unknown). On an unknown date at an unspecified time in 2008 the patient was vaccinated with ZOSTAVAX refrigerated vial 19400 PFU (lot number and expiry date unknown) (dosing regimen and frequency unknown) injection subcutaneously. The concomitant medications included three unspecified medications for diabetes. On an unknown date approximately in 2008 (also reported as since the injection) the patient has had recurring outbreak of shingles. On an unknown date approximately in March 2016 (also reported as a month ago) the patient experienced her most recent shingles. There were no lab diagnostics studies performed. The patient was treated with an unspecified dose of lidocaine (manufacturer unknown). It was also reported that the therapy with ZOSTAVAX was continued. The outcome of herpes zoster was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 15 year old female patient. The patient's medical history and concurrent conditions were not reported. On 26-APR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (0.5 ml, once, subcutaneous, lot # L050909, expiration date 14-JUN-2017) (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Vaccination failure
Clinical narrative: Information has been received from a registered nurse referring to a 54 year old male patient with no drug allergy/reaction. The patient's medical history included hepatitis C. In April 2014 (reported as "2 years ago") the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were unknown). No concomitant therapy was taken. On 27-APR-2016 the patient was seen at the facility for medical attention stating he developed "a tingling feeling on his left rib area" an unspecified time after receiving ZOSTAVAX. The patient also requested another dose of ZOSTAVAX since he did not think he built up enough antibodies from the first one (vaccination failure). No treatment was given to the patient for tingling and no lab was performed. The outcome of tingling feeling was reported as recovered (date unspecified). The outcome of "did not build up enough antibodies" was unknown. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 09-NOV-2015, RECOMBIVAX HB was stored under 32 F for 39.5 hours. Then on 06-DEC-2015 the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (lot # L018501, expiration date 22-JUN-2017, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to two patients of unknown age and gender. On 09-NOV-2015, RECOMBIVAX HB was stored under 32 F for 39.5 hours. Then on 03-DEC-2015 the patients were vaccinated with the improperly stored dose of RECOMBIVAX HB (lot # L018501, expiration date 22-JUN-2017, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". 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: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 09-NOV-2015, ROTATEQ was stored under 32 F for 39.5 hours. Then on 11-DEC-2015 the patient was vaccinated with the improperly stored dose of ROTATEQ (lot # K007246, expiration date 17-MAR-2016, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". 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: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 09-NOV-2015, ROTATEQ was stored under 32 F for 39.5 hours. Then on 03-DEC-2015 the patient was vaccinated with the improperly stored dose of ROTATEQ (lot # K007246, expiration date 17-MAR-2016, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". 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: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 09-NOV-2015, ROTATEQ was stored under 32 F for 39.5 hours. Then on 09-DEC-2015 the patient was vaccinated with the improperly stored dose of ROTATEQ (lot # K007246, expiration date 17-MAR-2016, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 19-APR-2016, the patient received an expired dose of ZOSTAVAX lot # L000461, expiry date 08-MAR-2016 (dose, route and site of administration were not reported). Additionally, the ZOSTAVAX had been exposed to a temperature excursion prior to administration (10 minutes, temperature 77 Fahrenheit). No symptoms reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 27-APR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K010630, Expiration date 30-OCT-2015; dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding the patients medical history and current conditions were not provided. On an unknown date the patient was vaccinated with improperly stored doses of PROQUAD (Merck) lot # L033697, expiry date 28-FEB-2017. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Diarrhoea, Gait disturbance, Injection site erythema, Irritability
Clinical narrative: The patient is a 4yo who received MMRV, Dtap and IPV. He developed severe nausea, emesis, irritability, low grade fever 6 hours after receipt. The MOP provided video of a crying, ill child which shows local reaction of erythema at both thigh injection sites and an abnormal gait, which resolved by next morning. He developed diarrhea the next day, which has continued intermittently since Apr 12 through when seen yesterday on April 27 2016. This alternates with normal stool and a sibling also has diarrhea symptoms starting a few days ago. The MOP c/o behavior regression. She was counseled the initial symptoms were likely vaccine related, the abnormal gait is most consistent with pain from local reaction, as it fully resolved by the next morning and the continued diarrhea and behavior changes are likely unrelated to vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction, Nausea, Pyrexia, Regressive behaviour, Vomiting
Clinical narrative: The patient is a 4yo who received MMRV, Dtap and IPV. He developed severe nausea, emesis, irritability, low grade fever 6 hours after receipt. The MOP provided video of a crying, ill child which shows local reaction of erythema at both thigh injection sites and an abnormal gait, which resolved by next morning. He developed diarrhea the next day, which has continued intermittently since Apr 12 through when seen yesterday on April 27 2016. This alternates with normal stool and a sibling also has diarrhea symptoms starting a few days ago. The MOP c/o behavior regression. She was counseled the initial symptoms were likely vaccine related, the abnormal gait is most consistent with pain from local reaction, as it fully resolved by the next morning and the continued diarrhea and behavior changes are likely unrelated to vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding the patients medical history and current conditions were not provided. On an unknown date the patient was vaccinated with improperly stored doses of VARIVAX (Merck) lot # L026406, expiry date-15-JUL-2017. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 66 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dosing regimen unspecified) lot # L029306, expiry date- 23-JUN-2016. On an unknown date the patient experienced redness and swelling localized at the injection site. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovering/resolving. The causality assessment was not provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding a patient of unknown age and gender. Information on the concurrent conditions, medical history and drug allergies of the patient were not reported. On 05-APR-2016, the patient was vaccinated with improperly stored M-M-R II lot # L024268, expiry date 01-JUL-2017 (dose number, dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccine was stored at temperature of 20 degree Centigrade for 11 hours, 15 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding two patients of unknown age and gender. Information on the concurrent conditions, medical history and drug allergies of the patients were not reported. On 05-APR-2016, the patients were vaccinated with improperly stored doses of M-M-R II lot # L024268, expiry date 01-JUL-2017 (dose number, dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccine was stored at temperature of 20 degree Centigrade for 11 hours, 15 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unspecified dates in 2016 (reported as starting on or after 28-MAR-2016), unspecified patients were vaccinated with a dose of improperly stored ROTATEQ (which had a lot # of L035510 and an expiration date of 13-MAY-2017. However, dosage number and route of administration were not reported). Although, no adverse effects were reported. The vaccine experienced the following temperature excursions: 27.7 F for 42 hours and 45 minutes on an unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned ones were no identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Concussion, Contusion, Face injury, Fall, Immediate post-injection reaction
Clinical narrative: Immediately after patient had MENACTRA, she suffered syncope, fell off table, had brief seizure after she fell onto her face. Patient diagnosed with syncope, brief convulsive seizure, facial contusion, concussion.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Seizure, Syncope
Clinical narrative: Immediately after patient had MENACTRA, she suffered syncope, fell off table, had brief seizure after she fell onto her face. Patient diagnosed with syncope, brief convulsive seizure, facial contusion, concussion.
Sex: F
Vaccine: HPVX
Symptoms: Drug ineffective, Incorrect product storage
Clinical narrative: This spontaneous report as received from a mother refers to her daughter of unknown age. In February 2016 the patient was vaccinated a dose of unidentified Merck HPV vaccine (name and lot number not provided). The vaccine was picked up from a local pharmacy so that eh patient's pediatrician could apply it. In April 2016 (last week), the reporter was informed that vaccine had been in refrigerator that was not functioning properly. As a result the vaccine given to the patient was not effective. The patient would have to take an extra dose of the vaccine. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a medical assistant referring to a 21 year old female patient. The patient had no pertinent medical history or drug allergies. On unknown dates, the patient was vaccinated with RECOMBIVAX HB series (dose, route and lot # were not reported). There was no concomitant therapy. On 11-APR-2014 the patient had negative titers so she received a booster dose of RECOMBIVAX HB on an unknown date in April 2014. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pt came in for a physical and stated she wanted a Hep A because she was traveling. I forgot we only had pediatric Hep A and gave her that one.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: PT stated swelling and pain at injection site. Provider believes cellulitis injection at injection site.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-APR-2014, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) lot #: L042817, expiration date on 26-APR-2017 (dose number, strength and anatomical location were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 9F during 10 hours. No previous temperature excursion was reported. It was unspecified if PROQUAD (Merck) lot #: L051101, expiration date on: 17-JUN-2017 was administered to the patient. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash erythematous
Clinical narrative: Redness and itching at injection site.  Small red bumps formed.  The bumps have since gone away.  There is a slight redness left on her arm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness and pain at site. The area to her left upper arm was warm to touch with erythema. Area was marked to see if redness expands. No SOB or respiratory symptoms.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Blood test abnormal, Inflammation, Musculoskeletal pain, Pain in extremity
Clinical narrative: Dec 14-injection, Dec 16 severe pain knees, hips, shoulders - 2 weeks pain gone from knees and 1 hip. Feb 4-pain in hands, shoulders and 1 hip. Progressed. No difficult to use hands. Pain continue in hands, wrists, arms and shoulders.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: X-ray limb normal
Clinical narrative: Dec 14-injection, Dec 16 severe pain knees, hips, shoulders - 2 weeks pain gone from knees and 1 hip. Feb 4-pain in hands, shoulders and 1 hip. Progressed. No difficult to use hands. Pain continue in hands, wrists, arms and shoulders.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema upper rt arm from axilla to elbow. Started immediately after injection and worsened over 48 hrs. Trx: Prednisone and NORCO.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (R) arm swelling and redness.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Paralysis
Clinical narrative: 1/2 hour after "free" flu shot in 2003 muscle paralysis started in my thighs. I was driving at time! Paralysis and muscle problems spread throughout body over next 3 days. 1 month later still diff to get up. 13 yrs later still have residual problems.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Nurse injected MENVEO diluent without reconstituting powder first. Only diluent given.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Flank pain
Clinical narrative: Approximately 10 minutes after inject. patient experience shortness of breath and complained of pain in her side. 911 was called to assist patient. Called the patient the next day and she said she was doing fine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mom reports that 4/7/16 that client had (L) arm itching, swelling and discoloration or redness to skin. Client skin just appears darker in area where received shots. She called ER and was told give MOTRIN, BENADRYL and she gave it over the weekend. Today slight darker in color no noticeable edema noted.
Sex: U
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Decreased appetite, Pain
Clinical narrative: Soreness for 1 week, joint hurt, weakness, lost appetite.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Decreased appetite, Fluid intake reduced, Pyrexia, Rash
Clinical narrative: Rash in circular motion, lack of appetite, lack of fluid intake, low fever (99-100) treatment TYLENOL, monitor, length of symptoms Tuesday -> Monday (6 days) symptoms started 24 hrs after given vaccine.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Drug administered at inappropriate site, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: After flu shot, patient experienced severe pain and inflammation of bursa sac on arm where flu shot administered. Pt's physician said caused by inappropriate placement of flu shot injection. Inflammation shown on MRI. Pt has been in physical therapy since 10/21/15 immunization  and has seen some improvement, but not 100%.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse via company representative regarding to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. It was reported that nurse was told by patient that she had never received PNEUMOVAX 23. On an unknown date in 2016 the patient received second dose of PNEUMOVAX 23, lot, dosing details and route unknown. However, nurse found out that the patient had been vaccinated with first dose of PNEUMOVAX 23 two years ago on an unknown date in 2014 (inappropriate schedule of vaccine administered). Concomitant medication were not reported. No adverse effects were reported. Product quality complaint was not filed (PQC). Additional information is  not expected as the reporter did not wish to contact further.
Age: 84.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray, Dyspnoea, Electrocardiogram, Headache
Clinical narrative: Fever, mild headache, shortness breathing. ZITHROMAX 150 mg, Levofloxacin 500 mg, Cefdinir 300 mg, Amox-Clav 500 mg.
Age: 84.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Fever, mild headache, shortness breathing. ZITHROMAX 150 mg, Levofloxacin 500 mg, Cefdinir 300 mg, Amox-Clav 500 mg.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding an unspecified number of patients of unknown age and gender. Patient demographics were not provided. Information on the concurrent conditions, medical history and drug allergies of the patients were not reported. On unknown date, unspecified number of patients were administered unspecified number of improperly stored doses of PROQAUD (Merck) lot # L045675, expiry date 09-MAY-2017 (dose number, dose, frequency, route and anatomical location were not specified). Concomitant medication were not specified There were no adverse effects reported. There was no product quality complaint (PQC) involved. Vaccine was stored at temperature of -0.1 degree centigrade for 11 hours, 45 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from the same reporter. Additional information has be been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding an unspecified number of patients of unknown age and gender. Patient demographics were not provided. Information on the concurrent conditions, medical history and drug allergies of the patients were not reported. On unknown date, unspecified number of patients were administered unspecified number of improperly stored doses of VARIVAX (Merck) lot # L044527, expiry date 09-NOV-2017 (dose number, dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccine was stored at temperature of -0.1 degree Centigrade for 11 hours, 45 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding an unspecified number of patients of unknown age and gender. Patient demographics were not provided. Information on the concurrent conditions, medical history and drug allergies of the patients were not reported. On unknown date, unspecified number of patients were administered unspecified number of improperly stored doses of PEDVAXHIB lot # L038501, expiry date 16-AUG-2018 (dose number, dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccine was stored at temperature of 20 degree Centigrade for 11 hours, 15 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding two patients of unknown age and gender. Information on the concurrent conditions, medical history and drug allergies of the patients were not reported. On 06-APR-2016, the patients were vaccinated with improperly stored M-M-R II lot # L024268, expiry date 01-JUL-2017 (dose, frequency, route and anatomical location were not specified). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccines was stored at temperature of 20 degree centigrade for 11 hours, 15 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from same reporter. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Tooth extraction
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 34 year old male patient. The medical history, concurrent condition and concomitant medications were not reported. On 08-OCT-2015, the patient was vaccinated with RECOMBIVAX HB dose 1. On 08-NOV-2015, the patient was vaccinated with RECOMBIVAX HB dose 2. On 11-APR-2016, the patient had an unspecified tooth extracted. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a unknown number of patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency, indication, route of administration were not reported, lot # reported as L048452 with expiration date 01-MAR-2017). No adverse effects reported. Additional information is not expected, the reporter did not wish to be contacted.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Developed rash. Started on face and spread over 1 day to trunk, neck, hands and legs but spared his palms. No fever associated with rash.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Herpes zoster, Rash, Vomiting
Clinical narrative: SHINGLES, RASH UNILATERAL IN 1 DERMATOME, VOMITING, HEADACHE. TREATED WITH ACYCLOVIR ON 03/23/2016.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Erythema, Malaise, Pain, Skin warm
Clinical narrative: Pain, redness, raised red area that was hot to the touch, diarrhea, overall yuck feeling.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Pain, redness, raised red area that was hot to the touch, diarrhea, overall yuck feeling.
Sex: M
Vaccine: PPV
Symptoms: Arterial injury, Injection site reaction, Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, strength and route were not provided). Concomitant medications were not reported. The pharmacist reported that, soon after receiving PNEUMOVAX 23, the patient experienced swelling of injection arm up to shoulder, on an unknown date. The patient was admitted to hospital emergency room where it was concluded that "injection must have hit an artery". The patient sought the medical attention by admitting into hospital emergency room. The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint was reported. The events were considered serious due to hospitalization. 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 a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-APR-2014, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) lot #: L042817, expiration date on 26-APR-2017 (dose number, strength and anatomical location were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 9F during 10 hours. No previous temperature excursion was reported. It was unspecified if PROQUAD (Merck) lot # L051101, expiration date on: 17- JUN-2017 was administered to the patient. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding a patient of unknown age and gender. Information on the concurrent conditions, medical history and drug allergies of the patient was not reported. On 11-APR-2016, the patient was vaccinated with improperly stored M-M-R II lot # L034368, expiry date 01-JUL-2017 (dose, frequency, route and anatomical location were not specified). Concomitant medication were not specified. There were no adverse effects reported. There was no product quality complaint (PQC) involved. Vaccine was stored at temperature of 20 degree centigrade for 11 hours, 15 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Joint crepitation, Joint stiffness, Myalgia, Pain
Clinical narrative: Soreness since vaccine. Joint and muscle pain since vaccine. Joint clicking and stiffened after 10 days.
Age: 43.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Bruising to LUA, red and warm to touch localized reaction noted to be approximately size of RN's hand. No streaking, no fever. Client plans to follow up at walk-in clinic.
Age: 6.0
Sex: F
Vaccine: RV5
Symptoms: Crying, Diarrhoea, Pain, Vomiting
Clinical narrative: This spontaneous report was received from a 6 months old female patient's grandmother. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, (reported as on a Monday), the patient was vaccinated with the 3rd dose of ROTATEQ, 2 ml, orally (lot number and expiration date were not provided). The patients' concomitant medications were not reported. It was reported by the patient's grandmother, that after vaccination, the patient started to throw up (vomiting) and later developed an "explosive" diarrhea which lasted for several day (date unspecified). On an unknown date (reported as a week later) the patient was in a lot of pain and cried for 2 and a half hours. On 23-APR-2016, reported as on Saturday, the diarrhea and vomiting started again. The reported stated, that the patient has been "throwing up off and on since". The patient sough for medical attention, but it was not reported if treatment was provided to the adverse events. Furthermore, no product quality issue was involved. At the time of the report, the outcome of pain, diarrhea, vomiting and crying were unknown. Causality between the adverse events and vaccination with ROTATEQ was not provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Pt describes pain in (L) upper arm the day after receiving Tdap vaccine which was worsened. She notes worsening with movement and relief with Ibuprofen and heat.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Erythema, Flushing, Respiration abnormal, Swelling
Clinical narrative: Swelling, redness, flushed, abdominal pain, diminished air movement, wheezing, Rx: BENADRYL, Prednisone, Albuterol.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Wheezing
Clinical narrative: Swelling, redness, flushed, abdominal pain, diminished air movement, wheezing, Rx: BENADRYL, Prednisone, Albuterol.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Seizure, Vomiting
Clinical narrative: Fever 101 with vomiting overnight, woke up with fever at 103, seizure at 0730, in office by 08:15am. Ibuprofen, observation.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received MMR vaccine on 12/28/2015 at her 12 month well-baby and then the doctor's office "misread" medical chart and administered another dose of MMR vaccine at patients 15 month well-baby exam.
Age: 0.19
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site rash, Skin exfoliation
Clinical narrative: Scaly patch and bumpy rash at site of injection on thigh. Was not noticeable at first, but very prominent now, has lasted for days.
Age: 1.48
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Allergy test negative, Bronchitis, Crying, Feeling abnormal, Influenza like illness
Clinical narrative: Baby started crying and I noticed large accumulation of hives all over her legs, which continued to spread throughout her body. The hives came and went for days, baby was in general not feeling good. In the weeks after she was getting sick with cold and flu like symptoms for months, hives coming and going, developed a severe bronchial infection. We tried boosting her immune system and children's BENADRYL when hives were severe.
Age: 1.48
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Nasopharyngitis, Urticaria
Clinical narrative: Baby started crying and I noticed large accumulation of hives all over her legs, which continued to spread throughout her body. The hives came and went for days, baby was in general not feeling good. In the weeks after she was getting sick with cold and flu like symptoms for months, hives coming and going, developed a severe bronchial infection. We tried boosting her immune system and children's BENADRYL when hives were severe.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Feeling abnormal, Oropharyngeal pain, Syncope
Clinical narrative: Received Tdap and MCV, and 1ast GARDISIL. Shortly afterwards was feeling bad, her throat hurt, very clammy, PO 100 degree F, P 101, respiratory and cardiovascular (N). Lay down symptoms eventually started to resolve and syncope recovered. Given BENADRYL because of throat as precaution. 20 minutes vital stable.
Age: 3.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Decreased appetite, Injection site haemorrhage, Injection site nodule, Lacrimation increased, Lethargy
Clinical narrative: About 1 hr after vaccines administered, patient became lethargic and developed fever, 100-102 degrees F overnight. For the following 8 days, He was treated with ibuprofen at recommended dose for his size, as well as POWERADE. He had no appetite, mild watery nasal discharge. Dime sized knot under skin at injection site as well as some blood at injection site - developed about 10 days post injection. (L) leg (no lesion on right leg although had one vaccine in each.).
Age: 3.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: About 1 hr after vaccines administered, patient became lethargic and developed fever, 100-102 degrees F overnight. For the following 8 days, He was treated with ibuprofen at recommended dose for his size, as well as POWERADE. He had no appetite, mild watery nasal discharge. Dime sized knot under skin at injection site as well as some blood at injection site - developed about 10 days post injection. (L) leg (no lesion on right leg although had one vaccine in each.).
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Rash, Vaccination complication
Clinical narrative: First extreme pain radiating down arm. Pain continued for four days. On April 22 a serious rash began to develop. On April 25 I called pharmacy. Pharmacist told me to come in. He examined rash; said if it extended perimeters of his markings, I should see primary care doc. It did!! Contracted PC doc. He said send photo. I did. He said it looked like adverse reaction to shot. Suggested intake loratidine. Watch spread of rash.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling in the Right thigh around shot site.  Fever 101+. Starting 4/17. 4/19 Provider note: swelling and redness with minor amount of erythema around injection site.  DX Cellulitis related to immunizations treated with Bactrim.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, swollen area around the injection site.  Treated with fluincodinde cream.  Tx still ongoing as of now.
Age: 1.09
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.  No sequelae.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Paraesthesia, Swelling
Clinical narrative: Burning sensation at time of injection, 1.5 inch diameter of mild erythematous patch, slightly elevated, tingling.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Unevaluable event
Clinical narrative: No adverse event.