chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates since 05-OCT-2015, patient were vaccinated with the doses of PROQUAD (Merck) (lot # L027634 with expiration date 21-JAN-2017 and lot # L024125 with expiration date 30-DEC-2016; dose and route of administration were not reported) which were exposed to the temperature outside of the recommended range. No adverse effects have been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates since 05-OCT-2015, patients were vaccinated with the doses of VARIVAX (Merck) (lot # K016128 with expiration date 23-SEP-2016, lot # L008272 with expiration date 11-MAR-2017 and lot # L004653 with expiration date 11-FEB-2017; dose and route of administration were not reported) which were exposed to the temperatures outside of the recommended range. No adverse effects have been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a 53 year old female patient with no drug reactions/allergies referring to herself. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous in the left arm (dose and lot# were unknown). Concomitant therapies included MIRAPEX. On 26-OCT-2015 the patient experienced a burning pain all the way down her arm into her fingertips, and a tingling feeling that went all the way down her leg. She also stated she has a dull ache in her shoulders that made it difficult to lift anything. The patient did not see her physician about this issue for financial concerns. No treatment was given for the events and no lab diagnostics studies were performed. At the time of the report, the patient said that her arms were still in pain and it hurt for her after being told her arm up to a certain level. The outcome of other events was reported as not recovered/not resolved. The causality was not reported. Additional information is not expected as the reporter didn't like to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant  medication and drug reactions or allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L018500, expiration date 13-APR-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDDVAXHIB lot # L009649, expiration date 29-NOV-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # 023232, expiration date 25-FEB-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, lot # reported as L008059, expiration date 18-DEC-2016 (strength and dose were not provided). No adverse effects were reported. This is one of several reports received from the source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 18-JUN-2015, the patients were vaccinated with a dose of improperly stored PROQUAD (Merck) (lot number: K020747, expiration date: 30-APR-2016) (dose and route were not reported). No adverse effects were reported. There was no product quality issue reported. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015. The reporting certified medical assistant would have to search the request made for patients' identifiers, lot numbers and expiration dates and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 22-JUN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # confirmed as K020747. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product and event information and narrative were updated.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 50 year old female patient with Diabetes. No information regarding the patient's medical history was provided. On 03-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX23 injection in her arm (lot# K016294; dose, route of administration and expiry date were not reported) and with a dose of an unspecified Flu vaccine (in the same arm; dose and route of administration were not reported). There were no concomitant therapies reported. On 04-NOV-2015, the patient experienced redness and swelling in an unspecified arm. On 06-NOV-2015, reported as today, the patient experienced fever of 101.4 degrees (units not further specified). There was no product quality complaint involved. The patient sought medical attention- she had an appointment scheduled for the day of this report. The outcome of the events was not reported. The relatedness between the suspect therapies and the events was not provided. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Pruritus, Urticaria
Clinical narrative: Itching with hives and upset stomach.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, warmth, swelling, soreness,p ain at injection site, headache, fever, pain in left shoulder and dizziness.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Redness, warmth, swelling, soreness,p ain at injection site, headache, fever, pain in left shoulder and dizziness.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection has continued from 11/5/2015 until today, 11/11/2015. Pain is not severe but still felt.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # K010339, expiration date 22-JUL-2016, dose and route unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 18-JUN-2015, the patients were vaccinated with a dose of improperly stored PROQUAD (Merck) (lot number: K020747, expiration date: 30-APR-2016) (dose and route were not reported). No adverse effects were reported. There was no product quality issue reported. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015. The reporting certified medical assistant would have to search the request made for patients' identifiers, lot numbers and expiration dates and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-215, regarding a 2-year-old patient of unknown gender. On 08-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # was confirmed to be K020747 with an expiry date of 30-APR-2016. This is one of several reports received from the same source. Additional information has been requested. Patient, product, event information and narrative were updated.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: Information has been received from a pharmacist referring to a 58 year old male patient. He was previously a stroke patient. On 16-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX lot # L000449, expiration date: 08-MAR-2016, 0.65 ml/one shot, subcutaneously. There was no concomitant medication. The patient experienced a migraine later that same day. Pharmacist did mention that the patient was "sensitive to monosodium glutamate (MSG)" which was an ingredient found in the ZOSTAVAX vaccine. None of lab diagnostics studies were performed. The FIORICET was given as treatment for the migraines. The outcome of event was reported as recovered/resolved in October 2015. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Given both PNEUMOVAX and flu shot in right arm - within 48 hours developed fever to 103 with right arm redness and swelling. Seen in ER.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pyrexia, Swollen tongue
Clinical narrative: Low grade fever, tongue swelling, facial redness, pain at injection site, redness to face and arm (right) treated with TYLENOL and MEDROL dose pack.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates in September 2015 the, 4 doses of improperly stored VARIVAX (Merck) (lot # K011801, expiration date 21-AUG-2015) were administered. In September 2015, 1 dose of improperly stored VARIVAX (Merck) (lot # L002215, expiration date 21-JAN-2017) (dosage, strength and route were not reported) was administered. There was no concomitant medication reported. No adverse symptoms was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Persistent Pain at injection site.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Cough, Eye discharge, Myalgia
Clinical narrative: Tightness and pain in chest, swollen painful throat, drainage from eyes, non-productive cough, body/muscle aches, rash on back of hands.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pharyngeal oedema, Rash
Clinical narrative: Tightness and pain in chest, swollen painful throat, drainage from eyes, non-productive cough, body/muscle aches, rash on back of hands.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 16 year old patient of unknown gender. No concurrent conditions or medical history were reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # K005958, Expiration date was not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: A little itchy and red at injection site.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on torso, some on legs, relieved with use of Benadryl and cortisone cream.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Muscle spasms, Paraesthesia, Pyrexia
Clinical narrative: Patient complained of tingling up arms and legs and also muscle spasms in legs. Also reported headache and fever. Lasted for 4 days.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site reaction, Injection site vesicles, Rash erythematous
Clinical narrative: Patient called on Wed 11/11/15 w/complaint of a red, angry rash w/a blister on arm where ZOSTAVAX shot was given.
Age: 41.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Odynophagia, Tonsillar hypertrophy
Clinical narrative: Swelling, redness, and itching on injection site. Tonsils were swollen which made swallowing very painful.
Sex: M
Vaccine: FLU4
Symptoms: Injection site nodule
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site nodule in a male patient who received FLUARIX. On an unknown date, the patient received FLUARIX .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced injection site nodule. On an unknown date, the outcome of the injection site nodule was unknown. It was unknown if the reporter considered the injection site nodule to be related to FLUARIX. Additional details provide were as follows: The patient experienced hard bubble underneath the injection site. The reporter mentioned that, the patient was not concerned. The reporter did not have the patient's birthdate, lot number and expiration date.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, concomitant medications and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with a dose of improperly stored PROQUAD (Merck) (lot number reported as L005297, expiration date: 17-AUG-2016) (dose and route not reported). No adverse effects were reported. Lot number L005297 has been verified to be a valid lot number for PROQUAD (Merck). Follow up information has been received on 03-AUG-2015 that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received on 05-AUG-2015. The reporting certified medical assistant would have to search the request made for patients' identifiers, lot numbers and expiration dates and dates of vaccination. Follow-up information was received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender, On 21-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck). This is one of several reports received from the same source. Additional information has been requested. Patient, product, event information and narrative were updated.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Discomfort, Pain in extremity, Sleep disorder
Clinical narrative: Within hour left arm started to get sore. Pain and discomfort kept pt up all night. 10/30 did not go to gym class because of discomfort 10/31 spoke to nurse line who advised pt to go to clinic. Went to walk-in clinic and PA tested range of motion and recommended ibuprofen 3 times a day. Ibuprofen did help. On 11/2 went to gym class and it was still uncomfortable to left 5 pounds of weight. Today feeling better. Pharmacist recommended to get regular flu vax going forward.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 62 year old patient of unknown age. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) 0.5 ml dose, intramuscular, lot # reported as "L031071" with exp "12-APR-2018". The vaccine was given instead of ZOSTAVAX. It was verified that VARIVAX (Merck) was administered by intramuscular injection. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 60 year old patient of unknown age. On 10-NOV-2015, the patient was vaccinated with a dose of VARIVAX (Merck) dose of 0.5ml, intramuscular, lot # was reported as "L031071" with exp. "12-APR-2018". The vaccine was given instead of ZOSTAVAX. It was verified that VARIVAX (Merck) was administered by intramuscular injection. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 09-NOV-2015 the patient was vaccinated with VARIVAX (Merck) lot # J013903/ exp 30-OCT-2015, subcutaneous (concentration and dosage were not reported). No concurrent therapies were reported. The patient was administered with expired VARIVAX. The VARIVAX (Merck) did not have any previous temperature excursions and was found to be supported with in-house post expiry data. The reporter also stated that the patient experienced no adverse symptoms. No treatment or no laboratory diagnostic studies were reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 63 year old female patient. The patient's concurrent conditions and medical history were not reported. On 09-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # K005402, expiration date: 07-NOV-2015), dose and route were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a multiple unspecified patients of unknown ages and gender. The patients medical history, drug reactions or allergies were not provided. On an unknown date, the patients were vaccinated with a dose of VARIVAX (Merck) (dose and route of administration were not provided) (confirmed Lot number reported as L023594, expiration date 26-JUN-2017; Lot number L021215, expiration date 10-JUN-2017) that was improperly stored. Concomitant medications were not provided. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: RV1
Symptoms: Laceration, Product quality issue, Syringe issue
Clinical narrative: This case was reported by a physician and described the occurrence of laceration of finger in a adult female patient who received ROTARIX (batch number A41CB548A, expiry date 28th February 2015) and (batch number A41CB528A, expiry date 28th February 2017). This case was associated with a product complaint. On an unknown date, the patient received ROTARIX. On an unknown date, the dose was an unknown dose. On an unknown date, immediately after receiving ROTARIX, the patient experienced laceration of finger and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration of finger to be related to ROTARIX. Additional details provided were as follows: The reporter stated that, a nurse had reconstituted the ROTARIX vaccine and while preparing to administer the vaccine, she cut her finger. The nurse stated that the glass under the plunger collar appeared broken. They did not administer the vaccine to the patient because fear of glass being in the vaccine. They set the vaccine aside for returning it to the GlaxoSmithKline.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Agitation, Chest pain, Epigastric discomfort, Fatigue
Clinical narrative: Some intermittent chest pain, gastric irritation, unusal fatigue and agitation.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Tremor, Vomiting
Clinical narrative: Vomiting, diarrhea, shaking, weakness.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient's arm (lower deltoid) warm, red, and painful.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation, Muscular weakness
Clinical narrative: Pt admitted to MC for progressive lower extremity Weakness.  Diagnosed with Guillain-Barre syndrome. Respiratory status declined and required mechanical intubation.  5 day course of IVIG was given with improvement.  Patient discharged to rehab 11/10/2015.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Respiratory disorder
Clinical narrative: Pt admitted to MC for progressive lower extremity Weakness.  Diagnosed with Guillain-Barre syndrome. Respiratory status declined and required mechanical intubation.  5 day course of IVIG was given with improvement.  Patient discharged to rehab 11/10/2015.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Mass, Tenderness
Clinical narrative: Lumps on lower left side and extreme sensativity to touch.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injected limb mobility decreased, Lymphadenopathy, Malaise, Neck pain
Clinical narrative: I received my injection in my left arm on 10/08/15.  That evening, I experienced malaise and a low grade fever of 99.4.  When I woke up the next morning, I had pain under my left arm, in my neck, and in the left clavicular area.  I noticed several pea sized swollen lymph nodes in the clavicular area and neck but I could not palpate any in the left armpit area.  I could hardly raise my left arm and it was even more painful to turn my neck.  I realized that last year these symptoms occurred but it was about a week after my injection and it was not as severe.  The symptoms lasted about 2 weeks. Last year I got my injection on the R) arm and the symptoms were on the right.  I did get the flu in January of this year.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: I received my injection in my left arm on 10/08/15.  That evening, I experienced malaise and a low grade fever of 99.4.  When I woke up the next morning, I had pain under my left arm, in my neck, and in the left clavicular area.  I noticed several pea sized swollen lymph nodes in the clavicular area and neck but I could not palpate any in the left armpit area.  I could hardly raise my left arm and it was even more painful to turn my neck.  I realized that last year these symptoms occurred but it was about a week after my injection and it was not as severe.  The symptoms lasted about 2 weeks. Last year I got my injection on the R) arm and the symptoms were on the right.  I did get the flu in January of this year.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Vaccination site pain
Clinical narrative: Pain in arm where vaccine was given, shoulder pain during certain motions, numbness radiating into fingers.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Pyrexia
Clinical narrative: Extreme fatigue, fever, lasting 24 hours.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dizziness, Dysstasia, Fatigue, Mobility decreased
Clinical narrative: Chills, pain. Dizziness. Extreme fatigue, inability to stand, nausea, inability to move arm.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain
Clinical narrative: Chills, pain. Dizziness. Extreme fatigue, inability to stand, nausea, inability to move arm.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Incorrect product storage, No therapeutic response
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 patient who received ENGERIX B. Co-suspect products included ENGERIX B and ENGERIX B. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX . On an unknown date, an unknown time after receiving ENGERIX B, an unknown time after receiving ENGERIX B and an unknown time after receiving ENGERIX B, the patient experienced therapy non-responder and incorrect product storage. On an unknown date, the outcome of the therapy non-responder and incorrect product storage were unknown. It was unknown if the reporter considered the therapy non-responder to be relate to ENGERIX B, ENGERIX B and ENGERIX B. Additional details provided were as follows: The healthcare professional reported that, unspecified number of patients underwent blood test for Hepatitis B antibody and showed no immunity after receiving the ENGERIX B vaccinations on unknown dates and after unspecified time. But then the reporter asked if the vaccines were exposed to lower recommended temperatures could that affect the vaccines. The reporter stated that, the vaccines might have been stored improperly. The reporter does not know if it was due to improper storage or not. The reporter did not have any information on other patients those received the vaccines and showed no immunity. The reporter only had information on the last patient (see case US2015157620).
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received FLUARIX (batch number 7HZ73, expiry date 30th June 2016). On 31st October 2015, the patient received FLUARIX (intramuscular). In 2015, less than a week after receiving FLUARIX, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unchanged. It was unknown if the reporter considered the injection site lump to be related to FLUARIX. Additional details were provided as follows: This case was not previously reported to anyone. The consumer called the reporter to inform that she experienced lump at injection site (left arm) after vaccination with FLUARIX. The call was transferred to Medical Information. No further details were available regarding the lump at the time of reporting.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Incorrect product storage, No therapeutic response
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 21-year-old female patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult and ENGERIX B adult (batch number 92M2J, expiry date 3rd November 2017). On 24th September 2014, the patient received the 1st dose of ENGERIX B adult. On 28th January 2015, the patient received the 2nd dose of ENGERIX B adult. On 31st July 2015, the patient received the 3rd dose of ENGERIX B adult. On 2nd November 2015, 1 year and 39 days after receiving ENGERIX B adult, 278 days after receiving ENGERIX B adult and 94 days after receiving ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the patient experienced drug dose administration interval too long, drug dose administration interval too long, and incorrect product storage. On an unknown date, the outcome of therapy non-responder, drug dose administration interval too long, drug dose administration interval too long and incorrect product storage were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: The healthcare professional reported a case (US2015GSK160472) for unspecified number of patients about lack of immunity to ENGERIX B therapy. But then the reporter asked if the vaccines were exposed to lower than recommended temperatures could that affect the vaccines. The reporter stated that, the vaccines might have been stored improperly. The reporter does not know if it was due to improper storage or not. The reporter did not have any information on other patients those received the vaccines and showed no immunity. The reporter only had information on the last patient concerned in this case. On 24th September 2014, the patient received the 1st dose of ENGERIX B adult. On 28th January 2015, the patient received the 2nd dose, which led to lengthening of the vaccination schedule. On 31st July 2015, the patient received the 3rd dose, which again led to lengthening of the vaccination schedule. On 2nd November 2015, 404 days after receiving 1st dose of ENGERIX B adult, 278 days after receiving 2nd dose and 94 days after receiving the 3rd dose, the patient underwent blood test for hepatitis B antibody and it showed no immunity (negative). Thus, it caused the patient to be a non-responder to therapy. The reporter only had lot number with an expiry date for 3rd dose.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Nystagmus, Vertigo
Clinical narrative: This case was reported by a physician via regulatory authority and described the occurrence of rotatory vertigo in a 63-year-old male patient who received INFLUSPLIT Tetra (batch number AFLBA083AA, expiry date 30th June 2016). Previously administered products included INFLUSPLIT Tetra (on 16th October 2014, well tolerated). On 15th October 2015, the patient received the 1st dose of INFLUSPLIT (intramuscular). On 15th October 2015, less than a day after receiving INFLUSPLIT, the patient experienced rotatory vertigo (serious criteria hospitalization) and nystagmus. On an unknown date, the outcome of the rotatory vertigo and nystagmus were not recovered/not resolved. It was unknown if the reporter considered the rotatory vertigo and nystagmus to be related to INFLUSPLIT Tetra. Additional details were provided as follows: The patient's concomitant medication was not reported. The patient experienced rotatory vertigo and nystagmus which lasted for more than 24 hours. On 16th October 2015, the patient was hospitalised for the events. At the time of reporting, the events were not resolved.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: She was fine the day of injection. But, upon awakening the next morning, she developed symptoms. They included numbness from her elbow down through her hand. Her hand also felt swollen. The numbness has continued off and on and every day since then.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Pruritus, Urticaria
Clinical narrative: Hives/pruritis and diarrhea occurred 20 minutes after administration. No airway issues. Patient given prednisone, Benadryl, and Zantac with resolution of all symptoms within 30 minutes.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Imz was given with daughter present.  Pt left as normal, other daughter returned the next day to ask what she could do for her mother.  Stated her mother was unable to move  her arm and having tingling.  After much discussion with pt, it changed to "pt can move her arm, but it's painful and has some tingling".  She has tried 1 ibuprofen 4 times.  She really wanted another recommendation and something to try topically.  I recommended if it continues, to definitely see the dr.  Pt took home menthol topical to see if that alleviated any discomfort and was encouraged to use ice as well. I followed up with the phone # on file the following day.  The daughter that was present at the time of imz stated that she was still having some tingling in her hand, but she hadn't spoken with mother yet that day.  She was supposed to have the pt call me back that day.  Still have not gotten to speak directly with the pt, therefore was hesitant how to report this due to some inconsistencies.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Immediate post-injection reaction, Musculoskeletal pain
Clinical narrative: Left Shoulder intense pain, started right after shot 10/24 and lasted thru 10/29. Pain restarted on 11/8 and it still exists as of 11/11. Lower back intense pain started on 10/26 and still have pain as of 11/11. Just been treating with heat but concerned that both pains have not gone away and may be related to the flu shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Pyrexia
Clinical narrative: Patient called today stating initial flare of 1-2 inches at injection site then subsided. Reporting redness has come back with decreased size- also feeling feverish but hasn't taken temp. Also states headache.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: PATIENT EXPERIENCING PAIN AND NUMBNESS IS ARM. TRIED ICE AND IBUPROFEN BUT REPORTS DOES NOT HELP MUCH.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Tenderness
Clinical narrative: Hard mass away from the injection site, on the deltoid muscle. The mass was very tender and slowly diminished over a one month period.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received on 26-OCT-2015 from a registered nurse concerning a patient of unknown age and gender who on 21-OCT-2009 was administered the primary dose of VAQTA two-dose series. On 26-OCT-2015, the patient was administered the booster dose but it was expired (lot number K008984; expiration 21-OCT-2015). No adverse events were reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling
Clinical narrative: Swollen left tricep.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose and route were not provided) lot # K025004 and expiry date on 22-JUL-2017. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (dose and route were not provided) lot # K023432 and expiry date on 18-JUN-2016. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Depressed level of consciousness, Dizziness
Clinical narrative: Nearly passed out very shortly after receiving the vaccine, before leaving the doctor's office dizziness and weakness.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Capillary nail refill test, Hypoaesthesia, Laboratory test normal, Phalen's test positive
Clinical narrative: C/o numbness in her hand and forearm on vaccine side.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Fever, swelling at injection site, muscle pain.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Right Arm pain following IM Flu vaccine.  Persisting 33 days postvaccine.  Pain has reportedly improved over the last week, but continues to have site injection pain.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site hypersensitivity, Injection site reaction, Rash pruritic
Clinical narrative: Patient called pharmacy from shore house stating itchy rash had formed at injection site and wanted to know if it was safe to use Benadryl cream to relieve the itch. I asked patient if rash was spreading or staying the same. She stated she thought rash was spreading. I suggested that she lightly trace the rash on her arm with pen so she would be able to determine if the rash was in fact spreading and told her if it does continue to spread, to contact her physician immediately. She stated she was going to call her doctor the following morning to discuss it with her. I asked the patient to keep me posted of the results. I called patient at home on 11/11/2015 at 9:00am to find out how she was feeling. Patient stated rash had spread to her elbow and was seeing the doctor this morning. I asked the patient again to please contact me regarding results of doctor visit. 11/11/2015 2:07 pm received call from Dr's office stating doctor believes patient had an allergic reaction to ingredient in the Prevnar-13 vaccine administered (lot# M06899 exp 03/2017). Doctor ordered prednisone and antibiotic.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Burning sensation, Erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Started as hive where shot was given, then, over course of 2 days, the entire arm and hand grew to twice its original size. The effects were swelling, itching and a burn-type feeling in the arm. The look and feel of the reaction resembled a 2nd degree burn - there was swelling, blisters, redness, and when that subsided, the skin started pealing.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling, Pruritus, Skin exfoliation
Clinical narrative: Started as hive where shot was given, then, over course of 2 days, the entire arm and hand grew to twice its original size. The effects were swelling, itching and a burn-type feeling in the arm. The look and feel of the reaction resembled a 2nd degree burn - there was swelling, blisters, redness, and when that subsided, the skin started pealing.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site inflammation, Injection site pain, Sleep disorder
Clinical narrative: Pain in shoulder - shot given high in bursa.  Pain radiating down to bicep muscle caused by inflammation.  Saw doctor on 10/23/15.  Was prescribed Prednisone.  Meds worked, but now the pain is back after completed Prednisone.  Very poor range of motion and interrupted sleep.  Am concerned this will be a chronic pain I have to live with.
Age: 71.0
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Feeling abnormal, Lethargy, Nasal congestion
Clinical narrative: EE states "I felt bad". Lethargic, achy. 2:00 AM woke up and had trouble breathing, nose completely stuffy. All respiratory symptoms.
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Pain and stiffness in body/arm.
Age: 31.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Pruritus
Clinical narrative: Red, itchy patches on bilateral Hands, anticubital fossa, armpits.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Full blood count, Metabolic function test, Speech disorder, Swelling face, Swollen tongue
Clinical narrative: Right sided facial swelling, tongue swelling and difficulty talking.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Patient experienced redness/swelling that spread down arm where vaccine was administered. Patient received a prescription for Naproxen on 11/11/2015.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Paraesthesia oral, Pruritus, Swelling face
Clinical narrative: Facial swelling, lips tingling, shortness of breath, itching.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Chills, Diarrhoea, Injection site haemorrhage, Pain
Clinical narrative: First presented with aches and pains in joints at 11:30, then severe chills. Temperature at 12:30 was 102.3, 15 minutes later 103.2, 15 minutes later 104.4. She had vomiting several times and diarrhea. At noon, she took 3 ibuprofen to little effect.  At 3 we tried Tylenol (2), but she threw them up. At 3:15 her temp started going down and at 3:45 was 100.5. She also presented with bleeding at the site of the injection.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: First presented with aches and pains in joints at 11:30, then severe chills. Temperature at 12:30 was 102.3, 15 minutes later 103.2, 15 minutes later 104.4. She had vomiting several times and diarrhea. At noon, she took 3 ibuprofen to little effect.  At 3 we tried Tylenol (2), but she threw them up. At 3:15 her temp started going down and at 3:45 was 100.5. She also presented with bleeding at the site of the injection.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: First presented with aches and pains in joints at 11:30, then severe chills. Temperature at 12:30 was 102.3, 15 minutes later 103.2, 15 minutes later 104.4. She had vomiting several times and diarrhea. At noon, she took 3 ibuprofen to little effect.  At 3 we tried Tylenol (2), but she threw them up. At 3:15 her temp started going down and at 3:45 was 100.5. She also presented with bleeding at the site of the injection.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Chills, Diarrhoea, Injection site haemorrhage, Pain
Clinical narrative: CHILLS, BODY ACHES, FEVER - 104, VOMITING. TREATMENT - IBUPROFEN AND TYLENOL.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: CHILLS, BODY ACHES, FEVER - 104, VOMITING. TREATMENT - IBUPROFEN AND TYLENOL.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: CHILLS, BODY ACHES, FEVER - 104, VOMITING. TREATMENT - IBUPROFEN AND TYLENOL.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Developed fever 102 degree and increase heart rate 109 bpm. Patient currently symptom free.
Age: 61.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Decreased appetite, Fatigue, Headache
Clinical narrative: Extreme fatigue; headache; loss of appetite; lasted more than seven days, with improvement. First time with combined flu shot and pneumonia shot.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Nasopharyngitis, Oropharyngeal pain, Pyrexia, Sneezing
Clinical narrative: Started feeling exhaustion, went to dinner at 6pm, threw up all of dinner, had chills, next day woke exhausted & with cold symptoms- sneezing, 99 degree fever, sore throat.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Started feeling exhaustion, went to dinner at 6pm, threw up all of dinner, had chills, next day woke exhausted & with cold symptoms- sneezing, 99 degree fever, sore throat.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site mass, Injection site swelling
Clinical narrative: Patient received TIV Fluvirin 0.5 ml in right deltoid. Within 10 seconds, some bleeding occurred and large lump the size of a golf ball appeared underskin. Patient applied an ice pack for 20 minutes to swelling. Site was rechecked at 11:25am and was less swollen, a little bruised but not bleeding. Patient denied any pain at site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Slight itching around the site (L deltoid area) followed by pain and stiffness in Left shoulder and upper arm. I took ASA gr. X at $:30 PM.  At 5:30 PM I noted slight pain reduction, but swelling and r3eddness.  The area of swelling and redness increased throughout the evening. I put ice on the area at 9:00 PM with some relief; took ASA gr. X at 11:30 PM with some pain relief.  The area of redness and swelling had increased and become harder.  I also put a warm compress on the area. 11/11/2015 @ 7:30 AM I awoke and found the area of swelling and redness had increased further, but the pain was much decreased.  I took ASA gr.X at 8:00 AM with some relief of discomfort, but at 1:00 PM, the area of swelling and redness had increased more. I iced the area again with relief of discomfort, but no reduction in swelling or redness.  At this time 4:30 PM, the area of involvement is ~ 6.5 x 4" over the outer aspect and biceps area of my left arm.  I have no itching, minimal pain (except for stiffness due to swelling), and no other symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Slight itching around the site (L deltoid area) followed by pain and stiffness in Left shoulder and upper arm. I took ASA gr. X at $:30 PM.  At 5:30 PM I noted slight pain reduction, but swelling and r3eddness.  The area of swelling and redness increased throughout the evening. I put ice on the area at 9:00 PM with some relief; took ASA gr. X at 11:30 PM with some pain relief.  The area of redness and swelling had increased and become harder.  I also put a warm compress on the area. 11/11/2015 @ 7:30 AM I awoke and found the area of swelling and redness had increased further, but the pain was much decreased.  I took ASA gr.X at 8:00 AM with some relief of discomfort, but at 1:00 PM, the area of swelling and redness had increased more. I iced the area again with relief of discomfort, but no reduction in swelling or redness.  At this time 4:30 PM, the area of involvement is ~ 6.5 x 4" over the outer aspect and biceps area of my left arm.  I have no itching, minimal pain (except for stiffness due to swelling), and no other symptoms.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Mobility decreased, Pain in extremity, Poor quality sleep
Clinical narrative: Have pain everyday since the vaccine, can not sleep well due to pain on arm, can not lift, have had headaches.  Its been more than a month and the pain is still persistent.