chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Oropharyngeal pain, Pruritus, Rash, Respiratory tract congestion, Urticaria
Clinical narrative: The day after vaccination with MENACTRA student reported experienced itching and hives on her stomach and back to mom later in the day.  Mom called our facility.  At 4:30-5pm spoke with nurse and doctor.  Advised to go to Urgent Care and come back the next day if necessary. Didn't go to emergency care but took Benedryl.  Rash cleared up in intesity but shifted from trunk to thighs, arm pits, back. Student later reported that she also had slight sore throat and congestion on the day after shot, but this cleared up with antihistamine.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Arm pain, severe arm pain, unable to move arm or sleep on arm.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Polymerase chain reaction, Pyrexia, Staphylococcus test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 25 years old female patient. Drug reactions/allergies included allergy to hydrocodone which caused vomiting and an allergy to an unspecified pneumococcal vaccine (Manufacturer unknown) on an unknown date, there was none additional pertinent medical history reported by the pharmacist. On 29-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M006922, expiration date: 21-JUN-2017, via subcutaneous. Patient's concomitant therapies included KEFLEX. On 31-AUG-2016, the patient was admitted at the hospital due to an adverse effect described as "fever, right arm pain at injection site and dizziness" experienced in approximately August 2016. The pharmacist reported that a treatment was prescribed during the admission by an unspecified provider of TYLENOL, ceftriaxone and KEFLEX, the patient was discharged on 03-SEP-2016. In addition, lab tests were performed in the hospital described as "Methicillin Resistant Staphylococcus aureus (MRSA) PCR twice and were negative". The pharmacist requested a lot check for PNEUMOVAX 23 lot # M006922, expiration date: 21-JUN-2017. The outcome of pyrexia, injection site pain and dizziness was reported as recovered on an unknown date in 2016. The outcome of allergy to an unspecified pneumococcal vaccine (Manufacturer unknown) was unknown. The relationship between the events and PNEUMOVAX 23 was not provided. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Inflammation, Pruritus
Clinical narrative: 5 days after vaccination, patient developed a severe inflammation, redness and pruritis.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Pyrexia, Repetitive speech
Clinical narrative: Patient had two of the GARDASIL shot the first shot was on 2-19-2014 and the 2 GARDASIL shot on the 7-31-2014. And on Aug 4-2014 I call Dr office and I report it in to them that patient did not get any sleep that night. Patient was saying things over and over and patient had a fever and Dr nurse told me to give patient about 1 or two weeks and patient will get better. And that night patient did went to sleep.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose: 0.65 ml, lot # L039094, expiry date: 08-JAN-2017). Pharmacist reported that the vaccine underwent temperature excursion at 6 degree Fahrenheit for 24 hours. No adverse effects were reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itching and rash at site of injection.
Age: 43.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives with itching on inner upper arms and some on belly.  Took Benadryl before going to bed.  Slight unraised red marks without itching remain this morning.
Age: 43.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Urticaria
Clinical narrative: Hives with itching on inner upper arms and some on belly.  Took Benadryl before going to bed.  Slight unraised red marks without itching remain this morning.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Redness, swelling, warmth at injection site. Hive-like. Lasted 2-3 days. Pt. became febrile and was seen for office visit. S/S resolved.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site swelling, Administration site warmth, Injection site erythema, Injection site pain
Clinical narrative: At site of administration, area became increasingly red, swollen, and hot to the touch.  Painful with light touch as well.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Red, Swollen, Pruritus, and warm to the touch.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Insomnia, Mobility decreased, Musculoskeletal disorder
Clinical narrative: My left are where shot was give became very sore. As the night went on it became very hard to move or sleep. This vaccine should really not be offered after any serious procedure. In my case after a heart operation. the effect of the shot have really worsened my recovery as the arm is now almost unusable.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Redness, swelling of injection site, tingling sensation area injection, warm to touch, feverish.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt reported swelling of her arm and redness.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever and swelling at site of vaccine given 9 days earlier. Same occurrence in twin brother. Seen at outside hospital ER and discharged home. Reported by parent to provider on 9/20/16.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 4.5 cm x 7 cm Erythema/edema localized to Inactive FLU vaccine injection site.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Left shoulder pain and decreased ROM. Left deltoid swelling/edema.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm of localized swelling erythema.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Injection site pain, Pyrexia, Tremor
Clinical narrative: Shaking chills, fever and pain at injection site for 24 hours.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This report was received via a Pfizer sales representative.  A female patient of an unspecified age and ethnicity received PREVNAR 13 and influenza vaccine; both via unspecified routes of administration on an unspecified date at single doses in the same arm for immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date, after the vaccination, the patient experienced very red painful swollen arm with erythema, and mild fever. The patient was seen at the Emergency Room. Therapeutic measures were taken included treatment with antibiotics. The clinical outcome of the events, was unknown. Follow-up (14Sep2016): New information from a contactable pharmacist via Pfizer sales representative includes: new events and description.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Mouth swelling, Paraesthesia oral
Clinical narrative: Shortness of air, tingling to tongue, feeling of oral swelling.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Imaging procedure, Musculoskeletal disorder, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Spoke with patient, influenza shot administered > 2 weeks prior, severe pain 8/10 in shoulder, radiating to the arm and neck. Unable to use the arm effectively, no benefit with current pain management. Will speak to Potential risk for bursitis vs capsulitis. Recommended ortho referral, pt wants to defer until prednisone effect appreciated. Current Plans Started PredniSONE 20MG, 1 (one) Tablet 1 tab po qd for 5 days, #5, 5 days starting 09/21/2016.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Dyspnoea, Injection site swelling
Clinical narrative: Per Patient, was eating supper after receiving vaccination- noted he was having difficulty swallowing so stopped eating. Also noted that injection site was very swollen. Went home and was still having some issues breathing - used his CPAP machine while at home - had issues until about 5 am this morning. Never sought outside medical help. When patient called today (~11 am) he states he is fine now. No issues noted. I did tell the patient he needed to follow-up with his PCP and that in the future if anything like this happened again after a vaccination to seek immediate assistance.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HPVX, RVX, UNK
Symptoms: Constipation, Dyspnoea, Seizure
Clinical narrative: My son began seizing and was having a hard time breathing during the seizure it lasted about one minute. Then it happened again about five minutes later. I called his doctor and the doctor on call called me back. His name was Dr.  He told me that it must have been reflux. I told him it was not reflux it was a seizure I know what I saw. I asked him if it could have been the vaccine and he insisted that it was not.  My son also became extremely constipated and did not have a bowel movement for about two weeks prior to the vaccines.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, MEN, TDAP
Symptoms: Abdominal pain, Arthralgia, Cough, Headache, Nausea
Clinical narrative: Collapsed in the morning during PT'ing at training after 2 weeks of headaches, upper respiratory tract infection, sore throat, joint pain, abdominal pain, cough, nausea. Was diagnosed with bilateral pneumonia & hospitalized 08/26/2016 to 08/29/2016.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, MEN, TDAP
Symptoms: Oropharyngeal pain, Pneumonia, Syncope, Upper respiratory tract infection
Clinical narrative: Collapsed in the morning during PT'ing at training after 2 weeks of headaches, upper respiratory tract infection, sore throat, joint pain, abdominal pain, cough, nausea. Was diagnosed with bilateral pneumonia & hospitalized 08/26/2016 to 08/29/2016.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Balance disorder, Chills, Cough, Headache
Clinical narrative: Severe cough, severe headache, chills, aches, weakness, and feeling of being "off balance" beginning 3 days after being vaccinated.  Patient had doctor visit where they gave him a prescription to treat the cough and said they will follow up with him in 3 days.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Severe cough, severe headache, chills, aches, weakness, and feeling of being "off balance" beginning 3 days after being vaccinated.  Patient had doctor visit where they gave him a prescription to treat the cough and said they will follow up with him in 3 days.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Atrial fibrillation, Pneumonia
Clinical narrative: Severe cough, severe headache, chills, aches, weakness, and feeling of being "off balance" beginning 3 days after being vaccinated.  Patient had doctor visit where they gave him a prescription to treat the cough and said they will follow up with him in 3 days.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: Right thigh pain and swelling; refusal to walk.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Local swelling, Pain, Paraesthesia
Clinical narrative: Late night local swelling and pain (down to fingertips) noted, also tingling, to ED with reassurance, pain/tingling resolved by office followup visit in am.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient has redness that continues to worsen at injection site - given steroid pack at walk in clinic.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness, swelling around injection site (on right arm). Also feels sore.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cold sweat, Dehydration, Dizziness, Erythema, Pruritus
Clinical narrative: 101.7 temp, fever for two days, cold soaking sweats on 3rd day with no fever. Entire upper arm red and itchy. Dehydrated and dizzy on morning after shots.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: 101.7 temp, fever for two days, cold soaking sweats on 3rd day with no fever. Entire upper arm red and itchy. Dehydrated and dizzy on morning after shots.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Injection site swelling, Peripheral swelling
Clinical narrative: Significant swelling involving entire ipsilateral extremity as injection site. No hives. Angioedema involving only affected extremity.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Migraine
Clinical narrative: Migraines, uncontrolled since vaccination.
Age: 1.25
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Differential white blood cell count, Full blood count, Joint swelling, Malaise, Pain
Clinical narrative: Swelling of hands, knees, feet with mobile rash and pain, with sensitivity to touch and movement. Diagnosis - urticarial rash/hives. Illness lasted 3 weeks. RX - prednisone, TYLENOL. Treated w/ ORAPRED and BENADRYL.
Age: 1.25
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Peripheral swelling, Rash, Tenderness, Urticaria
Clinical narrative: Swelling of hands, knees, feet with mobile rash and pain, with sensitivity to touch and movement. Diagnosis - urticarial rash/hives. Illness lasted 3 weeks. RX - prednisone, TYLENOL. Treated w/ ORAPRED and BENADRYL.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and heat at injection site. Swollen to approximate softball size.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. This 81-year-old female patient received PREVNAR 13 via an unspecified route of administration, in Jun2016 at 0.5 ml single for immunization. Relevant medical history  was not reported. Concomitant medications were none. On 22Jun2016, the patient experienced red arm and sore. No treatment was required, but the patient was hospitalized (unspecified date in 2016). The outcome of the events was recovered on an unspecified date in 2016. Follow-up (14Sep2016):  New information received from the same contactable consumer includes: additional event (sore), onset date, seriousness (hospitalization), outcome, info on concomitant medications.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Pallor
Clinical narrative: Itchy erythematous blanching hive-like swelling; non tender (R) deltoid 10x12 cm.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain Barre syndrome treated w/ 5 days IVIG, currently day 4.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pharyngitis
Clinical narrative: Guillain Barre syndrome treated w/ 5 days IVIG, currently day 4.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Pain, Pyrexia, Rash
Clinical narrative: Developed bodyaches and headache, following day fever, and next day rash.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Redness, rash, itching, pain at injection site; Patient did not treat.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Retching, Vomiting
Clinical narrative: Burning/swelling of the injection arm, vomiting, dry heaves.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Vaccination complication
Clinical narrative: Patient experienced mild reaction to Influenza vaccine. Had redness on neck and back of arms with itching.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling redness, pain and warmth at injection site. Diagnosed with cellulitis. Pt prescribed Levaquin.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Type II hypersensitivity
Clinical narrative: Swelling, itching, redness, tenderness to pressure on left arm admin site. Approx 20x8cm mild induration, probably type II hypersensitivity.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Nausea, Peripheral swelling
Clinical narrative: Upset stomach, nausea, arm swelling.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling redness and warmth at the injection site. Pt was treated with antibiotics: Keflex.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Fatigue, Nausea, Pain in extremity
Clinical narrative: Pt reports sore arm, fatigue, evening nausea, and possible mild fever (not confirmed) since given PNEUMOVAX on 08/17/16. Denies redness or swelling at injection site. Denies taking any fever suppressant medication. Denies vomiting/ diarrhea. Since then, pt has experienced migratory, intermittent and severe arthralgias. No history of chronic pain.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthritis, C-reactive protein increased, Joint range of motion decreased, Joint swelling, Platelet count increased
Clinical narrative: Pt reports sore arm, fatigue, evening nausea, and possible mild fever (not confirmed) since given PNEUMOVAX on 08/17/16. Denies redness or swelling at injection site. Denies taking any fever suppressant medication. Denies vomiting/ diarrhea. Since then, pt has experienced migratory, intermittent and severe arthralgias. No history of chronic pain.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Asthenia, Chills, Disturbance in attention, Erythema, Injection site pain
Clinical narrative: 3PM Right arm (where flu and PNEUMOVAX-23 was administered) become very sore. 6PM patient's throat began to swell/become tight, entire body ached, weakness, difficulty focusing & walking, visual problems, face and eyes became red. 9PM chills and low grade fever. 9/21 Patient states arm is no longer sore, temp normal, normal facial color. Throat still feels restricted. BENADRYL helped.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Ocular hyperaemia, Pain, Pharyngeal oedema, Pyrexia, Throat tightness
Clinical narrative: 3PM Right arm (where flu and PNEUMOVAX-23 was administered) become very sore. 6PM patient's throat began to swell/become tight, entire body ached, weakness, difficulty focusing & walking, visual problems, face and eyes became red. 9PM chills and low grade fever. 9/21 Patient states arm is no longer sore, temp normal, normal facial color. Throat still feels restricted. BENADRYL helped.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Visual impairment
Clinical narrative: 3PM Right arm (where flu and PNEUMOVAX-23 was administered) become very sore. 6PM patient's throat began to swell/become tight, entire body ached, weakness, difficulty focusing & walking, visual problems, face and eyes became red. 9PM chills and low grade fever. 9/21 Patient states arm is no longer sore, temp normal, normal facial color. Throat still feels restricted. BENADRYL helped.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: EXPIRED VACCINATION GIVEN, NO ADVERSE EFFECTS REPORTED BY PATIENT.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed hives on legs the morning of 9/16 while at school. By the end of day legs were covered in hives. Some were itching. Had some relief with Benadryl after home from school. 9/18 hives spread to knuckles and face. Was evaluated at an urgent care clinic and administerd 16 mg Dexamethasone and given steroid dose pack. Pt returns to office today reporting hives had improved until today when new hives erupted on legs again.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient walked into clinic stating he has a reddened area to the site where he had a pneumonia shot a week ago and it keeps getting bigger.  126/68 66 97.0, no pain but itchy, 18 95% on 2L. This writer noted a very large red area non raised no defined edges, 160cm across but when to measure vertical noted the rash was patchy and up into the  neck region.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Swelling and tenderness in left arm.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Injection site pain
Clinical narrative: Patient reported having pain in the injection arm and the chest. He suspected at first that he was having a heart attack.
Age: 1.42
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site rash, Injection site warmth
Clinical narrative: Rash on upper right thigh, hot to the touch. Developed one day after immunizations.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling jittery, Headache, Pain, Pyrexia
Clinical narrative: Subjective fever within 3 hours of vaccine. Also had fever this morning. Also had body aches and headache. Also noticed jitteriness. No rash.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Nausea, Pain, Pain in extremity
Clinical narrative: Patient states she developed a fever late monday/early tuesday along with nausea. Moderate/Severe redness, swelling and pain started Tuesday morning as well. She states Tuesday her arm was very painful and couldn't move it very well. She states it is improving at this point in time.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Patient states she developed a fever late monday/early tuesday along with nausea. Moderate/Severe redness, swelling and pain started Tuesday morning as well. She states Tuesday her arm was very painful and couldn't move it very well. She states it is improving at this point in time.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial soreness around injection spread to inner arm, starting about 1/2 way between shoulder and elbow, and going up toward shoulder. Stayed sore for a couple of days and then became very painful. Had about 3 days without being able to lift arm above head. Ice and ibuprofen seemed to address the worst of the pain. Seeing physical therapist to try to address the rest.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Flushing, Impaired work ability, Nasal congestion
Clinical narrative: Shortly after receiving flu shot, I developed flushing, dizziness, throat tightening, and nostrils closing, as a result had difficulty breathing and unable to continue working.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Shortly after receiving flu shot, I developed flushing, dizziness, throat tightening, and nostrils closing, as a result had difficulty breathing and unable to continue working.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Fatigue, Feeling hot, Nausea
Clinical narrative: Fatigued (slept approximately 20 hours from Friday 8PM to Sunday 2AM) and varied between cold chills and feeling very warm. I have had several instances of feeling nauseated, light-headed, and dizzy as well.
Age: 22.0
Sex: M
Vaccine: FLU4, HEPAB, MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: NO ADVERSE EFFECT.  HAD NOT EATEN GIVEN JUICE TO DRINK.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Myalgia, Pain of skin, Pyrexia
Clinical narrative: Fever, muscle ache, skin pain, extreme weakness.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Oropharyngeal pain, Pain in extremity, Peripheral swelling
Clinical narrative: After vaccinated left arm swelling to elbow. Pain radiates to left wrist. Sore throat.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Pain in arm, redness and warmth. Pain after injection, symptoms increased over next two days.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Red, warm induration at upper arm in 24 hours after injections, resolved on its own after 48 hours.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Peripheral swelling, Skin warm
Clinical narrative: Immunizations administered on 9/18 at 1:30pm. Patient came into Pharmacy on 9/20 at 6:20pm to pick-up RX for SMZ-TMP 800-160. Patient's arm was swollen from elbow to middle of upper arm. Area was hot red, swollen, nothing at actual injection site. Pt went to Dr on 9/20. Dr was not sure if from vaccine or not. Gave SMZ-TMP as precaution, also unsure if it was infection.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Fever, muscle aches, joint aches, headache, chills, dizziness, exhaustion. Lasted approximately 24 hours.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, joint aches, headache, chills, dizziness, exhaustion. Lasted approximately 24 hours.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Patient reports rash, red splotchy area. Got almost to the size of a baseball. No difficulty breathing-right arm.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: After administration of flu vaccine swelling at site-golf ball sized. Pain at site.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Started 2 days ago (9/18/16) with swelling, warmth and itching to Right arm Treated w/10 day course antibiotic.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Severe soreness in Right shoulder 9-12-16, now its turned into a severe pain that makes my arm hurt when lifting. The area is below the area of where the Flu shot was given and this started on 9/19/16.
Sex: F
Vaccine: PNC13
Symptoms: Pleural effusion, Pneumonia
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for herself. This female patient of unknown age received in Jul2016 a single dose of PREVNAR 13 for the prevention of pneumonia.  The patient medical history and concomitant medications were not reported. In Sep2016, in the week before this report, the patient reported that developed pneumonia. Her doctor told her that she had fluid in her left lung and it looked like pneumonia. Outcome was unknown. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 66-year-old American female patient received PREVNAR 13 for Immunisation on 26Jul2016 on the arm and PNEUMOVAX on 13Jul2015 for immunization. Medical history included type 2 diabetes mellitus diagnosed in 2011 and blood cholesterol abnormal. Concomitant medicines included metformin at 500 mg, 2x/day, ongoing for type 2 diabetic and pravastatin at 40 mg, 1x/day  for cholesterol. On 13Sep2016 the patient experienced pneumonia. Consumer was not hospitalized for the event and received treatment with antibiotic azithromycin (ZITHROMAX Z-Pak). She just had a chest X-RAY and she was diagnosed with Pneumonia. The patient received the vaccine at pharmacy. The outcome of the event was unknown.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nasal congestion
Clinical narrative: Patient began feeling nasal congestion, lightheadedness and dizziness.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: I developed a swollen lymph gland in the armpit, neck.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Blood creatine phosphokinase normal, Blood test normal, Body temperature increased, Borrelia test negative
Clinical narrative: Leg muscle pain moving to upper lower stomach and shoulders Sunday very fatigued. Wednesday more muscle pain very fatigued Thursday low grade temperature 99 to 99.4.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Metabolic function test normal, Musculoskeletal pain, Myalgia, Vitamin B12 normal
Clinical narrative: Leg muscle pain moving to upper lower stomach and shoulders Sunday very fatigued. Wednesday more muscle pain very fatigued Thursday low grade temperature 99 to 99.4.
Age: 47.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site swelling, Rash
Clinical narrative: Rash X3 days, Swelling at site, BENADRYL 25mg TID PRN prescribed to patient.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Injection site warmth, Skin tightness
Clinical narrative: Patient got a red welt around the injection site, it was warm and tight, it eventually extended down to the elbow. Arm was very sore.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Injection site pain, Vomiting
Clinical narrative: Sore legs and knees. Woke up and started vomiting.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Rash on arm, itchy. Warm at night. Advised at this time to take some BENADRYL.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Nasal congestion, Palpitations, Panic attack
Clinical narrative: Heart palpitations, tightening in chest, stuffed up nose, throat tight, dizziness. Called my physician and they said I was having a panic attack.  I have other mental issues but I know this wasn't a panic attack.  Never had a reaction from a flu shot; getting them over 20 years now.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Heart palpitations, tightening in chest, stuffed up nose, throat tight, dizziness. Called my physician and they said I was having a panic attack.  I have other mental issues but I know this wasn't a panic attack.  Never had a reaction from a flu shot; getting them over 20 years now.
Age: 52.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: PT STATED THE SITE WAS HARD (ABOUT THE SIZE OF A TANGERINE), A LITTLE ELEVATED, AND ITCHY.
Age: 39.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site papule, Injection site scab
Clinical narrative: Skin PWD, no rash on exposed skin. Right deltoid w pinprick scab at IM injection site. Mild erythema distal to injection. Scattered papules. No warmth, induration.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Headache, Lacrimation increased, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: PATIENT EXPERIENCED HEADACHES, SORE THROAT, NOSTRILS BURNING, LOW GRADE FEVER, EYES RED & WATERY. STARTED AFTER 5 HOURS GOT THE FLU SHOT.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: PATIENT EXPERIENCED HEADACHES, SORE THROAT, NOSTRILS BURNING, LOW GRADE FEVER, EYES RED & WATERY. STARTED AFTER 5 HOURS GOT THE FLU SHOT.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Syncope about 15 minutes after influenza vaccine.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Rash, Sinusitis
Clinical narrative: Arm sore and rash but did not report to Dr on appointment for sinus infection on 9/20/2016. On 9/21/2016 call pharmacy and came in.  Pharmacist counseled patient and examined body response to vaccine telling ptn some soreness swelling can occur and to take TYLENOL and BENADRYL every 6 hours for 48 hours and to call rx or dr if gets worse.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Hot flush, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, aches, chills, hot flashes, headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Cellulitis of 8cm x 15cm.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Pt developed hives all over.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen and reddened site of injection.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Swollen and reddened site of injection.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The patient presented to the pharmacy with a red spot the size of a silver dollar about an inch below the injection site. It was warm to the touch and she said it had gotten worse throughout the day. She had also received her allergy shot in that same arm the Friday before her vaccination. I informed her to use a cold compress and take acetaminophen or ibuprofen to help with the redness. We also contacted her PCP.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: Rash and hive effect at the injection site. Heat and itching.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Contusion, Peripheral swelling
Clinical narrative: Arm swollen and bruised, joint ached. No treatment, waiting to see if alleviates. Still bruised on Sept. 22, 2016, not sure if CLL is reason for prolonged bruising.
Age: 30.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: Heart rate increased, Musculoskeletal stiffness, Pyrexia, Rash erythematous, Urticaria
Clinical narrative: I had a fever of about 103 degree, arm was stiff, red hive like bumps. I when to the ER and they gave me tylenol and my fever continued to increase. Then they gave my potassium pills because it was low. Then after an hour they had to give me motrin. They said that my heartrate was high. They gave my IV fluids.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: Patient reported a reaction that started in her left arm (injection arm). Patient experience redness, soreness, and heat at the injection site. The swelling spread to below her left elbow and to her left inner thigh. Small, itchy blisters also appeared on her arm and thigh. Patient has pictures of the reaction.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Patient reported a reaction that started in her left arm (injection arm). Patient experience redness, soreness, and heat at the injection site. The swelling spread to below her left elbow and to her left inner thigh. Small, itchy blisters also appeared on her arm and thigh. Patient has pictures of the reaction.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Secretion discharge
Clinical narrative: Injection site, back of left arm a few inches above elbow, red, itchy, painful to touch, welt forming. Early next morning welt area blistered, by 3:00 PM blister was weeping and a 3/16" crater formed.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Injection site, back of left arm a few inches above elbow, red, itchy, painful to touch, welt forming. Early next morning welt area blistered, by 3:00 PM blister was weeping and a 3/16" crater formed.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Injection site, back of left arm a few inches above elbow, red, itchy, painful to touch, welt forming. Early next morning welt area blistered, by 3:00 PM blister was weeping and a 3/16" crater formed.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles, Urticaria
Clinical narrative: Injection site, back of left arm a few inches above elbow, red, itchy, painful to touch, welt forming. Early next morning welt area blistered, by 3:00 PM blister was weeping and a 3/16" crater formed.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Antinuclear antibody negative, Arthralgia, C-reactive protein normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Developed severe polyarthralgia that has lasted for 4 weeks thus far.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced warmth/swelling at injection site (approx. 3 inches in diameter) and the area became hard and sore for about 5 days.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Nausea, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Patient stated that she experienced nausea, vomiting, chills, fever over night and blurred vision the following morning.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Dyspnoea, Oropharyngeal pain, Streptococcus test negative, Tachypnoea
Clinical narrative: Called to patient room by nurse who reported that a few minutes after vaccines patient complaining of worsening throat pain and difficulty breathing. Went to see patient and he reported that he was mostly having severe throat pain. His respiratory exam was normal except for tachypnea; no stridor was noted. Per mom and nurse, patient was quite anxious during shot. A Rapid Strep test was done since patient was complaining of severe throat pain. He was able to drink water. He calmed and breathing slowed down.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site pain, Joint swelling, Peripheral swelling, Pyrexia
Clinical narrative: Substantial swelling in elbow (same arm as injection).  Day 1, swelling confined to bursa, approx. size of golf ball.  Day 2, swelling spread to upper forearm and skin was red, and I had a slight fever.  Day 3, swelling began to recede, redness faded to pink, I no longer had a fever.  Day 4, continued improvement.  By Day 5, 95% normal.  Fairly substantial pain on Days 1 & 2 when I touched my elbow/forearm, but no pain otherwise.  Never any pain (except typical mild soreness) from injection site.  Days 1-6, I took 1 OTC naproxen twice per day and applied ice to elbow and forearm every hour or two during the day.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. In approximately 2016 (reported as "may have occurred between 05-AUG-2016 and 20-SEP-2016"), the patients were vaccinated with M-M-R II injection, lot # L040961, expiration date 19-OCT-2017, (dosage number, route and anatomical location of administration were unknown), which were improperly stored. The temperature of excursion was 11.3 C and the time frame was 965 hours 19 minutes cumulative since 05-AUG-2016. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot number, expiration date, dose and route were unknown). The vaccines were exposed to 30.2 F for an unspecified amount of time. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-SEP-2016, the patient was vaccinated with an expired dose of ROTATEQ lot # L008034, expiration date: 05-AUG-2016, dose #1, oral (frequency was not provided). Information regarding concomitant medication was not provided. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapy were unknown. On 03-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot# M024673, expiration date 17-NOV-2017, dose unknown) intramuscularly. On an unknown date in September 2016, after the administration, the patient experienced extreme pain at the injection site with inability to lift the affected arm, and also experienced fever of 102 Fahrenheit degree (F). No lab diagnosis was performed. The pain and fever resolved in 1 days without requiring treatment. The outcome of inability to lift the affected arm was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. The pharmacist was requesting a lot check of lot # M024673. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Tonsillar hypertrophy
Clinical narrative: Information has been received from a pharmacist referring to a 20 years old female patient. The patient's concurrent condition, medical history, and concomitant medication were not provided. On 22-Aug-2016, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were unknown. In August 2016 (reported as after the (Oka/Merck) VARIVAX was administered), the patient experienced grossly swollen tonsils and sore throat. The patient saw her unspecified healthcare provider on 01-SEP-2016 for the events to seek medical attention. The patient was prescribed prednisone (unspecified dose) as treatment for 5 days. The events was not resolved until 01-SEP-2016. The causal relationship between the events and (Oka/Merck) VARIVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. In approximately 2016 (reported as "may have occurred between 05-AUG-2016 and 20-SEP-2016"), the patients were vaccinated with GARDASIL 9 injection, lot # L043214, expiration date 30-AUG-2017, (dosage number, route and anatomical location of administration were unknown), which were improperly stored. The temperature of excursion was 11.3 C and the time frame was 965 hours 19 minutes cumulative since 05-AUG-2016. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. In approximately 2016 (reported as "may have occurred between 05-AUG-2016 and 20-SEP-2016"), the patients were vaccinated with PEDVAXHIB injection, lot # L038502, expiration date 16-AUG-2018, (dosage number, route and anatomical location of administration were unknown), which were improperly stored. The temperature of excursion was 11.3 C and the time frame was 965 hours 19 minutes cumulative since 05-AUG-2016. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. In approximately 2016 (reported as "may have occurred between 05-AUG-2016 and 20-SEP-2016"), the patients were vaccinated with RECOMBIVAX HB injection, lot # M010671, expiration date 02-JUN-2018, (dosage number, route and anatomical location of administration were unknown), which were improperly stored. The temperature of excursion was 11.3 C and the time frame was 965 hours 19 minutes cumulative since 05-AUG-2016. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Information was received from a pharmacist regarding two patients of unknown age and gender s part of market research. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date the patients were vaccinated with one dose of ZOSTAVAX. On an unknown date, they complained of injection site reactions - redness and irritation. The patients recovered with sequelae from the events on unspecified dates The action taken was reported as none. The causal relationship between the event injection site reactions - redness and irritation and ZOSTAVAX was not reported. Additional information is not expected, as the consent was not given for further correspondence. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, reported as "several years ago", the patient was vaccinated with ZOSTAVAX 19400 PFU, 0.65 ml one time (Lot No. expiration date and anatomical location of administration were not reported). No concomitant therapy was provided. On an unknown date, reported as "several years ago", the patient developed shingles following the administration of the vaccine. No Product Quality Company (PQC) was involved. The outcome of herpes zoster was unknown. Additional information has been.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant therapy were not provided. On 16-NOV-2000, the patient was vaccinated with M-M-R II (dosing details, lot # and expiration date were unspecified). Nurse reported that on 04-DEC-2000, the patient was inadvertently administered with VARIVAX (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.