chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On an unspecified date of November 2014, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, lot number and route not reported). Concomitant medications were unknown. On an unknown date within a year after (approximately in 2015), the patient was hospitalized for an unspecified reason. During this hospitalization, the patient may have received another dose (dose 2) of PNEUMOVAX 23 less than one year after the first dose. The pharmacist was reporting the information on behalf of a physician who was attending the patient. The reporting pharmacist did not have any additional information at the time of this reporting. The outcome of the unspecified adverse event was unknown. The causality assessment was not provided. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Aspiration, Bronchitis, Bronchospasm, Chest X-ray abnormal, Cough
Clinical narrative: 5 minutes after shot my son went pitch white lips and all and felt sick to his stomach.  He started vomiting and they believe he aspirated.  His bronchial area inflamed and severe constant cough for 2 weeks followed.
Age: 8.0
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Nausea, Pallor, Vomiting
Clinical narrative: 5 minutes after shot my son went pitch white lips and all and felt sick to his stomach.  He started vomiting and they believe he aspirated.  His bronchial area inflamed and severe constant cough for 2 weeks followed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING, REDNESS, ITCHINESS, WARMTH AT AROUND INJECTION SITE.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Ininitally began with itching and redness at injection site. Redness about half dollar size. Pt was instructed to apply ice pack, Tylenol or Benadryl to relieve symptoms. Call if worsening. Pt called office on 9/25/15 stating a rash had developed. Pt seen in office on 9/25/15 and diagnosed with shingles. Unsure if this is related?
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: ARM WAS EXTREMELY PAINFUL, COULD NOT LIFT ELBOW OVER SHOULDER ON 9/24. TODAY 9/25 LARGE RED AREA NEAR SITE OF INJECTION THAT MEASURES 7 INCHES LONG AND 3-4INCHES WIDE, FEELS HOT TO TOUCH IN THAT AREA.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Dysphagia, Eyelid oedema, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: The evening after receiving the Fluzone HD and Prenvar 13, pt developed a tingling in her tongue that progressed to a 9 out of 10 pain in her throat, difficulty swallowing and eyelid swelling. She did not have shortness of breath or rash. She took two 25mg doses of diphenhydramine and called EMS. She was evaluated at hospital and was given 60mg prednisone and 20mg famotidine. She was discharged with prescriptions for 20mg famotidine bid and a prednisone dose pack. She did not fill these prescriptions because her symptoms had largely resolved by the end of the day on 9/22. She was re-evaluated in clinic on 9/24 and no long-term symptoms or harm were noted.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Blood pressure increased, Fatigue, Glossodynia, Hypersensitivity, Hypotension
Clinical narrative: The evening after receiving the Fluzone HD and Prenvar 13, pt developed a tingling in her tongue that progressed to a 9 out of 10 pain in her throat, difficulty swallowing and eyelid swelling. She did not have shortness of breath or rash. She took two 25mg doses of diphenhydramine and called EMS. She was evaluated at hospital and was given 60mg prednisone and 20mg famotidine. She was discharged with prescriptions for 20mg famotidine bid and a prednisone dose pack. She did not fill these prescriptions because her symptoms had largely resolved by the end of the day on 9/22. She was re-evaluated in clinic on 9/24 and no long-term symptoms or harm were noted.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Ocular hyperaemia, Paraesthesia oral, Pharyngeal oedema, Pyrexia
Clinical narrative: The evening after receiving the Fluzone HD and Prenvar 13, pt developed a tingling in her tongue that progressed to a 9 out of 10 pain in her throat, difficulty swallowing and eyelid swelling. She did not have shortness of breath or rash. She took two 25mg doses of diphenhydramine and called EMS. She was evaluated at hospital and was given 60mg prednisone and 20mg famotidine. She was discharged with prescriptions for 20mg famotidine bid and a prednisone dose pack. She did not fill these prescriptions because her symptoms had largely resolved by the end of the day on 9/22. She was re-evaluated in clinic on 9/24 and no long-term symptoms or harm were noted.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Cough, Diarrhoea, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, chills, diarrhea, sore throat, cough.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Feeling cold, Malaise
Clinical narrative: Started not feeling well on way home after dose.  By 9pm she had a 102.7 fever, explosive diarrhea and vomiting.  Severe stomach cramps and cold chills.  Vomiting stopped about 4am next morning.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Started not feeling well on way home after dose.  By 9pm she had a 102.7 fever, explosive diarrhea and vomiting.  Severe stomach cramps and cold chills.  Vomiting stopped about 4am next morning.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Oropharyngeal pain, Pain
Clinical narrative: Received flu vaccine, achy, sore throat, light headed, drained of energy, x 2 days.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: REDNESS AND ITCHING AT INJECTION SITE. HIVES FORMED 9/25/15. ITCHING ON LEFT SIDE OF BODY.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Day after receiving flu vaccine, fever 103, achy, sore throat, light headed x 2 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Pruritus, Rash generalised
Clinical narrative: Rash and swelling at site of injection. Rash and itchy primarily on face and a bit of rash on other area of body.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: PATIENT CAME IN THIS MORNING AND REPORTED A BIG RED SKIN AREA ON HER UPPER LEFT ARM, NEAR INJECTION SITE. IT'S WARM TO TOUCH. NO PAIN. NO FEVER.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Eye pain, Fatigue, Headache
Clinical narrative: Fever, chills, fatigue, dizziness, headache, pain in eyes, neck, and shoulder.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pyrexia
Clinical narrative: Fever, chills, fatigue, dizziness, headache, pain in eyes, neck, and shoulder.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Within a few hours of receiving flu vaccine, developed achiness, fever 102-103, no energy for 2 days.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Neck pain
Clinical narrative: Complained of pain on injection site side at neck up into back of her head. B/P 124/80, P 93 O2 sat 98%. Instructed to see her MD. No difficulty breathing.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Dizziness, Nausea
Clinical narrative: 4:00 PM  Had dizziness, nausea, abdominal pain, no energy.  Did no treatment, did not eat or drink much until came to Employee Health on 9/25 at 3PM.  Sent to Emergency room for evaluation of abdominal pain of 7/10 and nausea.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, IPV, MEN, RV5
Symptoms: Crying, Pyrexia
Clinical narrative: Excessive crying, fever.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm Pain, Shoulder Pain, Back Pain.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Severe swelling and pain in right deltoid associated with diminished appetite and nausea.  Patient's symptoms improving by 9/25/15 but not fully resolved.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Fear of injection, Hyperhidrosis
Clinical narrative: Patient received Fluzone HD and began profusely sweating and feeling faint. Stated anxiety of needles and not eating today. She received fluids and attention from pharmacist and store management. Once calmed down and feeling better she left the store.
Age: 18.0
Sex: M
Vaccine: IPV
Symptoms: Full blood count, Headache, Laboratory test, Pain in extremity, Pyrexia
Clinical narrative: Episodes of vomiting, pain in both legs, headaches, fevers. Seen in the ER x 2. Unsure of previous vaccine history.
Age: 18.0
Sex: M
Vaccine: IPV
Symptoms: Vomiting
Clinical narrative: Episodes of vomiting, pain in both legs, headaches, fevers. Seen in the ER x 2. Unsure of previous vaccine history.
Age: 1.0
Sex: M
Vaccine: MMRV, PPV
Symptoms: Full blood count normal, Pyrexia, Rash morbilliform, Streptococcus test negative
Clinical narrative: High fever of 102.  A day later (9-24-2015) he had the onset of a measle-like rash on neck (front and back) and on tummy.  The day after that (9-25-2015) the rash covered the trunk and torso and was spreading to arms, legs, and face.  The fever continued, but did go down with Tylenol and ibuprofen.  The highest temp was 103.4.  On 9-25-2015, the patient started refusing to eat at around 12:00 PM.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Hyperhidrosis, Injected limb mobility decreased, Injection site erythema
Clinical narrative: After Pneumovax given 9/18/15, she developed chills and sweats, did not check temperature, noted fatigue.  Injection site painful, and patient had difficulty lifting her arm.  9/19/15, injection site had redness and swelling at injection site which had increased in size from 9/18/15.  Arm, non specific began to swell, and redness continued to increase on 9/20/15.  Patient went to local Urgent Care Center where she was provided with an IM injection of steroids with Toradol for swelling and pain relief.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: After Pneumovax given 9/18/15, she developed chills and sweats, did not check temperature, noted fatigue.  Injection site painful, and patient had difficulty lifting her arm.  9/19/15, injection site had redness and swelling at injection site which had increased in size from 9/18/15.  Arm, non specific began to swell, and redness continued to increase on 9/20/15.  Patient went to local Urgent Care Center where she was provided with an IM injection of steroids with Toradol for swelling and pain relief.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Large rash at injection site (right arm) that was swollen, hard and painful. It was the size of a small envelope.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Eye pain, Fatigue, Headache, Myalgia
Clinical narrative: 1:45 PM: fatigue with mild chills. 8:00 PM: severe shaking and chills, body touch very cold, headache, eye ache, muscle ache, fever 100. Treatment: hot shower followed by heating pad and bed rest. 24 hour update: fatigue.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral coldness, Pyrexia, Tremor
Clinical narrative: 1:45 PM: fatigue with mild chills. 8:00 PM: severe shaking and chills, body touch very cold, headache, eye ache, muscle ache, fever 100. Treatment: hot shower followed by heating pad and bed rest. 24 hour update: fatigue.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cold sweat, Injection site erythema, Pyrexia
Clinical narrative: Patient had fever (100.9 degrees), cold sweats, and redness on her arms. Two red areas (one on each arm), although not at injection site. Left arm received Fluzone HD, and red area was approximately 6 inches down from injection site. Prevnar 13 was administered in right arm, and red area was located about an inch below injection site.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Headache
Clinical narrative: Sudden onset of headache, flushed feeling to head lasting 30 minutes.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vomiting
Clinical narrative: Vomit, severe headache, cold chills, fever; achy muscles.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient complained of a swollen arm in arm injection was given, and a rash in that arm. She was instructed to apply a cold compress and take Benadryl. Patient stated that she had been taking Benadryl.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Hypersensitivity
Clinical narrative: Patient complained of a swollen arm in arm injection was given, and a rash in that arm. She was instructed to apply a cold compress and take Benadryl. Patient stated that she had been taking Benadryl.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Headache
Clinical narrative: Flushed feeling to head then headache within 1/2 hour.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Intense pain below the waist. Fever of 102.4 Swollen injection site all within 2 hours of admin.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Infection, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient has cellulitis in left arm from shot- area is red and hot to the touch.  Patient currently taking antibiotics for infection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site of injection was extremely red and swollen. Approximately 3 to 4 inches in length. Patient had no other symptoms at time of presentation to the pharmacy (approx. 4pm 9/25/15).
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Crying, Dehydration, Fluid intake reduced, Pyrexia, Rash erythematous
Clinical narrative: T 36 C (102.2 F); vesicular rash X 3 now discolored approx 1-2 cm. Fever today 100.2 tympanic. Mother reports rash worstening. PHN observed generalized red pinpoint rash in groin; on abdomen on back on legs. Day 10 after vaccines mother concerned child with decreased fluid intake and decreased urine out put. She has not treated fever or pushed po fluids. Child very weak but verbally and physically responsive to PHN testing temperature tympanically. Other significant history; child started vaccines June 11 2016 when returned from abroad. Child normally very active and went to playground in local mall after receiving 2nd set of vaccines on 9/14/15. Mother reports 2 lb weight loss. PHN assessed probable dehydtation. PHN reported to NP. Mother instructed to administer childrens Tylenol q 6 hours and push po fluid such as water juice; pedialyte. If no improvement despite this mother instructed to bring child to ER since child does not have an established MD. PHN will follow up with T/C this PM and 9/25/15 AM. 9/24/15 5 PM mother reports child drank better voided x3 and has no fever. 9/25/15 mother reports child awake and crying all night; voided X 1 and she was unable to give him Tylenol or increase his fluid intake. PHN instructed mother to take child to ER for fluids. NP and Office manager notified. Incident report and VAERS filed. PHN request mother call with update.
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Rash vesicular, Urine output decreased, Weight decreased
Clinical narrative: T 36 C (102.2 F); vesicular rash X 3 now discolored approx 1-2 cm. Fever today 100.2 tympanic. Mother reports rash worstening. PHN observed generalized red pinpoint rash in groin; on abdomen on back on legs. Day 10 after vaccines mother concerned child with decreased fluid intake and decreased urine out put. She has not treated fever or pushed po fluids. Child very weak but verbally and physically responsive to PHN testing temperature tympanically. Other significant history; child started vaccines June 11 2016 when returned from abroad. Child normally very active and went to playground in local mall after receiving 2nd set of vaccines on 9/14/15. Mother reports 2 lb weight loss. PHN assessed probable dehydtation. PHN reported to NP. Mother instructed to administer childrens Tylenol q 6 hours and push po fluid such as water juice; pedialyte. If no improvement despite this mother instructed to bring child to ER since child does not have an established MD. PHN will follow up with T/C this PM and 9/25/15 AM. 9/24/15 5 PM mother reports child drank better voided x3 and has no fever. 9/25/15 mother reports child awake and crying all night; voided X 1 and she was unable to give him Tylenol or increase his fluid intake. PHN instructed mother to take child to ER for fluids. NP and Office manager notified. Incident report and VAERS filed. PHN request mother call with update.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Severe pain at the injection site.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient Stated that after she received the flu shot she felt rashes under the skin. Then she felt better after taking Benadryl.
Age: 35.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Adverse reaction, Fatigue, Injection site discolouration, Injection site inflammation, Injection site nodule
Clinical narrative: Injection site became inflamed and under the skin a knot could be felt.  Site was inflamed, hot, and itchy.  Additionally had a fever, fatigue, and am experiencing an adverse reaction to certain smells (raw and cooked meat in particular).  The size of the inflamed site grew until Tuesday, 9/22/2015.  I had to miss work on Monday, 9/21/2015 because I felt so ill.  As of 9/25 when this report is being submitted, the knot is still visible and site still inflamed but now a dull purple instead of bright red.
Age: 35.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Injection site pruritus, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Injection site became inflamed and under the skin a knot could be felt.  Site was inflamed, hot, and itchy.  Additionally had a fever, fatigue, and am experiencing an adverse reaction to certain smells (raw and cooked meat in particular).  The size of the inflamed site grew until Tuesday, 9/22/2015.  I had to miss work on Monday, 9/21/2015 because I felt so ill.  As of 9/25 when this report is being submitted, the knot is still visible and site still inflamed but now a dull purple instead of bright red.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: AT TIME OF INJECTION, PATIENT SAID THE AREA BURNED AND HURT. WITHIN 30 MINUTES, AREA WAS SILVER-DOLLAR SIZED AND RED AND INFLAMED. AT 3AM, PATIENT AWOKE WITH SORE QUADS AND SHOULDERS AND A RED, INFLAMED, HOT RASH ON THE DELTOID AREA (SITE OF VACCINATION). AFTER SPEAKING TO THE PHARMACIST, PATIENT WAS INSTRUCTED TO GO TO URGENT CARE WHERE SHE WAS DIAGNOSED WITH CELLULITIS. CURRENTLY RECEIVING TREATMENT WITH CLINDAMYCIN 300MG 4 TIMES DAILY FOR 10 DAYS.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site warmth, Musculoskeletal pain, Myalgia
Clinical narrative: AT TIME OF INJECTION, PATIENT SAID THE AREA BURNED AND HURT. WITHIN 30 MINUTES, AREA WAS SILVER-DOLLAR SIZED AND RED AND INFLAMED. AT 3AM, PATIENT AWOKE WITH SORE QUADS AND SHOULDERS AND A RED, INFLAMED, HOT RASH ON THE DELTOID AREA (SITE OF VACCINATION). AFTER SPEAKING TO THE PHARMACIST, PATIENT WAS INSTRUCTED TO GO TO URGENT CARE WHERE SHE WAS DIAGNOSED WITH CELLULITIS. CURRENTLY RECEIVING TREATMENT WITH CLINDAMYCIN 300MG 4 TIMES DAILY FOR 10 DAYS.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Balance disorder, Body temperature increased, Chills
Clinical narrative: About 11 a.m., Saturday, September 19, 2015, I received a "high dose flu shot" for those over 65.  About 45 minutes to one hour later, my head started to hurt.  I didn't feel well in general and tried to eat a saltine cracker.  I couldn't swallow the cracker.  It felt like something large was stuck in my throat.  I was able to drink water but my throat hurt and I couldn't swallow the cracker.  I began to cough and get hoarse. * Saturday mid-day:  My husband called facility and spoke with the nurse there.  He told her he thought I was having a reaction to the flu shot.  She told him that it was too soon for me to be having a reaction to the flu shot  that it would take 12-24 hours before a reaction would happen.  She said I probably just had an allergy and should take an antihistamine.  He asked her if he should bring me back to the clinic but she said not to bring me back.  She said it was too early to do diagnostic tests for the flu. * Saturday early afternoon:  My husband was not satisfied with the response the nurse gave him and called our pharmacist.  Pharmacist told him a reaction to the flu shot would be expected to occur within the first hour after taking the shot.  She was concerned about my throat problems (that swelling in my throat could cause breathing problems). She suggested I take an antihistamine but, if I didn't get better, that he should take me to an emergency room.  He went to the pharmacy and brought me Benadryl liquid antihistamine. * Saturday afternoon and night:  When he returned home from the pharmacy, I was feeling much worse.  I took the Benadryl.  He noticed the whites of my eyes had turned red and there was yellow matter in the corners of both eyes.  My neck was stiff and ached.  I began to have hard chills.  I ached all over.  My temperature was 102 degrees.  My throat hurt and it was hard to swallow.  My head hurt more and the chills were so hard I couldn't hold a glass to drink water to take ibuprofen  my husband held my glass of water so I could drink water.  After a couple hours, the big lump in my throat shrank a lot and I went to sleep.  I slept restlessly throughout the night.  * Sunday:  We ate breakfast early Sunday morning.  I had to eat soft food because my throat hurt.  My temperature was below normal.  My head hurt, my face and eyes were still swollen and my eyes were red.  I ached but had no chills.  My symptoms improved throughout the day.  I slept restlessly Sunday night.  Monday:  I woke with a headache but the swelling in my eyes and face was not as much.  I was wobbly and weak throughout the day.  By Monday evening, my headache had nearly subsided. Tuesday:  I went outside for the first time and walked about 15 minutes.  Still weak and wobbly but getting stronger. * Wednesday:  I felt stronger and walked outside for nearly an hour.  Symptoms had resolved.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Dysphonia, Eye discharge, Eye swelling
Clinical narrative: About 11 a.m., Saturday, September 19, 2015, I received a "high dose flu shot" for those over 65.  About 45 minutes to one hour later, my head started to hurt.  I didn't feel well in general and tried to eat a saltine cracker.  I couldn't swallow the cracker.  It felt like something large was stuck in my throat.  I was able to drink water but my throat hurt and I couldn't swallow the cracker.  I began to cough and get hoarse. * Saturday mid-day:  My husband called facility and spoke with the nurse there.  He told her he thought I was having a reaction to the flu shot.  She told him that it was too soon for me to be having a reaction to the flu shot  that it would take 12-24 hours before a reaction would happen.  She said I probably just had an allergy and should take an antihistamine.  He asked her if he should bring me back to the clinic but she said not to bring me back.  She said it was too early to do diagnostic tests for the flu. * Saturday early afternoon:  My husband was not satisfied with the response the nurse gave him and called our pharmacist.  Pharmacist told him a reaction to the flu shot would be expected to occur within the first hour after taking the shot.  She was concerned about my throat problems (that swelling in my throat could cause breathing problems). She suggested I take an antihistamine but, if I didn't get better, that he should take me to an emergency room.  He went to the pharmacy and brought me Benadryl liquid antihistamine. * Saturday afternoon and night:  When he returned home from the pharmacy, I was feeling much worse.  I took the Benadryl.  He noticed the whites of my eyes had turned red and there was yellow matter in the corners of both eyes.  My neck was stiff and ached.  I began to have hard chills.  I ached all over.  My temperature was 102 degrees.  My throat hurt and it was hard to swallow.  My head hurt more and the chills were so hard I couldn't hold a glass to drink water to take ibuprofen  my husband held my glass of water so I could drink water.  After a couple hours, the big lump in my throat shrank a lot and I went to sleep.  I slept restlessly throughout the night.  * Sunday:  We ate breakfast early Sunday morning.  I had to eat soft food because my throat hurt.  My temperature was below normal.  My head hurt, my face and eyes were still swollen and my eyes were red.  I ached but had no chills.  My symptoms improved throughout the day.  I slept restlessly Sunday night.  Monday:  I woke with a headache but the swelling in my eyes and face was not as much.  I was wobbly and weak throughout the day.  By Monday evening, my headache had nearly subsided. Tuesday:  I went outside for the first time and walked about 15 minutes.  Still weak and wobbly but getting stronger. * Wednesday:  I felt stronger and walked outside for nearly an hour.  Symptoms had resolved.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Musculoskeletal stiffness, Neck pain, Ocular hyperaemia
Clinical narrative: About 11 a.m., Saturday, September 19, 2015, I received a "high dose flu shot" for those over 65.  About 45 minutes to one hour later, my head started to hurt.  I didn't feel well in general and tried to eat a saltine cracker.  I couldn't swallow the cracker.  It felt like something large was stuck in my throat.  I was able to drink water but my throat hurt and I couldn't swallow the cracker.  I began to cough and get hoarse. * Saturday mid-day:  My husband called facility and spoke with the nurse there.  He told her he thought I was having a reaction to the flu shot.  She told him that it was too soon for me to be having a reaction to the flu shot  that it would take 12-24 hours before a reaction would happen.  She said I probably just had an allergy and should take an antihistamine.  He asked her if he should bring me back to the clinic but she said not to bring me back.  She said it was too early to do diagnostic tests for the flu. * Saturday early afternoon:  My husband was not satisfied with the response the nurse gave him and called our pharmacist.  Pharmacist told him a reaction to the flu shot would be expected to occur within the first hour after taking the shot.  She was concerned about my throat problems (that swelling in my throat could cause breathing problems). She suggested I take an antihistamine but, if I didn't get better, that he should take me to an emergency room.  He went to the pharmacy and brought me Benadryl liquid antihistamine. * Saturday afternoon and night:  When he returned home from the pharmacy, I was feeling much worse.  I took the Benadryl.  He noticed the whites of my eyes had turned red and there was yellow matter in the corners of both eyes.  My neck was stiff and ached.  I began to have hard chills.  I ached all over.  My temperature was 102 degrees.  My throat hurt and it was hard to swallow.  My head hurt more and the chills were so hard I couldn't hold a glass to drink water to take ibuprofen  my husband held my glass of water so I could drink water.  After a couple hours, the big lump in my throat shrank a lot and I went to sleep.  I slept restlessly throughout the night.  * Sunday:  We ate breakfast early Sunday morning.  I had to eat soft food because my throat hurt.  My temperature was below normal.  My head hurt, my face and eyes were still swollen and my eyes were red.  I ached but had no chills.  My symptoms improved throughout the day.  I slept restlessly Sunday night.  Monday:  I woke with a headache but the swelling in my eyes and face was not as much.  I was wobbly and weak throughout the day.  By Monday evening, my headache had nearly subsided. Tuesday:  I went outside for the first time and walked about 15 minutes.  Still weak and wobbly but getting stronger. * Wednesday:  I felt stronger and walked outside for nearly an hour.  Symptoms had resolved.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Poor quality sleep, Sensation of foreign body, Swelling face
Clinical narrative: About 11 a.m., Saturday, September 19, 2015, I received a "high dose flu shot" for those over 65.  About 45 minutes to one hour later, my head started to hurt.  I didn't feel well in general and tried to eat a saltine cracker.  I couldn't swallow the cracker.  It felt like something large was stuck in my throat.  I was able to drink water but my throat hurt and I couldn't swallow the cracker.  I began to cough and get hoarse. * Saturday mid-day:  My husband called facility and spoke with the nurse there.  He told her he thought I was having a reaction to the flu shot.  She told him that it was too soon for me to be having a reaction to the flu shot  that it would take 12-24 hours before a reaction would happen.  She said I probably just had an allergy and should take an antihistamine.  He asked her if he should bring me back to the clinic but she said not to bring me back.  She said it was too early to do diagnostic tests for the flu. * Saturday early afternoon:  My husband was not satisfied with the response the nurse gave him and called our pharmacist.  Pharmacist told him a reaction to the flu shot would be expected to occur within the first hour after taking the shot.  She was concerned about my throat problems (that swelling in my throat could cause breathing problems). She suggested I take an antihistamine but, if I didn't get better, that he should take me to an emergency room.  He went to the pharmacy and brought me Benadryl liquid antihistamine. * Saturday afternoon and night:  When he returned home from the pharmacy, I was feeling much worse.  I took the Benadryl.  He noticed the whites of my eyes had turned red and there was yellow matter in the corners of both eyes.  My neck was stiff and ached.  I began to have hard chills.  I ached all over.  My temperature was 102 degrees.  My throat hurt and it was hard to swallow.  My head hurt more and the chills were so hard I couldn't hold a glass to drink water to take ibuprofen  my husband held my glass of water so I could drink water.  After a couple hours, the big lump in my throat shrank a lot and I went to sleep.  I slept restlessly throughout the night.  * Sunday:  We ate breakfast early Sunday morning.  I had to eat soft food because my throat hurt.  My temperature was below normal.  My head hurt, my face and eyes were still swollen and my eyes were red.  I ached but had no chills.  My symptoms improved throughout the day.  I slept restlessly Sunday night.  Monday:  I woke with a headache but the swelling in my eyes and face was not as much.  I was wobbly and weak throughout the day.  By Monday evening, my headache had nearly subsided. Tuesday:  I went outside for the first time and walked about 15 minutes.  Still weak and wobbly but getting stronger. * Wednesday:  I felt stronger and walked outside for nearly an hour.  Symptoms had resolved.
Age: 56.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Chest discomfort, Laryngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose, sore throat, laryngitis, with some chest tightness.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Malformation venous, Nuclear magnetic resonance imaging
Clinical narrative: Swelling at painful lump at patient's Right thigh at site of Pediarix vaccine. Lump continued and grew slowly for 2 months, finally after U/S and MRI imaging, was given Dx of venolymphatic malformation, but then had spontaneous drainage and near resolution of Sx. Another similar lump occurred after vaccine (Infanrix) 10/13/2014, and now again on 7/30/2015 (Pedvax) both at Left leg.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Ultrasound scan
Clinical narrative: Swelling at painful lump at patient's Right thigh at site of Pediarix vaccine. Lump continued and grew slowly for 2 months, finally after U/S and MRI imaging, was given Dx of venolymphatic malformation, but then had spontaneous drainage and near resolution of Sx. Another similar lump occurred after vaccine (Infanrix) 10/13/2014, and now again on 7/30/2015 (Pedvax) both at Left leg.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Confusional state, Muscle twitching
Clinical narrative: Son reported patient could not talk, mouth was twitching 1:45pm, then again approximately 45 minutes later, at 6pm she was also confused.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: THE PATIENT IS STATING THAT HE HAS A LOT OF SORENESS AT THE INJECTION SITE. FROM DATE OF ADMINSTRATION TO 09-25-2015. THE PATIENT IS SAYING THAT HE CAN NOT LIFT HIS ARM.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site joint swelling, Lethargy, Nausea, Pyrexia
Clinical narrative: Lethargic, swelling to elbow on injected arm, fever for 2 days, bright red area, nausea.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Strange muscle spasm (that he did not feel) of the upper arm during vaccination..patient will follow up. He stated that a previous pharmacist experienced the same reaction from his muscle (again he did not feel) but he later had a stiff neck for 6 weeks...I was not told of this prior to vaccinating patient.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth at the injection site in deltoid and a larger area between the injection site and the elbow of the same arm.
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Disturbance in attention, Fatigue, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from a Nurse on 16 September 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number U5185BA, Expiration date 11 March 2017, dose, route, dose series and site of administration was not reported) on 17 August 2015. The patient medical history and concomitant medications were not reported. On an unspecified date following the vaccination, the patient experienced numbness all over her body, felt tired and weak, could not pick her backpack and could not concentrate or focus. It was also reported that her parents took her to urgent care. On 21 August 2015, the patient was sent to hospital. Lab data and corrective treatment was not reported. The outcome of events was not reported. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a 56-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7754S, expiry date 30th June 2016). On 14th September 2015, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 15th September 2015, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced weird feeling. On 16th September 2015, the patient experienced injection site cellulitis, injection site induration, injection site pain, injection site warmth and injection site erythema. The patient was treated with KEFLEX. On an unknown date, the outcome of the injection site cellulitis, weird feeling, injection site induration, injection site pain, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site cellulitis, weird feeling, injection site induration, injection site pain, injection site warmth and injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case as not previously reported to anyone. The patient received FLULAVAL QUADRIVALENT, at unknown deltoid. One day after receiving FLULAVAL QUADRIVALENT, the patient felt something funny. On 16th September 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site cellulitis, injection site induration, injection site pain, injection site warmth and injection site erythema. She did not look at her arm until th e16th September 2015, when she noticed redness and cellulitis on her arm and then went to the doctor. At the doctor's office it was noted that the area was a little sore, there was no fever, no chills, and an 11cm x 10 cm area of redness was associated with warmth and induration. The redness was about 4 to 5 inches below the vaccine injection site. The patient required an emergency visit. The patient was given KEFLEX 500 mg 3 times daily for 7 days as treatment. This case was linked to case US2015134385, as it concerned with the same reporter. This reported batch number 77546, which does not exist and was updated to be 7754S as per sales database.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a 56-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7754S, expiry date 30th June 2016). On 14th September 2015, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 15th September 2015, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced weird feeling. On 16th September 2015, the patient experienced injection site cellulitis, injection site induration, injection site pain, injection site warmth and injection site erythema. The patient was treated with KEFLEX. On an unknown date, the outcome of the injection site cellulitis, weird feeling, injection site induration, injection site pain, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site cellulitis, weird feeling, injection site induration, injection site pain, injection site warmth and injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case as not previously reported to anyone. The patient received FLULAVAL QUADRIVALENT, at unknown deltoid. One day after receiving FLULAVAL QUADRIVALENT, the patient felt something funny. On 16th September 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site cellulitis, injection site induration, injection site pain, injection site warmth and injection site erythema. She did not look at her arm until th e16th September 2015, when she noticed redness and cellulitis on her arm and then went to the doctor. At the doctor's office it was noted that the area was a little sore, there was no fever, no chills, and an 11cm x 10 cm area of redness was associated with warmth and induration. The redness was about 4 to 5 inches below the vaccine injection site. The patient required an emergency visit. The patient was given KEFLEX 500 mg 3 times daily for 7 days as treatment. This case was linked to case US2015134385, as it concerned with the same reporter. This reported batch number 77546, which does not exist and was updated to be 7754S as per sales database.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Injection site swelling, Insomnia
Clinical narrative: Swelling at injection site within 12 hours. Weakness within 12 hours. Insomnia. No treatment.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 54-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12th June 2016). On 15th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 15th September 2015, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site pain were recovering/resolving. The reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site pain to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reported injection site of FLUARIX was left deltoid. The patient experienced swelling, pain and redness at the injection site a couple hours after receiving a FLUARIX injection. The injection site was also warm to touch. The reported reactions were improving on the day before the time of reporting, but the reporter had not seen the patient on the day of reporting. This case was one of the five cases, reported by the same reporter (see cases US2015GSK133985, US2015GSK133986, US2015GSK133988 and US2015GSK134910).
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Swelling face
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of facial swelling in a 49-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12th June 2016). On 15th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 16th September 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced facial swelling and lip swelling. On an unknown date, the outcome of the facial swelling and lip swelling were recovering/resolving. It was unknown if the reporter considered the facial swelling and lip swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was 49 to 50 years old. The reported injection site of FLUARIX was left deltoid. The patient experienced swelling on the right side of his face, predominantly in his lips the day after receiving a FLUARIX injection. The injection site showed no sign of reaction. The reporter was not sure if the reaction was caused by FLUARIX, but the only other thing was that the patient had taken ginger tea. The swelling has improved and the last time the reporter saw him she could hardly tell it had occurred. This case was one of the five cases, reported by the same reporter (see cases US2015GSK133984, US2015GSK133986, US2015GSK133988 and US2015GSK134910).
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema in a adult patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). This case was associated with a product complaint. In September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and pharmaceutical product complaint. On an unknown date, the outcome of the erythema and pharmaceutical product complaint were unknown. The reporter considered the erythema to be probably related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a pharmacy buyer. On 15th September 2015 or after (exact date of administration unknown), the patient received FLUARIX QUADRIVALENT on an unknown arm. The patient experienced localized redness around the injection site and on arm. This is one of the five cases reported by the same reporter (see cases US2015133738, US2015133746, US2015133760 and US2015133773). The reporter was questioning about a specific lot administered to patients therefore filed related quality product complaint. At the time of reporting, any further details were not known by the reporter.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine received on 9/22/15. Localized redness and swelling to injection site beginning on 9/23/15.
Sex: U
Vaccine: FLU4
Symptoms: Product quality issue, Vision blurred
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of blurred vision in a adult patient who received FLUARIX QUADRVALENT (batch number 5C2L4, expiry date 18th June 2016). This case was associated with a product complaint. In September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. In September 2015, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced blurred vision. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the blurred vision and product complaint were unknown. The reporter considered the blurred vision to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a pharmacy buyer. The patient was one of the five employees of the hospital who were administered FLUARIX QIV by the clinic. The exact date of vaccination was unknown, it could be 15th September 2015 (Tuesday) or after that. The reporter was questioning about a specific lot administered to patients therefore filed related quality product complaint. The reporter also provided contact details of a nurse for more information. At the time of reporting, any further details were not known by the reporter. This case has been linked to other cases, reported by the same reporter (see cases US2015133740, US2015133746, US2015133760 and US2015133738).
Age: 62.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain to injection site (left deltoid) 6 days after immunization was given. Treated with ice, prednisone and antihistamine.
Age: 68.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Dermatitis, Injection site inflammation, Skin warm
Clinical narrative: Skin was inflamed and hot to touch. Area around immunization site was slightly inflamed, most of inflammation was 2-3 inch below injection site.
Age: 41.0
Sex: F
Vaccine: FLU3, MMR, TD
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Lip swelling, Oral mucosal erythema
Clinical narrative: Client called 9-25-15 at 2:49 p.m. report reaction to MMR vaccine received 9-17-15 left arm. C/O symptoms-swelling lips, red, oral mucosa, very sensitive "hot" itching at site, papule red ? 4 cm per client, no breathing problems.
Age: 41.0
Sex: F
Vaccine: FLU3, MMR, TD
Symptoms: Vaccination complication
Clinical narrative: Client called 9-25-15 at 2:49 p.m. report reaction to MMR vaccine received 9-17-15 left arm. C/O symptoms-swelling lips, red, oral mucosa, very sensitive "hot" itching at site, papule red ? 4 cm per client, no breathing problems.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Swelling
Clinical narrative: Patient reports residual muscle pain and slight swelling. Says this unusual from years past. Advised to use OTC TYLENOL, to call MD if unbearable. Will call in 24 hours.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Local reaction
Clinical narrative: Left upper arm local reaction to either flu or pneumonia vaccine. 19 cm x 11 cm reaction area.