chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Unsure if infection or allergic reaction. Left arm became red, swollen, and painful. Redness and swelling covered majority of the back of the upper arm. Pt experienced fever and chills as well.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Chills, Headache, Hot flush, Pain
Clinical narrative: Had headache and eyes felt strained the day after the vaccine. Took Advil and it subsided. Had headache and eye strain every day after. By Thursday afternoon, Advil wasn't working anymore & headache had gotten worse and was throbbing. Headache and intensity was still there on Friday. Stayed home from work. Headache was debilitating, & I couldn't get out of bed. Accompanied by alternating chills and hot flashes and body aches. Next day I could get out of bed. Was back to work on Monday.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor, Vomiting
Clinical narrative: CHILLS, SHAKES, VOMITING...PAGED HER PCP OFFICE AND HAD HER SENT TO ER.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Injection site erythema
Clinical narrative: Headache, chills, shaking by 8PM vomiting and after the vomiting stopped.  A temperature of 101.4. Sick throughout the night.  The next morning, I felt weak and had a large hard circle around where the shot had been administered.  The symptoms lasted approximately 24 hours.  I took Tylenol but didn't feel like eating and took a long nap. The following day I felt better though a little weak.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Tremor, Vomiting
Clinical narrative: Headache, chills, shaking by 8PM vomiting and after the vomiting stopped.  A temperature of 101.4. Sick throughout the night.  The next morning, I felt weak and had a large hard circle around where the shot had been administered.  The symptoms lasted approximately 24 hours.  I took Tylenol but didn't feel like eating and took a long nap. The following day I felt better though a little weak.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Insomnia, Local swelling
Clinical narrative: Received pneumococol shot in right arm, also same arm for wife. Area swelled up and became extremely, extremey painful to the touch. Neither of us could sleep that night, and swellig moved around to different areas of arm. It Is only today Sunday 10/5/2014 that the pain and swelling are going down. We should have gone to the ER but didn't vaccine # PPV23.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 103.6, vomiting.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Within seconds of the injection she c/o itching and redness at the injection site followed by itching to the face and throat. She was given 50 mg Benadryl PO and a cool cloth was placed at the injection site. Within 5-10 minutes her throat was feeling "tight" as if there "is something in my throat". She was taken to the ER where she received, NS, Methylprednisolone, Pepsid, and Zofran.  She was discharged with prescriptions for Prednisone and Pepcid.  On 10/05 she woke up with itching to the face, Benadryl was taken and provided relief.  Throughout the day she ran a fever up to 101.5 and intermittent facial itching.  The injection site remains swollen with a "knot" and bruising.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Pyrexia, Sensation of foreign body, Throat irritation, Throat tightness
Clinical narrative: Within seconds of the injection she c/o itching and redness at the injection site followed by itching to the face and throat. She was given 50 mg Benadryl PO and a cool cloth was placed at the injection site. Within 5-10 minutes her throat was feeling "tight" as if there "is something in my throat". She was taken to the ER where she received, NS, Methylprednisolone, Pepsid, and Zofran.  She was discharged with prescriptions for Prednisone and Pepcid.  On 10/05 she woke up with itching to the face, Benadryl was taken and provided relief.  Throughout the day she ran a fever up to 101.5 and intermittent facial itching.  The injection site remains swollen with a "knot" and bruising.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Haemorrhage, Injection site erythema, Injection site haematoma, Injection site warmth
Clinical narrative: Soon after the patient reports significant bruising and more bleeding than was expected.  Two days later the patient describes a redness and warmth about baseball-sized around the injection site. No fevers, no chills, no streaking and thus unlikely infection-related.  It seems that it was just due to administration and the symptoms sounded like a hematoma. No treatment other than ice and rest was required.  Patient's mother also consulted their physician, who agreed with likely a hematoma and no infectious process.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Malaise, Syncope
Clinical narrative: Patient wasn't feeling well after she got vaccinated and had syncope 10-15 minutes post vaccination. She did hit her head when she fell, but seemed to have no major injury. 911 was called, she was laid in floor until ambulance came.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Headache, Malaise, Muscular weakness
Clinical narrative: Patient called 10/4/14 and reported muscle weakness, body aches, joint pain, headache, nausea, and malaise. Cond lasted several days and pt. still wasn't able to resume normal daily activities as of 10/4/14 afternoon.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain
Clinical narrative: Patient called 10/4/14 and reported muscle weakness, body aches, joint pain, headache, nausea, and malaise. Cond lasted several days and pt. still wasn't able to resume normal daily activities as of 10/4/14 afternoon.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Patient experienced hives, swelling, rash at injection site which required an ER visit the day following vaccine administration. FLUZONE HIGH DOSE.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site mass, Injection site pain, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Pt reported upper arm pain and small lump fored at injection site after levaing. Pt called that same evening to report sx. RPh recommened OTC pain relief and f/u with PCP. Pt took Tylenol at 3 AM on 9/10 pt could not sleep due to severe arm soreness and difficulty moving arm - prompted ER visit. Per pt ER administered Percocet and two injections. Later recovered. Pt had received Pneumovax in the past and did not experience this reaction.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypertension, Immediate post-injection reaction, Mobility decreased, Pain in extremity, Paralysis
Clinical narrative: Pt reported upper arm pain and small lump fored at injection site after levaing. Pt called that same evening to report sx. RPh recommened OTC pain relief and f/u with PCP. Pt took Tylenol at 3 AM on 9/10 pt could not sleep due to severe arm soreness and difficulty moving arm - prompted ER visit. Per pt ER administered Percocet and two injections. Later recovered. Pt had received Pneumovax in the past and did not experience this reaction.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient experienced lightheadedness, dizziness and nausea following flu vaccine.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Pyrexia, Vaccination complication
Clinical narrative: Adverse reaction to HD flu vaccine. Patient had fever, soreness and itching at injection site.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The reporter reported an unspecified number of patients received improperly stored ROTATEQ on an unspecified date. No adverse symptoms reported. The temperature excursion for the ROTATEQ was a supported excursion with in-house stability data. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Around her left arm (where the shot was administered) it's warm, red, and swollen advise pt to take ibuprofen/acetaminophin for comfort and follow up w/MD if it doesnt' get better in 3 days.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 9/20/14 5:00 PM received vaccination. 9/20/14 6:30-7:00 PM redness, itchy, swelling by injection site. 9/24/14 swelling, redness gone.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: 10/05/14 pt came to pharmacy to report rxn to Flu shot vaccine. Pt has a large rash below site of injection. Touch is tender and red.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt called at 4PM 10-4-14. Say cellulitis type rxn on (L) arm from vaccine. "Size of head of Coke can". Red, hot, swollen in 2 places starting 2" below inj site down to elbow. Says she had fever 10-3-14. No itching or no breathing problems. .She is retired nurse. Told her to apply cool compresses. Couldn't lift arm 10-3-14 morn.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Pt called at 4PM 10-4-14. Say cellulitis type rxn on (L) arm from vaccine. "Size of head of Coke can". Red, hot, swollen in 2 places starting 2" below inj site down to elbow. Says she had fever 10-3-14. No itching or no breathing problems. .She is retired nurse. Told her to apply cool compresses. Couldn't lift arm 10-3-14 morn.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Pt got Adacel shot 9/25/14 @ 6PM - Friday PM restless while sleeping - had a big red mark 2 in below injection site. It hurt and got worse w/pain radiating to head and neck and tissue swelling. She felt sick and went to ER. Diagnosed with cellulitis and given antibiotics/pain med. MD couldn't say for sure what caused it.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Poor quality sleep, Swelling
Clinical narrative: Pt got Adacel shot 9/25/14 @ 6PM - Friday PM restless while sleeping - had a big red mark 2 in below injection site. It hurt and got worse w/pain radiating to head and neck and tissue swelling. She felt sick and went to ER. Diagnosed with cellulitis and given antibiotics/pain med. MD couldn't say for sure what caused it.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diplopia, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Left arm red and tender to touch above elbow and pt. claimed had fever and experienced double vision per other pharmacist on duty when she returned PM of 10/3/14. Tried to call her, left msg for her to call me.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Convulsion, Depressed level of consciousness, Eczema, Febrile convulsion, Immediate post-injection reaction
Clinical narrative: While leaving the Dr's office immediately after receiving the MMRV vaccine, my 1 yo was totally lethargic, an almost unconscious state. By the time we got HOME, I noticed she had a fever.  At 11 pm that night, she had a seizure.  The next morning after her seizure she woke up with eczema.  She's since had another fever induced seizure (her dr says she is 65% more likely to experience fever induced seizure until about age 5 since she developed one from vaccine).  We continue to struggle with severe eczema.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Lethargy, Pyrexia
Clinical narrative: While leaving the Dr's office immediately after receiving the MMRV vaccine, my 1 yo was totally lethargic, an almost unconscious state. By the time we got HOME, I noticed she had a fever.  At 11 pm that night, she had a seizure.  The next morning after her seizure she woke up with eczema.  She's since had another fever induced seizure (her dr says she is 65% more likely to experience fever induced seizure until about age 5 since she developed one from vaccine).  We continue to struggle with severe eczema.
Age: 42.0
Sex: F
Vaccine: MMR, MNQ, MMR, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Case number PHHY2014US112197, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534696) website on 03 Sep 2014, and with a follow up report received from QA department (reference number: 323677) on 01 Oct 2014. This report refers to a 42-year-old female patient. She was vaccinated with MENVEO (batch number: A13014) intramuscularly in the left arm along with MMR II (other manufacturer, batch number: H020255) subcutaneously in the right arm on 10 Jun 2014. On 11 Jun 2014, she experienced injection site reactions at both the sites with pain, redness and swelling (2-4 cm). The patient visited the emergency room and physician suspected the reaction as cellulitis. The events treated with antibiotics. The events resolved on an unknown date. The events reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, MENVEO (batch number: A13014) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323677) on 08 Sep 2014: Updated QA reference number only. Follow up report received from QA department (reference number: 323677) on 01 Oct 2014. Updated batch review report.
Age: 42.0
Sex: F
Vaccine: MMR, MNQ, MMR, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US112197, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534696) website on 03 Sep 2014, and with a follow up report received from QA department (reference number: 323677) on 01 Oct 2014. This report refers to a 42-year-old female patient. She was vaccinated with MENVEO (batch number: A13014) intramuscularly in the left arm along with MMR II (other manufacturer, batch number: H020255) subcutaneously in the right arm on 10 Jun 2014. On 11 Jun 2014, she experienced injection site reactions at both the sites with pain, redness and swelling (2-4 cm). The patient visited the emergency room and physician suspected the reaction as cellulitis. The events treated with antibiotics. The events resolved on an unknown date. The events reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, MENVEO (batch number: A13014) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323677) on 08 Sep 2014: Updated QA reference number only. Follow up report received from QA department (reference number: 323677) on 01 Oct 2014. Updated batch review report.
Age: 6.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 19-AUG-2014, the patient was inadvertently vaccinated with two doses of PROQUAD (Merck) (strength, dose and lot# unknown) subcutaneous. No adverse effects reported. Follow up information has been received from the nurse refers to the 6 years old female patient with no known allergy. There was no illness at time of vaccination. On 19-AUG-2014 the patient was vaccinated with the first dose of PROQUAD (Merck). On 19-AUG-2014 at 10:00 the patient was inadvertently received the second dose of PROQUAD (Merck) that was drawn up to give her twin sister. No adverse side effects, complications, or problems noted. The nurse notified her mother immediately, and they communicated again on 20-AUG-2014 (also reported as the next day). The mother of the patient said the patient had been fine. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Crying, Formication, Gait disturbance, Hallucination, visual, Mydriasis
Clinical narrative: Started out with vomiting then became unstable and unsteady while walking and standing. Woke up in at 3 Am screaming and crying saying that there were fish and snakes and bugs on the bedroom floor. Also started to say that there were bugs under his skin biting him. Pupils were huge and it was as if he was on LSD. The hallucinations finally stopped around 4 Pm. But still experiencing the unsteady movements and continues to walk into things and a rash had developed around his mouth and vomiting occasionally.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash, Screaming, Vomiting
Clinical narrative: Started out with vomiting then became unstable and unsteady while walking and standing. Woke up in at 3 Am screaming and crying saying that there were fish and snakes and bugs on the bedroom floor. Also started to say that there were bugs under his skin biting him. Pupils were huge and it was as if he was on LSD. The hallucinations finally stopped around 4 Pm. But still experiencing the unsteady movements and continues to walk into things and a rash had developed around his mouth and vomiting occasionally.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Patient c/o pain in left shoulder, and inability to raise arm above head.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: I had a large, bright red patch surrounding the area where I had received my flu shot. The red area was also warm to the touch and tender. The area was light pink on the morning of 10/06.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Laboratory test, Pain, Pyrexia, Rash
Clinical narrative: Fever, body aches, skin sloughing at injection site, rash with yellow bumps.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Skin exfoliation
Clinical narrative: Fever, body aches, skin sloughing at injection site, rash with yellow bumps.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Disturbance in attention, Headache, Insomnia, Nausea
Clinical narrative: HEADACHE, NAUSEA, INABILITY TO CONCENTRATE, INSOMNIA.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Blurred vision.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Night sweats
Clinical narrative: Left deltoid swollen, red, warm to touch. Fever, chills, night sweats, body aches from Friday night until Mon morning.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Left deltoid swollen, red, warm to touch. Fever, chills, night sweats, body aches from Friday night until Mon morning.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Injection site rash, Local swelling
Clinical narrative: Chills same day, next day rash L shoulder, L hand with some swelling, right thigh, right lower leg.  Patient relates at this visit did have similar rash 3 years ago s/p flu vaccine.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: swelling, itching, redness of injection site
Age: 28.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Injection site erythema, Rash
Clinical narrative: Pt noticed red area at the yellow fever injection site and rash on chest anb back. Went to MD.
Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Dizziness, Dyspnoea, Erythema, Feeling of body temperature change, Local swelling
Clinical narrative: Left arm swelling red and hot, Sunday felt ill, itching, pain in neck and left side of face felt swollen, trouble breathing, hot cold and shaking. Went to ER, oral prednisone and continue Benadryl. Dizziness, worsen very dizzy and chest broke out Monday. Off work for 2 days.
Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Malaise, Neck pain, Pruritus, Rash, Skin warm
Clinical narrative: Left arm swelling red and hot, Sunday felt ill, itching, pain in neck and left side of face felt swollen, trouble breathing, hot cold and shaking. Went to ER, oral prednisone and continue Benadryl. Dizziness, worsen very dizzy and chest broke out Monday. Off work for 2 days.
Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Swelling face, Tremor
Clinical narrative: Left arm swelling red and hot, Sunday felt ill, itching, pain in neck and left side of face felt swollen, trouble breathing, hot cold and shaking. Went to ER, oral prednisone and continue Benadryl. Dizziness, worsen very dizzy and chest broke out Monday. Off work for 2 days.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Nodule, Pruritus, Rash erythematous, Rash maculo-papular, Swelling face
Clinical narrative: Rash with raised red maculopapules on right arm and also pruritis.  Patient reports right sided chin swelling nodule inframandicular.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site anaesthesia, Skin tightness
Clinical narrative: Numbness and tension at the injection site and radiating down left arm.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Large red swollen area on left arm where shot given. Larger than a silver dollar. Pain X7 days.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Feeling abnormal, Nasopharyngitis, Pyrexia
Clinical narrative: Fever 40 C; chills, shaking, cold, overall no good feeling. Taken 2 Tylenol pills by 10 PM felt much better. 10/06/2014 8:00 AM symptoms gone however falls very week.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Fever 40 C; chills, shaking, cold, overall no good feeling. Taken 2 Tylenol pills by 10 PM felt much better. 10/06/2014 8:00 AM symptoms gone however falls very week.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Blood creatinine increased, Blood glucose normal, Computerised tomogram head normal, Staring
Clinical narrative: Became unresponsive while eating meal, staring into space, unresponsive to commands, trying to eat table cloth, picking at crumbs, called EMS, by time they arrived pt was oriented.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Unresponsive to stimuli, Urine analysis normal, White blood cell count normal
Clinical narrative: Became unresponsive while eating meal, staring into space, unresponsive to commands, trying to eat table cloth, picking at crumbs, called EMS, by time they arrived pt was oriented.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Rash, Rash macular
Clinical narrative: Itching over entire body, beginning to have blotching/rash on arms and legs. MD notified. Diphenhydramine 50 mg po given with some relief. Sent to urgent care, given Pepcid 20mg po, released to return to work on 10/4/14.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Aphonia, Cough, Dysphonia, Headache, Malaise
Clinical narrative: Coughing- caking and dry. Oct 3 fever 99.4, general body aches, headache, hoarseness, sore throat. General malaise, hacking cough, sore throat, and loss of voice persist today, Oct. 6. Trying to get appt with MD, but it's a Monday..... Can't get in.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Coughing- caking and dry. Oct 3 fever 99.4, general body aches, headache, hoarseness, sore throat. General malaise, hacking cough, sore throat, and loss of voice persist today, Oct. 6. Trying to get appt with MD, but it's a Monday..... Can't get in.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Syncope
Clinical narrative: Patient fainted and went into seizure or vaso-vagal response.
Age: 1.11
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: CSF culture, Herpes simplex serology negative, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old male patient with no drug reactions or allergies. The patient's medical history included cold, which he had on 01-SEP-2014, reported as 2 days prior to receiving VARIVAX (Merck). On 03-SEP-2014, the patient was vaccinated with one dose of VARIVAX (Merck) in the right thigh (dose, route and lot number were not reported) and with a dose of hepatitis A (manufacturer unknown) in the right arm (dose, route and lot number were not reported). There were no concomitant medications. On 13-SEP-2014, reported as 10 days after vaccination, the patient experienced weakness of the left arm. There was no rash. The patient sought medical attention. On 15-SEP-2014, the patient was admitted to a hospital and was given supportive care. The patient was discharged on 18-SEP-2014. On an unknown date in 2014, Varicella Zoster Virus DNA Testing was positive, Magnetic resonance imaging (MRI) of brain and cervical spine was normal, West Nile virus testing was negative, HSV (Herpes Simplex Virus) Testing was negative, Cerebrospinal fluid (CSF) culture was performed with an unspecified result. The outcome of weakness of the left arm was reported as not recovered. The relatedness between weakness of the left arm and VARIVAX (Merck) and hepatitis A (manufacturer unknown) was not reported. The event caused significant disability or incapacity. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Varicella virus test positive, West Nile virus test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old male patient with no drug reactions or allergies. The patient's medical history included cold, which he had on 01-SEP-2014, reported as 2 days prior to receiving VARIVAX (Merck). On 03-SEP-2014, the patient was vaccinated with one dose of VARIVAX (Merck) in the right thigh (dose, route and lot number were not reported) and with a dose of hepatitis A (manufacturer unknown) in the right arm (dose, route and lot number were not reported). There were no concomitant medications. On 13-SEP-2014, reported as 10 days after vaccination, the patient experienced weakness of the left arm. There was no rash. The patient sought medical attention. On 15-SEP-2014, the patient was admitted to a hospital and was given supportive care. The patient was discharged on 18-SEP-2014. On an unknown date in 2014, Varicella Zoster Virus DNA Testing was positive, Magnetic resonance imaging (MRI) of brain and cervical spine was normal, West Nile virus testing was negative, HSV (Herpes Simplex Virus) Testing was negative, Cerebrospinal fluid (CSF) culture was performed with an unspecified result. The outcome of weakness of the left arm was reported as not recovered. The relatedness between weakness of the left arm and VARIVAX (Merck) and hepatitis A (manufacturer unknown) was not reported. The event caused significant disability or incapacity. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Dehydration, Diarrhoea, Loss of consciousness, Vomiting
Clinical narrative: Initial report was received from a consumer on 11 September 2014. A 72 year-old female with a history of MS had received on an unspecified date in August 2014 a "flu shot" (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later had vomiting, diarrhea, became dehydrated and passed out at their HCP office. The patient went to the hospital where she received fluids and was sent home after about five hours. Concomitant medications included AUBAGIO, 14 mg daily orally starting 10 September 2013 for MS. No further information was provided at the time of this report. Outcome was recovered. Documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Influenza like illness, Oropharyngeal pain, Pyrexia
Clinical narrative: Flu like symptoms-sore throat, fever, chills, runny nose, cough.  Developed into a sinus infection.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea, Sinusitis
Clinical narrative: Flu like symptoms-sore throat, fever, chills, runny nose, cough.  Developed into a sinus infection.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, warmth, bruising adjacent to the injection site. Itching started 4 days post injection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: PAIN ON THE LEFT ARM, NO SIGNS OF FEVER, BRUISING, OR RASH. 9/30/2014 STILL PAIN AND CANNOT LIFT ARM UP
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Night sweats, Pyrexia
Clinical narrative: Localized rash and swelling at site of injection. Patient reports fever and night sweats over the weekend. Patient also reports soreness at site of injection, too.
Age: 56.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site rash, Night sweats, Pyrexia
Clinical narrative: Patient reports soreness at site of injection, fever, night sweats and localized rash to injection site.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient received both Fluvirin and Pneumovax in left deltoid and experienced soreness, redness, and her skin was warm to the touch about 6 inch patch of upper arm.  When reported on 10/3/2014 she stated it was getting better but she wanted to make sure it was ok.  I told her to apply cold compresses and take tylenol for comfort and if the condition worsens contact her physician.  She stated that she may have had a reaction like that once before with the pnuemonia shot but wasn't sure.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Body temperature increased, Headache, Lymphadenopathy, Neck pain
Clinical narrative: 10 hours after flu shot c/o "severe headache, severe joint aches, swollen glands in neck, entire back of neck very painful, intense temperature" for 2 days. No reaction at all last year per patient.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: According to the parents, he had a red rash develop the day of the vaccination when at home. It went from his left arm I believe to the parts of this chest and other parts of the body over the next few days. The entire family had the same vaccination given but he is the only one that reacted to it later on at home.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Headache, Heart rate increased, Pruritus, Pyrexia
Clinical narrative: Dizzy. Headache; rapid heart beat; itchy neck area; slight fever; lasted about 12 hrs.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose increased
Clinical narrative: Took usual after meal BG reading, after eating usual bowl of cereal with Almond Milk (readings usually around 130-140). Today it was 275 2 hours after eating. Scared me!
Age: 56.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella, Varicella virus test negative
Clinical narrative: Patient had a negative Varicella Zoster titer result. Was immunized for Varicella 9/15/14, developed chickenpox on 10/3/14 which was confirmed at time of appt. with his doctor 10/6/14.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Full blood count, Metabolic function test, Muscular weakness, Myalgia
Clinical narrative: Weakness and muscle pain in arm for 2 weeks so far,  pain level 7, interrupted sleep, neck and upper back pain, tingling sensation in hand.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Neck pain, Paraesthesia, Pulmonary function test, Sleep disorder
Clinical narrative: Weakness and muscle pain in arm for 2 weeks so far,  pain level 7, interrupted sleep, neck and upper back pain, tingling sensation in hand.
Age: 64.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Significant swelling, erythema, warmth, pain over the injection site and most of upper arm.
Age: 1.36
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Pertussis
Clinical narrative: This is one case out of a cumulative total of 236 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 25 September 2014. These 236 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 25 September 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received four doses of PENTACEL; dose one on 01 April 2011 (lot number C3740AA), dose two on 14 June 2011 (lot number C3800AA), dose three on 15 September 2011 (lot number C3879AA) and dose four on 11 June 2012 (lot number C4277AC) (routes and sites of administration for all doses not reported). Approximately two years after the last dose, on 01 September 2014, the subject developed cough. Fourteen days later, on 15 September 2014, the subject developed a paroxysmal cough. PCR laboratory testing was unknown. It is unknown if the patient had a catarrhal illness. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 15 September 2014 for five days. The subject was not hospitalized. At the time of final contact on 23 September 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dysstasia, Postural orthostatic tachycardia syndrome, Wheelchair user
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 18 year old female patient. On an unspecified dates, the patient received 3 doses of GARDASIL (dose, route, lot numbers and expiration dates not reported). In approximately 2013 (reported as about a year ago), the patient had developed postural orthostatic tachycardia syndrome (POTS). At the time of the report the patient was in a wheelchair because she was weak and she could not stand up which was considered as disability by physician. The patient sought medical attention by unspecified contact. At the time of the report the outcome of the events was reported as not recovered. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal pain, Paraesthesia oral, Throat irritation
Clinical narrative: 10 min after shot experience, throat irritation, asked for BENADRYL, 15 min later, throat sore and tongue feeling like jello, problem breathing administered EPIPEN 0.3mg. Called 911. Paramedics came gave epi and SOLU-MEDROL took to hospital.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Influenza like illness, Injection site pain, Local swelling, Nuclear magnetic resonance imaging
Clinical narrative: Painful right arm at site of injection w/flu-like symptoms. Went to ER 09/20/14 and discharged same night w/arm sling. Returned to ER 09/22/14 due to increased arm pain and swelling. She was admitted and treated for cellulitis w/IV antibiotics. She was discharged 09/25/14.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Endodontic procedure, Herpes zoster, Insomnia, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 73 year old male patient. No current condition was reported. Pertinent medical history was reported as bilateral knee replacement surgery. No historical medication was reported. Approximately in 2013, as reported 1 year ago the patient was vaccinated with ZOSTAVAX. No concomitant medication was reported. On 09-SEP-2014, the patient experienced difficulty in sleeping (disability) and severe shingles of the left face, mouth and ear. Approximately on 08-SEP-2014, a day before his shingles symptoms started patient received a root canal treatment. The patient was evaluated by physician on that date and was prescribed Gabapentin, acetaminophen, PERCOCET, and lidocaine mouth rinse. On 17-SEP-2014, the dose of Gabapentin was increased. The patient was having difficulty sleeping due to the pain of the shingles outbreak. The outcome of difficulty sleeping and severe shingles of the left face, mouth and ear was reported as not resolved. The outcome of root canal treatment was unknown. The causality was unknown. Sought medical attention was reported as Yes-office visit. No product quality complaint was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site nodule, Injection site rash
Clinical narrative: Rash and knot size of quarter to upper R arm at injection site after receiving vaccines. Recommended cool compress to affected site and iburprofen PRN.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Incorrect dose administered, Injection site extravasation, Muscle spasms
Clinical narrative: Case number PHEH2014US019641, is an initial spontaneous report from a pharmacist received on 30 Sep 2014. This report refers to a 56-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with first dose of FLUVIRIN (batch number: 145905) intramuscularly and the vaccine leaked from the injection site on 30 Sep 2014. On the same day one hour later, she was again vaccinated with FLUVIRIN (batch number: 145905) intramuscularly in the opposite arm. On the same day, she experienced fatigue, muscle cramp and shortness of breath. The final outcome of the events was unknown. Seriousness and causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Cough, Dizziness, Dyspnoea, Exposure during pregnancy
Clinical narrative: Headache, running nose, coughing, sneezing, dizziness, weak, hard to breathe, etc. and lasted more than 4 days so far. Still suffering.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Rhinorrhoea, Sneezing
Clinical narrative: Headache, running nose, coughing, sneezing, dizziness, weak, hard to breathe, etc. and lasted more than 4 days so far. Still suffering.
Age: 22.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Urticaria
Clinical narrative: Hives appearing all over body, treated with Benadryl.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site papule, Rash pruritic
Clinical narrative: Itchy rash on inner aspect left ankle. Erythema and erythematous papules at injection site (SQ tissue of right arm)
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Forced expiratory volume abnormal, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Developed almost immediate red, itchy swollen area at injection site. About 1 hour later developed chest tightness and several hours later developed hives.  Seen by allergist who completed PFTs and diagnosed immediate type I hypersensitivty reaction. Treated with epinephrine, Ventolin and steroid dose pack.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Pulmonary function test abnormal, Type I hypersensitivity, Urticaria
Clinical narrative: Developed almost immediate red, itchy swollen area at injection site. About 1 hour later developed chest tightness and several hours later developed hives.  Seen by allergist who completed PFTs and diagnosed immediate type I hypersensitivty reaction. Treated with epinephrine, Ventolin and steroid dose pack.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: THE PATIENT REPORTED GETTING A RED RASH ON THE ARM WHERE THE FLU SHOT WAS GIVEN THAT WENT FROM THE SHOULDER TO THE ELBOW AND LASTED FOR ABOUT 2 DAYS.
Age: 20.0
Sex: M
Vaccine: FLUN4
Symptoms: Ear discomfort, Fatigue, Oropharyngeal pain, Tonsillar hypertrophy
Clinical narrative: Temperature around 97 degrees.  Adverse Events: Sore throat, fatigue, enlarged right tonsil, and minor ear discomfort (such as when one has ear infection).  Events still occur more than 72 hours after FluMist administered.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Immediate pain at RUE injection site, progressive erythema, swelling, tenderness at injection site, mild increase in right 1st digit arthralgia, no systemic symptoms.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Tingling in left arm. Flu Vaccine administered in Left deltoid. No treatment provided at time of report of symptoms. Instructed patient to seek medical attention if symptoms do not go away within 24 hours or get worse. Patient's provider aware as well. Patient reports symptoms resolving at 9:00 PM that same day.
Age: 54.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Injection site discharge, Injection site erythema, Injection site induration, Injection site pruritus, Injection site scab
Clinical narrative: A couple of days after the immunizaiton, the Right arm injection area became red and then itchy and a little blistered, and now has a scab on it.  Patient denies any fever, generalized hives, or breathing difficulties. The injection site is at the Right deltoid, and it displays a 1 cm area of erythema, with a central area of dried exudate approx 4mm X 7mm in size.  There is no active drainage from the site.  There is a very mild amount of induration.  There are no areas of redness or tenderness elsewhere on the arm.
Age: 54.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Injection site vesicles
Clinical narrative: A couple of days after the immunizaiton, the Right arm injection area became red and then itchy and a little blistered, and now has a scab on it.  Patient denies any fever, generalized hives, or breathing difficulties. The injection site is at the Right deltoid, and it displays a 1 cm area of erythema, with a central area of dried exudate approx 4mm X 7mm in size.  There is no active drainage from the site.  There is a very mild amount of induration.  There are no areas of redness or tenderness elsewhere on the arm.
Age: 45.0
Sex: M
Vaccine: FLUC3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to the touch, painful. Advised ice pack and appointment with PCM for further care.
Age: 9.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: C-reactive protein increased, Headache, Inflammation, Injected limb mobility decreased, Injection site erythema
Clinical narrative: The patient was given influenza and PCV 23 vaccines at his PCP's office on 10/2/2014 around 1100. That evening he began to have R arm pain, which progressed on 10/3/14 to include redness at the site and severe pain. It progressed to severely limiting range of motion of the R arm, and by the time of evaluation on 10/4/14 he had an erythematous, 10x5cm well demarcated inflammatory response with extreme tenderness and severely limited range of motion. He had systemic symptoms including fever, vomiting, and HA. He was covered with IV clindamycin for possibility of bacterial source. The inflammation progressed beyond original borders to include the lateral aspect of the majority of the right upper arm, with more diffuse borders; very warm to touch. Most likely arthus reaction vs possibly cellulitis or erysipelas, and most likely due to PCV 23 vaccine.
Age: 9.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth, Joint range of motion decreased, Neutrophil percentage increased
Clinical narrative: The patient was given influenza and PCV 23 vaccines at his PCP's office on 10/2/2014 around 1100. That evening he began to have R arm pain, which progressed on 10/3/14 to include redness at the site and severe pain. It progressed to severely limiting range of motion of the R arm, and by the time of evaluation on 10/4/14 he had an erythematous, 10x5cm well demarcated inflammatory response with extreme tenderness and severely limited range of motion. He had systemic symptoms including fever, vomiting, and HA. He was covered with IV clindamycin for possibility of bacterial source. The inflammation progressed beyond original borders to include the lateral aspect of the majority of the right upper arm, with more diffuse borders; very warm to touch. Most likely arthus reaction vs possibly cellulitis or erysipelas, and most likely due to PCV 23 vaccine.
Age: 9.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Red blood cell sedimentation rate increased, Type III immune complex mediated reaction, Ultrasound scan normal
Clinical narrative: The patient was given influenza and PCV 23 vaccines at his PCP's office on 10/2/2014 around 1100. That evening he began to have R arm pain, which progressed on 10/3/14 to include redness at the site and severe pain. It progressed to severely limiting range of motion of the R arm, and by the time of evaluation on 10/4/14 he had an erythematous, 10x5cm well demarcated inflammatory response with extreme tenderness and severely limited range of motion. He had systemic symptoms including fever, vomiting, and HA. He was covered with IV clindamycin for possibility of bacterial source. The inflammation progressed beyond original borders to include the lateral aspect of the majority of the right upper arm, with more diffuse borders; very warm to touch. Most likely arthus reaction vs possibly cellulitis or erysipelas, and most likely due to PCV 23 vaccine.
Age: 9.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: The patient was given influenza and PCV 23 vaccines at his PCP's office on 10/2/2014 around 1100. That evening he began to have R arm pain, which progressed on 10/3/14 to include redness at the site and severe pain. It progressed to severely limiting range of motion of the R arm, and by the time of evaluation on 10/4/14 he had an erythematous, 10x5cm well demarcated inflammatory response with extreme tenderness and severely limited range of motion. He had systemic symptoms including fever, vomiting, and HA. He was covered with IV clindamycin for possibility of bacterial source. The inflammation progressed beyond original borders to include the lateral aspect of the majority of the right upper arm, with more diffuse borders; very warm to touch. Most likely arthus reaction vs possibly cellulitis or erysipelas, and most likely due to PCV 23 vaccine.
Age: 30.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was pregnant and received the flumist live virus.  The patient explained to the nurse that she was pregnant and should not be receiving the mist.  The nurse stated that the rules have changed and conferred with two other nurses who agreed and administered the vaccine to her.
Age: 24.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was pregnant and received the flu mist live virus.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Intense stomach cramps once or twice an hour, diarrhea, vomiting; treated with clear liquids, Pepto Bismol, prescription with anti-spasmatic