chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Drug administered at inappropriate site, Injection site haemorrhage
Clinical narrative: The company hold a Wellness Fair for employees providing biometric screening and flu shot. The administering immunizer as indicated who is from pharmacy gave me a flu shot in the wrong spot on my right arm. The needle poked several times and they are way too high - on the top of my shoulders, the vaccine was injected into my shoulder joint and caused severely bleeding.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Pharmacist administered 1.0 mL instead of prescribed 0.5mL.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Pharmacist administered 1.0 mL instead of prescribed 0.5mL.
Age: 0.83
Sex: M
Vaccine: HEP, PNC13
Symptoms: Injection site movement impairment, Injection site rash, Irritability, Pain, Swelling
Clinical narrative: 10 months old and is accompanied by the mother. Patient has a rash on his right thigh for one day. Patient was given his shots yesterday and was given Prevnar 13 immunization in the right thigh. The mother states patient started complaining of pain and was fussy last night and this morning the mother states that she saw the swelling and the patient is not moving his leg much.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Pharmacist administered 1.0 mL instead of prescribed 0.5mL.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient developed itching on both arms and whelps on both arms during the night, she woke up due to the itching (more whelps on the right arm). Also, developed a whelp on right side of face. Patient is taking benadryl for the reaction.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: I was told by guardian that the day after receiving his Tdap Boostrix and Mengococcal Menveo that patient had a grand mal seizure witnessed by patient's mother.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Erythema, Head banging
Clinical narrative: Malaise, sweating, headache, sick stomach, no appetite, watery bowel movements.  sleep all day.  9/27/16 improved but left arm is still red and swollen and 2" greater in circumference than right arm that was not injected.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Hypersomnia, Malaise, Peripheral swelling
Clinical narrative: Malaise, sweating, headache, sick stomach, no appetite, watery bowel movements.  sleep all day.  9/27/16 improved but left arm is still red and swollen and 2" greater in circumference than right arm that was not injected.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Full blood count normal, Local swelling, Metabolic function test normal, Pharyngeal oedema
Clinical narrative: Patient started to feel swelling in throat and neck at approx. 4:00 PM, came back into clinic at about 5:30 PM with some swallowing difficulty and visible edema in throat. Sent to ED for treatment. Treated with oral Benadryl and released. High Dose Flu Vaccine given, Sanofi Pasteur manufacter
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Localised infection
Clinical narrative: Left arm- local infection with pain and redness at the injection site. OTC Hydrocortisone 1% cream and Tylenol recommended as per Provider.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Injection site swelling, Nausea
Clinical narrative: Swelling of upper arm/area where shot was given. Area of where shot was given was hot. Headache. Nausea.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 5 years old and is accompanied by the mother. Patient has redness and swelling of the right thigh for one day. Patient was given immunization yesterday. Patient got KINRIX vaccine on the right thigh and patient now has redness swelling and itching at the site of the injection. No history of drainage from the site of the injection.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: 2-4 hours after flu vaccination, itching began on arms and legs, hives on ankles. Patient took a ZYRTEC at the office and when home from work, took BENADRYL 25mg po. She called her MD and was instructed to take an additional BENADRYL 50mg, po. By the next morning, all symptoms had subsided.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Feeling of body temperature change, Headache, Malaise, Night sweats
Clinical narrative: Initially had body aches, then headache, then high body temperature and difficulty breathing.  I felt better Thursday morning but gradually felt worst.  About 1600, my temp was 102.4.  I went to hospital and they told me I had a viral infection. They gave me both Tylenol eq and Motrin eq to break the fever. Over the next 5 days, I have switched between cold, normal and hot. My temperature has gone from 97.5 (normal for me) to 101.4.  I have had night sweats 4 of the 5 nights. I still feel unwell.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Viral infection
Clinical narrative: Initially had body aches, then headache, then high body temperature and difficulty breathing.  I felt better Thursday morning but gradually felt worst.  About 1600, my temp was 102.4.  I went to hospital and they told me I had a viral infection. They gave me both Tylenol eq and Motrin eq to break the fever. Over the next 5 days, I have switched between cold, normal and hot. My temperature has gone from 97.5 (normal for me) to 101.4.  I have had night sweats 4 of the 5 nights. I still feel unwell.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Full blood count, Immediate post-injection reaction, Inflammatory marker test, Injected limb mobility decreased
Clinical narrative: Pain immediately at time of injection, has continued with decreased range of motion in shoulder, new pain in R hip and R foot that patient relates to the same injection.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain immediately at time of injection, has continued with decreased range of motion in shoulder, new pain in R hip and R foot that patient relates to the same injection.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Painful, Swelling and big Bruise (black and purple).
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash vesicular, Urticaria
Clinical narrative: Patient broke out into hives (Fluid filled rash on arms).
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Left deltoid pain- chronic since the day after immunization to reporting date with no change in pain severity. Difficulty with left shoulder ROM > 90 degrees in any direction.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Patient reports that 2-3 hours after her flu vaccination she developed hives, SOB and tight, itchy throat. She went to the ER and received a course of steroids. 10 days after flu shot is still experiencing scratchy, itchy throat and upper body itching, unless she takes po BENADRYL. It was recommended to her to be seen by her medical doctor.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Headache, Influenza like illness, Injection site bruising, Injection site erythema
Clinical narrative: Woke up with high fever (102+), felt lethargic, head ache, flu like symptoms, cold sweats, redness and tender at injection site, bruising and swelling, arm became swollen from elbow to shoulder, had large hardened area the size of a goose egg at the injection site that lasted for more than 8 weeks.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Woke up with high fever (102+), felt lethargic, head ache, flu like symptoms, cold sweats, redness and tender at injection site, bruising and swelling, arm became swollen from elbow to shoulder, had large hardened area the size of a goose egg at the injection site that lasted for more than 8 weeks.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: The day after the flu vaccination, patient experienced a 2 1/2 to 3 inch red circle with itching around the injection site. Both itching and redness were resolving within 48 hours.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Hypoaesthesia, Metabolic function test normal, Mobility decreased, Myalgia
Clinical narrative: 17-year-old female with a history of chronic abdominal pain who was in her normal state of health until presenting to the ED with the complaint of weakness, decrease sensation, and muscle aches after receiving meningococcal vaccines (MENOMUNE ACWY and MenB) at the County Health Department yesterday. The patient states after IM injection of MENOMUNE ACWY and MenB she returned home, laid down then awakened to a phone call and was noted to have decreased sensation, weakness, and muscle aches in her lower back, shoulders, and bilateral lower extremities and was unable to get out bed. Patient also complains of a sore throat, numbness and tingling from the upper thighs down into her legs bilaterally, but denies a history of trauma, cough, runny nose, shortness of breath, new rashes, recent travel, nausea, vomiting, diarrhea, urgency, frequency, loss of bowel or bladder control, tick bite, recent camping, sick contacts or fevers. On exam in the ED, patient was alert and in no acute distress. He was normotensive, afebrile at 98.5 degrees Fahrenheit with a pulse rate at 113 beats/minute, respiratory rate at 18 breaths/minute and oxygen saturation at 100% on room air. A CBC revealed no leukocytosis with WBC at 9.12 K/ul and platelet count at 169. The iStat BMP was normal. Pediatric Neurology was consulted, imaging and admission were recommended. The MRI with and without contrast of the lumbar and thoracic spine were negative. She was admitted for further care and management.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Nuclear magnetic resonance imaging spinal normal, Nuclear magnetic resonance imaging thoracic normal, Oropharyngeal pain, Paraesthesia, Platelet count normal
Clinical narrative: 17-year-old female with a history of chronic abdominal pain who was in her normal state of health until presenting to the ED with the complaint of weakness, decrease sensation, and muscle aches after receiving meningococcal vaccines (MENOMUNE ACWY and MenB) at the County Health Department yesterday. The patient states after IM injection of MENOMUNE ACWY and MenB she returned home, laid down then awakened to a phone call and was noted to have decreased sensation, weakness, and muscle aches in her lower back, shoulders, and bilateral lower extremities and was unable to get out bed. Patient also complains of a sore throat, numbness and tingling from the upper thighs down into her legs bilaterally, but denies a history of trauma, cough, runny nose, shortness of breath, new rashes, recent travel, nausea, vomiting, diarrhea, urgency, frequency, loss of bowel or bladder control, tick bite, recent camping, sick contacts or fevers. On exam in the ED, patient was alert and in no acute distress. He was normotensive, afebrile at 98.5 degrees Fahrenheit with a pulse rate at 113 beats/minute, respiratory rate at 18 breaths/minute and oxygen saturation at 100% on room air. A CBC revealed no leukocytosis with WBC at 9.12 K/ul and platelet count at 169. The iStat BMP was normal. Pediatric Neurology was consulted, imaging and admission were recommended. The MRI with and without contrast of the lumbar and thoracic spine were negative. She was admitted for further care and management.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Scan with contrast normal, Sensory disturbance, White blood cell count normal
Clinical narrative: 17-year-old female with a history of chronic abdominal pain who was in her normal state of health until presenting to the ED with the complaint of weakness, decrease sensation, and muscle aches after receiving meningococcal vaccines (MENOMUNE ACWY and MenB) at the County Health Department yesterday. The patient states after IM injection of MENOMUNE ACWY and MenB she returned home, laid down then awakened to a phone call and was noted to have decreased sensation, weakness, and muscle aches in her lower back, shoulders, and bilateral lower extremities and was unable to get out bed. Patient also complains of a sore throat, numbness and tingling from the upper thighs down into her legs bilaterally, but denies a history of trauma, cough, runny nose, shortness of breath, new rashes, recent travel, nausea, vomiting, diarrhea, urgency, frequency, loss of bowel or bladder control, tick bite, recent camping, sick contacts or fevers. On exam in the ED, patient was alert and in no acute distress. He was normotensive, afebrile at 98.5 degrees Fahrenheit with a pulse rate at 113 beats/minute, respiratory rate at 18 breaths/minute and oxygen saturation at 100% on room air. A CBC revealed no leukocytosis with WBC at 9.12 K/ul and platelet count at 169. The iStat BMP was normal. Pediatric Neurology was consulted, imaging and admission were recommended. The MRI with and without contrast of the lumbar and thoracic spine were negative. She was admitted for further care and management.
Sex: F
Vaccine: MENB
Symptoms: Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant communicated to a Pfizer sales representative, and from a contactable nurse on behalf of a physician. The medical assistant reported similar events for 3 patients. This is the first of three reports. A 17-18 year-old female patient of an unspecified ethnicity received TRUMENBA (Lot L13514; Expiration date 31Jul2016), first dose on 21Jun2016 11:06 AM, intramuscular in left deltoid at 0.5 ml, single for immunisation. The patient was vaccinated at private physician's office. The patient medical history and concomitant medications were not reported. The patient past drug history included allergy to Bactrim on 05Feb2012. The patient experienced swelling and pain in Aug2016. The patient visited physician. She was not admitted to hospital. The nurse considered there was a reasonable possibility that the events were related to meningococcal group b rlp2086. The outcome of the events was recovered. Follow-up (19Sep2016): New information from a contactable nurse on behalf of a physician included vaccine Lot number and Expiration date, vaccine dose administered, route of administration, site of vaccination, past drug history, causality assessment, outcome of the events. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2016383050 similar report from same reporter; US-PFIZER INC-2016383100 similar report from same reporter.
Sex: F
Vaccine: MENB
Symptoms: Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced high fever 102-104°F and headache. The outcome of the events was unknown.
Age: 67.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Dizziness, Dry mouth, Headache, Hypersomnia
Clinical narrative: Very Dizzy, headache, dry mouth, cramps and abdominal pain, body aches, nausea, slept most of the day.
Age: 67.0
Sex: F
Vaccine: TYP
Symptoms: Muscle spasms, Nausea, Pain
Clinical narrative: Very Dizzy, headache, dry mouth, cramps and abdominal pain, body aches, nausea, slept most of the day.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Within 1 hour of flu vaccination, patient developed redness 3 inches distal to the injection site. The site was itching, no hives or swelling were present. She had a medical appointment scheduled for her doctor later that afternoon. Her MD stated that he was not concerned her response to the vaccine and to take BENADRYL for any itching. She was having some itching on her back and shoulders. She was instructed to follow up with doctor if symptoms did not resolve.
Age: 70.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LOCALIZED RED SWOLLEN AREA WHERE INJECTION WAS GIVEN. VERY SORE. SIZE OF AN ORANGE.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 9/25 patient woke with injection site reaction - described as red, half-dollar sized hard and warm.  Patient iced the area and went to work.  Patient stated 9/25 in the evening the area was radiating in a circular pattern around the injection site and continued hurting, she had a low-grade fever.  9/26 - Patient is taking Tylenol & Ibuprofen and is continuing to ice the area - she is seeking Medical treatment for a suspected cellulitis reaction from a local urgent care clinic.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 9/25 patient woke with injection site reaction - described as red, half-dollar sized hard and warm.  Patient iced the area and went to work.  Patient stated 9/25 in the evening the area was radiating in a circular pattern around the injection site and continued hurting, she had a low-grade fever.  9/26 - Patient is taking Tylenol & Ibuprofen and is continuing to ice the area - she is seeking Medical treatment for a suspected cellulitis reaction from a local urgent care clinic.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Tingling in arm.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Around 1 hour after receiving the vaccine, the area of the arm that the vaccine was given in began to swell, turn red and become warm and painful. Patient went to see physician the next morning. Doctor was unsure of cause and prescribed prednisone and cephalexin in case it was cellulitis.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Ache in right deltoid, lump found, tender to pressure, cold pack applied.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Patient started running fever of 102 degrees that lasted about 30 hours. Her Right upper arm became swollen, hot and has a knot. She stayed in bed all day Saturday and her face turned very red. She also had muscle and joint pain. She is better now but still has a knot where shot was given.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient started running fever of 102 degrees that lasted about 30 hours. Her Right upper arm became swollen, hot and has a knot. She stayed in bed all day Saturday and her face turned very red. She also had muscle and joint pain. She is better now but still has a knot where shot was given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Patient noticed rash in area vaccine was administered this morning when she woke up. She states that she only notices any feeling of mild pain/swelling if she touches it; otherwise it does not bother her. Rash is approx. 2 inches x 0.5 inches. Patient also stated she received the intradermal flu vaccine from her physician's office about 2 weeks ago and had a very similar reaction the next day.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Neck pain
Clinical narrative: Extreme muscle aches and pains both shoulder joints and across the back of the neck. Hard to move her left arm in a circle and left.  She contacted her physician and they recommended her calling us.  Recommended taking Tylenol for the aches and pain and use ice.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction. Two by two inch square that is red, swollen, itchy, and warm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chills, Headache, Myalgia, Nausea
Clinical narrative: Patient reported via email that about 2 hours after she received the flu vaccine (FLUZONE HIGH-DOSE Lot# UI642AC) that she had in increase in blood pressure, nausea with vomiting, chills, headache, and muscle aches. She states that the symptoms were present for 3 days and she did not start to feel "completely" better for 5 days. She did take BENADRYL the first night symptoms started and she said it "seemed to help" a little. She did not seek medical care but said she "almost called 9-1-1."
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient reported via email that about 2 hours after she received the flu vaccine (FLUZONE HIGH-DOSE Lot# UI642AC) that she had in increase in blood pressure, nausea with vomiting, chills, headache, and muscle aches. She states that the symptoms were present for 3 days and she did not start to feel "completely" better for 5 days. She did take BENADRYL the first night symptoms started and she said it "seemed to help" a little. She did not seek medical care but said she "almost called 9-1-1."
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left arm posterior and right axilla. Small pox vaccination administered in left arm. Provider thinks vaccination may exacerbated an inflammation process already in progress.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a red area growing from the site of the injection that was hot, painful, and swollen.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain, limited mobility.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood lactate dehydrogenase, Blood uric acid, C-reactive protein, Contusion, Full blood count
Clinical narrative: BRUISING BEGAN 2 DAYS AGO WITH SINGLE BRUISE, INCREASING TO MODERATE BRUISING ON HIS ENTIRE BODY. 9/27/2016 DX WITH ITP.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immune thrombocytopenic purpura, Metabolic function test, Urine analysis
Clinical narrative: BRUISING BEGAN 2 DAYS AGO WITH SINGLE BRUISE, INCREASING TO MODERATE BRUISING ON HIS ENTIRE BODY. 9/27/2016 DX WITH ITP.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Joint range of motion decreased, Peripheral swelling
Clinical narrative: Redness, swelling of deltoid that spread to triceps area with decreased rom of arm that lasted 3 days. Pt applied ice.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site reaction, Local reaction
Clinical narrative: Localized rxn at site of injection no itching or soreness.  Size of Silver dollar approx.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site swelling, Pyrexia, Rash
Clinical narrative: Rash, fever, chills, swelling in injection site. Patient was given Ibuprofen and Benadryl and recovered.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site cellulitis, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red rash and heat at site of injections.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Pain, Pain in extremity
Clinical narrative: Arm throbbed badly for over an hour.  Felt "weird" like somewhat dizzy, somewhat nauseous, achy. Cancelled errands and went home and to bed. Drank fluids. Called advice nurse. Didn't drive rest of the day. At 5:00 PM (now) getting better.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Myalgia, Pyrexia
Clinical narrative: Fevers, myalgias, localized erythema and swelling. Improved with ice and seen by physician on 09/27/16.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Nauseated, bad headaches, achy body, and exhausted.
Age: 18.0
Sex: M
Vaccine: HPVX
Symptoms: Death
Clinical narrative: Death.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient said her arm got swelling and painful, hot to touch the second day and she can't raise her arm. She took some Motrin and apply ice pack and the swelling went down today. She complained of itching now and was advised to take Benadryl.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Irritability, Mental disorder
Clinical narrative: DERMATOLOGIC- ERYTHEMA AT INJ SITE, SWELLING AT INJ SITE; GASTRO-DECREASED APPETITE; PSYCHIATRIC-IRRITABILITY.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Burning sensation, Dizziness, Eye irritation, Flushing
Clinical narrative: SEVERE FLUSHING, PALPITAIONS, DIZZINESS, WEAKNESS, BURNING SENSATION IN THE EYES & IN THE HEAD.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Palpitations
Clinical narrative: SEVERE FLUSHING, PALPITAIONS, DIZZINESS, WEAKNESS, BURNING SENSATION IN THE EYES & IN THE HEAD.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Dyspnoea, Injection site erythema, Injection site inflammation, Injection site pain, Tachycardia
Clinical narrative: Injection site pain, redness, inflammation, difficulty breathing and tachycardia.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Hypertonia, Loss of consciousness, Tremor
Clinical narrative: Patient had LOC for approx 1 minute, fell forward onto tile floor, brief tonic contraction followed by mild limb shaking, then regained consciousness.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Cellulitis, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Itching and swelling around injection site. feel warm to touch.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Altered state of consciousness, Back pain, Dyspnoea, Erythema, Malaise
Clinical narrative: As soon as I gave the vaccine, patient complained of not feeling well, having trouble breathing and complain of sharp back pain. She also turned all red. We called 911 and within 3-4 minutes she almost passed out so gave her EPIPEN and she started to feel better.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Death
Clinical narrative: He got flu shot on 8/27/16. According to family members he was admitted in hospital on 8/28/16 and passed away on 9/8/16.
Sex: M
Vaccine: FLU3, PER
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of Guillain Barre Syndrome in a male patient who received Influenza vaccine. Co-suspect products included Whooping Cough Vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose and Whooping Cough Vaccine at an unknown dose and frequency. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not provided. It was reported that, within 12 days after receiving the whooping cough vaccine, the patient experienced the Guillain Barre syndrome and almost did not survive. It reporter stated that the consumers need to know about the possibility of contracting the Guillain Barre syndrome after receiving vaccination, especially with additional vaccination, such as the flu vaccine.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Abscess drainage, Lip swelling, Swelling face
Clinical narrative: Patient came into clinic with swollen nose and upper lip. Was given methylprednisolone steroid shot and told to take diphenhydramine tablets until it resolved. Five days later showed up in ER with swollen lip, ER MD drained abscess in upper lip and prescribed course of antibiotics. Five days later, ENT MD saw patient and drained abscess was much improved, no further f/u needed.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Muscle spasms
Clinical narrative: Back hurting and fingers cramping up. Patient's back hurt and fingers are cramping. Problem remains one week later.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Gaze palsy, Loss of consciousness, Syncope
Clinical narrative: My 15 year old son fainted. My son received the GARDASIL vaccine and a minute or so later and he started to feel dizzy. The nurse had given him a stop watch with 10 minutes on it and told him to sit. We were not informed that there was a high risk of syncope with GARDASIL. When he said the dizziness was not going away I rushed to get a nurse. I just happened to turn and check on him before leaving the room. I glanced back and saw my son going forward, head first, off the exam table and his eyes ere in the back of his head. He is 6'0 and 185 pounds. He was sitting cross legged on the table. I was able to reach him just in time before his head smashed to the ground. He was unconscious for another 8 seconds or so and then he came to.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient came in to report that her left arm was in pain especially near her bicep area.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cyanosis, Listless, Pallor, Vomiting
Clinical narrative: 9/26/16 Received PENTACEL, PREVNAR 13 at 7 pm. At 5 am 9/27/16, pale, blue lips, listless, then vomit; settled quickly per mom. She says same reaction after 2 mos vaccines on 6/1/16 (Rota given then too).
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash. Diphenhydramine 25mg once, Prednisone 60mg once, Ranitidine 150mg once.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever of 102 began the day after immunizations. Treated with TYLENOL\Ibuprofen.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, X-ray
Clinical narrative: Pt received PPSV23 vaccine in (R) deltoid at 1000. Pt developed worsening pain from (R) shoulder down (R) arm. Pt presented to ED, found to have intact strength, pulses, sensation, limited ROM S/T pain, this was on 9/22. Pt calling clinic C/O continued pain, no improvement, Pt to be evaluated in clinic.
Age: 55.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Pt. reports that baseball-sized swelling occurred from injection site, urgent care diagnosed as cellulitis. Pt has been given antibiotic and BENADRYL to treat.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Myalgia
Clinical narrative: Severe muscle pain. Severe joint pain. Inflammation of joints relieved by Ibuprofen 800mg.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Leg at injection site warm and sore day after injection, had softball size red area around injection site by that night (mom outlined with black marker), redness had extended past outline a little bit by next morning. Brother had same vaccine at the same time with no reaction.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Dizziness, Injection site erythema, Injection site hypersensitivity, Injection site pain
Clinical narrative: Allergic reaction itchy, swelling, with pain and area was red hot. Swelling spread down to the elbow left arm. Patient was icing the area and took BENADRYL when it started to itch. Localized reaction is subsided. Still feel light headed and feel jaw pain and difficulty in turning the head. MD recommended physical therapy CX thinking probably exacerbation of her MS.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction, Mobility decreased
Clinical narrative: Allergic reaction itchy, swelling, with pain and area was red hot. Swelling spread down to the elbow left arm. Patient was icing the area and took BENADRYL when it started to itch. Localized reaction is subsided. Still feel light headed and feel jaw pain and difficulty in turning the head. MD recommended physical therapy CX thinking probably exacerbation of her MS.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Multiple sclerosis, Pain in jaw
Clinical narrative: Allergic reaction itchy, swelling, with pain and area was red hot. Swelling spread down to the elbow left arm. Patient was icing the area and took BENADRYL when it started to itch. Localized reaction is subsided. Still feel light headed and feel jaw pain and difficulty in turning the head. MD recommended physical therapy CX thinking probably exacerbation of her MS.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness, light headed within 10 minutes of administration. Treated with orange juice and sitting since pt. reported. Not eating-pt. felt better in 5 minutes.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Vaccinated approximately 5:15 pm on 9/21. Noticed unusual amount of soreness on Thurs morning (9/22). By Saturday 9/24 felt red, swollen, and hot on Sunday swelling had increased and redness spread over whole bicep area. Pt went to primary care and was given BACTRIM.
Age: 40.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Erythema, Induration, Injection site pruritus, Measles antibody negative
Clinical narrative: Minimal 1 cm without color, induration, fever. Some itching on upper arm. Urticaria, Pruritus and erythema.
Age: 40.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Mumps antibody test, Pruritus, Pyrexia, Rubella antibody negative, Skin discolouration
Clinical narrative: Minimal 1 cm without color, induration, fever. Some itching on upper arm. Urticaria, Pruritus and erythema.
Age: 40.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Minimal 1 cm without color, induration, fever. Some itching on upper arm. Urticaria, Pruritus and erythema.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Skin irritation
Clinical narrative: Patient came into pharmacy with a red arm and thought it was infected. Pharmacist on duty thought it was more likely irritation from the bandage, not an infection.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into pharmacy with a red arm and thought it was infected. Pharmacist on duty thought it was more likely irritation from the bandage, not an infection.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Arm still painful at injection site. ALEVE (OTC) helps with pain. More aware of pain when asleep.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Pt developed cellulitis in (L) deltoid, site of administration. Pt treated w/Keflex 500 mg po q 12 h x 5 days by treating physician. Course of ABX started on 9/16/2016.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient requested a "TDAP" shot. Shot administered. Patient stated she wanted a Tuberculin skin test not a Tetanus shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Incorrect route of drug administration, Initial insomnia, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse, who was also a 61 year old female patient referring to herself. The patient had asthma, depression and reactions/allergies to ZITHROMAX. On 30-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX, which might had been given intradermally (incorrect route of drug administration) (lot#, expiration date and dose unspecified). Concomitant therapies included citalopram, SYMBICORT, PROAIR RESPICLICK and TYLENOL. On the same date ("later that evening"), the patient developed itching at the injection site, a headache and she had a hard time falling asleep. The patient took BENADRYL as treatment for the itching (since an unspecified date), however, it was not working. The patient stated the itching was still present and she was still having a hard time falling asleep every night since getting ZOSTAVAX, however, it was unspecified if the headache resolved. The patient did not seek medical attention and no lab diagnostics studies performed. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: 5 minutes post administration of VARIVAX one hive noted to right thigh laterally to injection site. MD made aware and examined site, BENADRYL 5 mg was given P.O. 27 minutes post administration. Site reassessed. Redness and swelling persisted but no increase in size or redness noted. No SOB or difficulty breathing noted. E.R. precautions given. Pt. discharged.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: The next day pt noticed the injected arm swollen and went down to the arm and there was a blister. Pt came in 9/26 and the swollen already subsided but there was still a bit of blister remaining.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Vaccination site haematoma
Clinical narrative: 1 hr. later, after removing band aid Large purple and black bruise. Hard lump in center. Next day red rash under black and blue bruises. Around three inches long/rash almost going around the arm. Warm to touch. Still bruised with less rash.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Induration, Mass, Rash, Skin warm
Clinical narrative: 1 hr. later, after removing band aid Large purple and black bruise. Hard lump in center. Next day red rash under black and blue bruises. Around three inches long/rash almost going around the arm. Warm to touch. Still bruised with less rash.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Computerised tomogram normal, Dyskinesia, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Jerking of legs followed by jerking of arms. Not able to control it.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Computerised tomogram head normal, Full blood count normal, Hemiparesis, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Jerking of legs followed by jerking of arms. Not able to control it.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Speech disorder, Tremor, Urine analysis normal
Clinical narrative: Jerking of legs followed by jerking of arms. Not able to control it.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Balance disorder, Blood test, Claustrophobia, Computerised tomogram normal, Dyskinesia
Clinical narrative: Jerking of legs followed by jerking of arms. Not able to control it.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Electrocardiogram normal, Fatigue, Flushing, Headache, Hyperaesthesia
Clinical narrative: Jerking of legs followed by jerking of arms. Not able to control it.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity, Pyrexia
Clinical narrative: Jerking of legs followed by jerking of arms. Not able to control it.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Renal pain, Skin warm, Speech disorder, Tremor, Urinary tract infection
Clinical narrative: Jerking of legs followed by jerking of arms. Not able to control it.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Urine analysis abnormal
Clinical narrative: Jerking of legs followed by jerking of arms. Not able to control it.
Age: 35.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Feeling cold, Headache, Nausea, Pyrexia
Clinical narrative: Flu Vaccine 9/26/2016 at 11:00am; TDAP vaccine 9/26/2016 at 8:00 pm. Headache and nausea started 9/27/2016 at 9:00 am. Uncontrollable chills and fever (102.3) started at noon on 9/27/2016.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Large red hot hives bilateral legs, thighs abdomen and truck/back Benadryl po 50 mg and then to ED for more aggressive workup and treatment. Employee report to RN Office 09/28/16 at 12:25am .No respiratory distress or airway problems noted.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia
Clinical narrative: Febrile at 102.5 F, muscle aches.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial unsolicited report received from a consumer on 15 August 2016. This case involves a nine-years-old female patient who was vaccinated with a first dose of FLUZONE (batch number, expiry date, dose, site of administration were not reported) via intramuscularly on unspecified date. Illness at time of vaccination reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as eczema allergies. Concomitant medications were not reported. On unspecified date, following the vaccination patient experienced large raised red area at the injection site with heat and pain. It was reported that patient visited to pediatrician who circled the area. The patient's mother was instructed to call in about condition of the site as they were concerned about a blood infection. It was reported that it required patient to stay out of school. Lab data was reported as none. Patient received corrective treatment with ATARAX and patient's mother was instructed to compress. On unspecified date, (few days later) patient recovered from event. Follow up report received from a nurse on 22 Sep 2016. It was reported that Based on information received from the reporter case was not medically confirmed (as vaccine was not administered in their clinic). List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Platelet count decreased
Clinical narrative: Initial unsolicited report received from a consumeron 19 September 2016. This case involves a 17-year-old female patient who was vaccinated with a dose MENACTRA (batch number: unknown, expiration date, dose and site of administration were not reported) intramuscularly on 09 August 2016. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was denied. On unknown date, two weeks later following the vaccination, the patient developed platelet count went from 1, 88,000 to 5000. It was reported that cause could not be established. Patient required emergency room or doctor visit. Other lab data was not reported. The patient received unspecified corrective treatment to get her level up. Outcome of the patient was reported as unknown. List of documents held by sender: none.; Sender's Comments: A 17 years old patient experienced Platelet count decreased from 188,000 to 5000 two weeks later vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset in compatible with role of vaccine. However details regarding relevant medical history, investigational result ruling out other etiology, previous vaccination history are needed for complete assessment of the case.
Sex: U
Vaccine: MNQ
Symptoms: Cellulitis
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a patient who received MENVEO (batch number M15098, expiry date unknown). On an unknown date, the patient received MENVEO. On an unknown date, an unknown time after receiving MENVEO, the patient experienced cellulitis (serious criteria GSK medically significant). The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on an unknown arm. The age at vaccination was not provided. This case was linked to case US2016GSK137626, reported by the same reporter.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 07-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # L007720, expiration date: 08-JUL-2016; dose and route of administration were not reported). No adverse effects were reported. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored PEDVAXHIB (lot/batch# 1042835 with expiry date 19-AUG-2018 and dosing details not known). No adverse reactions reported. There was no product quality complaint (PQC) involved. Lot number 1042835 is an invalid lot number for PEDVAXHIB. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an adult female patient of unknown age via Pfizer reporting on herself. The patient's concurrent conditions included type 2 diabetes mellitus and moderate asthma. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot # and expiry date not reported). On an unknown date, the patient experienced severe problems. The outcome of event was unknown. Causality was not provided by the reporter. It was reported that, on an unknown date in May 2015 she was vaccinated with PREVNAR 13 without any problems. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Cough, Lymphadenopathy, Productive cough
Clinical narrative: Coughing with heavy phlegm. Glands swollen in neck. Chest pain.
Age: 56.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Chills, Cold sweat, Dizziness, Fatigue
Clinical narrative: HIGH FEVER, UNCONTROLABLE CHILLS, BODY PAIN EVERYWHERE ALSO PAIN IN ARM. AFTER SEVERAL TYLENOLS WERE TAKEN FEVER WENT DOWN AND I COVERED MY SELF IN COLD SWEATS, VERY DIZZY AND EVEN WHEN FEVER WENT DOWN I CONTINUE WITH THE CHILLS AND BODY ACHES THIS LASTED ALMOST THREE DAYS.
Age: 56.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain in extremity, Pruritus generalised, Pyrexia, Scar
Clinical narrative: HIGH FEVER, UNCONTROLABLE CHILLS, BODY PAIN EVERYWHERE ALSO PAIN IN ARM. AFTER SEVERAL TYLENOLS WERE TAKEN FEVER WENT DOWN AND I COVERED MY SELF IN COLD SWEATS, VERY DIZZY AND EVEN WHEN FEVER WENT DOWN I CONTINUE WITH THE CHILLS AND BODY ACHES THIS LASTED ALMOST THREE DAYS.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Swelling
Clinical narrative: Swollen, raised, and itchy.