chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On unknown date, the patient was vaccinated with M-M-R II lot # L005291, albumin status: rHA, expiry date 17-FEB-2017 (route of administration, dose and dose number were not reported). The administered vaccine was improperly stored at temperature 56 Fahrenheit degrees, for 2 hours, (no data logger was involved). There was no previous temperature excursion. No adverse effects were reported. The physician reported that the temperature excursion occurred on 29-NOV-2016 due to a power outage. Albumin status for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live has been verified as recombinant human albumin (rHA). This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007916: US-009507513-1612USA006317: US-009507513-1703USA000616:
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 13-MAR-2017, the patient was vaccinated with an expired dose of VAQTA lot # L027735, expiration date: 12-JAN-2017, as prophylaxis (Strength, dose and route of administration were not reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age, who was also a pharmacist, via a company representative, and refers to herself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). On an unknown date, reported as long time ago, the patient experienced shingles. On an unspecified date, the patient recovered from the event. The relatedness between shingles and the suspect therapies was not provided. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA008044.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative, refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). On an unknown date, reported as long time ago, the patient experienced shingles. On an unspecified date, the patient recovered from the event. The relatedness between shingles and the suspect therapies was not provided. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007879:
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Decreased appetite, Diarrhoea, Eye discharge, Irritability, Lethargy
Clinical narrative: My 19 month old daughter had the Hep A Vaccine on Wednesday and about 5 hours later she had no appetite, vomiting, diarrhea, lethargy, disrupted sleep, irritability, fever and green discharge from one eye. She has had these symptoms for 2 1/2 days now.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Sleep disorder, Vomiting
Clinical narrative: My 19 month old daughter had the Hep A Vaccine on Wednesday and about 5 hours later she had no appetite, vomiting, diarrhea, lethargy, disrupted sleep, irritability, fever and green discharge from one eye. She has had these symptoms for 2 1/2 days now.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea, Eye pruritus, Eye swelling, Injection site erythema
Clinical narrative: Pneumonia shot given high in left shoulder. Hour later left eye swollen and itchy, tightness in chest, breathing difficulty, throat felt like swollen up, red and swollen around shot area with red hives around shot area.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site urticaria, Pharyngeal oedema
Clinical narrative: Pneumonia shot given high in left shoulder. Hour later left eye swollen and itchy, tightness in chest, breathing difficulty, throat felt like swollen up, red and swollen around shot area with red hives around shot area.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Feeling hot, Rash macular
Clinical narrative: Felt "hot and dizzy". Blotchy, red skin to torso and arms.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash
Clinical narrative: Rash that seems to be injection site reaction with an extended duration.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, TYP
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Client stated she felt "lousy" on 3/16, had a headache and "fell asleep on the couch." States arm where vaccines were administered had "red patches" (not hive-like)towards the middle of the bicep. States this morning (3/17) patches had coalesced into a "red area with a white center" and had a "slight fever." When asked whether the white center was lighter than the rest of her skin, she answered "considerably." Client states that she has full range of motion and it is not the joint that hurts, but this red area between the shoulder and elbow. Describes the pain as "throbbing a bit" but feels the pain especially with movement. Describes the pain as "more of a constant dull" ache and describes it as feeling "tender" to the touch. She also states that it is "not that swollen." Client has taken extra strength Tylenol for the past two days. Advised icing the red area to help alleviate tenderness, pain, and swelling. Advised client to seek medical care if swelling/pain/tenderness continues to increase.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, TYP
Symptoms: Pyrexia
Clinical narrative: Client stated she felt "lousy" on 3/16, had a headache and "fell asleep on the couch." States arm where vaccines were administered had "red patches" (not hive-like)towards the middle of the bicep. States this morning (3/17) patches had coalesced into a "red area with a white center" and had a "slight fever." When asked whether the white center was lighter than the rest of her skin, she answered "considerably." Client states that she has full range of motion and it is not the joint that hurts, but this red area between the shoulder and elbow. Describes the pain as "throbbing a bit" but feels the pain especially with movement. Describes the pain as "more of a constant dull" ache and describes it as feeling "tender" to the touch. She also states that it is "not that swollen." Client has taken extra strength Tylenol for the past two days. Advised icing the red area to help alleviate tenderness, pain, and swelling. Advised client to seek medical care if swelling/pain/tenderness continues to increase.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site swelling, Rash, Vaccination site mass
Clinical narrative: Per mother: mild rash on body, lump in R leg where vaccine was administered the size of a golf ball and entire upper leg rediculously swollen.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Pruritus
Clinical narrative: Rash at site of injection and L upper arm. Hydrocortisone cream for itch.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt received shingles vax in 2010 but got shingles around the first of this year.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Local reaction, Pruritus, Skin warm
Clinical narrative: Approximate 2 inch local reaction. Area red, hot to touch, ithcy, bruised. Red bruised area traveling to top of forearm.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Pain in left arm centered in bicep muscle where inoculation with FLUZONE HIGH-DOSE 2016-17 serum. Experienced noticeable pain and difficulty in raising arm above shoulder, pain when using arm to lift, push or pull.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and referring to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On 16-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II lot number: L004656, expiration date: 11-FEB-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) for prophylaxis. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Meningitis pneumococcal, Pneumonia, Product quality issue, Vomiting
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A 2-year-old female patient had been fully vaccinated with PREVNAR 13 via an unspecified route of administration at 0.5 ml, single 3 doses on unknown dates and the 4th dose on 17Jun2016 (Lot # M79320), all for immunisation. The child received 3 doses in another pediatric clinic and received the 4th and final dose in reporting physician office. The patient medical history was and concomitant medications were not reported. On 08Mar2017 the patient was diagnosed with pneumococcal meningitis, invasive pneumonia presenting with vomiting when she was admitted to the hospital on 08Mar2017. The outcome pneumococcal meningitis and invasive pneumonia was not recovered, the outcome of vomiting was unknown. The patient went into the physician office on 08Mar2017 and was immediately sent to the hospital and was currently under the care of another physician at the hospital. The patient's hospitalization was prolonged as a result of this event. The reporting physician said that there was no medical conditions to report and he/she was not given any information about any tests the patient has had since she has been in the hospital. A product complaint was filed. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer reporting for him/herself. This patient of unknown age, gender and race/ethnicity received on 15Nov2015 a single dose of PREVNAR 13 for immunization. Concomitant medications and medical history were not reported. On an unspecified date the patient experienced double pneumonia for which was hospitalized in Aug2016. The patient commented that the vaccine did not work for him/her. Outcome was not reported.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient, who had gotten the pneumonia shot 5 days earlier, experienced pneumonia. Due to the event he was hospitalized. Outcome of the event was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 2 patients. This is the second of two reports. A male patient of an unspecified age, race and ethnicity received PREVNAR 13 at single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unknown date, 5 days after the shot, the patient experienced pneumonia. Hospitalization was required. Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017113220 same reporter/different patient, same product, same event.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR
Symptoms: Cough, Pyrexia, Seizure, Sneezing, Urticaria
Clinical narrative: Very high fever 105.7, head to toe hives, cough sneezing and seazures.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Received flu shot in arm and began developing hives on lower extremities.  Pt also reported on ER note that she has egg allergy.  Pt had taken Benadryl 50mg at home but still had hives.  Pt was evaluated and treated with Decadron for urticaria in ER on 17Feb17.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain of deltoid muscle, not able to move Left arm well.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Local swelling
Clinical narrative: Localized redness and swelling. Maximum size 3 inches by 4 inches. No fevers. Peaked on day 3 after vaccination, improving by day 4.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site warmth, Paraesthesia
Clinical narrative: Pain in arm at injection site, tingling and numbness in hand, then red hot ring around arm about 4 inches below injection site.
Age: 36.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Induration, Tenderness, Type III immune complex mediated reaction
Clinical narrative: Hard spot and sore to the touch, arthus-like reaction.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash head to toe on body.  Benadryl was given by grandmother and appt to was made at the clinic.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pT DEVELOPED REDNESS AND SIGNIFICANT SWELLING IN THE THIGH WHERE SHE GOT DTAP.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Per pt he was diagnosed and hospitalized with Guillian Barre.
Age: 29.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of painful, increased swelling noted on the back of the left arm from injection site down to left elbow with a purplish color to it.  No fever indicated.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Extreme swelling at site of injection. Upper thigh has become 1.5 to 2 times it's normal size. Upper thigh is also very hard and has rash all over upper thigh. No itching but very warm to touch.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itching at insertion site changing to redness. Large area the size of my palm raised and warm to the touch with mild discomfort?
Age: 82.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received Zoster immunization in her right arm. The following day she developed a raised, red area at her injection site. Diameter had increased through the course of the week - not painful or itchy.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt was given PENTACEL dose #4 one week after dose #3 was given. Mom denies any SX.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: (L) arm - red, sore, hot to touch. Width: 12 cm. Height: 10 cm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Facial paralysis, Hypoaesthesia oral
Clinical narrative: Vaccine (PREVNAR) was administered 3/12/17, patient's face start drooping Wednesday night 3/15/17. Pt went to ER because she cannot feel her mouth 3/16/17. ER MD gave patient VALTREX 1g, Prednisone 20mg, erythromycin eye ointment.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Gave KINRIX instead of PEDIARIX. KINRIX-Manufacturer GlaxoSmithKline. Lot # G352K. Route/site IM R-thigh.
Age: 36.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Musculoskeletal discomfort, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Strong discomfort in left shoulder immediately following injection. Shoulder continues to cause pain in certain positions due to diagnosed impingement.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patient came in 3/9/17 complaining of arm hurting from flu shot given on 2/11/17. There was a lump from shot (approximately 1" from top of arm/shoulder). Pain was associated with the lump. Patient was advised to go to doctor who referred to orthopedic.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Headache, Hyperhidrosis, Influenza like illness, Nausea, Tremor
Clinical narrative: Post immunization and off-site, vaccine recipient reported: headache, nausea with urge to vomit, shakiness, flu-like symptoms, sweaty, cold.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Viral upper respiratory tract infection
Clinical narrative: Post immunization and off-site, vaccine recipient reported: headache, nausea with urge to vomit, shakiness, flu-like symptoms, sweaty, cold.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Insomnia, Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: Headache, runny nose, sinusitis, fever, insomnia, malaise. Treatment Ibuprofen 200 mg.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Sinusitis
Clinical narrative: Headache, runny nose, sinusitis, fever, insomnia, malaise. Treatment Ibuprofen 200 mg.
Age: 24.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pyrexia
Clinical narrative: Area of redness 2 in. in diameter, fever.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Nasal congestion, Productive cough, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: 03/08/2017, Patient presents today with cold symptoms x 3 days. Associated symptoms include sneezing, nasal congestion, runny nose, productive cough and fever, but no dry cough, no ear pain, no nausea, no vomiting and no diarrhea. Male toddler, fever started 3 days ago with temperature 100-101, runny nose, cough and occasional wheeze. Cough is worse at night and sounds barky to dad. Throughout the day he is still playful, active and eating and drinking normally but the cough is concerning to them. Did notice him wheeze yesterday and gave him a breathing treatment. They felt the treatment was helpful. Has not noticed a wheeze today.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Viral upper respiratory tract infection, Wheezing
Clinical narrative: 03/08/2017, Patient presents today with cold symptoms x 3 days. Associated symptoms include sneezing, nasal congestion, runny nose, productive cough and fever, but no dry cough, no ear pain, no nausea, no vomiting and no diarrhea. Male toddler, fever started 3 days ago with temperature 100-101, runny nose, cough and occasional wheeze. Cough is worse at night and sounds barky to dad. Throughout the day he is still playful, active and eating and drinking normally but the cough is concerning to them. Did notice him wheeze yesterday and gave him a breathing treatment. They felt the treatment was helpful. Has not noticed a wheeze today.
Age: 20.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Ear swelling, Lip swelling
Clinical narrative: Patient developed swelling at ear day of vaccine. Also started with swelling at lips on 3/16/17. Mom  gave BENDADRY at 11pm on 3/16/17. Symptoms improved.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test normal, Culture urine negative, Febrile convulsion, Influenza virus test positive, Respiratory syncytial virus test negative
Clinical narrative: 5" Febrile seizure. Taken by ambulance to Hospital and at facility had extensive work-up.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Hives, swelling, redness. Treatment: Ice pack, ADVIL, take antihistamine for next 4-5 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site inflamed, red, warm to touch. Patient states it is 'itchy' and tender.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye irritation, Generalised erythema, Injection site pain, Pruritus
Clinical narrative: Shingle shot 15-20 minutes - redness, itchiness on hands - couldn't stop scratching - face rash/redness then arms, neck - looked like a bad sunburn - on way to ER - feet, legs red - eyes were burning - neck in hospital - back and rest of body totally red and itchy. Shot burned when injected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash
Clinical narrative: Shingle shot 15-20 minutes - redness, itchiness on hands - couldn't stop scratching - face rash/redness then arms, neck - looked like a bad sunburn - on way to ER - feet, legs red - eyes were burning - neck in hospital - back and rest of body totally red and itchy. Shot burned when injected.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Developed redness, warmth, firmness and pain at injection site. No fever. Seen in office 3/3/17 with erythema, warm and tender to touch left upper arm. Area improved at time of visit per mom.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Patient received immunization and was talking to vaccine administrator when she fainted and fell to floor unconscious for one to two minutes. Pt. regained consciousness and continued to lie prone. Called husband and she left under own power. Saw today. No further complaint of problems.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pneumonia, Pyrexia, Renal failure, Swelling
Clinical narrative: After vaccine given several weeks later I became sick and I begins to have fever a swelling that lead to pneumonia, and kidney failure symptoms. I was hospitalize for approx 4 days.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Night sweats
Clinical narrative: Chills, night sweats, reduced ROM on R arm, strong pain at injection site.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Paraesthesia
Clinical narrative: Patient noticed some redness, some tingling in his heel and in 4th and 5th digits.  This resolved by 1/17/2017.
Age: 23.0
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Soreness, erythema, and inflammation at injection site. Diagnosed as cellulitis.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, itching, redness, and swelling at inject site. Patient also reports dizziness.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Erythema, Inflammation, Peripheral swelling, Pruritus
Clinical narrative: ARTHRUS TYPE REACTION WITH SWELLING OF THE UPPER ARM ALONG WITH SEVERE ERYTHEMA AND ITCHING.  DR ADVISED PATIENT TO USE COLD COMPRESSES AND APPLY LOTION TO THE SKIN.  I RECOMMENDED THE PATIENT USE IBUPROFEN TO HELP RELIEVE INFLAMMATION AND DISCOMFORT.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Type III immune complex mediated reaction
Clinical narrative: ARTHRUS TYPE REACTION WITH SWELLING OF THE UPPER ARM ALONG WITH SEVERE ERYTHEMA AND ITCHING.  DR ADVISED PATIENT TO USE COLD COMPRESSES AND APPLY LOTION TO THE SKIN.  I RECOMMENDED THE PATIENT USE IBUPROFEN TO HELP RELIEVE INFLAMMATION AND DISCOMFORT.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Chills, Electrocardiogram, Erythema
Clinical narrative: Arm swollen, red and painful. Fever / chills / general malaise as well as pain in arm spreading to chest and back over 24 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm swollen, red and painful. Fever / chills / general malaise as well as pain in arm spreading to chest and back over 24 hours.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Burning sensation, Depression, Erythema, Neuropathy peripheral
Clinical narrative: Neuropathy, My Hands and Feet were Red and severely Burning. The onset of Depression.
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, and redness around the injection site. The redness continued grow in a larger circumference the following day. Still waiting to see if any other side effects occur.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Raised red rash around injection site, severe pruritus.  Attempted to use oral diphenhydramine and topical hydrocortisone to alleviate pruritus with minimal effect.  Symptoms alleviated after ~4 days. Patient said she was getting ready to seek medical attention if symptoms did not alleviate.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Ear pain, Headache, Injection site bruising, Injection site erythema
Clinical narrative: My entire left arm is painful with erythema, warmth at site, bruising, joint pain, left jaw pain, headache, muscle aches, and swollen/tender lymph nodes. The site on the first day 3/16/17, about 2 hours after injection, was 1x2cm with redness and bruising; 2nd day, 3/17/16 when I saw a physician it was 2x4cm- red, puffy, hot, burning, and headache; 3rd day, 3/18/17 it was 4x6cm (saw another physician) plus all same symptoms plus swollen glands and neck/ear/jaw pain; and today, 3/19/17 it is 7x9cm with all same symptoms plus my entire left arm is heavy, achy, and painful.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site warmth, Limb discomfort, Lymphadenopathy, Myalgia
Clinical narrative: My entire left arm is painful with erythema, warmth at site, bruising, joint pain, left jaw pain, headache, muscle aches, and swollen/tender lymph nodes. The site on the first day 3/16/17, about 2 hours after injection, was 1x2cm with redness and bruising; 2nd day, 3/17/16 when I saw a physician it was 2x4cm- red, puffy, hot, burning, and headache; 3rd day, 3/18/17 it was 4x6cm (saw another physician) plus all same symptoms plus swollen glands and neck/ear/jaw pain; and today, 3/19/17 it is 7x9cm with all same symptoms plus my entire left arm is heavy, achy, and painful.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Neck pain, Pain in extremity, Pain in jaw, Varicella virus test positive
Clinical narrative: My entire left arm is painful with erythema, warmth at site, bruising, joint pain, left jaw pain, headache, muscle aches, and swollen/tender lymph nodes. The site on the first day 3/16/17, about 2 hours after injection, was 1x2cm with redness and bruising; 2nd day, 3/17/16 when I saw a physician it was 2x4cm- red, puffy, hot, burning, and headache; 3rd day, 3/18/17 it was 4x6cm (saw another physician) plus all same symptoms plus swollen glands and neck/ear/jaw pain; and today, 3/19/17 it is 7x9cm with all same symptoms plus my entire left arm is heavy, achy, and painful.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Should have received PNEUMOVAX 23 instead of PREVNAR 13.
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAPIPV
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Evening of Tdap and flu shot, I started to experience sharp pain in left shoulder where shots were administered. I had no range of motion in my left shoulder and pain continues to date.
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAPIPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Evening of Tdap and flu shot, I started to experience sharp pain in left shoulder where shots were administered. I had no range of motion in my left shoulder and pain continues to date.
Age: 31.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal pain
Clinical narrative: Immediately pain in injection site and continued pain since then (2 weeks so far) as well as shoulder ache for past 3 days.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Dyspnoea, Headache, Pain
Clinical narrative: Bad body pain and short of breath and a bad headache and chest pain.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Chills, Erythema, Pyrexia
Clinical narrative: 3/8/17 - no pain when vaccine was given but became red. 3/9/17 - redness spreads/fever/chills. 3/10/17 - fever/chills redness from shoulder to elbow. 3/11/17 - ED visit and Dx: cellulitis. 3/15/17 - am: reported to pharmacy/pm: arm seen by other RPh and possible arthritis type reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On 22-FEB-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # L046293, expiration date 17-FEB-2017, dose and route not specified) for prophylaxis. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a pharmacist via a company representative referring to unknown number unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates the patients were vaccinated with doses of ZOSTAVAX subcutaneous injection (dose, route, site of administration, lot # and expiration date were not reported) for "shingles". On unknown dates the unspecified patients experienced "red spots" to form on the body, not related to shingles or injection site redness (rash papular); which was reported by the pharmacist reading information from unknown source on unknown date that ZOSTAVAX could cause "red spots" to form on the body. The outcome of the event was unknown. It was reported that the pharmacist was reading the information from unknown media source and no specific patients were mentioned in it. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema
Clinical narrative: Information has been received from a 76 year old male patient referring to himself. The patient had no pertinent medical history, drug reactions/allergies. Concomitant therapies included irbesartan, hydrochlorothiazide (reported as "Hcpz"), metoprolol succinate (TOPROL XL), allopurinol, finasteride (manufacturer unknown), tamsulosin hydrochloride, lovastatin and "Nyzan". On 27-FEB-2017 the patient was vaccinated with ZOSTAVAX (dose, lot # and expiration date unknown) via "vaccine" route in the left arm to prevent shingles. On 01-MAR-2017, the patient noticed that redness at the site of injection on his left arm, as well as headaches. No treatment was given for the adverse events. The outcome of the events injection site erythema and headache was reported as not recovered. No product quality complaint (PQC) was involved. The causality assessment was not provided.  Additional information is not expected because there is no consent to contact the physician.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that on an unknown date the patient was vaccinated with one of the improperly stored vaccines listed below for prophylaxis (dose, route unknown), but she was not sure which of the vaccines the vaccines was received. The involved were: PROQUAD (lot # M037012, expiration date 21-FEB-2018); or VARIVAX (lot # M039316, expiration date 20-SEP-2018; lot # M035141, expiration date 03-AUG-2018). "Data logger" was involved and there was no previous excursion. The temperatures conditions the vaccines exposed were reported as: PROQUAD lot # M022400, expiration date 01-NOV-2017 was stored in the temperature of between 5 and 14 degrees Fahrenheit for 3 hours and 58 minutes, stored in in the temperature of between 14 and 46 degrees Fahrenheit for 2 hours and 37 minutes and 2 hours and 59 minutes respectively. VARIVAX lot # M010481, expiration date 01-MAR-2018 was stored in the temperature of between 5 and 14 degrees Fahrenheit for 12 hours and 45 minutes, and in the temperature of between 14 and 46 degrees Fahrenheit for 5 hours and 17 minutes; lot # M025867, expiration date 19-JAN-2017 was stored in the temperature of between 14 and 46 degrees Fahrenheit for 4 hours and 19 minutes, 4 hours and 41 minutes, 4 hours and 55 minutes and 7 hours and 10 minutes, respectively. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Lip swelling
Clinical narrative: Information has been received from a registered nurse via a company representative referring to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with his first dose of GARDASIL 9 (dose, lot #, expiration date, site of administration not reported) intramuscularly for prophylaxis. Within 15 minutes after administration, the patient experienced lip swelling. The patient sought medical attention in office and was treated with oral diphenhydramine hydrochloride (BENADRYL). The patient recovered while still in the office. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L019835, expiration date: 23-MAR-2017; dose and route were not provided). The vaccine was exposed to temperature between 32 and 36 Fahrenheit degrees for total cumulative time of 96 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA002296: US-009507513-1703USA002311: US-009507513-1703USA002312.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to a unspecified number of patients of unknown genders and ages. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX Lot number M034584, expiration date 27-JUL-2018 (strength and route were not reported) for prophylaxis, and other VARIVAX vaccine which had a lot # L020004 with expiration date on 02-JUN-2017 , however no adverse effects were reported. It was mentioned that the vaccines were exposed to temperature of >-10 C but <8 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA008046: US-009507513-1703USA008047: US-009507513-1703USA008048: US-009507513-1703USA008049: US-009507513-1703USA008050: US-009507513-1703USA008051: US-009507513-1703USA001827:
Sex: M
Vaccine: DTAP
Symptoms: Anaphylactic reaction, Respiratory distress, Urticaria
Clinical narrative: Initial unsolicited report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the above reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A four-year-old male patient had received an injection of "DTaP" vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and ten minutes later, he experienced anaphylaxis with symptoms of diffuse hives, and respiratory distress. Corrective treatments consisted of Diphenhydramine and an oral steroid. The patient had a history of asthma and had been diagnosed with a milk allergy based on serologic testing performed to evaluate proctocolitis from cow's milk-based formula at three months of age. Laboratory testing showed the patient had increased IgE levels (82.9 (kIUA/L) within two years of vaccination. Outcome was not reported. This case was considered as serious by the reporter due to medically significant events. Follow-up information received 24 August 2011 from a physician who stated that they did not administer the vaccine to the patient. The patient was vaccinated by their primary physician; therefore, the reporter was unable to provide information pertaining to the name of the vaccine manufacturer, lot number, site and exact date of administration, symptom duration and stop dates/times, and specific medication dates and dosages received as treatment. No additional information was provided at the time of the report. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03275, -03276, -03277, -03278, -03279, -03280 and -03281. Follow-up information received from a physician on 06-Mar-2017. This case was found duplicate of case number 2016SA073837. Hence, case 2016SA073837 was deleted. The patient was vaccinated with booster dose of DTaP vaccine. List of documents held by sender: none.; Sender's Comments: Follow-up received on 06-MAR-2017, does not change the previous assessment of the case, Manufacturer of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE was not reported. Anaphylaxis is reported after administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. Time to onset 10 minutes is compatible with the role of the vaccine. In the study it has been observed that the patients who have cow milk allergy are more prone to the reaction after administration the diphtheria, tetanus and acellular pertussis vaccine. The presence of casein of the Tdap and DTaP vaccines may increase this risk. According to the provided information the role of the vaccine could not be ruled out.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site rash
Clinical narrative: Initial unsolicited report received from a consumer (Patient) on 06-Mar-2017. This case involves a 34-year-old male patient who was vaccinated with a first dose of SMALLPOX VACCINE (Batch number, expiry date, dose form frequency and route and of administration not reported) in the left deltoid on 25-Feb-2017. The patient denied any pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at time of vaccination. Concomitant medications were not reported. Any other vaccines with four weeks of vaccination were not reported. On 04-Mar-2017, seven days following the vaccination the patient developed a rash at the injection site of the area around the Band Aid and spread to the entire deltoid region. Relevant laboratory investigations and corrective treatment were not reported. The outcome of the events was unknown. List of documents held by the sender: None.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Rash - 10 days after MMR C/O itchiness, No fever.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Patient developed redness, bruising and warm to touch at injection site.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient given 0.5 dose of influenza vaccine instead of ordered PREVNAR. Patient has already received both doses of flu vaccine this season.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Non-specific non-injection-site rash at small sites on two arms and one leg. Rash resolved within a few days.
Age: 1.75
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a nurse practitioner concerning a 2 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.  On 16-AUG-2016, the patient was vaccinated with a first dose of VARIVAX (lot#, expiration date, dose and route were not reported)  and on 15-DEC-2016, the patient was vaccinated with an inadvertent dose of ZOSTAVAX (lot#, expiration date, dose and route were not reported) for prophylaxis. No adverse symptoms were reported.No product quality complaint was involved. Additional information is not expected, as all scheduled correspondence was returned.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant concerning a female patient of unknown age. Medical history and concomitant medications were not reported. On 24-FEB-2017, the patient was accidentally administered a dose of VARIVAX (dose, route and lot # not reported) instead of ZOSTAVAX. The outcome was not provided. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Information has been received from a physician assistant concerning a female patient of unknown age. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 for prophylaxis (dose, route, application site, frequency and lot # were not reported). By the following morning, the patient developed redness and swelling at the vaccination site. The patient was treated (medication not specified). The outcome of the events was unknown. The reporter considered the events to be related to PNEUMOVAX23. The reporter said that he had two patients that had a reaction to the same batch of PNEUMOVAX23 that occurred two weeks apart from each other. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005575:
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4
Symptoms: No adverse event
Clinical narrative: 3-8-17 None, mom states child fine. 3-20-17 Pt states baby is well, no issues.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head normal, Differential white blood cell count normal, Dizziness, Feeling abnormal, Full blood count normal
Clinical narrative: Dizziness, didn't feel "right".
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test normal
Clinical narrative: Dizziness, didn't feel "right".
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Chills, Cough, Dizziness, Headache
Clinical narrative: Dizziness and nausea vomiting. Ondansetron 4 mg PRN, meclizine 12.5 mg PRN, prochlorperazine 10 mg PRN.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oropharyngeal pain, Pain, Painful respiration, Productive cough
Clinical narrative: Dizziness and nausea vomiting. Ondansetron 4 mg PRN, meclizine 12.5 mg PRN, prochlorperazine 10 mg PRN.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Dizziness and nausea vomiting. Ondansetron 4 mg PRN, meclizine 12.5 mg PRN, prochlorperazine 10 mg PRN.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pharyngeal oedema
Clinical narrative: STARTED AS NAUSEA ENDED UP WITH THROAT SWELLING CLOSED.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm after flu shot-couldn't lift arm above head or out to side. Not able to do anything with left arm. Happened one day after shot. Reported to Family Doctor immediately- he sent me to Dr-who told Family Doctor I needed physical therapy. Couldn't get in therapy till Dec 29, 16, 2 month therapy-75% use now-no more therapy-only at home.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Acupuncture, Amblyopia, Asthenia, Back pain, Brachial plexopathy
Clinical narrative: Got the flu shot on 9-15-15 by the afternoon he complained having chills and body ache. 9-16-15 was unable to go to work he felt tired and body ache. 9-17-15 unable to go to work he had fever all night. 9-18-15 around 2:00 am woke up throwing up unable to get out of bed unable to hold a towel with right arm very weak rushed him to ER he was treated for a stroke we told ER dr. he had just got flu shot to check for virus he got released same day with right arm total paralyzed. 9-21-15 Primary dr referred him to have steroids pak and labs and see neurologist. 9-23-15 neurologist prescribed Methylprednisolone (MEDROL Pak) 4 mg oral dose. 9-25-15 due to his pain on his shoulder and back gabapentin 600 three times a day and consider referral for output IV SOLUMEDROL treatment. 9-21-15 went to ER with neck pain Monoplegia right arm. Weakness of left arm. Bilat brachial plexopathy. Discharged same day. I mentioned the flu shot again to check for virus due to his slurred speech and neck pain per nurse note RUE paralysis; LUE plus 4/5 strength slow speech and slightly slurred he is diaphoretic. Neurologist gave SOLUMEDROL 1 gram IV and arranged 2 more infusion he was identified as high risk for fall due to his weakness both arms and body, brain MRI normal. MRI c-spine normal diagnosed with brachial plexitis. 9-30-15 ER 3rd time lazy left eye blinking and itching left lip drooping lumbar puncture was done at 1:20 pm MRI brain w/wo contrast was admitted for 5 days today March 13 2017 with no diagnose first diagnose west nile and when I ask neurologist how he was based and if he was going to report it he said he was not sure now he said he doesn't know my husband is going to therapy acupuncture, is helping his right arm still paralyzed unable to move. Per neurologist it will take time to recuperate 100% or he can diagnose him with permanent disable. I called to report to CDC they took all the information and never hear from them. My husband still gets cramps on his shoulder and neck and gets tire he back to work light duties unable to move his right arm.