chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 35-year-old male patient who received FLULAVAL QUADRIVALENT (batch number 9K7E4, expiry date APRIL 2017). Concomitant products included Tetanus vaccine. On 17th OCTOBER 2016, the patient received FLULAVAL QUADRIVALENT, .5ml. On 17th OCTOBER 2016 4 hrs after receiving FLULAVAL QUADRIVSALENT, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved. The reporter considered the pruritus to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. On 30th SEPTEMBER 2016, the patient received tetanus vaccine. The patient received FLULAVAL QUADRIVALENT in his left deltoid. After receiving FLULAVAL vaccination, the patient experienced itching on scalp and head.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large erythematous, mildly warm, patch on left upper lateral arm - measures 10 cm wide  x 16 cm long.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Fever, swelling, aches, pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Patient stated she had normal muscle soreness for approx. 1 day post vaccine. 2 days later area began to have a periodic dull pain that has continued to recur 30 days post vaccine. No redness, swelling, or visible problems.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lip swelling, Pharyngeal oedema, Swollen tongue
Clinical narrative: Symptoms: swelling under tongue and lower lip, slight swelling throat headache. BENADRYL 50 mg taken at time of shot, 5 hours later for total of 150 mg taken. This is pt's 3rd dose in 3 years, reaction less this year than last.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Erythema, Headache, Myalgia
Clinical narrative: Red swelling, sore, muscle aches, weakness, headache, dizzy, fever.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Red swelling, sore, muscle aches, weakness, headache, dizzy, fever.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Chills, Laboratory test normal, Lethargy, Myalgia
Clinical narrative: 10-6-16 Woke up with lethargy. Progressive muscle/joint aches and uncontrolled chills. Did not check temp. Rash appeared - small pin head size red flat dots all over body except none on face. No itching, chills/aches resolved in 24 hours. Rash resolved - 7 days.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash, Rash erythematous
Clinical narrative: 10-6-16 Woke up with lethargy. Progressive muscle/joint aches and uncontrolled chills. Did not check temp. Rash appeared - small pin head size red flat dots all over body except none on face. No itching, chills/aches resolved in 24 hours. Rash resolved - 7 days.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia, Pain, Pyrexia, Swelling
Clinical narrative: Fever, swelling, aches, pain, no sleep.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Herpes zoster, Injection site nodule, Injection site pain, Pain
Clinical narrative: Right arm pain at site of Quad Flu shot. Pain worsened with arm feeling like it weight a ton and sudden movement feeling like arm would shatter. Experienced return of shingles with pain at arm site shooting up neck and down back like electricity. And shingle pain around chest area with chest outbreak of bumps. Shingles now gone but continued knot of pain at shot site. Treatment - aspirin/ADVIL, Heat.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Right arm pain at site of Quad Flu shot. Pain worsened with arm feeling like it weight a ton and sudden movement feeling like arm would shatter. Experienced return of shingles with pain at arm site shooting up neck and down back like electricity. And shingle pain around chest area with chest outbreak of bumps. Shingles now gone but continued knot of pain at shot site. Treatment - aspirin/ADVIL, Heat.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: States that after receiving the flu shot it was a little itchy. The next day she started scratching at injection site and it was tender and warm. She looked at the site and saw the whelp. Contacted me today and stated it has still a little tender to the touch and red but the whelp had not gotten any larger. Remeasured whelp at 65mm. Redness has decreased per patient. Advised patient compress/Ibuprofen if needed. Denies fever or rashes.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia, Skin reaction
Clinical narrative: After receiving vaccines, patient reported developing a high fever for several days and large part of arm became red and swollen.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Neck pain, Paraesthesia
Clinical narrative: Immediately after receiving flu vaccine, Pt. c/o: Left arm being numb, tingling, and prickly. Later on right hand with same symptoms and neck pain.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Pain in extremity
Clinical narrative: Pt claims that after taking the flu and pneumonia shot she experienced persistent headache and arm soreness.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Exercise tolerance decreased, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at shot site for over a week - unable to raise arm above head for over a week, could not resume exercises. Have not felt good since getting shot. No energy - was very active before shot. Moving slower now - not active as before shot.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Movement disorder, Pain, Peripheral swelling
Clinical narrative: (L) under arm swollen, not able to close arm down. Pain and fatigue for seven days.
Age: 4.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Red warm rash at injection site on (R) anterior thigh 10.0 cm x 6.0 cm.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Flushing, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Bruising, pain, redness, and swelling to left arm (injection site). Flushed, aches, and fatigue. Was seen in clinic, per physician assistant to take cefaclor 500mg only if symptoms worsen.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Pain
Clinical narrative: Bruising, pain, redness, and swelling to left arm (injection site). Flushed, aches, and fatigue. Was seen in clinic, per physician assistant to take cefaclor 500mg only if symptoms worsen.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Skin discolouration
Clinical narrative: My upper left arm where pneumonia shot was given hurt for 15 days, it turned real red and was very warm to the touch. It's still a little discolored on inside of arm.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia, Pain, Pyrexia, Swelling
Clinical narrative: Fever, swelling, aches, pains. No sleep.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site induration, Injection site pain, Injection site papule
Clinical narrative: Hepatitis A and VARIVAX given Rt thigh 10/11/2016. 10/18 developed papular induration and discoloration tenderness at injection site. Seen 10/24-
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pharyngeal oedema
Clinical narrative: Throat swelling with no problems breathing. Immediate reaction after vaccine after leaving pharmacy. Used albuterol inhaler to help with symptoms. Said symptoms on and off for 2 weeks.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dyspnoea, Nausea, Pain in extremity
Clinical narrative: 4 hours after administration patent experienced chills, nausea, shortness of breath, and pain arm. Symptoms cleared up within 5 hours and did not require medical attention.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain
Clinical narrative: Pain.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Within 20 mins tingling down arm through 3 middle fingers all the way to tips. Bent elbow made shooting pain/tingles shorten from elbow to fingers. Stronger shooting pain down entire arm while walking, rested arm for 20 minutes while working on emails, pain tingling and shooting. Pain better in 3 hours. But after 3 hours lots of pain and tingles down entire arm.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Diarrhoea, Energy increased, Feeling hot, Nervousness
Clinical narrative: Felt like hot liquid. Increased blood sugars. Diarrhea. Shakey feeling, like caffeine high.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Movement disorder, Musculoskeletal chest pain, Pyrexia
Clinical narrative: Starting late 10/18/16 pain in back radiating to ribs only on right side; worsened on 10/19/16 and had fever 100 degrees F; difficulty sitting, laying down due to pain intensity; peak 11 PM 10/19/16; start resolve AM 10/20/16 as fever breaks; no pain by 10/21/16; treated with: Aspirin, ICY HOT Back Patches and Cold Packs.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nodule, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient called 10/17/16 says arm has knot the size of an orange, red, swollen, hot to touch, painful. Pharmacist recommend patient see primary care doctor. And Pharmacist call Dr. for Patient.
Age: 38.0
Sex: U
Vaccine: FLU3
Symptoms: Eye pruritus, Lip swelling, Ocular hyperaemia, Throat tightness
Clinical narrative: Swelling of lips, closing of throat, red, itchy eyes.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt. got vaccine on 10/20 (Thurs.). Friday - she saw redness and swelling along upper arm inside of bicep area. Large area of redness and swelling, seemed abnormal. Saturday - less swelling, seemed to be getting better.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain, Swelling
Clinical narrative: Swelling and pain.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Lethargy, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, aches, soreness in arm, lethargic.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Nausea, Pain, Throat irritation, Tongue discomfort
Clinical narrative: Pt stated 2-3 days after immunization started to develop tongue burning, throat felt raw, trouble breathing, body aches and nausea. Symptoms were progressing. Pt notified pharmacy on 10/24/16.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm swollen/red at injection site x 1 week. Patient went to doctor and received antibiotic.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Red, hot, swollen and sore arm.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Fever, swelling, aches and pain.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: (L) arm swollen, hot to the touch and painful, redness.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site red, hot to touch and sore 2 days post injection. Patient directed to medical professional (clinic or PCP).
Age: 61.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Influenza like illness, Pain in extremity
Clinical narrative: Pt had 3 vaccines administered 10/24/16 in her right arm. Had mild flu like sx and redness; pain in right arm today.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pain lasting longer than a few days, seen at immediate care due to primary care doctor being out of the office, after 2nd wk, received MEDROL dose pack and no pain, completely fine now.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient presented to Emergency Department approximately 5 hours post vaccination with rash. Prescribed BENADRYL 12.5 mg/5m administer 1.5 mL oral/TID x 7 days prn.
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Patient had a febrile seizure within a week after receiving MMR. No prior history. Mom had febrile seizure as infant.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Movement disorder, Pain, Peripheral swelling
Clinical narrative: (L) under arm swollen, not able to close arm down. Pain and fatigue for seven days.
Age: 83.0
Sex: U
Vaccine: FLU3
Symptoms: Contusion, Muscle swelling
Clinical narrative: Big large bruise about 4 inches in diameter. Swelling on muscle.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient has pain in her shoulder and cannot move it. She claims she may have gotten bursitis. She visited her doctor and the doctor said it may have been caused the flu shot. RPh recommended ibuprofen.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Extreme swelling/warmth- injection occurred on 10/12/16 swelling and redness has moved away from inj. Site and is traveling down her arm.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Injection site erythema, Injection site pain, Liver function test increased, Mental status changes
Clinical narrative: Severe redness and pain at site of injection, fever requiring prednisone developed mental status changes, dizziness, hospitalized x 24 hours-neuro workup.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Severe redness and pain at site of injection, fever requiring prednisone developed mental status changes, dizziness, hospitalized x 24 hours-neuro workup.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, Erythema, Limb mass, Pain
Clinical narrative: Patient had a raised, sore, red lump in middle of arm after 1 day after flu shot. Shot was given too low. MD thought possible allergy or cellulitis.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None noted. Client was given high dose influenza vaccine but was not age eligible (63 should have been 65).
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: Right arm swollen, red and painful post flu vaccine received 10/20/16. Affected area 2.5 in x 5 in. Afebrile. Treated with ibuprofen and BENADRYL.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Asthenia, Chills, Decreased appetite, Depressed mood, Diarrhoea
Clinical narrative: Information has been received from a healthcare worker referring to a 45 years old male patient. The patient had no pertinent medial history, drug reactions/allergies nor concomitant medication. On 09-AUG-2016, the patient received the first dose of RECOMBIVAX HB and had no allergic reaction. On 08-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # reported as M033096, expiration date 31-MAY-2018, dose not reported) intramuscularly. On an unknown date in 2016, the patient had allergic reaction to the second dose of RECOMBIVAX HB. No treatment was given for the event. No laboratory test was performed. The outcome of the event was unknown. The causality between RECOMBIVAX HB and the event was not provided. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Full blood count, Impaired work ability, Metabolic function test, Pain, Pruritus
Clinical narrative: Information has been received from a healthcare worker referring to a 45 years old male patient. The patient had no pertinent medial history, drug reactions/allergies nor concomitant medication. On 09-AUG-2016, the patient received the first dose of RECOMBIVAX HB and had no allergic reaction. On 08-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # reported as M033096, expiration date 31-MAY-2018, dose not reported) intramuscularly. On an unknown date in 2016, the patient had allergic reaction to the second dose of RECOMBIVAX HB. No treatment was given for the event. No laboratory test was performed. The outcome of the event was unknown. The causality between RECOMBIVAX HB and the event was not provided. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Information has been received from a healthcare worker referring to a 45 years old male patient. The patient had no pertinent medial history, drug reactions/allergies nor concomitant medication. On 09-AUG-2016, the patient received the first dose of RECOMBIVAX HB and had no allergic reaction. On 08-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # reported as M033096, expiration date 31-MAY-2018, dose not reported) intramuscularly. On an unknown date in 2016, the patient had allergic reaction to the second dose of RECOMBIVAX HB. No treatment was given for the event. No laboratory test was performed. The outcome of the event was unknown. The causality between RECOMBIVAX HB and the event was not provided. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Information has been received from a healthcare worker referring to a 45 years old male patient. The patient had no pertinent medial history, drug reactions/allergies nor concomitant medication. On 09-AUG-2016, the patient received the first dose of RECOMBIVAX HB and had no allergic reaction. On 08-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # reported as M033096, expiration date 31-MAY-2018, dose not reported) intramuscularly. On an unknown date in 2016, the patient had allergic reaction to the second dose of RECOMBIVAX HB. No treatment was given for the event. No laboratory test was performed. The outcome of the event was unknown. The causality between RECOMBIVAX HB and the event was not provided. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Headache, Influenza like illness, Pruritus, Pyrexia, Vision blurred
Clinical narrative: Information has been received from a healthcare worker referring to a 45 years old male patient. The patient had no pertinent medial history, drug reactions/allergies nor concomitant medication. On 09-AUG-2016, the patient received the first dose of RECOMBIVAX HB and had no allergic reaction. On 08-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # reported as M033096, expiration date 31-MAY-2018, dose not reported) intramuscularly. On an unknown date in 2016, the patient had allergic reaction to the second dose of RECOMBIVAX HB. No treatment was given for the event. No laboratory test was performed. The outcome of the event was unknown. The causality between RECOMBIVAX HB and the event was not provided. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Vomiting
Clinical narrative: Information has been received from a healthcare worker referring to a 45 years old male patient. The patient had no pertinent medial history, drug reactions/allergies nor concomitant medication. On 09-AUG-2016, the patient received the first dose of RECOMBIVAX HB and had no allergic reaction. On 08-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # reported as M033096, expiration date 31-MAY-2018, dose not reported) intramuscularly. On an unknown date in 2016, the patient had allergic reaction to the second dose of RECOMBIVAX HB. No treatment was given for the event. No laboratory test was performed. The outcome of the event was unknown. The causality between RECOMBIVAX HB and the event was not provided. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a healthcare worker referring to a 45 years old male patient. The patient had no pertinent medial history, drug reactions/allergies nor concomitant medication. On 09-AUG-2016, the patient received the first dose of RECOMBIVAX HB and had no allergic reaction. On 08-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # reported as M033096, expiration date 31-MAY-2018, dose not reported) intramuscularly. On an unknown date in 2016, the patient had allergic reaction to the second dose of RECOMBIVAX HB. No treatment was given for the event. No laboratory test was performed. The outcome of the event was unknown. The causality between RECOMBIVAX HB and the event was not provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye discharge, Eye swelling, Headache
Clinical narrative: Had chicken pox as child, doctor getting shingles shot to prevent from happening. Well of Sept. 20, 2016, started out with headache and Friday 23, face and top of right side head covered. Went into right eye, swollen, matted.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PNEUMOVAX 23. Administering pharmacist administered in lower tricep area. Unknown if it was IM or SQ admin. After approx. 4 hours pt. noticed extreme redness, swelling and pain. Injection area and approx six inches below. Injection area was hot to touch. *Note-called Merck 9/12/16 to report case #00187376.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Severe pain, swelling (3x size of left arm) inside above and below elbow. Also serious itching, especially in the AM. Incident lasted 10-11 days.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Headache, Swelling face, Tremor
Clinical narrative: Joint pain, headaches, tremors, swollen in the face. Premature birth. Symptoms persist since vaccination.
Age: 20.0
Sex: F
Vaccine: FLUC4, MENB
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Rash pruritic
Clinical narrative: PT developed an itchy rash 2 days after receiving 1st dose of BEXSERO vaccine. She also has arm pain, chills, fatigue, felt feverish.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Tremor
Clinical narrative: I had the shot at 8:30 am. My arm became swollen and red by 1:00 pm. By 1:30 I was shaking violently. It lasted about 30 min. I went to bed and put on extra covers and drank hot tea. I also put ice pack on arm after I stopped shaking. My arm remained swollen for two days. No problems after that.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Urticaria
Clinical narrative: Hives/urticaria of face, arms, legs, and trunk occurring several hours after immunization, and lasting 1 wk. as of today. Treatment included BENADRYL 25 mg daily and prednisone.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 66 year old female patient. The patient's concurrent conditions included hypertension, hypothyroidism and gastrooesophageal reflux disease. The patient's medical history included diverticulitis. The patient did not have any drug reactions or allergies. On 05-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscularly, lot # M022947, expiry date 12-NOV-2017. Concomitant therapies included hydrochlorothiazide, triamterene, MAXALT, ranitidine, senna, levothyroxine sodium (manufacturer unknown), ALLEGRA, CELEXA, omeprazole, MACROBID and spironolactone. On 06-OCT-2016, the patient developed warmth, redness, soreness and swelling from the deltoid to the elbow in the arm where the PNEUMOVAX 23 was administered. No treatment was given for the events and no laboratory diagnostic studies were performed. The reporter stated that the patient sought medical attention due to the events and she was doing better, with just a little soreness at the injection site still. No product quality complaint (PQC) was involved. At the reporting time the patient was recovering from the events. The reporter did not provide a causality assessment between the events and the PNEUMOVAX 23. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 66 year old female patient. The patient's concurrent conditions included hypertension, hypothyroidism and gastrooesophageal reflux disease. The patient's medical history included diverticulitis. The patient did not have any drug reactions or allergies. On 05-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscularly, lot # M022947, expiry date 12-NOV-2017. Concomitant therapies included hydrochlorothiazide, triamterene, MAXALT, ranitidine, senna, levothyroxine sodium (manufacturer unknown), ALLEGRA, CELEXA, omeprazole, MACROBID and spironolactone. On 06-OCT-2016, the patient developed warmth, redness, soreness and swelling from the deltoid to the elbow in the arm where the PNEUMOVAX 23 was administered. No treatment was given for the events and no laboratory diagnostic studies were performed. The reporter stated that the patient sought medical attention due to the events and she was doing better, with just a little soreness at the injection site still. No product quality complaint (PQC) was involved. At the reporting time the patient was recovering from the events. The reporter did not provide a causality assessment between the events and the PNEUMOVAX 23. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: ANTH
Symptoms: Administration site swelling, Administration site warmth, Erythema, Injection site erythema, Pruritus
Clinical narrative: Red, raised and hot at site of administration. Redness and itching between toes and soles of feet and also on palms and webbing of fingers. Symptoms subsided with 25-50 mg diphenhydramine.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm pain-swollen-very itchy-red. Couldn't lift. 10 pm fainted/like seizure.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Arm pain-swollen-very itchy-red. Couldn't lift. 10 pm fainted/like seizure.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Rash, Vaccination complication
Clinical narrative: Adverse reaction: rash patch, red with itchiness. Rx: Triamcinolone 0.1 %: Apply 3 times a day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: 24 hours after receiving vaccine, developed redness, swelling tracking distally from site of vaccination. No fever or vesicular eruption.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Migraine, Panic attack
Clinical narrative: Red, swollen area at site of injection, migraine, panic attack. 4-5 days after.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Lymphadenopathy, Otitis media, Rash, Rash generalised, Rash morbilliform
Clinical narrative: Rash developed entire body. Swollen glands. 3/4-ER treated with Amoxicillin-Otitis Media. 4/8- Developed Rash over face, upper extremity torso, lower extremity palms, not soles (diffuse fine Morbilliform).
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: Rash, itching at bil upper arms and back.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Sore, elevated, erythematous, warm tissue at (R) deltoid injection site.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 3.0
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema
Clinical narrative: Inject site became red.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: Weakness to extremity. Affected ROM w/raising extremity to comb hair. Pain to extremity not improving. Occurred hours after injection and has persisted.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Very sore shoulder and arm-especially at night-constant pain.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis below and behind injection site. Visited MD on 10/21/16 and treated for cellulitis. Prednisone 10 y BID and Doxycycline 100 y BIDx5.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Girl's mom specifies that child was vaccinated on October 15,2016. KINRIX was administered on the right arm. MMR on the left arm. Varicella on the left arm. Around 3:00pm the right arm was swollen, red and hard. Mother applied ice. It looks swollen and warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Father specifies that the boy was vaccinated on Saturday October 25 2016. The 4 year old vaccines were administered. On Sunday morning the right arm was warm to touch, swollen and a little red. Today it looks swollen, red and hot to touch.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dyspepsia, Oesophageal pain, Somnolence
Clinical narrative: Patient complained of drowsiness, heartburn, and esophageal pain. Mother gave daughter TUMS to relieve heartburn.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Fatigue, Malaise, Tendonitis
Clinical narrative: On 11/8/15 pt complained of "not feeling well" since 10/8/15 when she received the second HPV vaccine - 1st HPV 4valent - 2nd HPV 9, and joint pain most painful in knees. 12/31/15 mother states pt reports 2 months of knee pain and fatigue. Ortho diagnosed tendinitis, but mom not sure of dx. No apt ever scheduled for follow up, even though recommended.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm area of swelling and redness, tender. Approx 2"x3" two inches below injection site but not directly at injection site.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills, fever, headache. No treatment. Chills, fever lasted about 8 hrs. Headache lasted 12-14 hrs.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Inflammation, Pain
Clinical narrative: Patient described body/joints hurt. 3 days later felt better but arm down past shot was red and inflamed. Getting better.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Band neutrophil count, Lymphocyte count, Pyrexia, White blood cell count normal
Clinical narrative: Fever 104.8 x 1 day. TYLENOL, IV Fluids x 1L
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Left arm became red and swollen. The arm was also painful. I was given cephalexin 500mg capsule and BENADRYL.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also reported as a nurse) referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot# M022400, expiration date 01-NOV-2017; dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 60 year old female patient. Her medical history, concurrent conditions and concomitant medications were not reported. On 13-OCT-2016, the patient was vaccinated with the dose of ZOSTAVAX (subcutaneously, lot # reported as M0272117, expiration date 26-JUL-2017; dose was not reported). On 15-OCT-2016, the patient developed one large, red, painful welt, which caused her arm to swell and to become inflamed. The patient sought medical attention via speaking to the pharmacist and the pharmacist advised the patient to place ice on the affected area and to take ibuprofen and CLARITIN as needed. The pharmacist did not know if the patient followed her medical advice. None lab diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between the adverse events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 07-SEP-2016 the patient was vaccinated with an improperly stored dose of VAQTA (lot # M009786, expiration date 26-MAY-2017, dose and route were unknown). The vaccine was stored under 48.2F for 32.9 hours. There was no previous temperature excursion. Data logger was involved. The patient had not experienced an adverse effect. No PQC was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient did not have any pertinent medical history, drug reactions and allergies. On an unknown date, the patient was vaccinated with initial dose of GARDASIL (dose and route were not reported) or GARDASIL 9 (dose and route were not reported). No concomitant medications were reported. On an unknown date, the patient experienced headache and nausea. The outcome of headache and nausea was reported as recovering/resolving. The causality was not reported. There was no product quality complaint involved. Additionally information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history and concomitant therapies were reported. On an unknown date, the patient was vaccinated with PROQUAD lot # M007961, expiration date: 15-AUG-2017, therapy type # rHA, subcutaneously in the back of the arm (dose and frequency were not reported) which underwent a temperature excursion. The patient did not experience any adverse event. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L048848, expiry date 09-AUG-2018, dose, dose number, vaccination site, route unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also reported as a nurse) referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot# M025865, expiration date 24-MAY-2018; dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored VAQTA 50/1.0 U/ml (lot # M002268, expiry date 20-SEP-2017, dose, dose number, vaccination site unspecified) intramuscular route. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2016, the patient was vaccinated with the first dose in the GARDASIL series with GARDASIL (dose, route of administration, lot # and expiration date were not reported). On 29-JUL-2016, the patient was vaccinated with the second dose in the GARDASIL series, but the reporter was not sure if it was GARDASIL or GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 18-OCT-216, the patient was vaccinated with the third dose in series with GARDASIL 9 (lot # M018810 with expiration date 28-MAY-2018; dose and route of administration were not reported). The reporter also stated that the dose of GARDASIL 9 was given too early in the series (on an unknown date in 2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recoded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patient received one dose of (wistar ra 27-3) M-M-R II on an unspecified date in 2010. On an unknown date, the patient became pregnant (the date of last menstrual period was not provided). On 04-OCT-2016, the patient was vaccinated with (wistar ra 27-3) M-M-R II injection (dose, route of administrations, lot #, albumin status and expiration date were not reported). The healthcare professional who administered the (wistar ra 27-3) M-M-R II could not be confirmed but it was not the physician listed in this case. The administration of the (wistar ra 27-3) M-M-R II was required by the patient's place of employment. At the time of administration of the (wistar ra 27-3) M-M-R II on 04-OCT-2016, the patient did not know she was pregnant. The patient did not report any adverse effect. The nurse did not supply the patient's specific demographic data. The outcome of the pregnancy was pending. It was reported that no treatment was given and no laboratory diagnostic studies were performed. Additional information has been requested.