chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Erythema, Measles antibody negative, Skin mass, Tenderness
Clinical narrative: I administered a subcutaneous injection of MMR with a 25g 5/8" needle to posterior aspect/triceps area of left arm on 10/26/2016. Patient reported feeling a nodule 2 hours after receiving the vaccine with mild erythema and mild tenderness. She did not report it because she has had subcutaneous nodules before after vaccine administration but they typically only last a week. She came in to see Dr. today because she noticed the nodule was still there. Per Dr. report. Nodule is not visible but palpable and in the subcutaneous tissue. It measures 3 x 3 cm and has a mild area of erythema that measures 5 x 5 cm. Neuromuscular activity intact to left arm. She has full range of motion to that arm with no pain. She expresses mild tenderness with palpation of nodule. Patient is required to have a second MMR vaccine for a health science program. She has no documented history of receiving an MMR vaccine. She had a titer negative for measles. Consulted with CDC and MFR. Both said they would get back to me later today. Will follow up with patient and Dr. after advice from CDC and MFR.
Age: 45.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Nodule
Clinical narrative: I administered a subcutaneous injection of MMR with a 25g 5/8" needle to posterior aspect/triceps area of left arm on 10/26/2016. Patient reported feeling a nodule 2 hours after receiving the vaccine with mild erythema and mild tenderness. She did not report it because she has had subcutaneous nodules before after vaccine administration but they typically only last a week. She came in to see Dr. today because she noticed the nodule was still there. Per Dr. report. Nodule is not visible but palpable and in the subcutaneous tissue. It measures 3 x 3 cm and has a mild area of erythema that measures 5 x 5 cm. Neuromuscular activity intact to left arm. She has full range of motion to that arm with no pain. She expresses mild tenderness with palpation of nodule. Patient is required to have a second MMR vaccine for a health science program. She has no documented history of receiving an MMR vaccine. She had a titer negative for measles. Consulted with CDC and MFR. Both said they would get back to me later today. Will follow up with patient and Dr. after advice from CDC and MFR.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: The day after the shot, the patient reported her arm being swollen, warm, red, and painful.  She reported it started itching on 11/19/2016.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Bursa injury, Drug administered at inappropriate site, Joint injection, Joint range of motion decreased, Pain in extremity
Clinical narrative: As a consequence of the shot, my arm began to hurt very badly. I went to my primary care physician on 9/16/2016 because the pain did not resolve and was worsening. She was confident the shot was inserted too high on my arm and consequently pierced into my bursa sac. Also, as a consequence, I was likely not protected from the flu. She prescribed me Naproxen. On 9/23/2016, I went to see a shoulder surgeon because my arm was worsening. He reaffirmed the shot went into my bursa sac. He gave me an injection of Cortisone and had me come back and see him if the pain did not resolve. On 10/28/2016, I went back to see him because of persistent pain and lack of range of motion (I have not been able to comfortably move my shoulder). At this point in time, he gave me another injection of Cortisone and prescribed physical therapy. I am currently still undergoing this physical therapy.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out 10 minutes after.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Intermittent shooting pains in left arm shoulder to wrist. Continued for 2 months, ongoing although less frequent. TYLENOL, ALEVE Rx.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Acute disseminated encephalomyelitis, Immunoglobulin therapy, Laboratory test, Muscular weakness, Myelitis transverse
Clinical narrative: Acute onset paresthesia, pain, weakness 1/1 of lower extremities. MRI - acute disseminated encephalomyelitis assoc. w/transverse myelitis. Corticosteroids and IVIG.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia
Clinical narrative: Acute onset paresthesia, pain, weakness 1/1 of lower extremities. MRI - acute disseminated encephalomyelitis assoc. w/transverse myelitis. Corticosteroids and IVIG.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Pallor
Clinical narrative: At approximately 416 pm the patient had received 4 vaccines and after the last vaccine the nurse noted the patient became pale, dizzy, and weak. He started leaning toward the left side of the stretcher. Patient's father and the nurse called his name and he responded. The nurse notified the Physician and she came in to the room to assess the patient. Physician ordered Epinephrine 0.3 ml which was given SQ at 424pm. Then she ordered BENADRYL 25 mg IM which was given at 426. IV line, 22 gauge was placed to Left Ae with NS hung at a rate of 60ml/hr at 432pm. Vial signs were as follows: 90/62, 98.20, and pulse ox 99%. Patient states that he was feeling better and denies any dizziness. Physician called hospital ED to inform them she was send patient to the ED. She then called 911 to transport the patient. EMS arrived and patient was stable at the time and report VS - 109/78, 96.18, and pulse ox 99%. Patient was transported to hospital ED and he was stable at that time. RN.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Hypersensitivity, Pruritus, Pyrexia, Swelling
Clinical narrative: Pt reported severe allergic rxn to flu vaccine (hives, itching, fever, spotty swelling and difficulty breathing) for which he sought treatment at medical center on 10/5/16 and 10/10/16. Was treated with prednisone, hydroxyzine and benzonatate. Pt reported this to us at a routine visit on 10/21/16 and reported feeling good at that time.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt reported severe allergic rxn to flu vaccine (hives, itching, fever, spotty swelling and difficulty breathing) for which he sought treatment at medical center on 10/5/16 and 10/10/16. Was treated with prednisone, hydroxyzine and benzonatate. Pt reported this to us at a routine visit on 10/21/16 and reported feeling good at that time.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Body temperature increased, Irritability
Clinical narrative: Fussy x2 hours after imms. Temp 100.7. No redness at site.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Chills, Fatigue, Full blood count normal
Clinical narrative: Initially had flu like symptoms-myalgia, chills, fatigue. Now after  month had persistent right arm pain, soreness, fatigue (arm) and arm weakness.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Initially had flu like symptoms-myalgia, chills, fatigue. Now after  month had persistent right arm pain, soreness, fatigue (arm) and arm weakness.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Hypersensitivity, Vaccination complication, Wheezing
Clinical narrative: 28 YO female with PMH Asthma, environmental allergies, pregnancy. Patient at appointment with PCP received immunization with flu vaccine on 9/19. Patient reports waking from her sleep because she was unable to breathe. Patient noted to have developed cough and wheezing several hours after the flu shot- which worsened overnight. Patient went to the ER. Patient had persistent SOB/wheezing and used her albuterol inhaler and did okay. Next day patient reported feeling fine to PCP. Patient told this was an allergic reaction to the flu shot and she should never receive it again.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Feeling hot, Gait disturbance, Injected limb mobility decreased, Injection site pain
Clinical narrative: Upper left arm in area of injection was very sore and warm. I felt very warm (did not check to see if I had a fever) and had a scratchy throat. I took one 500mg acetaminophen before bed. Next day arm not as sore but throat still scratchy. Gargled w/mouthwash before bed. 10/12/16 could barely move my left upper arm since I was in such extreme pain in that arm that I could only move my lower arm as high as my waist. I used ice packs intermittently and took one acetaminophen in the morning and one before bed for 3 days with some improvement in mobility of my left upper arm after two days. Improvement continued each day and by day six 10/17/16 of this event. I had very good mobility in my left arm with only slight discomfort. On 10/19/16 I again could barely move my left arm without extreme pain. I used ice intermittently and had x-rays on 10/20/16 after calling my Dr's office. I had spoken with them twice during the week when this limited mobility of my left arm first began. 11/2/16 I had a lot of soreness in my left hip bone joint. This began approximately 11:00 am and I began experiencing difficulty walking due to extreme pain in my hip (left). By about 6pm that night I had to use a cane to walk and still had extreme pain in my left hip. The next day I was much better however about 3 days later I experienced pain in my right hip but have had no difficulty walking. I still have pain in my right hip.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Limb discomfort, Pain, Pain in extremity, Throat irritation
Clinical narrative: Upper left arm in area of injection was very sore and warm. I felt very warm (did not check to see if I had a fever) and had a scratchy throat. I took one 500mg acetaminophen before bed. Next day arm not as sore but throat still scratchy. Gargled w/mouthwash before bed. 10/12/16 could barely move my left upper arm since I was in such extreme pain in that arm that I could only move my lower arm as high as my waist. I used ice packs intermittently and took one acetaminophen in the morning and one before bed for 3 days with some improvement in mobility of my left upper arm after two days. Improvement continued each day and by day six 10/17/16 of this event. I had very good mobility in my left arm with only slight discomfort. On 10/19/16 I again could barely move my left arm without extreme pain. I used ice intermittently and had x-rays on 10/20/16 after calling my Dr's office. I had spoken with them twice during the week when this limited mobility of my left arm first began. 11/2/16 I had a lot of soreness in my left hip bone joint. This began approximately 11:00 am and I began experiencing difficulty walking due to extreme pain in my hip (left). By about 6pm that night I had to use a cane to walk and still had extreme pain in my left hip. The next day I was much better however about 3 days later I experienced pain in my right hip but have had no difficulty walking. I still have pain in my right hip.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Walking aid user, X-ray limb abnormal
Clinical narrative: Upper left arm in area of injection was very sore and warm. I felt very warm (did not check to see if I had a fever) and had a scratchy throat. I took one 500mg acetaminophen before bed. Next day arm not as sore but throat still scratchy. Gargled w/mouthwash before bed. 10/12/16 could barely move my left upper arm since I was in such extreme pain in that arm that I could only move my lower arm as high as my waist. I used ice packs intermittently and took one acetaminophen in the morning and one before bed for 3 days with some improvement in mobility of my left upper arm after two days. Improvement continued each day and by day six 10/17/16 of this event. I had very good mobility in my left arm with only slight discomfort. On 10/19/16 I again could barely move my left arm without extreme pain. I used ice intermittently and had x-rays on 10/20/16 after calling my Dr's office. I had spoken with them twice during the week when this limited mobility of my left arm first began. 11/2/16 I had a lot of soreness in my left hip bone joint. This began approximately 11:00 am and I began experiencing difficulty walking due to extreme pain in my hip (left). By about 6pm that night I had to use a cane to walk and still had extreme pain in my left hip. The next day I was much better however about 3 days later I experienced pain in my right hip but have had no difficulty walking. I still have pain in my right hip.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea
Clinical narrative: I received the FLUZONE HIGH DOSE vaccine at around 1pm and at 5pm I had shortness of breath for five hours. Also I had some chills, and had to use my VENTOLIN inhaler about 8 times to breathe. It cleared up around 1 am.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: Started with (L) upper arm, shoulder anteriorly, and base of (L) neck redness 11/16/16. Today, redness is spreading that has pain in (L) shoulder/upper arm. Is afebrile. Treated with Rx: Ibuprofen 800mg TID, and Ceftriaxone sodium injection 1GM IM, KEFLEX 500mg every 6 hours times 7 days. Decreased redness x 50% - No pain 11/21/16.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a high dose flu vaccine in error. No complaint of symptoms or treatment needed on follow-up.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: Approximately one minute after receiving flu vaccine, pt asked if he could sit down again, became light-headed, and collapsed to the ground in stages. Within moments of lying flat the pt rose and sat down for several minutes. Glass of filtered water given.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein normal, Full blood count normal, Rash
Clinical narrative: Pt received inj 9/20/16 within a hour had a rash on arms, legs and neck - had OV on 9/21/16 - Dr. prescribed MEDROL Dose pak and 1.0 ml inj of DEPO-MEDROL, 9/26/16 OV - rash spreading, gave prednisone 5 mg 3 tabs once daily, OV - 10/3/16 still had rash - 10/20/16 OV - rash improving.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Patient received the flu shot in the right arm am 11-19-16. She returned the next morning (11-20-16) complaining of right shoulder soreness/pain. She also states pain/numbness in shoulder, under pit area and chest.
Age: 68.0
Sex: U
Vaccine: FLU4, PNC13
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash surrounding site of PREVNAR vac and itchy.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Swollen tongue, Urticaria
Clinical narrative: Patient broke out in hives a couple hours after vaccine. Nothing else changed or different for her. BENADRYL helped for a couple of days. On 11/18, felt tongue/throat swelling so went to ER. Starting steroids on 11/19.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Body temperature increased, Feeling abnormal, Feeling cold, Headache
Clinical narrative: 10-22- Felt off. 10-23- 48 hours after vacc started shaking violently-very cold-lasted 2 hours. Temp 103.3. TYLENOL bought temp down into 100-101. Severe headache-couldn't work, even read or watch TV. Sick for 7 days.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Tremor
Clinical narrative: 10-22- Felt off. 10-23- 48 hours after vacc started shaking violently-very cold-lasted 2 hours. Temp 103.3. TYLENOL bought temp down into 100-101. Severe headache-couldn't work, even read or watch TV. Sick for 7 days.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a High Dose Flu vaccine in error. No symptoms or treatment sought from primary physician office in follow-up.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient contacted us on 11-17-16 to inform us she is still having soreness/painful arm after receiving flu vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: On 11/14/16 patient called Emp Health to report that she got a flu shot in her (L) arm on 10/25/16 and that her arm has hurt ever since. She states that it's hard to get dressed and undressed since the muscle where the vaccine was given is so painful. I instructed her to see her healthcare provider and compete incident report.
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Malaise, Syncope, Unresponsive to stimuli
Clinical narrative: Pt. was given vaccine while sitting on exam table, band aid applied. Was standing by mom and talking minutes later, fell to knees and forward syncope. Unresponsive app. 10 sec. then awake but scared. No injury. Older sibling then C/O not feeling well after that. Observed x 15 min.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Received flu shot (L) at lateral thigh. Noted moderate diffuse swelling over injection site area 12 cm x 7 cm. No redness, no sign of infection.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: Patient arrived with 10cm diameter red area on upper bicep. Complained of area being tender, red, and hot to the touch. Pt reported the area itched slightly prior to turning hot and red.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Rec'd flu vaccine on 11-2-16. Morning of 11-3-16 child woke up with a raised red rash on chest, stomach, and back C/O itching. Went to school (dad works at school) gave him BENADRYL - rash became more red. Went to doctors office saw NP at 0945. NP told parent it was related to flu vaccine and recommended he not get flu vaccine again but it would be up to parents. Update: This afternoon child started having a fever. 11-4-16 Left message on both parents phone to call. No call. Obtained information from school nurse.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Second day, red rash, chest, back and sides 1-week. Caladryl-several time a day.
Age: 0.58
Sex: F
Vaccine: DTAPIPV, FLU4, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Induration, Musculoskeletal pain
Clinical narrative: Patient experienced soreness, redness over a large area of right shoulder over 6 days. Induration.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: Local pain injection site. Increasing local muscle pain next day. Pain moving up arm into deltoid and now shoulder and neck. Injection administration 11/2/2016. Reports redness over Rt perispinal area, ongoing discomfort "as if hurt neck". No limitation.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity, Tenderness
Clinical narrative: Local pain injection site. Increasing local muscle pain next day. Pain moving up arm into deltoid and now shoulder and neck. Injection administration 11/2/2016. Reports redness over Rt perispinal area, ongoing discomfort "as if hurt neck". No limitation.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: The day after his flu shot he started to get a headache and diarrhea. Left arm red and swollen around injection site and improvement with BENADRYL. Tx with KEFLEX for cellulitis.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache
Clinical narrative: Patient got FLUZONE HD 11/15/2016. Patient called pharmacy 11/16/16 to report she had diarrhea, dizziness and headache. Patient wanted the egg free vaccine, but instead got FLUZONE HD.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Urticaria
Clinical narrative: Right after receiving HAV, DTaP and Influenza vaccine hives on face and arm. Epinephrine 0.15mg IM given at 12:15pm. EMT called in. Mom refused to go to ER. Mom took him to PCP.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis (R) upper arm 4"x6". Pt seen 11/9/16 in office. He was Rx'd Cephalexin. On 11/18 mom reported child was well and cellulitis completely cleared.
Age: 57.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation
Clinical narrative: Patient states injection site reaction with redness, inflammation and bruising. MD treated with steroids and believes reaction was from BOOSTRIX injection.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dyspnoea, Heart rate increased, Injection site pain
Clinical narrative: Approx 6:00 pm - difficulty breathing, fast heartbeat - fever-chills,  able to breath better in 1-2 minutes. Painful shot site - left arm. Felt ill and weakness for 5-6 days. Never had reaction before.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: Approx 6:00 pm - difficulty breathing, fast heartbeat - fever-chills,  able to breath better in 1-2 minutes. Painful shot site - left arm. Felt ill and weakness for 5-6 days. Never had reaction before.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Diarrhoea, Facial pain, Facial paralysis, Facial paresis, Respiratory tract congestion
Clinical narrative: Bell's Palsy - pain on right side of face with weakness, congestion, loose stools.
Age: 66.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Flu vaccine administered on 10/21/16. Patient still has soreness of arm. Tingling and numbness in hand and fingers.
Age: 66.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Hypoaesthesia, Injection site pain, Myalgia, Paraesthesia
Clinical narrative: Flu vaccine administered on 10/21/16. Patient still has soreness of arm. Tingling and numbness in hand and fingers.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Bruising noted to injection site Pt stated initially site was red and hot.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Rec'd vaccination 11/14/16 left deltoid, on 11/15/16, front of left arm (not deltoid where vax was rec'd) raised, red, warm to touch - patient says it's itchy, but is solid and extends from just underneath the shoulder to the inner elbow of Left arm. Injection site is not affected.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Head discomfort, Headache, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: 11/20/16 Headache, pressure, sick to stomach, achy, Rt arm hurts, red, swollen at site. 11/21/16 slept all day/lethargic, achy. -
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: 11/20/16 Headache, pressure, sick to stomach, achy, Rt arm hurts, red, swollen at site. 11/21/16 slept all day/lethargic, achy. -
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of site where MENACTRA and TDaP given Right arm.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site induration
Clinical narrative: Patient is a 16 month old male had immunizations in both legs a few days ago. The right thigh has cellulitis and induration. I prescribed antibiotics and a cream.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin reaction
Clinical narrative: Swollen, red arm for 12 hours iced, ibuprofen and diphenhydramine.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Swelling at arm.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Influenza, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt developed flu symptoms (chills, fever, shaking) and red/swelling at injection site since 11/16/16 - Pt got both FLUZONE HD and PNEUMOVAX 23 on same left arm - As of 11/19/16 flu-like symptoms get better, just redness at injection site.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Pt developed flu symptoms (chills, fever, shaking) and red/swelling at injection site since 11/16/16 - Pt got both FLUZONE HD and PNEUMOVAX 23 on same left arm - As of 11/19/16 flu-like symptoms get better, just redness at injection site.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Low grade fever and chills night of vaccine (lasted a few hours).
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Mobility decreased
Clinical narrative: Received vaccine on 10/21/2016 approximately 6:30pm. Instantly felt pain at injection site which radiated to (L) shoulder and upper back. Experienced HA for first week and could not lift arm. Treated by physician w/cortisone shot, NSAID TX.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV9, MNQ
Symptoms: Abdominal pain, C-reactive protein increased, Nausea, Pain, Platelet count decreased
Clinical narrative: Fever, body aches, chills, nausea, abd pain -lasting 2 days and starting 6 hrs post vaccines.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV9, MNQ
Symptoms: Pyrexia, White blood cell count normal
Clinical narrative: Fever, body aches, chills, nausea, abd pain -lasting 2 days and starting 6 hrs post vaccines.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV9, MNQ
Symptoms: Abdominal pain, Chills, Full blood count normal, Nausea, Pain
Clinical narrative: Fever, body aches, chills, nausea, abd pain -lasting 2 days and starting 6 hrs post vaccines.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV9, MNQ
Symptoms: Platelet count decreased, Pyrexia
Clinical narrative: Fever, body aches, chills, nausea, abd pain -lasting 2 days and starting 6 hrs post vaccines.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Itchy rash and swollen/tender arm.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Rash pruritic, Tenderness
Clinical narrative: Itchy rash and swollen/tender arm.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 14 years old female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 01-AUG-2013, the patient was administered with a dose of GARDASIL (dosing details not reported). The patient also received a dose of GARDASIL 9 on 11-SEP-2015 and a dose of GARDASIL 9 on 10-NOV-2016. No adverse effects were reported. No product quality complaint was involved. This is one of the two reports: 1611USA006730 (same reporter link). Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unknown number of patients of unknown age and gender. On an unknown dates in 2016, reported as since August 2016, the patients were inadvertently vaccinated with doses of ROTATEQ lot # M004883, expiration date 02-OCT-2017, expiration date 30-MAY-2018 that had been improperly stored. No adverse event was reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 30 minutes. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent to contact a healthcare professional.
Sex: U
Vaccine: HEPAB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patients medical history, concurrent condition and concomitant medication were unknown. In 2008, the patient was vaccinated with the first dose of VAQTA (dose and route unknown). On 28-OCT-2016, the patient mistakenly received a dose of TWINRIX (dose and route unknown) as the 2nd dose  in the Hepatitis A series, this was outside the recommendations per the VAQTA prescribing information. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, 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 was not reported. On 11-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L027322, expiration date 21-OCT-2016 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history included celiac disease. The patient had no drug reactions/allergies. Concomitant medication was unknown. On 10-NOV-2016, the patient was vaccinated with (Oka/Merck) VARIVAX (lot # M023384, expiration date 11-MAY-2018; dose and route were unknown. On 11-NOV-2016, the patient experienced injection site redness, warm to touch and felt hard. Also, the pharmacist stated that the patient stated that the diameter of the injection site looked like it was getting larger by the day. The patient went to Urgent Care on 12-NOV-2016 and was given antibiotics as a treatment for the adverse effects. The outcome of the events was reported as not recovered. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # M025193, expiration date 21-MAR-2019, (dose number, route and anatomical location of administration were unknown). The temperature of excursion was 51 F for 30 minutes. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant therapies were not reported. In 2013, the patient was vaccinated with the first pediatric dose of VAQTA 0.5 ml at the age of 16 years old, then in approximately 2016, the patient was vaccinated with the second pediatric dose of VAQTA 0.5 ml at the age of 19 years old (route, anatomical location, lot number and expiration date were not reported for the above described vaccines). No adverse effects reported. (Drug administered to patient of inappropriate age and inappropriate schedule of drug administration). Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Received a Shingles shot last year with no side effects. This year I received a flu shot and within 10 days I developed a case of Shingles. I am a healthy 75 yr old female and do not believe this was a coincidence but rather a catalyst that awakened the virus that was introduced with shingles shot. I have had flu shots for the past 20 yrs with no reactions. After suspecting this is what occurred, I found many people that have experienced this exact scenario on the internet. I am now truly wary of ever getting another flu shot and am still suffering much pain from this case of shingles after 3 weeks. I was treated with an antiviral and still taking Neurontin. I think this may be a serious problem for people being advised to get a Shingles shot and flu shot.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L040054, expiration date 26-DEC-2017, intramuscular, dose unknown). The vaccines were stored under the temperature of 37 centigrade for 4 hours. There was no previous temperature excursion. No adverse effects were reported. The call was because of a data logger. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to her daughter who is a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date the patient was vaccinated with varicella vaccine (manufacturer unknown) (dose, route and lot number not reported). On an unknown date, the patient experienced chicken pox. The outcome of varicella was unknown. Causality assessment was not provided. The patient was vaccinated with rubella (manufacturer unknown) during childhood and showed negative titer (Reported in MARRS # 1611USA009930) and the patient also showed negative titers for hepatitis B (manufacturer unknown) (reported in MARRS# 1611USA009931). Subsequently, the patient was vaccinated with GARDASIL and experienced adverse events (reports in MARRS # 1611USA008442). Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to her daughter who is a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown) vaccine (dose, route and lot # not reported). The reporter stated that on an unknown date, the patient had titers drawn for Hepatitis B for nursing program and result was negative for hepatitis B (Vaccination failure) despite being vaccinated for it during childhood. The outcome of event and causality assessment was not given. The patient was vaccinated with varicella vaccine (manufacturer unknown) during childhood and experienced chickenpox (Reported in MARRS # 1611USA009929) and patient also showed negative titers for rubella (manufacturer unknown) (reported in MARRS # 1611USA009930). Subsequently, the patient was vaccinated with GARDASIL and experienced adverse events (reported in MARRS # 1611USA008442). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer sales employee (reference number 2016505520), referring to a patient of unknown age and gender. Concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown date, the patient was vaccinated with PNEUMOVAX and the reporter stated that on unknown date the patient received PREVNAR 13 (manufacturer Pfizer) (formulation, concentration, dose, frequency, route, lot number and expiration date were not reported). On unknown date, after the vaccination with PNEUMOVAX the patient experienced cellulitis and when the patient was given PREVNAR 13 the patient also had cellulitis after a few days. At the time of the report, the outcome of the event was unknown. A product quality complaint was not involved. The pharmacist stated that cellulitis was a result of vaccination with PNEUMOVAX and PREVNAR 13 was unknown. Upon internal review the cellulitis was considered to be medical significant. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to her daughter who is female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with rubella vaccine (manufacturer unknown) (This case is created for M-M-R II) since Merck product could not be ruled out). On an unknown date, the patient had titers drawn for rubella (manufacturer unknown) for nursing program and result was negative despite having being vaccinated for it during the childhood. The outcome of event and causality assessment was not reported. The patient was vaccinated with varicella vaccine (manufacturer unknown) during childhood and experienced chickenpox (Reported in MARRS # 1611USA009929) and patient also showed negative titers for hepatitis B (manufacturer unknown) (reported in MARRS # 1611USA009931). Subsequently, the patient was vaccinated with GARDASIL and experienced adverse events (reported in MARRS # 1611USA008442). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Neurological symptom
Clinical narrative: This spontaneous report as received from a health care worker via company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, several years ago, the patient was vaccinated with GARDASIL, (dosing details not provided). On an unknown date, the patient experienced unspecified neurological symptoms after receiving the unspecified doses on unspecified dates. Outcome of the event and the causality were not reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not give consent for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 08-NOV-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX, 0.5 ml, lot # M023380, expiry date 11-MAY-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 36 degrees Fahrenheit 43 days. There was no previous temperature excursion. Data logger was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 lot # M013636 with expiration date: 15-FEB-2018 (dose and route of administration were not reported) that was not delivered on time to the office. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. On 26-OCT-2016 phone call to certified medical assistant who clarified four patients were administered improperly stored GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with GARDASIL or with GARDASIL 9 (unidentified Merck hpv vaccine administered; lot #, expiry date, dose, route of administration and anatomical location were not reported). On an unknown date, following the administration of unidentified Merck hpv vaccine, the patient experienced syncope. The outcome of syncope was unknown. The relatedness between the event of syncope and unidentified Merck hpy vaccine was not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a male patient of unknown age. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 10-OCT-2016, the patient was vaccinated intramuscularly with an improperly stored dose of PNEUMOVAX 23 injection (lot # L017265 with expiry date on 10-FEB-2017 or lot # L040456 with expiry date on 10-MAY-2017 (it was unspecified which lot # was administered) (dose and anatomical location were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 01-NOV-2016, the patient was vaccinated intramuscularly with an improperly stored dose of PNEUMOVAX 23 injection (lot # L017265 with expiry date on 10-FEB-2017 or lot # L040456 with expiry date on 10-MAY_2017 (it was unspecified which lot # was administered) (dose and anatomical location were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unknown number of patients of unknown age and gender. On an unknown dates in 2016, reported as since August 2016, the patients were inadvertently vaccinated with doses of PEDVAXHIB lot # M010439, expiration date 08-DEC-2018 that had been improperly stored. No adverse event was reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 30 minutes. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent to contact a healthcare professional.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unknown number of patients of unknown age and gender. On an unknown dates in 2016, reported as since August 2016, the patients were inadvertently vaccinated with GARDASIL 9 lot # M017983, expiration date 30-MAY-2018 that had been improperly stored. No adverse event was reported. Administered doses of vaccines experienced the temperature of 32 degrees Fahrenheit for 30 minutes. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent to contact a healthcare professional.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 26 infant patients of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates between 01-JAN-2014 and 27-OCT-2016, the patients were vaccinated with three doses of RECOMBIVAX HB injection, intramuscularly (lot # and dose were not provided) in following schedule: first dose at 0 months, second dose at 2 months and third dose at 4 months. There were no adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a currently 39-year-old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot number and expiry date were not reported). No concomitant therapy was reported. On an unknown date, titers drawn with blood work showed no immunity measles, mumps, and rubella. On an unknown date, the patient received another dose of M-M-R II. The patient's outcome was not reported. Relatedness between the adverse events and the vaccination with M-M-R II was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Diarrhoea, Injection site erythema, Injection site pain
Clinical narrative: 53 y/o F with a PMH of IDDM, alpha-thalassemia, hypothyroidism, sinusitis, mitral regurgitation, dyslipidemia, and obesity presented to PCP for follow up visit. Patient's listed allergies included penicillin, sulfa antibiotics, and TDaP. Patient was administered PREVNAR 13 at the office. Patient went home and developed significant erythema, swelling, pain, and warmth at injection site. Patient also reported elevated temperature (99.5 degrees F), shivering, and diarrhea. Patient called two days after the vaccination to report the reaction. Patient was instructed to use cold compresses and acetaminophen to self-treat. Patient retuned for a follow up visit 6 days after vaccination. Reaction was resolving and patient was instructed to continue.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 53 y/o F with a PMH of IDDM, alpha-thalassemia, hypothyroidism, sinusitis, mitral regurgitation, dyslipidemia, and obesity presented to PCP for follow up visit. Patient's listed allergies included penicillin, sulfa antibiotics, and TDaP. Patient was administered PREVNAR 13 at the office. Patient went home and developed significant erythema, swelling, pain, and warmth at injection site. Patient also reported elevated temperature (99.5 degrees F), shivering, and diarrhea. Patient called two days after the vaccination to report the reaction. Patient was instructed to use cold compresses and acetaminophen to self-treat. Patient retuned for a follow up visit 6 days after vaccination. Reaction was resolving and patient was instructed to continue.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 27-OCT-2016 from a pharmacy intern. It was reported that on 26-OCT-2016 a male patient (age unknown) was vaccinated with a dose of PNEUMOVAX 23 (lot #L003188, exp. 06-JUL-2016) that was expired. No adverse event was reported. Vaccine was properly stored prior to administration. No other information was provided. No further information to report. Additional information has been requested.