chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: FLU4, HEPA, MNQ, TDAP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccines 10/23/13 (see below) and on 10/24/13 right arm had increased redness, warmth, swelling. Pt. very fatigued. Seen in office 10/25/13 at 1440, right deltoid with 6 cm diameter area of redness, mild swelling and warmth. Mom states it is improving.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV4, MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm, size is about 3 inches oval in right arm.
Age: 1.4
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: 12 mths vaccines where repeated instead of 15 mths.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Redness, soreness, and swelling at injection site. 10/25 1:19 PM: Pt's mother called stating the night after she received her shots, Pt had a rash on her thigh around the injection site, and mother was concerned and took Pt to the ER around 9:00 PM. Physician said it was probably from the band-aid. Mother stated the rash has gone away but Pt has a red, warm, lump about the size of a 50 cent piece at the injection site. Mother has tried to cool wet wash cloth and hydrocortisone cream, but they have not helped. CR informed of  mothers reported and Pt received MMRV vaccine in that thigh. Per CR, give Pt ibuprofen per size and weight and apply ice with clothe in-between, if the area does not start to get better or gets worse to come in tomorrow for Saturday Clinic. Mother verbalized understanding and agreed to call with any further questions.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Redness, soreness, and swelling at injection site. 10/25 1:19 PM: Pt's mother called stating the night after she received her shots, Pt had a rash on her thigh around the injection site, and mother was concerned and took Pt to the ER around 9:00 PM. Physician said it was probably from the band-aid. Mother stated the rash has gone away but Pt has a red, warm, lump about the size of a 50 cent piece at the injection site. Mother has tried to cool wet wash cloth and hydrocortisone cream, but they have not helped. CR informed of  mothers reported and Pt received MMRV vaccine in that thigh. Per CR, give Pt ibuprofen per size and weight and apply ice with clothe in-between, if the area does not start to get better or gets worse to come in tomorrow for Saturday Clinic. Mother verbalized understanding and agreed to call with any further questions.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Oral discomfort, Rash
Clinical narrative: Rash and swelling of arm. Mouth "feels funny".
Sex: U
Vaccine: FLU3, PPV, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Ultrasound scan normal
Clinical narrative: Left upper arm pain occurring immediately after vaccine given. Now persisting > 3 weeks with severe radiating pain. U/S (-) for DVT. Tried NORCO, naproxen, LIDODERM patch, LYRICA, MEDROL with little relief.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient mother upset about pharmacy's billing process (new pharmacist wasn't aware that certain insurance was covered) mother mentioned pain the arm of the patient.
Age: 95.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis in arm given. Given cephalexin for treatment.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: Soreness down entire arm, hard lump at injection site. Lasting > 4 wks.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Erythema, Pruritus, Rash
Clinical narrative: Patient came in 10-16-13 she said she had a rash in a different spots arms and legs with a blister in the center she said red and itchy. She was seeing her PCP the next day. PCP said it was from Flu shot. Pt called me on 10/17/13 to let me know this.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness/warmth/itching around the injection site of Boostrix.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site urticaria, Rash, Urticaria
Clinical narrative: Rash/hives in and around site of injection from flu vaccine on upper left arm and wrist.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Electrocardiogram normal, Heart rate increased, Hyperhidrosis, Swelling face
Clinical narrative: Pt reported feeling lightheaded, diaphoretic with an elevated HR, about 20 minutes after vaccine administration. Pt received the Tdap (Sanofi Pasteur). HR 120 by palpation. Doctor present, took pt to downstairs doctor's office - EKG completed. No rash, no throat, no tongue, facial swelling. 1500 BENADRYL 50mg PO per Dr.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 21-OCT-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (Lot # J001729, expiration date 20-OCT-2013) subcutaneously. No adverse effect was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Pain, Pyrexia, Sluggishness
Clinical narrative: Admits to fever of 101'F, chills, sluggish, headache, and body aches. Denies rash and difficulty breathing.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Skin warm, Swelling
Clinical narrative: Received shot in upper arm. From about 1 hour after shot, swelling began. The swelling is now approximately 3 in. in diameter, is red, painful to touch, and hot. It has slowly gotten larger since it began. Last night, the lymph nodes above my clavicle became swollen and very painful.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Received shot in upper arm. From about 1 hour after shot, swelling began. The swelling is now approximately 3 in. in diameter, is red, painful to touch, and hot. It has slowly gotten larger since it began. Last night, the lymph nodes above my clavicle became swollen and very painful.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Lymph node pain, Lymphadenopathy
Clinical narrative: Vaccinated in left arm.  Left armpit became red and sensitive and inflamed. Flu vaccination was Sanofi.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Dyspnoea, Electrocardiogram abnormal, Exposure during pregnancy
Clinical narrative: Woke up with nausea and a stomachache. Later also developed chills and body aches. I also had some shortness of breath, but this has been ongoing for the past 2 months of my pregnancy so probably wasn't related. Left work early at 4pm due to the body aches, nausea, and chills (was supposed to work until 7:30 pm). At 4:30, I developed a fever up to 100.9F. I took acetaminophen at home. I called on call physician whom I heard back from at 6:30pm. She advised me to go to the ED to evaluate the fever. At ED, where I was for almost 5 hours, I had vital signs checked, a CBC drawn, a flu swab sent, and a urinalysis sent. All were within normal limits according to staff. I was discharged home from the ED, and the physician felt it could have been a viral illness or perhaps a side effect from the TDAP vaccine the day prior. On 10/24/13, I developed increased swelling at the injection site also.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Foetal monitoring normal, Full blood count normal, Influenza virus test negative, Injection site swelling, Nausea
Clinical narrative: Woke up with nausea and a stomachache. Later also developed chills and body aches. I also had some shortness of breath, but this has been ongoing for the past 2 months of my pregnancy so probably wasn't related. Left work early at 4pm due to the body aches, nausea, and chills (was supposed to work until 7:30 pm). At 4:30, I developed a fever up to 100.9F. I took acetaminophen at home. I called on call physician whom I heard back from at 6:30pm. She advised me to go to the ED to evaluate the fever. At ED, where I was for almost 5 hours, I had vital signs checked, a CBC drawn, a flu swab sent, and a urinalysis sent. All were within normal limits according to staff. I was discharged home from the ED, and the physician felt it could have been a viral illness or perhaps a side effect from the TDAP vaccine the day prior. On 10/24/13, I developed increased swelling at the injection site also.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Sinus tachycardia, Urine analysis normal
Clinical narrative: Woke up with nausea and a stomachache. Later also developed chills and body aches. I also had some shortness of breath, but this has been ongoing for the past 2 months of my pregnancy so probably wasn't related. Left work early at 4pm due to the body aches, nausea, and chills (was supposed to work until 7:30 pm). At 4:30, I developed a fever up to 100.9F. I took acetaminophen at home. I called on call physician whom I heard back from at 6:30pm. She advised me to go to the ED to evaluate the fever. At ED, where I was for almost 5 hours, I had vital signs checked, a CBC drawn, a flu swab sent, and a urinalysis sent. All were within normal limits according to staff. I was discharged home from the ED, and the physician felt it could have been a viral illness or perhaps a side effect from the TDAP vaccine the day prior. On 10/24/13, I developed increased swelling at the injection site also.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site pain, Chills, Fatigue, Headache, Malaise
Clinical narrative: Rigors, fever, headache, body aches, nausea, (rigors & fever, nausea duration four hours) malaise, body aches, fatigue continues but more mild. Local pain at administration site two days.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Rigors, fever, headache, body aches, nausea, (rigors & fever, nausea duration four hours) malaise, body aches, fatigue continues but more mild. Local pain at administration site two days.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Faeces discoloured, Malaise, Transfusion
Clinical narrative: Pt states that he felt "sick and had very dark stools.  He went to the hospital and had to get blood transfusions.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Depressed level of consciousness, Disturbance in attention, Dizziness, Dyspnoea, Dysstasia
Clinical narrative: Very lightheaded and dizzy. Became extremely pale and hot.  Felt like I was going to pass out.  Hard to stand or talk and could not focus. Heart felt like it was pounding and I remember when I made it home and got in bed I was breathing really hard and fast right before I fell asleep.  That was around 4 PM.  Slept for most of the evening and was feeling much better the next morning.  My coworkers kept telling me how pale I was.  And I remember feeling very hot and sick to my stomach if I tried to talk or listen to someone talk.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Nausea, Pallor, Palpitations, Respiratory rate increased
Clinical narrative: Very lightheaded and dizzy. Became extremely pale and hot.  Felt like I was going to pass out.  Hard to stand or talk and could not focus. Heart felt like it was pounding and I remember when I made it home and got in bed I was breathing really hard and fast right before I fell asleep.  That was around 4 PM.  Slept for most of the evening and was feeling much better the next morning.  My coworkers kept telling me how pale I was.  And I remember feeling very hot and sick to my stomach if I tried to talk or listen to someone talk.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Influenza like illness, Injection site bruising, Injection site haemorrhage, Malaise
Clinical narrative: I rec'd a flu shot the afternoon of the 17th. By the afternoon of the 19th I was feeling flu symptoms and I became really sick over the next few days. It has been 8 days and I am just now feeling a little better. I missed 3 days of work. My arm bled a lot when the technician injected me and the bruise was very dark.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Ocular hyperaemia, Ophthalmological examination
Clinical narrative: Red Eye--left side of left eye was red.  Examined by eye physician.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At injection site: raised swelling, pain, hot to the touch. Margins about 2.5 inches in diameter. Tiredness. Even with premedication with diphenhydramine.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Swelling to L arm from shoulder to above L elbow with pain, redness, swelling, warmth, induration and tight shiny appearance noted the morning after 2013 quadrivalent flu vax was given. Patient's first IM flu vax. Previous years received Flu Mist. Pictures available on request. Redness, pain, warmth and swelling increased the next day. PT was evaluated by MD, given oral prednisone to try for 24hr then to follow with Keflex if redness spread. Redness has increased and extended beyond margins from 11:30 am appt to 3:30pm.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Swelling to L arm from shoulder to above L elbow with pain, redness, swelling, warmth, induration and tight shiny appearance noted the morning after 2013 quadrivalent flu vax was given. Patient's first IM flu vax. Previous years received Flu Mist. Pictures available on request. Redness, pain, warmth and swelling increased the next day. PT was evaluated by MD, given oral prednisone to try for 24hr then to follow with Keflex if redness spread. Redness has increased and extended beyond margins from 11:30 am appt to 3:30pm.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chest pain, Herpes zoster
Clinical narrative: Severe pain, chest.  By Friday, 10/18/2013, blisters appeared on chest, left side, and back.  Diagnosed as shingles.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthma
Clinical narrative: Pt took nap and woke up feeling as if she was having and asthma attack. Felt better after she got up. Then came to pharm to report.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Child pulled away from the needle while injecting.  It appeared that some of the flu vaccine may have entered the subcutaneous space.  Area around injection became red.  Child kept rubbing the area.  The mother asked the child to stop rubbing so as to see the extent of the redness, but it was difficult to tell.  The mother said she would keep an eye on it.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Pain in extremity, Vaccination site pain
Clinical narrative: Arm where vacine was administered started to become slightly red, tender, achy and itchy late on Tuesday, but it was easy to ignore until Thursday when it had grown in pain and size. Doctor's visit on Thursday evening. By Friday morning it was VERY red, tender, and itchy and the elbow and fingers on that hand were achy too.
Age: 66.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Although patient reported no pain immediately afterwards, her left arm begain getting progressively more painful a few hours after administration and continues to persist despite treatment from her primary care provider. She reports burning pain in her whole arm that keeps her up at night.
Age: 66.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Discomfort, Injection site reaction, Pain in extremity
Clinical narrative: Although patient reported no pain immediately afterwards, her left arm begain getting progressively more painful a few hours after administration and continues to persist despite treatment from her primary care provider. She reports burning pain in her whole arm that keeps her up at night.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Gastrointestinal pain
Clinical narrative: CRAMPING IN BOWELS.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Patient indicated had sudden onset of fever, chills, vomiting and diarrhea for 2 days.  No medical treatment received and made full recovery.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial Onset: itchy, red at injection site on 09/12/2013; followed by circular dark red/purple color & swelling - approx. half dollar size at injection site, right upper arm (09/13/2013). Followed by dark red spots on chest (09/14/2013). Followed by breakout of dark red spots on face, ears, then forearms, upper arms, and thighs within a 2 day period (09/15/2013).  As of this date 10/26/2013 dark red spots continue to cover the entire body other than the abdomen and below knees. Patient seen at primary physician office by NP on 10/07/2013, noon. Given cephalaxin antibiotic and steroid cream for injection site only. Seen by dermatologist for the spots (triacinolone acetonide).
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pityriasis lichenoides et varioliformis acuta, Rash erythematous, Rash generalised
Clinical narrative: Initial Onset: itchy, red at injection site on 09/12/2013; followed by circular dark red/purple color & swelling - approx. half dollar size at injection site, right upper arm (09/13/2013). Followed by dark red spots on chest (09/14/2013). Followed by breakout of dark red spots on face, ears, then forearms, upper arms, and thighs within a 2 day period (09/15/2013).  As of this date 10/26/2013 dark red spots continue to cover the entire body other than the abdomen and below knees. Patient seen at primary physician office by NP on 10/07/2013, noon. Given cephalaxin antibiotic and steroid cream for injection site only. Seen by dermatologist for the spots (triacinolone acetonide).
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Beginning two days after Fluvirin vaccination the patient reports having arm and neck pain. The patient went to his doctor for treatment. The patient states that he was given a cortisone injection from his doctor to help with his arm and neck pain.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Local swelling, Mobility decreased, Pain, Pain in extremity
Clinical narrative: My arm starting itching right afterwards. It swelled up with a small bump to start out with and was hot. Within an hour or so the redness was about 3 inches in diameter. By the next morning (10/25/13) the swelling had spread, the bump had spread and the heat was severe. My arm was hard to move, it still itched and hurt. I took 600 mg Ibuprofen and Benadryl and put ice on it. When I woke up this morning (10/26/13) the swelling has spread to about 6 inches in diameter, the redness is about the same, and the heat coming from it feels like a bad fever. It hurts to move my arm or carry anything with my right arm. I took pictures, and continued to take Ibuprofen and Benadryl and ice it. Considering going to doctor if it is not better or if it gets worse by tomorrow.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Skin warm
Clinical narrative: My arm starting itching right afterwards. It swelled up with a small bump to start out with and was hot. Within an hour or so the redness was about 3 inches in diameter. By the next morning (10/25/13) the swelling had spread, the bump had spread and the heat was severe. My arm was hard to move, it still itched and hurt. I took 600 mg Ibuprofen and Benadryl and put ice on it. When I woke up this morning (10/26/13) the swelling has spread to about 6 inches in diameter, the redness is about the same, and the heat coming from it feels like a bad fever. It hurts to move my arm or carry anything with my right arm. I took pictures, and continued to take Ibuprofen and Benadryl and ice it. Considering going to doctor if it is not better or if it gets worse by tomorrow.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Some light vertigo. This was intermittent, but has now continued x 2 days. My husband also complained of an episode of lightheadedness, the same night. He also rec'd the shot, at the same time and same place as I did. However, he has been out of town all weekend so I don't know if his symptoms have continued like mine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Local swelling, Skin warm
Clinical narrative: Start of itching at injection site...then pain which radiates to elbow.  At 11:00  there was a large area of swelling approximately 3 inches in diameter.. it was hot to the touch.  I put ice on it for 2 days, swelling went down and area of pain turned to bruising...6 days now and it is still slightly swollen and painful.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TDAP
Symptoms: Fatigue, Headache, Measles, Pyrexia, Rash
Clinical narrative: 10/21, she began to feel very tired and had a headache.  10/22, she worsened and spiked a fever at 104.  Mother treated with medications and essential oils and she was better the next 2 days.  Fever returned 10/25, and rash appeared that evening.  Rash worsened overnight despite Benadryl.  10/26, PA at an Urgent Care diagnosed her with Measles.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Inflammation, Rash erythematous
Clinical narrative: Pt. received FLUZONE IM on 10/8/13 at 7:10 PM. Pt. contacted pharmacy at 11:30 AM on 10/9/13 stating she was experiencing inflamed, red, rash on left upper arm. Pt. states experiencing burning sensation after admin.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Pruritus, Rash pustular
Clinical narrative: Pt had site reaction with redness starting 2 days after shot. 1 pustule formed 10 days after shot. Patient had itching in area and no other complaints. Saw MD at office on 10-25-13 said minor site reaction and prescribed KEFLEX 500 qid and BACTROBAN ointment to be used if pustule opened.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient received ZOSTAVAX on 10/24/13. She came in 10/26/13 and showed me her arm. Red, little swollen, hot to the touch - from injection site to elbow on her right arm. There was little white bump at injection site. I recommend she see a doctor. Suggested urgent care.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Malaise
Clinical narrative: Administered flu shot at 2:30pm. Patient returned to pharmacy counter at 2:40pm complaining of not feeling well. I instructed her to take a seat in the waiting area and she put her feet up on a chair. She then complained of feeling like it was hard to swallow. I activated the emergency protocol and instructed my cashier to call 911. I obtained the blood pressure monitor and EPIPENS. I took the patient's blood pressure at 2:49pm. It was 130/80. Patient complained it was still hard to swallow but was not having difficulty breathing. Emergency responders arrived at 2:51pm and took over patient care. Patient was then taken by emergency responders to the emergency room.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pyrexia, Vomiting
Clinical narrative: Patient called 3 days after receiving FLUVIRIN multidose influenza vaccination and reported severe illness. Vomiting, fever, etc. flu-like symptoms.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Feeling hot, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: Eyes rolled back, convulsions, stiff, stated he felt hot, over 1 minute duration then pt snapped out of it. No treatment. Rested for 20 minutes and had water. Father took pt to MD to get evaluated.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Left arm feels painful at times over 2 months later, at the administration site.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Injection site pain, Neck pain, Pain in jaw
Clinical narrative: Patient bled more than normal. Informed the pharmacists that the inject site stung when the vaccine was administered. Later called and complained that her neck and jaw began to hurt.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Hyperhidrosis, Malaise
Clinical narrative: Pt was very sick from flu vaccine the next day w/ severe diarrhea and sweating and he could not leave bed.
Age: 67.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Redness in right deltoid.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Hyperhidrosis, Malaise, Muscle spasms
Clinical narrative: Pt was very sick from the vaccine the next day w/severe stomach cramps, sweating, and headache.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (Lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 23-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This report is one of the several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (Lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 20-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This report is one of the several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient reported large red, hot area where pneumonia vaccine given. Fever of 105. Pt seen in local emergency room and diagnosed with cellulitis.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Muscular weakness
Clinical narrative: Patient says hand is swollen and cannot lift anything.
Age: 75.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Abdominal pain, Herpes zoster, Pain, Rash
Clinical narrative: Patient presented with active singles within 2 days of receiving ZOSTAVAX infection. Patient seen in urgent care center and given Acyclovir complaint of shooting pain from outbreak site.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Rash generalised, Urticaria
Clinical narrative: Pt developed hives/rash all over body the day after receiving vaccine. Took diphenhydramine by mouth. Which helped. Then developed rash at injection site. Was told to continue diphenhydramine. Rash cleared after 1 week.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: Patient has experienced radiating pain down her arm x 15 days in arm received flu shot in she says it hurts to put weight on it. No redness or inflammation. She has been taking acetaminophen and ibuprofen around the clock.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Apallic syndrome, Asthenia, Blood test, Computerised tomogram head normal, Confusional state
Clinical narrative: Day 2-3 post injection hyper somnolence. Day 3 increased confusion. Day 4 altered mental status with confusion and weakness. Went to hospital by ambulance. Vegetative state for 3.5 days until after IV steroids initiated on hospital Day 3.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Culture negative, Imaging procedure, Lumbar puncture, Mental status changes, Somnolence
Clinical narrative: Day 2-3 post injection hyper somnolence. Day 3 increased confusion. Day 4 altered mental status with confusion and weakness. Went to hospital by ambulance. Vegetative state for 3.5 days until after IV steroids initiated on hospital Day 3.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Paraesthesia
Clinical narrative: Nerves in face felt tingly.  Some difficulty breathing.  Extreme weakness.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Local injection site reaction: redness, swelling, itching, stinging, scaly feeling to touch, heat-producing.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Local reaction, Skin exfoliation
Clinical narrative: Local injection site reaction: redness, swelling, itching, stinging, scaly feeling to touch, heat-producing.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms....chills, aches from head to toe.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Started out as itching and redness around injection site.  Reaction spread to larger area on arm just above the elbow and below the back of the shoulder.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Soreness in left arm, limited range of motion in arm that vaccine was given.
Age: 81.0
Sex: F
Vaccine: FLUX, VARZOS, FLU3, VARZOS
Symptoms: Rash
Clinical narrative: Mild, non-itchy rash on upper legs, arms, and all over torso.
Age: 1.85
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Blood test, Dizziness, Dysarthria, Headache
Clinical narrative: SEVERE HEADACHES; VERTIGO; SLURRING OF SPEECH; NUMBNESS IN FACE [RIGHT SIDE] AND RIGHT ARM; DIZZINESS; UNSTEADINESS.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Laboratory test, Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: SEVERE HEADACHES; VERTIGO; SLURRING OF SPEECH; NUMBNESS IN FACE [RIGHT SIDE] AND RIGHT ARM; DIZZINESS; UNSTEADINESS.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Head injury, Injection site discolouration, Loss of consciousness, Syncope
Clinical narrative: Stood up and fainted- felt like spinning; sight turned blue green and my son fell to the floor hitting head, after hitting regained woke up.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Stood up and fainted- felt like spinning; sight turned blue green and my son fell to the floor hitting head, after hitting regained woke up.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Pharyngeal oedema
Clinical narrative: Throat swelled-pus came out of her eyes. Took Benadryl.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Injection site pruritus, Injection site swelling, Local swelling, Swelling face
Clinical narrative: Swelling at injection site by morning the swelling had gone to my finger tips, neck and face and breathing problems. I had to use an Epipen to take the swelling down and my inhaler for breathing.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Hives, beginning on arm and spreading to neck, chest, back, other arm. Began as rash and then progressed to develop red welts as well.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Dizziness, Dysarthria, Fatigue, Hyperhidrosis
Clinical narrative: Dizziness. Extreme muscle weakness. Slurred speech. Giddy laughing replaced by crying. (I always cry when I get a fever, for some reason, so this might be an indication of one.) Sweating. All of this lasted 10-15 minutes. For the rest of the day felt tired, achy, had a constricted throat.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain, Throat tightness
Clinical narrative: Dizziness. Extreme muscle weakness. Slurred speech. Giddy laughing replaced by crying. (I always cry when I get a fever, for some reason, so this might be an indication of one.) Sweating. All of this lasted 10-15 minutes. For the rest of the day felt tired, achy, had a constricted throat.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Burning sensation, Grip strength decreased, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: I live in the town where my Doctor is. I was shortly have pain right after I received the shot.  During the night I was in so much pain in my arm where the shot was given I could hardly sleep.  I called the doctors office the next day asking if they maybe got my shot mixed up with my daughter tentanus.   They replied no.  It has has been a month now.  I lost use of my left arm.  I symptons have not gone away. I have burning, weekness, and can not hold much in my left hand anymore.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Insomnia
Clinical narrative: I live in the town where my Doctor is. I was shortly have pain right after I received the shot.  During the night I was in so much pain in my arm where the shot was given I could hardly sleep.  I called the doctors office the next day asking if they maybe got my shot mixed up with my daughter tentanus.   They replied no.  It has has been a month now.  I lost use of my left arm.  I symptons have not gone away. I have burning, weekness, and can not hold much in my left hand anymore.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Depression, Fatigue, Somnolence
Clinical narrative: Feelings of severve depression and dread. No energy, weakness, very tired, and cant get enough sleep.  Symptoms lasted 6-7 days.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood test, Chills, Dyspnoea, Injection site inflammation, Injection site pain
Clinical narrative: High fever, chills, body aches, trouble breathing. Pain and inflammation at sight.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia, Urine analysis
Clinical narrative: High fever, chills, body aches, trouble breathing. Pain and inflammation at sight.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Fever of 102.8 chills and feeling sick.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Swollen arm for 3 days. Resolved.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Very itchy arm at injection site.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Induration, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Arm sore, burning (other family mbrs that got it were OK) stiffness in AM, (quarter-size redness) pt called 10/27: very hard to touch; area feels warm.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Arm sore, burning (other family mbrs that got it were OK) stiffness in AM, (quarter-size redness) pt called 10/27: very hard to touch; area feels warm.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Cellulitis, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Received 3 shots - flu and DTAP and ZOSTAVAX. Red rash at site at inj SQ of ZOSTAVAX on left arm. Onset within 1 hr, fever next day. ER said cellulitis. KEFLEX, primary MD changed to BACTRIM DS.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Feeling abnormal, Pain, Vomiting
Clinical narrative: 5 hours after injection had to lay down 3 times or pass out, diarrhea, throw up total body sore, stomach ache to 3 days.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Middle insomnia, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Ongoing dull throbbing ache. Was unable/is unable to lift arm. Cannot rotate arm. Now having pain in shoulder and down arm which wakes her up at night. +/- nerve issue ? not sure.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Ongoing dull throbbing ache. Was unable/is unable to lift arm. Cannot rotate arm. Now having pain in shoulder and down arm which wakes her up at night. +/- nerve issue ? not sure.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (Lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 27-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This report is one of the several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (Lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 27-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This report is one of the several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 26-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (Lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 27-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This report is one of the several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (Lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 23-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This report is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age. Approximately in October 2011 ("about 2 years ago") the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose, route not reported) and to receive the second dose of GARDASIL on 21-OCT-2013. No adverse event reported. Additional information is not expected.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old patient of unknown gender. On 02-OCT-2013 (also reported as 02-OCT-2014) the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified) (dose, location unspecified). In October 2013 (in the past week) the patient experienced a dermatological reaction with redness and swelling (had injection site reactions, size of swelling around injection site and redness, the redness was approximately 3 inches in diameter). At the time of report, the outcome of the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 80 year old male patient. On 14-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J005721, expiry date: 29-AUG-2014) (dose, location unspecified). Concomitant therapy included with COUMADIN. In October 2013 (in the past week) the patient experienced a dermatological reaction with redness and swelling and pain at injection site (had injection site reactions, size of swelling around injection site and redness, the redness was approximately 3 inches in diameter). The patient visited an unspecified physician on an unspecified date as a result of the injection site reaction. The patient was prescribed an unspecified antibiotic. At the time of report, the outcome of the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a 64 years old female patient with penicillin allergy and sulfa allergy. In October 2012, "about 1 year ago in October", the patient was vaccinated with PNEUMOVAX23 1 standard dose injection. Administration route and lot# were unspecified. Concomitant therapies included FORTEO, NASONEX, multivitamins and calcium supplement, and influenza virus vaccine(manufacturer unknown), administered 2 weeks before PNEUMOVAX23. In October 2012, within 1 hour of receiving the vaccine, the patient experienced swelling, rash, and tenderness at the injection site. Events were recovered shortly after the vaccine was administered. No treatment was given. No lab test was done. The patient talked to a doctor to seek medical attention. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 76 year old female nurse with PROCARDIA allergy and TENORMIN allergy refers to herself. The patient's medical history included generalized neuropathy of the leg. On 09-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route unspecified). Concomitant therapies included estrogens, conjugated PREMARIN. On 10-OCT-2013 (the next day), the patient's arm became extremely sore. Later in the day on 10-OCT-2013 the patient developed swelling, soreness, pain and warmth in an area about 6 inches around the injection site. The nurse stated that she also developed a fever, headache and swollen lymph nodes on 10-OCT-2013. In addition, the nurse developed a rash on the upper part of the arm in which ZOSTAVAX was administered. The patient had sought medical attention via called physician's office. No lab diagnostics studies performed. MOTRIN was given for headache treatment. The nurse reported that she was recovering, on an unspecified date, her fever, headache and swollen lymph nodes went away and the adverse injection site reactions had decreased to only cover an area of about 1.5 inches. The patient stated it was okay to send VZVIP packet to her physician. VZVIP packet faxed. Additional information has been requested.