chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate
Clinical narrative: It started the day I got the injection. There was a dull ache and pain at the site. I was told that was normal. It continued and at day 4, I started getting aches and pains in my neck, both knees, feet and hands. There was noticeable swelling in these joints. As the days progressed, the aches and pain radiated to my elbows. I finally made an appointment to see my doctor. I went in on July 25, 2018 and described what I was going through. The CNP did some blood work and told me to try TYLENOL Extra Strength and ASPERCREAM with Lidocaine. I tried both, but neither worked. The blood work came back, showed inflammation. I asked about the vaccine, since the time frame seemed to correlate to all my symptoms. The nurse called me back and spoke to my doctor as well as an internal medicine doctor on staff, and both agreed that it could be an adverse reaction to the vaccine. The internal medicine doctor said he had a patient with similar symptoms caused by the vaccine and the symptoms lasted about 6 weeks. I was advised NOT to get the 2nd part of the vaccine. I am now week 7 and there hasn't been any significant change. Last week, the swelling, aches and pains were so severe that I couldn't get out of bed, out of a chair or get dressed or do any activities of daily living without the assistance from my husband. The pain may subside a little for a little while and then come back again, but the ache and swelling is constant. I have also tried ice packs, soaking the extremities in cold water. It gives me temporary relief. I have been taking ibuprofen 400 mg in the morning and at night and that seems to help a little, but the swelling still remains in the joints. I have not experienced any fever, headache or the like. Prior to this vaccine, I had no problems with my joints. I have a follow up visit with my primary care doctor September 24th. If the symptoms don't get any better before that, I will have to try to get to see another doctor or go to the ER. I should mention that I thought the pharmacy assistant who gave me the injection gave it up too high on my arm. It was almost to the shoulder. He gave my husband the injection as well, in the same area of his arm, but my husband only had flu like symptoms for a few days. I would also like to mention that I received the original Shingles vaccine (ZOSTAVAX) on November 27, 2014 when I turned 60. I did not have any reaction to that vaccine. I also forgot to mention that there were 2 days where the injection site hurt so badly that I couldn't lift my arm at all.
Age: 20.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient stated that the night of 8/10/18 her right arm was red, swollen, and itchy. At home patient was using an ice pack. When patient came into the health center (8/11 at 1:15 PM) the redness was decreased and was no longer itchy. Treatment from health center was to continue with ice packs and take ibuprofen, return to center if symptoms get worse.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Alanine aminotransferase normal, Anion gap normal, Aspartate aminotransferase increased, Basophil count normal, Basophil percentage decreased
Clinical narrative: Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Blood creatinine normal, Blood glucose normal, Blood osmolarity normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Blood urea normal, C-reactive protein normal, Carbon dioxide normal, Differential white blood cell count abnormal, Eosinophil count normal
Clinical narrative: Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Eosinophil percentage, Full blood count abnormal, Globulin, Granulocyte count, Granulocyte percentage
Clinical narrative: Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Haematocrit normal, Haemoglobin normal, Joint swelling, Lymphocyte count normal, Lymphocyte percentage
Clinical narrative: Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Metabolic function test abnormal
Clinical narrative: Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Monocyte count normal, Monocyte percentage increased, Neutrophil count normal, Neutrophil percentage, Peripheral swelling
Clinical narrative: Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Platelet count normal, Protein total normal, Pruritus, Pruritus generalised, Pyrexia
Clinical narrative: Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Rash generalised, Red blood cell count normal, Red cell distribution width normal, Swelling face, Urticaria
Clinical narrative: Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erosion, Injection site erythema, Injection site induration, Injection site swelling, Urticaria
Clinical narrative: Large red area of swelling at site of injections on left thigh. 8-9/18 large urticarial wheals on bilateral LE, left UE, cheeks, torso, injection site w/ induration and excoriation.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Child vomited once, felt nauseous after, resolved after 15 minutes with drinking Gatorade and eating peanut butter. Patient reported not eating anything that day.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Myositis, Pain in extremity, Peripheral swelling, Rash erythematous
Clinical narrative: Left arm swelling and pain. Red rash overlying the swelling. Muscle inflammation. Improving when seen in clinic.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local Reaction: LUA with 13x16 cm redness and swelling, warmth, Temp 99.6. No pain was on ABX as well.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 70x70mm 3x3 inches No specific knots, warm, red, slighting raised. No limited ROM no pain. Self limited. Treated systematically. Denied any systemic reaction.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Lip swelling, Urticaria
Clinical narrative: Few hours after injection (after clinic closed), patient had swelling lips, hives on opposite arm of injection. She was referred to ER by administration (clinic was closed). Patient later reported that she went to ER, did not receive any treatment, and was sent home without further problems.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Redness at site, small hematoma slight swelling-immediate progression to 2"x2" area of warmth and erythema-required cold packs and BENADRYL.
Age: 50.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Lethargy, Pain, Pain of skin, Paraesthesia
Clinical narrative: Whole body ache, skin tingling and painful to the touch, lethargy lasting two days.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia, Pain, Pyrexia, Rash erythematous
Clinical narrative: Patient reported fever Saturday night (same day as vaccine), then Sunday night about 36 hours after vaccine administration she had a rash that started on her chest described as flat and red, not itchy or painful and by Monday afternoon it had spread from neck to groin area arms included.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Patient reported fever Saturday night (same day as vaccine), then Sunday night about 36 hours after vaccine administration she had a rash that started on her chest described as flat and red, not itchy or painful and by Monday afternoon it had spread from neck to groin area arms included.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Brain oedema, Croup infectious, Dry skin, Eczema, Food allergy
Clinical narrative: Brain swelling. Chronic croup. Eczema. Food allergies. Sensory processing. Dry skin.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Sensory processing disorder
Clinical narrative: Brain swelling. Chronic croup. Eczema. Food allergies. Sensory processing. Dry skin.
Age: 56.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: I am breaking out with a rash on my arms and legs that hurt very much and itch at the same time. They form as small bumps on my skin that hurt very bad and itch at the same time. New bumps keep forming every day and spread.
Age: 32.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site infection, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: Patient stated she received the smallpox vaccine on 30 July 2018 at the Center and while at home she experienced swelling, pain and infection at the injection site that affected her upper right arm down to the elbow. She was seen at the hospital diagnosed as reaction to the smallpox vaccine and prescribe clindamycin. Upon returning she followed up with her Care Provider and steroids.
Age: 1.25
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Exposure to communicable disease, Rash vesicular
Clinical narrative: Child exposed to friend with shingles and developed a rash. Approximately 50 small blisters with red base on arms and trunk at time of visit in the office with more areas appearing.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Fatigue, chills, headache, body aches, arm soreness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Swelling
Clinical narrative: Patient describes redness and itching at the injection site on 8/7 then the redness got brighter and swelling bigger to around 2 to 3 inches diameter by 8/9. Patient got concerned and went to see her Primary care Doctor on Friday and she was prescribed AUGMENTIN. She is taking medication since then and she is feeling better. The swelling is going down and she is feeling better.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever (102), vomiting, sore arm.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-JUL-2018, the patient was vaccinated both with PROQUAD (rHA) lot # N019825, expiration date: 09-JAN-2019 (dose, route and site of administration were not reported) and VARIVAX lot# N017395, expiration date: 07-JUN-2019 (dose, route and site of administration were not reported) for prophylaxis. The vaccines were diluted with sterile diluent (MRK INJ). No adverse effects were reported. Product quality complaint was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist who referred to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 19-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number R006754, expiration date: 06-MAR-2020, strength, dose site and route of administration were not reported) for prophylaxis. It was reported that sterile diluent (STERILE DILUENT) (lot number M037018, expiration date: 01-MAY-2019) used for reconstitution of the vaccine was properly stored. It was reported that the vaccine was stored in temperature range of 15 to 46 Fahrenheit degrees for 3 days (date unspecified). There were no previous temperature excursions. A Digital Data Logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare professional, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # R002344, expiration date on 16-NOV-2011, intramuscularly (anatomical location and dose number were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA001261: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA00126.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours and temperature of 6 F to 14 F for 30 minutes on 16-JUN-2018 and 01-AUG-2018, respectively. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA001261: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004381:     Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261  US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA001261: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA001261: Original Case : 1808USA001261.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 29-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Diluent MRK Inj was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261; US-009507513-1808USA004381: Original Case : 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case : 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case : 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case : 1808USA001261; US-009507513-1808USA004362: Original Case : 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case : 1808USA001261; US-009507513-1808USA004363: Original Case : 1808USA001261; US-009507513-1808USA004364: Original Case : 1808USA001261; US-009507513-1808USA004389: Original Case : 1808USA001261; US-009507513-1808USA004390: Original Case : 1808USA001261; US-009507513-1808USA004391: Original Case : 1808USA001261; US-009507513-1808USA004392: Original Case : 1808USA001261; US-009507513-1808USA004365: Original Case : 1808USA001261; US-009507513-1808USA004393: Original Case : 1808USA001261; US-009507513-1808USA004394: Original Case : 1808USA001261; US-009507513-1808USA004395: Original Case : 1808USA001261; US-009507513-1808USA004396: Original Case : 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA00126.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 31-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Diluent MRK Inj was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261; US-009507513-1808USA004381; US-009507513-1808USA004382; US-009507513-1808USA004383; US-009507513-1808USA004384; US-009507513-1808USA004385; US-009507513-1808USA004380; US-009507513-1808USA004379; US-009507513-1808USA004376; US-009507513-1808USA004377l; US-009507513-1808USA004378; US-009507513-1808USA004386; US-009507513-1808USA004387; US-009507513-1808USA004388; US-009507513-1808USA004362; US-009507513-1808USA004363; US-009507513-1808USA004389; US-009507513-1808USA004390; US-009507513-1808USA004391; US-009507513-1808USA004364; US-009507513-1808USA004392; US-009507513-1808USA004393; US-009507513-1808USA004394; US-009507513-1808USA004395; US-009507513-1808USA004396; US-009507513-1808USA004365; US-009507513-1808USA004366; US-009507513-1808USA004367; US-009507513-1808USA004397; US-009507513-1808USA004399; US-009507513-1808USA004368; US-009507513-1808USA004369; US-009507513-1808USA004400; US-009507513-1808USA004401; US-009507513-1808USA004370; US-009507513-1808USA004371; US-009507513-1808USA004372; US-009507513-1808USA004373; US-009507513-1808USA004374; US-009507513-1808USA004375.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a nurse, concerning a 39 year old female patient. The patient's medical history was not reported. Her concurrent conditions included asthma and an allergy to eggs and eggs derivative. The patient did not have any concomitant medications to report. On 02-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 as vaccine, intramuscularly, in her left arm, lot #R006466 (strength, dose, frequency and expiration date were not reported). On 03-AUG-2018, the patient experienced redness, swelling and warmth down her left arm and torso. The patient went to an unspecified emergency room and received BENADRYL on an unspecified date. At the time of reporting, the patient was recovering from redness, swelling and warmth down her left arm and torso. The causal relationship between the vaccination with PNEUMOVAX 23 and the events was not provided by the reporter.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, via company representative, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient inadvertently received prematurely a third dose of with GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported); the vaccine was administered with only a 3 week separation from the second dose. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 08-AUG-2018, the patient was vaccinated with VARIVAX (lot # N020014, Expiry date : 17-JUL-2019) 1 DF, via intramuscular route for prophylaxis (incorrect route of drug administration). Concomitant therapies included sterile diluent. There was no adverse event reported. There was no product quality compliant involved.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, numerous patients have reported soreness at the injection site which resolved after a couple of days. This case has been linked to the case US2018140164, reported by the same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 63-year-old male patient who received SHINGRIX (batch number BN9L9, expiry date unknown) for prophylaxis. The patient's past medical history included shingles. On 20th April 2018, the patient received the 1st dose of SHINGRIX. On 20th April 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the shingles was not recovered/not resolved. The reporter considered the fever and shingles to be possibly related to SHINGRIX. Additional details were provided as follows: In April 2018, fever resolved after lasting for a week. Less than a year after vaccination, the patient experienced a sensation which was described as, a reactivation of his shingles in the areas where he previously had shingles. The pharmacist was unsure if lot number was BN919 or BN9I9 for SHINGRIX, which did not exist and was updated to BN9L9, according to sales database. The batch number was unknown. This case has been linked to US2018140190, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Feeling cold, Headache, Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (Refer case US2018GSK144869). On 31st July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced sleepiness. On 2nd August 2018, the patient experienced headache. On 3rd August 2018, the patient experienced fever. On an unknown date, the patient experienced pain, heaviness in limbs, swelling arm, chills, injection site pain, feels awful, multiple allergies and injected limb mobility decreased. On an unknown date, the outcome of the headache, chills, feels awful, sleepiness and injected limb mobility decreased were unknown and the outcome of the pain, heaviness in limbs, swelling arm and multiple allergies were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the fever was recovering/resolving. It was unknown if the reporter considered the headache, pain, heaviness in limbs, swelling arm, chills, injection site pain, feels awful, multiple allergies, sleepiness, injected limb mobility decreased and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter was unable to provided batch number or expiry date. NDC number was provided as 58160-0823-11. The patient received her 1st dose of SHINGRIX on 20th April 2018 and 2nd dose on 31st July 2018 around 12.30 pm at her local Pharmacy, in her left arm and within 14 to 16 hours of the 2nd dose she experienced cold chills although she did not feel sick. The patient slept most of the day on 1st August 2018 and when she woke up that morning, she had horrible headache, she was uncertain if it was allergy related but it resolved that morning, she overall felt horrible with aches and pains that are not normal. The reporter stated that her left arm felt heavy, almost lead like and it hurt to lift the arm, and that her arm was swollen and she had ongoing pain or soreness around injection site. The patient woke up on the day of reporting with a slight fever. Permission was given to contact Pharmacy and primary health care professional. No further information was provided. This case has been linked with case US2018GSK144869 reported by the same reporter for the same patient.