chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of unspecified age received at the same time single dose of PREVNAR 13 and high dose of Influenza vaccine (unknown manufacturer), both on unspecified date about a month before the report. Medical history and concomitant medications were not provided. The patient was still having at time of report a lot of pain in her arm to the point that she could not use it. The events developed on unknown date in 2014. Follow-up (14Jan2015): Follow-up attempts completed. No further information expected.
Age: 88.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Blood glucose increased
Clinical narrative: This is a spontaneous report from non-contactable nurse on a behalf of her mother, via Pfizer sales representative. A 88-year-old female patient received PREVNAR 13 single dose and Flu vaccine (unspecified), both via an unspecified route of administration on the same unspecified date. Medical history included diabetes mellitus since a weeks or two before vaccination. The patient's concomitant medications were not reported. In the middle of night of the vaccination date, the patient experienced extremely high blood sugar. The outcome of the event was unknown. No follow up attempts possible. No further information expected.
Age: 70.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Chest pain, Headache, Oropharyngeal pain, Pharyngeal erythema, Pharyngeal oedema
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This consumer reported events with the same suspect vaccines for herself and her husband. This is the first of two reports (referred to the consumer herself). This 70 year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 and flu shot, both via an unspecified route of administration on 03Nov2014. Relevant medical history included Addison's disease in the past and ongoing inclusion body myositis (IBM), a muscle disease. Concomitant medication included prednisone at low dose. Past drug events included adverse reactions to LYRICA and CELEBREX and to other unspecified fourteen medications. The patient reported that on 07Nov2014 after vaccinations she started feeling bad in chest, throat and head with pain down in her chest. Her pain medications were not helping her with headache. On her throat, she had white patches, red streaks and swelling. She had pain all time. She went to the doctor. It was not a streptococcal throat infection. He told her that she had a viral infection and that her symptoms were not related to the injections she received. On an unknown date in Nov2014 the patient underwent laboratory tests which included streptococcal throat test with negative results and blood culture viral positive. She wanted to know if PREVNAR 13 could have caused a viral infection. The reported events had worsened at the time of this report. The patient did not want to provide any more information and she stated she did not want to get her doctor into any trouble. No follow up attempts possible. No further information expected.
Age: 70.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Streptococcus test negative, Viral infection, Viral test positive
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This consumer reported events with the same suspect vaccines for herself and her husband. This is the first of two reports (referred to the consumer herself). This 70 year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 and flu shot, both via an unspecified route of administration on 03Nov2014. Relevant medical history included Addison's disease in the past and ongoing inclusion body myositis (IBM), a muscle disease. Concomitant medication included prednisone at low dose. Past drug events included adverse reactions to LYRICA and CELEBREX and to other unspecified fourteen medications. The patient reported that on 07Nov2014 after vaccinations she started feeling bad in chest, throat and head with pain down in her chest. Her pain medications were not helping her with headache. On her throat, she had white patches, red streaks and swelling. She had pain all time. She went to the doctor. It was not a streptococcal throat infection. He told her that she had a viral infection and that her symptoms were not related to the injections she received. On an unknown date in Nov2014 the patient underwent laboratory tests which included streptococcal throat test with negative results and blood culture viral positive. She wanted to know if PREVNAR 13 could have caused a viral infection. The reported events had worsened at the time of this report. The patient did not want to provide any more information and she stated she did not want to get her doctor into any trouble. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose and flu vaccine, both via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient's arm popped up a little bit. The event was non-serious with outcome of unknown. Follow-up (15FEB2015): Follow-up attempts complete. No further information expected.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Patient presents with reddish, cluster of bumps on back of arm.  She states that she did not notice it until it itched that day and she looked and saw "little pimples that were red-like".  She thought she had been bit by something but then she remember that a month or so ago that is where she received her Zostavax vaccination. She does not know how long it might have actually been there, since she can't see that area.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT SAID INJECTION SITE STARTED TO GET RED, RAISED AND HOT THE EVENING AFTER INJECTION. IT CONTINUED TO GROW IN SIZE FOR 7 DAYS. AFTER 7 DAYS, IT WAS ABOUT 4 INCHES BY 6 INCHES IN SIZE AND WENT TO THE UNDERSIDE OF HER ARM. AFTER A WEEK, THE AREA WENT AWAY BUT HER ARM WAS "BLUE-LOOKING" AFTER THE SWELLING AND REDNESS WENT DOWN.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Abnormal behaviour, Arthralgia, Asthenia, Back pain, Dyspnoea
Clinical narrative: Noticed pain in wrists/hands (mainly R side).  When moving wrists movement is shakey (tremor?) nerve can be felt vibrating up both forearms with movement.  C/O back pain between both shoulder blades.  Headache, dyspnea, neck pain. Had appt with MD on 9/15/15.  Behavior changes: quiet, c/o pain frequently, tired all the time, no energy, tearful.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Fatigue, Headache, Neck pain, Pain in extremity, Tearfulness
Clinical narrative: Noticed pain in wrists/hands (mainly R side).  When moving wrists movement is shakey (tremor?) nerve can be felt vibrating up both forearms with movement.  C/O back pain between both shoulder blades.  Headache, dyspnea, neck pain. Had appt with MD on 9/15/15.  Behavior changes: quiet, c/o pain frequently, tired all the time, no energy, tearful.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Tremor
Clinical narrative: Noticed pain in wrists/hands (mainly R side).  When moving wrists movement is shakey (tremor?) nerve can be felt vibrating up both forearms with movement.  C/O back pain between both shoulder blades.  Headache, dyspnea, neck pain. Had appt with MD on 9/15/15.  Behavior changes: quiet, c/o pain frequently, tired all the time, no energy, tearful.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Injection site induration, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Itchy, Hives rash softball size around the injection site. Would travel down one vein at time and up neck. That hand would become very sweaty at times. Softball are around injection site would also get hard and very hot on and off throughout day. Very very itchy.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Itchy, Hives rash softball size around the injection site. Would travel down one vein at time and up neck. That hand would become very sweaty at times. Softball are around injection site would also get hard and very hot on and off throughout day. Very very itchy.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema and mild swelling noted to injection site and left upper arm.  States mild itching.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Lip swelling, Swelling face
Clinical narrative: Experienced numbness and swelling in left facial area, specifically swelling in left lower lip. Benadryl 50 mg P.O. administered.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives, raised and red.  Slight itching.  Lasted for about 2-3 days.  Patient did not seek treatment. Takes daily anti-histamine (Zyrtec) which seemed to help.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Vision blurred, Visual impairment
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, at single dose, on unknown date. Relevant medical history was not reported. Concomitant medication included a shot of Flu vaccine, via an unspecified route of administration, administered the same day of PREVNAR 13. The year before the patient received PREVNAR 13 and Flu vaccine and her arm popped up a little bit. The patient experienced vision changes, and blurry vision the next morning of vaccination, on an unspecified date. Outcome of events was unknown. Follow-up (12Dec2014, 15Dec2014): New information received from a contactable pharmacist includes: patient's gender, event blurred vision detail, concomitant influenza vaccine added, previous vaccination. Follow-up (06Feb2015): Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Blood test normal, Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. An 80-year-old female patient received PREVNAR 13, via an unspecified route of administration on 17Dec2014 at single dose for immunization and an influenza vaccine via an unspecified route of administration on 17Dec2014 at single dose. Medical history included hypertension and osteoporosis from unknown dates. Concomitant medication included lisinopril for hypertension. Past vaccination history included flu shot in Sep2013 and pneumococcal 23 in Sep2013. The patient reported that on 17Dec2014: "I went to a local drug store and they gave me a sheet to be filled out and I contacted my local insurance company, they said they would cover my pneumonia 13 shot so I went to local drug store, they gave me a sheet and I filled it out and they went to get the shot but the pharmacist accidentally gave me a Regular seasonal vaccine flu shot." The patient reported that she noticed and asked whether it was PREVNAR 13 and the pharmacist did not realize that was not the one. The patient reported that she had received the "regular flu shot" in September of last year (2013). The pharmacist apologized and gave the patient the PREVNAR 13. The patient went home and experienced a temperature of 102 degrees Fahrenheit, and figured it was a reaction to one of the vaccines, so she stayed home and took TYLENOL. The patient reported that as of 20Dec2014, her fever came down but she still has aches and pains like a chill and I still have a little bit of the symptoms. The patient reported that she had a blood test in 2013 and everything was okay. The clinical outcome of the body temperature increased was reported as recovered and the chills and aches was reported as not recovered.
Age: 65.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer calling on behalf of her husband via a non-clinical study program, Pfizer. A 65-year-old male patient received first dose of PREVNAR 13, 0.5 ml single and influenza vaccine at 1 DF single, both for immunization, intramuscular, in the left upper arm, on 29Jan2015. Medical history included pain, nerves pains, depression, anxiety. Concomitant medications included oral tramadol 50 mg tablet, two tablets every three hours, for pain, trazodone 100 mg once a day at night time, for nerves pains to relax at night and for depression, methadone 5 mg tablet twice a day for pain, omeprazole 20 mg once a day for stomach, clonazepam 1 mg tablet, two tablets a day, for anxiety, oral hydrocodone 5 mg tablet, one to two tablets twice a day, vitamin C supplement, vitamin D, vitamins (Rainbow Light) once a day, vitamin D and oral gemfibrozil 600 mg tablet twice a day for cholesterol. On 30Jan2015 the patient experienced left upper arm red, hot, and swollen and it hurt him really bad for 2 days. She had put a line around the red swollen area to see if it was going to spread. The reporting consumer was also concerned about the flu shot administered along with PREVNAR 13 and was wondering if it is safe to take it again. The patient was getting better at time of report. Follow up (02Feb2015): New information from the same contactable consumer includes: reporter inquiry and events outcome.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales presentative. A patient of an unspecified age and ethnicity received, on 16Oct2014, PREVNAR 13, Lot. H86680, Expiration Date: Oct2015, NDC: 0005-1971-02) single dose, for immunization. Anatomical location of vaccination was left arm. Flu shot was given at the same time but in a separate arm. Relevant medical history was unknown. On an unspecified date, the patient experienced swelling and redness at the injection site and it seemed outside of the normal expected reactions according to the pharmacist. Clinical outcome of the events was unknown at time of this report. Follow-up (29Nov2014): Follow-up attempts completed. No further information expected.
Age: 83.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer Sales Representative. A 83-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13, and influenza vaccine, both via an unspecified route of administration in the same arm on 22Oct2014. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2014, the patient experienced redness, soreness and swelling of deltoid. The patient was seen in urgent care. The Pfizer Sales Representative believed that patient had these adverse events on the next day of vaccination but he was not sure. It was reported that patient received unspecified antibiotic as treatment of these events. Patient still have these symptoms after nine days of the administration; the outcome of the events was not recovered. Causality was not provided. Follow-up (17Nov2014): New information reported from the same contactable physician includes: Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: Pt received vaccine 9/14/15. She received AFLURIA at the same time. A few days later she experienced redness and swelling at the injection site. She went to ER on Saturday 9/19 and was admitted to the hospital. She was transported to another hospital and is being treated for infection.
Age: 57.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This is a spontaneous report from a physician who reported for 3 patients and from a nurse via a Pfizer Sales Representative. This is third of the three reports. A 57 year-old female patient received, on 05Dec2014 at 14:39, PREVNAR 13 (Lot. J49849, expiration date: 02Jan2016) on the right deltoid, at 0.5 ml, single dose. On the same day, on 05Dec2014, she received FLUVIRIN (Novartis, Lot. 1411401, expiration date: 05Jan2015) on her left deltoid, at 0.5 ml, single dose. Relevant medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications were unknown. On 06Dec2014, the patient experienced swelling, redness and pain. The nurse mentioned that the patient was not hospitalized. The patient did not experience the same event before. One of the patients called back to the doctor's office to report the side effects and took a picture to show the reaction and sent it to the office. The nurse mentioned that swelling of arms, redness and pain was due to PREVNAR 13. The patient recovered from the events on an unspecified date. Follow-up (21Jan2015): New information reported from the contactable nurse through a Pfizer sales representative includes: patient details, vaccinations details, reaction data and reporter's assessment.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Gait disturbance, Joint swelling, Peripheral swelling, Vaccination site erythema
Clinical narrative: 09/16/15-mild, redness at site of vaccination. 09/17/15-thigh and knee got swollen and red to twice the size and this lasted x 48 hours-no fever, mild limping.
Age: 61.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Excoriation, Pallor, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on left leg itching. No fever or joint swelling. (+) blanching/pruritic erythematous papular rash to LLE with some excoriation from scratching.
Age: 39.0
Sex: M
Vaccine: HEP, PPV, TDAP
Symptoms: Asthenia, Erythema, Headache, Heart rate increased, Injection site erythema
Clinical narrative: Began feeling nauseous, weak, fast heartbeat, sweating, headache, and very high fever.  Later developed redness all over arm where shots were administered, which were also painful and hot.  This lasted 3 days.
Age: 39.0
Sex: M
Vaccine: HEP, PPV, TDAP
Symptoms: Injection site pain, Injection site warmth, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Began feeling nauseous, weak, fast heartbeat, sweating, headache, and very high fever.  Later developed redness all over arm where shots were administered, which were also painful and hot.  This lasted 3 days.
Age: 39.0
Sex: M
Vaccine: HEP, PPV, TDAP
Symptoms: Skin warm
Clinical narrative: Began feeling nauseous, weak, fast heartbeat, sweating, headache, and very high fever.  Later developed redness all over arm where shots were administered, which were also painful and hot.  This lasted 3 days.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever 102.9.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Extreme pain in upper right shoulder. Having trouble moving arm without feeling pain. Went to hospital following up with a doctor.
Age: 1.04
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Local swelling, Malaise, Peripheral swelling, Pruritus
Clinical narrative: 9/21/15 left arm itching, 36 hours post injection left arm 13 cm x 14 cm raised red area with warmth, left arm tightness and swelling, soreness, intermittent fever, left arm itching and general malaise. Left wrist positive pulse and normal sensation to touch.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Pyrexia, Skin tightness, Skin warm
Clinical narrative: 9/21/15 left arm itching, 36 hours post injection left arm 13 cm x 14 cm raised red area with warmth, left arm tightness and swelling, soreness, intermittent fever, left arm itching and general malaise. Left wrist positive pulse and normal sensation to touch.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: 7 cm left upper arm w/ erythema, edema, and itching. Localized allergic rxn.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Atrial fibrillation
Clinical narrative: Afib-Dr said could be from flu shot and also stress etc. in her life. Episode happened in middle of night 4 day after vaccines.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Rash
Clinical narrative: Patient called two days after vaccine admin and stated she had a rash near injection site and soreness at injection site.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pain, Skin warm, Tenderness
Clinical narrative: Swollen, redness, hot-3 inches x 2 inch circle. Received vaccine Monday 9/21/ 2100-> 9/22/ 0000-noticed it was red tender, swollen about 2 inch x 2 inch. 9/23 0000 - redness spreading very achey and painful.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Induration, Local swelling, Pain
Clinical narrative: 2" x 3" warm, red, raised and hard-like welt, bruised in center area, sore itchy. Iced area to relieve the soreness.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: 2" x 3" warm, red, raised and hard-like welt, bruised in center area, sore itchy. Iced area to relieve the soreness.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: After the flu shot in (L) deltoid, felt pain in (L) forearm, and hard sharp, shooting in nature, denies any weakness or numbness. No rash or allergic reaction, denies CP/SOB/dizzy.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Electroencephalogram, VIIth nerve paralysis
Clinical narrative: Intermittent facial palsy.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Erythema, Fatigue, Listless
Clinical narrative: Muscle and joint followed by worsening pain over the next 4 days!  After 7 days very listless and weak, tired, sever muscle and joint pain with moderate high fever and skin lesions breathing out starting on chest. Lesions advanced to stomach, legs, feet, arms and legs and upper right shoulder on back.  Most lesions were dark red the size of a quarter or a dime some bubbling effect at the center of the larger ones? No itching! These conditions lasted about 10 more days at which time I began feeling less pain reduced fever and slowly regaining strength over the following week to 12 days!  Lesions regressed slowly with some scarring remaining!
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Pyrexia, Scar, Skin lesion
Clinical narrative: Muscle and joint followed by worsening pain over the next 4 days!  After 7 days very listless and weak, tired, sever muscle and joint pain with moderate high fever and skin lesions breathing out starting on chest. Lesions advanced to stomach, legs, feet, arms and legs and upper right shoulder on back.  Most lesions were dark red the size of a quarter or a dime some bubbling effect at the center of the larger ones? No itching! These conditions lasted about 10 more days at which time I began feeling less pain reduced fever and slowly regaining strength over the following week to 12 days!  Lesions regressed slowly with some scarring remaining!
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection, left upper arm.  Pain persisting after 17 days.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Nausea, Syncope
Clinical narrative: Patient fainted in chair in waiting room. Hot and nauseous.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Headache, Lacrimation increased, Pain, Rhinorrhoea
Clinical narrative: Watery eyes, runny nose, sneezing, achy body, chest pain, wheezing, headache.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing, Wheezing
Clinical narrative: Watery eyes, runny nose, sneezing, achy body, chest pain, wheezing, headache.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Middle insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme pain in arm and shoulder.  Pain worsened as evening and night progressed.  Pain woke me during the night.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Swelling, induration, redness.
Age: 47.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Blister, Burning sensation, Fatigue, Groin pain, Headache
Clinical narrative: Phone call from patient with complaints following vaccination on 9/17/15 with Twinrix and Yellow Fever. Patient denies soreness, redness or swelling at site of yellow fever injection. She states she has a small bruise at the site of the Twinrix injection but denies redness or soreness. She stated the afternoon following these vaccines she began to have a headache and fatigue (which can be normal with either vaccine) and began running a fever which she states was 100-101 degrees Fahrenheit over the weekend. She states she also developed a rash on the bag of her left leg that spread to her left gluteus. She states it originally started as red bumps and has progressed to vesicles. She describes initial itching and burning then has turned into "searing pain" that feels like a "hot fire poker" in the gluteus and groin area. She also complains of a swollen lymph node in her left groin. She denies a rash on the front of the left leg or in any other area. She states she had 2 doses of varicella as an adult. Discussed with patient that I do not believe her symptoms are vaccine related and that her symptoms are consistent with shingles. I explained how shingles can occur if someone has had varicella vaccine or a history of chicken pox. I explained how stress or an immunocompromising condition may cause the virus which has laid dormant to be activated as shingles. I recommended she phone her PCP as soon as possible for possible anti-viral treatment which she can discuss with her PCP. I let her know that I will report her symptoms to VAERS but that I do not think her symptoms are vaccine related and that I would encourage her to continue her Twinrix series, yellow fever in the future if necessary and a shingles vaccine at age 60. I offered to call and discuss my thoughts and recommendations with her PCP and she declined.
Age: 47.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Herpes zoster, Injection site bruising, Lymphadenopathy, Myalgia, Pruritus
Clinical narrative: Phone call from patient with complaints following vaccination on 9/17/15 with Twinrix and Yellow Fever. Patient denies soreness, redness or swelling at site of yellow fever injection. She states she has a small bruise at the site of the Twinrix injection but denies redness or soreness. She stated the afternoon following these vaccines she began to have a headache and fatigue (which can be normal with either vaccine) and began running a fever which she states was 100-101 degrees Fahrenheit over the weekend. She states she also developed a rash on the bag of her left leg that spread to her left gluteus. She states it originally started as red bumps and has progressed to vesicles. She describes initial itching and burning then has turned into "searing pain" that feels like a "hot fire poker" in the gluteus and groin area. She also complains of a swollen lymph node in her left groin. She denies a rash on the front of the left leg or in any other area. She states she had 2 doses of varicella as an adult. Discussed with patient that I do not believe her symptoms are vaccine related and that her symptoms are consistent with shingles. I explained how shingles can occur if someone has had varicella vaccine or a history of chicken pox. I explained how stress or an immunocompromising condition may cause the virus which has laid dormant to be activated as shingles. I recommended she phone her PCP as soon as possible for possible anti-viral treatment which she can discuss with her PCP. I let her know that I will report her symptoms to VAERS but that I do not think her symptoms are vaccine related and that I would encourage her to continue her Twinrix series, yellow fever in the future if necessary and a shingles vaccine at age 60. I offered to call and discuss my thoughts and recommendations with her PCP and she declined.
Age: 47.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Phone call from patient with complaints following vaccination on 9/17/15 with Twinrix and Yellow Fever. Patient denies soreness, redness or swelling at site of yellow fever injection. She states she has a small bruise at the site of the Twinrix injection but denies redness or soreness. She stated the afternoon following these vaccines she began to have a headache and fatigue (which can be normal with either vaccine) and began running a fever which she states was 100-101 degrees Fahrenheit over the weekend. She states she also developed a rash on the bag of her left leg that spread to her left gluteus. She states it originally started as red bumps and has progressed to vesicles. She describes initial itching and burning then has turned into "searing pain" that feels like a "hot fire poker" in the gluteus and groin area. She also complains of a swollen lymph node in her left groin. She denies a rash on the front of the left leg or in any other area. She states she had 2 doses of varicella as an adult. Discussed with patient that I do not believe her symptoms are vaccine related and that her symptoms are consistent with shingles. I explained how shingles can occur if someone has had varicella vaccine or a history of chicken pox. I explained how stress or an immunocompromising condition may cause the virus which has laid dormant to be activated as shingles. I recommended she phone her PCP as soon as possible for possible anti-viral treatment which she can discuss with her PCP. I let her know that I will report her symptoms to VAERS but that I do not think her symptoms are vaccine related and that I would encourage her to continue her Twinrix series, yellow fever in the future if necessary and a shingles vaccine at age 60. I offered to call and discuss my thoughts and recommendations with her PCP and she declined.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Local swelling and redness gradually becoming larger.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Case number PHHY2015US077302 is an initial spontaneous report from a consumer (patient's mother) via Vaccine Adverse Event Reporting System (VAERS ID 568772) received on 15 Jun 2015. This report refers to an approximately 03-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unknown date in Feb 2011. In Feb 2011 she had light symptoms of flu. The outcome of the event was reported as recovered. The event was reported as non-serious. Causality was not reported.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Patient experienced severe chills and elevated fever lasting several hours (~3).  Chills caused uncontrollable shaking.  Patient decided to take a dose of aspirin the next morning to help with symptoms at which time his fever had already dropped.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Bedridden, Cough, Decreased appetite, Dizziness, Hypotension
Clinical narrative: Fever highest 102.7, dry cough, muscle aches, migraine headaches, dizziness, confined to bed, anorexia, hypotension.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Myalgia, Pyrexia
Clinical narrative: Fever highest 102.7, dry cough, muscle aches, migraine headaches, dizziness, confined to bed, anorexia, hypotension.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling abnormal, Hyperhidrosis, Influenza like illness
Clinical narrative: Patient mentioned flu-like symptoms requiring her to stay in bed and take a day off of work. She stated being weak and achy, sweating, and chills.  In addition she had a rash at the injection side that was warm, swollen and itchy. She is still feeling a little down today 9/23, but better than yesterday.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient mentioned flu-like symptoms requiring her to stay in bed and take a day off of work. She stated being weak and achy, sweating, and chills.  In addition she had a rash at the injection side that was warm, swollen and itchy. She is still feeling a little down today 9/23, but better than yesterday.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Gave vaccine and getting ready to put bandaid on the site grew to a swollen area size of grape. Patient had flu shot before and I confirmed with the his primary doctor. Had patient place ice pack on the area 2 times. By 35- 45 minutes the swelling had gone down some. Told him to take Tylenol for pain. Ask additional help if needed. He was able to walk out of pharmacy area with no problem.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Local swelling, Skin warm, Tenderness
Clinical narrative: Palm sized swelling. Hot, raised, tender, bruised, etc.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Hypersensitivity, Rhinorrhoea
Clinical narrative: Severe allergic symptoms such as running nose and Sweating.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Abasia, Bedridden, Fatigue, Pain, Vomiting
Clinical narrative: Tred, achy, vomiting, no fever, unable to walk, bed ridden. Took Tylenol. Told to go to urgent care. Much better the next day.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient woke up before going to work and noticed a red rash at site of injection.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Breast pain, Peripheral swelling
Clinical narrative: HER ARM IS SWOLLEN AND SHE SAYS SHE HAS SHOOTING PAIN DOWN BY HER BREASTS.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: Patient called and said she just had vomiting and diarrhea and chills.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Rec'd HD flu shot and PCV23 Monday afternoon both in left arm. Noticed redness, swelling, pain left arm Monday night. Worse on Tuesday. Denies fever.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient reported severe swelling around the injection site extending up to her shoulder and down to the elbow, as well as profuse rash and itching.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Tongue disorder
Clinical narrative: 5 mins after the Flu Shot patient complained that her tongue felt thick which made her uncomfortable.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: Within a few minutes of vaccination, patient reported dizziness.  Patient was moved from sitting to the floor.  A few minutes later, patient lost consciousness for a minute and began having seizures.  Patient regained consciousness afterwards.  Paramedics came to help the patient within 10 minutes of the incident.  Patient was alert afterwards, vitals were normal, and patient's mom insisted he not go via ambulance to the Emergency room.  He did not have a repeat episode after the 1st incident.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Rash, Swelling
Clinical narrative: Patient came in yesterday to pick up medication and was counsel to recieve the flu vaccination and pneumo. The patient elected to have both the vaccines however soon after recieving the injection later that night, she felt a burning sensation/swelling and put on a ice pack. This morning she noted that the swelling had gone down but there was a large rash that had been developed on the backside/tricep area of her arm. When speaking with the patient, patient stated that she had already been on Allegra once daily thus we suggested to add Benadryl liq for quicker onset and liberally apply Benadryl/Allegra cream/ung in place of physically scratching the area. The rash could not be determine from the long duration of ice therapy nor itching thus I suggested using  the cream in place of scratching and a towel to buffer the area with the ice with 20 on/off intervals to minimize possible skin irritation. Hydrocort was not suggested since the itching had minimized and if the scratching had lead to a small case of infection - it would proliferate the affected area. Furthermore we ask the patient to follow-up with us the following day to let us know if the skin rash continue to advance and seek urgent care for possible steroid therapy. To mark the development for the rash, we had told the patient to mark around the area and time/date it on the skin before seeing the provider to indicate growth of the rash.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient has large 4 inch swelling in area of injection on right arm with itching and pain.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing
Clinical narrative: Generalized flushing occurred approximately 3 hours after vaccine administration per RN in report called to myself.
Age: 45.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Back pain, Dysstasia, Gait disturbance, Muscle tightness
Clinical narrative: I got the flu shot at the Pharmacy I work at. About an hour or so later I got violent back pain, could barely walk or stand. It got progressively worse.
Age: 45.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Back pain, Muscle spasms
Clinical narrative: I got the flu shot at the Pharmacy I work at. About an hour or so later I got violent back pain, could barely walk or stand. It got progressively worse.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL
Symptoms: Condition aggravated, Full blood count, Generalised vaccinia, Mononucleosis heterophile test positive, Pyrexia
Clinical narrative: 19 year old male presented for smallpox vaccination on 9SEP2015, also issued medication to treat current case of tinea pedis. Patient did not follow recommended follow up instructions for 7 days post vaccination and presented on day 9. Satellite lesions noted, as well as increased severity of tinea pedis, along with improper vaccination site care. The following day Patient presented to the Emergency Room for possible generalized vaccinia (10 days post vaccination), patient was febrile (104 degree oral temp), tachycardic, and had a transient blood pressure of 110/70. Treated with fluids and anti-inflammatories at ER. No labs drawn at this time due to vital signs. Patient followed up next day (day 11) to rule out meningitis and encephalitis. Asymptomatic at that time, however, later that night patient presented again to ER with 102.8 degree temperature, tachycardia and was treated for possible streptococcal pharyngitis. Rapidstrep, CBC and monospot labs taken, and later results were positive for infectious mononucleosis, which could have contributed to systemic spread by suppressing the immune system. The next day (day 12, 21SEP2015) patient presented with multiple smallpox lesions on the feet, one on the face, four on the lower back, and one on the right leg along with the same number of satellite lesions as noted on day 9. Patient referred to Dermatology same day, diagnosed with generalized vaccinia due to systemic spread and not accidental autoinoculation. Normal vital signs noted and recommended isolation precautions x14 days. Patient currently is checked twice a day to monitor for vital signs and possible development of new lesions.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL
Symptoms: Streptococcus test, Tachycardia, Tinea pedis, Vaccination complication
Clinical narrative: 19 year old male presented for smallpox vaccination on 9SEP2015, also issued medication to treat current case of tinea pedis. Patient did not follow recommended follow up instructions for 7 days post vaccination and presented on day 9. Satellite lesions noted, as well as increased severity of tinea pedis, along with improper vaccination site care. The following day Patient presented to the Emergency Room for possible generalized vaccinia (10 days post vaccination), patient was febrile (104 degree oral temp), tachycardic, and had a transient blood pressure of 110/70. Treated with fluids and anti-inflammatories at ER. No labs drawn at this time due to vital signs. Patient followed up next day (day 11) to rule out meningitis and encephalitis. Asymptomatic at that time, however, later that night patient presented again to ER with 102.8 degree temperature, tachycardia and was treated for possible streptococcal pharyngitis. Rapidstrep, CBC and monospot labs taken, and later results were positive for infectious mononucleosis, which could have contributed to systemic spread by suppressing the immune system. The next day (day 12, 21SEP2015) patient presented with multiple smallpox lesions on the feet, one on the face, four on the lower back, and one on the right leg along with the same number of satellite lesions as noted on day 9. Patient referred to Dermatology same day, diagnosed with generalized vaccinia due to systemic spread and not accidental autoinoculation. Normal vital signs noted and recommended isolation precautions x14 days. Patient currently is checked twice a day to monitor for vital signs and possible development of new lesions.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pharyngeal oedema, Throat irritation
Clinical narrative: Pt had swelling of upper lip, itching of throat and then swelling of throat.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Notable swelling and rash (swollen and red) per patient.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Biliary cirrhosis primary, Blood alkaline phosphatase increased, Fatigue
Clinical narrative: Felt extremely tired for 6 weeks after vaccination. Abnormal liver labs just started 5 weeks after vaccination. Diagnosis of Primary Biliary Cirrhosis in September at clinic.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Liver function test abnormal
Clinical narrative: Felt extremely tired for 6 weeks after vaccination. Abnormal liver labs just started 5 weeks after vaccination. Diagnosis of Primary Biliary Cirrhosis in September at clinic.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hepatic enzyme increased, Muscle spasms
Clinical narrative: Felt extremely tired for 6 weeks after vaccination. Abnormal liver labs just started 5 weeks after vaccination. Diagnosis of Primary Biliary Cirrhosis in September at clinic.
Sex: U
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number (2015262159). This was originally reported by a physician concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown), which was administered incorrectly in the triceps tendon (also reported as in the shoulder on deltoid tendon) (Lot. No., dose and route were not reported). No concomitant therapy was provided. On an unknown date, the patient was in a lot of pain and ended up being hospitalized for two days. The shot was administered in a pharmacy. No Product Quality Complaint (PQC) was involved. The outcome of pain was unknown. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Dyspnoea, Flushing, Headache, Heart rate increased, Lacrimation increased
Clinical narrative: About 5 minutes after receiving both vaccines, patient stated that she had a left-sided headache and felt like her head wanted to explode. Her face flushed, her eyes became red and watery. She started to have SOB and wheezing. The heart rate increased from the 120's - 130's from 99.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Ocular hyperaemia, Wheezing
Clinical narrative: About 5 minutes after receiving both vaccines, patient stated that she had a left-sided headache and felt like her head wanted to explode. Her face flushed, her eyes became red and watery. She started to have SOB and wheezing. The heart rate increased from the 120's - 130's from 99.
Age: 63.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Dizziness, Dysphagia, Heart rate increased, Urticaria
Clinical narrative: 9/12/15-c/o dizziness. 9/14/15-hard to swallow. 9/15/15-hives (R) and (L) leg, rapid heart rate, trouble swallowing.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Hyperhidrosis, Lethargy, Malaise
Clinical narrative: Malaised, lethargic, sweating, chills mild fever, nausea and headache.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Malaised, lethargic, sweating, chills mild fever, nausea and headache.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Arm was red around sites the size of half dollar. Advised to take BENADRYL and use cold compress.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Malaise, Vomiting
Clinical narrative: Felt extremely sick and threw up after taking metformin.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Felt extremely sick and threw up after taking metformin.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: About 24 hrs after ZOSTAVAX, had soreness and an approximately 5 in. diameter red area around injection site. 48 hours later, soreness has improved. Left arm.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Gastrointestinal disorder, Genital rash, Stomatitis
Clinical narrative: Lining of mouth irritated; bowel problem, rash genital area.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Gastrointestinal disorder, Rash generalised, Stomatitis
Clinical narrative: Lining of mouth irritated, bowel problem; full body rash; blistering on foot incision.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Lymph node pain, Neck pain, Pain
Clinical narrative: Was given Friday Sept 18, still sore, sharp pain up neck to glands under ear-still some pain Tuesday Sept 22-injection site-bruised.
Age: 35.0
Sex: U
Vaccine: FLU3
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Parent reported severe cramping, stabbing pain from shoulder to fingertips approximately 1 hour after receiving flu shot.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: 24 hours after patient received vaccines (2) she got really red, bright red on face, neck, chest, shoulder area. Patient started taking BENADRYL and ZYRTEC for the hives/redness.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Nausea, Paraesthesia, Paraesthesia oral, Throat irritation
Clinical narrative: Approximately one hour after receiving flu vaccine, patient returns to clinic c/o, not feeling well", nausea, tingling fingertips and lips. At that time denies SOB/difficulty breathing. Soon began experiencing "itchy throat". Assessed by doctor. Released home with Rx for oral BENADRYL.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Patient returned to office with swelling to left arm where injection was administered. Patient advised to ice arm, admin ibuprofen or TYLENOL and to continue to monitor for other signs and symptoms and if trouble breathing call 911.