chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Rash, Rash erythematous
Clinical narrative: Extensive bruising and redness near injection site. Red rash moving down injection arm. Recommended 50 mg BENADRYL every 4-5 h as needed.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pallor, Injection site pruritus
Clinical narrative: Pt. had a white colored area around injection site (right arm). Also accompanied by itching and extreme redness on arm surrounding white patch of skin.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), lot # L015047, expiration date 29-APR-2017 (dose and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning 20 unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were inadvertently vaccinated with doses of VARIVAX (Merck) lot # L026410, expiration date 15-FEB-2017 (dose and route unspecified), which had been improperly stored. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning unspecified amount of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # reported as L0164228 with expiration date 30-JUL-2017, lot # L019287 with expiration date 14-SEP-2017 and lot # L019286 with expiration date 14-SEP-2017; dose and route unspecified). No adverse effects were reported. In addition, the reporter also stated that she was unsure if other improperly stored vaccines such as RECOMBIVAX HB, VAQTA, ROTATEQ, PEDVAXHIB or PNEUMOVAX 23 were also administered. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about patients concurrent conditions and medical history was not reported. On unknown dates the patients received doses of improperly stored (being exposed to temperatures outside of the recommended range) GARDASIL (dose and route not reported, lot# K007264 with expiration date 02-MAR-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Body mass index, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse and refers to a 5 year 4 month old female patient. Upon examination, the patient was found to be pleasant, alert and oriented in no apparent distress, well developed and well-nourished, cooperative, normal speech, non-focal exam. patient had no known drug allergies. The patient had dry skin, dermatitis atopic/folliculitis proteinuria and fee dog bits on her right lower leg. The patient's family (brother and maternal uncle) had history of asthma, paternal grandfather had history of Type 2 Diabetes and mother had depression. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) PROQUAD 0.5 ml (lot#K011311), on right vastus lateralis (incorrect product storage). Patient was concomitantly vaccinated with KINRIX 0.5 and PREVNAR 0.5 on left vastus lateralis. The patient's other medications included multi-vitamin gummy (1 gummy daily), fluoride, ivermectin topical and Ovide lotion. No adverse effect was reported. This is one of several reports from the same report. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse and refers to a 4 year old male patient. The patient had no known drug allergies. The patient was well nourished, alert, active, with normal tone and motor development, normal sensory system and reflexes and normal cranial nerves II-XII, but had ichthyosis. The patient's medical history included circumcision. After birth, the patient was in the NICU (neonatal intensive care unit) for 3 weeks. Patient had an innocent murmur with normal echocardiogram in 2013. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose of PROQUAD 0.5, dose 1, (lot #K011311), on the left vastus lateralis. Patient was concomitantly vaccinated with KINRIX 0.5 on right vastus lateralis. The patient's other medications included fluoride, amoxicillin, albuterol, BACTROBAN, and LAC HYDRIN cream. No adverse effect was reported. This is one of several reports from the same report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L010146, expiry date: 24-MAR-2017, dose, route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (lot # L023112, expiry date: 24-DEC-2016, dose, route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unknown dates the patients received doses of improperly stored (being exposed to temperatures outside of the recommended range) ROTATEQ (dose not reported, lot # L008578 with expiration date 14-DEC-2016) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unknown dates the patients received doses of improperly stored (being exposed to temperatures outside of the recommended range) VAQTA (dose and route not reported, lot # L007559 with expiration date 01-JUN-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. During the time period of 30-OCT-2015 through 04-NOV-2015, the patients were vaccinated with improperly stored VAQTA (lot # L018498, expiration date 28-APR-2016) (dose and route were not reported). No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Activities of daily living impaired, Dyskinesia, Muscle twitching, Streptococcus test, Thyroid function test
Clinical narrative: Patient started with tic of moving arm, turning head sharply to right.  Needing to snap fingers. Progressed to some vocal tics also.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Tic
Clinical narrative: Patient started with tic of moving arm, turning head sharply to right.  Needing to snap fingers. Progressed to some vocal tics also.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Antibody test negative, Dyskinesia, Thyroid function test normal, Tic
Clinical narrative: Patient started with tic of moving arm, turning head sharply to right.  Needing to snap fingers. Progressed to some vocal tics also.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Angioedema, Cough, Dyspnoea, Immediate post-injection reaction, Stridor
Clinical narrative: Anaphylaxis, hives, swelling within 1-2 minutes of receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Urticaria, Wheezing
Clinical narrative: Anaphylaxis, hives, swelling within 1-2 minutes of receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Anaphylactic reaction, Swelling, Urticaria
Clinical narrative: Anaphylaxis, hives, swelling within 1-2 minutes of receiving vaccine.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Face injury, Loss of consciousness
Clinical narrative: Initial unsolicited report received from a nurse via other company on 26 October 2015. This case is linked with 2015SA176376 and 2015SA176377 (same reporter). This case involves an adult male patient (age not reported) who was vaccinated with a dose of Influenza vaccine (batch number, route and site of administration not reported) and also received a dose of PNEUMOVAX 23 (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history was not reported and concomitant medications includes hydrochlorothiazide, trazodone and insulin. On an unspecified date, after the vaccination the patient had passed out and hit his face. The patient was then taken to the hospital where he was not admitted but kept overnight for observation, however nothing wrong was found with him. Laboratory investigations were not reported and the patient had received unspecified corrective treatment. The final outcome for the events was not reported. The case was assessed as serious due to overnight hospitalization. Documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Contusion, Mobility decreased, Swelling
Clinical narrative: Bruising and numbness at site of injection. Numbness has gone down to hand. Still sore, has been 15 days.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypoaesthesia, Injection site bruising, Injection site hypoaesthesia, Pain
Clinical narrative: Bruising and numbness at site of injection. Numbness has gone down to hand. Still sore, has been 15 days.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chest pain, Pain, Tachycardia, Urticaria
Clinical narrative: Headache, fever, chest pains, chills, very weak, heart rate 130, symptoms occurred about seven hours after flu vaccine was administered. Treatment was an emergency visit to the emergency ward at hospital, two bags of I.V. fluid, chest x-ray, blood draws.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Blood test, Chest X-ray, Chest pain, Chills
Clinical narrative: Headache, fever, chest pains, chills, very weak, heart rate 130, symptoms occurred about seven hours after flu vaccine was administered. Treatment was an emergency visit to the emergency ward at hospital, two bags of I.V. fluid, chest x-ray, blood draws.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Headache, Pyrexia
Clinical narrative: Headache, fever, chest pains, chills, very weak, heart rate 130, symptoms occurred about seven hours after flu vaccine was administered. Treatment was an emergency visit to the emergency ward at hospital, two bags of I.V. fluid, chest x-ray, blood draws.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Limb discomfort, Musculoskeletal discomfort
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: C-reactive protein increased, Flank pain, Joint range of motion decreased, Musculoskeletal pain, Myositis
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Nausea, Neck pain, Nuclear magnetic resonance imaging abnormal, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Back pain, C-reactive protein increased, Chest pain, Endoscopy gastrointestinal abnormal, Gastrointestinal haemorrhage
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Gastrointestinal viral infection, Haemoglobin decreased, Hallucination, Injection site rash, Mobility decreased
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Musculoskeletal pain, Myositis, Nausea, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased, Tenderness, Transfusion
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Type IV hypersensitivity reaction, White blood cell count increased
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Endoscopy, Gastrointestinal haemorrhage, Mobility decreased, Myositis, Transfusion
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: 10/28 started with local rash in left deltoid (1.5 in diameter). 10/30 nausea and aching arm and temp of 102.3. 10/31 morning went to urgent care and diagnosed as GI virus and arm as virus side effect. 10/31 evening fever of 104.3, hallucinating so we went to the ER and was diagnosed with GI virus and severe arm pain was a result of the virus. We were told to return if fever gets worse or rash develops. 11/1 rash near left arm pit developed, low fever and left side (chest, shoulder, back and arm) were in severe pain to touch so went back to ER.  He couldn't lift his arm at all.  After an MRI was diagnosed with delayed bacterial myositis. Admitted and given IV antibiotics.  11/2 Consultation with infectious disease specialist changed diagnosis to delayed hypersensitivity reaction to flu vaccine resulting in myositis.  Treated with steroids and NSAIDs which improved symptoms considerably.  11/4 Patient started having GI bleed.  They stopped steroids and NSAIDs.  11/5 Transferred to different hospital due to GI bleeding and had endoscope (find GI bleed but they had stopped bleeding).  Patient received two units of blood.  Myositis started to flare back up in left side.  11/7 Patient was released with continued left side myositis but was no longer a candidate for steroid or NSAID treatment due to GI bleed.  We were recommended to follow-up with Gastroenterologist, Hematologist, Infectious Disease Specialist, and Allergy/Immunologist.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Breast pain, Culture negative, Erythema, Hyperaesthesia
Clinical narrative: Pt with acute pain at injection site (l deltoid) that has not resolved, pt within 4-5 days developed fullness in axillae, then developed intermittent left breast pain. On 4 OCT 15 breast pain was constant. Mastitis in L breast developed and pt had surgery 7 OCT and had breast implant removed. Pt was 3 1/2 years post op, not breast feeding, no other trauma or invasive event took place but Flu immunization.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Incisional drainage, Induration, Injection site pain, Lip oedema, Malaise
Clinical narrative: Pt with acute pain at injection site (l deltoid) that has not resolved, pt within 4-5 days developed fullness in axillae, then developed intermittent left breast pain. On 4 OCT 15 breast pain was constant. Mastitis in L breast developed and pt had surgery 7 OCT and had breast implant removed. Pt was 3 1/2 years post op, not breast feeding, no other trauma or invasive event took place but Flu immunization.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Pruritus, Seroma, Swelling face, Ultrasound scan normal
Clinical narrative: Pt with acute pain at injection site (l deltoid) that has not resolved, pt within 4-5 days developed fullness in axillae, then developed intermittent left breast pain. On 4 OCT 15 breast pain was constant. Mastitis in L breast developed and pt had surgery 7 OCT and had breast implant removed. Pt was 3 1/2 years post op, not breast feeding, no other trauma or invasive event took place but Flu immunization.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Wrong technique in product usage process
Clinical narrative: Pt with acute pain at injection site (l deltoid) that has not resolved, pt within 4-5 days developed fullness in axillae, then developed intermittent left breast pain. On 4 OCT 15 breast pain was constant. Mastitis in L breast developed and pt had surgery 7 OCT and had breast implant removed. Pt was 3 1/2 years post op, not breast feeding, no other trauma or invasive event took place but Flu immunization.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Breast pain, Breast prosthesis removal, Discomfort, Injection site pain, Mastitis
Clinical narrative: Pt with acute pain at injection site (l deltoid) that has not resolved, pt within 4-5 days developed fullness in axillae, then developed intermittent left breast pain. On 4 OCT 15 breast pain was constant. Mastitis in L breast developed and pt had surgery 7 OCT and had breast implant removed. Pt was 3 1/2 years post op, not breast feeding, no other trauma or invasive event took place but Flu immunization.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated, Death, Decreased appetite, Disorientation
Clinical narrative: Flushing, dizziness, sweating and disoriented. Then he had an asthma attack. Was put on steroids. They helped minimally. Within the next few days he lost appetite, started hallucinating, lost continence and 17 days after his vaccination, he died.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Hallucination, Hyperhidrosis, Incontinence
Clinical narrative: Flushing, dizziness, sweating and disoriented. Then he had an asthma attack. Was put on steroids. They helped minimally. Within the next few days he lost appetite, started hallucinating, lost continence and 17 days after his vaccination, he died.
Age: 50.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal pain upper, Gastric hypomotility
Clinical narrative: RUQ AND EPIGASTRIC PAIN 3-4 DAYS AFTER ANTHRAX VACCINE 30 JUN 2015. PAIN LASTED ABOUT A MONTH AND GOT BETTER. 2ND ANTHRAX VACCINE 3AUG2015 WITH RELAPSE OF ABD PAIN FEW DAYS AFTER 2ND VACCINE. EXTENSIVE WORK UP SHOWED DELAYED GASTRIC MOTILITY. QUERY WHETHER ABD PAIN/DELAYED GASTRIC MOTILITY IS 2NDARY FROM ANTHRAX VACCINE. SHE HAS NO PRIOR HX OF ABD PAIN OR DX WITH DELAYED GASTRIC EMPTING.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Limb discomfort, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Vaccine given too high up on left arm at shoulder joint. Intense pain in shoulder and arm. Shoulder and arm warm to the touch, low grade fever, heaviness feeling in arm. Still having pain 6 weeks later.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Skin warm
Clinical narrative: Vaccine given too high up on left arm at shoulder joint. Intense pain in shoulder and arm. Shoulder and arm warm to the touch, low grade fever, heaviness feeling in arm. Still having pain 6 weeks later.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Pruritus, Swelling
Clinical narrative: Morning of injection - itching; Evening of injection - swelling, redness, itching, palpable mass in deltoid about the size of a silver dollar; arm goes to sleep easily and hand pain exists.  Is still that way, although redness has faded somewhat.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Upper extremity mass
Clinical narrative: Morning of injection - itching; Evening of injection - swelling, redness, itching, palpable mass in deltoid about the size of a silver dollar; arm goes to sleep easily and hand pain exists.  Is still that way, although redness has faded somewhat.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Condition aggravated, Hypertension
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research program, refers to herself, a 54 year old female patient. The patient's concurrent conditions included high blood pressure, hypertension and diabetes. The patient's medical history was not reported. On 04-NOV-2015, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On 04-NOV-2015, the patient experienced high blood pressure and was hospitalized. The outcome of the event was reported as recovering/resolving. The reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician and from a nurse via a company representative refers to a 5 year old male patient. There were no concomitant medications, concurrent conditions and medical history reported. On 23-SEP-2015, the patient was vaccinated with PREVNAR (route of administration, dose, lot# and expiration date were not reported). On 23-OCT-2015, the patient was vaccinated with one dose of PNEUMOVAX 23 lot # K020215 (route of administration and expiration date were not reported). On an unknown date in October 2015, after receiving PNEUMOVAX 23, the patient's whole arm was red, swollen, and painful. On an unknown date in October 2015, the patient was admitted to a hospital for an unspecified length of time. The physician reported that after 48 hours after being given the vaccine, the child began to normalize. The patient was treated with BENADRYL. The outcome of the events was reported as recovered/resolved on an unknown date in 2015. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Headache, Pain
Clinical narrative: This spontaneous report as received on 30-OCT-2015 from a 74 year old male patient refers to himself. No medical history, concurrent conditions and concomitant therapies were reported. On 27-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 subcutaneously (lot number, dose and anatomical location were not reported). On 28-OCT-2015 (reported as "the next day"), the patient experienced chills, headache, body aches, redness and soreness in his biceps area and feeling hot without having fever. No lab results were reported. On an unknown date, the patient sought medical attention and visited physician's office. Subsequently, he received treatment with BENADRYL (dose, frequency, route of administration were not specified). The outcome of feeling hot, headache, injection site pain, injection site erythema, chills and pain was reported as recovering. No product quality complaint was filed. The relatedness between events and PNEUMOVAX 23 was not reported. Additional information is not expected because no contact information was provided.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received on 30-OCT-2015 from a 74 year old male patient refers to himself. No medical history, concurrent conditions and concomitant therapies were reported. On 27-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 subcutaneously (lot number, dose and anatomical location were not reported). On 28-OCT-2015 (reported as "the next day"), the patient experienced chills, headache, body aches, redness and soreness in his biceps area and feeling hot without having fever. No lab results were reported. On an unknown date, the patient sought medical attention and visited physician's office. Subsequently, he received treatment with BENADRYL (dose, frequency, route of administration were not specified). The outcome of feeling hot, headache, injection site pain, injection site erythema, chills and pain was reported as recovering. No product quality complaint was filed. The relatedness between events and PNEUMOVAX 23 was not reported. Additional information is not expected because no contact information was provided.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to four patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with ROTATEQ orally (dose, dose number and lot# were not reported), which was improperly stored. No adverse effects were reported. On 19-OCT-2015, a telephone call was placed to the registered nurse, who was unable to provide the patient's identifiers at that time. Follow-up information has been received from the registered nurse on 20-OCT-2015. A 9-week-old patient (gender unknown) was vaccinated with an improperly stored dose of ROTATEQ lot# L000571, on 02-SEP-2015. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product, event information and narrative were updated.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 08-JUL-2014, the patient was vaccinated with a dose (the first dose in series) of GARDASIL (strength, dose, route of administration, lot # and expiration date were not provided). The office intended to have the patient complete the series of vaccination with GARDASIL 9 and on 15-SEP-2015, the patient was vaccinated with a dose (the second dose in series) of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not provided). On 30-OCT-2015, the patient was vaccinated with a dose (the third dose in series) of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not provided) which was given "too early". These were the only doses of GARDASIL and GARDASIL 9, this patient had received. No symptoms of adverse events were reported. The outcome of off label use was unknown. The relatedness between off label use and GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intensive care, Intussusception, Irritability, Melaena, Surgery
Clinical narrative: Vomiting and Melena.  Persistent irritability.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting and Melena.  Persistent irritability.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient awoke extremely dizzy, nauseated, throwing up; got some relief with cold cloth to forehead; symptoms would worsen when she tried to move; she is resting now, asleep since about 8:15 AM.  She is too ill to go into work today.  She felt well when she got the flu shot yesterday, which was the 4-in-1 shot.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Myalgia
Clinical narrative: Approximately 30 minutes after receiving the tetanus shot I began having labored breathing and extreme muscle pain in my middle back. My labored breathing continued for approx 4-5 hours and was somewhat relieved by taking 5 mg lortabs, given to me for my ear having been lanced. Soreness was relieved further by using a heat pad in the days after the injection. I am concerned others who may have the same reaction similar, could have a more extreme reaction leading to suffocation. I have in the past had at one point 3 broken (not cracked) ribs, my pain in breathing after my tetanus injection was equally comparable. This is the 4th day since the injection, my back is only slightly sore at this point. I do not feel any permanent was damage was done, but strongly feel this type of reaction should be noted and investigated.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Facial pain, Flushing, Full blood count, Lymph node pain
Clinical narrative: Starting within hours after getting shot with jaw and facial achiness, then the next day swollen, painful lymph gland on right side back of neck, then next day golf ball size swollen, painful lymph gland right armpit, was instructed to go to urgent care by physician I work with.  Also had general achiness with pain in hands/wrists, then a week later noticed facial flushing and low grade temp 99.2.  Follow-up appointment with MD on 11/3/15 who advised it could take up to 6 weeks for lymph node to fully resolve and also advised before ever getting another flu shot to have allergy testing.  I am an RN and have gotten the flu shot for many years and never had a reaction before this.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: Starting within hours after getting shot with jaw and facial achiness, then the next day swollen, painful lymph gland on right side back of neck, then next day golf ball size swollen, painful lymph gland right armpit, was instructed to go to urgent care by physician I work with.  Also had general achiness with pain in hands/wrists, then a week later noticed facial flushing and low grade temp 99.2.  Follow-up appointment with MD on 11/3/15 who advised it could take up to 6 weeks for lymph node to fully resolve and also advised before ever getting another flu shot to have allergy testing.  I am an RN and have gotten the flu shot for many years and never had a reaction before this.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Pruritus, Urticaria, Vertigo, Vomiting
Clinical narrative: Patient was sitting on cough, and experienced spinning and dizziness very badly. Then violent vomiting for 3 hours. Followed by itching on neck, arms. Left side of face and chest. Hives broke out on arms, face and chest. Itching continued for a few days. No treatment.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Axillary mass, Contusion, Erythema, Tenderness
Clinical narrative: Patient received 2 vaccines in left arm on 11-2-15. On 11-4-15 mom noticed bruise and softball size lump under arm. Area was red and tender to touch. Denies fever, nausea, vomiting, open sore or drainage. Mom will give BENADRYL, ice pack and monitor.
Age: 10.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: (L) upper arm - site where vaccine given - swollen, hard to the touch, red, and sore. Temp 100.1.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Peripheral swelling, Ultrasound scan
Clinical narrative: Extreme swelling of left arm with redness from shoulder to elbow, warmth and tenderness. Minimal soreness.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Arm at injection became sore and tender. Noticed four red areas around injection sight. Warm to touch. Patient applied ice packs and OTC ointment per self. Symptoms improved.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cough, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Notice hard area around injection site about the size of a tennis ball. Site was hot, hard, painful.  Started getting chills on and off thru-out the next two days.  Size grew to approx. a grapefruit, hard, hot, painful.  Myalgias started and continued x 48 hrs. Started having runny nose and cough Saturday.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: Notice hard area around injection site about the size of a tennis ball. Site was hot, hard, painful.  Started getting chills on and off thru-out the next two days.  Size grew to approx. a grapefruit, hard, hot, painful.  Myalgias started and continued x 48 hrs. Started having runny nose and cough Saturday.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Pain, swelling, difficulty raising arm.