chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Arthralgia, C-reactive protein increased, Conjunctival hyperaemia, Conjunctivitis
Clinical narrative: Based on the second medical examination of the case during internal review on 10 February 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from healthcare professional on 03 February 2014. A 04-year-old female patient, who has no relevant medical history with no illness at the time of vaccination, had received intramuscular dose of DAPTACEL, batch number: C4457AA having expiry date 11 December 2015 in left deltoid (dose number not reported), subcutaneous dose of IPOL, batch number: J1028 having expiry date 09 February 2015 in right arm (dose number not reported), subcutaneous dose of MMR, batch number: J006955 in left arm (dose number not reported) of another manufacturer and subcutaneous dose of MEASLES/MUMPS/RUBELLA/VARICELLA-ZOSTER VACCINE, batch number: J005692 in right arm (dose number not reported) of other manufacturer on 17 January 2014. It was reported that on 27 January 2014 i.e. 10 days after receiving vaccine, the patient developed a serum sickness like reaction with symptoms of rash, fever, headache, joint aches and belly aches. Reporter stated patient was not admitted to the hospital. The corrective treatment was not reported. in Laboratory investigations, CBC was found normal; sedimentation rate was 3.7 with elevated liver function studies. At time of this report, the outcome was unknown. Documents held by sender: none. Addendum 14 February 2014: Upon second medical examination of case at time of internal review on 10 February 2014, the following has been modified in this case: The case has been identified as serious due to the event serum sickness and hence upgraded accordingly. The event developed a serum sickness like reaction had been taken as diagnosis and the other events as symptoms of serum sickness like reaction. Previously this case was processed as non-serious case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Full blood count, Laboratory test, Liver function test abnormal, Pain, Platelet count increased
Clinical narrative: Based on the second medical examination of the case during internal review on 10 February 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from healthcare professional on 03 February 2014. A 04-year-old female patient, who has no relevant medical history with no illness at the time of vaccination, had received intramuscular dose of DAPTACEL, batch number: C4457AA having expiry date 11 December 2015 in left deltoid (dose number not reported), subcutaneous dose of IPOL, batch number: J1028 having expiry date 09 February 2015 in right arm (dose number not reported), subcutaneous dose of MMR, batch number: J006955 in left arm (dose number not reported) of another manufacturer and subcutaneous dose of MEASLES/MUMPS/RUBELLA/VARICELLA-ZOSTER VACCINE, batch number: J005692 in right arm (dose number not reported) of other manufacturer on 17 January 2014. It was reported that on 27 January 2014 i.e. 10 days after receiving vaccine, the patient developed a serum sickness like reaction with symptoms of rash, fever, headache, joint aches and belly aches. Reporter stated patient was not admitted to the hospital. The corrective treatment was not reported. in Laboratory investigations, CBC was found normal; sedimentation rate was 3.7 with elevated liver function studies. At time of this report, the outcome was unknown. Documents held by sender: none. Addendum 14 February 2014: Upon second medical examination of case at time of internal review on 10 February 2014, the following has been modified in this case: The case has been identified as serious due to the event serum sickness and hence upgraded accordingly. The event developed a serum sickness like reaction had been taken as diagnosis and the other events as symptoms of serum sickness like reaction. Previously this case was processed as non-serious case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Polymerase chain reaction, Pruritus, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Based on the second medical examination of the case during internal review on 10 February 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from healthcare professional on 03 February 2014. A 04-year-old female patient, who has no relevant medical history with no illness at the time of vaccination, had received intramuscular dose of DAPTACEL, batch number: C4457AA having expiry date 11 December 2015 in left deltoid (dose number not reported), subcutaneous dose of IPOL, batch number: J1028 having expiry date 09 February 2015 in right arm (dose number not reported), subcutaneous dose of MMR, batch number: J006955 in left arm (dose number not reported) of another manufacturer and subcutaneous dose of MEASLES/MUMPS/RUBELLA/VARICELLA-ZOSTER VACCINE, batch number: J005692 in right arm (dose number not reported) of other manufacturer on 17 January 2014. It was reported that on 27 January 2014 i.e. 10 days after receiving vaccine, the patient developed a serum sickness like reaction with symptoms of rash, fever, headache, joint aches and belly aches. Reporter stated patient was not admitted to the hospital. The corrective treatment was not reported. in Laboratory investigations, CBC was found normal; sedimentation rate was 3.7 with elevated liver function studies. At time of this report, the outcome was unknown. Documents held by sender: none. Addendum 14 February 2014: Upon second medical examination of case at time of internal review on 10 February 2014, the following has been modified in this case: The case has been identified as serious due to the event serum sickness and hence upgraded accordingly. The event developed a serum sickness like reaction had been taken as diagnosis and the other events as symptoms of serum sickness like reaction. Previously this case was processed as non-serious case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Red blood cell sedimentation rate increased, Serum sickness, Swelling, Urine analysis, Vasculitic rash
Clinical narrative: Based on the second medical examination of the case during internal review on 10 February 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from healthcare professional on 03 February 2014. A 04-year-old female patient, who has no relevant medical history with no illness at the time of vaccination, had received intramuscular dose of DAPTACEL, batch number: C4457AA having expiry date 11 December 2015 in left deltoid (dose number not reported), subcutaneous dose of IPOL, batch number: J1028 having expiry date 09 February 2015 in right arm (dose number not reported), subcutaneous dose of MMR, batch number: J006955 in left arm (dose number not reported) of another manufacturer and subcutaneous dose of MEASLES/MUMPS/RUBELLA/VARICELLA-ZOSTER VACCINE, batch number: J005692 in right arm (dose number not reported) of other manufacturer on 17 January 2014. It was reported that on 27 January 2014 i.e. 10 days after receiving vaccine, the patient developed a serum sickness like reaction with symptoms of rash, fever, headache, joint aches and belly aches. Reporter stated patient was not admitted to the hospital. The corrective treatment was not reported. in Laboratory investigations, CBC was found normal; sedimentation rate was 3.7 with elevated liver function studies. At time of this report, the outcome was unknown. Documents held by sender: none. Addendum 14 February 2014: Upon second medical examination of case at time of internal review on 10 February 2014, the following has been modified in this case: The case has been identified as serious due to the event serum sickness and hence upgraded accordingly. The event developed a serum sickness like reaction had been taken as diagnosis and the other events as symptoms of serum sickness like reaction. Previously this case was processed as non-serious case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Vasculitis, White blood cell count normal
Clinical narrative: Based on the second medical examination of the case during internal review on 10 February 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from healthcare professional on 03 February 2014. A 04-year-old female patient, who has no relevant medical history with no illness at the time of vaccination, had received intramuscular dose of DAPTACEL, batch number: C4457AA having expiry date 11 December 2015 in left deltoid (dose number not reported), subcutaneous dose of IPOL, batch number: J1028 having expiry date 09 February 2015 in right arm (dose number not reported), subcutaneous dose of MMR, batch number: J006955 in left arm (dose number not reported) of another manufacturer and subcutaneous dose of MEASLES/MUMPS/RUBELLA/VARICELLA-ZOSTER VACCINE, batch number: J005692 in right arm (dose number not reported) of other manufacturer on 17 January 2014. It was reported that on 27 January 2014 i.e. 10 days after receiving vaccine, the patient developed a serum sickness like reaction with symptoms of rash, fever, headache, joint aches and belly aches. Reporter stated patient was not admitted to the hospital. The corrective treatment was not reported. in Laboratory investigations, CBC was found normal; sedimentation rate was 3.7 with elevated liver function studies. At time of this report, the outcome was unknown. Documents held by sender: none. Addendum 14 February 2014: Upon second medical examination of case at time of internal review on 10 February 2014, the following has been modified in this case: The case has been identified as serious due to the event serum sickness and hence upgraded accordingly. The event developed a serum sickness like reaction had been taken as diagnosis and the other events as symptoms of serum sickness like reaction. Previously this case was processed as non-serious case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Arthralgia, Full blood count, Full blood count normal, Headache
Clinical narrative: Based on the second medical examination of the case during internal review on 10 February 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from healthcare professional on 03 February 2014. A 04-year-old female patient, who has no relevant medical history with no illness at the time of vaccination, had received intramuscular dose of DAPTACEL, batch number: C4457AA having expiry date 11 December 2015 in left deltoid (dose number not reported), subcutaneous dose of IPOL, batch number: J1028 having expiry date 09 February 2015 in right arm (dose number not reported), subcutaneous dose of MMR, batch number: J006955 in left arm (dose number not reported) of another manufacturer and subcutaneous dose of MEASLES/MUMPS/RUBELLA/VARICELLA-ZOSTER VACCINE, batch number: J005692 in right arm (dose number not reported) of other manufacturer on 17 January 2014. It was reported that on 27 January 2014 i.e. 10 days after receiving vaccine, the patient developed a serum sickness like reaction with symptoms of rash, fever, headache, joint aches and belly aches. Reporter stated patient was not admitted to the hospital. The corrective treatment was not reported. in Laboratory investigations, CBC was found normal; sedimentation rate was 3.7 with elevated liver function studies. At time of this report, the outcome was unknown. Documents held by sender: none. Addendum 14 February 2014: Upon second medical examination of case at time of internal review on 10 February 2014, the following has been modified in this case: The case has been identified as serious due to the event serum sickness and hence upgraded accordingly. The event developed a serum sickness like reaction had been taken as diagnosis and the other events as symptoms of serum sickness like reaction. Previously this case was processed as non-serious case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Hepatic enzyme increased, Pyrexia, Rash, Red blood cell sedimentation rate, Serum sickness-like reaction
Clinical narrative: Based on the second medical examination of the case during internal review on 10 February 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from healthcare professional on 03 February 2014. A 04-year-old female patient, who has no relevant medical history with no illness at the time of vaccination, had received intramuscular dose of DAPTACEL, batch number: C4457AA having expiry date 11 December 2015 in left deltoid (dose number not reported), subcutaneous dose of IPOL, batch number: J1028 having expiry date 09 February 2015 in right arm (dose number not reported), subcutaneous dose of MMR, batch number: J006955 in left arm (dose number not reported) of another manufacturer and subcutaneous dose of MEASLES/MUMPS/RUBELLA/VARICELLA-ZOSTER VACCINE, batch number: J005692 in right arm (dose number not reported) of other manufacturer on 17 January 2014. It was reported that on 27 January 2014 i.e. 10 days after receiving vaccine, the patient developed a serum sickness like reaction with symptoms of rash, fever, headache, joint aches and belly aches. Reporter stated patient was not admitted to the hospital. The corrective treatment was not reported. in Laboratory investigations, CBC was found normal; sedimentation rate was 3.7 with elevated liver function studies. At time of this report, the outcome was unknown. Documents held by sender: none. Addendum 14 February 2014: Upon second medical examination of case at time of internal review on 10 February 2014, the following has been modified in this case: The case has been identified as serious due to the event serum sickness and hence upgraded accordingly. The event developed a serum sickness like reaction had been taken as diagnosis and the other events as symptoms of serum sickness like reaction. Previously this case was processed as non-serious case.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Migraine, Migraine with aura
Clinical narrative: Pt. reporting migrains after flu shot administration.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Migraine
Clinical narrative: Pt. reporting migrains after flu shot administration.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis, Dermatitis contact, Rash erythematous, Secretion discharge
Clinical narrative: Felt like something was in my right eye; later that afternoon looked like conjunctivitis and right side of nose seemed to have contact dermatitis, which quickly got worse and was oozing one day later...odd pattern of red rash began on half face.
Age: 1.03
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient was given the wrong vaccine. Patient was due for MMR, and was given Menveo.
Age: 1.04
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Polymerase chain reaction, Vaccination site vesicles, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Patient developed varicella (varicella zoster PCR from one of the 4 vesicles at vaccine site was positive) 10 days after VARIVAX given.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Condition aggravated, Diabetes mellitus, Dizziness
Clinical narrative: Injection site swelled on right forearm injection site. Injection site started itching really bad. I itched the injection site around the swelling. I became severely dizzy with an internal nausea feeling. My wife thought I was having a heart attack. I tried laying down and started getting sicker so I sat back up and wondered what in the world was going on. My wife took me back to the doctors office 15 minutes after I received the injection. They placed me in a wheel chair and placed some cold paper towels on my forehead, took vitals. The cold paper towels started reducing my severe dizziness so I refused the ER at this time fear of another injection and affordability of ER. My spine hurts worse. Diabetes feels worse 25 days later my liver enzymes are up.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Glycosylated haemoglobin increased, Hepatic enzyme increased, Injection site pruritus, Injection site swelling, Malaise
Clinical narrative: Injection site swelled on right forearm injection site. Injection site started itching really bad. I itched the injection site around the swelling. I became severely dizzy with an internal nausea feeling. My wife thought I was having a heart attack. I tried laying down and started getting sicker so I sat back up and wondered what in the world was going on. My wife took me back to the doctors office 15 minutes after I received the injection. They placed me in a wheel chair and placed some cold paper towels on my forehead, took vitals. The cold paper towels started reducing my severe dizziness so I refused the ER at this time fear of another injection and affordability of ER. My spine hurts worse. Diabetes feels worse 25 days later my liver enzymes are up.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Spinal pain
Clinical narrative: Injection site swelled on right forearm injection site. Injection site started itching really bad. I itched the injection site around the swelling. I became severely dizzy with an internal nausea feeling. My wife thought I was having a heart attack. I tried laying down and started getting sicker so I sat back up and wondered what in the world was going on. My wife took me back to the doctors office 15 minutes after I received the injection. They placed me in a wheel chair and placed some cold paper towels on my forehead, took vitals. The cold paper towels started reducing my severe dizziness so I refused the ER at this time fear of another injection and affordability of ER. My spine hurts worse. Diabetes feels worse 25 days later my liver enzymes are up.
Sex: U
Vaccine: FLU3
Symptoms: Injection site infection, Laboratory test
Clinical narrative: Initial case received from pharmacist on 10 February 2014. An unspecified patient, age and gender not reported, received a dose of FLUZONE Intradermal (lot number and site of administration not reported) and subsequently experienced an injection site infection. The event required an ER or doctor's visit. No additional information was reported. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 64 year old female patient. Patients medical history, drug reactions and allergies were unspecified. On 18-DEC-2006, the patient was vaccinated with ZOSTAVAX Subcutaneous Injection, (dose, frequency, route of administration, lot number and expiry date were unspecified) for vaccination. Concomitant medications were unspecified. On 13-JAN-2014, the patient was evaluated in the reporters office and was diagnosed with shingles. The patient was referred to an unspecified ophthalmologist and was prescribed steroid (unspecified) eye drops. No intervention required to prevent any serious criteria. There was no disability or incapacity to the patient due to the event. No hospitalization required to treat the event. The event was not life threatening. No product quality complaint was involved. The outcome of the event was unknown. The reporters causality for the event with the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Body temperature, Body temperature increased, Chills, Influenza
Clinical narrative: This case was obtained from a non-scientific publication on 10 February 2014. A 25 year old female patient, with an medical history and concomitant medications was vaccinated with flu vaccine last November, year not specified, (manufacturer, batch, site and route of administration were not reported). The patient's mother vaccinated her family every year. The patient's previous medications were not reported. On an unspecified date the patient developed back pain, chills and a fever of 101 degrees. The patient was advised by her mother to visit a doctor right away where an "on-the-spot test" confirmed she had influenza. The patient was treated with TAMIFLU, dose, route and duration were not reported. The patient's mother stated that "the doctors seem to think that her flu strain probably wasn't covered in the flu shot". The patient outcome was not reported. Further details were not available at the time of this report. Documents held by sender: None.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza virus test, Influenza virus test positive, Pyrexia
Clinical narrative: This case was obtained from a non-scientific publication on 10 February 2014. A 25 year old female patient, with an medical history and concomitant medications was vaccinated with flu vaccine last November, year not specified, (manufacturer, batch, site and route of administration were not reported). The patient's mother vaccinated her family every year. The patient's previous medications were not reported. On an unspecified date the patient developed back pain, chills and a fever of 101 degrees. The patient was advised by her mother to visit a doctor right away where an "on-the-spot test" confirmed she had influenza. The patient was treated with TAMIFLU, dose, route and duration were not reported. The patient's mother stated that "the doctors seem to think that her flu strain probably wasn't covered in the flu shot". The patient outcome was not reported. Further details were not available at the time of this report. Documents held by sender: None.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a female patient of unknown age. No medical history was reported. It was reported that the patient was currently pregnant, but no further details were provided. On 24-JAN-2014 the patient was vaccinated with M-M-R II (albumin status: rHA), subcutaneous for vaccination. Lot number was reported as 0664AA with an expiration date of 04-MAY-2013. Therefore, this concerned an expired dose of M-M-R II. No adverse effects or any details regarding the patient's pregnancy were reported. No further information was provided. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Discomfort, Dry skin, Pain, Pain in extremity
Clinical narrative: Pt reported pain and tingling near injection site and around arm and into breast area. Unable to wear bra/clothing comfortably. No visible rash, but pt. reports skin feels "rough." Started on 1/24/14.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Pt reported pain and tingling near injection site and around arm and into breast area. Unable to wear bra/clothing comfortably. No visible rash, but pt. reports skin feels "rough." Started on 1/24/14.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Heart rate increased, Laboratory test, Ocular hyperaemia
Clinical narrative: Initial report was received on 07 February 2014 from a non healthcare professional. An adult female had received a 0.5 ml dose of FLUZONE, lot number UH892AA (route, site and date of administration not reported) and four hours later, was admitted to the ER with a very swollen throat and mouth, increased heart rate, difficulty breathing and red eyes. The symptoms resolved around 11 PM and then the patient developed body chills. According to the report, the patient had never been diagnosed with an egg allergy. No further information was provided at the time of the report. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Oedema mouth, Pharyngeal oedema
Clinical narrative: Initial report was received on 07 February 2014 from a non healthcare professional. An adult female had received a 0.5 ml dose of FLUZONE, lot number UH892AA (route, site and date of administration not reported) and four hours later, was admitted to the ER with a very swollen throat and mouth, increased heart rate, difficulty breathing and red eyes. The symptoms resolved around 11 PM and then the patient developed body chills. According to the report, the patient had never been diagnosed with an egg allergy. No further information was provided at the time of the report. Documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Malaise
Clinical narrative: 2 to 3 days post vaccine her joints that are already affected with arthritis swelled and were painful. This pain was also accompanied by feeling of malaise. Both resolved in 4-5 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Dyspnoea, Exercise tolerance decreased, Guillain-Barre syndrome
Clinical narrative: Back pain. Developed symptoms of weakness, numbness and tingling extremities, shortness of breath, activity intolerance - Guillain Barre - hospitalization 11-6 - 11-16 IGG therapy. I would like to know why these serious adverse events are not being reported. Guillain Barre is a horrible syndrome to live with. It is much more common than 2 in one million. Nurses in the hospital named over 2 to 3 people who had the syndrome. This is a rural community concerned.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture, Paraesthesia
Clinical narrative: Back pain. Developed symptoms of weakness, numbness and tingling extremities, shortness of breath, activity intolerance - Guillain Barre - hospitalization 11-6 - 11-16 IGG therapy. I would like to know why these serious adverse events are not being reported. Guillain Barre is a horrible syndrome to live with. It is much more common than 2 in one million. Nurses in the hospital named over 2 to 3 people who had the syndrome. This is a rural community concerned.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Neck pain
Clinical narrative: This patient rec'd his first HPV on 8/9/2013 and his second on 2/11/2014.  On both injections, he developed severe neck pain on the same side of his body that he rec'd his injections.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy bone marrow, Blood test, Dyspepsia, Platelet count decreased, Thrombocytopenia
Clinical narrative: I had a blood test for a digestive problem and my platelet count had dropped to 85,000.  I was checked again on 01/30/14 and my platelet count had dropped to 4,000.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy bone marrow abnormal, Dyspepsia, Platelet count decreased, Thrombocytopenia
Clinical narrative: I had a blood test for a digestive problem and my platelet count had dropped to 85,000.  I was checked again on 01/30/14 and my platelet count had dropped to 4,000.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Nausea, fever/feeling of warmth over whole body, pain with movement of arm, warmth at injection site, swelling and redness at injection site (left arm at deltoid site).
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Nausea, fever/feeling of warmth over whole body, pain with movement of arm, warmth at injection site, swelling and redness at injection site (left arm at deltoid site).
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling to left arm at injection site.
Age: 0.33
Sex: M
Vaccine: PNC
Symptoms: Electroencephalogram abnormal, Infantile spasms
Clinical narrative: Infantile spasms and West syndrome.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Muscle spasms, Nausea, Sensation of pressure, Tremor
Clinical narrative: Reported nausea, tremors, "pressure" and "burning" in upper spine area.  Spasms in back.  Treated with Benadryl 50 mg IM, ibuprofen 800 mg PO, Valium 5 mg PO, and Benadryl 50 mg PO.  Reported to have hives that night also.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: Reported nausea, tremors, "pressure" and "burning" in upper spine area.  Spasms in back.  Treated with Benadryl 50 mg IM, ibuprofen 800 mg PO, Valium 5 mg PO, and Benadryl 50 mg PO.  Reported to have hives that night also.
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Discomfort, Headache, Immediate post-injection reaction, Injection site pain, Insomnia
Clinical narrative: Patient reported on 02/11/2014 that immediately following vaccination she experienced pain in her left arm and neck and developed a headache. She stated these symptoms subsided after 24 hours. Reported still having soreness at the injection site. Denies any warmth, or redness. States not painful to touch. Feels as if muscle is "pulling" during certain activities. Reports difficulty sleeping due to discomfort. Interventions include Ibuprofen. Advised to report to PCP.
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Musculoskeletal discomfort, Neck pain, Pain in extremity
Clinical narrative: Patient reported on 02/11/2014 that immediately following vaccination she experienced pain in her left arm and neck and developed a headache. She stated these symptoms subsided after 24 hours. Reported still having soreness at the injection site. Denies any warmth, or redness. States not painful to touch. Feels as if muscle is "pulling" during certain activities. Reports difficulty sleeping due to discomfort. Interventions include Ibuprofen. Advised to report to PCP.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Eye swelling, Rash
Clinical narrative: Pt reports rash on right arm and upper torso, as well as peri orbital swelling. Pt was advised to take Benadryl 25mg and visit the emergency room for evaluation.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchospasm, Cough, Dyspnoea, Eye discharge, Eye pruritus
Clinical narrative: Bronchoconstriction and shortness of breath with cough lasting about 2 hours. Red, itchy eyes with discharge upon waking the next morning. Soreness and swelling at injection site.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Ocular hyperaemia
Clinical narrative: Bronchoconstriction and shortness of breath with cough lasting about 2 hours. Red, itchy eyes with discharge upon waking the next morning. Soreness and swelling at injection site.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Patient was unaware that she was pregnant at the time of vaccination.  The first day of her last period was 1/1/2014 and was vaccinated on 1/21/2014, and miscarried on 1/29/2014.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Influenza
Clinical narrative: Flu symptoms. Numbness in back and feet. Back pain. Pain all over.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Flu symptoms. Numbness in back and feet. Back pain. Pain all over.
Sex: U
Vaccine: HEP, HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from a pharmacist regarding patients of unknown demographics. The pharmacist reported a temperature excursion which resulted in GARDASIL, (lot number and expiry date were unspecified), injection for VAQTA (lot number and expiry date were unspecified) and RECOMBIVAX HB (lot number and expiry date were unspecified) being not supported. The reporter stated that there was a potential that the unsupported products might have been administered post excursion, but he was not sure and did not currently have any additional information to provide. Concomitant medication was unspecified. No adverse effects provided by patients. No product quality complaint involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 03-JUL-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB INJ 10, 0.5 ml, intramuscularly (lot number was not provided). No co-suspect or concomitant therapies were reported. The nurse reported that on 10-SEP-2013, the patient was vaccinated with the second dose of RECOMBIVAX HB INJ 10, 0.5 ml, intramuscularly (lot number not provided). No adverse effects were reported. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Patient got a Tdap on 2/12/14 and says it started itching on 2/14/14. It is still itchy today. Her doctor told her to use a hot pack on site.
Age: 1.05
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site nodule
Clinical narrative: Varicella given 1/30/14 to L. outer thigh per protocol. Immediately (L) thigh with increased redness extending 7cm in diameter - palpable knot. Cold pack applied and BENADRYL given PO. Hep A given in same leg but reaction at varicella site. Patient monitored 15 min w/redness decreased.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 37 year old female patient. On an unknown date approximately in 2008 while she was in the military service the patient was vaccinated with dose 1 (oka/merck) VARIVAX (dosage and lot# unspecified). The pharmacist reported that the patient had not received further doses. She currently had negative titers to varicella (date unspecified). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe pain, swelling, redness injection site, worsened after 3 days.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, Pregnancy
Clinical narrative: A report has been received from a Health Professional concerning product exposure during pregnancy in female patient. The patient's medical history and concomitant medications were not reported. It was reported that patient took FLUMIST (intranasal) two weeks ago (Jan-2014) for flu, then she discovered after that she was pregnant. The patient available for follow up and pregnancy result was unknown. The reporter considered the event of took FLUMIST then discovered she was pregnant to be serious with seriousness criteria of Important medical event.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Clostridium test negative, Clostridium test positive, Condition aggravated, Corynebacterium test negative
Clinical narrative: Information has been received from a published literature article. Nephrotic syndrome (NS) comprises of several signs and symptoms that denote kidney damage, which include proteinuria, hypoalbuminemia, hyperlipidemia, and edema. In addition, immune abnormalities have been reported to be associated with NS. We present 3 patients with congenital NS who demonstrate unique patterns of immune deficiency and illustrate the importance of immune evaluation in this condition. Case Report: Three 4-year old patients (two males and one female) presented with chronic nasal congestion, recurrent otitis and a history of frequent relapsing idiopathic minimal change NS. Immune evaluation revealed normal lymphocyte subsets, IgA and IgM, as well as protective antibody titers for tetanus and diphtheria. However, they were found to have IgG 300-400 and non-protective pneumococcal antibodies despite vaccination (manufacturer unknown). Variability was present in lymphocyte mitogen stimulation test with low pokeweed mitogen simulation response. This case report refers to one of the 4 year old male patient. Conclusion: Children with NS may have a high prevalence of impaired antibody response to pneumococci and pneumococcal polysaccharide vaccine (manufacturer unknown), which may lead to susceptibility to bacterial infections, particularly pneumococci. Thus, immune evaluation is warranted in this condition regardless of remission state. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Corynebacterium test positive, Immunology test normal, Nasal congestion, Nephrotic syndrome, Otitis media
Clinical narrative: Information has been received from a published literature article. Nephrotic syndrome (NS) comprises of several signs and symptoms that denote kidney damage, which include proteinuria, hypoalbuminemia, hyperlipidemia, and edema. In addition, immune abnormalities have been reported to be associated with NS. We present 3 patients with congenital NS who demonstrate unique patterns of immune deficiency and illustrate the importance of immune evaluation in this condition. Case Report: Three 4-year old patients (two males and one female) presented with chronic nasal congestion, recurrent otitis and a history of frequent relapsing idiopathic minimal change NS. Immune evaluation revealed normal lymphocyte subsets, IgA and IgM, as well as protective antibody titers for tetanus and diphtheria. However, they were found to have IgG 300-400 and non-protective pneumococcal antibodies despite vaccination (manufacturer unknown). Variability was present in lymphocyte mitogen stimulation test with low pokeweed mitogen simulation response. This case report refers to one of the 4 year old male patient. Conclusion: Children with NS may have a high prevalence of impaired antibody response to pneumococci and pneumococcal polysaccharide vaccine (manufacturer unknown), which may lead to susceptibility to bacterial infections, particularly pneumococci. Thus, immune evaluation is warranted in this condition regardless of remission state. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: FLUN4
Symptoms: Type 1 diabetes mellitus
Clinical narrative: A report from a health professional via medical representative concerns a child of unknown gender. No medical history, concurrent disease, or concomitant medications reported. On an unspecified date the patient received nasal FLUMIST Quadrivalent. On an unknown subsequent date the patient was diagnosed with type 1 diabetes. The outcome of the type 1 diabetes was unknown. The reporter assessed the event as non-serious. The company physician upgraded the event to serious due to medical importance. Corrected Report on 14-Feb-2014: the event of type 1 diabetes was upgraded to serious. Case upgraded to expeditable. Notes page and reporter order corrected. Responsible physician was deleted.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Clostridium test negative, Clostridium test positive, Condition aggravated, Corynebacterium test negative
Clinical narrative: Information has been received from a published literature article. Nephrotic syndrome (NS) comprises of several signs and symptoms that denote kidney damage, which include proteinuria, hypoalbuminemia, hyperlipidemia, and edema. In addition, immune abnormalities have been reported to be associated with NS. We present 3 patients with congenital NS who demonstrate unique patterns of immune deficiency and illustrate the importance of immune evaluation in this condition. Case Report: Three 4-year old patients (two males and one female) presented with chronic nasal congestion, recurrent otitis and a history of frequent relapsing idiopathic minimal change NS. Immune evaluation revealed normal lymphocyte subsets, IgA and IgM, as well as protective antibody titers for tetanus and diphtheria. However, they were found to have IgG 300-400 and non-protective pneumococcal antibodies despite vaccination. Variability was present in lymphocyte mitogen stimulation test with low pokeweed mitogen simulation response. This case report refers to one of the 4 year old male patient. Conclusion: Children with NS may have a high prevalence of impaired antibody response to pneumococci and pneumococcal polysaccharide vaccine, which may lead to susceptibility to bacterial infections, particularly pneumococci. Thus, immune evaluation is warranted in this condition regardless of remission state. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Corynebacterium test positive, Immunology test normal, Nasal congestion, Nephrotic syndrome, Otitis media
Clinical narrative: Information has been received from a published literature article. Nephrotic syndrome (NS) comprises of several signs and symptoms that denote kidney damage, which include proteinuria, hypoalbuminemia, hyperlipidemia, and edema. In addition, immune abnormalities have been reported to be associated with NS. We present 3 patients with congenital NS who demonstrate unique patterns of immune deficiency and illustrate the importance of immune evaluation in this condition. Case Report: Three 4-year old patients (two males and one female) presented with chronic nasal congestion, recurrent otitis and a history of frequent relapsing idiopathic minimal change NS. Immune evaluation revealed normal lymphocyte subsets, IgA and IgM, as well as protective antibody titers for tetanus and diphtheria. However, they were found to have IgG 300-400 and non-protective pneumococcal antibodies despite vaccination. Variability was present in lymphocyte mitogen stimulation test with low pokeweed mitogen simulation response. This case report refers to one of the 4 year old male patient. Conclusion: Children with NS may have a high prevalence of impaired antibody response to pneumococci and pneumococcal polysaccharide vaccine, which may lead to susceptibility to bacterial infections, particularly pneumococci. Thus, immune evaluation is warranted in this condition regardless of remission state. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient in her "Mid" 60 years old. In approximately February 2012 ("1-2 years prior"), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry date, dose, strength and route not reported). Concomitant therapies included TYLENOL. The physician reported that the patient developed a shingles outbreak in the "last two weeks" (on approximately 24-JAN-2014). The physician stated that the patient developed dermatomes on her "right side mid line to mid line from T5-T8 or 9". The patient was seen by the physician on an unspecified date. At the time of reporting, the outcome of the event was recovering. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Medical Assistant via Field Employee refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX single dose (route, dose and lot # were unknown). Without any concomitant vaccination. On an unknown date the patient experienced "a herpes outbreak" after receiving ZOSTAVAX. The outcome was unknown. No additional information was available pertaining to recovery time, treatment or severity of outbreak. The patient sought medical attention via contacting physician. This is one of two reports from the same reporter. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a Medical Assistant via Field Employee refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX Single dose (route, dose and lot # were unknown). Without any concomitant vaccination. On an unknown date the patient experienced extreme swelling of the arm, which lasted for an unspecified period of time. The patient was recovered within an unspecified period of time, without any intervention. The patient sought medical attention via contacting physician. This is one of two reports from the same reporter. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to the physician's 12 year old daughter. The physician stated that 11 years ago, approximately in 2003, the physician's 12 years old (she was currently 23 years old) got VARIVAX (Merck), (lot#, dose unknown) via "injection". It was unknown if this was her first VARIVAX (Merck) vaccination. "Six months to a year" after her injection, she developed shingles. It was said "shingles presented on T5 (thorax 5)". It was indicted that this physician did not treat it. On an unspecified date, the patient recovered from shingles. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site rash, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient. On 30-JUL-2013, the patient was vaccinated with ZOSTAVAX lot # J005850 (Expiry: 17-AUG-2014), 0.65 ml, subcutaneous. On 01-AUG-2013, 3 days after onset of therapy, the patient experienced a rash at the injection site that was 2-inches in diameter, was red, painful, itching and burning with a hive after receiving ZOSTAVAX. The patient sought medical attention and saw the pharmacist on 01-AUG-2013. The patient received BENADYRL. On 01-AUG-2013, the patient went to an unspecified urgent care when rash increased to 5-inches in diameter and received cephalexin. It was reported that on 02-AUG-2013, the patient returned to the pharmacy and rash had decreased in size to 2-inches. The outcome of the events at the injection site that was 2-inches in diameter, was red, painful, itching and burning with a hive was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient. On 30-JUL-2013, the patient was vaccinated with ZOSTAVAX lot # J005850 (Expiry: 17-AUG-2014), 0.65 ml, subcutaneous. On 01-AUG-2013, 3 days after onset of therapy, the patient experienced a rash at the injection site that was 2-inches in diameter, was red, painful, itching and burning with a hive after receiving ZOSTAVAX. The patient sought medical attention and saw the pharmacist on 01-AUG-2013. The patient received BENADYRL. On 01-AUG-2013, the patient went to an unspecified urgent care when rash increased to 5-inches in diameter and received cephalexin. It was reported that on 02-AUG-2013, the patient returned to the pharmacy and rash had decreased in size to 2-inches. The outcome of the events at the injection site that was 2-inches in diameter, was red, painful, itching and burning with a hive was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.