chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Dysstasia, Movement disorder
Clinical narrative: Case number PHHY2016US065709, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System, reference number 631611 website on 11 May 2016. This report refers to a 76 year old male patient.  Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 06 Oct 2015. On 13 Nov 2015, the patient the patient felt weak and could not either stand or sit for a long time. Final outcome of the events was reported as condition unchanged. Seriousness and causality of the events were not reported.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Dysstasia
Clinical narrative: Case number PHHY2016US065709, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System, reference number 631611 website on 11 May 2016. This report refers to a 76 year old male patient.  Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 06 Oct 2015. On 13 Nov 2015, the patient the patient felt weak and could not either stand or sit for a long time. Final outcome of the events was reported as condition unchanged. Seriousness and causality of the events were not reported.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Burning sensation, Dizziness, Hypoaesthesia oral
Clinical narrative: This spontaneous report as received from a physician refers to a 48 years old, non pregnant female patient. The patient's medical history included chronic sinusitis, house dust allergy and food allergy. On 31-MAY-2016 the patient was vaccinated with PNEUMOVAX 23 lot # M005286, EXP. 08-OCT-2017, intramuscular in the left deltoid. The dose was not provided. Concomitant therapies included SINGULAIR. No other suspect or concomitant therapy were reported. On 31-MAY-2016, five minutes after onset of therapy the patient's blood pressure was high 178/120 (hypertensive crisis) and stated she could not breathe, she felt dizziness, back pain, flushed and felt hot burning sensation. Additionally, the pulse (Heart rate) was 92. Patient stated, "I felt like I was going to die (feeling abnormal) and my lips feel numb". The reporter stated that the patient was in the Dr's office at the time of the adverse events and she received treatment that includes CLARITIN (10 mg) and MOTRIN. The outcome of the adverse events was reported as recovered on 03-JUN-2016. Upon internal review the event of hypertensive crisis was considered medically significant. The causality between adverse events and PNEUMOVAX 23 was unknown. This report is one of two reports from the same reporter (1606USA011863). Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Blood pressure increased, Burning sensation, Dizziness, Dyspnoea
Clinical narrative: This spontaneous report as received from a physician refers to a 48 years old, non pregnant female patient. The patient's medical history included chronic sinusitis, house dust allergy and food allergy. On 31-MAY-2016 the patient was vaccinated with PNEUMOVAX 23 lot # M005286, EXP. 08-OCT-2017, intramuscular in the left deltoid. The dose was not provided. Concomitant therapies included SINGULAIR. No other suspect or concomitant therapy were reported. On 31-MAY-2016, five minutes after onset of therapy the patient's blood pressure was high 178/120 (hypertensive crisis) and stated she could not breathe, she felt dizziness, back pain, flushed and felt hot burning sensation. Additionally, the pulse (Heart rate) was 92. Patient stated, "I felt like I was going to die (feeling abnormal) and my lips feel numb". The reporter stated that the patient was in the Dr's office at the time of the adverse events and she received treatment that includes CLARITIN (10 mg) and MOTRIN. The outcome of the adverse events was reported as recovered on 03-JUN-2016. Upon internal review the event of hypertensive crisis was considered medically significant. The causality between adverse events and PNEUMOVAX 23 was unknown. This report is one of two reports from the same reporter (1606USA011863). Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling abnormal, Feeling hot, Flushing, Hypertensive crisis, Hypoaesthesia oral
Clinical narrative: This spontaneous report as received from a physician refers to a 48 years old, non pregnant female patient. The patient's medical history included chronic sinusitis, house dust allergy and food allergy. On 31-MAY-2016 the patient was vaccinated with PNEUMOVAX 23 lot # M005286, EXP. 08-OCT-2017, intramuscular in the left deltoid. The dose was not provided. Concomitant therapies included SINGULAIR. No other suspect or concomitant therapy were reported. On 31-MAY-2016, five minutes after onset of therapy the patient's blood pressure was high 178/120 (hypertensive crisis) and stated she could not breathe, she felt dizziness, back pain, flushed and felt hot burning sensation. Additionally, the pulse (Heart rate) was 92. Patient stated, "I felt like I was going to die (feeling abnormal) and my lips feel numb". The reporter stated that the patient was in the Dr's office at the time of the adverse events and she received treatment that includes CLARITIN (10 mg) and MOTRIN. The outcome of the adverse events was reported as recovered on 03-JUN-2016. Upon internal review the event of hypertensive crisis was considered medically significant. The causality between adverse events and PNEUMOVAX 23 was unknown. This report is one of two reports from the same reporter (1606USA011863). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bloody discharge, Culture, Erythema, Incisional drainage, Influenza like illness
Clinical narrative: Initial unsolicited report received from a non- healthcare professional (Office staff) on 07 June 2016. This case involves a 71-year-old female patient who was vaccinated with a dose ADACEL (batch number: U5406AA, expiration date, site and route of administration: not reported) on 10 May 2016. The patient had a medical history of rash on her face. Concomitant medications were not reported. On an unspecified date, few days after vaccination (reported as in the days after being given the vaccine), the patient experienced flu like symptoms. On 01 June 2016, 22 days following the vaccination the patient noticed thick yellow bloody drainage coming from the injection site. On 03 June 2016, 24 days following the vaccination patient had a cutaneous abscess at the injection site and also visited the physician on the same day. Lab data included culture test on which was negative (it grew nothing). The patient's corrective treatment was not reported. Outcome of the events was unknown. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Subcutaneous abscess
Clinical narrative: Initial unsolicited report received from a non- healthcare professional (Office staff) on 07 June 2016. This case involves a 71-year-old female patient who was vaccinated with a dose ADACEL (batch number: U5406AA, expiration date, site and route of administration: not reported) on 10 May 2016. The patient had a medical history of rash on her face. Concomitant medications were not reported. On an unspecified date, few days after vaccination (reported as in the days after being given the vaccine), the patient experienced flu like symptoms. On 01 June 2016, 22 days following the vaccination the patient noticed thick yellow bloody drainage coming from the injection site. On 03 June 2016, 24 days following the vaccination patient had a cutaneous abscess at the injection site and also visited the physician on the same day. Lab data included culture test on which was negative (it grew nothing). The patient's corrective treatment was not reported. Outcome of the events was unknown. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Influenza like illness, Injection site abscess, Injection site reaction, Purulent discharge
Clinical narrative: Initial unsolicited report received from a non- healthcare professional (Office staff) on 07 June 2016. This case involves a 71-year-old female patient who was vaccinated with a dose ADACEL (batch number: U5406AA, expiration date, site and route of administration: not reported) on 10 May 2016. The patient had a medical history of rash on her face. Concomitant medications were not reported. On an unspecified date, few days after vaccination (reported as in the days after being given the vaccine), the patient experienced flu like symptoms. On 01 June 2016, 22 days following the vaccination the patient noticed thick yellow bloody drainage coming from the injection site. On 03 June 2016, 24 days following the vaccination patient had a cutaneous abscess at the injection site and also visited the physician on the same day. Lab data included culture test on which was negative (it grew nothing). The patient's corrective treatment was not reported. Outcome of the events was unknown. List of documents held by sender: none.
Age: 8.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthma, Cough, Dyspnoea, Erythema, Petechiae
Clinical narrative: This spontaneous report as received from a physician refers to an 8 years old male patient. The patient's medical history included adenoidectomy, seasonal allergies and allergy to pet dander. On 21-JUN-2016 the patient was vaccinated with PNEUMOVAX 23 lot # M005286, intramuscular in the left arm. The dose was not provided. Concomitant therapies included NASONEX and ALLEGRA. No other suspect or concomitant therapy were reported. On 21-JUN-2016, five minutes after onset of therapy the patient experienced that "he could not breath", patient also presented petechiae, pulse ox dropped, heart rate was elevated to 86 beats per minute, the patient presented erythema of chest, face, arms and legs and was coughing with a productive cough. The reporter stated that the patient was in the Dr's office at the time of the adverse events and he received an unknown treatment. The outcome of the adverse events was reported as recovered on 21-JUN-2016. The causality between adverse events and PNEUMOVAX 23 was unknown. The is one of two reports from the same reporter (1606USA011031). Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Tachycardia
Clinical narrative: This spontaneous report as received from a physician refers to an 8 years old male patient. The patient's medical history included adenoidectomy, seasonal allergies and allergy to pet dander. On 21-JUN-2016 the patient was vaccinated with PNEUMOVAX 23 lot # M005286, intramuscular in the left arm. The dose was not provided. Concomitant therapies included NASONEX and ALLEGRA. No other suspect or concomitant therapy were reported. On 21-JUN-2016, five minutes after onset of therapy the patient experienced that "he could not breath", patient also presented petechiae, pulse ox dropped, heart rate was elevated to 86 beats per minute, the patient presented erythema of chest, face, arms and legs and was coughing with a productive cough. The reporter stated that the patient was in the Dr's office at the time of the adverse events and he received an unknown treatment. The outcome of the adverse events was reported as recovered on 21-JUN-2016. The causality between adverse events and PNEUMOVAX 23 was unknown. The is one of two reports from the same reporter (1606USA011031). Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Erythema, Heart rate increased, Oxygen saturation decreased, Petechiae
Clinical narrative: This spontaneous report as received from a physician refers to an 8 years old male patient. The patient's medical history included adenoidectomy, seasonal allergies and allergy to pet dander. On 21-JUN-2016 the patient was vaccinated with PNEUMOVAX 23 lot # M005286, intramuscular in the left arm. The dose was not provided. Concomitant therapies included NASONEX and ALLEGRA. No other suspect or concomitant therapy were reported. On 21-JUN-2016, five minutes after onset of therapy the patient experienced that "he could not breath", patient also presented petechiae, pulse ox dropped, heart rate was elevated to 86 beats per minute, the patient presented erythema of chest, face, arms and legs and was coughing with a productive cough. The reporter stated that the patient was in the Dr's office at the time of the adverse events and he received an unknown treatment. The outcome of the adverse events was reported as recovered on 21-JUN-2016. The causality between adverse events and PNEUMOVAX 23 was unknown. The is one of two reports from the same reporter (1606USA011031). Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Productive cough
Clinical narrative: This spontaneous report as received from a physician refers to an 8 years old male patient. The patient's medical history included adenoidectomy, seasonal allergies and allergy to pet dander. On 21-JUN-2016 the patient was vaccinated with PNEUMOVAX 23 lot # M005286, intramuscular in the left arm. The dose was not provided. Concomitant therapies included NASONEX and ALLEGRA. No other suspect or concomitant therapy were reported. On 21-JUN-2016, five minutes after onset of therapy the patient experienced that "he could not breath", patient also presented petechiae, pulse ox dropped, heart rate was elevated to 86 beats per minute, the patient presented erythema of chest, face, arms and legs and was coughing with a productive cough. The reporter stated that the patient was in the Dr's office at the time of the adverse events and he received an unknown treatment. The outcome of the adverse events was reported as recovered on 21-JUN-2016. The causality between adverse events and PNEUMOVAX 23 was unknown. The is one of two reports from the same reporter (1606USA011031). Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient called to report he has a rash, swelling, and tenderness at pneumo 23 inj site. Allergy list updated. Denies SOB, numbness/tingling in lips, mouth, tongue. Cool packs and BENADRYL. To ER if any SOB, tingling/numbness to mouth/lips/tongue. He voiced understanding.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Pt. developed fever and then proceeded to have 5 generalized tonic clonic seizures without returning to baseline in between. Required VERSED x2 and fosphenytoin load in ER.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Blister
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016247853) on 18-May-2016. This case was linked to 2016SA098084 (same reporter, same event). This case involves an 18-year-old male patient who was vaccinated with a dose of MENINGOCOCCAL VACCINE (batch number, expiry date, route and site of administration: not reported) on 25-Apr-2016. Patient's medical history and concomitant medication was not reported. On an unspecified date, following the vaccination, patient had blisters. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016262956) on 25 May 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of TETANUS TOXOID (Batch number, expiration date, dose, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient developed allergic to tetanus toxoid. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Grip strength decreased
Clinical narrative: Initial unsolicited report received from pharmacist via other company (Merck) on 27 May 2016. This case involves patient (age and gender was reported as unknown) who was vaccinated with dose of FLUZONE (batch number, expiry date, dose, and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination, patient lost the grip in his hands. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer via other company (pfizer) (under the reference number: 2016286705) on 09-JUN-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed allergy to vaccine. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Influenza like illness, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Arm extremely sore with the pain going into my shoulders. That night my muscles in my upper arm and armpit were a little swollen as well. 6/23 I started with a headache mid-morning. About 10:00 PM I had a welt come up on my upper arm around the shot area. It is approximately 4" X 8". I still have it. My shoulders, neck, and upper back are hurting like I have the flu. The area has a burning painful sensation and is hot to touch.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle swelling, Musculoskeletal pain, Pain in extremity, Urticaria
Clinical narrative: Arm extremely sore with the pain going into my shoulders. That night my muscles in my upper arm and armpit were a little swollen as well. 6/23 I started with a headache mid-morning. About 10:00 PM I had a welt come up on my upper arm around the shot area. It is approximately 4" X 8". I still have it. My shoulders, neck, and upper back are hurting like I have the flu. The area has a burning painful sensation and is hot to touch.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Cough, Decreased appetite, Echocardiogram, Electrocardiogram, Headache
Clinical narrative: The patient had a robust reaction Monday June 20th, with a low grade fever, general malaise, anorexia and left axillary lymphedema, 13 x 11 cm erythema and edema around the site around of the vaccine. The site had serous drainage. On June 21, he felt better, no fever, and the site improved with a scab. On Wednesday June 22, the worker c/o dyspnea on exertion from this morning and afternoon while walking to and from lunch and back to work. He stated he came in and took a nap at his desk and proceeded to the scheduled appointment. He has no chest pain or edema. He did report a slight headache and cough with a feeling in his throat that he needs to cough. The vaccine site looks improved with less erythema and lymphatic streaking fading. It is still warm to touch and continues having a scab. He was afebrile and still has non-tender left axillary lymphedema. After consulting an infectious disease doctor, it was decided that further evaluation was necessary to rule out myopericarditis and he went to the emergency department at a local hospital. He was evaluated and released the next day with negative findings. However he will have a stress test today.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site scab, Injection site streaking
Clinical narrative: The patient had a robust reaction Monday June 20th, with a low grade fever, general malaise, anorexia and left axillary lymphedema, 13 x 11 cm erythema and edema around the site around of the vaccine. The site had serous drainage. On June 21, he felt better, no fever, and the site improved with a scab. On Wednesday June 22, the worker c/o dyspnea on exertion from this morning and afternoon while walking to and from lunch and back to work. He stated he came in and took a nap at his desk and proceeded to the scheduled appointment. He has no chest pain or edema. He did report a slight headache and cough with a feeling in his throat that he needs to cough. The vaccine site looks improved with less erythema and lymphatic streaking fading. It is still warm to touch and continues having a scab. He was afebrile and still has non-tender left axillary lymphedema. After consulting an infectious disease doctor, it was decided that further evaluation was necessary to rule out myopericarditis and he went to the emergency department at a local hospital. He was evaluated and released the next day with negative findings. However he will have a stress test today.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site warmth, Laboratory test, Lymphoedema, Malaise, Pyrexia
Clinical narrative: The patient had a robust reaction Monday June 20th, with a low grade fever, general malaise, anorexia and left axillary lymphedema, 13 x 11 cm erythema and edema around the site around of the vaccine. The site had serous drainage. On June 21, he felt better, no fever, and the site improved with a scab. On Wednesday June 22, the worker c/o dyspnea on exertion from this morning and afternoon while walking to and from lunch and back to work. He stated he came in and took a nap at his desk and proceeded to the scheduled appointment. He has no chest pain or edema. He did report a slight headache and cough with a feeling in his throat that he needs to cough. The vaccine site looks improved with less erythema and lymphatic streaking fading. It is still warm to touch and continues having a scab. He was afebrile and still has non-tender left axillary lymphedema. After consulting an infectious disease doctor, it was decided that further evaluation was necessary to rule out myopericarditis and he went to the emergency department at a local hospital. He was evaluated and released the next day with negative findings. However he will have a stress test today.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Secretion discharge, Throat irritation
Clinical narrative: The patient had a robust reaction Monday June 20th, with a low grade fever, general malaise, anorexia and left axillary lymphedema, 13 x 11 cm erythema and edema around the site around of the vaccine. The site had serous drainage. On June 21, he felt better, no fever, and the site improved with a scab. On Wednesday June 22, the worker c/o dyspnea on exertion from this morning and afternoon while walking to and from lunch and back to work. He stated he came in and took a nap at his desk and proceeded to the scheduled appointment. He has no chest pain or edema. He did report a slight headache and cough with a feeling in his throat that he needs to cough. The vaccine site looks improved with less erythema and lymphatic streaking fading. It is still warm to touch and continues having a scab. He was afebrile and still has non-tender left axillary lymphedema. After consulting an infectious disease doctor, it was decided that further evaluation was necessary to rule out myopericarditis and he went to the emergency department at a local hospital. He was evaluated and released the next day with negative findings. However he will have a stress test today.
Sex: M
Vaccine: DT
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: Initial unsolicited report received from a healthcare professional on 07 June 2016. This case involves a male patient of an unknown age (current age 62 year) who was vaccinated with a dose of DIPHTHERIA AND TETANUS TOXOIDS (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient allergic reaction to vaccine. It was reported that, "horse antigen it in which caused it". The patient did not experience any adverse event this time with the Sanofi product. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Guillain-Barre syndrome, Paralysis
Clinical narrative: Weakness/paralysis - Guillain-Barre illness and required hospitalisation.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired driving ability, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain, Periarthritis
Clinical narrative: Severe pain in left shoulder where vaccine was given. It hurt to move the arm in any direction. It was not the kind of soreness that is generally associated with a vaccine. I could not move my arm and the pain was so severe that I could not even drive my vehicle. I went straight to medical back to the vaccine administration department and explained the symptoms and they gave me an ice pack and told me to make an appointment with my primary doctor. She explained that the pain was normal and should subside within a week. I ended up going to the emergency room on the 12th of December in excruciating pain. At this point my shoulder was completely frozen and I could not move it or engage the muscle without severe pain.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, X-ray normal
Clinical narrative: Severe pain in left shoulder where vaccine was given. It hurt to move the arm in any direction. It was not the kind of soreness that is generally associated with a vaccine. I could not move my arm and the pain was so severe that I could not even drive my vehicle. I went straight to medical back to the vaccine administration department and explained the symptoms and they gave me an ice pack and told me to make an appointment with my primary doctor. She explained that the pain was normal and should subside within a week. I ended up going to the emergency room on the 12th of December in excruciating pain. At this point my shoulder was completely frozen and I could not move it or engage the muscle without severe pain.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient came back to pharmacy several minutes after receiving Prevnar 13 vaccine and stated she felt "faint". I brought her to a chair to sit down and gave her water to drink. A few minutes later she passed out in the chair. I called my tech to come stay with her while I called 911. The store manager also was called over. After several minutes, she regained consciousness. As I stayed on the line with 911, the ambulance arrived. They assessed her and convinced her to go to the hospital. At approximately 11:15 AM, she was transported by ambulance to the hospital.
Age: 0.92
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Dizziness, Gait disturbance, Pyrexia, Vomiting
Clinical narrative: Puking non stop dizzy trouble walking.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016276718) on 01 June 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, site and route of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed allergic reaction. Lab data and corrective treatment were not reported. Outcome of the event was unknown. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster disseminated, Polymerase chain reaction, Varicella virus test
Clinical narrative: Disseminated zoster rash.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Injection site erythema, Injection site reaction, Injection site warmth, Mobility decreased
Clinical narrative: High fever, her whole body is hot, can barely move arm, huge rashy looking red splotch where shot was taken, hot to touch, will be taking her to emergency room after work today on 06/24/16.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash macular
Clinical narrative: High fever, her whole body is hot, can barely move arm, huge rashy looking red splotch where shot was taken, hot to touch, will be taking her to emergency room after work today on 06/24/16.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Lumbar puncture, Pneumonia streptococcal
Clinical narrative: Strep pneumonia invasive disease, drug resistant.
Age: 68.0
Sex: F
Vaccine: JEV
Symptoms: Malaise, Nausea, Vertigo, Vomiting
Clinical narrative: This is to report significant side effects from the series of 2 Japanese encephalitis travel vaccinations I received. Shot 1 February 5 - about three days later woke up with severe vertigo (couldn't stand or walk unsupported), nausea, malaise. BP normal. Rested/slept all morning, vomited, OK by noon. Next day normal. Shot 2 March 4 (recommended 28 day interval) - next morning woke up with slight vertigo lasting 1 hour. Second day woke up with worse vertigo, nausea, malaise. Rested/slept all morning, OK by afternoon. Third day normal. I did not connect the first reaction with the shot because it was delayed by days and I am used to shots with no issues. I guessed I had food poisoning! The second shot & reaction changed that.
Age: 39.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Head discomfort, Headache, Injection site erythema
Clinical narrative: Patient stated that she had pressure in her head and it felt like someone was constantly holding her head. She also complained of dizziness and weakness and a small area of redness at injection site. In a later statement she states she had a headache as well.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: Arm pain, redness, swelling, warmth and itching.
Age: 1.38
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: Broke out in hives covering entire body for 72 hours.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Started aching immediately. As the day progressed site became swollen, red and painful. Eventually the redness went away after 1 1/2 yrs. There is still a lump which is still very painful. I am unable to sleep on my right side.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Sleep disorder
Clinical narrative: Started aching immediately. As the day progressed site became swollen, red and painful. Eventually the redness went away after 1 1/2 yrs. There is still a lump which is still very painful. I am unable to sleep on my right side.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site rash, Neck pain
Clinical narrative: Client reports rash redness and pain to the injection site and up her shoulder and neck and went to Dr where she was treated with medications.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Client reports rash redness and pain to the injection site and up her shoulder and neck and went to Dr where she was treated with medications.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Injection sight was red, itchy, hot to touch, painful to touch, swollen, hard and 2.5" diameter in size.  Brought in to Doctor who said it was a localized reaction.  It grew a little more in size over the next 24 hours before starting to resolve. The 2.75" diameter circle was less swollen, hot and itchy after 1 week.  Then turned into bruise/mark that is still slightly visible 2 months later. **Received DTAP/IPV in leg 1 month earlier on 4/4/2016.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Injection sight was red, itchy, hot to touch, painful to touch, swollen, hard and 2.5" diameter in size.  Brought in to Doctor who said it was a localized reaction.  It grew a little more in size over the next 24 hours before starting to resolve. The 2.75" diameter circle was less swollen, hot and itchy after 1 week.  Then turned into bruise/mark that is still slightly visible 2 months later. **Received DTAP/IPV in leg 1 month earlier on 4/4/2016.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis-like reaction (red, inflamed, hot to the touch, pain, tenderness) in left arm from injection site down to hand.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis-like reaction (red, hot to the touch, inflamed, tender, painful) in left arm at injection site reaction down to his elbow.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: On 06/23/16, 73 yo F presented to clinic for an annual wellness visit. During this appointment, pt was ordered to receive Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23) . Per immunization record, 0.5 mL was injected into left deltoid (NDC #0006-4943-00, lot #M003027, exp: 6/21/2017). Pt was then discharged home. On 06/24/16, pt returned to clinic with complains of itching, redness and warmth at the injection site. Pt examination by RN found an ~2x6 inch area of erythema on pt's left upper arm, ventral aspect. Although injection site had been documented as IM, clinical findings suggested that site selection was more likely in subQ tissue in the back of pt's upper arm. MD made aware and recommended supportive care with topical hydrocortisone cream, oral diphenhydramine and localized application of ice/cold compresses. Pt was also instructed to report to ED for any symptom worsening. Pt verbalized understanding and was discharged home.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site reaction, Paraesthesia, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Mom describes a red blotchy rash about a silver dollar size around the injection site. Her son complains that there is pins and needles all over his body.  He had a fever of 101.6 6/23/2014 and vomiting from 2:30 am to 3:30 am on 6/24/2016.  The vomiting has stopped but he still has a fever of 100 on 6/24/2016.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Mom describes a red blotchy rash about a silver dollar size around the injection site. Her son complains that there is pins and needles all over his body.  He had a fever of 101.6 6/23/2014 and vomiting from 2:30 am to 3:30 am on 6/24/2016.  The vomiting has stopped but he still has a fever of 100 on 6/24/2016.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Asthenia, Blood creatine phosphokinase normal, Headache, Hypoaesthesia, Musculoskeletal chest pain
Clinical narrative: Headache, Neck pain, fever, myalgias, weakness, numbness, tingling, pain with inspiration at rib cage.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Myalgia, Neck pain, Painful respiration, Paraesthesia, Pyrexia
Clinical narrative: Headache, Neck pain, fever, myalgias, weakness, numbness, tingling, pain with inspiration at rib cage.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: White blood cell count normal
Clinical narrative: Headache, Neck pain, fever, myalgias, weakness, numbness, tingling, pain with inspiration at rib cage.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Asthenia, Blood culture, CSF culture, Chest X-ray, Erythema
Clinical narrative: Headache, Neck pain, fever, myalgias, weakness, numbness, tingling, pain with inspiration at rib cage.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Musculoskeletal chest pain, Myalgia, Pyrexia, Swelling
Clinical narrative: Headache, Neck pain, fever, myalgias, weakness, numbness, tingling, pain with inspiration at rib cage.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Drug administered at inappropriate site, Insomnia, Mobility decreased, Nausea
Clinical narrative: Severe pain. Could not move arm. I had to sit down so I wouldn't pass out or throw up from pain. I could not sleep in a bed for 6 weeks. The vaccine was given too high on the shoulder. On a scale of 1-10, the pain was a 10. At the emergency room, I was given an antibiotic, cyclobenzapr & Hydrocod/acetam. I saw Dr. at the Hospital. I saw her 2 more times and then had an x-ray that was negative. Also had some therapy.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain, X-ray normal
Clinical narrative: Severe pain. Could not move arm. I had to sit down so I wouldn't pass out or throw up from pain. I could not sleep in a bed for 6 weeks. The vaccine was given too high on the shoulder. On a scale of 1-10, the pain was a 10. At the emergency room, I was given an antibiotic, cyclobenzapr & Hydrocod/acetam. I saw Dr. at the Hospital. I saw her 2 more times and then had an x-ray that was negative. Also had some therapy.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Dizziness, Headache, Visual impairment
Clinical narrative: Headaches started 2 days after vaccines.  A week later upon arising saw black spots, dizzy, could not see well.  Laid down and symptoms resolved in one minute.  Called ER and told to wait to see if symptoms reoccurred.  Checked in with Dr's. office.  Currently has headache's daily but only last about 5 minutes.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Sleep disorder
Clinical narrative: Developed nodule at site of administration and pain radiating distally.  Sleep was affected.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Soreness, decreased mobility, pain - has continued since 4/15.  Asked his primary physician regarding this...he had no explanation.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on both thighs.
Age: 0.45
Sex: M
Vaccine: HIBV, IPV, PNC13
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 4 days ago.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness, Paraesthesia
Clinical narrative: Initially with sore right upper arm, soon followed by numbness and tingling down the entire arm. In 2 to 3 days soreness resolved but numbness persisted. Patient also notes increased fatigue to right arm.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Patient received 12 month vaccination series at his Pediatrician's office 3 days ago. Mother is unsure of which vaccinations he received. Had 4 inoculations. Presents to my clinic with varicella rash. No other complaints. No signs of cerebral or pulmonary involvement.  Pt's mother was told to treat the symptoms. No antiviral medications administered. Instructed to watch for complications.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient today presented with a red area that seems inflammed on the left arm that we injected with ADACEL 8 days ago. She says she has some pain and tenderness in the area and under it, she feels it is swollen.
Age: 53.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pain in jaw, Swelling face
Clinical narrative: Pain on the left side of my jaw along with swelling.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Nausea, Paraesthesia, Tremor
Clinical narrative: Patient became severely nauseated, had tremors in one arm/lost control of it and had a tingling feeling in the other, and ultimately passed out briefly.
Age: 27.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Pt reported that her arm was sore after administration and the following day but did not have any type of reaction until the 22nd (2 days after administration- pt reported redness at the injection site and sporadic fever and weakness- she went to an after hours clinic where she reported the dr thought she had bronchitis? (pt has asthma and is a smoker) - I saw the pt on 6/24 and there was indeed redness/swelling at the injection site but she felt well enough to come into work.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that her arm was swollen, red, hard to touch, and painful after the Tdap and ZOSTAVAX injection.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Lymphoma, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: This spontaneous report was received from a Rheumatologist (also referred as Physician Assistant), concerning a 52 year old male patient. Information about the patient's medical history and concurrent conditions was not provided. The patient had no drug reactions or allergies. On an unknown date, as a child, the patient was vaccinated with his first dose of M-M-R II (administration route, lot number and expiration date were not provided). On an unspecified date in 2015 reported as "sometime last year", the patient was latter vaccinated with a second dose (administration route, lot number and expiration date were not provided). According to the reporter it was not sure if the patient received the second dose series due to a "history of an unknown lymphoma", or if it was given due to a job requirement. The reporting Physician Assistant was not sure if the patient's lymphoma came prior to or after the administration of the first series of M-M-R II. The reporter also stated that on approximately June 2016, reported as "last week", the patient got his titers drawn, which showed that the patient was immune to everything, but the measles (antibody test negative). No Product Quality Complaint (PQC) was involved. The outcome of lymphoma and antibody test negative was unknown at the time of this report. The reporter did not provide a causality assessment between the events and therapy with M-M-R II. Additional information is not expected, as there was no consent given to contact the physician.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Nerve injury, Pain
Clinical narrative: This spontaneous report was received from a 62 year old female patient referring to herself. The patient's concurrent conditions included diabetes, colorectal cancer, enlarged heart, fatty liver disease, neuropathy, back pain, and allergic reactions to Ibuprofen, VALIUM, Aspirin, Penicillin, Sulfa, Cephalexin, Tetracycline and other unspecified medications. The patient's medical history included several unspecified surgeries. On 12-NOV-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot number and expiry date were not reported). Concomitant therapies included TOPAMAX, PROTONIX, an unspecified hypertension medication and other unspecified medications. On approximately 07-JUN-2016 (reported as "Two weeks ago today"), a little red spot appeared on the patient's stomach which she originally thought was just a painful bug bite. The patient said that over time, the red spot began to blister and she then began to experience a painful burning sensation. It was reported that the red spots spread across her stomach to her side and back. The patient also reported that she experienced nerve damage and, as a result, she would experience pain for the rest of her life. the patient visited the nurse practitioner and a treatment with an unspecified antibiotic was given. No laboratory diagnostic studies were performed. No product quality complain (PQC) was involved. At the time of reporting, the outcome of the events was reported as not recovered. The reporter did not provide a causality assessment between the events and the ZOSTAVAX. Upon internal review, the event nerve damage which would result in pain for the rest of the patient's life was considered as disabling. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2016US005427, is an initial spontaneous report received from a consumer on 29 Feb 2016. This report refers to an adult female patient. Past medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient suffered with allergic reaction to influenza vaccine. The outcome, seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Case number PHEH2016US010432, is an initial spontaneous report received from a health care professional via pharmaceutical company (Manufacturer ID: 2016224102) on 26 Apr 2016. This report refers to a adult female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with Influenza virus vaccine (manufacturer unknown, batch number: not reported) on an unknown date. After vaccination, the patient experienced allergy to flu vaccine. Outcome, seriousness and causality of the event was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of patients. The nurse reported that unknown doses of VARIVAX (lot # L001326, expiry date 13-JAN-2017; lot # L042265 expiry date 26-OCT-2016; lot # L023594, expiry date 26-JUN-2016) were administered to an unknown patients on unknown dates. No adverse effect was reported. Digital data logger indicated that temperature excursion occurred during the storage of the vaccines. Temperature was 26F and time frame was 16 hours. 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 (certified medical assistant) concerning multiple patients. The healthcare worker reported that multiple unspecified patients were administered improperly stored ROTATEQ (lot # L033545, expiry date 30-MAY-2017, dose and frequency was not reported) on an unknown date. Data logger shown the vaccine was excursed in temperature of 0.3 C, duration of excursion was 2 hours. There was no previous temperature excursion. There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of patients. The nurse reported that unknown doses of PROQUAD (lot # L041627, expiry date 20-APR-2017 and lot # L046507 expiry date 17-MAY-2016) were stored incorrectly and were administered to an unknown patients on unknown dates. Digital data logger indicated that temperature excursion occurred during the storage of the vaccines. Temperature of excursion was 26F and time frame was 16 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.