chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Pain, Periarthritis, X-ray
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 56 year-old female patient who had no current illness and a medical history of mild idiopathic thrombocytopenia purpure (ITP). Concomitant medications included multivitamins and calcium. On 23-SEP-2014, the patient received intramuscular AFLURIA (batch number not provided) in the left arm. On 23-SEP-2014, the patient experienced pain at the time of vaccination, which increased over time. It became so bad that the patient could not move her shoulder. She went to her doctor 5 weeks after the injection because the pain was not getting better. During the doctor visit, blood work, X-ray, medications and physical therapy were ordered. She was diagnosed with adhesive capsulitis.  The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the terms of "x-ray" and "blood test", and the patient presented at the Emergency Room. The reporter reported that the adhesive capsulitis was related to CSL bio therapies.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 57 year-old female patient who had a medical history of Henoch-Schonlein Purpura with vasculitis and right temporal hemorrhagic stroke (27-SEP-2014). Concomitant medications included diphenhydramine, paracetamol and methotrexate. On 29-OCT-2014, the patient received intramuscular AFLURIA (batch number T53309) in the left arm. On 29-OCT-2014, the patient experienced severe swelling of left arm from shoulder to two inches above elbow - hot, burning and felt like skin was going to pop. There was also red, itches (sic) and rash just below the injection site. The patient was placed on prednisone and antibiotics after the vaccine administration. The outcome was recovered. Reporters comments: The regulatory authority assessed the case as non-serious, reported the term of "rash", and reported that the patient presented to the Emergency Room.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 57 year-old female patient who had a medical history of Henoch-Schonlein Purpura with vasculitis and right temporal hemorrhagic stroke (27-SEP-2014). Concomitant medications included diphenhydramine, paracetamol and methotrexate. On 29-OCT-2014, the patient received intramuscular AFLURIA (batch number T53309) in the left arm. On 29-OCT-2014, the patient experienced severe swelling of left arm from shoulder to two inches above elbow - hot, burning and felt like skin was going to pop. There was also red, itches (sic) and rash just below the injection site. The patient was placed on prednisone and antibiotics after the vaccine administration. The outcome was recovered. Reporters comments: The regulatory authority assessed the case as non-serious, reported the term of "rash", and reported that the patient presented to the Emergency Room.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Rash erythematous
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 50 year-old female patient who had no current illness and a medical history of chronic allergic rhinitis at the time of vaccination. Concomitant medications included fluoxetine hydrochloride, clonazepam and trazodone. ON 03-NOV-2014, the patient received intramuscular AFLURIA (batch number T57505) in the left arm. On 03-NOV-2014, the patient initially experienced pain and redness at site (left deltoid). It then developed to diffuse erythremic rash across chest and both upper outer arms. Treatment included diphenhydramine but without relief. On 07-NOV-2014, the patient saw a doctor and started on prednisolone. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the term of "rash" and reported the patient presented at the Emergency Room.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial test, Ear pain, Fatigue, Fungal test, Middle ear effusion
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 67 year-old female patient who had no current illness at the time of vaccination. Concomitant medications included acetylsalicylic acid, metoprolol, iansoprazole, trazodone, isosorbide and lorazepam. On 03-NOV-2014, the patient received intramuscular AFLURIA (batch number T57405) in the right arm. On 04-NOV-2014, the patient experienced runny nose, sinus pressure, jaw pain, left ear pain, fluid in left air, green discharge from patient sinus, body aches and fatigue. On 07-NOV-2014, the patient saw the doctor and was given antibiotic for 7  days and ear drops. Tests performed included nasal culture for bacteria and fungus. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the terms of "bacterial test", "fungal test" and "sinus headache".
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal discharge discolouration, Pain, Pain in jaw, Paranasal sinus discomfort, Paranasal sinus hypersecretion
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 67 year-old female patient who had no current illness at the time of vaccination. Concomitant medications included acetylsalicylic acid, metoprolol, iansoprazole, trazodone, isosorbide and lorazepam. On 03-NOV-2014, the patient received intramuscular AFLURIA (batch number T57405) in the right arm. On 04-NOV-2014, the patient experienced runny nose, sinus pressure, jaw pain, left ear pain, fluid in left air, green discharge from patient sinus, body aches and fatigue. On 07-NOV-2014, the patient saw the doctor and was given antibiotic for 7  days and ear drops. Tests performed included nasal culture for bacteria and fungus. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the terms of "bacterial test", "fungal test" and "sinus headache".
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 67 year-old female patient who had no current illness at the time of vaccination. Concomitant medications included acetylsalicylic acid, metoprolol, iansoprazole, trazodone, isosorbide and lorazepam. On 03-NOV-2014, the patient received intramuscular AFLURIA (batch number T57405) in the right arm. On 04-NOV-2014, the patient experienced runny nose, sinus pressure, jaw pain, left ear pain, fluid in left air, green discharge from patient sinus, body aches and fatigue. On 07-NOV-2014, the patient saw the doctor and was given antibiotic for 7  days and ear drops. Tests performed included nasal culture for bacteria and fungus. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the terms of "bacterial test", "fungal test" and "sinus headache".
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 53 year old female patient who had a medical history of rheumatoid arthritis. Concomitant medications included sulindac and tramadol. The patient had no current illness. On the 07-NOV-2014, the patient received AFLURIA syringe (batch number T59406) in the right arm. On the 07-NOV-2014, the patient developed acute pain after injection, and was sore and weak - severe. It lasted for three days. It was difficult to move and the patient felt sore as of the 10-NOV-2014. Outcome was unknown. Reporter comments; The regulator reported the case as non-serious.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Malaise, Myalgia, Nausea, Wheezing
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 61 year old male patient who had no medical history. Concomitant medications included phenobarbital (100 mg taken the evening before), lansoprazole (30 mg taken in the morning) and des loratadine (5 mg taken in the morning). The patient had no current illness at the time of vaccination. On the 11-NOV-2014, the patient received AFLURIA injection (batch number "0414") via the intramuscular route in the left arm. On the 11-NOV-2014, the patient developed wheezing, muscle ache, headache and nausea. Treatment included guaifenesin and paracetamol and it seemed to help. On the 12-NOV-2014, the patient still did not feel well.  Outcome was not recovered.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 52 year old female patient. On the 30-SEP-2014, the patient received AFLURIA (batch number T58006) via the left arm. On an unspecified date, the patient developed a continued sore arm in the spot of the vaccine, no redness or other reaction, just off and on soreness It was recommended to her to use a heating pad and massage and follow up with the PCP (Primary Care Physician) if necessary. Outcome was not recovered. Reporter comment: The regulator reported the case as non-serious. Batch record review for lot T58006noted: Batch records and QA batch review checklists for the seed lot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues of atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished product lot T58006, were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seed lot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were statis factory with no out of specification results reported.  Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 55 year-old male patient. On 10-OCT-2014, the patient received intramuscular AFLURIA injection (batch number 09749221A) in th left arm. On 11-OCT-2014, the patient experienced left deltoid red, warm and itchy. The patient went to the clinic for PPD reading and revealed vaccine site. The skin was intact, red and warm. Had full movement of left arm. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Insomnia, Nausea
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 62 year old female patient who had no medical history and no current illness at the time of vaccination. Medications at the time of vaccination included fesoterodine and a nasal decongestant. On the 11-NOV-2014, the patient received AFLURIA (batch number T52408) via the intramuscular route in the right arm. On the 11-NOV-2014, soon after she received the vaccine, she felt slight dizziness, nausea and feeling of warmth. The patient stated that the symptoms disappeared within five minutes from when they initially occurred. Later the same day at 19:10, the patient was followed up and the patient stated that she was completely fine and felt the reaction may have been due to  her lack of sleep/insomnia recently. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the term "insomnia".
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Periarthritis
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 63 year old male patient who had a medical history of mild HBP (high blood pressure). Concomitant medications included amlodipine 10mg, losartan 50 mg, atorvastatin 10 mg, vit/min sup (supplement), tumeric and low dose aspirin. On the 23-SEP-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the left arm. ON the 25-SEP-2014, the patient developed increased pain in the shoulder joint and arm. The pain intensified in the afternoon. The patient was seeing the doctor for an annual visit and will be evaluated then. His wife wen to the doctor for the same issue 2 weeks ago and was diagnosed with adhesive capsulitis. Outcome was not recovered.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 39 year-old female patient who had no known current illness, no lab data and no medical history at the time of vaccination. Concomitant medications included omega-3 fatty acids, magnesium, vitamins and loratadine. On 07-NOV-2014, the patient received intramuscular AFLURIA injection (batch number 09749221A) in the left arm. On 07-NOV-2014, the patient experienced back pain along the kidney area. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 63 year-old female patient who had no known allergies at the time of vaccination. On 16-OCt-2014, the patient received AFLURIA injection (batch number T51408) in the left arm. On 17-OCT-2014, the patient experienced a sore arm (muscle) which lasted for 7 days. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 64 year old male patient who had NKA (no known allergies). On the 16-OCT-2014, the patient received AFLURIA (batch number T51408) via the left arm. On the 17-OCT-2014, the patient developed a sore arm (muscle) that lasted for seven days. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 37 year old female patient with a medical history of asthma and hypertension. On the 07-NOV-2014, the patient received AFLURIA injection (batch number T59907) in the left arm. The patient also received PNEUMOVAX (batch number K009874) in the left arm. The day after the shots, the patient developed fever. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 29 year old female patient with no medical history and no current illness at the time of vaccination. On the 29-OCT-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the left arm. On the 29-OCT-2014, the patient developed persistent pain in the upper left arm since injection. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious and the term "injection site pain".
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Lethargy, Nasal congestion, Nasal discharge discolouration, Nausea
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 16-FEB-2015) concerns a 53-year-old female patient who had no known current illness at the time of vaccination. Her medical history included "milk", "trees", "grasses", "animals", HTN (hypertension) and DM II (diabetes mellitus type II). Concomitant medications included metformin, simvastatin and olmesartan medoxomil. On Tuesday 18-NOV-2014, the patient received AFLURIA injection (batch number 097492221A) in the left arm. On Tuesday, 18-NOV-2014, later in the evening, the patient experienced a sore throat. The next day, the patient experienced a sore throat and nasal congestion on left nare. On Thursday, the patient had an intermittent non-productive cough. On Friday and Saturday, the patient had green nasal discharge. On Sunday, the patient felt lethargic and had a sore throat, nausea, and nasal congestion. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious and reported the term "rhinorrhea".
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 16-FEB-2015) concerns a 53-year-old female patient who had no known current illness at the time of vaccination. Her medical history included "milk", "trees", "grasses", "animals", HTN (hypertension) and DM II (diabetes mellitus type II). Concomitant medications included metformin, simvastatin and olmesartan medoxomil. On Tuesday 18-NOV-2014, the patient received AFLURIA injection (batch number 097492221A) in the left arm. On Tuesday, 18-NOV-2014, later in the evening, the patient experienced a sore throat. The next day, the patient experienced a sore throat and nasal congestion on left nare. On Thursday, the patient had an intermittent non-productive cough. On Friday and Saturday, the patient had green nasal discharge. On Sunday, the patient felt lethargic and had a sore throat, nausea, and nasal congestion. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious and reported the term "rhinorrhea".
Age: 54.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Paraesthesia, Sensation of foreign body, Urticaria
Clinical narrative: Case number PHHY2015US084879, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 573877) website on 07 Jul 2015 with a follow up received from the quality assurance department on 17 Jul 2015. This report refers to a 54-year-old male patient. Concurrent conditions included diabetes. The patient was allergic to penicillin and codeine. Concomitant medications included simvastatin, metformin and metoprolol tartrate. The patient was vaccinated with RABAVERT (batch number: not reported) into the right leg on 13 Apr 2015. On the same day after vaccination at 04:45 PM, the patient went to clinic with complains of hives. The patient face feels tingly and developed urticarial rash on bilateral upper extremities and upper back. At 04:50 PM, an order was given for diphenhydramine 50 mg intramuscularly and 80 mg (2 mL of 40 mg/mL) DEPO MEDROL intramuscularly as a treatment for the events. At 05:00 PM, the patient had a feeling of "lump in throat". EPI-PEN Auto-injector was administered to the patient. At 5:20 PM, the patient still feels the lump in the throat, but it did not worse. The patient had no erythema or edema of pharynx. The patient does not have difficulty breathing and showed no apparent distress. The patient denied throat itch and drowsiness. The patient blood pressure was 140/72 in the left arm (sitting) and apical pulse of 80. The patient was alert and oriented and there was no spread of urticarial rash. The patient's lungs were clear to auscultation. The patient was sent home and was advised to continue OTC BENADRYL every 4-6 hours and was told DEPO MEDROL may increase the blood sugar. The patient was advised to call primary care physician for follow up on 14 Apr 2015 and was told to go to the emergency room immediately if there was a difficulty in breathing. On 14 Apr 2015, the patient still had the rash. The final outcome of the events was condition unchanged. Seriousness and causality was not reported. Seriousness of the events sensation of foreign body and urticaria were upgraded based on information available in the source document. The QA department stated that the reported batch number 26NP7W1 for RABAVERT was not a valid batch number. Hence a standard investigation will not be performed. Follow-up received from Quality Assurance Department on 17 Jul 2015: Updated QA comment.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abscess oral, Breath odour, Hypoaesthesia, Tooth extraction
Clinical narrative: Case number PHHY2015US084885, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 577090) website on 07 Jul 2015 and a follow up report from the QA department received on 17 Jul 2015. This report refers to a 11-year-old female patient. Her current conditions included attention deficit/hyperactivity disorder (ADHD) and anxiety disorder (not specified). Concomitant drug included VYVANSE. On 06 May 2015, she was vaccinated with MENVEO (batch number: unknown) in the right arm along with BOOSTRIX (other manufacturer, batch number: D9X9Z) in the right arm and GARDASIL (other manufacturer, batch number: K008931) in the left arm, intramuscularly. On the same date, after vaccinations she experienced facial numbness. She underwent tooth pulling on an unknown date and following it she had occult abscess and malodorous breath. The outcome of the events reported as recovered. The events reported as non-serious. The reporter thought that facial numbness was due to MENVEO, BOOSTRIX and GARDASIL. The causality of other events was not reported. Seriousness assessment of the event occult abscess was upgraded based on the available information in the source document. The batch number KO0R0P8.814 is not valid batch number. As this is a standard request and it was not possible to determine the correct batch number, the case will not be investigated by QA department. Follow up report from the QA department received on 17 Jul 2015: Removed the incorrect batch number from product tab and narrative. Updated QA comments.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abscess, Breath odour, Hypoaesthesia
Clinical narrative: Case number PHHY2015US084885, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 577090) website on 07 Jul 2015 and a follow up report from the QA department received on 17 Jul 2015. This report refers to a 11-year-old female patient. Her current conditions included attention deficit/hyperactivity disorder (ADHD) and anxiety disorder (not specified). Concomitant drug included VYVANSE. On 06 May 2015, she was vaccinated with MENVEO (batch number: unknown) in the right arm along with BOOSTRIX (other manufacturer, batch number: D9X9Z) in the right arm and GARDASIL (other manufacturer, batch number: K008931) in the left arm, intramuscularly. On the same date, after vaccinations she experienced facial numbness. She underwent tooth pulling on an unknown date and following it she had occult abscess and malodorous breath. The outcome of the events reported as recovered. The events reported as non-serious. The reporter thought that facial numbness was due to MENVEO, BOOSTRIX and GARDASIL. The causality of other events was not reported. Seriousness assessment of the event occult abscess was upgraded based on the available information in the source document. The batch number KO0R0P8.814 is not valid batch number. As this is a standard request and it was not possible to determine the correct batch number, the case will not be investigated by QA department. Follow up report from the QA department received on 17 Jul 2015: Removed the incorrect batch number from product tab and narrative. Updated QA comments.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Mobility decreased
Clinical narrative: On June 29 I received a Pneumococcal Conjugate vaccine in my right arm between 10:30 and 11 a.m. During the following 2 hours, I lost about 80% use of my arm. As of today, which is seven days later, I am still unable to perform functions as before without pain - such as, raising my arm whether straight or bent at the elbow - picking up anything slightly heavy - combing my hair - brushing my teeth - trying to wash my back, and etc. As I complete this form I keep my right arm close to my body - if I move it further away I get a jolt of pain either under my arm or on top - I can only lie on my right arm while in bed for a short time due to pain - and - there is sporadic pain where I was injected.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: On June 29 I received a Pneumococcal Conjugate vaccine in my right arm between 10:30 and 11 a.m. During the following 2 hours, I lost about 80% use of my arm. As of today, which is seven days later, I am still unable to perform functions as before without pain - such as, raising my arm whether straight or bent at the elbow - picking up anything slightly heavy - combing my hair - brushing my teeth - trying to wash my back, and etc. As I complete this form I keep my right arm close to my body - if I move it further away I get a jolt of pain either under my arm or on top - I can only lie on my right arm while in bed for a short time due to pain - and - there is sporadic pain where I was injected.
Age: 36.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a 36 year old pregnant female patient and refers to herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck), subcutaneous (dose, lot # and expiration date were not provided). It was unknown how many doses of VARIVAX (Merck) the patient had received and if she was pregnant before or after receiving VARIVAX (Merck). The last menstrual period (LMP), date of conception and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending. Follow up information was received from the patient on 17-JUL-2015. The patient updated details of the physician who administered the vaccine. The patient underwent a pregnancy test on 02-JUN-2015, which indicated that she was not pregnant. On 05-JUN-2015, patient was vaccinated with ZOSTAVAX. Patient reported that she also visited a specialist since she expected to be in high risk of pregnancy. She was found to be pregnant on 20-JUN-2015 (and hence last menstrual period was estimated to be in approximately 2015). On an unspecified date in 2015 (reported as since the last contact), the patient had a miscarriage (abortion spontaneous). Outcome of the miscarriage was unknown. Causality assessment was not provided. Upon internal review, the event, abortion spontaneous was considered to be medically significant. Additional information is not expected as the reporter did not wish further contact.
Age: 36.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a 36 year old pregnant female patient and refers to herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck), subcutaneous (dose, lot # and expiration date were not provided). It was unknown how many doses of VARIVAX (Merck) the patient had received and if she was pregnant before or after receiving VARIVAX (Merck). The last menstrual period (LMP), date of conception and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending. Follow up information was received from the patient on 17-JUL-2015. The patient updated details of the physician who administered the vaccine. The patient underwent a pregnancy test on 02-JUN-2015, which indicated that she was not pregnant. On 05-JUN-2015, patient was vaccinated with ZOSTAVAX. Patient reported that she also visited a specialist since she expected to be in high risk of pregnancy. She was found to be pregnant on 20-JUN-2015 (and hence last menstrual period was estimated to be in approximately 2015). On an unspecified date in 2015 (reported as since the last contact), the patient had a miscarriage (abortion spontaneous). Outcome of the miscarriage was unknown. Causality assessment was not provided. Upon internal review, the event, abortion spontaneous was considered to be medically significant. Additional information is not expected as the reporter did not wish further contact.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pruritus generalised
Clinical narrative: Woke up with severe itching over entire body. Pins and needles sensation. Or thousands of ants biting at once. Took 50 mg of Benadryl every 4 hours for 5 days. Still experienced a prickly sensation with occasional stabbing stings.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Bronchospasm, Cardiac arrest, Chronic obstructive pulmonary disease, Condition aggravated, Endotracheal intubation
Clinical narrative: Patient was hospitalized for an acute COPD exacerbation but was preparing for discharge. When the patient was seen by the nurse on the morning of 7/19/15 she seemed to be moving air well on 2L nasal cannula but on repeat exam a few minutes later, she seemed very tight and to not be moving air with oxygen sats in the 70s. This change occurred 3-5 minutes after receiving the Pneumovax-23 vaccine (Adult 25 mcg/0.5mL; Merck Lot: KO18528; NDC 0006-4943-01), according to the nurse. Breathing treatment was started but patient was still hypoxemic and progressed into tense bronchospasm leading to acute onset hypoxic respiratory failure, followed by cardiac arrest with loss of pulse.  Code blue was called and CPR was started at 1000 with bag mask ventilation, and spontaneous circulation returned within two minutes. Patient had to be intubated and sent to the medical ICU. Patient also experienced hypoxic seizures for which she received lorazepam 2mg twice at 1017 and 1028.Patient remained in the MICU for one day and then was transferred back to the general medicine floor. She was discharged home on 7/24/15.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Hypoxia, Intensive care, Pulse absent, Respiratory failure, Resuscitation
Clinical narrative: Patient was hospitalized for an acute COPD exacerbation but was preparing for discharge. When the patient was seen by the nurse on the morning of 7/19/15 she seemed to be moving air well on 2L nasal cannula but on repeat exam a few minutes later, she seemed very tight and to not be moving air with oxygen sats in the 70s. This change occurred 3-5 minutes after receiving the Pneumovax-23 vaccine (Adult 25 mcg/0.5mL; Merck Lot: KO18528; NDC 0006-4943-01), according to the nurse. Breathing treatment was started but patient was still hypoxemic and progressed into tense bronchospasm leading to acute onset hypoxic respiratory failure, followed by cardiac arrest with loss of pulse.  Code blue was called and CPR was started at 1000 with bag mask ventilation, and spontaneous circulation returned within two minutes. Patient had to be intubated and sent to the medical ICU. Patient also experienced hypoxic seizures for which she received lorazepam 2mg twice at 1017 and 1028.Patient remained in the MICU for one day and then was transferred back to the general medicine floor. She was discharged home on 7/24/15.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site warmth, Rash pruritic
Clinical narrative: Hot, itchy, rash from elbow to shoulder in onjection arm.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Urticaria. This was just reported to the office today 7/27/15.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Extreme pain in arm for 7 days with ongoing current pain in arm; constant headaches, overall body and muscle aches, nausea and lack of appetite, have to take Tylenol or Advil every two hours in order to try to get through the day and am constantly feeling sick.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Extreme pain in arm for 7 days with ongoing current pain in arm; constant headaches, overall body and muscle aches, nausea and lack of appetite, have to take Tylenol or Advil every two hours in order to try to get through the day and am constantly feeling sick.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Joint pain. Most severe around hips and lower back.  Fever of 100.7.  Chills.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: VIIth nerve paralysis
Clinical narrative: Facial palsy left side of the face.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: "Given Tdap, patient developed cellulitis at the site of the injection." Upon furhter review, cellulitis very rarely associated with Tdap vaccine but injection site reaction (swelling, redness, tenderness) are very common. Entry into hospital's adverse drug reaction reporting system contains inadequate information to differentiate the presentation and does not include if antibiotics were given to treat as a presumed bacterial cellulitis.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: "Received Tdap developed cellulitis. Treated w/ Motrin PRN." Upon further review, cellulitis very rarely associated with Tdap vaccine but injection site reaction (swelling, redness, tenderness) are very common. Entry into hospital's adverse drug reaction reporting system contains inadequate information to differentiate the presentation and does not include that antibiotics were given to treat as a presumed bacterial cellulitis.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Approx 5 hours after injection patient reports pain started. Quickly becoming "severe" with mild swelling. Was seen that evening again in office (8pm) at which time exam was done. She was unable to lift her arm past about 40 degrees of abduction. Good distal sensation. Had tried ice and ibuprofen and was encouraged to continue both of these. This pain continued 07/24 07/25 07/26 (which she states some improvment in ROM) on 7/27 nurse followed -up with phone call. Patient reports pain is just as severe and no improvement in ROM. Dr prescribed Neurotin and patient was told it could be another week until symptoms resolve. She is encouraged to come for re-eval any time and office will continue to f/u with her.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: "Given Tdap, developed cellulitis. Treated with Keflex." Information entered through hospital's internal adverse event reporting system; available documentation inadequate to differentiate if this is truly a bacterial cellulitis versus a common injection site reaction. Patient was treated with cephalexin (Keflex).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blindness unilateral, Central nervous system lesion, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: January 21, 2015 optic neuritis left eye begins. By Fri vision loss in left eye. Patient went to ER, ophthalmologist and back to ER for MRI. Find lesions in brain. Treated with 5 days of IV infusion steroids. Diagnosed with M.S. Feb. 3, 2015. Withdrew from school Feb 11, 2015.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Optic neuritis, Visual field tests
Clinical narrative: January 21, 2015 optic neuritis left eye begins. By Fri vision loss in left eye. Patient went to ER, ophthalmologist and back to ER for MRI. Find lesions in brain. Treated with 5 days of IV infusion steroids. Diagnosed with M.S. Feb. 3, 2015. Withdrew from school Feb 11, 2015.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Intussusception, Irritability, Vomiting
Clinical narrative: Intussusception; 15 days after receiving vaccinations. Presented to local ER with vomiting and irritability.
Age: 51.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Areflexia, Asthenia, Dysphagia, Full blood count, Gait disturbance
Clinical narrative: Numbness starting in feet while moving up within the 24 hrs he was numb/weak-unsteady gait, had no reflexes, never had to on ventilator but did have shallow breathing and difficulty swallowing spinal tap confirmed. Tx plasma freeze, IVIG.
Age: 51.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Hypoaesthesia, Hypopnoea, Immunoglobulin therapy, Lumbar puncture, Lumbar puncture abnormal
Clinical narrative: Numbness starting in feet while moving up within the 24 hrs he was numb/weak-unsteady gait, had no reflexes, never had to on ventilator but did have shallow breathing and difficulty swallowing spinal tap confirmed. Tx plasma freeze, IVIG.
Age: 51.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Plasmapheresis
Clinical narrative: Numbness starting in feet while moving up within the 24 hrs he was numb/weak-unsteady gait, had no reflexes, never had to on ventilator but did have shallow breathing and difficulty swallowing spinal tap confirmed. Tx plasma freeze, IVIG.
Age: 51.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Dysphagia, Dyspnoea, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Numbness starting in feet while moving up within the 24 hrs he was numb/weak-unsteady gait, had no reflexes, never had to on ventilator but did have shallow breathing and difficulty swallowing spinal tap confirmed. Tx plasma freeze, IVIG.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired driving ability, Joint swelling, Local swelling, Peripheral swelling, Pyrexia
Clinical narrative: Swelling of right arm, shoulder, neck, fever. Unable to driver to go to school.
Age: 62.0
Sex: M
Vaccine: HEPAB, TDAP, YF
Symptoms: Facial pain, Headache, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Headache, nausea fever. Painful, swollen left arm. Face pain. Subjective fever.
Age: 62.0
Sex: M
Vaccine: HEPAB, TDAP, YF
Symptoms: Pyrexia
Clinical narrative: Headache, nausea fever. Painful, swollen left arm. Face pain. Subjective fever.
Sex: U
Vaccine: PNC13
Symptoms: Contusion
Clinical narrative: This spontaneous report was received from Pfizer and was assigned manufacturer report # 2015220077 concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported). Secondary suspect therapy included PREVNAR 13 (dose, route and lot # not reported) administered in April 2015. Concomitant therapies included and COUMADIN. "Recently", on an unknown date in 2015, the patient was hospitalized. The reason for hospitalization was unknown. There was also reported that the patient had a large bruise on the arm of injection. At the time of the report, the patient's outcome was unknown. This was originally reported by a pharmacist. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, tenderness and redness at the site of injection.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Insomnia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: The patient is having pain in the arm shooting down the inside arm to the palm. The pain is so severe he is having trouble sleeping and is unable to move the arm. We spoke with his Dr and recommended he be seen have not heard back to if the patient scheduled an apointment.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Rash, Swelling
Clinical narrative: About 2 hours following the administration of the immunization, pain, redness, rash, and swelling began. Pain is now so intense, that I am unable to move my arm.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: Little pain when she raises her left arm. Redness just above the elbow to just below the shoulder approximately 60% of circumference of arm. Warm to touch and swollen.  Patient had a similar reaction more than 5 years ago to Pneumovax 23.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Skin discolouration, Urticaria
Clinical narrative: Approximately 10 minutes after administration the patient developed redness and itching around the site of the injection and a white welt.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Chills, Cough
Clinical narrative: From 07/22/2015 to 07/24/2015 Pain at vaccine site, chills, fever 102F, dry cough, diarrhea, vomiting, painful joints (all), severe headache, neck pain, arm pain, rashes, weakness, dizziness. From 07/25/2015 to 07/27/2015 headache and severe pain deep within the left arm where shot was administered, became more severe and unbearable. Unable to move left arm, not able to function, work or even type. Not able to sleep due to severe pain. Today 07/27/2015, I am still experiencing severe arm pain, unable to move it and neck and head pain on left side.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Headache, Injection site pain, Insomnia
Clinical narrative: From 07/22/2015 to 07/24/2015 Pain at vaccine site, chills, fever 102F, dry cough, diarrhea, vomiting, painful joints (all), severe headache, neck pain, arm pain, rashes, weakness, dizziness. From 07/25/2015 to 07/27/2015 headache and severe pain deep within the left arm where shot was administered, became more severe and unbearable. Unable to move left arm, not able to function, work or even type. Not able to sleep due to severe pain. Today 07/27/2015, I am still experiencing severe arm pain, unable to move it and neck and head pain on left side.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Neck pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: From 07/22/2015 to 07/24/2015 Pain at vaccine site, chills, fever 102F, dry cough, diarrhea, vomiting, painful joints (all), severe headache, neck pain, arm pain, rashes, weakness, dizziness. From 07/25/2015 to 07/27/2015 headache and severe pain deep within the left arm where shot was administered, became more severe and unbearable. Unable to move left arm, not able to function, work or even type. Not able to sleep due to severe pain. Today 07/27/2015, I am still experiencing severe arm pain, unable to move it and neck and head pain on left side.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: From 07/22/2015 to 07/24/2015 Pain at vaccine site, chills, fever 102F, dry cough, diarrhea, vomiting, painful joints (all), severe headache, neck pain, arm pain, rashes, weakness, dizziness. From 07/25/2015 to 07/27/2015 headache and severe pain deep within the left arm where shot was administered, became more severe and unbearable. Unable to move left arm, not able to function, work or even type. Not able to sleep due to severe pain. Today 07/27/2015, I am still experiencing severe arm pain, unable to move it and neck and head pain on left side.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dyspnoea, Feeling abnormal, Gait disturbance, Hyperhidrosis
Clinical narrative: Upon receiving the vaccine my son became pale, his lips turned white, he couldn't walk, he was sweating and he was moaning. The medical assistant gave me an ice pack to put on the back of my son's neck and said he should raise his legs. The doctor and medical assistant said they never saw a child have this type of reaction. My son laid across two chairs in the doctor's hallway for an hour and a half before he could stand up to go home. My son said that he felt like he was going to die. A few hours later he regained color in his face. He had no energy and laid down the rest of the day. The next day 5/10/14 he wasn't himself, he was quiet all day and didn't have energy. To me it seemed as though he was trying to catch his breath at times, he has Asthma. The next night he had a fever of 102.9, he had deep shallow breathing. I woke him up to take Motrin, I told him to use his inhaler. We followed up with the doctor the next day, and it wasn't until a day or two after that, that my son felt better. My son has always had bad reactions to vaccines, but this was the worse. Since he's always had vomiting, fevers, night sweats, and swelling at injection sites, and this was the worse reaction, I'm concerned for what could happen in the future.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperventilation, Hypopnoea, Lip discolouration, Moaning, Pallor
Clinical narrative: Upon receiving the vaccine my son became pale, his lips turned white, he couldn't walk, he was sweating and he was moaning. The medical assistant gave me an ice pack to put on the back of my son's neck and said he should raise his legs. The doctor and medical assistant said they never saw a child have this type of reaction. My son laid across two chairs in the doctor's hallway for an hour and a half before he could stand up to go home. My son said that he felt like he was going to die. A few hours later he regained color in his face. He had no energy and laid down the rest of the day. The next day 5/10/14 he wasn't himself, he was quiet all day and didn't have energy. To me it seemed as though he was trying to catch his breath at times, he has Asthma. The next night he had a fever of 102.9, he had deep shallow breathing. I woke him up to take Motrin, I told him to use his inhaler. We followed up with the doctor the next day, and it wasn't until a day or two after that, that my son felt better. My son has always had bad reactions to vaccines, but this was the worse. Since he's always had vomiting, fevers, night sweats, and swelling at injection sites, and this was the worse reaction, I'm concerned for what could happen in the future.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Upon receiving the vaccine my son became pale, his lips turned white, he couldn't walk, he was sweating and he was moaning. The medical assistant gave me an ice pack to put on the back of my son's neck and said he should raise his legs. The doctor and medical assistant said they never saw a child have this type of reaction. My son laid across two chairs in the doctor's hallway for an hour and a half before he could stand up to go home. My son said that he felt like he was going to die. A few hours later he regained color in his face. He had no energy and laid down the rest of the day. The next day 5/10/14 he wasn't himself, he was quiet all day and didn't have energy. To me it seemed as though he was trying to catch his breath at times, he has Asthma. The next night he had a fever of 102.9, he had deep shallow breathing. I woke him up to take Motrin, I told him to use his inhaler. We followed up with the doctor the next day, and it wasn't until a day or two after that, that my son felt better. My son has always had bad reactions to vaccines, but this was the worse. Since he's always had vomiting, fevers, night sweats, and swelling at injection sites, and this was the worse reaction, I'm concerned for what could happen in the future.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Biopsy, Herpes zoster disseminated
Clinical narrative: biopsy-proven disseminated Zoster. treated with valacyclovir, responding well.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Chest X-ray normal, Full blood count abnormal, Headache, Liver function test abnormal, Musculoskeletal stiffness
Clinical narrative: biopsy-proven disseminated Zoster. treated with valacyclovir, responding well.