chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLUX, MEN
Symptoms: Eczema, Psoriasis, Rash pruritic, Urticaria
Clinical narrative: Itchy rash/hives all over body, increasing in severity over the course of four weeks; has not resolved at this time. Also, patch of eczema or psoriasis on back of right hand. Not responding to OTC diphenhydramine or cortisone cream.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test normal, Computerised tomogram normal, Ophthalmological examination abnormal, Vision blurred, Visual impairment
Clinical narrative: My left eye was blurred. Called Doctor 10/28/2016 he check my eye. Sent me for a CT scan and blood work.  Results came back fine. Went to my eye Doctor on 11/02/2016. He did an eye exam. Found that my left eye changed from 04/2016.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Peripheral swelling, Ultrasound scan normal, Vein disorder
Clinical narrative: Initial unsolicited report received from a consumeron 21 October 2016. This case involves an 85-year-old male patient who was vaccinated with a dose FLUZONE HD (batch number: unknown, expiration date, dose was not reported) intramuscularly in the left deltoid on 13 September 2016. Patient's Illness at time of vaccination was reported as unknown and Pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergy (NKA). Patient had a pacemaker put in on the left side of chest one month before injection and had gone multiple times to the doctor. Concomitant medications were not reported. On 14 September 2016, one day following the vaccination, the patient left arm was swollen from the shoulder to fingertips and had decreased 50% but was still swollen. It was reported that left chest area near the shoulder showed 3 areas that "looked like varicous veins". Patient was treated at urgent care, emergency room visit (ER) and other doctors. Lab data included ultrasound which was negative on an unknown date. Patient's corrective treatment was not reported. Outcome of the event was reported as not recovered. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial unsolicited report received from a Pharmacist on 21 October 2016. This case involves seven patients (gender not reported) who were vaccinated with a second dose of FLUZONE HD (batch number: UI685AB, expiration date: 23 April 2017, dose and site of administration were not reported) intramuscularly on 20 October 2016. Patient Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. Any other vaccinations within 4 weeks of vaccinations were reported as unknown. On 21 October 2016, one day following the vaccination, the patients had a site reaction. It was reported that all the reactions were as golf to tennis ball size, red, itchy and non-painful. Relevant diagnostic tests or laboratory data was reported as none. The patients were advised to take OTC medications and apply compresses. Outcome of the events was reported as not recovered. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Local swelling
Clinical narrative: Initial unsolicited report received from a pharmacist on 21 Oct 2016. This case involves six patients (gender and age not reported) who were vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration 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 unknown date, unspecified timeframe following the vaccination, the patients had developed tennis ball size red swollen local reactions on the arm. Laboratory investigations 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: M
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Initial unsolicited report received from a consumer on 20 Oct 2016. This case involves a 54-year-old male patient who was vaccinated with first dose of injection of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 15 Oct 2016. The patient's medical history and concomitant medications were not reported. On 15 Oct 2016, same day following the vaccination, the patient had flu like symptoms. The patient's laboratory data and corrective treatment was not reported. On 16 Oct 2016, the patient was recovered from flu like symptoms. List of documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Developed a rash on both inner forearms with pruritis treated with benadryl and calamine spray.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dry throat, Dyspnoea, Feeling hot, Pain in extremity, Pyrexia
Clinical narrative: Vaccine was injected on left arm- by 4:00 PM my arm began to hurt and I can't move the arm. The arm was flushed to my body and I can't raise it, hold anything with my hand. By 7:30PM the pain increased, I developed some fever, not to high but warm enough I knew I was getting fever. I developed some bumps on my face, above the right eye, and I had difficulty breathing. Again, not to the point where I can't breath, but I was not my normal self. I was trying to yawn and my throat felt dry and no air going into my lungs. I did some deep breathing exercises and walked around. This helped. The pain continue for few more hours. I placed an ice bag on my arm, on and off, for several hours and this seemed to help. I couldn't sleep. Close to 3:00 AM the pain diminished and I was able to sleep few hours. By 8:00 AM, I was feeling better. I called the DR. and they asked me to come in. The Dr. said I can take Ibuprofin 600 mg.. I did and it helped. Tuesday night I was able to sleep and Wednesday I went back to work.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Vaccine was injected on left arm- by 4:00 PM my arm began to hurt and I can't move the arm. The arm was flushed to my body and I can't raise it, hold anything with my hand. By 7:30PM the pain increased, I developed some fever, not to high but warm enough I knew I was getting fever. I developed some bumps on my face, above the right eye, and I had difficulty breathing. Again, not to the point where I can't breath, but I was not my normal self. I was trying to yawn and my throat felt dry and no air going into my lungs. I did some deep breathing exercises and walked around. This helped. The pain continue for few more hours. I placed an ice bag on my arm, on and off, for several hours and this seemed to help. I couldn't sleep. Close to 3:00 AM the pain diminished and I was able to sleep few hours. By 8:00 AM, I was feeling better. I called the DR. and they asked me to come in. The Dr. said I can take Ibuprofin 600 mg.. I did and it helped. Tuesday night I was able to sleep and Wednesday I went back to work.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Disturbance in attention, Dizziness, Feeling abnormal, Flushing, Heart rate increased
Clinical narrative: Increased heart rate, back of throat swelling (minor), dizziness, itching, felt flush, felt as if my body was buzzing-rushing, could not concentrate, felt as if I was going to faint, later my legs felt 3xs their size.   Took Benadryl.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb discomfort, Pharyngeal oedema, Pruritus
Clinical narrative: Increased heart rate, back of throat swelling (minor), dizziness, itching, felt flush, felt as if my body was buzzing-rushing, could not concentrate, felt as if I was going to faint, later my legs felt 3xs their size.   Took Benadryl.
Sex: F
Vaccine: HPV4
Symptoms: Throat cancer
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a female patient of unknown age. No information on patient's pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot # and expiration date were not provided). Concomitant medications were not reported. On an unknown date after receiving GARDASIL injection, the patient was diagnosed with throat cancer. The outcome of the throat cancer was unknown. The causality between the event and the vaccination with GARDASIL was not reported. Upon internal review, the event of throat cancer was considered to be medically significant. Additional information is not expected, as the reporter did not wish the company to contact physician.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Chest discomfort, Cough, Pneumonia
Clinical narrative: States 30-40 minutes after vaccine was administered started felt tightening in the chest and progressively got worse and had to use her asthma Albuterol inhaler.  One week post of getting Flu vaccine developed a cough and went to the doctor.  she was given another inhaler(ProAir) Steroids, Z-pack, Tessalon Pill and Cherratussin cough syrup.  States over the weekend progressively got worse and had to go back to see her PCP on Monday  and was given an X-Ray of the chest and was diagnosed with early Pneumonia. More medications was prescribed. Levaquin, Was given a Solumedrol IM injection and increased the Z-Pack medication.  States referral was given to see and Allergist.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Flushing, Peripheral swelling, Skin tightness, Tenderness
Clinical narrative: L leg with swelling of entire thigh, redness/flushed appearing, tight, tender to touch, swelling from upper thigh down to knee. Entire leg tight and tender to touch.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left deltoid swelling/pain/itchy. Loss of consciousness, seizure, head trauma from fall.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Left deltoid swelling/pain/itchy. Loss of consciousness, seizure, head trauma from fall.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Injection site atrophy, Malaise, Skin discolouration
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 26Oct2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and other HCP (registered medical assistant) via a sales representative. This other HCP reported similar events for two patients. This is 1st of two reports. The reporter was calling on behalf of both of the physicians who administered PREVNAR 13 to the 2 patients. A 75-year-old female patient received PREVNAR 13 (Lot Number N16560, Expiry date Sep2017, NDC number 0005197101) intramuscular at 0.5 ml, single in the left deltoid on 29Sep2016 01:45 for immunisation. Medical history included ongoing hypertension (taking NORVASC and COZAAR for it), ongoing atrial fibrillation (taking LOPRESSOR for it), ongoing blood pressure measurement, ongoing diabetes mellitus. Concomitant medication included LOPRESSOR orally 25 mg tablet, twice a day ongoing for atrial fibrillation, NORVASC orally 5 mg tablet, once a day ongoing for hypertension, COZAAR orally 50 mg tablet, twice a day ongoing for hypertension. The patient previously took prednisone and experienced blood glucose abnormal. The patient experienced greater than 10 cm redness on 01Oct2016 with outcome of recovered, swelling on an unspecified date with outcome of unknown, malaise on 01Oct2016 with outcome of recovered, headache on 01Oct2016 with outcome of recovered, depression spot in the middle where with the needle had been injected on an unspecified date with outcome of unknown, slight dark area where the swelling had been on an unspecified date with outcome of unknown. Treatment received for redness and swelling included some Prednisone but the patient discontinued it after few days because the patient was a diabetic and it (Prednisone) was messing with her (patient) sugar so the patient discontinued Prednisone on her own. Sender's Comments: Linked Report(s): US-PFIZER INC-2016504326 Same reporter/drug, different patients, similar event.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 26Oct2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and other HCP (registered medical assistant) via a sales representative. This other HCP reported similar events for two patients. This is 1st of two reports. The reporter was calling on behalf of both of the physicians who administered PREVNAR 13 to the 2 patients. A 75-year-old female patient received PREVNAR 13 (Lot Number N16560, Expiry date Sep2017, NDC number 0005197101) intramuscular at 0.5 ml, single in the left deltoid on 29Sep2016 01:45 for immunisation. Medical history included ongoing hypertension (taking NORVASC and COZAAR for it), ongoing atrial fibrillation (taking LOPRESSOR for it), ongoing blood pressure measurement, ongoing diabetes mellitus. Concomitant medication included LOPRESSOR orally 25 mg tablet, twice a day ongoing for atrial fibrillation, NORVASC orally 5 mg tablet, once a day ongoing for hypertension, COZAAR orally 50 mg tablet, twice a day ongoing for hypertension. The patient previously took prednisone and experienced blood glucose abnormal. The patient experienced greater than 10 cm redness on 01Oct2016 with outcome of recovered, swelling on an unspecified date with outcome of unknown, malaise on 01Oct2016 with outcome of recovered, headache on 01Oct2016 with outcome of recovered, depression spot in the middle where with the needle had been injected on an unspecified date with outcome of unknown, slight dark area where the swelling had been on an unspecified date with outcome of unknown. Treatment received for redness and swelling included some Prednisone but the patient discontinued it after few days because the patient was a diabetic and it (Prednisone) was messing with her (patient) sugar so the patient discontinued Prednisone on her own. Sender's Comments: Linked Report(s): US-PFIZER INC-2016504326 Same reporter/drug, different patients, similar event.
Sex: M
Vaccine: PPV, PPV
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician from a Pfizer-sponsored program, Pfizer RXPathways. A male patient of an unspecified age (currently 88 year-old), race and ethnicity had experienced allergy on an unspecified date  following the administration of a single dose of pneumococcal vaccine (TRADE NAME UNKNWON) for immunisation. The patient medical history and concomitant medications were not reported. Outcome was unknown. Pfizer is a marketing authorization holder of pneumococcal vaccine in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal vaccine has submitted the same report to the regulatory authorities. No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 66-years-old female patient received PREVNAR 13 (Lot # M56416, Expiry Date Jun2017, NDC number 0005197102), intramuscular at 0.5 ml single in the right deltoid on 24Oct2016 for immunisation. Medical history included ongoing allergy to Sulfa, ongoing to latex. There were no concomitant medications. The patient experienced rash at the injection site, pretty big on 25Oct2016 with outcome of not recovered.
Age: 0.7
Sex: U
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Product quality issue, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse and a physician via a sales representative. An 8-month-old patient of an unspecified ethnicity and gender received PREVNAR 13, (lot # N34935) at single dose, and PENTACEL, both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had some vomiting, fever, lot# had been reported back on 12Oct2016 as being bad. No treatment was received for vomiting and fever. The outcome of the events was unknown. The mom had said that she had something on mind, there was something wrong with the Lot. Nurse was just trying to find out that if there was something with the Lot.  A Product Complaint was filed. Course of events: A physician had received a call from a mother in the middle of the night and said that there was a severe reaction, that is the child had fever and one episode of vomiting after receiving Pentacel and Prevnar 13 vaccine Lot# N34935 but the mother did not mention about what type of severe reaction. The mother told the doctor that how does the doctor did not know that Prevnar 13 had a bad Lot # out there and the doctor gave it to the mother's patient. The mother who had reported the incident to the physician said that this Lot# had been reported back on 12Oct2016 as being bad. The doctor said that he/she had looked at several websites and did not see anything and was assuming that it was a baseless claim and they wanted to make sure that the doctor was not missing something. The physician had sent the email to all the providers and the nurse had forwarded it to her. The nurse said that the doctor did not say anything about it but it was the mother who thought that the severe reaction was because the Prevnar 13 Lot# was reported on 12Oct2016.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on herself. A 61-year-old female patient received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), via an unspecified route of administration on the left arm on an unknown date (13 years ago) at a single dose for immunization. Ongoing medical history included decreased lung capacity due to scoliosis. There were no concomitant medications. The patient previously received the first and second dose of pneumococcal vaccine (MANUFACTURER UNKNOWN) in 1980 and then 10 years later in (1990) respectively for immunization. She previously received the "shingles shot" varicella zoster vaccine (MANUFACTURER UNKNOWN) about 4 years ago for immunization. The patient did not experience adverse events following prior vaccines. On an unknown date "13 years ago", the patient experienced drug use in unapproved population. The patient reported that "13 years ago" she received the 3rd dose of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein), in her left arm and the injection got red. The patient elaborated that the injection site was deep red, there was a 6 inch diameter around the injection site that felt hard and hot, it was swollen and sore. The patient believes the soreness started the day the vaccine was administered and the rest of the symptoms occurred the next day (unspecified dates). The patient reported there was no illness at the time of vaccination. She went to the doctor a few weeks later when the symptoms were not going away. Her doctor told her it was a reaction to the vaccine and to use cold compresses. The injection site was swollen and red for about 6 weeks after receiving pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein). She thinks that hardness probably resolved sooner than the swelling and the redness, but still took a few weeks and slowly decreased. The patient thinks she should have the PREVENAR 13 vaccine, but her doctor was concerned because of the reaction that she had to last pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein). There was no laboratory data. The clinical outcome of the events,  injection site was deep red, there was a 6 inch diameter around the injection site that felt hard and hot, it was swollen, sore, and drug use in unapproved population, was unknown.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Chills, Fatigue, Pain, Swelling
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 21-Oct-2016. This case involves a 65-year-old male patient who was vaccinated with a dose of Fluzone HD (Batch number, expiration date, dose, dose in series were not reported) intramuscularly in the left deltoid on 20-Oct-2016. Patient's medical history was reported that Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Illness at the time of vaccination was also reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 20-Oct-2016, four hours following the vaccination, the patient felt tired, achy, and had the chills. He did not check his temperature. He reported that his Achilles tendon became inflamed, slightly swollen, and sore to touch. He stated he could not walk, and it was very painful. Laboratory investigations were reported as none. Patient received three Advil as corrective treatment and went to bed. The patient was recovered from all the events on an unknown date (reported as he stated that this morning, he was fine). List of documents held by the sender: None.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Tenderness, Tendon pain, Tendonitis
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 21-Oct-2016. This case involves a 65-year-old male patient who was vaccinated with a dose of Fluzone HD (Batch number, expiration date, dose, dose in series were not reported) intramuscularly in the left deltoid on 20-Oct-2016. Patient's medical history was reported that Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Illness at the time of vaccination was also reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 20-Oct-2016, four hours following the vaccination, the patient felt tired, achy, and had the chills. He did not check his temperature. He reported that his Achilles tendon became inflamed, slightly swollen, and sore to touch. He stated he could not walk, and it was very painful. Laboratory investigations were reported as none. Patient received three Advil as corrective treatment and went to bed. The patient was recovered from all the events on an unknown date (reported as he stated that this morning, he was fine). List of documents held by the sender: None.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Urticaria
Clinical narrative: Hives on neck, back, and back of neck, around the mouth, Chest, Abdomen, Burning sensation in back, chest, abdomen, neck and face.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram head, Diplopia, Nuclear magnetic resonance imaging brain, Vision blurred
Clinical narrative: Double Vision/ Blurred Vision ... still continues. .. Opthamologist is monitoring. No treatment.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Tic
Clinical narrative: Complex motor tics.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HIBV, MMRV, PNC13
Symptoms: Blood pressure measurement, Cardiac arrest, Cardio-respiratory arrest, Death, Endotracheal intubation
Clinical narrative: Full arrest noted approximately 45 minutes after being put to bed at home. EMS notified and pt was transported to ED where she was intubated, given epi and sodium bicarb. She remained in total asystole during resuscitation efforts.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HIBV, MMRV, PNC13
Symptoms: Heart rate, Respiratory rate, Resuscitation
Clinical narrative: Full arrest noted approximately 45 minutes after being put to bed at home. EMS notified and pt was transported to ED where she was intubated, given epi and sodium bicarb. She remained in total asystole during resuscitation efforts.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blister, Erythema, Macule, Papule, Rash
Clinical narrative: Pt presented to our office on 11-1-16 with a scattered rash on back, arms, legs and head. The rash had erythematous macules to papules and vesicles.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Angioedema, Epigastric discomfort, Oropharyngeal pain, Skin exfoliation, Stevens-Johnson syndrome
Clinical narrative: On 10/14/16, 51 yo F presented to clinic for nurse only visit for second hepatitis B vaccination. Pt received first vaccination on 09/14/16 without incident. On 10/14 at 1019, pt received hepatitis B vaccine 0.5 mL in right deltoid (NDC: 58160-821-43, Lot #JT379, Exp: 3/10/2019). On 10/16, pt developed blistering and pruritic rash all over her body. After self-treatment with diphenhydramine 50 mg at 1000 and 25 mg at 1500 failed to provide relief, pt presented to urgent care. Pt denied any throat swelling, but did report a mild sore throat sensation and epigastric discomfort. Pt further reported numerous episodes of spontaneous angioedema and urticaria in the past. Pt was referred to ED and report was called in advance of her arrival. Pt prescribed prednisone and was to follow up with her dermatologist. Dermatologist diagnosed mild Stevens-Johnson syndrome and prescribed higher dose of prednisone which pt was taking as directed. On 10/24, pt returned to clinic and exam found symptom improvement with diminished rash and no further skin peeling. Pt continues to be followed by dermatologist. On 10/20, pt's allergy profile was updated to include Hepatitis B Virus Vaccine (rxn: Hives).
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: On 10/14/16, 51 yo F presented to clinic for nurse only visit for second hepatitis B vaccination. Pt received first vaccination on 09/14/16 without incident. On 10/14 at 1019, pt received hepatitis B vaccine 0.5 mL in right deltoid (NDC: 58160-821-43, Lot #JT379, Exp: 3/10/2019). On 10/16, pt developed blistering and pruritic rash all over her body. After self-treatment with diphenhydramine 50 mg at 1000 and 25 mg at 1500 failed to provide relief, pt presented to urgent care. Pt denied any throat swelling, but did report a mild sore throat sensation and epigastric discomfort. Pt further reported numerous episodes of spontaneous angioedema and urticaria in the past. Pt was referred to ED and report was called in advance of her arrival. Pt prescribed prednisone and was to follow up with her dermatologist. Dermatologist diagnosed mild Stevens-Johnson syndrome and prescribed higher dose of prednisone which pt was taking as directed. On 10/24, pt returned to clinic and exam found symptom improvement with diminished rash and no further skin peeling. Pt continues to be followed by dermatologist. On 10/20, pt's allergy profile was updated to include Hepatitis B Virus Vaccine (rxn: Hives).
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Mass, Peripheral swelling
Clinical narrative: Swelling and a baseball sized lump on leg.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Ultrasound scan, X-ray
Clinical narrative: Severe Left Knee pain requiring rest, ice, anti-inflammatory drugs. Resolved in 6 weeks. Then reappeared in Right knee, only more severe and incapacitating. It lasted 9 weeks, then resolved.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Headache, Injection site atrophy, Malaise, Swelling
Clinical narrative: This is a spontaneous report from contactable Other HCP (registered medical assistant). This Other HCP reported similar events for 2 patients. This is 2nd report of 2 reports. The reporter was calling on behalf of both of the physicians who administered Prevnar 13 to the 2 patients. An 80-year-old female patient received the 1st dose of PREVNAR 13 (Lot # N47827, Expiry date Nov2017, NDC number: 0005197101, UPC # 005197102) at 0.5ml single dose at and the 2nd dose of FLUVIRIN (Novartis, Lot # 1619801), both IM at Left upper quadrant of the gluteus on 20Oct2016 2:38 pm for immunization, in the doctor's office. Medical history included ongoing hypertension taking MAXZIDE, ongoing thyroid disorder taking SYNTHROID. Concomitant medication included hydrochlorothiazide, MAXZIDE 37.5/25 mg, tablet, orally, once daily ongoing for Hypertension, SYNTHROID 75 mcg, tablet, orally, once daily ongoing for thyroid PNEUMOVAX. The patient never have received one (Prevnar 13). No other vaccines were given 4 weeks prior to the day of suspected vaccine. On 22Oct2016 the patient had pretty moderate to severe reaction: she experienced greater than 10 cm redness and swelling, normal malaise and headache on 22Oct2016 all with outcome of not recovered. On an unspecified date the patient had like a depression spot in the middle where with the needle had been injected with outcome of unknown. Treatment received: Keflex, 500 mg. No AE required an emergency room or doctor visit. The patient was still experiencing redness and swelling, malaise and headache as far as 25Oct2016. In the reporter medical opinion, there a reasonable possibility this events were related to this suspect product. Sender's Comments: Linked Report(s): US-PFIZER INC-2016501596 Same reporter/drug, different patients, similar event.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Lymphadenopathy, Musculoskeletal stiffness, Neck pain
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program received via a contactable consumer reporting for herself. A 76-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 19Oct2016, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain in neck, headache, stiff neck and stiff glands all on 26Oct2016 with outcome of unknown.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Renal failure, Urine output decreased
Clinical narrative: This is a spontaneous report obtained from a contactable Health Care Professional (retired physician's  assistant that reported for his mother). A 96 year old female patient received, on 25Oct2016, PREVNAR 13 single dose, for immunization. Relevant medical history included coronary artery disease (3-5 years before this report), open heart surgery (10-15 years before this report, coronary bypass for 4-5 arteries), pacemaker (3-5 years before this report), colon cancer that resolved after surgery, total knee replacement, carpal tunnel repair and dementia. Concomitant medications were unknown. The patient previously received, on an unspecified date, flu vaccine and streptococcus pneumonia vaccine, both for immunization.  On 26Oct2016, the patient's urine output decreased: put out less than 500cc of urine and on 27Oct2016, renal failure was diagnosed. In response to renal failure, she was hospitalized on 27Oct2016. Treatment was received. The patient did not recover from the events at time of this report. Sender's Comments: The reported events are considered most likely as coincidental events, unrelated to PREVNAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A patient of an unspecified age, gender and race received, on an unknown date PREVNAR 13 single dose, for immunization. The patient previously, on an unspecified date, received PNEUMOVAX for immunization and experienced cellulitis.  Relevant medical history and concomitant medications were unknown.  On an unspecified date, few days after the vaccination with pneumococcal 13-val conj vac (dipht crm197 protein), the patient developed cellulitis. Clinical outcome of the event was unknown at time of this report.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the event. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Motor dysfunction, Pyrexia, Rash, Regressive behaviour
Clinical narrative: My son stopped cooing and babbling after his vaccine. My son did not develop any new skills from date of vaccine to 8.5 months. His speech and motor skills that were developed regressed. (among other adverse reactions not limited to fever, prolonged crying for 7 days, rash).
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Speech disorder developmental
Clinical narrative: My son stopped cooing and babbling after his vaccine. My son did not develop any new skills from date of vaccine to 8.5 months. His speech and motor skills that were developed regressed. (among other adverse reactions not limited to fever, prolonged crying for 7 days, rash).
Age: 1.0
Sex: M
Vaccine: DTPIHI, HEPA, MMRV, PER
Symptoms: Eyelid oedema, Swelling face, Urticaria
Clinical narrative: Face swollen. Eyes almost swollen shut followed by horrible hives 2 days later which have still not stopped on November 3 2016. Dr says it's only coincidental to vaccination. But I believe that not to be true based on the cases I've read and researched.
Age: 17.0
Sex: M
Vaccine: HPV9, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Neck pain, Pain in extremity
Clinical narrative: Immediately after injection of HPV #1, patient states he has severe pain in left arm and neck. Patient stayed for 15 minutes with continued pain and then went home with his parent. Encouraged to take ibuprofen or TYLEONOL and apply ice pack to arm when home.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Lip swelling, Pain in extremity
Clinical narrative: Patient stopped by the clinic 2 weeks after she received the vaccination and reported she had experienced a sore arm and swollen lips after she received the vaccination. She had a picture on her phone of her lips which were quite swollen.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chronic throat clearing, Lacrimation increased, Ocular hyperaemia, Pruritus, Rash erythematous
Clinical narrative: Reported advers event 11/2/2016. Stated began being itchy within 6 hors of vaccine. Stated that she was taking benadryl and had used her daughter's inhaler on 11/1/16. When seen in clinic on 11/2/2016, had itchy red rash, eys were red and watery and was clearing throat frequently. Complained of wheezing. Was escorted to the Emergency Department.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Reported advers event 11/2/2016. Stated began being itchy within 6 hors of vaccine. Stated that she was taking benadryl and had used her daughter's inhaler on 11/1/16. When seen in clinic on 11/2/2016, had itchy red rash, eys were red and watery and was clearing throat frequently. Complained of wheezing. Was escorted to the Emergency Department.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Patient reports was outside gardening, arm felt itchy and she began scratching her upper left arm, and a welt began to appear and remains about 2 in in diameter. She believes that where the welt is where she received the vaccine. She reports no fever or feelings of sickness, and the itchy welt on her arm is the only symptom. Did not seek medical attention and will take an antihistamine that she has at home and report to MD if symptoms persist or worsen.
Age: 0.33
Sex: F
Vaccine: DTAP, FLU4, HIBV, MMR
Symptoms: Blood bicarbonate decreased, Chills, Decreased appetite, Dehydration, Fluid intake reduced
Clinical narrative: Patient admitted into hospital on 10/04/2016 due to diagnosis of "dehydration secondary to vomiting and fever". Was stated that "symptoms started 5 days prior to admission. Had given TYLENOL. Had some sweats and chills. No Rash. Decreased appetite. Won't drink milk, but does take little water. No wet diapers since night before mouth and tongue get red when she gets a fever. No blood in stool. No blood or bile in emesis. Throws up after anything gets to her stomach. "Dad was taking medication for H. pylori. Given IV fluids during course of hospitalization.
Age: 0.33
Sex: F
Vaccine: DTAP, FLU4, HIBV, MMR
Symptoms: Hyperhidrosis, Oral mucosal erythema, Pyrexia, Tongue discolouration, Vomiting
Clinical narrative: Patient admitted into hospital on 10/04/2016 due to diagnosis of "dehydration secondary to vomiting and fever". Was stated that "symptoms started 5 days prior to admission. Had given TYLENOL. Had some sweats and chills. No Rash. Decreased appetite. Won't drink milk, but does take little water. No wet diapers since night before mouth and tongue get red when she gets a fever. No blood in stool. No blood or bile in emesis. Throws up after anything gets to her stomach. "Dad was taking medication for H. pylori. Given IV fluids during course of hospitalization.
Age: 3.0
Sex: M
Vaccine: FLUX, HIBV
Symptoms: Abscess, Body temperature increased, Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Right deltoid swollen red warm to touch febrile 101.8 rectal temp dr called was told was normal reaction 10/28/2016 child arm doubled in size warm to touch red child taken to urgent care placed on amoxicillin 1/2 tsp 1xday. For cellulitis on 10/30/2016 pediatrician notified patient was screaming in pain was worse child taken to hospital told patient had abcess and switched to clindamyacin 4ml 3xday. On 11/3/2016 child taken to pediatrician for reevaluation of arm pain and hardness in area no better was told to continue antibiotics give Motrin 7.5ml around clock and 5ml of Claritin and follow up Monday 11/7/2016 for evaluation see if needs to be drained.
Age: 3.0
Sex: M
Vaccine: FLUX, HIBV
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Right deltoid swollen red warm to touch febrile 101.8 rectal temp dr called was told was normal reaction 10/28/2016 child arm doubled in size warm to touch red child taken to urgent care placed on amoxicillin 1/2 tsp 1xday. For cellulitis on 10/30/2016 pediatrician notified patient was screaming in pain was worse child taken to hospital told patient had abcess and switched to clindamyacin 4ml 3xday. On 11/3/2016 child taken to pediatrician for reevaluation of arm pain and hardness in area no better was told to continue antibiotics give Motrin 7.5ml around clock and 5ml of Claritin and follow up Monday 11/7/2016 for evaluation see if needs to be drained.
Age: 40.0
Sex: M
Vaccine: FLUR3
Symptoms: Paraesthesia
Clinical narrative: Tingling in lateral aspect of first didget of left hand. Exacerated by position/squeezing hand and grip. Increased with abduction. Seems to spread with certain movements, such as making a fist - felt into part of hand. Seems to have gotten somewhat worse since it started but not more so over the past few days.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Flushing, Headache, Periorbital oedema, Rhinorrhoea
Clinical narrative: Flushed feeling in face, sneezing, runny nose, chest tightness, audible wheeze (lung sounds clear), headache, periorbital edema bilaterally. Ice applied to eyes, Benadryl 50mg taken, symptoms improved in 1-3 hrs except for periorbital edema.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Sneezing, Wheezing
Clinical narrative: Flushed feeling in face, sneezing, runny nose, chest tightness, audible wheeze (lung sounds clear), headache, periorbital edema bilaterally. Ice applied to eyes, Benadryl 50mg taken, symptoms improved in 1-3 hrs except for periorbital edema.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Vomiting
Clinical narrative: Onset of chills, then progressed to sore throat, headache, then 3 days later vomiting, then followed for a sore throat and cough for 3 more days, for a total of 5 days total illness.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: HIVES ALL OVER BODY.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site rash, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: PATIENT WOKE UP THE NEXT DAY WITH A SORE ARM, A FEVER OF 102, HEADACHE, AND A STIFF ARM. ON 11/3/16 SHE WOKE UP WITH A RASH AT THE INJECTION SITE AND HEADACHE, BUT NO FEVER. PATIENT STATED IBUPROFEN OR ACETAMINOPHEN DID NOT HELP THE PAIN OR SWELLING.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: PATIENT WOKE UP THE NEXT DAY WITH A SORE ARM, A FEVER OF 102, HEADACHE, AND A STIFF ARM. ON 11/3/16 SHE WOKE UP WITH A RASH AT THE INJECTION SITE AND HEADACHE, BUT NO FEVER. PATIENT STATED IBUPROFEN OR ACETAMINOPHEN DID NOT HELP THE PAIN OR SWELLING.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, RV5
Symptoms: Blood test, Body temperature increased, Dehydration, Diarrhoea, Haematochezia
Clinical narrative: Started screaming in pain and inconsolable. By that evening (8:30) he started pooping blood. He had a 101.2 temp.  I called ER and was told not to worry unless he is still pooping blood in AM. The next morning it continued and brought him in. They did blood work, ultrasound twice and X-ray. Then admitted him to hospital. Put him on a 24 Hr Pedialyte diet and sent us home the following day. Two days later the blood was back. Went back to ER. He received IV of fluids to help his dehydration from diarrhea and did more blood work and then sent us home. This was yesterday and he is still battling diarrhea.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, RV5
Symptoms: Irritability, Pain, Screaming, Ultrasound scan, X-ray
Clinical narrative: Started screaming in pain and inconsolable. By that evening (8:30) he started pooping blood. He had a 101.2 temp.  I called ER and was told not to worry unless he is still pooping blood in AM. The next morning it continued and brought him in. They did blood work, ultrasound twice and X-ray. Then admitted him to hospital. Put him on a 24 Hr Pedialyte diet and sent us home the following day. Two days later the blood was back. Went back to ER. He received IV of fluids to help his dehydration from diarrhea and did more blood work and then sent us home. This was yesterday and he is still battling diarrhea.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy skin shortly after injection; aware of Hives 2 hours after vaccine received. No respiratory symptoms. Self medicated with BENADRYL.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Decreased appetite, Induration, Injection site erythema, Pain
Clinical narrative: Large red ring encircling entire upper arm.  Inner red ring more red than outer ring, 4 large yellow fluid filled blisters nearest the needle insertion site.  Arm is hot, firm to the touch, painful, itchy.  Fever x 2 days, body aches, diminished appetite.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity, Pruritus, Pyrexia, Skin warm
Clinical narrative: Large red ring encircling entire upper arm.  Inner red ring more red than outer ring, 4 large yellow fluid filled blisters nearest the needle insertion site.  Arm is hot, firm to the touch, painful, itchy.  Fever x 2 days, body aches, diminished appetite.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Insomnia, Pain in extremity
Clinical narrative: Substantial pain in arm where shot was given.  Onset of shivering at 10:00 PM thus did not sleep well (pain in arm and shivering).  Took ibuprofen to lessen pain.  Pain continues to mid-day following day but effects are lessening.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a Pfizer-Sponsored program, by a contactable physician. A 76-year-old female patient of unspecified race received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced drug allergy to PREVNAR 13. The clinical outcome was unknown. Follow-up (21-AUG-2016):  Follow-up attempts are completed. No further information is expected. Follow-up (26Oct2016): New information received from a Pfizer-sponsored program by a contactable physician includes: Reporter's information and patient's DOB and gender.
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a sales representative. A 70-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced right arm was like he had a big bicep, like the bicep was bulged and swollen up on an unspecified date with outcome of unknown.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Decreased appetite, Insomnia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported the same events for herself and for her mother. This is the first of two reports (patient case). A female patient of unspecified age received a single dose of PREVNAR 13, in arm on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU SHOT) given on the other arm for immunisation. Since an unknown date, the patient lost her appetite (she did not eat from 1 o'clock in the afternoon until 7 of the day after) and it was hard to sleep for her. The outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016509530 different patient same drug/event.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Decreased appetite, Insomnia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported the same events for herself and for her mother. This is the second of two reports (reporter's mother case). A female patient of unspecified age received a single dose of PREVNAR 13, in arm on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU SHOT) given on the other arm for immunisation.  Since an unknown date, the patient lost her appetite (she did not eat from 1 o'clock in the afternoon until 7 of the day after) and it was hard to sleep for her. The outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016509473 different patient same drug/event.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthma, Chest discomfort, Dyspnoea, Sensation of foreign body
Clinical narrative: Patient asthmatic. Had breathing problems and felt like a knot in chest. Still having breathing problems feels like tennis ball in throat, went to doctor next day. Used inhaler and was given BENADRYL and Vitamin B6.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Arm and shoulder extreme pain when moving.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Laboratory test, Pyrexia, Swelling, X-ray
Clinical narrative: Swelling, red, fevers - within 24-48 hours. Admitted to hospital - IV antibiotics.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Jaw fracture, Syncope
Clinical narrative: Patient fainted within a few minutes of receiving the injection, fell and sustained an open mandibular fracture.