chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 75 year old male patient. There was no pertinent medical history. Information about drug reactions/allergies was unknown. On 06-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency and route not reported, lot # L038522, expiration date: 11-AUG-2017). Concomitant therapies included unspecified influenza virus vaccine in opposite arm on 06-OCT-2016. It was reported that the patient developed myalgia in the PNEUMOVAX 23 injection arm later on the same day and he could not move the arm. The patient came back to the pharmacy on 07-OCT-2016 and stated that he couldn't move the arm. There were no redness, bumps, or swelling at the injection site when he inspected the arm. Unspecified treatment was given for the event. There were no lab diagnostic studies performed. The patient sought medical attention by pharmacy visit. At the time of reporting, the patient was not recovered from the events. The causality was not reported. The pharmacist considered that "couldn't move the arm" was a significant disability or incapacity. This is one of the two reports from the same reporter (linked to MARRS# 1610USA003570). Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 75 year old male patient. There was no pertinent medical history. Information about drug reactions/allergies was unknown. On 06-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency and route not reported, lot # L038522, expiration date: 11-AUG-2017). Concomitant therapies included unspecified influenza virus vaccine in opposite arm on 06-OCT-2016. It was reported that the patient developed myalgia in the PNEUMOVAX 23 injection arm later on the same day and he could not move the arm. The patient came back to the pharmacy on 07-OCT-2016 and stated that he couldn't move the arm. There were no redness, bumps, or swelling at the injection site when he inspected the arm. Unspecified treatment was given for the event. There were no lab diagnostic studies performed. The patient sought medical attention by pharmacy visit. At the time of reporting, the patient was not recovered from the events. The causality was not reported. The pharmacist considered that "couldn't move the arm" was a significant disability or incapacity. This is one of the two reports from the same reporter (linked to MARRS# 1610USA003570). Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Disability, Mobility decreased
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 75 year old male patient. There was no pertinent medical history. Information about drug reactions/allergies was unknown. On 06-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency and route not reported, lot # L038522, expiration date: 11-AUG-2017). Concomitant therapies included unspecified influenza virus vaccine in opposite arm on 06-OCT-2016. It was reported that the patient developed myalgia in the PNEUMOVAX 23 injection arm later on the same day and he could not move the arm. The patient came back to the pharmacy on 07-OCT-2016 and stated that he couldn't move the arm. There were no redness, bumps, or swelling at the injection site when he inspected the arm. Unspecified treatment was given for the event. There were no lab diagnostic studies performed. The patient sought medical attention by pharmacy visit. At the time of reporting, the patient was not recovered from the events. The causality was not reported. The pharmacist considered that "couldn't move the arm" was a significant disability or incapacity. This is one of the two reports from the same reporter (linked to MARRS# 1610USA003570). Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Severe (R) shoulder pain stiffness loss of range of motion. Decrease quality of life. Can't do normal routine. Pain mile to severe all times.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Quality of life decreased
Clinical narrative: Severe (R) shoulder pain stiffness loss of range of motion. Decrease quality of life. Can't do normal routine. Pain mile to severe all times.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Reaction covered whole (R) thigh wrapping around thigh, radiating to muscles in (R) side of groin-red hard hot to touch, area groin to knee- MD visit 10/12/16.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Skin lesion, Skin reaction
Clinical narrative: Skin reaction within 1 hour of administration of Flu vaccine. Raised lesions on lower legs. Itching of torso. No swelling of lips, mouth. No breathing, swallowing complaints. came to the clinic for guidance.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Cough, Ocular hyperaemia
Clinical narrative: Cough, chest tightness, red eyes, and chills.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Pt has redness and raised lump on arm at site. No itching, rash etc.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Rashes scattered all over body accompanied with itching.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Pt. developed redness and swelling on 10/5/16. Went to urgent care on 10/8/16 with cellulitis of (L) arm.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Rash erythematous, Vaccination site reaction
Clinical narrative: Received FLUZONE Quadval vaccine within 20 min, developed erythematous rash, itching to (R) upper arm at site of vaccine; Antihistamine given; improved.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Chills, Feeling cold, Paraesthesia
Clinical narrative: I feel cold and was shivering all the time. I never got warm. I always rest under blanket with hot electric blanket. When I went to my doctor she gave me antibiotic and refers me to a infection specialist but all my blood test was good. Beside I feel tingling in my hands and feet and tongue.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, tenderness at injection site.  No drainage. Rx amoxicillin 500mg BID.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Patient complained of itching.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: Chills, sweaty, fatigue.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: She developed left shoulder pain at site of injection. Pain worsened so that lifting her left arm was very painful in the shoulder.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pt called office and described localized redness, soreness, mild swelling of L arm with difficulty lifting arm. Pt describes the reddened area to be about 6 inches around. Pt denies fevers, headaches or any other generalized symptoms. Pt's aunt who was given permission to speak on her behalf on the phone by the pt stated that the reddened area was only about 1 inch around and denied any streaking. Pt then called on 5/19/16 and stated that she was seen by her allergist for the reaction and was given recommendation on receiving subsequent doses of the Trumenba vaccine, but upon calling to request a report from the visit our office was informed that she was not seen there for this concern.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chest discomfort, Dyspnoea, Injected limb mobility decreased, Injection site pain, Pruritus
Clinical narrative: Vaccine administered in R bicep ~6-6:15 pm 10/11/16. Hives/itching/heat down at elbow around 7pm. Noticed pain/swelling/soreness radiating from area of injection, difficulty moving/lifting R arm increasing over the next few hours. Applied ice around 10pm and helped reduce heat/swelling slightly.  Woke up due to pain overnight. massaged arm and used natural oils to help loosen muscle. Slight fever. Chest tightened some. Took hot shower 10/12/16 5am - was able to lift arm enough to dress and come to work. Out of breath walking up hill to work every day. Arm is still swollen and painful as of 11AM 10/11/16. Took small dose of Benedryl (1/2 teaspoon) with no reduction of swelling. Took 1 aleve and fever has gone down. Will be visiting the doctor later today.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Skin warm, Swelling, Urticaria
Clinical narrative: Vaccine administered in R bicep ~6-6:15 pm 10/11/16. Hives/itching/heat down at elbow around 7pm. Noticed pain/swelling/soreness radiating from area of injection, difficulty moving/lifting R arm increasing over the next few hours. Applied ice around 10pm and helped reduce heat/swelling slightly.  Woke up due to pain overnight. massaged arm and used natural oils to help loosen muscle. Slight fever. Chest tightened some. Took hot shower 10/12/16 5am - was able to lift arm enough to dress and come to work. Out of breath walking up hill to work every day. Arm is still swollen and painful as of 11AM 10/11/16. Took small dose of Benedryl (1/2 teaspoon) with no reduction of swelling. Took 1 aleve and fever has gone down. Will be visiting the doctor later today.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Ovarian cyst
Clinical narrative: Parent called the clinic and stated that her daughter has an ovarian cyst and she believes it is from the GARDASIL 9 Vaccine.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Trigger finger
Clinical narrative: Patient's left thumb folded and is unable to stretch it out all the way.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Balance disorder, Irritability
Clinical narrative: 1-2 days after the vaccine patient very fussy and had balance problems. Resolved after 3-4 days.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Intense itching all over body and red.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Nausea: onset 10/10 8 PM - has continued for 2 days now. Headache: onset 10/10 9:30 PM - quit after sleep Body aches: onset 10/11 6:30 AM - 10/12 6:30 AM Swelling/pain at injection site: onset 10/10-10/11.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Pain, itching, swelling, hard lump, hot to touch.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Pain
Clinical narrative: Soreness in upper arm where shot was administered. Pain kept accelerating throughout next day - thought I had a joint problem.  Realized it was site of shot.  Bruise, some swelling as well.  Today is 5th day.  Took OTC painkillers last couple of days.  Can't sleep on that side.  Even hurts when I tilt back from keyboard.  Just holding it a certain way helps.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration
Clinical narrative: 10/12/2016 3.5X5cm reddened area of induration. Advised Tylenol &/or Ibuprofen. Alternate heat and cold compresses.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right deltoid pain, swelling, redness.
Age: 0.25
Sex: M
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, PNC13, RVX
Symptoms: Cough, Crying, Diarrhoea, Feeling abnormal, Lethargy
Clinical narrative: My 3 ½ month old son was accidentally given a flu shot along with the Hib, Hepatitis B, Polio, PCV13, DTaP/DT/Td, and Rotavirus vaccinations due for his age. A few hours after the shots, he began to cry inconsolably. He started vomiting and had diarrhea. He began running a fever by 4PM (100.5°F). He suddenly became congested. I began using saline and trying to suction his nose with no success. He also developed a wet cough that seemed to choke him. I began giving him 3 mL of TYLENOL every 6 hours once his fever began. He refused to drink a bottle. He seemed like it hurt him to try and drink it. He was lethargic and seemed dazed. His fever peaked by midnight at 101.2°F. All throughout the night, his breathing was very rapid. He didn't sleep but for 10 -15 minutes at a time and didn't rest comfortably during those periods. His fever broke at 3:30AM the next morning. He was still registering over 99°F but not as high as before. He continued this behavior the entire day after the shots. His temperature increased to 100.7°F as the day progressed and he still refused a bottle. By 3PM, he had only had a portion of 2 4oz bottles and had begun to cry inconsolably again. I returned him to the Doctor's office to have him checked out. I was repeatedly told nothing he was experiencing had anything to do with him being mistakenly given the flu shot. I was told he has a viral infection. The doctor told me to basically do exactly what I had been doing with the TYLENOL, saline, suction and using a humidifier. My 3 ½ month old didn't have any problems or side effects from his first dose of the vaccinations when he was 2 months old. His older brother also has not had any adverse reactions from any of the vaccinations given to him except the flu shot. Every time my 2 ½ year old has ever gotten the flu shot, he has experienced a fever, congestion, vomiting and diarrhea. It would last a few days and he would feel better. My baby is on day 3 after the vaccinations and is still not feeling himself. The vomiting is better, he still has diarrhea, however, and is still congested. His temp hasn't reached 100°F again, but is not in his normal range either. He isn't as lethargic and not as dazed. He is trying to interact with me but will still whine and cry. He has taken a 5 oz bottle, although very slowly. It took him an hour to drink the entire bottle. His usual appetite is 6 oz every 2 ½ hours.
Age: 0.25
Sex: M
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, PNC13, RVX
Symptoms: Pain, Pyrexia, Respiratory rate increased, Respiratory tract congestion, Viral infection
Clinical narrative: My 3 ½ month old son was accidentally given a flu shot along with the Hib, Hepatitis B, Polio, PCV13, DTaP/DT/Td, and Rotavirus vaccinations due for his age. A few hours after the shots, he began to cry inconsolably. He started vomiting and had diarrhea. He began running a fever by 4PM (100.5°F). He suddenly became congested. I began using saline and trying to suction his nose with no success. He also developed a wet cough that seemed to choke him. I began giving him 3 mL of TYLENOL every 6 hours once his fever began. He refused to drink a bottle. He seemed like it hurt him to try and drink it. He was lethargic and seemed dazed. His fever peaked by midnight at 101.2°F. All throughout the night, his breathing was very rapid. He didn't sleep but for 10 -15 minutes at a time and didn't rest comfortably during those periods. His fever broke at 3:30AM the next morning. He was still registering over 99°F but not as high as before. He continued this behavior the entire day after the shots. His temperature increased to 100.7°F as the day progressed and he still refused a bottle. By 3PM, he had only had a portion of 2 4oz bottles and had begun to cry inconsolably again. I returned him to the Doctor's office to have him checked out. I was repeatedly told nothing he was experiencing had anything to do with him being mistakenly given the flu shot. I was told he has a viral infection. The doctor told me to basically do exactly what I had been doing with the TYLENOL, saline, suction and using a humidifier. My 3 ½ month old didn't have any problems or side effects from his first dose of the vaccinations when he was 2 months old. His older brother also has not had any adverse reactions from any of the vaccinations given to him except the flu shot. Every time my 2 ½ year old has ever gotten the flu shot, he has experienced a fever, congestion, vomiting and diarrhea. It would last a few days and he would feel better. My baby is on day 3 after the vaccinations and is still not feeling himself. The vomiting is better, he still has diarrhea, however, and is still congested. His temp hasn't reached 100°F again, but is not in his normal range either. He isn't as lethargic and not as dazed. He is trying to interact with me but will still whine and cry. He has taken a 5 oz bottle, although very slowly. It took him an hour to drink the entire bottle. His usual appetite is 6 oz every 2 ½ hours.
Age: 0.25
Sex: M
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, PNC13, RVX
Symptoms: Vomiting, Wrong drug administered
Clinical narrative: My 3 ½ month old son was accidentally given a flu shot along with the Hib, Hepatitis B, Polio, PCV13, DTaP/DT/Td, and Rotavirus vaccinations due for his age. A few hours after the shots, he began to cry inconsolably. He started vomiting and had diarrhea. He began running a fever by 4PM (100.5°F). He suddenly became congested. I began using saline and trying to suction his nose with no success. He also developed a wet cough that seemed to choke him. I began giving him 3 mL of TYLENOL every 6 hours once his fever began. He refused to drink a bottle. He seemed like it hurt him to try and drink it. He was lethargic and seemed dazed. His fever peaked by midnight at 101.2°F. All throughout the night, his breathing was very rapid. He didn't sleep but for 10 -15 minutes at a time and didn't rest comfortably during those periods. His fever broke at 3:30AM the next morning. He was still registering over 99°F but not as high as before. He continued this behavior the entire day after the shots. His temperature increased to 100.7°F as the day progressed and he still refused a bottle. By 3PM, he had only had a portion of 2 4oz bottles and had begun to cry inconsolably again. I returned him to the Doctor's office to have him checked out. I was repeatedly told nothing he was experiencing had anything to do with him being mistakenly given the flu shot. I was told he has a viral infection. The doctor told me to basically do exactly what I had been doing with the TYLENOL, saline, suction and using a humidifier. My 3 ½ month old didn't have any problems or side effects from his first dose of the vaccinations when he was 2 months old. His older brother also has not had any adverse reactions from any of the vaccinations given to him except the flu shot. Every time my 2 ½ year old has ever gotten the flu shot, he has experienced a fever, congestion, vomiting and diarrhea. It would last a few days and he would feel better. My baby is on day 3 after the vaccinations and is still not feeling himself. The vomiting is better, he still has diarrhea, however, and is still congested. His temp hasn't reached 100°F again, but is not in his normal range either. He isn't as lethargic and not as dazed. He is trying to interact with me but will still whine and cry. He has taken a 5 oz bottle, although very slowly. It took him an hour to drink the entire bottle. His usual appetite is 6 oz every 2 ½ hours.
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Disturbance in attention, Fatigue, Vision blurred
Clinical narrative: Inability to concentrate, blurry vision, and tiredness. Was unable to work and therefore sent home.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient has severe arm tenderness at vaccine injection site and limited motility in arm vaccine was administered.  Patient stated was improving each day.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injection site erythema, Injection site pain, Injection site pruritus, Injection site scab
Clinical narrative: UPRAISED SLIGHTLY RED AND SCABBY AND CONTINUED TO BURN AND ITCH AT INJECTION SITE.  ALSO A PERSISTENT DRY COUGH.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site discharge, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Child's left arm where the vaccine had been administered the day before was swollen, reddened, seeping clear fluid, mildly tender. The mother took the child to a pediatrician this morning who diagnosed it as cellulitis and gave the child antibiotics. The mother came back to our clinic afterward to report the incident.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood immunoglobulin E increased
Clinical narrative: This is a spontaneous report from a contactable consumer via  non-clinical study program. The consumer reported the same event for two patients, this is the first of two reports. A 12-month-old female patient received,  a single dose of PREVNAR 13, MMR, varicella vaccine and hepatitis A vaccine, all on an unspecified date for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient's IgE increased. Patient's clinical course was the following: at 8 months-old, her serum IgE values (in IU/mL) were total 61.4, peanut 13.6, almond 4.04, milk 3.84, egg 2.01, soy 1.6, and wheat 0.98,  compared to total  44.1, peanut 11.2, almond 1.54, milk 2, egg 1.71, soy 1.62, and wheat 2.2 at 12 months-old. After the 12 month-old laboratory tests were drawn, she received the vaccines pneumococcal 13-val conj vac (dipht crm197 protein) , measles vaccine/mumps vaccine/rubella vaccine , varicella vaccine and hepatitis A vaccine. Three weeks later, at 12.7 months , her IgE values were total 75.6, peanut 16.5, almond 2.18, milk 5.06, egg 3.4, soy 3.64, and wheat 3.75. The outcome of the event IgE increasedwas unknown. One or more of these four suspect vaccines could have contributed to the increase in peanut IgE. However, the patient already was sensitized at 8 months. Since hepatitis A, measles vaccine/mumps vaccine/rubella vaccine and varicella were only administered at 12 months, the sensitization was most likely due to pneumococcal 13-val conj vaccine. Per CDC vaccine schedule, by 8 months, the patient likely already received 3 shots of pneumococcal 13-val conj vaccine. The pneumococcal 13-val conj vaccine at 12 months boosted the peanut IgE levels already induced by the previous shots. Follow-up (30Jun2016): Follow-up attempts are completed. No further information is expected. Follow-up (07Oct2016): New information received from contactable consumer via program includes: comment/causality. Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Drug hypersensitivity, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received, when she was 68 year old, a single dose of PREVNAR 13, (Lot: L87117, Exp: Feb2017) IM on right deltoid on 15Sep2015 at midday to prevent pneumonia. Medical history included blood pressure and abnormal cholesterol. The patient never had a seizure disorder for which she was on seizure medications, a brain disorder, Guillain-Barre syndrome. She was not pregnant or considering becoming pregnant in the next month. Concomitant medication included hydrochlorothiazide/ lisinopril (12.5mg/ 20mg) tablet, started in 2010 and ongoing for blood pressure 1 DF 1x/day oral, NEXIUM 24HR 20 mg for long time and stopped in Spring 2016 and simvastatin started in 2009 and ongoing for cholesterol at 20mg (one tablet) 1x/day oral, FLUZONE HIGH-DOSE, (SANOFI, Lot: UL436AA, Exp: 08Apr2016, NDC: 49781-397-88) IM in left deltoid on 15Sep2015 for immunization. She also took a multivitamin and supplements. She experienced allergy to Codeine. The patient never had a reaction after receiving an immunization. The patient experienced pneumonia in Dec2015 and went to urgent care. Patient was not admitted to hospital. She received antibiotic treatment. The outcome of the event was recovered. Follow-up (04Oct2016): New information report from a contactable consumer included: concomitants data; no hospitalization; suspect and conmed details; medical history; past drug history; course of events.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable physician via a Pfizer sales representative, and from a contactable nurse on behalf of physician.  An 89-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot# M27555, Exp date 30Apr2017), intramuscular in left deltoid, on 01Dec2015 at 11:06 AM, at 0.5 ml single, for immunization. Relevant medical history included Cipro allergy with nausea, doxycycline allergy with generalized rash, allergy to sulfonamides with rash. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), from an unspecified date and ongoing; cyanocobalamin (VITAMIN B-12), from an unspecified date and ongoing; isosorbide mononitrate (unspecified trade name), from an unspecified date and ongoing; carvedilol (unspecified trade name), from an unspecified date and ongoing; furosemide (unspecified trade name), from an unspecified date and ongoing; warfarin (unspecified trade name), from an unspecified date and ongoing; cetirizine (unspecified trade name), for itching, from an unspecified date and ongoing; hydroxyzine hydrochloride (HYDROXYZINE HCL), for itching, from an unspecified date and ongoing; melatonin unspecified trade name), from an unspecified date and ongoing; digoxin (unspecified trade name), from an unspecified date and ongoing; lisinopril (unspecified trade name), from an unspecified date and ongoing; calcium citrate, colecalciferol (CALCIUM CITRATE-VITAMIN D3). The patient did not have illness at time of vaccination. On 01Dec2015 the patient experienced arm was very red and swollen. Therapeutic measures were not taken as a result of the reported events. The events recovered on an unknown date after about a day. The reporting nurse assessed that PREVNAR 13 had a causal effect to the adverse events. Follow-up (07Oct2016): New information received from a contactable nurse on behalf of physician includes: patient's age, causality assessment, PREVNAR 13 details, vaccination details, event onset date, illness at time of vaccination details, relevant medical history, concomitant medications, treatment for events details. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Hypersomnia, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer that reported for her daughter and from a contactable nurse. An 18-year-old female patient received TRUMENBA, (Lot. M77282, Expiration date: Jun2017), intramuscular, at 0.5 ml, single dose, intramuscular in the left upper arm, on 06Sep2016 at 15:00, for immunization. The vaccinated at private doctor's office/hospital, and it was purchased with private funds. The patient medical history was not reported. Concomitant medication included naproxen 500 mg as needed, from 21Aug2013 and ongoing, for dysmenorrhea. On 06Sep2016, the patient experienced pain at site of injection with outcome of not recovered, her body aches all over/body ache on an unspecified date with outcome of not recovered, sleeping a lot on an unspecified date with outcome of unknown, napping out a couple of hours on and off on an unspecified date with outcome of unknown, tired/fatigue on an unspecified date with outcome of not recovered. Therapeutic measures were taken as a result of pain at the injection site and body aches included Tylenol. The nurse considered that there was a reasonable possibility that events was related with the suspect product meningococcal group b rlp2086. Follow-up (04Oct2016): New information received from a contactable nurse includes: suspect drug and concomitant medications details. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration in the arm on an unspecified date at 0.5 ml single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the reporting pharmacist seemed to think the vaccine was administered too high up on the arm and might have done some nerve damage as she had limited arm movement continuing for almost a week. The outcome for the events was unknown.
Sex: U
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age (reported as 58 (no units provided) ethnicity and gender received PREVNAR 13, via an unspecified route of administration and FLU SHOT, via an unspecified route of administration, both administered on 20Sep2016 as single dose for immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced shingles on an unspecified date in 2016. The event was described as patient received both the flu shot and PREVNAR 13 vaccine on the same day, 20Sep2016, and came down with shingles within 2 weeks; patient was certain this was caused by having both vaccinations at the same time. The action taken with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine was not applicable. The outcome of shingles was unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer calling on behalf of her. A male patient of an unspecified age received the 1st dose TRUMENBA, (Lot # M95612, NDC # 0005010005) at 0.5 ml, single on 09Aug2016 for immunisation. Medical history included pancreatic insufficiency before since he was much younger, probably from birth. Concomitant medication included ENZYMEDICA DIGEST BASIC oral for pancreas. The patient was given different vaccines. On 09Aug2016 the patient experienced fatigue, fever, headache, muscle pain, joint pain from the injection, pretty much in bed most of the time, weak, all for 5 to 7 days after. The symptoms slightly got a little bit better 5 days after and may be about 7 days after the patient was doing better. The outcome of the events was recovered completely 7 or 8 days after the shot. No treatment received. Laboratory work were done just to ensure he was doing okay. He was due to have his second dose. He was on the 3 dose series. He was on way to college and he would not be back in time for his second dose, so the reporter queried if her son could wait till Thanksgiving for his second dose.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer calling on behalf of her. A male patient of an unspecified age received the 1st dose TRUMENBA, (Lot # M95612, NDC # 0005010005) at 0.5 ml, single on 09Aug2016 for immunisation. Medical history included pancreatic insufficiency before since he was much younger, probably from birth. Concomitant medication included ENZYMEDICA DIGEST BASIC oral for pancreas. The patient was given different vaccines. On 09Aug2016 the patient experienced fatigue, fever, headache, muscle pain, joint pain from the injection, pretty much in bed most of the time, weak, all for 5 to 7 days after. The symptoms slightly got a little bit better 5 days after and may be about 7 days after the patient was doing better. The outcome of the events was recovered completely 7 or 8 days after the shot. No treatment received. Laboratory work were done just to ensure he was doing okay. He was due to have his second dose. He was on the 3 dose series. He was on way to college and he would not be back in time for his second dose, so the reporter queried if her son could wait till Thanksgiving for his second dose.
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Food allergy, Hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent's patient) reported that a 14-month-old male patient of unknown race received PREVNAR 13, at single dose, varicella vaccine,  MMR, FLUZONE and VAQTA all on unknown date for immunization. Five days later (over the weekend), on unknown date the patient developed an allergic reaction to peanut butter. The outcome of the event was unknown.
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of unknown age (between 16-18) and ethnicity received third dose of TRUMENBA for Immunization at single dose on unknown date. On unknown date the patient experienced chills, dizzy, pain at the injection site that was unlike prior 2 immunizations. The outcome of the events were unknown.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Nausea, Tremor
Clinical narrative: Chills, shaking, headache, fatigue, nausea.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Pain and swelling of right upper arm. Redness and warmth. Tender to light touch.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Vomiting
Clinical narrative: Chills, throwing up, belly pain, diarrhea.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt reports itching and hives. Pt taking BENADRYL. Pt currently recovering without professional medical care.
Age: 93.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: PT DEVELOPED FLU LIKE SYMPTOMS THE DAY AFTER FLU SHOT.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat, swelling at injection site.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Severe headache, weakness, dizziness, fatigue, nausea, loss of appetite.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Severe headache, weakness, dizziness, fatigue, nausea, loss of appetite.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Myelitis transverse, Nasopharyngitis, Paraesthesia
Clinical narrative: Initially felt cold-like symptoms. Mild reaction. Then, peripheral numbness and tingling began on or around 8/22/2016. Developed into transverse myelitis affecting lower extremities, upper extremities and thorax. Was seen at hospital.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood creatine phosphokinase increased, Pyrexia
Clinical narrative: Fever and generalized weakness.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Intermittent red raised itchy rashes on arms, back, hands, and stomach; duration of 15-30 minutes before spontaneously resolving.
Age: 38.0
Sex: F
Vaccine: FLUC4, FLU3
Symptoms: Chills, Injection site pain, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: I received vaccine 10/6, developed injection site soreness, muscle aches and chill along with low grade fever of 99, kept low grade fever daily, 10/12 fever increased to 101, continued aches, chills, developed cough and sore throat, went to primary care doctor office 10/12, had to miss work due to fever, had been controlling low grade temp and aches with ibuprofen which continued to progressively get worse.
Age: 38.0
Sex: F
Vaccine: FLUC4, FLU3
Symptoms: Activities of daily living impaired, Condition aggravated, Cough, Impaired work ability, Injection site pain
Clinical narrative: I received vaccine 10/6, developed injection site soreness, muscle aches and chill along with low grade fever of 99, kept low grade fever daily, 10/12 fever increased to 101, continued aches, chills, developed cough and sore throat, went to primary care doctor office 10/12, had to miss work due to fever, had been controlling low grade temp and aches with ibuprofen which continued to progressively get worse.
Age: 38.0
Sex: F
Vaccine: FLUC4, FLU3
Symptoms: Muscular weakness, Myelitis transverse, Oropharyngeal pain, Pain, Paraesthesia
Clinical narrative: I received vaccine 10/6, developed injection site soreness, muscle aches and chill along with low grade fever of 99, kept low grade fever daily, 10/12 fever increased to 101, continued aches, chills, developed cough and sore throat, went to primary care doctor office 10/12, had to miss work due to fever, had been controlling low grade temp and aches with ibuprofen which continued to progressively get worse.
Age: 38.0
Sex: F
Vaccine: FLUC4, FLU3
Symptoms: Pyrexia, Respiratory tract infection, Vaccination site pain, Viral infection, Wheezing
Clinical narrative: I received vaccine 10/6, developed injection site soreness, muscle aches and chill along with low grade fever of 99, kept low grade fever daily, 10/12 fever increased to 101, continued aches, chills, developed cough and sore throat, went to primary care doctor office 10/12, had to miss work due to fever, had been controlling low grade temp and aches with ibuprofen which continued to progressively get worse.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site swelling
Clinical narrative: Injection site is red and swollen. Approximately the size of a dime. Was the approximately the size of a quarter before. Also site of injection appears to be lower than the recommended site. Pt. is seeing physician today.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Patient got the flu shot and notes throat tightening and SOB. Felt like "cotton mouth". Pt presented to Urgent Care, given EPIPEN upon arrival and BENADRYL injection at 9:30 PM. Sent to nearest ER.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, nausea continued all night and into the following day.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle twitching, Musculoskeletal pain, Paraesthesia
Clinical narrative: Shoulder pain, arm tingling and twitching.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Feeling abnormal, Lip swelling
Clinical narrative: Patient said she began to feel bad when she laid down to go to bed. Started rash so took BENADRYL. When she woke up the next morning her lips had swelled and she was having trouble breathing.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: I felt extreme tightness in my chest making it very difficult to breathe. I became very hoarse and I felt extremely dizzy.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm sore for the following 3 weeks. Not able to move arm laterally or above horizontal to the ground. It has been 3 weeks and 1 day, and it is slowly improving, but still painful. Doctor's appt at 2 weeks indicated no infection. No action taken by Dr other than use of OTC pain medications.
Sex: M
Vaccine: PNC13
Symptoms: Drug ineffective, Inappropriate schedule of drug administration, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional. This report was received via a Pfizer sales representative.  A male patient of an unspecified age (over the age of 1 years-old, not further specified), race, and ethnicity received two doses of PREVNAR 13 on an unknown date and on 26Sep2016, respectively; both via unspecified routes of administration at single doses for immunisation. The patient's medical history and concomitant medications were not reported.  On 30Sep2016, the patient was diagnosed with pneumonia in the right middle lobe , left lower lobe, and possibly the right upper lobe. On an unknown date in 2016, it was also reported that the patient experienced inappropriate schedule of vaccine administered. This was further elaborated as the patient had only received two doses of the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) when he should have had 4 doses by his current age. The clinical outcome of the events, drug ineffective, pneumonia, and inappropriate schedule of vaccine administered, was unknown. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Sex: U
Vaccine: PNC13
Symptoms: Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse who reported the same event for eight different patients. This is the 1st of eight reports. A patient (baby) of unspecified age, ethnicity and gender received PREVNAR 13 (Lot # N16560, Expiry Date 30Sep2017, NDC number  0005-1971-02, UPC number 30051971022), via an unspecified route of administration at 0.5 ml, single on an unspecified date in Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The maximum temperature was 49 degree Fahrenheit and in response to minimum temperature, nurse stated that it did not go outside of the range negatively, it was only too warm. Nurse provided the duration of temperature excursion as 52 minutes. In Oct2016, the patient received the vaccine after temperature excursion with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016474382 Same reporter/drug/event, different patient.;US-PFIZER INC-2016474285 same reporter/drug/event, different patient.;US-PFIZER INC-2016474390 Same reporter/drug/event, different patient.;US-PFIZER INC-2016474345 same reporter/drug/event, different patient;US-PFIZER INC-2016474367 same reporter/drug/event, different patient;US-PFIZER INC-2016474369 same reporter/drug/event, diff patients;US-PFIZER INC-2016474374 Same reporter/product/event, different patient
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Noticed swelling and redness on upper left arm next day. Localized R and N.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Contusion, Pain
Clinical narrative: Patient received ADACEL and AFLURIA vaccines on 10/6. She developed a bruise like AE, that was about 5x5 inches large. Was very sore for about 3 days. No fever, and she was feeling a lot better when I saw her.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a 44-year-old female patient who received FLUARIX QUADRIVALENT (batch number B9G34, expiry date 20th May 2017). Previously administered products included FLUARIX QUADRIVALENT (received vaccine in last year and had no reaction). On 3rd October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 4th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced swelling arm (serious criteria disability), pain in arm (serious criteria disability) and injected limb mobility decreased (serious criteria disability). On an unknown date, the outcome of the swelling arm, pain in arm and injected limb mobility decreased were unknown. The reporter considered the swelling arm, pain in arm and injected limb mobility decreased to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were reported as follows: On 3rd October 2016 at 8:47 hours, the patient received the FLUARIX QUADRIVALENT. On the next day, the patient reported a swollen left arm which ached and she was not able to raise her left arm. The reporter stated that the patient felt both these adverse events were somewhat disabling to the patient.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Blood glucose decreased, Hypotension, Loss of consciousness, Syncope
Clinical narrative: Pt. experienced syncope. Called 911. Pt. had low BP, low blood sugar, and abdominal pain. Paramedics were going to take her to hospital but pt declined and had a friend pick her up. Afterward she said she passed out before with shot.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Swollen tongue
Clinical narrative: Pt experienced "swelling of tongue and numbness" the evening after vaccine administered. Resolved without seeking medical attention.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Lethargy, Limb discomfort
Clinical narrative: Numbness in lower lip, dizziness, lethargic, numbness, tingling, in (L) arm to 4th and 5th fingers, arm feels heavy.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: Numbness in lower lip, dizziness, lethargic, numbness, tingling, in (L) arm to 4th and 5th fingers, arm feels heavy.
Age: 75.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 4x2 1/2 cm red/tender spot at Injection site.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left Deltoid Region, circular skin erythema size 8x9 cm, tender, warm to touch, no discharge.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: 1 week after flu shot pt got nauseous and had a fever, told pt to contact MD (TYLENOL and ZOFRAN helped a little).
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pallor
Clinical narrative: Developed red swollen area to left upper arm after receiving PREVNAR and Influenza vaccines in left deltoid. Slightly painful, no itchiness. 5x4 area slightly raised erythematous, bleachable on 10/12/16.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Tenderness
Clinical narrative: Pt presented 10-8 with bruise that wraps around arm down to elbow. Stated it was previously red, sore to touch and more bruised. Stated it was not sore when given. Symptoms started day after. She said she was travelling for a few days after and it had gotten a lot better. Denied injuring or hurting arm. Says she is a breast cancer survivor and is very careful about how she moves her arms around.
Age: 10.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Red, swollen area at vaccination site 12 hours after injection of TDAP and Influenza. 2in x 1 1/2in oval area with swelling and redness.