chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy bone marrow normal, Blood test abnormal, Bronchoscopy, Chemotherapy, Chest X-ray abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 62-year-old female patient who received FLUARIX QUADRIVALENT. On 8th November 2016, the patient received FLUARIX QUADRIVALENT. On 14th November 2016, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced fever (serious criteria hospitalization). In November 2016, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant), leukemia (serious criteria hospitalization and GSK medically significant), sickness (serious criteria hospitalization) and chest pain (serious criteria hospitalization). On an unknown date, the patient experienced difficulty breathing (serious criteria hospitalization). The patient was treated with Chemotherapy, nos. In November 2016, The outcome of the chest pain was recovered/resolved. On an unknown date, the outcome of the pneumonia, leukemia, sickness, fever and difficulty breathing were unknown. It was unknown if the reporter considered the pneumonia, leukemia, sickness, fever, difficulty breathing and chest pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's daughter. Concomitant medication included high blood pressure medications. The patient received the vaccine in her right arm. Within two days of the vaccination, the patient started to feel sick. She developed chest pain that lasted for four days. On Sunday, 13th November 2016, the patient went to the emergency room (ER). A computerized tomography scan and blood tests were performed. Leukemia cells were detected at this time. She was not admitted and told to follow-up with her physician. On Monday, 14th November 2016, she started having fevers with the maximum temperature reading 101 degrees. On Wednesday, 16th November 2016, the patient saw her physician and he told her she should have been admitted to the hospital and should go back to the hospital to have treatment for the leukemia. She was admitted to the hospital that same day. Chest x-rays at the hospital also showed pneumonia. On Thursday, 17th November 2016, chemotherapy was started and this treatment lasted for seven days. On 5th December 2016, a biopsy was performed, which results showed that there were no leukemia cells. The physician would recheck in another two weeks. The patient was still in the hospital because her lungs were getting worse and the physician was unable to determine what was wrong. A scope of her lungs was performed. At the time of reporting, the patient had a breathing tube. Further details were unable to obtain. The reporter would call back to provide additional details including the lot number and expiration date for the product administered, as well as concomitant medications.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Computerised tomogram abnormal, Dyspnoea, Leukaemia, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 62-year-old female patient who received FLUARIX QUADRIVALENT. On 8th November 2016, the patient received FLUARIX QUADRIVALENT. On 14th November 2016, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced fever (serious criteria hospitalization). In November 2016, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant), leukemia (serious criteria hospitalization and GSK medically significant), sickness (serious criteria hospitalization) and chest pain (serious criteria hospitalization). On an unknown date, the patient experienced difficulty breathing (serious criteria hospitalization). The patient was treated with Chemotherapy, nos. In November 2016, The outcome of the chest pain was recovered/resolved. On an unknown date, the outcome of the pneumonia, leukemia, sickness, fever and difficulty breathing were unknown. It was unknown if the reporter considered the pneumonia, leukemia, sickness, fever, difficulty breathing and chest pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's daughter. Concomitant medication included high blood pressure medications. The patient received the vaccine in her right arm. Within two days of the vaccination, the patient started to feel sick. She developed chest pain that lasted for four days. On Sunday, 13th November 2016, the patient went to the emergency room (ER). A computerized tomography scan and blood tests were performed. Leukemia cells were detected at this time. She was not admitted and told to follow-up with her physician. On Monday, 14th November 2016, she started having fevers with the maximum temperature reading 101 degrees. On Wednesday, 16th November 2016, the patient saw her physician and he told her she should have been admitted to the hospital and should go back to the hospital to have treatment for the leukemia. She was admitted to the hospital that same day. Chest x-rays at the hospital also showed pneumonia. On Thursday, 17th November 2016, chemotherapy was started and this treatment lasted for seven days. On 5th December 2016, a biopsy was performed, which results showed that there were no leukemia cells. The physician would recheck in another two weeks. The patient was still in the hospital because her lungs were getting worse and the physician was unable to determine what was wrong. A scope of her lungs was performed. At the time of reporting, the patient had a breathing tube. Further details were unable to obtain. The reporter would call back to provide additional details including the lot number and expiration date for the product administered, as well as concomitant medications.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Mechanical ventilation, Pneumonia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 62-year-old female patient who received FLUARIX QUADRIVALENT. On 8th November 2016, the patient received FLUARIX QUADRIVALENT. On 14th November 2016, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced fever (serious criteria hospitalization). In November 2016, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant), leukemia (serious criteria hospitalization and GSK medically significant), sickness (serious criteria hospitalization) and chest pain (serious criteria hospitalization). On an unknown date, the patient experienced difficulty breathing (serious criteria hospitalization). The patient was treated with Chemotherapy, nos. In November 2016, The outcome of the chest pain was recovered/resolved. On an unknown date, the outcome of the pneumonia, leukemia, sickness, fever and difficulty breathing were unknown. It was unknown if the reporter considered the pneumonia, leukemia, sickness, fever, difficulty breathing and chest pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's daughter. Concomitant medication included high blood pressure medications. The patient received the vaccine in her right arm. Within two days of the vaccination, the patient started to feel sick. She developed chest pain that lasted for four days. On Sunday, 13th November 2016, the patient went to the emergency room (ER). A computerized tomography scan and blood tests were performed. Leukemia cells were detected at this time. She was not admitted and told to follow-up with her physician. On Monday, 14th November 2016, she started having fevers with the maximum temperature reading 101 degrees. On Wednesday, 16th November 2016, the patient saw her physician and he told her she should have been admitted to the hospital and should go back to the hospital to have treatment for the leukemia. She was admitted to the hospital that same day. Chest x-rays at the hospital also showed pneumonia. On Thursday, 17th November 2016, chemotherapy was started and this treatment lasted for seven days. On 5th December 2016, a biopsy was performed, which results showed that there were no leukemia cells. The physician would recheck in another two weeks. The patient was still in the hospital because her lungs were getting worse and the physician was unable to determine what was wrong. A scope of her lungs was performed. At the time of reporting, the patient had a breathing tube. Further details were unable to obtain. The reporter would call back to provide additional details including the lot number and expiration date for the product administered, as well as concomitant medications.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information was received from a licensed practical nurse via Pfizer, Inc. (manufacturer report number 2016514979) on 28-NOV-2016 concerning a child (age unknown). No information was provided regarding the child's medical history. The nurse reported that her child was administered PREVNAR followed by PNEUMOVAX23 four weeks later by a hematologist/oncologist (lot number, dosage, and route of administration not provided). No further information was available at this time. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  Approximately in October 2016 (reported as between 09-OCT-2016 to 21-OCT-2016 ), the patients were vaccinated with improperly stored GARDASIL lot # L018466, expiry date: 16-JUN-2017 (dosing details and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to the temperature of 30.2F during a time frame of 12 days. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. Lot number# L018466 is an invalid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003211: US-009507513-1612USA003212: US-009507513-1612USA003210.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a contactable nurse through a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA (lot number M95612, expiration date 30Jul2017), intramuscular on 23Jun2016 12:22 as single dose for immunization/ preventive vaccination. Medical history included dysmenorrhoea from 24Jan2013, treated with ethinylestradiol, norgestimate, anxiety from 24Oct2015 to an unknown date treated with vortioxetine hydrobromide. Concomitant medication included DOXY from 20Jun2016 till 23Jun2016 for upper respiratory tract infection (URI), BRINTELLIX from 240ct2015 and ongoing for anxiety, ORTHO TRI-CYCLEN for dysmenorrhea from 01May2013 and ongoing and  TRINTELLIXfor anxiety 24Oct2015 and ongoing. The patient experienced hives all over/ severe hives on 24Jun2016. Therapeutic measures were taken as a result of hives all over/ severe hives; patient was administered CELESTONE; batch 511700, expiration date Sep2017 at 6 m given intramuscular for hives and the hives went away patient got better. The patient recovered from hives all over/ severe hives on 24Jun2016. Per the reporter, the Pfizer product maybe had a casual effect to the adverse event. Follow-up (01Oct2016): Follow-up attempts are completed. No further information is expected. Follow up (28Nov2016): New information reported from a contactable nurse (reported on behalf of physician) includes: patient data, suspect product data, medical history, concomitant medication, detailed event description, treatment received and causality. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth, Irritability, Pain
Clinical narrative: A 3 1/2" diameter hot red circle appeared around injection with a 1/2" hard, hot, bump in the center.  Pt. reported irritability, pain and swelling.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: A 3 1/2" diameter hot red circle appeared around injection with a 1/2" hard, hot, bump in the center.  Pt. reported irritability, pain and swelling.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Patient stated her left arm was warm and swollen. I noticed that it was swollen from her bicep down to her elbow. She stated she had difficult raising her arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling unresponsive to ice or ibuprofen.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Pain
Clinical narrative: Pt. left the immunization clinic and returned home.  After returning home the patient called the health department to report that while leaving the health department (3rd Floor) while taking the steps he experienced the onset of sharp pain in his lower back and pain in his hips.  He made his way to the car and began to drive home.  On his way home he reports the pain in his back and his hips became "very intense".  After driving the 5 minutes to his home he states he had difficulty getting out of the car due to the pain.  While on the phone with this nurse at the Health Department, approximately 15 minutes after leaving, the patient reports he is feeling better.  He states the pain has decreased by 90%.  I encouraged him to contact his physician if the pain persists.  If a physician is not available he should seek medical assistance at the Urgent Care Clinic.  I will return a phone call to the patient tomorrow to ensure he is feeling better.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage
Clinical narrative: This spontaneous report was received from a medical assistant referring a 79 year old female patient. The patient's pertinent medical history included vaccination with Prevnar (manufacturer unknown) on an unspecified date in 2015. In addition, the patient's drug reaction or allergies information were not reported. On 14-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23 0.5 ml, intramuscularly (dosage schedule, lot # and expiration date were not reported) for prophylaxis (reported as "the patient was due to receive PNEUMOVAX23 because the patient received PREVNAR in the past"). Concomitant medications were not provided. It was mentioned that on the same date, upon administration, the medical assistant noted "a little blood return in the syringe". No treatment was given for the treatment of the adverse event. No laboratory test were performed. This is one of the several reports of the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA007183.
Age: 64.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Arthralgia, Cough, Fatigue, Myalgia, Pyrexia
Clinical narrative: Severe muscle and joint aches, fatigue lasting about 5 days. Fever, slight cough developed two days later. No congestion. Symptoms better with increasing TYLENOL, sleep.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Skin reaction
Clinical narrative: Patient's arm became red, painful, swollen, with red streak running down arm. She started to develop fever. She went to doctor (unknown which date), and received a prescription for KEFLEX. They told her arm appeared infected.
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cardiac function test normal, Chest pain, Pain in extremity
Clinical narrative: Left arm pain and chest pain. Went to ED, had a cardiac work up which was all negative. Significant left arm pain continuing.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Unclear of exact date of first adverse event complaint since she went to the ER with this complaint prior to reporting effects to PCP. She declines redness or swelling at injection side. Complaints of pain down left arm s/p injection. Pain radiated throughout deltoid muscle for >1 month.
Age: 59.0
Sex: M
Vaccine: FLUC4, PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: PATIENT HAD HARD PAINFUL SIX IN AREA AT INJECTION SITE. SORE ARM CAUSED HIM TO MISS TWO DAYS WORK.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient developed redness and swelling not only at the injection site but whole upper arm where the vaccine was administered.
Age: 31.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Feeling hot, Syncope
Clinical narrative: Patient felt hot and fainted after the shots were administered.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Erythema, Pruritus, Pyrexia, Rash
Clinical narrative: Left shoulder rash itchiness, redness and warm. Chill and fever since 12/8/2016 to 12/11/2016.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Left shoulder rash itchiness, redness and warm. Chill and fever since 12/8/2016 to 12/11/2016.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain
Clinical narrative: AT night could not move his arm. Had to put it in position where he wanted. The shot may have been too high according to him. Sore for a couple of day.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: PATIENT STATED THAT HER LEFT ARM STILL HURT. NO REDNESS AT SITE OR PAIN WHEN TOUCHED. SHE STATED THAT IT HURT WHEN LIFTING THE ARM.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Rash generalised, Skin discomfort
Clinical narrative: Systemic fine rash over entire body, uncomfortable feeling on skin, no fever, Still have after almost 3 weeks.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose, Dyskinesia, Electrocardiogram, Eye movement disorder, Foaming at mouth
Clinical narrative: Seizure type of activity. Slight jerking movements, foam at mouth, rolled eyes and contracted arms.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle contractions involuntary, Seizure like phenomena
Clinical narrative: Seizure type of activity. Slight jerking movements, foam at mouth, rolled eyes and contracted arms.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, localized pain to injection site.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness, Paraesthesia, Seizure
Clinical narrative: Patient reported feeling lightheaded about 3 minutes after the vaccine. After sitting down, patient had a seizure that lasted about 1 minute. Patient regained consciousness and felt tingling sensation. He had no history of seizures.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Severe muscle pain at injection site continues 3 months from administration. Pain is in muscle, not shoulder joint. No pain upon pressing externally on area, pain is only present when arm is moved under it's own power. Similar to a pulled muscle. Requested non-preservative vaccine. Shot given very low on arm muscle.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Swelling
Clinical narrative: Marked swelling, pain.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Haematoma, Injection site pain, Pallor, Syncope, Vomiting
Clinical narrative: 15-20 minutes after HPV/Flu shots patient fainted, no dizziness. He recovered quickly (2 secs). He was pale, HR 60's. Follow-up phone call, vomited once at 2 hrs, then 5 hrs after. Just a sore injection site.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: Entire body covered in hives/rash, so itchy almost went to ED.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Ear congestion, Urticaria
Clinical narrative: Hives developed evening of shot. Still spreading. complained stuffy ear. When she eats goes straight thru. Will try diphenhydramine to see if this helps with hive. Will follow up tomorrow.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Tendonitis
Clinical narrative: Patient said vaccine hurt more than usual during administration but he didn't think anything of it. The next day his arm started hurting more. It got better in a few days, but then got worse. Still hurting a month later.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: 61 yo female with PMH CAD, Acute MI, Gastric ulcer, Prediabetes, OA, SOB, Ptosis of R eyelid, pulmonary emphysema, GERD, Iron deficiency anemia. Patient reports to outpatient provider for appointment and received influenza and PNEUMOVAX vaccines and both were delivered IM into the L deltoid. Within an hour of the combination injection, the patient developed significant swelling, redness, and pain spreading down the L arm and persisted for several days. She did not report anaphylactic symptoms and her arm pain and swelling improved with symptomatic management.
Age: 21.0
Sex: U
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient was given I.M. flu shot at 12:45pmon 12/12/16. He passed out/fainted briefly after administration. We observed him and talked with him for 30 min post fainting.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: About 6 hrs after shot was administered, there was a large softball size swelling around the injection site which was hot to touch and hard. As of today, it is still swollen and started to decrease swelling by 10% when BENADRYL taken W/I last 12 hrs.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within 8hrs he developed left thigh redness warmth and swelling. I did remove 2 latex bandages in the office and over the course of 20 mins felt there was some improvement, but this remained at the knee.
Age: 7.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Soft tissue swelling
Clinical narrative: Severe swelling of entire upper arm with redness, limited motion due to swelling of soft tissue at shoulder. Oral BENADRYL and prednisone given when seen in ER.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Eye allergy, Fatigue, Headache
Clinical narrative: Fever of 101.3 and chills Sat night, exhaustion, slight nausea a little on Sat evening before fever, headache, achy all over and overall feeling not well, swollen, red and itchy at sight of injection (started really swelling by Sat evening and swollen and red approx 3.5 cm in diameter by Monday). Headache worse on same side as injection and scalp pain on same side of injection. Fever and chills gone by Sunday morning. Allergy feeling in eyes and throat by Monday and "feeling of throat closing a little". Lower arm beginning to itch by Mon. Finally took a BENADRYL Monday. Redness/swelling decreasing in arm (still about 3 cm), itchiness at site has lessened and pain is pretty much gone but still sore, eyes and throat are a little better, achiness is almost gone, headache is almost gone, no more body aches, scalp pain and sensitivity almost gone within 12 hours of taking 1 BENADRYL. Seem to have a loss of appetite.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Malaise
Clinical narrative: Fever of 101.3 and chills Sat night, exhaustion, slight nausea a little on Sat evening before fever, headache, achy all over and overall feeling not well, swollen, red and itchy at sight of injection (started really swelling by Sat evening and swollen and red approx 3.5 cm in diameter by Monday). Headache worse on same side as injection and scalp pain on same side of injection. Fever and chills gone by Sunday morning. Allergy feeling in eyes and throat by Monday and "feeling of throat closing a little". Lower arm beginning to itch by Mon. Finally took a BENADRYL Monday. Redness/swelling decreasing in arm (still about 3 cm), itchiness at site has lessened and pain is pretty much gone but still sore, eyes and throat are a little better, achiness is almost gone, headache is almost gone, no more body aches, scalp pain and sensitivity almost gone within 12 hours of taking 1 BENADRYL. Seem to have a loss of appetite.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain of skin, Pruritus, Pyrexia
Clinical narrative: Fever of 101.3 and chills Sat night, exhaustion, slight nausea a little on Sat evening before fever, headache, achy all over and overall feeling not well, swollen, red and itchy at sight of injection (started really swelling by Sat evening and swollen and red approx 3.5 cm in diameter by Monday). Headache worse on same side as injection and scalp pain on same side of injection. Fever and chills gone by Sunday morning. Allergy feeling in eyes and throat by Monday and "feeling of throat closing a little". Lower arm beginning to itch by Mon. Finally took a BENADRYL Monday. Redness/swelling decreasing in arm (still about 3 cm), itchiness at site has lessened and pain is pretty much gone but still sore, eyes and throat are a little better, achiness is almost gone, headache is almost gone, no more body aches, scalp pain and sensitivity almost gone within 12 hours of taking 1 BENADRYL. Seem to have a loss of appetite.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: Fever of 101.3 and chills Sat night, exhaustion, slight nausea a little on Sat evening before fever, headache, achy all over and overall feeling not well, swollen, red and itchy at sight of injection (started really swelling by Sat evening and swollen and red approx 3.5 cm in diameter by Monday). Headache worse on same side as injection and scalp pain on same side of injection. Fever and chills gone by Sunday morning. Allergy feeling in eyes and throat by Monday and "feeling of throat closing a little". Lower arm beginning to itch by Mon. Finally took a BENADRYL Monday. Redness/swelling decreasing in arm (still about 3 cm), itchiness at site has lessened and pain is pretty much gone but still sore, eyes and throat are a little better, achiness is almost gone, headache is almost gone, no more body aches, scalp pain and sensitivity almost gone within 12 hours of taking 1 BENADRYL. Seem to have a loss of appetite.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: (R) arm redness and swelling hot to touch and itchy.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Headache, Injection site mass, Nausea
Clinical narrative: Lump at injection site, low grade temp, diarrhea, headache, dizziness, nausea, achiness.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia
Clinical narrative: Lump at injection site, low grade temp, diarrhea, headache, dizziness, nausea, achiness.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever x 1day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed small hives over body and itching within 12 hrs of receiving KINRIX (DTaP and IPV), MMR #2 and VARIVAX #2.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Eye pain, Facial pain, Pruritus, Rash, Sinusitis
Clinical narrative: Within two days of receiving PREVNAR 13, left side of my face and eye became intensely painful. Saw eye doc and he prescribed ZPAK. He said my eye was fine but I had a major sinus infection. During this time a rash appeared on my upper torso from neck to hips. Itching ensued and continued through Sept, Oct. and November to present. Doctor who administered PREVNAR 13 recommended ZYRTEC to help with itching. Hopefully I'll be better soon.
Age: 98.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt with redness and swelling at site on injection.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site very red, swollen, painful, hot, as large as a baseball.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain, Urticaria
Clinical narrative: 9-30-2016: Severe R-shoulder pain (10++). 10-1-16: Very bad shoulder pain, 7pm hives appear on R-arm, R-ribcage area. I called the doctor office for advice. Advised to take ZYRTEC, and it was a 24-hour problem. Use cool or warm compress. 10-2-16 Hives were bad, more hives come up neck. 10-3-16 Things finally calm down.
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: Vaccine was administered by incorrect route. It was given intramuscularly rather than subcutaneously. No known symptoms occurred; no treatment was required.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Has warmth, pain and swelling at injection site.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Has warmth, pain and swelling at injection site.
Age: 72.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme pain in upper arm (point of injection) for 3 days, then redness and swelling for next 4 days, fatigue for 3 days (I took Hydrocodone, TYLENOL and Ibuprofen).
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: No other systemic s/sx (L) UE rash 10cm x 10cm erythematous patch, mild warmth, no tenderness.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Pallor, Syncope, Vomiting
Clinical narrative: No allergies noted, no medications taken, vaccine screening completed, no issues w/HPV #1. HPV #2 given 12/3/16 w/in 5 minutes of administration patient fainted, falling from exam table to floor, hitting head first - neuro check completed, vitals taken, O2 near by if needed. Pale in skin color, threw up (vomited) a few times. Called 911, in about 10 minutes they arrive. A and Ox3, vitals monitored until rescue squad arrived. Syncope episode.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Sx began - 12-12-16 - pain/soreness (L) arm quarter size red raised bump- warm to touch. Pt taking ibuprofen and applying cool compress to site prn.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Pt. received 2 intramuscular vaccines on 12/06/16. 24 hours later mom noticed rash forming on the leg. Mom reports initial rash was about 3 bumps. Rash then began to spread on legs with induration at injection site. The provided ordered BENADRYL to patient's pharmacy.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema
Clinical narrative: 8 x 7 cm left anterior thigh redness at injection site.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Hallucination, Myalgia, Pyrexia
Clinical narrative: High fever, hallucinations, myalgias began 2-3 hrs after administration. No other problems. It lasted 24-36 hours.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Vaccination complication
Clinical narrative: PNEUMOVAX 23 administered on 11/21/16. Patient returned to pharmacy on 12/1/16 and said she contracted an infection in her arm due to the vaccine and had to received antibiotics from the emergency room.
Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Anoxia, Autopsy, Death, Pneumonia viral
Clinical narrative: This is a spontaneous report from a contactable pediatrician.  A 5-month-old female patient of an unspecified age and ethnicity receive PREVNAR 13, intramuscular on 16Oct2014, at the age of 12 weeks, at single dose for recommended immunization.  The patient medical history was not reported. The reporter mentioned as other medication  as 'Dtap HB IP',  but she was not sure.  The patient experienced anoxia due to viral pneumonia on an unspecified date and died on 15Jan2015. The autopsy was performed at 8:39 hours on 21Jan2015, cause of death was determined as anoxia due to viral pneumonia. The pediatrician did not know if the pneumococcal 13-val conj vac (dipht crm197 protein) had causal relationship, however she did not believe that the event was due to pneumococcal 13-val conj vac (dipht crm197 protein). Sender's Comments: Based on the information currently available, the company does not attribute the events to PREVNAR 13 based on the known adverse event profile of PREVNAR 13 and on the pathophysiology of the events. 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. Reported Cause(s) of Death: Child died after receiving PREVNAR/Anoxia due to viral pneumonia; Anoxia due to viral pneumonia.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Nausea
Clinical narrative: Pain, swelling and redness at injection site radiating down to wrist of affected arm.  Lasted ~2 months - Advil helped manage pain. Nausea, no vomiting - off and on.  Lasted ~ 3 months - Promethazine helped manage symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: Pain, swelling and redness at injection site radiating down to wrist of affected arm.  Lasted ~2 months - Advil helped manage pain. Nausea, no vomiting - off and on.  Lasted ~ 3 months - Promethazine helped manage symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pain, swelling and redness at injection site radiating down to wrist of affected arm.  Lasted ~2 months - Advil helped manage pain. Nausea, no vomiting - off and on.  Lasted ~ 3 months - Promethazine helped manage symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pain, swelling and redness at injection site radiating down to wrist of affected arm.  Lasted ~2 months - Advil helped manage pain. Nausea, no vomiting - off and on.  Lasted ~ 3 months - Promethazine helped manage symptoms.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anti-glomerular basement membrane antibody positive, Biopsy kidney abnormal, Blood creatinine increased, Dialysis, Fatigue
Clinical narrative: Chills, cold sweats, loss of appetite, lethargy, blood in urine - autoimmune response triggered, antiGBM antibodies began to be produced leading to acute kidney injury and rapidly progressing glomerulonephritis.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Goodpasture's syndrome, Influenza like illness, Plasmapheresis, Renal impairment
Clinical narrative: Chills, cold sweats, loss of appetite, lethargy, blood in urine - autoimmune response triggered, antiGBM antibodies began to be produced leading to acute kidney injury and rapidly progressing glomerulonephritis.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Acute kidney injury, Anti-glomerular basement membrane antibody, Autoimmune disorder, Blood creatine increased, Blood urine present
Clinical narrative: Chills, cold sweats, loss of appetite, lethargy, blood in urine - autoimmune response triggered, antiGBM antibodies began to be produced leading to acute kidney injury and rapidly progressing glomerulonephritis.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Cold sweat, Decreased appetite, Glomerulonephritis rapidly progressive, Lethargy
Clinical narrative: Chills, cold sweats, loss of appetite, lethargy, blood in urine - autoimmune response triggered, antiGBM antibodies began to be produced leading to acute kidney injury and rapidly progressing glomerulonephritis.
Age: 3.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood culture, Blood test, Chills, Influenza like illness, Pain
Clinical narrative: Received FLUZONE HD and PREVNAR 13 vaccines 2015 with no problem. Spouse reported problems around October 15/16/17. Doctor identified cellulitis at site of vaccination that lead to low blood counts, inflammatory release and was hospitalized for 2 days. Patient doing OK now.
Age: 3.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood count abnormal, Inflammation, Inflammatory marker increased, Vaccination site cellulitis
Clinical narrative: Received FLUZONE HD and PREVNAR 13 vaccines 2015 with no problem. Spouse reported problems around October 15/16/17. Doctor identified cellulitis at site of vaccination that lead to low blood counts, inflammatory release and was hospitalized for 2 days. Patient doing OK now.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axonal neuropathy, CSF protein increased, Electroencephalogram abnormal, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Acute motor axonal neuropathy with tetraparesis.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging brain normal
Clinical narrative: Acute motor axonal neuropathy with tetraparesis.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Acute motor axonal neuropathy, Cytomegalovirus test negative, Guillain-Barre syndrome, Lumbar puncture abnormal, Quadriplegia
Clinical narrative: Acute motor axonal neuropathy with tetraparesis.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: West Nile virus test negative
Clinical narrative: Acute motor axonal neuropathy with tetraparesis.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Pruritus systemic. Upper arms, abdomen, back.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sick... body aches, fever, arm pain that has not gone away. I need to see a physician concerning the issue.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, C-reactive protein increased, CSF culture negative, CSF glucose normal, CSF protein decreased
Clinical narrative: Bulging fontanelle in well appearing infant and fever within 18 hours of recieveing 4 month immunizations. She was sent to the ED and had a lumbar puncture which did not show signs of meningitis. She had a cranial ultrasound which was normal. She was observed in the hospital overnight. Notably, she also had a respiratory viral panel which was positive for RSV and Human Rhino-Enterovirus.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF red blood cell count, CSF red blood cell count positive, CSF virus no organisms observed, CSF white blood cell count negative, CSF white blood cell differential
Clinical narrative: Bulging fontanelle in well appearing infant and fever within 18 hours of recieveing 4 month immunizations. She was sent to the ED and had a lumbar puncture which did not show signs of meningitis. She had a cranial ultrasound which was normal. She was observed in the hospital overnight. Notably, she also had a respiratory viral panel which was positive for RSV and Human Rhino-Enterovirus.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture urine negative, Enterovirus infection, Fontanelle bulging, Full blood count normal, Herpes simplex test negative
Clinical narrative: Bulging fontanelle in well appearing infant and fever within 18 hours of recieveing 4 month immunizations. She was sent to the ED and had a lumbar puncture which did not show signs of meningitis. She had a cranial ultrasound which was normal. She was observed in the hospital overnight. Notably, she also had a respiratory viral panel which was positive for RSV and Human Rhino-Enterovirus.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Human rhinovirus test positive, Laboratory test normal, Lumbar puncture normal, Polymerase chain reaction, Pyrexia
Clinical narrative: Bulging fontanelle in well appearing infant and fever within 18 hours of recieveing 4 month immunizations. She was sent to the ED and had a lumbar puncture which did not show signs of meningitis. She had a cranial ultrasound which was normal. She was observed in the hospital overnight. Notably, she also had a respiratory viral panel which was positive for RSV and Human Rhino-Enterovirus.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Rhinovirus infection, Ultrasound skull normal
Clinical narrative: Bulging fontanelle in well appearing infant and fever within 18 hours of recieveing 4 month immunizations. She was sent to the ED and had a lumbar puncture which did not show signs of meningitis. She had a cranial ultrasound which was normal. She was observed in the hospital overnight. Notably, she also had a respiratory viral panel which was positive for RSV and Human Rhino-Enterovirus.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Three unspecified patients received improperly stored VAQTA, lot# L0154607 exp. 20-JUL-2017; three unspecified patients received improperly stored VAQTA, lot# M011839/ exp. 13-SEP-2017; This spontaneous report as received from a certified medical assistant refers to 6 patients of unknown demographics. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided. On an unknown dates, three patients were vaccinated with improperly stored doses VAQTA which had a lot number of L015460 with expiration date on 20-JUL-2017 and three patients were vaccinated with VAQTA which had a lot number of M011839 and expiration date on 13-SEP-2017  (doses, routes of administrations and anatomical locations were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. As, on 09-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. The narrative was updated.; Sender's Comments:  US-009507513-1611USA000313: MERCK 1610USA003123:Mfr number.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route, lot# and expiration date were not reported) for prophylaxis. On unknown dates, the patients felt "itchy" at the injection site for an unknown amount of time. At the time of reporting, the outcome of the event was unknown. The relatedness between the event and ZOSTAVAX)was not reported. Follow up information has been received from pharmacist on 30-NOV-2016, via a phone call. The Pharmacist stated that she had provided all of the information for the one patient that experienced the above adverse event and that there were no other patients. No further information is available. Additional information is not expected as No further information is available.; Sender's Comments: ,MERCK 1610USA005046:Mfr number.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-JUL-2016, the patient was vaccinated with improperly stored GARDASIL single-dose vial (SDV) (lot # L035105 expiration date 01-MAY-2017, dose and route were unspecified) for prophylaxis. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 24 hours with the highest recorded temperature of 30.8 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Follow up information has been received on 06-DEC-2016. The letter requesting follow up information has been returned by the post office. Additional information is not expected because the letter requesting follow up information has been returned by the post office. Narrative has been updated. Sender's Comments: US-009507513-1608USA005743: MERCK 1610USA006510: Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored with VARIVAX, injection, lot # L017146, expiry date 13-MAY-2017 and lot # L035127, expiry date 14-SEP-2017 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. This is one of two reports received from the same source. Follow up information has been received on 12-DEC-2016 that all telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested. Reporter and narrative were updated.; Sender's Comments:  US-009507513-1611USA000865:,MERCK 1610USA014127:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored VARIVAX subcutaneously, lot # L010148, expiration date: 24-MAR-2017 (strength and dose were not provided) for prophylaxis. No adverse event was reported. This is one of two reports received from the same reporter. Follow up information has been received on 12-DEC-2016 that all telephone attempts to obtain follow-up information had been unsuccessful. Additional information is not expected as no further information was available. Sender's Comments: US-009507513-1610USA011591: MERCK 1611USA000114:Mfr number.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided. On an unknown dates the patient was vaccinated with a improperly stored dose of RECOMBIVAX HB which had a lot number of L038018 with expiration date on 13-SEP-2017 (dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. As, on 09-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. The narrative was updated. Sender's Comments: US-009507513-1610USA003123: MERCK 1611USA000313:Mfr number.