chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 60 year old non pregnant, female patient with hypertension. The patient had no known drug reactions or allergies. On 01-OCT-2016, the patient was vaccinated subcutaneously with ZOSTAVAX in the deltoid region of the right arm, lot # M001746 with expiration date of 07-APR-2017 (dose and frequency were not reported). Concomitant therapies included PRINIVIL. On 03-OCT-2016, the patient stated that her injection site was itchy. Additionally, the reporting pharmacist stated that the injection site was "swollen and larger than a golf ball" and the injection area was bumpy, "like a rash". However, the reporter was unable to state with certainty whether or not the patient appeared to have a zoster-like rash. Therefore, the patient stated she was planning to consult with her healthcare provider for treatment recommendations. At the time of reporting, the outcome of the events and their relatedness with the suspect therapy were unknown. Additional information is not expected as the reporter did not allow to be contacted.
Age: 60.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Rash, Skin swelling
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 60 year old non pregnant, female patient with hypertension. The patient had no known drug reactions or allergies. On 01-OCT-2016, the patient was vaccinated subcutaneously with ZOSTAVAX in the deltoid region of the right arm, lot # M001746 with expiration date of 07-APR-2017 (dose and frequency were not reported). Concomitant therapies included PRINIVIL. On 03-OCT-2016, the patient stated that her injection site was itchy. Additionally, the reporting pharmacist stated that the injection site was "swollen and larger than a golf ball" and the injection area was bumpy, "like a rash". However, the reporter was unable to state with certainty whether or not the patient appeared to have a zoster-like rash. Therefore, the patient stated she was planning to consult with her healthcare provider for treatment recommendations. At the time of reporting, the outcome of the events and their relatedness with the suspect therapy were unknown. Additional information is not expected as the reporter did not allow to be contacted.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a 55 years old female medical assistant, via company representative. The medical assistant was reporting on herself. Prior medical history, concomitant therapies and drug/allergies reactions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, single dose, (Lot # and expiration date were not reported). On an unknown date, approximately one year after the patient was vaccinated with ZOSTAVAX, she experienced herpes zoster on her back. The patient sought unspecified medical attention. The relationship between the suspect therapy and the adverse event was unknown, as well as the outcome of herpes zoster was also unknown at the time of the report. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter refused to be contacted.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 55 years old female medical assistant, via company representative. The medical assistant was reporting on herself. Prior medical history, concomitant therapies and drug/allergies reactions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, single dose, (Lot # and expiration date were not reported). On an unknown date, approximately one year after the patient was vaccinated with ZOSTAVAX, she experienced herpes zoster on her back. The patient sought unspecified medical attention. The relationship between the suspect therapy and the adverse event was unknown, as well as the outcome of herpes zoster was also unknown at the time of the report. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter refused to be contacted.
Sex: F
Vaccine: FLU4
Symptoms: Blister, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in extremity in a 58-year-old female patient who received FLUARIX QUADRIVALENT (batch number HX3XT, expiry date 29th June 2017). On 30th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced pain in extremity and blister. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in extremity was recovered/resolved and the outcome of the blister was unknown. It was unknown if the reporter considered the pain in extremity and blister to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. At 12 hours, the reporting nurse administered a dose of FLUARIX QUADRIVALENT to the patient (physician) in her left deltoid. The patient reported that she had experienced pain in her left arm especially over her left thumb. A couple of blisters also appeared. The time frame was unknown.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Intensive care, Pneumonia, Respiratory syncytial virus infection, Urticaria
Clinical narrative: Patient acute onset of vomiting with SOB, wheezing and hives one hour after flu vaccine. Patient was in slight distress upon arrival with triad of vomiting, wheezing and hives, he was immediately given EPIPEN JR, 25 mg of BENADRYL and an Albuterol Neb. initial 02 SAT of 90% with HR 110, within 5 minutes O2 sat was 96% and wheezing resolved, hives slightly better. EMS was called to transport patient to hospital ED in stable condition but for close observation in case of rebound after EPI wears off. Patient significant RSV pneumonia and wheezing in past with PICU admission so therefore transported to ED.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting, Wheezing
Clinical narrative: Patient acute onset of vomiting with SOB, wheezing and hives one hour after flu vaccine. Patient was in slight distress upon arrival with triad of vomiting, wheezing and hives, he was immediately given EPIPEN JR, 25 mg of BENADRYL and an Albuterol Neb. initial 02 SAT of 90% with HR 110, within 5 minutes O2 sat was 96% and wheezing resolved, hives slightly better. EMS was called to transport patient to hospital ED in stable condition but for close observation in case of rebound after EPI wears off. Patient significant RSV pneumonia and wheezing in past with PICU admission so therefore transported to ED.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call representative and described the occurrence of pain in arm in a 51-year-old female patient who received Influenza vaccine unspecified. In October 2015, the patient received Influenza vaccine unspecified. In October 2015, 1 day after receiving Influenza vaccine unspecified, the patient experienced pain in arm. In April 2016, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to Influenza vaccine unspecified. Additional details were provided as follows: This case was previously reported to a doctor. The patient reported that she experienced severe pain in left arm injected with an unknown GlaxoSmithKline flu vaccine last year. She reported that this pain had lasted 6 months after injection. The patient was required to visit the emergency room. The patient also reported that she had visited a specialist regarding the pain.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of neck swelling in a 41-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9PX3H, expiry date 30th June 2017). On 28th September 2016, the patient received FLUARIX QUADRIVALENT 0.5 ml. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced neck swelling. On an unknown date, the outcome of the neck swelling was recovering/resolving. The reporter considered the neck swelling to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received the FLUARIX QUADRIVALENT at 14:00 pm and developed swelling near her left lateral neck from her ear to where her neck meets her shoulder. The event was reported on the morning of 30th September 2016, but the exact time and date was unknown.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swollen tongue in a 32-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced swollen tongue. The patient was treated with BENADRYL. On an unknown date, the outcome of the swollen tongue was recovered/resolved. It was unknown if the reporter considered the swollen tongue to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a nurse practitioner. No other vaccines were given on that day. The date of vaccination was not known by the representative. Limited information was provided by sales representative.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site burning in an unspecified number patients who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown. It was unknown if the reporter considered the injection site burning to be related to FLULAVAL QUADRIVALENT.  Additional details were provided as follows: The nurse told GlaxoSmithKline representative that several of their patients experienced injection site burning at the moment of injection with the FLULAVAL. Initial reporter did not provide any specifics on the patients.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Bone pain, Depressed level of consciousness, Dyspnoea, Fatigue
Clinical narrative: Pt presents for evaluation concerning potential reaction following the flu vaccine. She had the flu vaccine on October 5 around 11:40. Approximately a couple hours afterward she developed pain at the site of the injection and the sensation she had to clear her throat. She stated her chest felt congested and she noticed that she was wheezing and short of breath. She felt mildly feverish at that time. No sweats. She was able to complete work at 6:00 and went home. When she arrived home, she described having intense pain as her muscles and bones were being ripped apart. It was diffuse. That night she reported being in significant agony. She was at decreased alertness and was noticed by her husband moaning and groaning. He took her temperature, it was 99.3. She felt hot but there was no sweating. She began to feel better around 12:30 that night. The next morning she felt exhausted, sore all over. She was able to resume her work. She noticed left arm was sensitive. She remained exhausted for the remainder of the day but then improved. Today she feels back to baseline. She reports a history of significant prior allergies. She described an anaphylactic type reaction with cats and prior skin testing where they had to stop and use steroids. She is required to have two EpiPens with her at all times. She sees an allergist on a regular basis. Her last food reaction was 12 years ago. Systemic reaction to flu vaccines. Unable to rule out anaphylaxis. Patient described fairly significant systematic response to the flu vaccines. The level of symptoms suggest mild anaphylaxis with an arthralgia picture. The symptoms resolved one or two days which is typical for the vaccine. She has a prior history of fairly robust response to allergens. At this time, we would recommend the patient be evaluated by her allergist to be determine whether she is truly allergic to the flu vaccines and, if so, then documentation will be obtained to exam different future flu vaccine. Patient will discuss this with doctor. Patient to set up a referral with her allergist.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Injection site pain, Moaning, Myalgia, Pain
Clinical narrative: Pt presents for evaluation concerning potential reaction following the flu vaccine. She had the flu vaccine on October 5 around 11:40. Approximately a couple hours afterward she developed pain at the site of the injection and the sensation she had to clear her throat. She stated her chest felt congested and she noticed that she was wheezing and short of breath. She felt mildly feverish at that time. No sweats. She was able to complete work at 6:00 and went home. When she arrived home, she described having intense pain as her muscles and bones were being ripped apart. It was diffuse. That night she reported being in significant agony. She was at decreased alertness and was noticed by her husband moaning and groaning. He took her temperature, it was 99.3. She felt hot but there was no sweating. She began to feel better around 12:30 that night. The next morning she felt exhausted, sore all over. She was able to resume her work. She noticed left arm was sensitive. She remained exhausted for the remainder of the day but then improved. Today she feels back to baseline. She reports a history of significant prior allergies. She described an anaphylactic type reaction with cats and prior skin testing where they had to stop and use steroids. She is required to have two EpiPens with her at all times. She sees an allergist on a regular basis. Her last food reaction was 12 years ago. Systemic reaction to flu vaccines. Unable to rule out anaphylaxis. Patient described fairly significant systematic response to the flu vaccines. The level of symptoms suggest mild anaphylaxis with an arthralgia picture. The symptoms resolved one or two days which is typical for the vaccine. She has a prior history of fairly robust response to allergens. At this time, we would recommend the patient be evaluated by her allergist to be determine whether she is truly allergic to the flu vaccines and, if so, then documentation will be obtained to exam different future flu vaccine. Patient will discuss this with doctor. Patient to set up a referral with her allergist.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory tract congestion, Throat irritation, Wheezing
Clinical narrative: Pt presents for evaluation concerning potential reaction following the flu vaccine. She had the flu vaccine on October 5 around 11:40. Approximately a couple hours afterward she developed pain at the site of the injection and the sensation she had to clear her throat. She stated her chest felt congested and she noticed that she was wheezing and short of breath. She felt mildly feverish at that time. No sweats. She was able to complete work at 6:00 and went home. When she arrived home, she described having intense pain as her muscles and bones were being ripped apart. It was diffuse. That night she reported being in significant agony. She was at decreased alertness and was noticed by her husband moaning and groaning. He took her temperature, it was 99.3. She felt hot but there was no sweating. She began to feel better around 12:30 that night. The next morning she felt exhausted, sore all over. She was able to resume her work. She noticed left arm was sensitive. She remained exhausted for the remainder of the day but then improved. Today she feels back to baseline. She reports a history of significant prior allergies. She described an anaphylactic type reaction with cats and prior skin testing where they had to stop and use steroids. She is required to have two EpiPens with her at all times. She sees an allergist on a regular basis. Her last food reaction was 12 years ago. Systemic reaction to flu vaccines. Unable to rule out anaphylaxis. Patient described fairly significant systematic response to the flu vaccines. The level of symptoms suggest mild anaphylaxis with an arthralgia picture. The symptoms resolved one or two days which is typical for the vaccine. She has a prior history of fairly robust response to allergens. At this time, we would recommend the patient be evaluated by her allergist to be determine whether she is truly allergic to the flu vaccines and, if so, then documentation will be obtained to exam different future flu vaccine. Patient will discuss this with doctor. Patient to set up a referral with her allergist.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema
Clinical narrative: Angioedema 3 days after flu vaccine. Has a history of angioedema (not related to vaccines). He is also on Lisinopril. Stopped lisinopril, started prednisone taper, ZYRTEC, PEPCID, BENADRYL, EPIPEN PRN.
Age: 79.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Pain in extremity, Rash
Clinical narrative: Patient got shot on 10-7-16 and came back on 10-12 claiming that her arm was sore and had rash in surrounding area and was getting wider. I've suggested to take TYLENOL and call her MD in the morning. She did get flu shot on the same day, but we are sure it PREVNAR.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: R upper arm, swelling, erythema hot to touch extended from shoulder to antecubital region. Cellulitis treatment - Cephalexin 250 mg/5ml 10 ml BID x 7 days.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Patient was given influenza and pneumonia (PNEUMOVAX 23) and was swollen the next day. He requested to be given in same arm.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Hyperhidrosis, Lymphadenopathy, Malaise
Clinical narrative: After receiving the flu shot- dizziness, sweating, shaking, cold chills, fever, swollen cervical lymph nodes, malaise persisting for 48 hours plus.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Tremor
Clinical narrative: After receiving the flu shot- dizziness, sweating, shaking, cold chills, fever, swollen cervical lymph nodes, malaise persisting for 48 hours plus.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Patient had cellulitis at the injection site after flu shot was administered.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Presyncope, Seizure like phenomena
Clinical narrative: Vasovagal Reaction with Seizure like activity. Sent to Hospital by Ambulance.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Headache, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, severe headache, chills, weakness.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: My child developed a fever of 102 degrees at about noon on Oct 10, 2016 and had it for the whole day and night following, and a slightly lower fever the following day and evening, tempered only by the administration of Infant TYLENOL every 4 hours (as described in the instructions on the bottle). On Oct. 12th, the fever was gone, but we had noticed that he had a rash all over his torso. I will be keeping my eye on this.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Pruritus, Swelling
Clinical narrative: 1 hour after receiving vaccine c/o itching, swelling, numbness of lips.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria, Injection site warmth, Joint swelling
Clinical narrative: Initially hives at site of injection that night. Then went away. Next day hives on both sides of body, then swelling of arm and vomiting on 10/13/2016- upper arm was almost double in size- red, hard, warm.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Initially hives at site of injection that night. Then went away. Next day hives on both sides of body, then swelling of arm and vomiting on 10/13/2016- upper arm was almost double in size- red, hard, warm.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Skin burning sensation
Clinical narrative: Rash and itching, skin is burning sensation.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site pain, Oedema peripheral
Clinical narrative: Pain noted at the injection site (Right deltoid) the next day that radiated to the underarm area. She noticed swelling of the right underarm area. Pain of the underarm was a 5 out of 10 lasted about 1-2 days. Now pain is a 2 out of 10 and the swelling persists. Pain at the injection site was an 8 out of 10 the day after administration and lasted x 3 days- has since stopped hurting.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Ear pain, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Dizziness (continuing still). Bodyaches. Sore throat. Ear ache, slight Nausea.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Patient called 10/13/2016 stating the PNEUMOVAX 23 injection site was bright red (like a sunburn), swollen and painful and that she was not feeling well overall.  I called her primary care doctor and spoke to the nurse who then contacted the patient and called me back.  The doctor advised the patient to place ice on the injection site a few times per day and take OTC ibuprofen (2 tablets by mouth three times daily for 2 days) and call doctor after that if she is still not feeling well.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initially the injection stung, followed my intense itching. 10/13/2016 woke up to my arm being swollen, itching terribly, and there is a hard, tender, red area approximately 1.5" in diameter around the injection site. Take benadryl for the itch and Motrin for the swelling.
Age: 10.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash on abdomen and thighs.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Fatigue, sore throat, body ache, cough.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Inadvertently received high-dose FLUZONE.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Angina pectoris, Myalgia, Sleep disorder
Clinical narrative: All over muscle pain, heart pain, unable to sleep or lie down, up all night. Started to subside at 6am the next morning.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema
Clinical narrative: She called pharmacy on 10/13/16. She spoke to pharmacist. She stated she had redness at injection site developed same day and now it is travelling down the arm. She was advised to see physician. She stated she was seeing dosctor in ER.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Patient experienced shaking for 3 hours and low grade fever next day.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity, Tenderness
Clinical narrative: Arm painful (L) deltoid, injection site reaction redness. Arm red, tender/sore, painful. Recommended if very painful that one can't stand to see Urgent care/ER. Normal side effects Pt. says next day it's when she felt soreness.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Poor peripheral circulation
Clinical narrative: Patient went to pain management Dr and Dr believes patient may have had the start of cellulitis from poor circulation, wanted to be cautious and gave patient BACTRIM DS
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Swelling
Clinical narrative: Described by patient very large, raised hot to touch, red. Asked about breathing or swelling of lips or tongue, answered No.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient complained that her arm is still sore 3 weeks after her flu shot. There was no swelling or redness present.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: 1st day soreness. 3rd to 4th day got worse. Dr. on Friday. As of 9/25/16 patient reports limited mobility in her left arm and constant muscle soreness - taking ibuprofen.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Soreness of the shoulder and limited ability four arm movement.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia
Clinical narrative: Patient complained of radiating arm pain to her wrist. It was "intense" for 2 days and then diminished. Patient said it was not red and it was not swollen.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Dizziness, Muscle spasms
Clinical narrative: Cough, chest spasm, light headed, dizzy. 25 mg BENADRYL adm. - monitored x 20 more min. 120/78, RR 18, AP 75. Encouraged to seek medical treatment.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Diplopia, Dizziness, Fatigue, Feeling hot
Clinical narrative: 30 minutes post vaccination C/O dizziness, double vision/feeling warm/nauseated/(L) arm aches from deltoid to wrist. C/O fatigue, malaise.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Malaise, Nausea, Pain in extremity, Visual acuity tests normal
Clinical narrative: 30 minutes post vaccination C/O dizziness, double vision/feeling warm/nauseated/(L) arm aches from deltoid to wrist. C/O fatigue, malaise.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Mobility decreased, Pain, Pyrexia, Speech disorder
Clinical narrative: This is a spontaneous report from a contactable physician and medical assistant via a Pfizer Company representative reporting similar events for two patients. This is the second of two reports. A 18-year-old male patient received on 03Aug2016 09:56 am TRUMENBA (Batch/Lot: N16808PMP) at 0.5 ml single dose via intramuscular route on the right deltoid and second dose of MENVEO, (Manufacturer: Novartis, Lot#: M15149PMP) at 1 DF single, via intramuscular route on the left deltoid both for immunization. Relevant medical history and concomitant medications were not reported. On 03Aug2016, the patient had body ache, fever, joint pain and diffulty in moving and speaking. The patient recovered from the events. The events did not require an emergency room or physician visit. The reporters were wondering if the events occurred because the patient received the vaccines together. Follow-up (07Oct2016): additional information received from the physician includes date of vaccination, batch/Lot of the vaccine, route of administration, anatomical location of the administration of the vaccine, outcome of the events. Sender's Comments: Linked Report(s): US-PFIZER INC-2016407735 same reporter/drug, similar events, different patient.
Age: 15.0
Sex: U
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Food allergy, Rash
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer stated that another consumer reported for a 15-month old patient of an unspecified ethnicity and gender who received a single dose of PREVNAR 13, PENTACEL and MMR II, all via an unspecified route of administration, on an unspecified date, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced onset of apparent peanut allergy with rash on 3rd exposure to peanuts 15 days after receiving the vaccines. Event outcome was unknown at time of report.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Activities of daily living impaired, Chills, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner reporting on behalf of the son. A 17-year-old male patient received TRUMENBA intramuscular, in right shoulder, on 19Sep2016 at about 14:00 at 0.5 ml, single for meningitis pain. No other vaccines were administered 4 weeks prior to 19Sep2016. Medical history included asthma since he was 8 years old. The patient previously took on unknown dates influenza vaccine for prevention of the influenza and TRUMENBA for meningitis pain and experienced no adverse event. Concomitant medication included influenza vaccine, taken on unknown date, for prevention of influenza. The patient was not taking any other medications. On 19Sep2016 at about 20:00 the patient experienced entire body aches, severe headache, chills and fever at 101. The patient missed his school and his sports due to the events. Fever was treated with MOTRIN but the patient continued to have it even on treatment. The patient had fever for so long and if it would continue the reporter would have taken him in to the Emergency room. The other events resolved on an unknown date in 2016. Laboratory test: none.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Hypersensitivity, Nodule, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. This female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose in the arm on an unspecified date for immunisation. The patient medical history wand concomitant medications were not reported. On an unspecified date, the patient experienced big knot and its turned into like wrap that was going around her arm, allergic symptoms, swelling on the back of the left knee, it was stinging, itching and painful, burning sensation going up the left side of the head. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. This female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose in the arm on an unspecified date for immunisation. The patient medical history wand concomitant medications were not reported. On an unspecified date, the patient experienced big knot and its turned into like wrap that was going around her arm, allergic symptoms, swelling on the back of the left knee, it was stinging, itching and painful, burning sensation going up the left side of the head. The outcome of the events was unknown.
Sex: U
Vaccine: FLUR3
Symptoms: Cough, Headache, Influenza like illness, Pulmonary pain
Clinical narrative: This is an initial report of an AE, received on 05Oct2016, for Protein Sciences FLUBLOK. Subject, received FLUBLOK Intramuscular on 23Sep2016. On an unknown date after receiving FLUBLOK, the subject developed a hack for two days and head pain. The subject also reported that parts of the lungs would feel sore or in pain and could feel the flu in them. At the time of the report, the events of cough, headache and sore lungs had resolved. Medical or surgical history and concomitant medications were not reported.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, X-ray
Clinical narrative: Inability to move/raise arm. Numbness in injected arm. Stiffness in neck and shoulder.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Hot flush, Hyperhidrosis, Insomnia, Muscle fatigue
Clinical narrative: Severe chills and muscle spasms that lasted several hours. It was very difficult to sleep when many of the muscles in my back and in various parts of my body were spasming.  Early on the morning of 10/11/2016 (6:30 AM) I proceeded to have severe hot flushes and sweats that lasted several hours (until about 10:00 AM on 10/11/2016.  I took 400 - 600 mg ibuprofen every 6-8 hr to try and alleviate the muscle cramps and pain. There was significant muscle fatigue and pain that lasted until 10/12/2016.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Severe chills and muscle spasms that lasted several hours. It was very difficult to sleep when many of the muscles in my back and in various parts of my body were spasming.  Early on the morning of 10/11/2016 (6:30 AM) I proceeded to have severe hot flushes and sweats that lasted several hours (until about 10:00 AM on 10/11/2016.  I took 400 - 600 mg ibuprofen every 6-8 hr to try and alleviate the muscle cramps and pain. There was significant muscle fatigue and pain that lasted until 10/12/2016.
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Chest X-ray abnormal, Pain, Pneumococcal bacteraemia, Pyrexia
Clinical narrative: Soreness and fever begun. Next two days of high fever (101 to 102.5) followed by the onset of pneumonia (diagnosed 10/13/16).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Gram stain, Gram stain positive, Meningitis, Meningitis meningococcal, Pyrexia
Clinical narrative: Patient received in ER unresponsive, Fever 104, lumbar puncture revealed provisional dx. of meningitis/neisseria meningitidis.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Unresponsive to stimuli, White blood cell count increased
Clinical narrative: Patient received in ER unresponsive, Fever 104, lumbar puncture revealed provisional dx. of meningitis/neisseria meningitidis.
Age: 21.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Activities of daily living impaired, Chills, Headache, Insomnia, Pain
Clinical narrative: Woke up with headache, then body ached a little, R arm sore.  Increasing more achy, unable to workout, then unable to sleep at night due to pain.  Tactile fever and chills.  Wednesday more pain.
Age: 21.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Woke up with headache, then body ached a little, R arm sore.  Increasing more achy, unable to workout, then unable to sleep at night due to pain.  Tactile fever and chills.  Wednesday more pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Zoster Vaccine given IM instead of Subcutaneous.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Inadvertently received high dose FLUZONE.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Inadvertently received high dose FLUZONE.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Inadvertently received high dose FLUZONE.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported itching at vaccine site about 10 minutes after receiving vaccine. Two days later, patient reports redness, swelling, and discomfort around injection site.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Inadvertently received high dose FLUZONE.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Inadvertently received high dose FLUZONE.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Eye irritation, Eye pruritus, Ocular hyperaemia, Throat irritation
Clinical narrative: Started to get irritated eyes a couple hours after vaccination.  About 5 hours after vaccination he had red, itchy eyes, burning throat, and cough.  Seen by provider and given Solumedrol injection, Benadryl and Prednisone prescription.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccination site raised a size of a quarter above arm, red, area hard like bee sting, very sore, a little itchy.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Mild redness and injection site pain.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Severe bruising at the site of injection 3 inches in diameter, no systemic reaction, no pain, patient feels fine.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient received PNEUMOVAX 23 and FLUZONE HD on the same arm an inch apart. Patient stopped by store on 10/13/2016 to show arm swollen and red from shoulder area to elbow. Patient was told to take a diphenhydramine to decrease reaction.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Pt received PNEUMOVAX and FLUZONE HD in left arm on 10-11-16, pt reported severe pain beginning evening after injection, reported to pharmacy on 10-13-16 with pain and inflammation/redness covering about 80% of upper left arm.  Pt was referred to physician for evaluation.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Musculoskeletal pain
Clinical narrative: Extreme pain & bruising in shoulder joint. Decreased ability to move arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising
Clinical narrative: Immediately after getting the shot the injection site developed a non-painful welt the size of a quarter. No redness or discomfort. Patient remained calm and mentioned she has bruises easily with injections. The welt was iced and appeared to receed upon later inspection about an hour later.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Extreme pain in shoulder.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Immune thrombocytopenic purpura, Injection site bruising
Clinical narrative: Patient developed bruising at injection site and all over body.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching at injection site.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain, Pain in extremity, Tenderness
Clinical narrative: Patient reports vaccination stung her upon administration, the stinging is felt off and on, once in a while..patient also reports pain and tenderness, and numbness of entire arm, down to hand.
Age: 90.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Sore arm for a month.  No redness, tingling, or warmth.  sore to the touch.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Biopsy bone marrow, Full blood count, Rash erythematous
Clinical narrative: Red rashes were noted on his body, would stay for days and then go away. 12/2015 we went to the allergist and labs were drawn.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia, Rash generalised, Skin warm
Clinical narrative: Patient complained of her arm being swollen and red and warm to touch from elbow to shoulder. She also complained of fever. She also broke out in a fine rash all over her body.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Very Red and Swollen, Very Painful.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Movement disorder, Sleep disorder, Vertigo
Clinical narrative: Patient was sleeping on 10/11/2016 night and "was awoken by an attack of vertigo--the room was spinning." She states she is unable to bend over without getting dizzy. She "feels that she is having a reaction to the flu shot."
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Ataxia, Photophobia, Somnolence
Clinical narrative: Patient experienced increased eye sensitivity to light, ataxia and grogginess after receiving the vaccine. His symptoms slowly dissipated over the course of the next week. On 10/13/16 patient stated that he had fully recovered from all adverse effects of the vaccine. I did not ask him at what time his symptoms started.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling in area around the vaccine site. Warm and tender to touch.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Swelling in area of injection, redness spreading around area of injection, warm to the touch.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Extreme limb swelling, hot skin, redness, mobility impaired in affected limb.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Antibody test, CSF culture, CSF oligoclonal band, Nuclear magnetic resonance imaging brain, Optic neuritis
Clinical narrative: Optic neuritis 9/27/16 blurred vision Rx high dose steroids.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: Optic neuritis 9/27/16 blurred vision Rx high dose steroids.
Age: 66.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Electromyogram, Mobility decreased, Musculoskeletal disorder, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Extreme pain on arm, unable to lift it or use it without extreme pain. Dr. ordered MRI of arm and shoulder. Almost 4 weeks since vaccine given, cannot use left arm at - all.
Age: 66.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain in extremity
Clinical narrative: Extreme pain on arm, unable to lift it or use it without extreme pain. Dr. ordered MRI of arm and shoulder. Almost 4 weeks since vaccine given, cannot use left arm at - all.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Dry mouth, Dysgeusia, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sweating in a 33-year-old male patient who received FLUARIX QUADRIVALENT (batch number 359MH, expiry date 22nd June 2017. On 3rd October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 3rd October 2016, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced sweating, dry mouth, nausea, fatigue, taste metallic and vomiting. On an unknown date, the outcome of the sweating, dry mouth, nausea, fatigue, taste metallic and vomiting were unknown. The reporter considered the sweating, dry mouth, nausea, fatigue, taste metallic to be related FLUARIX QUADRIVALENT. It was unknown if the reporter considered the vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The pharmacist reported that she and others went to an office to give flu shots. They were alerted that there were 4 patients that experienced the same side effects from the vaccine afterwards. The patient concerned in this case received FLUARIX QUADRIVALENT in his right deltoid and on the same day at 10 hours, he experienced sweating, mouth dryness, nausea, fatigue (tiredness), metal taste and vomiting. The patient did not mention the severity of the side effects he experienced. The reporter did not have any further information about the patient. As per the reporter, there were also donuts at the clinic which might have been the cause for the adverse events experienced by the patient. This was one of the 4 cases reported by the same reporter.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sweating in a 33-year-old male patient who received FLUARIX QUADRIVALENT (batch number 359MH, expiry date 22nd June 2017. On 3rd October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 3rd October 2016, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced sweating, dry mouth, nausea, fatigue, taste metallic and vomiting. On an unknown date, the outcome of the sweating, dry mouth, nausea, fatigue, taste metallic and vomiting were unknown. The reporter considered the sweating, dry mouth, nausea, fatigue, taste metallic to be related FLUARIX QUADRIVALENT. It was unknown if the reporter considered the vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The pharmacist reported that she and others went to an office to give flu shots. They were alerted that there were 4 patients that experienced the same side effects from the vaccine afterwards. The patient concerned in this case received FLUARIX QUADRIVALENT in his right deltoid and on the same day at 10 hours, he experienced sweating, mouth dryness, nausea, fatigue (tiredness), metal taste and vomiting. The patient did not mention the severity of the side effects he experienced. The reporter did not have any further information about the patient. As per the reporter, there were also donuts at the clinic which might have been the cause for the adverse events experienced by the patient. This was one of the 4 cases reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site rash, Injection site warmth
Clinical narrative: Rash to (L) upper arm began after immunization. Progressed to 13cm x 11cm. Warm, edematous, erythematous rash over 36 hrs until patient sought care. Pt denied any SOB/wheeze, tongue or lip swelling. Cutaneous reaction only.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Pt experienced nausea and vomiting following vaccine.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction-quarter sized redness, swelling, redness warm to touch, some pain/discomfort; No shoulder pain; No fever/chills. No numbness
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Inflammation, Local reaction, Skin warm
Clinical narrative: Patient presented on 10/6 with a local reaction to ZOSTAVAX. Red, inflamed area, slightly warm to touch. This was 48 hours after vaccine given. No patient harm. F/U in 24 hours to pharmacy.
Age: 30.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Received annual flu shot and it was given improperly. The RN administered the shot into the shoulder capsule and not into the meaty part of the bicep. I have had shoulder pain and limited range of motion ever since.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt complained red bump and itchy at site of injection. After 7 days of injection.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Vomiting
Clinical narrative: Pt vomiting, and feel sick.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 1.5 in by 1 in indurated, warm, erythematous region of left upper arm; no discharge. No treatment, no fever.
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Rash, Throat irritation
Clinical narrative: Rash, itchy throat and some shortness of breath.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 9X11cm 2cm below injection. Red, indurated tender and warm to touch. No fever, no chills. Rx KEFLEX x10 days. After second dose of antibiotic, it improved dramatically.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Nasal congestion, Pain in extremity
Clinical narrative: Vaccine given 9/15. Patient began to experience pain at site on 10/4 with stuffy nose, and leg aches.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Sleep disorder, Vomiting
Clinical narrative: Nauseated around midnight, lost sleep, vomiting (x2) around 9AM 10/7/16, slept (2 hours), nauseated and dizziness since.