chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Chills, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of malaise in a 35-year-old male patient who received BOOSTRIX (batch number TB2R2, expiry date 18th May 2019). On 16th January 2018, the patient received BOOSTRIX (intramuscular) .5 ml. In January 2018, 2 hrs after receiving BOOSTRIX, the patient experienced malaise (serious criteria other: as per reporter), injection site swelling (serious criteria disability and other: as per reporter), injected limb mobility decreased (serious criteria disability and other: as per reporter), fatigue (serious criteria other: as per reporter), abdominal pain (serious criteria other: as per reporter), headache (serious criteria other: as per reporter), fever (serious criteria other: as per reporter) and chills (serious criteria other: as per reporter). On an unknown date, the outcome of the malaise, injection site swelling, injected limb mobility decreased, fatigue, abdominal pain, headache, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the malaise, injection site swelling, injected limb mobility decreased, fatigue, abdominal pain, headache, fever and chills to be related to BOOSTRIX. Additional details were provided as follows: The patient was not on any medication. The nurse practitioner reported that one of her patients had the BOOSTRIX vaccine on left deltoid. Within a couple of hours the patient experienced high fever, malaise, swelling at injection site, chills, fatigue, abdominal pain, headache and loss of motion on that arm where he received the injection due to the swelling. No other vaccines were given on that same day. At the time of this report, the patient had not recovered from side effects and the nurse was treating him. The reporter said that she was hoping with her treatment that the patient would not have to be admitted to the hospital.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Malaise, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of malaise in a 35-year-old male patient who received BOOSTRIX (batch number TB2R2, expiry date 18th May 2019). On 16th January 2018, the patient received BOOSTRIX (intramuscular) .5 ml. In January 2018, 2 hrs after receiving BOOSTRIX, the patient experienced malaise (serious criteria other: as per reporter), injection site swelling (serious criteria disability and other: as per reporter), injected limb mobility decreased (serious criteria disability and other: as per reporter), fatigue (serious criteria other: as per reporter), abdominal pain (serious criteria other: as per reporter), headache (serious criteria other: as per reporter), fever (serious criteria other: as per reporter) and chills (serious criteria other: as per reporter). On an unknown date, the outcome of the malaise, injection site swelling, injected limb mobility decreased, fatigue, abdominal pain, headache, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the malaise, injection site swelling, injected limb mobility decreased, fatigue, abdominal pain, headache, fever and chills to be related to BOOSTRIX. Additional details were provided as follows: The patient was not on any medication. The nurse practitioner reported that one of her patients had the BOOSTRIX vaccine on left deltoid. Within a couple of hours the patient experienced high fever, malaise, swelling at injection site, chills, fatigue, abdominal pain, headache and loss of motion on that arm where he received the injection due to the swelling. No other vaccines were given on that same day. At the time of this report, the patient had not recovered from side effects and the nurse was treating him. The reporter said that she was hoping with her treatment that the patient would not have to be admitted to the hospital.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site warmth, Somnolence
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 58-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concurrent medical conditions included hyperthyroidism. Concomitant products included atorvastatin. On 16th January 2018, the patient received the 1st dose of SHINGRIX .5 ml. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth, sleepiness and generalized joint pain. In January 2018, the outcome of the injection site warmth and sleepiness were recovering/resolving and the outcome of the generalized joint pain was recovered/resolved. The reporter considered the injection site warmth and generalized joint pain to be related to SHINGRIX. The reporter considered the sleepiness to be possibly related to SHINGRIX. Additional details were provided as follows: The reporter was notified on the day of reporting by the patient about the side effects he experienced and if the second dose of the vaccine should be given. The patient did not give any timeframes as to when the side effects started after receiving the vaccine. When the patient came into the pharmacy on the day of reporting, the reporter could feel that the skin at the injection site was still warm to the touch. The reporter felt the skin through the patient's shirt. The body aches were experienced in the joints in the entire body of the patient. The reporter was told by the patient that he had sleepiness and could not stay awake. The reporter said that sleepiness was atypical for this patient.
Age: 67.0
Sex: U
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Injection site pain, Joint injection, Joint range of motion decreased, Pain
Clinical narrative: Shooting Pain down arm to finger tips. Diagnosis - frozen shoulder. 11/21/17 Flu vaccine administered in high left shoulder by pharmacist. I had shooting pain all the way down my arm to my finger tips upon vaccine administration. 12/17/17 I made call to pharmacist reporting continued and worsening left shoulder pain since vaccine administration. Reported I would be seeking medical care since all attempts with pain meds and icing had not resolved pain. Being an RN and having managed the vaccine program for a local public health department, I was familiar with VAERS reporting and suggested this be done. Pharmacist said she was from another location but would have someone call me. 12/19/17 Received call from Pharmacist. Explained my situation and she said to let them know medical information after my orthopedic appt. 12/20/17 Seen by PA at Orthopedic. Diagnosis: tendonitis from improperly administered vaccine. Shoulder xray done. Steroid injection given. To return if no improvement in 2-4 weeks. 1/9/18 Returned to Orthopedic due to continued L shoulder pain and limited range of motion. Seen by Dr. Diagnosis: adhesive capsulitis (frozen shoulder). Recommended steroid injection into different shoulder space than previous injection. Also, recommended physical therapy. 1/15/18 Steroid injection given by Dr. 1/24/18 Will begin physical therapy appts. 4 set up for initial treatment. Medical records have been requested.
Age: 67.0
Sex: U
Vaccine: FLUC4
Symptoms: Pain in extremity, Periarthritis, Tendonitis, X-ray limb
Clinical narrative: Shooting Pain down arm to finger tips. Diagnosis - frozen shoulder. 11/21/17 Flu vaccine administered in high left shoulder by pharmacist. I had shooting pain all the way down my arm to my finger tips upon vaccine administration. 12/17/17 I made call to pharmacist reporting continued and worsening left shoulder pain since vaccine administration. Reported I would be seeking medical care since all attempts with pain meds and icing had not resolved pain. Being an RN and having managed the vaccine program for a local public health department, I was familiar with VAERS reporting and suggested this be done. Pharmacist said she was from another location but would have someone call me. 12/19/17 Received call from Pharmacist. Explained my situation and she said to let them know medical information after my orthopedic appt. 12/20/17 Seen by PA at Orthopedic. Diagnosis: tendonitis from improperly administered vaccine. Shoulder xray done. Steroid injection given. To return if no improvement in 2-4 weeks. 1/9/18 Returned to Orthopedic due to continued L shoulder pain and limited range of motion. Seen by Dr. Diagnosis: adhesive capsulitis (frozen shoulder). Recommended steroid injection into different shoulder space than previous injection. Also, recommended physical therapy. 1/15/18 Steroid injection given by Dr. 1/24/18 Will begin physical therapy appts. 4 set up for initial treatment. Medical records have been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site started getting red, hot and swollen last night.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large local redness and swelling into right upper arm, itching and discomfort.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Right vastus lateralis region of thigh was edematous and erythematous and slightly tender to touch. Induration was approximately 3 inches in diameter. Non fluctuant.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: Edema.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The right leg was swollen and red. The redness extended from the top portion of his thigh to his knee.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site swelling
Clinical narrative: Received vaccines (PEDIARIX, PedVaxHib, PCV-13) 9:42am on 8-29-17. Developed swelling of Right leg, crying >2 hours. Treated with oral TYLENOL and hydroxyzine.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: One bump was initially found on chest w/itchiness then increased bumps noted (little red) (L) breast, back chest.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dyspnoea, Swelling, Urticaria
Clinical narrative: After leaving the office patient experienced shortness of breath, swelling and hives. Patient went to the ER.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Anaphylactic reaction, Dyspnoea, Urticaria
Clinical narrative: After leaving the office patient experienced shortness of breath, swelling and hives. Patient went to the ER.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, diaphoresis, tiredness, weakness, nausea started within a minute after immunization lasted for about an hour; Treatment was pt. laid down and sips of water.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Breast pain, Chest X-ray normal, Chest pain, Electrocardiogram normal
Clinical narrative: Pt called this office on 12/8/17 and reported episodes of upper left back and left chest/breast pains since getting PREVENAR 13 on 11/29/17. She went to Urgent Care and was worked up. Pt C/O some residual head and rib pains. Will see PCP to address.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Musculoskeletal chest pain
Clinical narrative: Pt called this office on 12/8/17 and reported episodes of upper left back and left chest/breast pains since getting PREVENAR 13 on 11/29/17. She went to Urgent Care and was worked up. Pt C/O some residual head and rib pains. Will see PCP to address.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Reports soreness left deltoid less than 2 wks no redness no swelling.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb injury, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US176269, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 648376) website on 21 Dec 2016. This report refers to a 43-years-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 185284) intramuscularly in left arm on 09 Aug 2016. On the same day after vaccination the patient experienced shoulder injury related to vaccine administration and shoulder pain. The outcome of events was reported as condition unchanged. The seriousness of the events was not reported. The causality of the event shoulder injury was assessed as suspected to be related with FLUCELVAX QUADRIVALENT and causality for event shoulder pain was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Oedema
Clinical narrative: Case number PHHY2016US165657, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 649237) website on 21 Nov 2016. This report refers to a female patient of an unspecified age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date. On an unspecified date, the patient experienced edema. The outcome, seriousness and causality of event edema were not reported.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure decreased, Contraindicated product administered, Diarrhoea, Exposure during pregnancy, Flushing
Clinical narrative: Case number PHHY2016US178413, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 651881) on 21 Dec 2016. This report refers to a 32 years old female patient. Medical history was not reported. Current condition included allergies to latex, eggs, milk, shellfish, hazelnut, banana, mustard, soybean, strawberries. Concomitant medications included COLACE, ranitidine and Prenatal vitamin. The patient who was 37 weeks pregnant was vaccinated with of FLUCELVAX QUADRIVALENT (batch number: 185285) intramuscularly into the left arm on 12 Sep 2016. On same day after vaccination the patient experienced sudden onset of tachycardia up to 166 bpm, nausea, pre syncope, facial flushing, diarrhea, shakiness/tremors, blood pressure was 101/63. Emergency medical service came to assess the patient and they were going to take the patient to the hospital, but the patient refused. Hours later at 19:30 hours, the patient was feeling better, but still nauseous. The outcome of the event nausea was reported as condition unchanged and for other events was reported as complete recovery. The seriousness of the events was reported as non serious and causality not reported.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Presyncope, Tachycardia, Tremor
Clinical narrative: Case number PHHY2016US178413, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 651881) on 21 Dec 2016. This report refers to a 32 years old female patient. Medical history was not reported. Current condition included allergies to latex, eggs, milk, shellfish, hazelnut, banana, mustard, soybean, strawberries. Concomitant medications included COLACE, ranitidine and Prenatal vitamin. The patient who was 37 weeks pregnant was vaccinated with of FLUCELVAX QUADRIVALENT (batch number: 185285) intramuscularly into the left arm on 12 Sep 2016. On same day after vaccination the patient experienced sudden onset of tachycardia up to 166 bpm, nausea, pre syncope, facial flushing, diarrhea, shakiness/tremors, blood pressure was 101/63. Emergency medical service came to assess the patient and they were going to take the patient to the hospital, but the patient refused. Hours later at 19:30 hours, the patient was feeling better, but still nauseous. The outcome of the event nausea was reported as condition unchanged and for other events was reported as complete recovery. The seriousness of the events was reported as non serious and causality not reported.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Palpitations, Pruritus
Clinical narrative: Case number PHHY2016US179389, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 653070) website on 21 Dec 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) into the right arm on 09 Sep 2016. On the same day after vaccination, the patient experienced racing heart and itchiness on both forearms. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Case number PHHY2016US167788, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 653889) on 21 Nov 2016. This report refers to a 58 years old female patient. Historical conditions included post-traumatic stress disorder (PTSD), atrial fibrillation, bipolar and had severe reaction. Current conditions included high blood pressure, diabetic, Parkinson's disease, Schizotypal and she was latex allergic. Concomitant medication included pantoprazole, metformin, diltiazem, bupropion XL, duloxetine DR, topiramate, vision formula with lutein, D3, losartan, loratadine, carbidopa/levodopa. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) on 15 Sep 2016. On same day after vaccination, the patient experienced numb right side of face cheek down to under chin and lip, like after dental visit. The event lasted about 45 minutes. Next day on 16 Sep 2016, symptoms returned about 02:00, more left side of face and chin area involvement. The patient decided to look on CDC site for information on flu vaccines. The patient was concerned because when she saw online there might be latex in the vaccine. The final outcome of the event as condition unchanged. The seriousness and causality of the event was not reported.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Eye swelling, Lip discolouration, Wheezing
Clinical narrative: Case number PHHY2016US178575 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 654092) on 21 Dec 2016. This report refers to a 6 year old male patient. Current conditions included amoxicillin allergy, asthma and allergies. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185286) intramuscularly into left arm on 15 Sep 2016. On the same day, when the doctor left, the patient developed cough and wheezing. His eyes swelling and lips turned purple. Following the events the patient visited emergency room/urgent care. The patient was treated with Albuterol and steroid. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: Case number PHHY2016US165560, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 654396) website on 21 Nov 2016. This report refers to a 08 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number; 185887) intramuscularly in left arm on 19 Sep 2016. On the same day while vaccination, it was found that the wrong student was vaccinated. Staff went to a classroom and called for someone to get her flu vaccine. The patient got up and the VAR was handed to her. She went to the nurse who called her by name and she was vaccinated. The child that was to be vaccinated was also the same name however was not int he classroom that staff went to. On 19 Sep 2016, in the evening the mother of the child told that the child did not have any symptoms of distress. No adverse event was reported following this administration error.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Erythema, Injection site pain, Joint swelling, Pain in extremity
Clinical narrative: Case number PHHY2016US164902, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 654622) website on 21 Nov 2016. This report refers to a 57-years-old female patient. Past medical history was not reported. Current condition included allergic to aspirin and sulfa drugs. Concomitant medication included amitriptylin (reported as did not recall if he took one within 02 days of vaccination). The patient had flu vaccinations annually for 15 years and never had an adverse reaction. The patient was vaccinated with FLUCELVAX (batch number: 185286, expiry date: not reported) intramuscularly on 13 Sep 2016. On 14 Sep 2016 after vaccination, the patient experienced substantial pain when she touched her elbow and forearm. However, no pain otherwise and swelling in elbow (same arm as injected) and swelling confined to bursa, approximately size of golf ball. On the second day, swelling spread to upper forearm and skin was red and had a slight fever. On the third day, swelling began to recede, redness faded to pink, and the patient no longer had a fever. On the fourth day improvement was continued and by the fifth day the patient was 95 percent normal. The patient stated that she never had any pain (except typical mild soreness) from the injection site. The patient received treatment with naproxen (manufacturer unknown) at a dose of 1 DF twice per day and applied ice to elbow and forearm every hour or two during the day. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2016US164902, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 654622) website on 21 Nov 2016. This report refers to a 57-years-old female patient. Past medical history was not reported. Current condition included allergic to aspirin and sulfa drugs. Concomitant medication included amitriptylin (reported as did not recall if he took one within 02 days of vaccination). The patient had flu vaccinations annually for 15 years and never had an adverse reaction. The patient was vaccinated with FLUCELVAX (batch number: 185286, expiry date: not reported) intramuscularly on 13 Sep 2016. On 14 Sep 2016 after vaccination, the patient experienced substantial pain when she touched her elbow and forearm. However, no pain otherwise and swelling in elbow (same arm as injected) and swelling confined to bursa, approximately size of golf ball. On the second day, swelling spread to upper forearm and skin was red and had a slight fever. On the third day, swelling began to recede, redness faded to pink, and the patient no longer had a fever. On the fourth day improvement was continued and by the fifth day the patient was 95 percent normal. The patient stated that she never had any pain (except typical mild soreness) from the injection site. The patient received treatment with naproxen (manufacturer unknown) at a dose of 1 DF twice per day and applied ice to elbow and forearm every hour or two during the day. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Flushing, Hypoaesthesia, Livedo reticularis, Paraesthesia
Clinical narrative: Case number PHHY2016US165800, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 654765) website on 21 Nov 2016. This report refers to a 24-years-old male patient. Historical condition included post-traumatic stress disorder. Current condition included ex-smoker. Concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 13549221A) intramuscularly in left arm on 22 Sep 2016. On the same day 45-60 minutes after vaccination the patient experienced that left arm was asleep where he received the injection (unspecified details). Bilateral palms of hand had mottled appearance and redness and flushing of the skin noted on bilateral arms and neck. The patient also reported having a "scratchy" throat but attributed it to quitting smoking three weeks ago. The patient received treatment with BENADRYL at a dose of 25mg orally was administered at 15:10 (unspecified date). The patient denied having any chest tightness, shortness of breath, difficulty breathing and inability to swallow own salvia, and other severe adverse reaction signs. Capillary refill was less than 2 seconds. Vital signs stable. The patient was kept for observation until 15:50(unspecified date). The patient was directed to see his primary care provider to report symptoms and to also receive evaluation for the left arm numbness and tingling. The outcome of events was reported as complete recovery on an unspecified date. The seriousness and causality were not reported.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Case number PHHY2016US165800, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 654765) website on 21 Nov 2016. This report refers to a 24-years-old male patient. Historical condition included post-traumatic stress disorder. Current condition included ex-smoker. Concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 13549221A) intramuscularly in left arm on 22 Sep 2016. On the same day 45-60 minutes after vaccination the patient experienced that left arm was asleep where he received the injection (unspecified details). Bilateral palms of hand had mottled appearance and redness and flushing of the skin noted on bilateral arms and neck. The patient also reported having a "scratchy" throat but attributed it to quitting smoking three weeks ago. The patient received treatment with BENADRYL at a dose of 25mg orally was administered at 15:10 (unspecified date). The patient denied having any chest tightness, shortness of breath, difficulty breathing and inability to swallow own salvia, and other severe adverse reaction signs. Capillary refill was less than 2 seconds. Vital signs stable. The patient was kept for observation until 15:50(unspecified date). The patient was directed to see his primary care provider to report symptoms and to also receive evaluation for the left arm numbness and tingling. The outcome of events was reported as complete recovery on an unspecified date. The seriousness and causality were not reported.
Sex: F
Vaccine: FLUC4
Symptoms: Flushing, Pain in extremity, Pharyngeal oedema, Pruritus
Clinical narrative: Case number PHHY2016US178619, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 655378) on 21 Dec 2016. This report refers to a 21 years old female patient. Historical condition included allergic reaction in the past year to unknown causes. Current conditions included seasonal allergies, allergies to kiwi, pantoprazole and tetracycline. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 1620001) intramuscularly into left arm on 23 Sep 2016. On the same day in the evening after vaccination, the patient's left arm started hurting, had flushing, itching and throat swelling. The patient was treated with BENADRYL, ranitidine and prednisone. The patient went to emergency room on an unknown date. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality was not reported.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Nausea, Pruritus, Urticaria
Clinical narrative: Case number PHHY2016US178026 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 656383) website on 21 Dec 2016. This report refers to 27 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185886) intramuscularly into right arm on 27 Sep 2016. On the same day, within half an hour post vaccination the patient experienced nausea, dizziness, itching, hives on arms legs, face, trunk, back. The patient was treated with BENADRYL 50 mg. The patient was offered EPI PEN. It was stated that the patient referred and directed to follow up as needed if not better or it worse at emergency room. The outcome of the events was reported as complete recovery on an unknown date. The causality of the events was not reported.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2016US166191, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 656611) website on 21 Nov 2016. This report refers to a 50-years old male patient. Past medical history included vaccination with influenza vaccine (manufacturer unknown) without any side effects. Concomitant medications were not reported. Current conditions included shellfish allergy. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1619801) intramuscularly in arm on 27 Sep 2016. On the same day after vaccination, the patient experienced hives and itching about the face. The patient denied other symptoms including chest pain, shortness of breath (SOB) or difficultly swallowing. Patient was given BENADRYL orally and observed. It was reported that, symptoms resolved over time. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events was not reported.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyspnoea, Pain, Pyrexia
Clinical narrative: Case number PHHY2016US178877, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 657133) website on 21 Dec 2016. This report refers to a 42 years old male patient. Past medical history was not reported. Concomitant medications included LEXAPRO, DEXILANT and MIRAPEX. He was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) intramuscularly into the right arm on 03 Oct 2016. After vaccination, on 04 Oct 2016, the patient experienced extreme aches, fever, shortness of breath and labored breathing. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: Case number PHHY2017US019142 is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 657909) website on 23 Jan 2017. This report refers to a male patient of unspecified age. Historical condition was not reported. Current condition included Diabetes Mellitus and FARXIGA allergy. It was reported that the patient was also on concomitant medications but they were unknown. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into left arm on an unknown date. The patient was also vaccinated with PNEUMOVAX 23 (manufacturer unknown, batch number: M027552, expiry date: 04 Feb 2018) at a dose of 0.5 ml intramuscularly into right arm on an unknown date concomitantly with the flu vaccine. On the same day after vaccination with in 24 hours, patient experienced soreness at the injection site where the vaccine was administered, within the past 24 hours the patient developed an unspecified rash at the injection site that spread to his chest. It was reported that the patient was scheduled to see his physician on 21 Sep 2016, regarding this adverse events. At the time of the report, the outcome of the events injection site pain, injection site rash and rash was reported as condition unchanged (reported as not recovered/not resolved). The seriousness of the events was reported as non serious and causality was not reported. It was reported that the reporter did not assess the causal relationship between the adverse events and the vaccination with PNEUMOVAX 23.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Cardiac disorder, Malaise
Clinical narrative: Case number PHHY2016US177615, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 659105) website on 21 Dec 2016. This report refers to a 52-years-old female patient. Past medical history was not reported. Historical drug included NEOSPORIN. Current condition not reported. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185237) intramuscularly in left arm on 13 Oct 2016. On the same day after vaccination the patient experienced something wrong with heart and not feeling well. The outcome of events was reported as condition unchanged. The seriousness was not reported. The causality of the events were not reported.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2016US165037, is an initial spontaneous report received from a nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 659320) website on 21 Nov 2016. This report refers to a 39 years old female patient. Past medical history was not reported. Concomitant medication included multivitamin. The patient was vaccinated with FLUCELVAX (batch number: 185327, expiry date 30 Apr 2017) at a dose of 0.5 ml intramuscularly in left arm on 13 Oct 2016. On the same day a minutes after receiving the flu vaccine, her arm was in pain from her shoulder to the top of her hand. The pain radiated down her arm until the evening and the pain continued until the next morning. As of 10:15 at morning the pain was seems to be going away and was not as intense. The outcome of event pain in extremity was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Vaccination site oedema, Vaccination site pain
Clinical narrative: Case number PHHY2016US166168, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 660009) on 21 Nov 2016. This report refers to a 56 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185325A, expiry date: not reported) intramuscularly into left arm on 10 Oct 2016, the vaccine was not administered in her deltoid. On same day after vaccination, the patient's vaccination site was red, edematous, tender to touch. The patient declined vitals. The outcome of the events was reported as complete recovery. The seriousness and causality of the events was not reported.
Age: 42.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site rash, Rash
Clinical narrative: Case number PHHY2017US019916, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS: 664008) on 23 Jan 2017. This report refers to a 42-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with influenza virus vaccine INN (manufacturer unknown, batch number not reported) and PNEUMOVAX 23 (batch number: M018766) on an unknown date. The patient developed a rash that started at the injection site and spread to his abdomen. It was unspecified if the rash started at the PNEUMOVAX 23 or influenza virus vaccine (unspecified) injection site. The outcome of the adverse events was unknown. Seriousness was reported as non-serious and causality was not reported.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 672748) and concerns a 61 years old female patient. The patient's medical history Included: Coronary artery disease, acute myocardial infarction, gastric ulcer, prediabetes, osteoarthritis, shortness of breath, ptosis of right eyelid, pulmonary emphysema, Gastroesophageal reflux disease, Iron deficiency anaemia. The patient's concomitant medication included: Omeprazole, Potassium chloride, Ranitidine, Acetaminophen, Albuterol, Aspirin, Atorvastatin, Bumetanide, Cetirizine, Ezetimibe, Fluticasone, Hydralazine, Magnesium oxide, Metformin, Montelukast. Administration of Company suspect drug: On 31-Oct-2016 the patient was administered Influenza virus vaccine polyvalent via intramuscular route of administration into left deltoid of unknown (dose, batch number, expiry date). Non-company suspect drug: On 31-Oct-2016 the patient was administered PNEUMOVAX via intramuscular route of administration into left deltoid of unknown (dose, batch number, expiry date). Adverse reactions/events and outcomes: On unspecified date patient received Influenza virus vaccine polyvalent and PNEUMOVAX vaccines and both were delivered Intramuscular into the left deltoid. The patient had no contraindications to injection. Within an hour of the combination injection (medication error), the patient developed significant swelling, redness and pain spreading down the left arm and persisted for several days. She did not report anaphylactic symptoms and her arm pain and swelling improved with symptomatic management. The outcome of the event Significant swelling and pain in arm was recovered and for event erythema and vaccine administered at inappropriate site was not reported. Reporter's Assessment: The other non-Health professional did not provide the causality. This report is non serious.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4, MMR, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2017US019730, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 667386) on 23 Jan 2017. This report refers to a 04 years old male patient. Medical history and concomitant medication was reported as none. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185286) and KINRIX (batch number: 3425B) both intramuscularly into left arm, MMR II (batch number: M014902) and VARIVAX (batch number: M025867) both subcutaneously into right arm, all vaccines administered on 11 Nov 2016. On 12 Nov 2016 after vaccination, the patient's left upper arm was swollen, itchy and tender about 3 inches in all directions surrounding vaccination site. The other arm was fine. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Laboratory test, Pain
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by other non-health professional (consumer) via Health Authority (reference no: 670468) and concerns a 66 years old female patient. The patient's medical history and concomitant medications were not reported. Administration of Company suspect drug: On 09-Nov-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch no, route of administration: not reported) at right arm. Non-company suspect drug: On 09-Nov-2016, the patient also received PNEUMOVAX 23 (dose: 0.5 ml, batch no: not reported) at left arm via intramuscular route. Adverse reactions/events and outcomes: On 09-Nov-2016 after administration of influenza vaccine and pneumococcal vaccine, later the same evening, the patient felt pain in the right shoulder. She could not open the car door or raise arm past hips. Her arm was extremely painful (Injection site pain), red, swollen and she felt the pain circling from arms to shoulders. The patient could not roll over without experiencing terrible pain. On an unknown date, the patient called to the physician and had unspecified laboratory diagnostic studies (results were not provided).  Treatment medications: TYLENOL for pain. Action taken with the vaccine was not reported. The outcome of the event pain was recovering and other events was not resolved/not recovered. Reporter's Assessment: The reporter did not provide the causality assessment of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by other non-health professional (consumer) via Health Authority (reference no: 670468) and concerns a 66 years old female patient. The patient's medical history and concomitant medications were not reported. Administration of Company suspect drug: On 09-Nov-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch no, route of administration: not reported) at right arm. Non-company suspect drug: On 09-Nov-2016, the patient also received PNEUMOVAX 23 (dose: 0.5 ml, batch no: not reported) at left arm via intramuscular route. Adverse reactions/events and outcomes: On 09-Nov-2016 after administration of influenza vaccine and pneumococcal vaccine, later the same evening, the patient felt pain in the right shoulder. She could not open the car door or raise arm past hips. Her arm was extremely painful (Injection site pain), red, swollen and she felt the pain circling from arms to shoulders. The patient could not roll over without experiencing terrible pain. On an unknown date, the patient called to the physician and had unspecified laboratory diagnostic studies (results were not provided).  Treatment medications: TYLENOL for pain. Action taken with the vaccine was not reported. The outcome of the event pain was recovering and other events was not resolved/not recovered. Reporter's Assessment: The reporter did not provide the causality assessment of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Sex: F
Vaccine: MENB
Symptoms: Chills
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar adverse events for three patients. This is third of three reports. An adolescent female patient of unspecified ethnicity received on an unknown date a single dose of TRUMENBA for immunization. Medical history and concomitant medications were not reported. Next day after vaccination, the patient experienced chills. Outcome was unknown. The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018031093 Same reporter/product/event, different patient;US-PFIZER INC-2018031110 Same reporter/product/event, different patient.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Injected limb mobility decreased, Loss of personal independence in daily activities, Mobility decreased, Tendonitis
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional on 20-Sep-2017, concerning a 23-year-old adult female patient. It was reported that, the patient had no medical history. The patient's concomitant medications included: cyclobenzaprine and high dose ibuprofen for unknown indication. On 28-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number, expiry date: not reported). One week after receiving the flu vaccine, patient developed bursitis, tendinitis and the patient had difficulty in raising arms that affected the task as difficulty in dressing themselves. The patient was treated with ice packs, Ibuprofen and steroids. It was reported that, the could not rotate the shoulder actively or passively. The physician thought that, it was related to muscle rather than bursitis or tendinitis. The outcome of the event was not recovered (ongoing). The reporter assessed the events as non-serious. Follow-up report received on 13-Oct-2017: It was reported that, the patient had no medical history. Route of administration and anatomical location of the suspect vaccine was updated. The physician thought that, it was related to muscle rather than bursitis or tendinitis, the same have been updated. Amended narrative accordingly.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pruritus, Local reaction, Paraesthesia
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health Professional (nurse) on 20-Oct-2017, concerning a 35-year-old adult female patient. This refers to 01 out of 02 patients. On 18-Oct-2017, at 08:15 hours, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195211, expiry date: Mar-2018). On the same day, the patient developed localized reaction on the left arm such as itching and redness around the injection site, numbness and tingling down the arm. The patient took BENADRYL. The patient recovered from the events the same evening and she returned to work the next day. It was reported that the patient denied having a similar reaction in the past. At the time of this report, the patient had recovered from the event on 18-Oct-2017. The reporter assessed the event as non-serious. Follow-up received from the reporter on 08-Nov-2017: Added stop date of the events (18-Oct-2017). It was reported that the patient denied having similar reaction in the past. The narrative was amended accordingly.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Lethargy, Malaise, Somnolence
Clinical narrative: This initial spontaneous case, was received on 20-Oct-2017, from other health professional, concerning a 46-year-old adult male patient. This refers to 02 out of 02 patients. The patient's medical history and concomitant medications were not reported. On 18-Oct-2017, at 08:15 am, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195211, expiry date: Mar-2018). On the same day, around 09:30 am, the patient was lethargic, sleep, very weak, dizzy and felt asleep while talking. The patient was taken to ER (emergency room) and was given unspecified fluids. On the same day, evening or within 24 hours (as reported), the patient was discharged. On the same day, the patient recovered from the events and went to work the next day. It was reported that the patient denied having a similar reaction in the past. The reporter assessed the events as non-serious. The causality was not reported as the reporter could not determine the relationship between the event and the flu shot. Follow-up received from the reporter on 08-Nov-2017: Added stop date of the events (18-Oct-2017). It was reported that the patient denied having a similar reaction in the past. The narrative was amended accordingly. Significant case correction received 20-Oct-2017: The event 'malaise' was added and listedness was done and reporter causality was changed to unassessable.