chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Insomnia, Migraine, Nausea, Postural orthostatic tachycardia syndrome, Serum ferritin decreased
Clinical narrative: Case number PHHY2014US170414, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547879) website on 29 Dec 2014, with the follow up information received from Quality Assurance Department on 12 Jan 2015. This report refers to an 11 year old female patient. Her medical history was not reported. Concomitant medication included amoxicillin. On 25 Sep 2013, she was vaccinated with MENVEO (batch number: unknown) into arm. On the same day she also received GARDASIL (batch number: J002641, other manufacturer) and BOOSTRIX (batch number: N4352, other manufacturer) both into arm. On 01 Nov 2013, she developed postural orthostatic tachycardia syndrome (POTS) treated with salt tabs and FLORINEF, syncope, chronic fatigue syndrome, migraines treated with doxepin, ferritin deficiency treated with iron supplement, vitamin D deficiency treated with vitamin D supplement, insomnia, abdominal pain, nausea and dizziness. Lab data reported as tilt table test patient fainted on minute 13 of tilt when blood pressure was at 39/36, pulse went to a high of 152; ferritin in blood was 8 and Vitamin D 17. She went to the emergency room. Outcome of the events was condition unchanged. Events were reported as serious (permanent disability). Causality assessment was not reported. Upon on FU from QA department, it stated that, the reported batch number: U4511AA for MENVEO is invalid. Therefore, no investigation will be performed for unknown batch number. Follow up information received from Quality Assurance Department on 12 Jan 2015: Upon on FU from QA department, it stated that, the reported batch number: U4511AA for MENVEO is invalid. Therefore, no investigation will be performed for unknown batch number.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope, Tilt table test positive, Vitamin D decreased, Vitamin D deficiency
Clinical narrative: Case number PHHY2014US170414, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547879) website on 29 Dec 2014, with the follow up information received from Quality Assurance Department on 12 Jan 2015. This report refers to an 11 year old female patient. Her medical history was not reported. Concomitant medication included amoxicillin. On 25 Sep 2013, she was vaccinated with MENVEO (batch number: unknown) into arm. On the same day she also received GARDASIL (batch number: J002641, other manufacturer) and BOOSTRIX (batch number: N4352, other manufacturer) both into arm. On 01 Nov 2013, she developed postural orthostatic tachycardia syndrome (POTS) treated with salt tabs and FLORINEF, syncope, chronic fatigue syndrome, migraines treated with doxepin, ferritin deficiency treated with iron supplement, vitamin D deficiency treated with vitamin D supplement, insomnia, abdominal pain, nausea and dizziness. Lab data reported as tilt table test patient fainted on minute 13 of tilt when blood pressure was at 39/36, pulse went to a high of 152; ferritin in blood was 8 and Vitamin D 17. She went to the emergency room. Outcome of the events was condition unchanged. Events were reported as serious (permanent disability). Causality assessment was not reported. Upon on FU from QA department, it stated that, the reported batch number: U4511AA for MENVEO is invalid. Therefore, no investigation will be performed for unknown batch number. Follow up information received from Quality Assurance Department on 12 Jan 2015: Upon on FU from QA department, it stated that, the reported batch number: U4511AA for MENVEO is invalid. Therefore, no investigation will be performed for unknown batch number.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pruritus generalised, Skin warm
Clinical narrative: Case number PHEH2014US020154 is an initial spontaneous report received from a pharmacist on 06 Oct 2014. This report refers to a 39 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1413501) intramuscularly on an unknown date. It was reported that on 06 Oct 2014, patient experienced warmth and itching all over his body and his ears turned red and warm to the touch after receiving FLUVIRIN. He took BENADRYL and within 30 minutes the side effects began to resolve. The seriousness and causality were not reported.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Case number PHEH2014US00689 is an initial spontaneous report received from a pharmacy student on 10 OCT 2014. This report refers to a 71 year old male patient. His past medical history and concomitant medications were not reported. On 08 OCT 2014, he was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412601) intramuscularly and with pneumococcal vaccine (other manufacturer, batch number: not reported). On the same day, after the vaccinations, he developed redness from his upper arm to his elbow and also it was sore around the injection site about a soft ball sized. It was reported that the reaction started the same day as the vaccination. The outcome of the events was not reported. The seriousness and causality of the events was not reported.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Injection site rash
Clinical narrative: Case number PHHY2014US021905, is an initial spontaneous report from a health care professional received on 29 Oct 2014. This report refers to a 26-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1411501) intramuscularly on 16 Oct 2014. On the same day, after vaccination, the patient experienced dizziness, flushed face and rash at the injection site. The patient went to emergency room (ER) and was given BENADRYL and instructed to not get the flu shot next year without being monitored. It was reported that the patient did not have any respiratory issues and did not need epinephrine. Outcome of the events was reported as unknown. Seriousness and causality of the events was unknown.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call representative and described the occurrence of enlargement of lymph nodes in a 78-year-old male patient who received FLUARIX (batch number 7329G, expiry date June 2015). The patient's past medical history included brain operation and shoulder replacement (right shoulder, early 2014). Concurrent medical conditions included blood pressure high and diabetes. On 7th October 2014, the patient FLUARIX (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, 7 days after receiving FLUARIX, the patient experienced enlargement of lymph nodes, pain upon movement and fever. The patient was treated with steroids nos (Steroids), antibiotics unknown and narcotics, nos. On an unknown date, the outcome of the enlargement of lymph nodes was recovering/resolving and the outcome of the pain upon movement was not recovered/not resolved and the outcome of the fever was recovered/resolved. The reporter considered the enlargement of lymph nodes, pain upon movement and fever to be related to FLUARIX. Additional information received: Patients reports that 1.5-2 weeks after receiving FLUARIX vaccine he suddenly began experiencing pain in the left side of his neck and down into his shoulder. He was unable to turn hi head to the left or right, preventing him from driving. He also started running a fever of 102. He saw his HCP who examined his neck and found a swollen lymph node in the left side of his neck. It is thought that the swollen lymph node caused a muscle to contract around a vein causing the pain. He is now on steroids, antibiotics and narcotics to treat the pain and swelling. The lymph node has reduced, but is still a little swollen. The fever has resolved. He is still in a lot of pain, but it is controlled with the narcotics and he can now turn his head. He finds that he still cannot raise his arm up and he has an appointment with a physical therapist. He has had 12 x-rays and has visited his doctor 3 times for this reaction. He, his doctor and his pharmacist all believe this is due to the vaccine. He is on multiple medications, but did not have his list available.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash pruritic
Clinical narrative: Case number PPHEH2014US021590 is an initial spontaneous report from the nurse received on 23 OCT 2014. This report refers to a 29-year-old female patient. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413201) intramuscularly from a multi dose vial on an unknown date. On 23 OCT 2014, 34 minutes after vaccination she experienced redness and itchy rash (erythema) on the arm of the injection. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Allergy test, Wheezing
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient with OMNICEF reactions/allergies. On an unknown date, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (dose, lot #, route and site of administration were not reported). on 22-DEC-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot# K007786, expiration date: May 2016 (dose, route and site administration were not reported) and a dose of M-M-R II lot# K007106, expiration date: May 2016 (dose, route and site of administration were not reported). On 22-DEC-2014, the patient experienced wheezing. Nurse stated that wheezing was not treated. The patient referred to an allergist for evaluation of wheezing through allergy skin testing (results were not reported). The outcome of wheezing was unknown. The relatedness between wheezing and (Oka/Merck) VARIVAX and M-M-R II was not reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site extravasation
Clinical narrative: Case number PHHY2014US121197, is an initial spontaneous report received from a pharmacist on 17 Sep 2014 with a follow-up received from a quality assurance department (QA ref number: 325775) on 18 Sep 2014 and 19 Sep 2014. This report refers to a 31 year old female patient. Past medical history and concomitant medication was not reported. Pharmacist reported that during the administration of FLUVIRIN (batch number: 1410901) intramuscular from a multidose vial, "quite a bit" of FLUVIRIN leaked out from the injection site on the patient's arm on 08 Sep 2014 (see related case: PHEH2014US018445). A week later, the patient was revaccinated with FLUVIRIN (batch number: unknown) and "only a little bit" leaked out from the injection site on the patient. The patient did receive FLUVIRIN last year, but this was the first time it leaked out of the injection site on the patient. The patient did not experience any adverse events to FLUVIRIN. No sample was available for return. Upon the follow-up from QA department, it was reported that investigation cannot be performed as they refer to FLUVIRIN vial batches. Hence this presentation does not include a syringe; therefore this was not an event which could be related to the FLUVIRIN product. No further information provided. Non-significant follow-up information received from the quality assurance department on 18 Sep 2014: Updated QA reference number only. Follow-up received from quality assurance department on 19 Sep 2014: Updated QA department comments.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Generalised erythema, Pruritus generalised, Rash generalised
Clinical narrative: All over body redness/rash. Warm itchy feeling all over.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness and swelling on left arm started 1-13-15. 1-14-15 swelling had increased to 4-5" square and was itchy. Seen by private physician who felt a Vaers report needed to be completed. Advised to give Benadryl and apply ice to the area.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, X-ray
Clinical narrative: Shoulder pain, decreased range of motion.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Lethargy
Clinical narrative: Large area of erythema to right upper arm with pain and tenderness to site. Lethargy.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Pain in left arm, red rash ~3" x 4", warmth to touch.
Age: 74.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Activities of daily living impaired, Arthralgia, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: On 1/13/15 the patient states he started to experience bilateral hand tremors, patient dropped one thing, and he had to really concentrate to bring a cup to his mouth or utensils.  He also had joint pain, fever and diaphoresis.  He took Tylenol which help alleviate his symptoms. Site Reaction was noted on the right upper extremity on the distal/medial and latter portion of the arm.  The site was red, warm and painful to touch.
Age: 74.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site warmth, Pyrexia, Tremor
Clinical narrative: On 1/13/15 the patient states he started to experience bilateral hand tremors, patient dropped one thing, and he had to really concentrate to bring a cup to his mouth or utensils.  He also had joint pain, fever and diaphoresis.  He took Tylenol which help alleviate his symptoms. Site Reaction was noted on the right upper extremity on the distal/medial and latter portion of the arm.  The site was red, warm and painful to touch.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: At first it was just a common ache in arm at the injection site, but then I was unable to raise my arm higher than 180 degrees without pain. After 2 weeks, I mentioned it to the pharmacy. They said they had not had that complaint. After a month, I reported it to Novartis Pharmaceuticals. They said that they had had reports of similar pain from others. Unfortunately, it's over 3 months now, and I continue to have the same pain, I can't lift anything too high with that arm without pain. I can't sleep on that shoulder without pain. I was hoping the pain would abate, but it has not.
Age: 39.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Diarrhoea, Vomiting
Clinical narrative: Stomach upset, diarrhea, vomiting.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Guillain-Barre Syndrome.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Cough, Fatigue, Feeling cold, Headache
Clinical narrative: Pain in Arm, Mild fever, Severe Headache, persistent coughing, sore throat, severe throat congestion (yellow green Phlegm, very Tired, chills (could not get warm for hours).
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Increased upper airway secretion, Oropharyngeal pain, Pain in extremity, Pyrexia, Sputum discoloured
Clinical narrative: Pain in Arm, Mild fever, Severe Headache, persistent coughing, sore throat, severe throat congestion (yellow green Phlegm, very Tired, chills (could not get warm for hours).
Age: 30.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache, chills, joint pain, body aches, fever 101.4.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Paraesthesia, Tenderness
Clinical narrative: Patient states severe pain in his shoulder with tenderness all the way down to the elbow and tingling down to his fingers.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Influenza like illness, Pain in extremity
Clinical narrative: Donor stated he felt weak, had right arm pain, and flu like symptoms.
Age: 12.0
Sex: F
Vaccine: FLUN4, MNQ
Symptoms: Syncope
Clinical narrative: Fainted.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Chest pain, Dyspnoea, Electrocardiogram normal, Presyncope
Clinical narrative: Chest pain, SOB, near syncope. Lasted 10 min.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Arthralgia, Chills, Headache, Injection site swelling
Clinical narrative: SEVERE HEADACHE WITH CHILLS, SEVERE ENDO CRAMPING, JOINT PAIN WITH VERY LIMITED RANGE OF MOTION (ANKLES, KNEES AND ELBOWS) FEVER AND SWELLING IN INJECTION SITE, PAIN STILL PRESENT IN JOINTS, ABDOMINAL AREA AND INJECTION SITE (20150115/1622) AT TIME OF SUMBISSION OF THIS REPORT.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Joint range of motion decreased, Muscle spasms, Pyrexia
Clinical narrative: SEVERE HEADACHE WITH CHILLS, SEVERE ENDO CRAMPING, JOINT PAIN WITH VERY LIMITED RANGE OF MOTION (ANKLES, KNEES AND ELBOWS) FEVER AND SWELLING IN INJECTION SITE, PAIN STILL PRESENT IN JOINTS, ABDOMINAL AREA AND INJECTION SITE (20150115/1622) AT TIME OF SUMBISSION OF THIS REPORT.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Rash macular, Visual impairment
Clinical narrative: Pateint was given her 3rd injection in the Hep B series in her left deltoid. After the injection was given, another employee came and informed the nurse, that patient was feeling "woozy". The nurse, went to check on patient and patient stated that she felt nauseated and was seeing spots. Patient had red blotches on her neck, chest, and behind her left ear. Patient denied any swelling of her throat or tongue. 911 was called and they came to the center and spoke with patient. She was asked if she wanted to go and get checked out and she replied that she did. At hopsital, she was given 2 shots. 1 was Benadryl and the other was a steroid. She was also sent home with a prescription for a Medrol pak.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported a fever of 100.5 F.  Instructed patient's wife to watch fever and let pharmacy and doctor office know if fever got any higher.  Patient was going to try some fever remedies such as Tylenol and Ibuprofen.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Asthenia, Cough, Crying, Erythema, Lip swelling
Clinical narrative: Patient began crying and developed persistent cough which worsened and eventually became somewhat weak.  Face red, hives on lower face and neck, lips swollen.  Mild wheezing.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Urticaria, Wheezing
Clinical narrative: Patient began crying and developed persistent cough which worsened and eventually became somewhat weak.  Face red, hives on lower face and neck, lips swollen.  Mild wheezing.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Asthenia, Cough, Lip swelling, Urticaria, Wheezing
Clinical narrative: Patient began crying and developed persistent cough which worsened and eventually became somewhat weak.  Face red, hives on lower face and neck, lips swollen.  Mild wheezing.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Choking, Retching
Clinical narrative: Patient began crying and developed persistent cough which worsened and eventually became somewhat weak.  Face red, hives on lower face and neck, lips swollen.  Mild wheezing.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Headache, body ache, redness at the vaccine site, fever, nausea, dizziness, arm pain and stiffness, tiredness, chills, joint pain.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Musculoskeletal stiffness, Nausea, Pain, Pain in extremity
Clinical narrative: Headache, body ache, redness at the vaccine site, fever, nausea, dizziness, arm pain and stiffness, tiredness, chills, joint pain.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia
Clinical narrative: Headache, body ache, redness at the vaccine site, fever, nausea, dizziness, arm pain and stiffness, tiredness, chills, joint pain.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abasia, Arthralgia, Asthenia, Back pain, Chills
Clinical narrative: Headache, body ache, redness at the vaccine site, fever, nausea, dizziness, arm pain and stiffness, tiredness, chills, joint pain.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dizziness, Feeling hot, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache, body ache, redness at the vaccine site, fever, nausea, dizziness, arm pain and stiffness, tiredness, chills, joint pain.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Musculoskeletal stiffness, Pain
Clinical narrative: Headache, body ache, redness at the vaccine site, fever, nausea, dizziness, arm pain and stiffness, tiredness, chills, joint pain.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Pyrexia, Somnolence, Vision blurred
Clinical narrative: Headache, body ache, redness at the vaccine site, fever, nausea, dizziness, arm pain and stiffness, tiredness, chills, joint pain.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Rash, Skin discolouration
Clinical narrative: Started as a few small pimple like bumps and some mild redness the size of a quarter. Redness turned purplish and grew to the size of a golf ball with hard bumps underneath. Measured 4.5cm by 2.5cm by physician.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm to touch, hard, at injection site, feverish feeling.  Symptoms increased over the next 48 hrs with size increasing & redness spreading down arm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Swelling, redness, warm to touch, hard, at injection site, feverish feeling.  Symptoms increased over the next 48 hrs with size increasing & redness spreading down arm.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Muscle oedema, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Approximately 14 hours after receiving mandatory flu vaccine, which was given very high in right shoulder, I experienced pain in shoulder joint with movement. This worsened significantly over next 2 weeks. I was seen by employee health physician, who ordered an MRI, and then referred me to an orthopedic surgeon, based on those results. NSAIDS, pain medications, and physical therapy were prescribed. Mild improvement has occurred; physical therapy is on-going.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome, X-ray limb normal
Clinical narrative: Approximately 14 hours after receiving mandatory flu vaccine, which was given very high in right shoulder, I experienced pain in shoulder joint with movement. This worsened significantly over next 2 weeks. I was seen by employee health physician, who ordered an MRI, and then referred me to an orthopedic surgeon, based on those results. NSAIDS, pain medications, and physical therapy were prescribed. Mild improvement has occurred; physical therapy is on-going.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site extravasation
Clinical narrative: Case number PHEH2014US023855 is an initial spontaneous report received from a pharmacist on 26 Nov 2014, with a follow up received from pharmacist on 09 Jan 2015. This report refers to a 61 year old female patient. The patient's past medical history was none. Concomitant medications were not reported. The patient had tolerated the vaccines well in the past. On 25 Nov 2014, she was vaccinated with a partial dose of FLUCELVAX (batch number: 012022A, expiry date: Mar 2015) intramuscularly into the arm. During the vaccination, some of the vaccine came out of the injection site and trickled down her arm. The reporter noted that the patient was visually obese and her arm had more adipose tissue and wondered if the vaccine was injected into her muscle. It was reported that the patient was hospitalized (no further details provided). Follow up received from pharmacist on 09 Jan 2015: updated seriousness criteria (hospitalization) and other clinically relevant information in the narrative.
Sex: U
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: This case was reported by a other health professional and described the occurrence of influenza in a patient who received FLUARIX quadrivalent. On an unknown date, the patient received FLUARIX quadrivalent at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown. It was unknown if the reporter considered the influenza to be related to FLUARIX quadrivalent. Additional information: three patients vaccinated with FLUARIX QIV that got the flu later in the season. MD did not have any further information at this time.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received FLULAVAL quadrivalent (batch number 5ZT94, expiry date 1st June 2015). On an unknown date, the patient received by accident FLULAVAL quadrivalent .5 ml. On an unknown date, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to FLULAVAL quadrivalent.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 39-year-old female patient who received BOOSTRIX (batch number P39A2, expiry date 15th February 2015). On 29th October 2014, the patient received BOOSTRIX. On 30th October 2014, 1 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unkonwn if the reporter considered the injection site pain to be related to BOOSTRIX. Additional information: The patient was vaccinated on 29 October 2014 and pain at injection site has not gone away yet. Hurts to move her arm.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hives in a adult female patient who received FLUARIX (batch number AFLUA708BA, expiry date 30th June 2013). Concomitant products included medication unknown. On an unknown date, the patient received FLUARIX. On an unknown date, 2 hrs after receiving FLUARIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. The reporter considered the hives to be possibly related to FLUARIX. Additional details provided: The patient did not seek medical attention. The reporter recommended to contact the patient's allergist for any follow-up.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Off label use, Tachycardia, Throat tightness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hives in a adult female patient who received FLUARIX (batch number AFLUA708BA, expiry date 30th June 2013). Concomitant products included medication unknown. On an unknown date, the patient received FLUARIX. On an unknown date, 2 hrs after receiving FLUARIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. The reporter considered the hives to be possibly related to FLUARIX. Additional details provided: The patient did not seek medical attention. The reporter recommended to contact the patient's allergist for any follow-up.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Pt has sore arm at injection site. Recommended f/u w/ PCP or MD.
Age: 82.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: (L) deltoid pain and inability to raise arm. No swelling, no redness.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging, Seizure like phenomena
Clinical narrative: Patient received intranasal live flu vaccine on 12/3/14. On 12/5/14 or there about began having seizure like activity which has grown progressively worse.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, since 13-NOV-2014 (also reported as since the first call when the reporter asked to evaluate improperly stored vaccines) those patients were possibly vaccinated with an improperly stored doses of ROTATEQ (therapy route defaulted to oral, dose, units, lot number were not reported). No adverse effects reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Extra dose administered
Clinical narrative: Tdap (ADACEL) given to LD on 1/12/15 had previous Tdap on 6/21/2012.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (lot#, expiration date, dose, frequency and route were unknown). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (pharmacy technician) refers to an unspecified number of patients of unknown gender and age. On an unknown dates, the patients have been possibly vaccinated with doses of oral, ROTATEQ (lot/batch numbers, expiration dates, doses, number of doses and frequencies were not reported) that have been improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Blister, Erythema, Injection site induration
Clinical narrative: Erythema, blistering, 30 mm induration at injection site x 96 hours. Antihistamines topical, PO used. Ice applied with relief.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt given incorrect vaccine. Wanted BOOSTRIX and was administered FLUVIRIN PF.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood calcium normal, Blood glucose normal, Eye movement disorder
Clinical narrative: He is 4 month old boy was in office on 1/12/15 afternoon for first dose of immunization which was done 15 min after shots. Was in office no reaction. Next day parents brought him to office around 13:00 on 1/13/15 and mentioned few min before had roll eyes and mouth opened which be pertussis cause seizure on 1/13/15.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Rt upper arm redness, swelling and itching
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unspecified age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown dates, the patients were vaccinated with doses of oral, ROTATEQ (dose, anatomical location, lot# and exp.date were not reported) that were improperly stored. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and ender. On an unknown date those patients were vaccinated with a dose of improperly stored ROTATEQ (therapy route defaulted to oral, dose, units, lot number were not reported). No adverse effects were noted. This is one of several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: I took flu shot two months ago. After 24 hours, my right side of face, eye, and right hand were swollen badly. The swollen slowly came down and vanished after two days. I did not go to see my doctor during this period.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Eye swelling, Peripheral swelling, Swelling face
Clinical narrative: I took flu shot two months ago. After 24 hours, my right side of face, eye, and right hand were swollen badly. The swollen slowly came down and vanished after two days. I did not go to see my doctor during this period.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified infant (gender not reported) who on 17-OCT-2014 was 16 weeks and 14 days and received the first dose of ROTATEQ 2ml oral and the second dose was given on 17-DEC-2014 at age 25 weeks and 2 days. No adverse effects were reported. No other information was provided. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Pallor, Skin discolouration
Clinical narrative: After administration of 2 month vaccines last vaccine administered PCV13, infant was crying and had color change around the mouth to a dusky color, followed by face and turning pale, mucous membranes remained pink, oxygen SATs within normal limit 95%. Provider monitored 30 minutes.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling in arm. Pain steadily increasing in strength and in length of arm - from shoulder to above wrist.
Sex: U
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling arm in several patients who received FLUARIX quadrivalent. On an unknown date, the patient received FLUARIX quadrivalent at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced swelling arm and limbs stiffness. On an unknown date, the outcome of the swelling arm and limbs stiffness were unknown. It was unknown if the reporter considered the swelling arm and limbs stiffness to be related to FLUARIX quadrivalent. Additional information: Several patients at the hospital indicated symptoms of swollen and hard arms after receiving QIV flu vaccine. Per representative, HCP was not sure which GSK vaccine.
Age: 0.3
Sex: F
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of vomiting in a 4-month-old female patient who received ROTARIX (batch number A41FB446A, expiry date 30th January 2016). On 3rd November 2014 15:00, the patient received the 2nd dose of ROTARIX (oral). On 3rd November 2014, 10 min after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was recovered/resolved. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional information received: 4 months old girl administered 2nd dose of ROTARIX, after drinking a lot of milk, and then spit out/vomited. No further information provided.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received FLULAVAL quadrivalent. On an unknown date, the patient received FLULAVAL quadrivalent at an unknown dose. On an unknown date, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to FLULAVAL quadrivalent. Additional information received: Sales rep, phoned in to report that Dr. has been noticing pain, redness and swelling with FLULAVAL QIV. This is all the information that the sales rep had about these AE's.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site rash, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site rash in a 51-year-old female patient who received FLUARIX quadrivalent (batch number 7329G, expiry date 30th June 2015). Previously administered products included flu vaccine with an associated reaction of no adverse event. Concomitant products included PNEUMOVAX. On 1st November 2014, the patient received FLUARIX quadrivalent (injection). On 2nd November 2014, 1 day after receiving FLUARIX quadrivalent, the patient experienced injection site rash, fever, chills and pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site rash, fever, chills and pain were recovering/resolving. The reporter considered the injection site rash, fever, chills and pain to be probably related to FLUARIX quadrivalent. Additional information received: RPh called to report that their patient received the FLUARIX QIV on 11/1/2014 and less than 24 hours later developed fever, chills, body ache, and "apple" sized rash at the injection site. The patient received FLUARIX QIV on the right arm and the rash is also at that injection site on the right arm. The patient also received PNEUMOVAX on that day as well this was given in the left arm. After the onset of symptoms the patient took ibuprofen and the symptoms have improved but has not completely resolved.
Sex: U
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: This case was reported by a other health professional and described the occurrence of Influenza in a patient who received QIV FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced Influenza. On an unknown date, the outcome of the Influenza was unknown. It was unknown if the reporter considered the Influenza to be related to FLUARIX. Additional information: three patients vaccinated with FLUARIX QIV that got the Flu later in the season. MD did not have any further information at this time.
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 54-year-old female patient who received FLULAVAL (batch number unknown, expiry date unknown). Previously administered products included eye drops with an associated reaction of hypersensitivity (to thimerosal because of a reaction she had to some eye drops that contained thimerosal in the past). Concurrent medical conditions included drug allergy (to thimerosal). In 2011, the patient received FLULAVAL (intramuscular). On an unknown date, the dose was an unknown dose. In 2011, an unknown time after receiving FLULAVAL, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved. The reporter considered the generalized rash to be related to FLULAVAL. Additional details provided: Caller reported that she received a flu vaccine 3 years ago, probably the fall of 2011, and she broke out in a full body rash that looked like a sun burn that lasted for 7-10 days. The rash started the evening of receiving the vaccine, or the next evening, and it was all over her body by the morning after the rash started. The flu vaccine she received that year was from a multi-dose vial, so she thought it likely had thimerosal in it. While she had not received any additional flu vaccines since 2011, she has received other vaccines like pneumonia and yellow fever due to the traveling that she did and did not have a reaction to any of those vaccines. She knew that all the vaccines she had received since have been from single dose vials or syringes and do not contain thimerosal.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHEH2014US022012, is an initial spontaneous report received from a health care professional (material's manager) on 31 Oct 2014. This report refers to a 47 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 Oct 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Case number PHEH2014US021992 is an initial spontaneous report received from a consumer (patient) on 29 Oct 2014 with a follow-up report received from a consumer (patient) on 29 Oct 2014. This report refers to a 63-year-old female patient. Her vaccination history included Influenza vaccine (manufacturer and batch number: not reported) 25 years. On 27 Oct 2014, she was vaccinated with FLUVIRIN, (batch number: not reported) at a dose of 0.5 ml intramuscularly. On the same day, after the vaccination, she went to bed with chills, mild fever and then developed a headache. On 28 Oct 2014, she was in bed all day which was unusual for her but she was up and was able to walk around at the time of this report. The outcome of chills, fever and headache was not reported. The seriousness and causality of the events were not reported. Follow up information report received from a consumer (patient) on 29 Oct 2014: Patient demographics (date of birth and age) updated.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: Case number PHEH2014US021993 is an initial spontaneous report received from a consumer (patient's wife) on 29 Oct 2014 with a follow up information report received from a consumer (patient's wife) on 29 Oct 2014. This report refers to a 66 years old male patient. His vaccination history included influenza vaccine (manufacturer and batch number: not reported) at a dose of 0.5 ml intramuscularly. On 28 Oct 2014 evening, he had chills and it was unusual for the patient. The outcome of chills was not reported. The seriousness and causality of the events were not reported. Follow up information report received from a consumer (patient's wife) on 29 Oct 2014: Patient demographics (month and year of birth and age) and vaccination date updated.
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Case number PHEH2014US021997 is an initial spontaneous report received from a pharmacist on 29 Oct 2014. This report refers to a female patient of an unspecified age. Her medical history and concomitant medications were not reported. On an unspecified date, 20 years prior to this report, the patient was vaccinated with FLUVIRIN (batch number: not reported) and developed a rash around the site of administration of FLUVIRIN. The patient thought it was due to a thimerosal allergy. The outcome of the event was not reported. The seriousness and causality of the event were not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Case number PHEH2014US022003 is an initial spontaneous report received from a health care professional on 31 Oct 2014. This report refers to a 54 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 Oct 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Tenderness
Clinical narrative: Case number PHEH2013US024034 is an initial spontaneous report received from a pharmacist on 14 Nov 2013. This report refers to a 25-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly on 22 Oct 2013. On the same day after vaccination, she had a sore arm from the injection site and 9 inches down the arm. The pain was worsened when the arm was raised and was tender. She denied of any redness and swelling. She had been taking EXCEDRIN for pain relief and had not sought any medical care. Outcome of the event was unknown. No seriousness and causality was reported for the events.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2013US023970 is an initial spontaneous report received from a nurse on 13 Nov 2013. This report refers to a 27-years-old pregnant female patient. Her medical history and concomitant medications was not reported. She was vaccinated with an intramuscular dose of FLUVIRIN (batch number: 1308901) from a multi dose vial on 13 Nov 2013. She was 38 weeks pregnant at the time of vaccination and the nurse who administered the vaccine did not know that the patient was pregnant. No adverse events were reported following the maladministration. 24 Feb 2014: Multiple attempts have been made to obtain follow-up information and outcome of pregnancy event without success. This case is considered lost to follow-up.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHEH2014US022011 is an initial spontaneous report received from a health care professional (materials manager) on 31 Oct 2014. This report refers to a 33 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 Oct 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHEH2014US022013, is an initial spontaneous report received from a health care professional (materials manager) on 31 Oct 2014. This report refers to a 35 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 Oct 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2013US024166 is an initial spontaneous report received from a consumer via claim examiner on 18 Nov 2013: This report refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: 1309701 and expiry date: Mar 2014) on 23 Oct 2013 and experienced allergic reaction on an undetermined date. No further information about outcome, seriousness and causality was reported.