chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Bacterial test, Bone pain, Dyspnoea, Fatigue, Full blood count normal
Clinical narrative: Pt described considerable exhaustion within 30 - 45 minutes of getting the vaccine followed by headache, pain at the site of vaccine and by the early evening started having shortness of breath that was concerning enough that she contacted 911 and a medic came to evaluate her at her home, she was not taken to the ED. 72 hours later (today) she continues to have headache, some throat pain, considerable fatigue and now complains of bone pain in her thighs.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Influenza virus test negative, Metabolic function test normal, Oropharyngeal pain, Streptococcus test positive
Clinical narrative: Pt described considerable exhaustion within 30 - 45 minutes of getting the vaccine followed by headache, pain at the site of vaccine and by the early evening started having shortness of breath that was concerning enough that she contacted 911 and a medic came to evaluate her at her home, she was not taken to the ED. 72 hours later (today) she continues to have headache, some throat pain, considerable fatigue and now complains of bone pain in her thighs.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Vaccination site pain
Clinical narrative: Pt described considerable exhaustion within 30 - 45 minutes of getting the vaccine followed by headache, pain at the site of vaccine and by the early evening started having shortness of breath that was concerning enough that she contacted 911 and a medic came to evaluate her at her home, she was not taken to the ED. 72 hours later (today) she continues to have headache, some throat pain, considerable fatigue and now complains of bone pain in her thighs.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Immediate post-injection reaction, Skin warm, Swelling
Clinical narrative: Patient received the FLUZONE quad vaccine. She immediately had a reaction such as a bruise and swelling and warm to touch.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Adverse reaction, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Shots were administered, 10/13/17 at 3:55 PM. Pt began experiencing adverse reactions at 9 AM 10/14/2017 including: redness, warmth and swelling beginning 3-4 inches below injection site, running the length of the arm and total circumference of the arm and ending at the elbow. Pt also experienced total body aches and fever beginning 9 AM 10/14/17. Symptoms continued until this date and time with some improvement of all symptoms. Pt has been treating symptoms with ibuprofen and ALEVE. Pt was instructed to continue to monitor symptoms and reach out to PCP via phone to update records and discuss additional treatment. Will follow-up with pt tomorrow.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Hypophagia
Clinical narrative: 30 minutes after injection, arm started to swell and get red, and hot at injection site. That evening, heat and ring grew to 5 inch circle and swelled to about golf-ball size. Slight headache. Next morning, woke up tired, not feeling well. By 1pm arm swelled to soft-ball in size as did redness which became darker red and began to itch. (have picture) Throat scratchy. No fever by head reading but arm reading was 101.3 (where redness was) and circle enlarged and became more oval almost down to my elbow. Next morning woke extreme nausea, red arm still hot, still swollen. Chills all day, never vomited, just couldn't drink or eat anything. Next morning called Dr. Office and reported in. Same symptoms all day. Ice was applied to arm all days. Saturday had more headache than before, tired.  Arm began to go down in swelling and redness. Slight fever and diarrhea all day. Sunday still tired but was able to eat crackers. By evening redness gone, swelling gone. Woke this morning feeling nearly 'normal'.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: 30 minutes after injection, arm started to swell and get red, and hot at injection site. That evening, heat and ring grew to 5 inch circle and swelled to about golf-ball size. Slight headache. Next morning, woke up tired, not feeling well. By 1pm arm swelled to soft-ball in size as did redness which became darker red and began to itch. (have picture) Throat scratchy. No fever by head reading but arm reading was 101.3 (where redness was) and circle enlarged and became more oval almost down to my elbow. Next morning woke extreme nausea, red arm still hot, still swollen. Chills all day, never vomited, just couldn't drink or eat anything. Next morning called Dr. Office and reported in. Same symptoms all day. Ice was applied to arm all days. Saturday had more headache than before, tired.  Arm began to go down in swelling and redness. Slight fever and diarrhea all day. Sunday still tired but was able to eat crackers. By evening redness gone, swelling gone. Woke this morning feeling nearly 'normal'.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pyrexia, Throat irritation
Clinical narrative: 30 minutes after injection, arm started to swell and get red, and hot at injection site. That evening, heat and ring grew to 5 inch circle and swelled to about golf-ball size. Slight headache. Next morning, woke up tired, not feeling well. By 1pm arm swelled to soft-ball in size as did redness which became darker red and began to itch. (have picture) Throat scratchy. No fever by head reading but arm reading was 101.3 (where redness was) and circle enlarged and became more oval almost down to my elbow. Next morning woke extreme nausea, red arm still hot, still swollen. Chills all day, never vomited, just couldn't drink or eat anything. Next morning called Dr. Office and reported in. Same symptoms all day. Ice was applied to arm all days. Saturday had more headache than before, tired.  Arm began to go down in swelling and redness. Slight fever and diarrhea all day. Sunday still tired but was able to eat crackers. By evening redness gone, swelling gone. Woke this morning feeling nearly 'normal'.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: Chills accompanied by throbbing pain in shoulders, back, legs, arms plus headache and extreme fatigue and lethargy which lasted until 4:30 p.m. 10/14/2017. ADVIL reduced the pain, but the lethargy continued with no appetite.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Musculoskeletal pain, Pain in extremity
Clinical narrative: Chills accompanied by throbbing pain in shoulders, back, legs, arms plus headache and extreme fatigue and lethargy which lasted until 4:30 p.m. 10/14/2017. ADVIL reduced the pain, but the lethargy continued with no appetite.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient called on 10-14-17 around 11 am with complaints of swollen left arm, approximately 2 inches below the injection site. She said it was swollen, red and itchy. I suggested she take 650 mg of TYLENOL every 6 hours, apply a cold compress for 15 minutes 4 times a day, and take 25-50 mg of BENADRYL 3-4 times a day to reduce the itching reaction. I spoke with her at 3:15 pm on 10-16-17 and she said she has been following these instructions and it is getting better but not quite resolved and that she will continue these recommendations. She said she did not feel like she needed to contact her doctor at this time. She did mention on 10-16-17 that it had been swollen the size of a baby grapefruit when she called on 10-14-17 but she had not mentioned that initially. She said it is just slightly red and swollen now.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Lip swelling, Pain in extremity
Clinical narrative: Initial unsolicited report received from nurse via pharmacist on 03 Oct 2017. This case is linked with 2017SA195908 and 2017SA195913 (Same lot number). This case involves female patient (Age was not reported and reporter thinks that gender was female) who was vaccinated with a dose of FLUZONE QIV (batch number: UT5936LA, expiry date: 30 Jun 2018, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination patient had lips swollen, numbness and pain in arm radiating to under arm. Laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash
Clinical narrative: Initial unsolicited report received from a nurse on 03-Oct-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route and site of administration were not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced shortness of breath and a rash. The patient's laboratory data and corrective treatment were not reported. The event's outcome was not reported. List of documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt in the evening on day of Immunization felt chills, aches, and run down and pain in his arm - so he went to walk in/ER and got LEVAQUIN, then next day couldn't move, so he got doxy from another MD at hospital, then week later got AUGMENTIN and Prednisone - pt. had a swollen red hot sore arm around pneumonia shot - very painful - MD thought at 1st cellulitis, then Lyme disease, then pneumonia.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt in the evening on day of Immunization felt chills, aches, and run down and pain in his arm - so he went to walk in/ER and got LEVAQUIN, then next day couldn't move, so he got doxy from another MD at hospital, then week later got AUGMENTIN and Prednisone - pt. had a swollen red hot sore arm around pneumonia shot - very painful - MD thought at 1st cellulitis, then Lyme disease, then pneumonia.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, and warmth to right arm. Patient treated with Prednisolone and Cetirizine.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Patient broke out in rash extending from arm to rest of body. Patient went to ER 3 days later and received RX for prednisone.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Both injections given in same arm. Patient returns 2 days later with prescription for clindamycin, states she has developed cellulitis.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation
Clinical narrative: Patient given both injections in same arm, now complaining of inflammation.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema
Clinical narrative: Patient describes still having a red spot at injection site.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Depressed level of consciousness, Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: After it was administered, her upper extremities became stiff, flexed. She lost consciousness, eyes rolled back into her head. Her upper extremities started shaking. LOC x approx 1 minute. Once she woke up she was oriented, answering appropriately but not alert. Hands were clammy +palor. C/o nausea, especially when standing up. EMS arrived shortly thereafter and pt was transported to Dr. and ER.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pallor, Tremor
Clinical narrative: After it was administered, her upper extremities became stiff, flexed. She lost consciousness, eyes rolled back into her head. Her upper extremities started shaking. LOC x approx 1 minute. Once she woke up she was oriented, answering appropriately but not alert. Hands were clammy +palor. C/o nausea, especially when standing up. EMS arrived shortly thereafter and pt was transported to Dr. and ER.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Employee had lightheadedness approx. 5 minutes after injection.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at immunization site.
Age: 93.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Muscular weakness, Pneumonia, Urinary tract infection
Clinical narrative: Chills, Weak Muscles started about 2 days after vaccination. Significant. Pt went to hospital.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Productive cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Pt began feeling sick the day after the shot. became very congested, productive cough, fever. Took a day off of work and weekend to recover. Has since recovered today (10/16/17).
Age: 57.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: The FLUAD (over 65 dose) of flu vaccine was inadvertantly five to patient who is 56 years old.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: Swelling, fever, rash (both arms, legs and torso). Rash still present 5 days after the vaccination.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Lymphadenopathy, Pain
Clinical narrative: Pt had right arm erythema, and induration along with swollen axillary lymph nodes and pain with movement of right arm.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Liquid part of PENTACEL was given in error to patient. No adverse reaction was noted.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema multiforme, Rash
Clinical narrative: 2 hours after receiving the vaccine the patient started with a rash on the extremities which has spread to the trunk despite use of BENADRYL. He had no cough, wheezing, respiratory symptoms. The rash appears consistent with erythema multiforme.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Swelling
Clinical narrative: Had swelling in the arm after one of giving the shot, slight redness and swollen.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received FLUZONE Quad 2017-2018 vaccination at our pharmacy on 10/11/17 around 5:30pm. The patient came into the pharmacy 2 days later  (10-13-17) to pick up a prescription for Keflex, when she told the pharmacist that it was for a reaction to the FLUZONE Quad she received here. The patient stated the injection site started to turn a little red and was a little smaller than the size of her thumb the morning after (10/12/17). Then by 10/13/17, it had turned into a 3-inch circumference area that was reddened, slightly swollen, warm to touch, with slight burning sensation, but no itching occurred. No hospitalization occurred. The patient contacted her physician, who was unsure if it was an allergic reaction or possible cellulitis. The physician called in Keflex 500 mg to take for the reaction which the patient picked up on 10/13/17 and was when the pharmacy was notified. A follow-up call today was made to the patient who said her injection site was "much better" and "almost cleared up".
Age: 13.0
Sex: F
Vaccine: FLUR3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: RN gave patient FLUBLOK who is under 18. Pt is allergic to eggs and RN grabbed the box that had a sticker that said "Egg free product" over the warning label that states 18 and older. Pt is 13.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Musculoskeletal stiffness
Clinical narrative: Red irritation around injection site and patient complains of stiffness along the left side of her neck.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: Dizziness, blurred vision, nausea  within 15 minutes and lasting approximately 7-9 hours. Symptoms improved within 2 hours after dose of 10mg cetirizine.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Chest discomfort, Dyspnoea, Erythema, Swelling
Clinical narrative: Chest tightness w/ mild difficulty breathing, erythema, swelling > 24 hours after immunization.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4, FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm is in severe pain a month later.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4, FLUX
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Wrong technique in product usage process
Clinical narrative: Arm is in severe pain a month later.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Pruritus, Skin injury
Clinical narrative: Patient reported she had received a flu shot on 10/09/2017 and had no adverse effects until 10/15/17 morning. She described itching which lead to scratching and as a result of fingernails lead to scratches. Patient stated she felt a knot for the first time on 10/15/2017. Patient stated she had begun taking diphenhydramine for 2 doses on 10/15/17. Recommended pt to utilize ice on area and contact doctor.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Pt. had erythema 5.5 x 5 cm diameter with minimal pruritus that started the day after vaccine was given. Rash is now spreading to arm.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Rash, Vaccination complication
Clinical narrative: Rash, fever Dr. feels reaction is to Rotavirus vaccine.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dreamy state, Dysphagia, Lethargy, Pharyngeal oedema
Clinical narrative: Patient described feeling very dizzy and in a dream like state. Patient states felt like she was dreaming in the middle of the night that her throat was swelling shut and her husband informed her she was actually awake. She said she was unable to get off the couch for 3 days, felt very dizzy and felt unable to swallow.
Age: 73.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity
Clinical narrative: Lingering arm pain four weeks post injection in both arms.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Limb discomfort, Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: On the day I got the vaccine I felt a little pain. By the second day I wasn't able to move my arm, it was a strong pain so I took Advil. I wasn't able to move my arm without feeling pain for about one week.  Within the next days I was slowly able to move my arm, but the pain persisted. My arm feels fatigued, heavy and weak. My fingers fingers feel as if they at asleep. I also feel lots of pain in the area I received the vaccine. I feel a sharp pain all over my shoulder every time I move my arm.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Vaccination site pain
Clinical narrative: On the day I got the vaccine I felt a little pain. By the second day I wasn't able to move my arm, it was a strong pain so I took Advil. I wasn't able to move my arm without feeling pain for about one week.  Within the next days I was slowly able to move my arm, but the pain persisted. My arm feels fatigued, heavy and weak. My fingers fingers feel as if they at asleep. I also feel lots of pain in the area I received the vaccine. I feel a sharp pain all over my shoulder every time I move my arm.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Limb discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: On the day I got the vaccine I felt a little pain. By the second day I wasn't able to move my arm, it was a strong pain so I took Advil. I wasn't able to move my arm without feeling pain for about one week.  Within the next days I was slowly able to move my arm, but the pain persisted. My arm feels fatigued, heavy and weak. My fingers fingers feel as if they at asleep. I also feel lots of pain in the area I received the vaccine. I feel a sharp pain all over my shoulder every time I move my arm.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Paraesthesia, Peripheral swelling
Clinical narrative: About 45 minutes after receiving vaccination patient return and stated that her arm was swelling and she had a pins and needles feeling. The said the injection site was a little tinder. Upon checking there was no redness or warmth of the site. Check with the patient at 12:40pm and she state that if felt about the same. Attempted to contact patient at 8pm without success.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Aphasia, Borrelia test negative, CSF glucose normal, CSF lymphocyte count increased, CSF monocyte count decreased
Clinical narrative: Patient initially presented with a seizure after a soccer game, then proceeded to have 3 more seizures, followed by aphasia, difficulty using right hand. Initial MRI showed a 0.8 mm deep white matter lesion, likely demyelinating.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: CSF protein normal, CSF white blood cell count increased, Chest X-ray normal, Cytomegalovirus test negative, Demyelination
Clinical narrative: Patient initially presented with a seizure after a soccer game, then proceeded to have 3 more seizures, followed by aphasia, difficulty using right hand. Initial MRI showed a 0.8 mm deep white matter lesion, likely demyelinating.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Epstein-Barr virus test negative, Immunoglobulin therapy, Laboratory test normal, Musculoskeletal disorder, Mycoplasma test positive
Clinical narrative: Patient initially presented with a seizure after a soccer game, then proceeded to have 3 more seizures, followed by aphasia, difficulty using right hand. Initial MRI showed a 0.8 mm deep white matter lesion, likely demyelinating.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal normal, Reading disorder, Seizure, Speech disorder
Clinical narrative: Patient initially presented with a seizure after a soccer game, then proceeded to have 3 more seizures, followed by aphasia, difficulty using right hand. Initial MRI showed a 0.8 mm deep white matter lesion, likely demyelinating.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound abdomen normal, White matter lesion
Clinical narrative: Patient initially presented with a seizure after a soccer game, then proceeded to have 3 more seizures, followed by aphasia, difficulty using right hand. Initial MRI showed a 0.8 mm deep white matter lesion, likely demyelinating.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Chest pain, Dyspnoea, Electrocardiogram normal, Injection site pain
Clinical narrative: Prescription for PREVNAR-13 was sent from Dr. to our pharmacy on 10/10/17. Patient came to pharmacy on 10/16/17 to receive vaccine. Patient reports that she had pain at the injection site beginning at 8pm on the evening of the vaccine 10/12/17. She states she then had a lot of pain through the weekend, Friday, Saturday and Sunday. On Sunday she reports that she had a welt and the site of the injection was hot. At 8pm on Sunday 10/15/17 patient states "her chest started hurting and she had a hard time breathing". She describes the pain as "being a sharp pain on the back of her shoulder blade, circling internally". She states that it reminded her of the pain of when she had fluid in her lung. She took her temperature Sunday 10/15/17 and it was 99.9 degrees F. She went to the emergency room at 11:30am on 10/16/17 and called our pharmacy. She had a complete cardiac workup and was discharged. I received a copy of the discharge summary stating "shoulder pain and chest pain of uncertain etiology".
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site warmth, Laboratory test normal, Musculoskeletal pain, Urticaria
Clinical narrative: Prescription for PREVNAR-13 was sent from Dr. to our pharmacy on 10/10/17. Patient came to pharmacy on 10/16/17 to receive vaccine. Patient reports that she had pain at the injection site beginning at 8pm on the evening of the vaccine 10/12/17. She states she then had a lot of pain through the weekend, Friday, Saturday and Sunday. On Sunday she reports that she had a welt and the site of the injection was hot. At 8pm on Sunday 10/15/17 patient states "her chest started hurting and she had a hard time breathing". She describes the pain as "being a sharp pain on the back of her shoulder blade, circling internally". She states that it reminded her of the pain of when she had fluid in her lung. She took her temperature Sunday 10/15/17 and it was 99.9 degrees F. She went to the emergency room at 11:30am on 10/16/17 and called our pharmacy. She had a complete cardiac workup and was discharged. I received a copy of the discharge summary stating "shoulder pain and chest pain of uncertain etiology".
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, swelling, redness at injection side encompassing 13.5 x 13.5 cm and lasting 6 days at time of reporting.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Fall, Head injury, Headache, Hunger
Clinical narrative: Patient received the vaccines and then walked to the reception desk with mother. Patient was leaning over the counter then fell forward hitting forehead on glass of reception area. Patient then stood up straight for a second before collapsing backwards. Code Blue was called. Provider then ordered patient back to exam room to watch vitals. Patient stayed in office for 30 minutes to be monitored. Patient noted headache, lightheadedness, and being hungry. Patient was give small cup of Grape Fanta and felt better after. Mother was given ER precautions and to bring patient back in 24hrs to check status.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Cough, Dizziness, Fatigue, Flushing
Clinical narrative: A few hours after the shot, I had normal localized pain but began to feel pain in my armpit of the same arm I was vaccinated in, my left arm. When I woke in the morning, the pain was very intense and ended up taking taking 2 Advil for pain relief. I also had the normal cold like symptoms such as a headache, grogginess, small cough, and fatigue. The pain persisted throughout the day. The morning of the 13th, I woke up to a ready, itchy rash on my chin and on the tops of both of my hands. My face appeared to be constantly flushed the entire day while I felt a bit woozy. The FNP I saw in the clinic stated that I appeared to be blotchy all over. The pain in my arm pit had increased to the point where I struggled to raise my arm to put my hair up in a pony tail; I took a naproxen to help. Earlier that morning I attempted to examine my armpits to look and feel if my lymph nodes appeared to be swollen as I knew it wasn't a muscular pain - I believed my left under arm lymph nodes to be swollen. The FNP gave me prednisone for the rash.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Headache, Injection site pain, Lymphadenopathy, Nasopharyngitis
Clinical narrative: A few hours after the shot, I had normal localized pain but began to feel pain in my armpit of the same arm I was vaccinated in, my left arm. When I woke in the morning, the pain was very intense and ended up taking taking 2 Advil for pain relief. I also had the normal cold like symptoms such as a headache, grogginess, small cough, and fatigue. The pain persisted throughout the day. The morning of the 13th, I woke up to a ready, itchy rash on my chin and on the tops of both of my hands. My face appeared to be constantly flushed the entire day while I felt a bit woozy. The FNP I saw in the clinic stated that I appeared to be blotchy all over. The pain in my arm pit had increased to the point where I struggled to raise my arm to put my hair up in a pony tail; I took a naproxen to help. Earlier that morning I attempted to examine my armpits to look and feel if my lymph nodes appeared to be swollen as I knew it wasn't a muscular pain - I believed my left under arm lymph nodes to be swollen. The FNP gave me prednisone for the rash.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular, Rash pruritic, Somnolence, Vaccination site movement impairment
Clinical narrative: A few hours after the shot, I had normal localized pain but began to feel pain in my armpit of the same arm I was vaccinated in, my left arm. When I woke in the morning, the pain was very intense and ended up taking taking 2 Advil for pain relief. I also had the normal cold like symptoms such as a headache, grogginess, small cough, and fatigue. The pain persisted throughout the day. The morning of the 13th, I woke up to a ready, itchy rash on my chin and on the tops of both of my hands. My face appeared to be constantly flushed the entire day while I felt a bit woozy. The FNP I saw in the clinic stated that I appeared to be blotchy all over. The pain in my arm pit had increased to the point where I struggled to raise my arm to put my hair up in a pony tail; I took a naproxen to help. Earlier that morning I attempted to examine my armpits to look and feel if my lymph nodes appeared to be swollen as I knew it wasn't a muscular pain - I believed my left under arm lymph nodes to be swollen. The FNP gave me prednisone for the rash.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Eyelid oedema, Swelling face
Clinical narrative: Patient states that she has experienced swelling of the left side of face and very lumpy. That her eyes are almost swollen shut.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: High temperature (up to 102 degrees ), redness/swelling of arm all the way down to elbow soreness.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Chest X-ray normal, Computerised tomogram normal, Eye contusion, Eye swelling, Haemorrhage
Clinical narrative: After getting both shots on my left arm, the nurse said "okay you're good"  and allowed me to walk out. About 2 minutes of walking out the door, i sat on a post because i felt nauseous I then fainted on my right side. I was out for about 20-30 seconds and woke up in a pile of blood. The nurse who saw me on the floor denied to call 911 twice. After 30 minutes the doctor of the office called 911. The EMT took me to the hospital after 1 hour of the incident. I got 7 stitches inside and outside my mouth, a swollen, black eye, neck pain on my left side, constant migraines, and a messed up front right tooth . I got out of the hospital after 5 hours.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Migraine, Nausea, Neck pain, Spinal X-ray normal, Suture insertion
Clinical narrative: After getting both shots on my left arm, the nurse said "okay you're good"  and allowed me to walk out. About 2 minutes of walking out the door, i sat on a post because i felt nauseous I then fainted on my right side. I was out for about 20-30 seconds and woke up in a pile of blood. The nurse who saw me on the floor denied to call 911 twice. After 30 minutes the doctor of the office called 911. The EMT took me to the hospital after 1 hour of the incident. I got 7 stitches inside and outside my mouth, a swollen, black eye, neck pain on my left side, constant migraines, and a messed up front right tooth . I got out of the hospital after 5 hours.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope, Tooth injury
Clinical narrative: After getting both shots on my left arm, the nurse said "okay you're good"  and allowed me to walk out. About 2 minutes of walking out the door, i sat on a post because i felt nauseous I then fainted on my right side. I was out for about 20-30 seconds and woke up in a pile of blood. The nurse who saw me on the floor denied to call 911 twice. After 30 minutes the doctor of the office called 911. The EMT took me to the hospital after 1 hour of the incident. I got 7 stitches inside and outside my mouth, a swollen, black eye, neck pain on my left side, constant migraines, and a messed up front right tooth . I got out of the hospital after 5 hours.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Insomnia, Joint range of motion decreased, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: I had NO reaction to the vaccine. What I have is extreme soreness and pain as the shot was given at the very top of my arm at the shoulder joint. I cannot do any of my usual chores, I cannot sleep at night. I am in pain (day 14) with no end in sight. My range of motion is severely limited and my arm aches and throbs. I never take pain meds, but have been taking about 6 aspirin a day to help control the pain. I have a high pain threshold usually. I called the pharmacist and he didn't care. I was seen by a G.P who told me to try moving my arm more. That seriously intensified the pain, so I'm now resting it as much as possible.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nerve injury, Pain
Clinical narrative: I had NO reaction to the vaccine. What I have is extreme soreness and pain as the shot was given at the very top of my arm at the shoulder joint. I cannot do any of my usual chores, I cannot sleep at night. I am in pain (day 14) with no end in sight. My range of motion is severely limited and my arm aches and throbs. I never take pain meds, but have been taking about 6 aspirin a day to help control the pain. I have a high pain threshold usually. I called the pharmacist and he didn't care. I was seen by a G.P who told me to try moving my arm more. That seriously intensified the pain, so I'm now resting it as much as possible.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nodule, Peripheral swelling
Clinical narrative: PT STATED THAT BOTH SHOTS HURT UPON ADMINISTRATION (WHICH THEY HAVE NOT DONE IN THE PAST). ALSO THE VACCINATOR USED THE INJECTION SITE BARRIER BANDAGES WHICH HAVE NOT BEEN USED ON HER BEFORE (LATEX ALLERGY). SHE CALLED AT ABOUT 8:17 AND STATED THAT BOTH ARMS WERE SWOLLEN AND HAD A HARD KNOT ON BOTH. SHE SAID THAT IT HURT TO MOVE EITHER ARM. I ASKED IF TAKEN IBUPROFEN AND SHE SAID THAT SHE COULDN'T TAKE IT DUE TO ULCER. I TOLD HER TO PUT ICE ON BOTH ARMS AND TAKE A BENADRYL. I THEN CALLED THE MANUFACTURER OF THE BARRIER BANDAGES TO SEE IF THEY HAD LATEX IN THEM.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: RED, HARDENED SKIN NOTED ON RIGHT DELTOID AREA, PT STATES THAT THIS WAS RESULT OF VACCINE GIVEN.
Age: 24.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Syncope, sweating, paleness.
Age: 24.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Deafness, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Syncope, sweating, paleness.
Age: 24.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nausea, Sluggishness
Clinical narrative: Syncope, sweating, paleness.
Age: 24.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: After receiving the shot I immediately began to feel lightheaded and could not hear. I informed the pharmacist who had me sit and tested my vision. I felt very sluggish, but was able to follow his hands. He left momentarily to talk with another pharmacist at which point I began to feel very nauseous and lost consciousness. My husband stopped me from falling out of my chair and the pharmacists instructed him to lay me down. They took my pulse and saw I was still breathing and then approximately 20 seconds later I came to. The pharmacists gave me ice packs as I was sweating profusely and I began to be able to hear again and was very aware that I was laying on the floor in the middle of a grocery store. We waited 15 minutes before leaving the store and I feel 100% fine at this moment in time. I had the flu shot last year and many times as a child and have never had this reaction before.
Age: 24.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Deafness, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: After receiving the shot I immediately began to feel lightheaded and could not hear. I informed the pharmacist who had me sit and tested my vision. I felt very sluggish, but was able to follow his hands. He left momentarily to talk with another pharmacist at which point I began to feel very nauseous and lost consciousness. My husband stopped me from falling out of my chair and the pharmacists instructed him to lay me down. They took my pulse and saw I was still breathing and then approximately 20 seconds later I came to. The pharmacists gave me ice packs as I was sweating profusely and I began to be able to hear again and was very aware that I was laying on the floor in the middle of a grocery store. We waited 15 minutes before leaving the store and I feel 100% fine at this moment in time. I had the flu shot last year and many times as a child and have never had this reaction before.
Age: 24.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nausea, Sluggishness
Clinical narrative: After receiving the shot I immediately began to feel lightheaded and could not hear. I informed the pharmacist who had me sit and tested my vision. I felt very sluggish, but was able to follow his hands. He left momentarily to talk with another pharmacist at which point I began to feel very nauseous and lost consciousness. My husband stopped me from falling out of my chair and the pharmacists instructed him to lay me down. They took my pulse and saw I was still breathing and then approximately 20 seconds later I came to. The pharmacists gave me ice packs as I was sweating profusely and I began to be able to hear again and was very aware that I was laying on the floor in the middle of a grocery store. We waited 15 minutes before leaving the store and I feel 100% fine at this moment in time. I had the flu shot last year and many times as a child and have never had this reaction before.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Cellulitis- warm red and tender to the touch 24 hours post injection.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Peripheral swelling, Rash
Clinical narrative: Patient called two days later saying her arm swelled up from shoulder to elbow. Next day didn't go down at all. Sunday 10/15/17 she woke up in the morning and both eyes swollen and rash on arms, as well as face. She saw Dermatologist who prescribed Triamcinolone and Hydrocortisone cream for rash area. I talked with the clinician and she didn't know if it was the vaccine but felt I should submit this form. Patient has had the FLUZONE for the last 3 years here at our pharmacy with no problems ever.
Age: 54.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Blood test, Computerised tomogram, Facial paralysis, Nuclear magnetic resonance imaging
Clinical narrative: Bell's palsy diagnosis.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphemia
Clinical narrative: Mother of child reports approx 5 days after child received the varicella vaccination, child developed stuttering that lasted 1-2 weeks. Child was seen by a naturopath who put him on a homeopathic protocol. Mother states child is better but still has a little bit of stuttering now and then.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Malaise, Nausea, Pain, Pruritus
Clinical narrative: Woke up 10-3-17 very sick, fever, nauseated. Couldn't get out of bed all day. The rest of the week I felt nauseated, itchy, wheezing when I would take a breath. I took ADVIL to help with the pain.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Woke up 10-3-17 very sick, fever, nauseated. Couldn't get out of bed all day. The rest of the week I felt nauseated, itchy, wheezing when I would take a breath. I took ADVIL to help with the pain.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: About 90 minutes after injection, developed headache worsening over the course of the day - body aches and low grade fever. Took ibuprofen 800 and felt some relief but went home and went to bed. Better the next day but took another dose of NSAID. Of course, arm is sore, but no site reaction.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Neck pain, Nerve compression, Pyrexia
Clinical narrative: Neck pain felt like a pinched nerve couldn't turn to the right. Fever 101.4. Took ADVIL and kepta heating pad on my neck.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain in extremity
Clinical narrative: Patient couldn't sleep at night because of the pain and inflammation in arm. He put his arm in cold water to relieve pain. It got a little better but still some redness and inflammation exists.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Pain, Rash macular, Swelling
Clinical narrative: Injection given in right arm. Mom reports swelling and pain 24hrs following injection. Blotchy red patches appear around area of injection.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Fatigue, Injection site pain, Malaise, Mobility decreased
Clinical narrative: Pain at injection site, could not lift arm at 7:30 PM on 10-13-17. Overnite on 10/13/17 I developed fever and chills, temperature 100.1. On 10-14-17, same sorenss, temperature and chills, fever hitting 100.4. General fatigue, malaise, and myalgia. On 10-15-17 symptoms somewhat improved.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Pain at injection site, could not lift arm at 7:30 PM on 10-13-17. Overnite on 10/13/17 I developed fever and chills, temperature 100.1. On 10-14-17, same sorenss, temperature and chills, fever hitting 100.4. General fatigue, malaise, and myalgia. On 10-15-17 symptoms somewhat improved.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction with getting this immunization.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Erythema, Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: 9/22/17 Received FLUCELVAX Quadrivalent Lot # 195212 in Right Deltoid IM felt soreness with lump at injection site over next 2 days-had this this type of soreness in past. Noted Wednesday 10/11/17 lump and bruising not going away today 10/16/17. Noted redness and discomfort in knee joints. 10/16/17 Reported through Employee's Worker's Comp claim for direction to medical.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Pt. developed red raised rash around injection site.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Oedema, Skin warm
Clinical narrative: Localized reaction to flu shot. 3 inch area of erythema with mild edema and warmth.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Lip swelling, Rash
Clinical narrative: Pt. given varicella vaccine on 9-7-17. She reported developing a mild rash on arm of injection, and lip swelling 24 hours after vaccine given. Swelling lasted 2 days with pt. taking BENADRYL for symptoms.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Back pain, Dizziness, Dysstasia, Feeling hot
Clinical narrative: Gave flu shot and patient had symptoms immediately shooting pain across middle of back, lower back spasms, felt like fainting, flushing head, head, back spasms-lower, couldn't stand-very weak.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Flushing, Immediate post-injection reaction, Muscle spasms, Pain
Clinical narrative: Gave flu shot and patient had symptoms immediately shooting pain across middle of back, lower back spasms, felt like fainting, flushing head, head, back spasms-lower, couldn't stand-very weak.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Arm stated to itch, became red and hot. BENADRYL taken P.O.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Approximately 2 hrs after PNEUMOVAX in right arm unable to move, bend or stretch arm without significant pain, swollen a lot, also became hot. Lasted 3 days significantly till subsided slowly.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pt's night arm was in a lot of pain in the evening of vaccination. By next day, it was swollen and itchy. At 6:30pm on Friday (10/18/17). the entire arm from shoulder to elbow was swollen 6 inches length, and warm to touch.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received FLUARIX QUADRIVALENT (batch number 77R93, expiry date 30th June 2018) and (batch number 34RE5, expiry date 30th June 2018). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On an unknown date, 5 min after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, and injection site erythema were not recovered/not resolved. The reporter considered the injection site pain, injection site swelling and injection site erythema to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by Medical Assistant. The health care professional reported the patient had injection site reactions after receiving FLUARIX. The symptoms reported included pain, swelling, and redness the size of a half dollar. No patient information was available. This was 1 of 4 cases as reported by same reporter for same events.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Large area of warmth, redness, swelling started on 10/14 (small area redness) then enlarging. Was seen on 10/16/17 and treated for cellulitis with cefadroxil.
Sex: U
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Product quality issue, Syringe issue, Wrong technique in product usage process
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a patient who received FLULAVAL QUADRIVALENT. This case was associated with pharmaceutical product complaint. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), wrong injection technique, syringe leak and pharmaceutical product complaint. On an unknown date, the outcome of the anaphylactic reaction, wrong injection technique, syringe leak and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient had to receive the shot three times (due to leakage), which led to wrong injection technique. The patient developed an unspecified anaphylactic reaction although they received the flu vaccine yearly. This case was associated with pharmaceutical product complaint. No further information was reported regarding the event.