chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient vomited 1 time that evening, approximately 7 hours after administration of the flu vaccine. Had no other signs of illness. Mom reported that patient was "fine" the next day but wanted reported to VAERS.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Gait disturbance, Hyperhidrosis
Clinical narrative: Sweats, very fatigue could not hardly walk, chills from time of shot at 2:40pm till about 5:00pm when these symptoms developed.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Atrial fibrillation, Pain in extremity, Pyrexia
Clinical narrative: Pt complained of high fever. Pain in arms and legs. Atrial fibrillation went to ER. Weakness.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Seizure, Tremor
Clinical narrative: Patient said that the same night while sleeping he woke up with "convulsions"/shaking/chill and had a fever of 101 (his usual is 97) - he was scared enough to almost call the ambulance but did not. He was fine when he woke up in the morning.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient became dizzy, feeling like she might faint within 5 minutes of administration. Nausea and 1 episode of vomiting followed at 15 minutes after administartion.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Contraindication to vaccination, Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site swelling
Clinical narrative: Pt said her endocrinologist told her NOT to get the HD vaccine. Gave an injection into left arm but the needle/syringe leaked significantly at the hub. Then gave one in the Right arm. It immediately swelled and bleed. Pt was on clopidogrel for blood thinning. Bleeding stopped quickly. Paitent's arm was checked 15 minutes later. The swelling had gone down significantly, but still a little swollen. Also had some light bruising. Patient felt fine and went home.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: Pt said her endocrinologist told her NOT to get the HD vaccine. Gave an injection into left arm but the needle/syringe leaked significantly at the hub. Then gave one in the Right arm. It immediately swelled and bleed. Pt was on clopidogrel for blood thinning. Bleeding stopped quickly. Paitent's arm was checked 15 minutes later. The swelling had gone down significantly, but still a little swollen. Also had some light bruising. Patient felt fine and went home.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported signs and symptoms of swelling, redness, tenderness and painful of the arm in which the vaccine was injected.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient reported signs and symptoms of swelling, redness, tenderness and painful of the arm in which the vaccine was injected.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Impaired work ability, Pain, Pain in extremity
Clinical narrative: Got sore arm and pounding headache in one hour. Up at midnight vomiting feverish with total body aches. My legs have never hurt so bad also felt slightly SOB. 10/3 was able to start very light food. Tried to work 10/4 but left early as still getting flash fevers. Returned to work 10 / 8 but still only feeling about 80 percent recovered.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Got sore arm and pounding headache in one hour. Up at midnight vomiting feverish with total body aches. My legs have never hurt so bad also felt slightly SOB. 10/3 was able to start very light food. Tried to work 10/4 but left early as still getting flash fevers. Returned to work 10 / 8 but still only feeling about 80 percent recovered.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported extreme tenderness the evening after the vaccination. Over Friday, Saturday and Sunday, the patient reports that her arm has swollen significantly and is still very tender. She also reports that the skin of her arm is hot to the touch. The redness and swelling seems to be most prominent around the site of injection, but she states the whole upper arm area is affected.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Soreness/limited range of motion.
Age: 52.0
Sex: F
Vaccine: FLU4, HEPAB, MMR, MNQ, TDAP
Symptoms: Contraindication to vaccination, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient is on ACTEMRA for RA and should not have received any live vaccines, the patient did not report any symptoms from MMR vaccine. However, since the patient received 4 vaccines in one arm, patient has stated its been more than a month and her arm is swollen, sore, painful, and hard for her to lift her arm up.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling
Clinical narrative: Arm was swollen the size of his palm where he received his PREVNAR vaccination.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia, Urticaria
Clinical narrative: A Fever of 100-104 that lasted five days. On the sixth day she broke out in hives on her back, chest and face. Hives lasted roughly five days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, headache. Total time I was sick was 36 hours.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Arrhythmia, Blood thyroid stimulating hormone increased, Palpitations
Clinical narrative: Increasing frequent heart palpitations and cardiac arrythmias, and becoming so bad, I went to the local urgent care on Oct. 18 at 2:30 AM. The Dr. thought it might be due to an electrolyte imbalance. I tried to go to work Saturday morning, and after an hour commute, was only able to stay a few minutes as my heart was racing uncontrollably. The blood results were called in to me this morning and it said my TSH was almost 100 and I need to see an Endocrinologist ASAP.
Age: 0.08
Sex: M
Vaccine: PNC13
Symptoms: Crying, Pyrexia, Rash generalised, Screaming
Clinical narrative: Hospital with uncontrollable scream crying, rash all over body, high fever.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury
Clinical narrative: Patient was given a shot he walked out to the waiting room and while talking to his siblings he fell backwards and hit his head on the floor. Patient was alert when we got over to him.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PNEUMOVAX and SHINGRIX on the left arm. Two days later, she came back. Her left arm was swollen from the elbow to the shoulder. It was very warm to touch and patient said it was very painful to touch. Patient was advised to take Ibuprofen and go see MD.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient stated she woke up in the middle of the night in the early morning after she got the shot. Injection arm was painful and warm and red about the middle to inner upper arm. She states she went to see doctor on 10/20/2018 and was diagnosed with cellulitis. Was prescribed doxycycline. Called patient for an update on 10/21/2018 and she said arm was getting better. I asked if she was taking ibuprofen or acetaminophen, she said she wasn't and I advised that she take that.
Age: 80.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient called 10/21/18 to inform pharmacy that the PNEUMOVAX 23 vaccine received on 10/19/18 has resulted in swelling of her arm and has now progressed down to her arm to her elbow (left arm). Taken some BENADRYL and ADVIL and has been icing and will call her doctor on Monday 10/22/18.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling at the site of the injection.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Rash pruritic, Rash pustular
Clinical narrative: Four hours after the SHINGRIX shot, I developed an itchy rash around the back of my waist. By the next morning my trunk and thighs were filled with the rash. Two days later I saw Dr. who diagnosed me as having chicken pox. The pox continued to spread to the remainder of my body over the next week. I began taking a seven day course of VALTREX given to me by Dr. on October 2nd. The chicken pox were extremely itchy which lasted 3 weeks. I am still covered with the healing lesions.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic, Rash pustular, Skin lesion, Varicella
Clinical narrative: Four hours after the SHINGRIX shot, I developed an itchy rash around the back of my waist. By the next morning my trunk and thighs were filled with the rash. Two days later I saw Dr. who diagnosed me as having chicken pox. The pox continued to spread to the remainder of my body over the next week. I began taking a seven day course of VALTREX given to me by Dr. on October 2nd. The chicken pox were extremely itchy which lasted 3 weeks. I am still covered with the healing lesions.
Age: 73.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: The patient received two immunizations on 10/16/18 and alledgedly developed cellulitis. He presented to the pharmacy today 10/22/18. He stated that he received a flu shot in his right arm and a pneumonia shot in his left arm. He subsequently experienced a great amount of redness and soreness. He went to a walk in clinic and was told he had cellulitis and then went to the ER because he wanted to see a MD. The MD at the hospital told him he had cellulitis or possible shingles. He started antibiotics filled at pharmacy and presented to the pharmacy today. His arm appears fine and no visible redness or swelling was observed. The patient states that he simply did not want anyone else to be hurt if something was done wrong.
Age: 73.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: The patient received two immunizations on 10/16/18 and alledgedly developed cellulitis. He presented to the pharmacy today 10/22/18. He stated that he received a flu shot in his right arm and a pneumonia shot in his left arm. He subsequently experienced a great amount of redness and soreness. He went to a walk in clinic and was told he had cellulitis and then went to the ER because he wanted to see a MD. The MD at the hospital told him he had cellulitis or possible shingles. He started antibiotics filled at pharmacy and presented to the pharmacy today. His arm appears fine and no visible redness or swelling was observed. The patient states that he simply did not want anyone else to be hurt if something was done wrong.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and heat below site of infection.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Infection, Skin warm
Clinical narrative: Redness and heat below site of infection.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Redness and heat below site of infection.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: 12.5 hours after the shot I had chills, headache, muscle ache, fever and fatigue. I was awake from 2:00 am - 6:00 am.  I stayed home and slept from 9:00 am - 2:00 pm. I felt better by 3:00 pm. I had mild headaches for one week after the shot.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Inflammation, Injection site rash, Injection site swelling, Lymphadenopathy
Clinical narrative: Rash and swelling at the right arm injection site within 24 hours; by 36-40 hours (Wednesday AM), several of the lymph nodes under the arm had swollen from normal enlarged size of a walnut to baseball size, with surrounding inflammation, to the point of either constant nerve pain down the entire right arm and eventual intermittent numbness. Pain intensity caused back muscle spasms by Thursday AM. Treated at home with warm compresses/heating pad, gentle attempts at lymphatic massage, pain managed (not well) with max doses of ALEVE.  As of 10/22, swelling decreased by about one third and pain has lessened.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms, Neuralgia
Clinical narrative: Rash and swelling at the right arm injection site within 24 hours; by 36-40 hours (Wednesday AM), several of the lymph nodes under the arm had swollen from normal enlarged size of a walnut to baseball size, with surrounding inflammation, to the point of either constant nerve pain down the entire right arm and eventual intermittent numbness. Pain intensity caused back muscle spasms by Thursday AM. Treated at home with warm compresses/heating pad, gentle attempts at lymphatic massage, pain managed (not well) with max doses of ALEVE.  As of 10/22, swelling decreased by about one third and pain has lessened.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Nausea
Clinical narrative: Very painful muscle about 4 hours after injection. I felt slightly nauseous and I could barely move my arm. It felt like a serious sprain. The pain slowly subsided over 3 full days.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Musculoskeletal stiffness, Urticaria
Clinical narrative: Neck stiffness and headache. Hives.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Vomiting
Clinical narrative: Mother reported child woke at 5:15am with uncontrollable shaking, denies hives or rashes, denies trouble breathing, denies fevers and pain. Attempted to soothe and calm her, then 20 minutes after was going to go to ER for evaluation, and child with vomiting x1. Then 10 minutes after shaking subsided and she was able to drink water, TYLENOL was given to patient by mother and child returned to rest. Mother was advised to take patient to ER for evaluation for continued symptoms, or any new symptoms. Advised follow up with PCP, call today for appointment.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Full blood count, Metabolic function test, Pruritus
Clinical narrative: Patient received the flu shot at an off site flu clinic at the Court House. RN left after all employees received vaccine. The RN was called about 30 minutes later and informed the patient had difficulty breathing and was itching, they transported her to the ER. RN called the employee who drove the patient to the ER and said she was given meds IV ans sent hone about 1.5 hour later. RN called to follow up with the patient on 10/12/18, patient was fine and had returned to work.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypertension, Urticaria
Clinical narrative: Hives/Hive-like symptoms, high blood pressure, headache.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypertension, Urticaria
Clinical narrative: Hives/hive-like symptoms; high blood pressure, headache.
Age: 24.0
Sex: U
Vaccine: FLU4
Symptoms: Anxiety, Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache, arm pain (where the injection occurred), nausea, rapid heart beating, anxiety.
Age: 26.0
Sex: U
Vaccine: FLU4
Symptoms: Anxiety, Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache, arm pain (where the injection occurred), nausea, rapid heart beating, anxiety.
Age: 33.0
Sex: U
Vaccine: FLU4
Symptoms: Anxiety, Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache, arm pain (where the injection occurred), nausea, rapid heart beating, anxiety.
Age: 27.0
Sex: U
Vaccine: FLU4
Symptoms: Anxiety, Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache, arm pain (where the injection occurred), nausea, rapid heart beating, anxiety.
Age: 48.0
Sex: U
Vaccine: FLU4
Symptoms: Anxiety, Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache, arm pain (where the injection occurred), nausea, rapid heart beating, anxiety.
Age: 46.0
Sex: U
Vaccine: FLU4
Symptoms: Anxiety, Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache, arm pain (where the injection occurred), nausea, rapid heart beating, anxiety.
Age: 40.0
Sex: U
Vaccine: FLU4
Symptoms: Anxiety, Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache, arm pain (where the injection occurred), nausea, rapid heart beating, anxiety.
Age: 41.0
Sex: U
Vaccine: FLU4
Symptoms: Anxiety, Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache, arm pain (where the injection occurred), nausea, rapid heart beating, anxiety.
Age: 38.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: C/o fever 100.8 x2 days. Pain,Redness and swelling at injection site "the size of a Baseball".
Sex: U
Vaccine: HEP, HEPA
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: This literature report has been received from the authors of a published article, titled as stated above and refers to a 27 patients between the ages of 1 and 15 years old (the age group with less than 19 years was considered as children by the authors). The patients' gender was not provided. On unknown dates, the patients were vaccinated with a Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot# and expiration date were not provided). As part of the initial patient assessment programme and in accordance with the Centers for Disease Control and Prevention (CDC) guidelines, all incoming patients received their first vaccination against hepatitis A and B at their first healthcare encounter. The patients received three or four previous documented doses of Hepatitis B Vaccine (Recombinant) (manufacturer unknown). Tests for immunity to both viruses were performed also at the first healthcare encounter. Decisions about the continuation or discontinuation of the vaccine series were made on the basis of test results. Demographic data, vaccination history, and results of blood tests for hepatitis A antibody (HAV Ab), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and hepatitis B core antibody (HBcAb) were collected. HBsAb was deemed reactive if detected at =10 mIU/mL. On unknown date, it occurred that HBsAb was absent in the patients. The patients were considered nonresponders. The interval between the last received dose of vaccine and testing for HBsAb in this group averaged 47 months (median 35 months) and ranged from 5 months to 178 months. Refugees showed no immunity in spite of having received three or four documented doses of Hepatitis B Vaccine (Recombinant) (manufacturer unknown). This apparent nonresponse was considered to be due to many things including genetic factors, malnutrition or other illness, documentation errors, expired vaccine, or poor vaccination technique. Some individuals might have had no initial serologic response to vaccination, others might have had initially adequate antibody levels that waned over time. On the other hand, since no interval between series completion and testing was shorter than 5 months, the nonresponse is unlikely to be attributable to a postvaccination gap during which provoked immune systems were not yet producing antibodies. A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a female patient currently 18 years old. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not unknown. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (strength, dose, lot number and expiration date were not reported), for prophylaxis (reported as "prevention Human papillomaviruses (HPV)"). On an unknown date, the patient experienced an excessive hair loss (alopecia). It was unknown if the patient sought medical attention, if any treatment was administered or if any lab diagnostics/studies were performed. It was reported that the patient completed the vaccination series on unspecified dates and had no problems. The outcome of alopecia was unknown. The causality assessment between GARDASIL 9 and the aforementioned event was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-JUL-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N022728 and expiration date 31-MAY-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. A 71-year-old female patient received PREVNAR 13; (NDC number: 0005197102; Lot Number: S35324; Expiry date: Aug2018) on 12Oct2018 at single for Pneumonia prevention. The patient medical history and concomitant medications were not reported. On 12Oct2018 the patient was administered a dose of vaccine that had already expired (expired in Aug2018).
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff manager).This case is linked to cases 2018SA289714, 2018SA289702, 2018SA289666, 2018SA289651, 2018SA289640, 2018SA289611, 2018SA289688, 2018SA289731 and 2018SA290377, same reporter. This case involves a 13 years old male patient who received vaccine IPOL. The patients past medical history, concomitant medication and family history were not provided. On 18-Sep-2018, the patient received injection of suspect IPOL lot number- N1K931M, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that IPOL opened reached 32.76 F for 19 hours 44 minutes/ did not freeze, doses were indeed given out of opened multi dose vial of IPOL after temperature excursion. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 49.0
Sex: U
Vaccine: FLUR4
Symptoms: Anxiety, Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache, arm pain (where the injection occurred), nausea, rapid heart beating, anxiety.
Age: 57.0
Sex: U
Vaccine: FLUR4
Symptoms: Anxiety, Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache, arm pain (where the injection occurred), nausea, rapid heart beating, anxiety.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Grabbed Adult Hep A in the bin where we keep Ped/Ado and gave to patient, there was no bad outcome or treatment course. Didn't realize it was given until almost 2 weeks after the fact.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Fatigue, Induration, Peripheral swelling
Clinical narrative: Fever, couldn't barely move the next day, Arm swollen, hard, Red the size of an orange, breathing was hard.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, couldn't barely move the next day, Arm swollen, hard, Red the size of an orange, breathing was hard.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Headache, Laboratory test normal, Pain, Palpitations
Clinical narrative: Severe headache, palpitations, chills, fever, body aches. Symptoms started on 10/15/2018. Rash started on 10/18/2018.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Severe headache, palpitations, chills, fever, body aches. Symptoms started on 10/15/2018. Rash started on 10/18/2018.
Age: 28.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Musculoskeletal pain
Clinical narrative: Extreme soreness of shoulder down to elbow.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever of 103.9 ~Chills~ extreme muscle pain~stomach pain~Massive headache ~nausea~extremely tired symptoms stared the morning after and last 4 days started with extreme tiredness ~nausea~ muscle pain~headache progressed to stomach pains and really debiltating muscle pain headache nausea and severe stomach pain fever did not break until day 4 when symptons started to subside.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever of 103.9 ~Chills~ extreme muscle pain~stomach pain~Massive headache ~nausea~extremely tired symptoms stared the morning after and last 4 days started with extreme tiredness ~nausea~ muscle pain~headache progressed to stomach pains and really debiltating muscle pain headache nausea and severe stomach pain fever did not break until day 4 when symptons started to subside.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness and heat at injection site of MENVEO vaccine in R arm, measuring 11 x 14mm. DX: Cellulitis. Treated with Cephalexin 500mg q 6 hours x 5 days. Guardian reports symptoms have resolced.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Rash, Skin irritation, Urticaria
Clinical narrative: Recipient stated that a couple days or so after injection, she noticed some discomfort down her side, from under her arm where the injection was given to her hip area. Upon examination, she discovered a "hives-like" rash down her side. There was no pain, just irritation when her clothes came into contact with the rash. There was no itching. She did not experience any fever nor did she "feel bad."  After a couple days, the rash had disappeared, according to her. She was not sure that it was related to the injection, but since it was on the same side of her body, she thought it might be. She did not report this information to me until 18 days after the injection.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Radical nerve pain across my abdomen and groin area. Pain in my left lower leg. Dr. put me on  medication believe it was carbamazepine 200 mg. Pain went away in leg after about 3 days and abdomen in about 7-9 days. One of the problems of being specific is that when I contacted you and then you sent me the way to contact you on 9.26 could not enter your site because it was insecure and neither web browser would let me in.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Joint swelling, Polyarthritis, Pyrexia
Clinical narrative: Fever and left leg swelling; went to left knee swelling and 2 days after still febrile went to left wrist swelling- polyarthritis related to influenza vaccine.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Erythema, Injection site abscess sterile, Nodule, Pain in extremity
Clinical narrative: Arm hurt, was achy, big red circle with extreme heat, knot - went to ER and was diagnosed with Sterile Abscess at injection site and cellulitis of left upper extremity and was put on a 7 day antibiotic (Cephalexin 500MG).
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Skin warm
Clinical narrative: Arm hurt, was achy, big red circle with extreme heat, knot - went to ER and was diagnosed with Sterile Abscess at injection site and cellulitis of left upper extremity and was put on a 7 day antibiotic (Cephalexin 500MG).
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Awoke from sleep with need to vomit. Vomited on three occasions that night and once again the following afternoon.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: WITHIN 2 MINUTES, I BECAME DIZZY AND LIGHTHEADED - ALMOST FAINTED. WITHIN 15 MINUTES, MY TONGUE BEGAN TO SWELL I HAD A HEADACHE &  GENERALLY FELT "OFF." FOUR DAYS LATER, MY ARM IS STILL SLIGHTLY SWOLLEN, PAINFUL, ITCHY & RED  AND THE HEADACHES HAVE NOT SUBSIDED. I TOOK A BENADRYL UPON RETURNING TO MY OFFICE AND FOR THE NEXT 2 DAYS.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Presyncope, Pruritus, Swollen tongue
Clinical narrative: WITHIN 2 MINUTES, I BECAME DIZZY AND LIGHTHEADED - ALMOST FAINTED. WITHIN 15 MINUTES, MY TONGUE BEGAN TO SWELL I HAD A HEADACHE &  GENERALLY FELT "OFF." FOUR DAYS LATER, MY ARM IS STILL SLIGHTLY SWOLLEN, PAINFUL, ITCHY & RED  AND THE HEADACHES HAVE NOT SUBSIDED. I TOOK A BENADRYL UPON RETURNING TO MY OFFICE AND FOR THE NEXT 2 DAYS.
Age: 45.0
Sex: M
Vaccine: SMALL
Symptoms: Acute kidney injury, Blindness, Chest discomfort, Deafness, Decreased appetite
Clinical narrative: Per patient email: After my injection site fully erupted, I began to have bouts of fever, severe cramping, fatigue, headache, tightness in chest, etc, and these continued to worsen/persist. Yesterday, I displayed symptoms of vertigo, loss of vision, hearing loss, and near unconsciousness. I was admitted to the Medical Center where I was treated and tested. After several hours, it was determined that I had succumbed to acute renal failure. After stabilization, I was referred to a kidney specialist, with whom I have yet to see. Most of my symptoms were alleviated, but I'm still enduring extreme pain in the kidneys, fatigue, sleeplessness (due to extreme pain), and loss of appetite.
Age: 45.0
Sex: M
Vaccine: SMALL
Symptoms: Depressed level of consciousness, Fatigue, Headache, Insomnia, Muscle spasms
Clinical narrative: Per patient email: After my injection site fully erupted, I began to have bouts of fever, severe cramping, fatigue, headache, tightness in chest, etc, and these continued to worsen/persist. Yesterday, I displayed symptoms of vertigo, loss of vision, hearing loss, and near unconsciousness. I was admitted to the Medical Center where I was treated and tested. After several hours, it was determined that I had succumbed to acute renal failure. After stabilization, I was referred to a kidney specialist, with whom I have yet to see. Most of my symptoms were alleviated, but I'm still enduring extreme pain in the kidneys, fatigue, sleeplessness (due to extreme pain), and loss of appetite.
Age: 45.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Renal pain, Vertigo
Clinical narrative: Per patient email: After my injection site fully erupted, I began to have bouts of fever, severe cramping, fatigue, headache, tightness in chest, etc, and these continued to worsen/persist. Yesterday, I displayed symptoms of vertigo, loss of vision, hearing loss, and near unconsciousness. I was admitted to the Medical Center where I was treated and tested. After several hours, it was determined that I had succumbed to acute renal failure. After stabilization, I was referred to a kidney specialist, with whom I have yet to see. Most of my symptoms were alleviated, but I'm still enduring extreme pain in the kidneys, fatigue, sleeplessness (due to extreme pain), and loss of appetite.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Burning sensation, Erythema, Fatigue, Headache
Clinical narrative: Face burning and red, felt weak and shaky, thought I might pass out. Returned to pharmacy where blood pressure and pulse were checked. Blood pressure was OK pulse was a little high for me. Later I experienced aches throughout my entire body, headache and fatigue.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Nervousness, Pain
Clinical narrative: Face burning and red, felt weak and shaky, thought I might pass out. Returned to pharmacy where blood pressure and pulse were checked. Blood pressure was OK pulse was a little high for me. Later I experienced aches throughout my entire body, headache and fatigue.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Blood magnesium, Brain natriuretic peptide, Chest X-ray, Chills, Coagulation test
Clinical narrative: Chills, fever, body aches, difficulty walking.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram, Full blood count, Gait disturbance, Metabolic function test, Pain
Clinical narrative: Chills, fever, body aches, difficulty walking.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Troponin
Clinical narrative: Chills, fever, body aches, difficulty walking.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pain in R deltoid.
Age: 37.0
Sex: F
Vaccine: SMALL
Symptoms: Urticaria
Clinical narrative: Hives for 2 days 17 days after the vaccination. No other symptoms and self resolved.
Age: 59.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Fatigue, Headache, Influenza like illness, Lethargy, Myalgia
Clinical narrative: Fever 101.5.  Profound lethargy, headache, runny nose, muscle aches, fatigue. Some improvement by this report 10/22/18.
Age: 59.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fever 101.5.  Profound lethargy, headache, runny nose, muscle aches, fatigue. Some improvement by this report 10/22/18.
Age: 59.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Headache, Influenza like illness, Lethargy, Myalgia, Pyrexia
Clinical narrative: Fever 101.5.  Profound lethargy, headache, runny nose, muscle aches, fatigue. Some improvement by this report 10/22/18.
Age: 59.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rhinorrhoea
Clinical narrative: Fever 101.5.  Profound lethargy, headache, runny nose, muscle aches, fatigue. Some improvement by this report 10/22/18.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain, difficulty moving the limb for several days- still cannot move arm completely normally.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Axillary pain, Chest X-ray, Electrocardiogram, Full blood count, Injection site erythema
Clinical narrative: Vaccination site redness, warmth, pain to arm and axilla. Low grade fever at home.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Metabolic function test, Pain in extremity, Pyrexia, Vaccination site warmth
Clinical narrative: Vaccination site redness, warmth, pain to arm and axilla. Low grade fever at home.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Received Immunization on Tuesday 11:08A 10/17/18 early AM started with rash on abdomen - Then spread to arms-legs chest. Given meds today.
Sex: U
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a week after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. Last week from the reporting date, the patient received a dose of whooping cough/tetanus vaccine in one arm and flu vaccine in the other arm as per primary care physician (PCP) recommendation. The patient had no big deal, his both arms were a little bit sore. It was unknown if the reporter considered the arms a little sore to be related to whooping cough/tetanus vaccine. This case has been linked to the US2018GSK190710, reported by the same reporter.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of localized erythema in a 16-year-old female patient who received BEXSERO (batch number 16E901, expiry date 31st March 2019) for prophylaxis. On 17th August 2018, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, less than a year after receiving BEXSERO, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was not reported. It was unknown if the reporter considered the localized erythema to be related to BEXSERO. Additional details were provided as follows: The reporter was a Certified Medical Assistant (CMA) or an office manager. The reporter stated that patient developed a large circular red ring on her arm after vaccination with BEXSERO. The shape was mentioned to be circle.
Age: 66.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Asthenia, Chills, Dizziness, Headache
Clinical narrative: Dizziness and chills, weakness, headache. Acetaminophen PRN, Bag PRN.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Pyrexia, Vaccination site pain
Clinical narrative: Chest pain, arm pain at vaccination site x several days. Low grade fevers.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass
Clinical narrative: Colleague arrived to report a small hard pea sized lump to area of MMR vaccination on back of right arm.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased, Neck pain
Clinical narrative: Patient complained of left shoulder and neck pain starting the evening after receiving the flu vaccine.  Patient describes the pain as a constant ache and having difficulties turning neck to the side.
Age: 38.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Contusion, Erythema, Induration, Injection site erythema, Nodule
Clinical narrative: Pt. was experiencing soreness the night of the vaccine in the arm of her tetanus shot. The next day she noticed swelling and redness at the site of vaccination that was as big as her palm. She noticed a hard knot in that arm as well. She iced her arm all weekend and the swelling has gotten worse. Today, Monday October 22nd, she came to the clinic and her arm has a hard knot and is slightly red and bruised. She said her pain is tolerable. It was slightly red to the touch.
Age: 38.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: Pt. was experiencing soreness the night of the vaccine in the arm of her tetanus shot. The next day she noticed swelling and redness at the site of vaccination that was as big as her palm. She noticed a hard knot in that arm as well. She iced her arm all weekend and the swelling has gotten worse. Today, Monday October 22nd, she came to the clinic and her arm has a hard knot and is slightly red and bruised. She said her pain is tolerable. It was slightly red to the touch.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Inflammation, Peripheral swelling, Pruritus
Clinical narrative: Arm was very warm and had raised areas that were itchy and entire arm burned and was red and inflamed. Patient took pictures starting Thursday following shot. It has now turned into scabs with slight redness surrounding those areas. Appears to be healing.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Scab, Skin warm
Clinical narrative: Arm was very warm and had raised areas that were itchy and entire arm burned and was red and inflamed. Patient took pictures starting Thursday following shot. It has now turned into scabs with slight redness surrounding those areas. Appears to be healing.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient described pain and redness to injection site. No other information obtained as medical documents not obtained up to this reporting date. Patient discharged and has recovered.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Lightheadedness and dizziness starting 10 minutes after the vaccine and lasting the rest of the day and into the next day.
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood creatine phosphokinase, Blood lactic acid, Blood magnesium, Chest X-ray, Computerised tomogram head
Clinical narrative: On 10/8/18, 81-y/o woman got her flu shot at the pharmacy. Pharmacist told her based on the  database, she was also eligible to get her PREVNAR 23 booster, so she agreed; they were both administered in the same arm. She could not remember when she got the previous PNEUMOVAX, but it had been awhile. She has a tendency for vagus reactions to pain (passing out), but did fine with the vaccines at the time of injection. However overnight she had some significant reaction: pain, warmth and swelling in her arm and lapse of consciousness. We scheduled an urgent care appt the next day and she ended up in the ER after she passed out several times during the exam. On Weds. 10/10/18, she had a follow-up with her regular physician, who looked on the website/registry and determined that she had already had the PREVNAR 13 in 2016, the PREVNAR 23 booster in 12/17, and had now gotten a third dose of vaccine and was suffering from a significant arthus response. Not life-threatening, but certainly dangerous for a woman with no threshold for pain. This may have been an oversight by the Pharmacist who didn't know how to check the registry correctly, or it may have been intentional because these retail pharmacies appear to be incentivized to administer as many vaccines as they can. She will no longer receive vaccines outside of her physician's office. I've been advised that I can file a complaint with Agency regarding my concern about financial gain.
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Differential white blood cell count, Electrocardiogram, Full blood count, Inappropriate schedule of product administration, Injection site cellulitis
Clinical narrative: On 10/8/18, 81-y/o woman got her flu shot at the pharmacy. Pharmacist told her based on the  database, she was also eligible to get her PREVNAR 23 booster, so she agreed; they were both administered in the same arm. She could not remember when she got the previous PNEUMOVAX, but it had been awhile. She has a tendency for vagus reactions to pain (passing out), but did fine with the vaccines at the time of injection. However overnight she had some significant reaction: pain, warmth and swelling in her arm and lapse of consciousness. We scheduled an urgent care appt the next day and she ended up in the ER after she passed out several times during the exam. On Weds. 10/10/18, she had a follow-up with her regular physician, who looked on the website/registry and determined that she had already had the PREVNAR 13 in 2016, the PREVNAR 23 booster in 12/17, and had now gotten a third dose of vaccine and was suffering from a significant arthus response. Not life-threatening, but certainly dangerous for a woman with no threshold for pain. This may have been an oversight by the Pharmacist who didn't know how to check the registry correctly, or it may have been intentional because these retail pharmacies appear to be incentivized to administer as many vaccines as they can. She will no longer receive vaccines outside of her physician's office. I've been advised that I can file a complaint with Agency regarding my concern about financial gain.
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Loss of consciousness, Metabolic function test, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: On 10/8/18, 81-y/o woman got her flu shot at the pharmacy. Pharmacist told her based on the  database, she was also eligible to get her PREVNAR 23 booster, so she agreed; they were both administered in the same arm. She could not remember when she got the previous PNEUMOVAX, but it had been awhile. She has a tendency for vagus reactions to pain (passing out), but did fine with the vaccines at the time of injection. However overnight she had some significant reaction: pain, warmth and swelling in her arm and lapse of consciousness. We scheduled an urgent care appt the next day and she ended up in the ER after she passed out several times during the exam. On Weds. 10/10/18, she had a follow-up with her regular physician, who looked on the website/registry and determined that she had already had the PREVNAR 13 in 2016, the PREVNAR 23 booster in 12/17, and had now gotten a third dose of vaccine and was suffering from a significant arthus response. Not life-threatening, but certainly dangerous for a woman with no threshold for pain. This may have been an oversight by the Pharmacist who didn't know how to check the registry correctly, or it may have been intentional because these retail pharmacies appear to be incentivized to administer as many vaccines as they can. She will no longer receive vaccines outside of her physician's office. I've been advised that I can file a complaint with Agency regarding my concern about financial gain.
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Type III immune complex mediated reaction
Clinical narrative: On 10/8/18, 81-y/o woman got her flu shot at the pharmacy. Pharmacist told her based on the  database, she was also eligible to get her PREVNAR 23 booster, so she agreed; they were both administered in the same arm. She could not remember when she got the previous PNEUMOVAX, but it had been awhile. She has a tendency for vagus reactions to pain (passing out), but did fine with the vaccines at the time of injection. However overnight she had some significant reaction: pain, warmth and swelling in her arm and lapse of consciousness. We scheduled an urgent care appt the next day and she ended up in the ER after she passed out several times during the exam. On Weds. 10/10/18, she had a follow-up with her regular physician, who looked on the website/registry and determined that she had already had the PREVNAR 13 in 2016, the PREVNAR 23 booster in 12/17, and had now gotten a third dose of vaccine and was suffering from a significant arthus response. Not life-threatening, but certainly dangerous for a woman with no threshold for pain. This may have been an oversight by the Pharmacist who didn't know how to check the registry correctly, or it may have been intentional because these retail pharmacies appear to be incentivized to administer as many vaccines as they can. She will no longer receive vaccines outside of her physician's office. I've been advised that I can file a complaint with Agency regarding my concern about financial gain.