chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: JEV1
Symptoms: Urticaria
Clinical narrative: Hives all over her body; The following information was received from a pharmacist on 15 Jan 2019.  A 34 year old female received her first dose of IXIARO (Japanese encephalitis vaccine, batch number JEV17M64E) on 11 Jan 2019.  Two days later (13 Jan 2019) she experienced hives all over her body. Under treatment with Benadryl the event did not resolve.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Computerised tomogram, Palpitations, Troponin
Clinical narrative: Chest pressure and pain, heart palpitations
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SIGNIFICANT SWELLING OF LEFT UPPER ARM, WARMTH, ERYTHEMA
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Feeling cold, Injection site pain, Lethargy
Clinical narrative: Feverish, chills, lethargy, pain at injection site, diarrhea
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Feverish, chills, lethargy, pain at injection site, diarrhea
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: Patient said after receiving her second dose of Shingrix she started feeling flu-like symptoms (fever, chills, sweating) that afternoon after receiving the vaccine in the morning. She was feeling better the next day but still felt achy and tired.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient said after receiving her second dose of Shingrix she started feeling flu-like symptoms (fever, chills, sweating) that afternoon after receiving the vaccine in the morning. She was feeling better the next day but still felt achy and tired.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Severe left shoulder pain disabling use of left arm.  Facility contacted the next day, and was told the reaction was normal and to take ibuprofen to relieve pain.  I have had trouble with kidney function in the past taking ibuprofen and when I told the nurse that, she just said the pain would subside soon anyway and had no other pain relief recommendation.  It was 3 days later when the pain subsided just enough to be able to unholster and reholster my cell phone.  It's been over a week now and I still have pain in my left shoulder whenever attempting to use my arm to move or lift anything significant.  The muscles in my left shoulder have apparently been damaged and I suspect will take take several weeks of rehab.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Rash, Rash erythematous, Vaccination complication, Viral rash
Clinical narrative: Has a painful red rash that is located on his abdomen, left arm and legs. Did have a rash last week and this rash started today 10/11/2019 and redness around injections site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Nausea, Pain, Pyrexia
Clinical narrative: Fever up to 101,, nausea, achy, and flushed.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Lethargy, Nausea, Pyrexia, Respiratory tract congestion
Clinical narrative: About 5 hours after shot, I started feeling nauseous, headache, congested, fever. Lethargic.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Enlarged uvula, Malaise
Clinical narrative: PATIENT EXPERIENCED SWELLING OF HER UVULA, MALAISE, CHILLS, JOINT PAIN & SORENESS
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain, Peripheral swelling, Pruritus
Clinical narrative: Day after left arm swoll for about 2 days. On or about 3 day the burning/stinging started. Had to apply medication and than take Benadryl. At this writing (10/18/2019) the symptoms are still present,more like itching.  I took the same injection last year and had the same problem, but I forgot and took it again.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Swelling
Clinical narrative: Pain at the site of the flu injection which increased over the next day. Swelling at the site and up her neck and at her collar bone occurred two days after injection. She was seen at urgent care and given steroids and a muscle relaxer. Symptoms have completely resolved.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain
Clinical narrative: Patient says that she started having neck pain the day that she received the vaccine on 10/14/19. Patient called pharmacy on 10/18/19 to alert us of this adverse reaction. She says she has tried heating pads and cream to help with the pain to no avail.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Pyrexia, Rash erythematous, Varicella
Clinical narrative: Patient states that later on, he had experienced a fever, diarrhea, and a single "chickenpox" (upon pharmacist observation, it is a red bump) on the inner arm of the arm that the vaccine was administered. Patient states that he no longer has fever and diarrhea, but he still has the red bump on his inner arm
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: cellulitis symptoms- warm, red, painful area below injection site
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis
Clinical narrative: Pharmacist sterilized the vaccination area prior to starting immunization clinic. Patient received the vaccine on 10/08/2019. Patient states pharmacist swabbed her arm with alcohol and let it dry before administering the vaccine. The patient called on 10/10/19 stating she had a reaction to the vaccine and went to see Dr. Dr. then prescribed her doxycycline for what she thought looked like a cellulitis.
Sex: U
Vaccine: MENB
Symptoms: Pain, Swelling
Clinical narrative: Pain; Swelling; This case was reported by a nurse via sales rep and described the occurrence of pain in an unknown number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were unknown.   It was unknown if the reporter considered the pain and swelling to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Registered Nurse (RN). The age at vaccination was not reported. The reporter stated that the patients experienced of pain and swelling with the use of Bexsero as a general adverse event they were seeing. The reporter did not agree to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site of injection; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included herpes zoster (herpes zoster history) and joint pain. Concurrent medical conditions included immunocompromised (had a heart transplant, and a compromised immune system) and diabetes.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 73 years old at the time of reporting. The patient experienced soreness at the site of injection for couple of days. The reporter consented to follow up. This case has been linked with cases US2019AMR182433 and US2019181795 reported by the same reporter for same patient.
Sex: M
Vaccine: MENB
Symptoms: Injection site swelling, Muscle fatigue, Pyrexia
Clinical narrative: Fever; swelling at the injection site; muscle fatigue; This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in 2019 at single dose for immunization. Medical history and concomitant medications were not reported. In fall of 2019, the patient experienced fever, swelling at the injection site and muscle fatigue, which all took place after use of vaccine. Clinical outcome of the events was unknown.
Sex: F
Vaccine: FLU4
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Placenta praevia, Ultrasound antenatal screen abnormal
Clinical narrative: Low lying placenta; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 10-Oct-2019, concerning a 40-year-old, pregnant, female subject of body weight: 157.5 lbs, height: 62 inches and body mass index (BMI): 28.8, enrolled in, a prospective observational study.  The subject's obstetrical history included four previous pregnancies with one full term live birth, two spontaneous abortions and one elective abortion. No birth defects were reported. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of alcohol or illicit drugs during pregnancy. The subject was a smoker (10 cigarettes per day). The subject's medical history included pulmonary venous thrombosis, asthma, hypothyroidism, advanced maternal age and high body mass index (28.8). Concomitant medications included prenatal vitamin (minerals NOS, vitamins NOS) for pregnancy, ProAir HFA (salbutamol sufate) and Pulmicort (budesonide) both for asthma, levothyroxine for hypothyroidism, enoxaparin for pulmonary venous thrombosis and vitamin D2 as a supplement.    The subject's last menstrual period (LMP) date was 02-Jun-2019, the estimated delivery date (EDD) was reported as 09-Mar-2020 and corrected estimated date of delivery (CEDD) was reported as 08-Mar-2020. The type of pregnancy was singleton.   On 19-Jul-2019 and 02-Aug-2019, the subject underwent ultrasound scan and no major congenital malformation (MCM) was noted.   On 25-Sep-2019, at gestational age of 17 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [influenza vaccine; batch number: P100118566, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.  On the same date, the subject underwent ultrasound scan and MSAFP/serum (Maternal Alpha-1-phoetoprotein) markers test and no MCM was noted.   On 08-Oct-2019, the subject underwent ultrasound scan and low lying placenta was noted.   At the time of initial reporting, the outcome of the event 'low lying placenta' was not reported.   The reporter did not provide a causality assessment.; Sender's Comments: A pregnant subject developed placenta praevia, 13 days after administration of Flu Vaccine Egg Split QIV CSL. Chronology is plausible. Vaccine was administered at gestational age of approximately 17 weeks. Causality was highly confounded my medical history of previous pregnancies, two spontaneous abortions and one elective abortion, advanced maternal age (40) and tobacco use. However, causal role of the suspect product cannot be excluded and it is assessed as unlikely related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: After leaving pharmacy patient called reporting numbness on her neck, on the left side, radiating up to her lip and nose.  She stated feeling was not pain, but a numb sensation.  At the time no rash or itching was reported. Advised patient to go to emergency if swelling or difficulty breathing occurs. Explained that rash is a potential side effect so rash is not necessarily an indication of allergic reaction. Patient will monitor symptoms and go to emergency if condition worsens or if breathing is affected.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 11.5 CM x 18 CM reaction site. Red, swollen, and itchy. Reaction began shortly after administration and has worsened over the past two days. Course of treatment includes Ibuprofen, benadryl, and ice packs on reaction site PRN.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Dizziness
Clinical narrative: Immediately at time of injection a very weird feeling throughout my body, became dizzy. Later than night I had chills, and starting aching all over as if I had the flu, had a good size knot- like the size of half of a boiled egg at the site of my injection  The next day (Wednesday) all of my joints were very sore and hurting, my muscles hurt - and when I walked I would have a really bad pain. Bad headache  ( Thursday) severe stomach cramping and watery diarrhea, the joints and muscles hurting worse today. (Friday) Can barely walk - joints and muscles in my hips/leg hurting very bad
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Gait disturbance, Headache, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Immediately at time of injection a very weird feeling throughout my body, became dizzy. Later than night I had chills, and starting aching all over as if I had the flu, had a good size knot- like the size of half of a boiled egg at the site of my injection  The next day (Wednesday) all of my joints were very sore and hurting, my muscles hurt - and when I walked I would have a really bad pain. Bad headache  ( Thursday) severe stomach cramping and watery diarrhea, the joints and muscles hurting worse today. (Friday) Can barely walk - joints and muscles in my hips/leg hurting very bad
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Laboratory test, Myalgia, Pain
Clinical narrative: Immediately at time of injection a very weird feeling throughout my body, became dizzy. Later than night I had chills, and starting aching all over as if I had the flu, had a good size knot- like the size of half of a boiled egg at the site of my injection  The next day (Wednesday) all of my joints were very sore and hurting, my muscles hurt - and when I walked I would have a really bad pain. Bad headache  ( Thursday) severe stomach cramping and watery diarrhea, the joints and muscles hurting worse today. (Friday) Can barely walk - joints and muscles in my hips/leg hurting very bad
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Fatigue, Influenza like illness, Pain
Clinical narrative: body ache like flu symptoms, fatigue, general pain in body .. bones ache  Took a total of 2 advil, one at a time over 8 hour period .   The advil helps .. feeling better today, 10/18/2019
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 2 1/2 inch hard swelling, redness, itchy, painful at site
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Ear pain, Injection site pain, Lymphadenopathy, Muscle spasms
Clinical narrative: Pt reports she received the flu vaccine around 10:00am.  She returned to her desk and around 3:00 she started noticing her neck was stiff, and the left side was sore; at that time she took Tylenol.  At dinner between 6-7 pm, she reported taking 4 Ibuprofen.  She complained of ear pain, like her gland on the left side was swollen, it hurt to turn her neck to the left and the pain would shoot down her back, into her left shoulder and down her left arm.  She decribed the pain like an "icy feeling down her arm and it followed the vein over the top of her forearm. This is like what happens when I get stung by a wasp."  She applied a heating pad to her neck.  She reports she could move her arm in all directions but it was painful.  She applied the heating pad to her neck.  The meds and the heating pad helped some but did not relieve all her pain.  This morning at 4:40 am she took 2 Ibuprofen and had a hot shower hoping that would help loosened her stiffness with some relief.   Patient has doctor's appt today, 10/19/2018 at 10:00am. RN observed site of injection and found no redness, swelling, bruising and not warm to touch. Patient could move her left arm in all directions but did appear guarded and stiff when turning head.  Telephone call from PA-C at Clinic.  She reports there was no testing or labs needed, the dx was muscle spasm, was given recommendations of management and prescribed muscle relaxers.  She saw no ROM issues or concerns with the site of the vaccine.  PA felt the area of concern were the trapezius and stabilizing muscles.  Patient to give PA follow-up call Monday 10/21/2019 if no improvement.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: Pt reports she received the flu vaccine around 10:00am.  She returned to her desk and around 3:00 she started noticing her neck was stiff, and the left side was sore; at that time she took Tylenol.  At dinner between 6-7 pm, she reported taking 4 Ibuprofen.  She complained of ear pain, like her gland on the left side was swollen, it hurt to turn her neck to the left and the pain would shoot down her back, into her left shoulder and down her left arm.  She decribed the pain like an "icy feeling down her arm and it followed the vein over the top of her forearm. This is like what happens when I get stung by a wasp."  She applied a heating pad to her neck.  She reports she could move her arm in all directions but it was painful.  She applied the heating pad to her neck.  The meds and the heating pad helped some but did not relieve all her pain.  This morning at 4:40 am she took 2 Ibuprofen and had a hot shower hoping that would help loosened her stiffness with some relief.   Patient has doctor's appt today, 10/19/2018 at 10:00am. RN observed site of injection and found no redness, swelling, bruising and not warm to touch. Patient could move her left arm in all directions but did appear guarded and stiff when turning head.  Telephone call from PA-C at Clinic.  She reports there was no testing or labs needed, the dx was muscle spasm, was given recommendations of management and prescribed muscle relaxers.  She saw no ROM issues or concerns with the site of the vaccine.  PA felt the area of concern were the trapezius and stabilizing muscles.  Patient to give PA follow-up call Monday 10/21/2019 if no improvement.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Malaise, Nausea, Pain
Clinical narrative: Chills and shivering started about 10 PM, lasting 45 minutes.  Nausea. Temp of 101.6. General malaise. Overall body aches, headache. These lasted all night. Nausea, headaches, body aches and general malaise persisting today (10/18/2019) No treatments other than trying to get warm, even with high temp
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Chills and shivering started about 10 PM, lasting 45 minutes.  Nausea. Temp of 101.6. General malaise. Overall body aches, headache. These lasted all night. Nausea, headaches, body aches and general malaise persisting today (10/18/2019) No treatments other than trying to get warm, even with high temp
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue
Clinical narrative: Patient had received a Flu vaccine from prefilled syringe. On completion, nurse was engaging the safety device and the syringe broke in half. There was no harm to the patient.
Age: 58.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Herpes zoster, Malaise, Rash
Clinical narrative: Vaccination with varicella (?live virus?) in 2006 was first ever, requirement as part of application. Did not have chicken-pox or shingles previously.  Adverse event began on Monday, December 10th, 2018 (began to be unwell), and later that same week rash began on right shoulder and arm, spread from there to neck and up the back of head and over the head, and over right chest and upper back near right shoulder, and upper right arm. Diagnosed on Monday,  December 17th, 2018, as a severe case of shingles - PA said, "the worst she had seen". Lasted until mid-February, 2019, and then I resumed doing exercise again. Did not scratch the blisters and they healed without scarring.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: About 24 hours after the vaccines, the left upper arm became red, warm and tender to touch.  They applied ice to it but today it seems like a larger area of redness, so Mom would like him checked.  No fever or numbness or tingling of the left arm or fingers. Patient was seen 10/7/19 in clinic.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Peripheral swelling, Pruritus
Clinical narrative: Presented to ER on 10/17/19 with complaints of right arm pain, swelling, and itching with onset 3 days after receipt of vaccination.  Patient was scratching injection site at night and using rubbing alcohol to help.  Patient stated arm pain was at injection site only.  Patient denied allergy to eggs, latex, shellfish, or citrus.  Prescribed oral hydroxyzine for itching, mupirocin topical for any infection, and non-pharmacologic RICE (rest, ice, compression, elevation).  Instructed to f/u with primary care provider in 1-2 weeks or return to ER if symptoms worsen.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Antibody test positive, Chills, Food allergy, Lip swelling
Clinical narrative: RTO 9/21/19 10:34 am ,daughter states checked Pt at night he was C/O chills ,lips were swollen she gave Pt benadryl 50mg  states in the morning swelling better /
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose, C-reactive protein, Full blood count, HIV test, Hypoaesthesia
Clinical narrative: Left thumb numbness with wrist droop started 8 days after injection. Went to ED and saw neurology who thought could be related and dx as radial nerve palsy. On prednisone taper and seeing PT after EMG next week.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging, Metabolic function test, Radial nerve palsy
Clinical narrative: Left thumb numbness with wrist droop started 8 days after injection. Went to ED and saw neurology who thought could be related and dx as radial nerve palsy. On prednisone taper and seeing PT after EMG next week.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Nodule
Clinical narrative: FREE MOVING NODULE NOTED ABOVE DISTAL PORTION OF LEFT CLAVICLE.  NO HISTORY OF SAME.  NOT PAINFUL. NO FEVER.  MINOR LEFT UPPER ARM SORENESS NOTED.
Age: 67.0
Sex: U
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Peripheral swelling, Pruritus
Clinical narrative: Received FluHD and pneumo vaccines last fall (possibly October). Both arms were itchy and swollen. Took Benadryl and waited for symptoms to alleviate. Approximately one week before I recovered.   Received  FluHD shot 10/7/2019.  Immediate itching and swelling. Took Benadryl and waited 7-10 days for symptoms to go away.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: initially there was redness, warmth, swelling and tenderness at injection site.  Rash spread to neck and torso then to lower extremities. Throat irritation and swelling occurred with airway obstruction within an hour Treatment rendered in the ED for anaphylactic reaction
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Obstructive airways disorder, Pharyngeal swelling, Rash, Throat irritation
Clinical narrative: initially there was redness, warmth, swelling and tenderness at injection site.  Rash spread to neck and torso then to lower extremities. Throat irritation and swelling occurred with airway obstruction within an hour Treatment rendered in the ED for anaphylactic reaction
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Myalgia, Pyrexia
Clinical narrative: MUSCLE PAIN, HEADACHE, SHIVERING, FEVER, LOSS  OF APPETITE  RASH ON BACK, SENSITIVE  AREAS ON BACK HAVING HAD SHINGLES 15 YEARS AGO, THE CURRENT SYMPTOMS ARE MUCH MILDER
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: MUSCLE PAIN, HEADACHE, SHIVERING, FEVER, LOSS  OF APPETITE  RASH ON BACK, SENSITIVE  AREAS ON BACK HAVING HAD SHINGLES 15 YEARS AGO, THE CURRENT SYMPTOMS ARE MUCH MILDER
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Muscular weakness, Pain
Clinical narrative: Pain in my left shoulder beginning a few hours after the initial soreness went away and still ongoing. It is painful to make certain movements like to lift my arm above my head or to put downward pressure on my arm. I have experienced weakness in my left arm as well and difficulty sleeping on my left side. I have an appointment to see a physician, Dr. regarding my shoulder pain on November 5.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Swelling face, Urticaria
Clinical narrative: Facial swelling and hives all over body, went to ER received epinephrine and reaction resolved.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Chest discomfort, Facial pain, Lip pain, Oral discomfort
Clinical narrative: burning/pain/tingling to face/lips and mild chest tightness, onset 15 min after vaccination.  Burning/pain/tingling to face lasted approx. 50min, mild chest tightness lasted approx. 30 min
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: burning/pain/tingling to face/lips and mild chest tightness, onset 15 min after vaccination.  Burning/pain/tingling to face lasted approx. 50min, mild chest tightness lasted approx. 30 min
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: Diarrhea for approximately 8 hours was the first symptom. A fever of 100.6 with over all muscle aches, extreme fatigue and no appetitie persisted for 24-36 hrs which began approximately 6-8 hrs after injection. I was told it was a Tetanus shot which I've had before but was not told that it also had the whooping cough virus in it.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse effects; The nurse reported that the patient, who is 16 years old, was given one dose of VAQTA 50/1.0 U/ml; This spontaneous report was received from a nurse concerning a 16 year old patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions.  On 07-OCT-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), 1 dose (50/ 1.0 U/ml), via intramuscular, lot # R024008, expiration date 15-NOV-2019  for prophylaxis (frequency and anatomical location were not reported) (incorrect dose administered). No adverse effects were reported
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles or herpes zoster; This spontaneous report was received from a lawyer an the patient regarding a case in litigation and refers to a male patient (pt) of unspecified age. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  In or about 2013, the patient was inoculated by a healthcare provider with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of herpes zoster or shingles.  On an unspecified date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles or herpes zoster and was hospitalized; he received unspecified treatment for the event. It was stated that as a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages.  At the reporting time, the patient had not recovered from the event and it was considered it to be related to zoster vaccine live (ZOSTAVAX).
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen Injection Site; Red at site of injection; Hot to the touch at site of injection; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 3-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 425T2, expiry date unknown) for prophylaxis.   On 1st October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. In October 2019, less than 2 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that the 3 years old patient experienced swollen and red and hot to the touch at site of injection after vaccination. The batch number reported for Fluarix Quadrivalent 2019-2020 season(42512) did not exist and was updated to 425T2, as per sales database. The reporter did not agree to the follow up. This case has been linked with case US2019AMR185046, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Skin reaction
Clinical narrative: Severe topical reaction; This case was reported by a pharmacist via sales rep and described the occurrence of skin reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Quadrivalent .5 ml. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced skin reaction. The patient was treated with prednisone. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: This case was reported by the reporter for his/her one of the prisons employee. The age at vaccination was not reported. The reporter stated that the patient had severe topical reactions to FluLaval. This is 1 of the 2 cases reported by the same reporter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes; This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional information received were as follows: The pharmacist called in to question that whether there was any information on reaction of swollen lymph nodes after 1st injection of Shingrix. The patient received Shingrix on left arm. The patient experienced swollen nodes after injection. The adverse event was collected.  The healthcare professional was unable to provide lot and expiration of vaccine.  The reporter did not consent to follow-up.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity, Pruritus
Clinical narrative: Swelling at the injection site / MIinuscule swelling near what may have been the injection site; Itching; Pain; Pain at Injection Site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, 1 hr after receiving Shingrix, the patient experienced pain in arm. On 20th August 2019, the patient experienced injection site swelling, pruritus and pain. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the injection site swelling and pruritus were not recovered/not resolved and the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the injection site swelling, pruritus, pain in arm and pain to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. 1 to 2 hours following vaccination, the patient experienced pain. Approximately 3 to 4 hours following vaccination, the patient experienced swelling at the injection site which lasted approximately 3 to 4 days. 3 to 4 hours after receiving Shingrix, the patient had very minor itching when he had swelling. Several weeks later there was re-occurrence of itching and pain which he believed was near the injection site but was unsure. The caller reported that the itching that reoccurred was much more severe and itches various times of the day. The caller reported cortisone cream helped, but sometimes he may had minor itching in the morning and minor itching again the same evening. Lastly, the caller mentioned minuscule swelling near what may had been the injection site that had been ongoing for approximately 2 weeks. The reporter mentioned that this minuscule swelling may not be noticed by others, but he can tell.  The reporter did not consent to follow-up. The reporter did not consent to healthcare professional follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis, Eye infection
Clinical narrative: Eye infections of conjunctivitis type; Conjunctivitis; This case was reported by a pharmacist via call center representative and described the occurrence of eye infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced eye infection and conjunctivitis. On an unknown date, the outcome of the eye infection and conjunctivitis were not recovered/not resolved.   It was unknown if the reporter considered the eye infection and conjunctivitis to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced eye infections of conjunctivitis type. The reporter consented to follow up. The healthcare professional was asked to provide more details regarding patient and product but did not do so during course of chat he did provide address for follow up to be sent.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Expired product administered, Headache, Induration, Limb discomfort
Clinical narrative: patient that received Menactra a day after it had been expired; Headaches; left arm is hard; Initial information received on 10-Oct-2019, 11-Oct-2019, 14-Oct-2019 and 15-Oct-2019 were processed together regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced headaches (headache) and left arm is hard (limb discomfort), while she received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HPV VACCINE VLP RL1 9V (YEAST) [GARDASIL 9].  The patient's past medical history included Headache and Visual impairment. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and HPV VACCINE (HPV VACCINE) for Immunisation.  On 07-Oct-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA, Exp. Date 06-Oct-2019 via intramuscular route in the left deltoid. On 07-Oct-2019, the patient received a dose of suspect GARDASIL 9 not produced by Sanofi Pasteur lot number not reported via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious headaches (headache) and left arm is hard (limb discomfort) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and GARDASIL 9.  It was also a case of expired vaccine used.  It was reported that RA's doctor has deduced it is not the expired Menactra that caused the Headaches and the left arm that is hard. It is the Guardasil 9.  Other relevant tests not reported.   Final diagnosis was headaches and left arm is hard.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for headaches and left arm is hard.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Local reaction, Peripheral swelling
Clinical narrative: large local reactions on the arm, systemic symptoms and swelling from his shoulder to his fingertips; systemic symptoms; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional.   This case involves male patient (age not reported) who experienced large local reactions on the arm, systemic symptoms and swelling from his shoulder to his fingertips (extensive swelling of vaccinated limb)( adverse event), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the arm.  On an unknown date, the patient developed a non-serious large local reactions on the arm, systemic symptoms and swelling from his shoulder to his fingertips (extensive swelling of vaccinated limb) (adverse event)(unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that the patient has had systemic symptoms and swelling from his shoulder to his fingertips with each Fluzone injection in the past. It is unknown how many injections of Fluzone the patient has received in the past.  Other relevant tests not reported.   Final diagnosis was extensive swelling of vaccinated limb.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for extensive swelling of vaccinated limb.  Information on the batch number was requested.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Doctor inadvertently administered a 60 years old patient a dose of Fluzone High Dose vaccine, he assumed that the patient was 65 years old/No AE; Doctor inadvertently administered a 60 years old patient a dose of Fluzone High Dose vaccine, he assumed that the patient was 65 years old/No AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 60 years old patient (gender unknown) who was inadvertently administered a dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] by a doctor, he assumed that the patient was 65 years old lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Immunosuppression.   It was an actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.   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.  Information on the batch number was requested.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Adcel vaccine that was given to a patient, 5 days past the expiration date, no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 months old female patient who received a 0.5 mL dose (4th dose in series) of expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: C52881AA, expiry date: 05-Oct-2019) via intramuscular route in left thigh on 10-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used. Adacel vaccine that was given to a patient, 5 days past the expiration date.   At the time of reporting, no adverse event was reported.   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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received an expired dose of Daptacel, no AE; 3 years old patient received an expired dose of Daptacel (4th dose in series) , no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old female patient who received a 0.5 mL dose (4th in series) of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5281AA, expiry date: 05-Oct-2019), via intramuscular route in the right thigh on 11-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  It was a case of actual medication error due to expired vaccine used and inappropriate schedule of vaccine administered.  At the time of reporting, no adverse event was reported.   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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Age: 1.83
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 22 month old received a Flublok Quadrivalent, no adverse event; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 22 months old female patient who received a dose of 0.5 ml of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV  lot QSAA1921/QSAA191, exp date: 30-Jun-2020 via unknown route in the left thigh on 11-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration.  The patient did not experience any adverse event.  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.  Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old female was given Flublok Quadrivalent, no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old female patient who was given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot# QFAA1927, exp date: June 30/2020, via unknown route in the deltoid nos on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given.   It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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.