chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on torso that spread toward armpits and face.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Muscle spasms, Myositis, Pain
Clinical narrative: Patient started feeling aching and pain. Her range of motion froze up. 3hrs after the vaccination. The patient went to her provider the next day. NP could move her arms with full range of motion. The patient could not. NP felt that the muscle was inflamed and in spasm. Patient's arm was better on the 10th, but she still could not raise it above her shoulder.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site erythema, Malaise
Clinical narrative: VACCINE GIVEN 11/08/2017, PATIENT CALLED STORE ON 11/13/2017 TO SAY SHE HAD A LARGE HER WORDS "SAUCER" SIZE RED AREA AROUND VACCINE SITE, SHE REPORTS IT STARTED THE MORNING OF 11/10/2017 AND SHE SAID SHE DIDN'T FEEL WELL ALL WEEKEND. DUE TO SIZE AND DURATION I TOLD HER TO GO LET HER DOCTOR LOOK AT IT FOR PRECAUTION. SHE DID AND DOCTOR WASN'T CONCERNED AND TOLD HER TO KEEP TREATING IT AS A ALLERGIC REACTION. ANTIHISTAMINE AND COLD COMPRESS AND TO WATCH IT.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Peripheral swelling, Rash pustular
Clinical narrative: Huge local reaction spanning entire upper arm, with redness & swelling. Fluid filled pustules forming on upper arm also.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Flushing, Stridor, Throat tightness
Clinical narrative: Couple of minutes after injection flushing, complaining about closed throat feeling, difficulty breathing/stridor. Nurse left room, instructed to call EMS and doctor was called in. Doctor administered 1ml 1mg/ml Epinephrine. Immediate response regression of symptoms. Squad took patient to ER when they arrived. ER administered Famotidine IVPB 20mg, Methylprednisolone, Diphenhydramine 25mg inj, patient to continue prednisone 2 days. Scheduled office visit 12/27/17 for follow-up and to complete annual.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Feeling cold, Tremor
Clinical narrative: At 5 in the evening pt got cold and was shaking. He was weak and had a loss of appetite. This started Wednesday evening and he finally felt better Sunday evening (November 12).
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: Gave Td vs. Tdap needed to prevent pertussis in unborn child. Client was 29 weeks when vaccine was given. Her due date is Jan. 10 of 2018. No reported S/S R/T vaccination. Will contact client to receive Tdap before 36 weeks of Gestation as directed by supervisor.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: On 10/30 (10 days after vaccination) patient reported that had pain in left shoulder that started approximately 12 hours after the injection. And he sent a photo of where the Band Aid had been placed. Complained of pain at night as well as with some range of motion. Seen by PCP who contacted ortho physician - determined injection possibly went into bursa and should resolve with MEDROL. Pain persisted so patient was seen by ortho physician on 11/8 who said it was possible intra-bursa ortra-articular injection. Feels should have a full recovery in 3-4 weeks with full range of motion.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm is red, swollen and warm to the touch. She complained about severe pain on her right arm the night after the injection. Patient presented to the pharmacy 48 hours after vaccination. Informed patient to continue ice/ibuprofen/rest. If not resolved in 24 hours to contact primary care physician.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Lacrimation increased, Nasal congestion, Sneezing
Clinical narrative: Later in the day patient stated her eyes got very watery, a lot of sneezing more than 3x in duration . other s/s stuffy nose, coughing with wheezing, slight sob included. In the evening patient stated she felt worse, woke up during the night with sob. Today Monday patient stated she feels a little better, still has stuffy nose, a little wheezing , coughing a little less.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Later in the day patient stated her eyes got very watery, a lot of sneezing more than 3x in duration . other s/s stuffy nose, coughing with wheezing, slight sob included. In the evening patient stated she felt worse, woke up during the night with sob. Today Monday patient stated she feels a little better, still has stuffy nose, a little wheezing , coughing a little less.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient had pain and swelling of the arm (shoulder to elbow). After the swelling went down the patient experienced itching of the same area.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Patient had pain and swelling of the arm (shoulder to elbow). After the swelling went down the patient experienced itching of the same area.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site oedema, Injection site rash
Clinical narrative: Patient reports bruising, rash and edema @ site. Patient seen by MD for office eval.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given Tdap instead of DTaP at age 15 months. No adverse effects noted. Patient is now 30 months.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Patient experienced chills, fever-like symptoms, shaking uncontrollably.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Feeling abnormal, Nervousness
Clinical narrative: Patient experienced chills, fever-like symptoms, shaking uncontrollably.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema, Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Received FLUZONE on Friday 11/10, right arm and forearm swollen, warm to touch, little redness, moderately painful when touched - mom first noticed the swelling Saturday morning and decided to monitor, but swelling has not decreased, also with small cluster of blisters on right arm above elbow - patient seen in office and doctor noted: right arm with swelling compared to the left - angioedema noted around the injection site below to the elbow - no streaking noted on the skin but overall mildly erythematous and pruritic - 2 small blisters noted right above the elbow where she was "itching a lot" per mom - diagnosed with allergic reaction - prescribed BENADRYL and to monitor for now.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Received FLUZONE on Friday 11/10, right arm and forearm swollen, warm to touch, little redness, moderately painful when touched - mom first noticed the swelling Saturday morning and decided to monitor, but swelling has not decreased, also with small cluster of blisters on right arm above elbow - patient seen in office and doctor noted: right arm with swelling compared to the left - angioedema noted around the injection site below to the elbow - no streaking noted on the skin but overall mildly erythematous and pruritic - 2 small blisters noted right above the elbow where she was "itching a lot" per mom - diagnosed with allergic reaction - prescribed BENADRYL and to monitor for now.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash erythematous
Clinical narrative: Fever, red spots, fussy.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: NONE.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's left arm was swollen, red and warm to the touch. We helped her find Benadryl, Zantac and Zyrtec otc and recommended ice. We followed up with her today and she is all better.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Influenza like illness, Injection site rash, Malaise
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's parent). A 16-year-old male patient received the 2nd dose of TRUMENBA, via an unspecified route of administration in left arm, on 01Nov2017 at 11:30 AM, at single dose, for immunisation. Patient was vaccinated at doctor's office. Previously the patient received the 1st dose of TRUMENBA at the end of Jul2017 and experienced really sick, fever for 2 days and sore muscles in the injected arm for 3 days. He recovered completely. The patient experienced flu like symptoms in Nov2017 with outcome of unknown, headache around 06:00 PM on 01Nov2017 with outcome of unknown for which took ADVIL, injection site rash on 02Nov2017 with outcome of not recovered, he was really tired on 02Nov2017 with outcome of not recovered, arm really sore on 01Nov2017 with outcome of not recovered.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's parent). A 16-year-old male patient received the 2nd dose of TRUMENBA, via an unspecified route of administration in left arm, on 01Nov2017 at 11:30 AM, at single dose, for immunisation. Patient was vaccinated at doctor's office. Previously the patient received the 1st dose of TRUMENBA at the end of Jul2017 and experienced really sick, fever for 2 days and sore muscles in the injected arm for 3 days. He recovered completely. The patient experienced flu like symptoms in Nov2017 with outcome of unknown, headache around 06:00 PM on 01Nov2017 with outcome of unknown for which took ADVIL, injection site rash on 02Nov2017 with outcome of not recovered, he was really tired on 02Nov2017 with outcome of not recovered, arm really sore on 01Nov2017 with outcome of not recovered.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Cough, Feeling cold, Headache
Clinical narrative: Headache, "severe" chills, sensation of cold throughout body within 8hrs of vaccination. Stomach upset, body aches for 3 days following vaccination. Also cough. All resolved except dull headache which was present prior to vaccination.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Headache, "severe" chills, sensation of cold throughout body within 8hrs of vaccination. Stomach upset, body aches for 3 days following vaccination. Also cough. All resolved except dull headache which was present prior to vaccination.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass, Pain in extremity, Ultrasound scan
Clinical narrative: My daughter received her second GARDASIL shot on 10/12/17. She developed a lump at the injection site. I looked at the possible side effects and saw that this was normal. Now a month later the lump is the size of a tennis ball and the injection site has its own lump. The injection lump almost looks bruised. Her arm is rock hard and her entire arm hurts. She has been to two different doctors and has had an ultrasound done. The are unable to determine the problem. The nurse from the office just called to give her the results of the ultrasound. The nurse was under the impression that the shot was given last week. When my daughter told her it was almost a month she told my daughter to get into an urgent care. Please advise if this is a side effect. I'd like a call back before the weekend. Thank you.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Loss of personal independence in daily activities, Sleep disorder
Clinical narrative: I developed severe joint aches in both arm and legs; shoulders to hands and hips to ankles, starting during the night following administration of the vaccine. There has been no fever or headache. No outside medical attention was obtained. As a healthcare professional, I was able to self-diagnose and treat with anti-inflammatory medications and other palliative remedies. The pain is severe enough to disrupt sleep and normal ADLs. Symptoms are still present after 4 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received FLUZONE HD, PREVNAR 13 and ADACEL on 11/6/17. FLUZONE & PREVNAR both given in left arm. Pt developed 6 in by 4 in redness and swelling on left arm, lower injection site, that did not respond to Benadryl. Patient called pharmacy to report on 11/13. rph advised patient to contact PCP or go to urgent care for further treatment. VAR does not clearly state which vaccine was lower admin site. Rph suspects PREVNAR 13 was lower admin site, based on practice habits.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Malaise
Clinical narrative: Chills, malaise, fatigue occurring at 19:00.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Right upper arm: 9cm x 7cm redness, no pain with palpation or much in duration; Left upper arm: very slight redness with mild pain with palpation.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin, Injection site erythema, Rash, Rash vesicular, Varicella virus test positive
Clinical narrative: Pt had flu shot to the left deltoid on 11/2/17. The following day he developed a vesicular rash that started on the left deltoid and then spread to involve the left mid volar forearm and left thenar eminence, He described  the vesicles are tense and painful. He was seen at our office on11/09/2017.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain
Clinical narrative: Pain lasting more than 48 hours after vaccination. I examined the patient to see where the vaccination was given. It is possible that the vaccination was given too high on the arm and was injected too close to the acromion. I advised patient that if symptoms do not resolve after 5-7 days then consult with PCP.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt was vaccinated 11/5/17.  She reported she started to have rash on her chest/back and left arm 11/12/17. She was recently diagnosed with lymphoma but not on any medication or treatment for that.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin tightness, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot tight, traveled down the arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Pt reported "feeling ill" and having a red, swollen, warm and hard area about 3-4 inches in diameter in left shoulder (site of injection) for 24-48 hours after injection. She also reports this is the first time she's had the High Dose vaccine. She did ice the area once a day.
Age: 24.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Arthralgia, Joint range of motion decreased, Ligament pain, Pain, Tendon pain
Clinical narrative: Pt c/o pain in elbows when he tries to move them, especially the left arm. It started two days after the shots. He says it feels like his tendons and ligaments are really sore. They are slightly sore to the touch but very sore when he tries to move them, he feels like his range of motion is limited. There is possibly slight swelling at the elbow on the left arm but none on the right arm.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Blood test, Dehydration, Diarrhoea, Diet refusal, Encephalitis
Clinical narrative: High fever by 3:00 am of 104, high pitch screaming and fussiness. By afternoon refused to eat with diarrhea. Took to doctors and was informed to alternate Tylenol and Motrin. Dr. also gave mylicon drops and mylanta. Temperature persisted. On 3/8/2008, child was in pain all over. Parent could not touch without child screaming in pain. Diarrhea still persistent. Child taken to ER where spinal was done. Child transferred by ambulance to another hospital. Blood work, x-rays were performed.  Treated for encephalitis, significant fluid loss, and gastroenteritis.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Gastroenteritis, Irritability, Lumbar puncture, Pain, Pyrexia
Clinical narrative: High fever by 3:00 am of 104, high pitch screaming and fussiness. By afternoon refused to eat with diarrhea. Took to doctors and was informed to alternate Tylenol and Motrin. Dr. also gave mylicon drops and mylanta. Temperature persisted. On 3/8/2008, child was in pain all over. Parent could not touch without child screaming in pain. Diarrhea still persistent. Child taken to ER where spinal was done. Child transferred by ambulance to another hospital. Blood work, x-rays were performed.  Treated for encephalitis, significant fluid loss, and gastroenteritis.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Scan, Screaming, Tenderness, X-ray
Clinical narrative: High fever by 3:00 am of 104, high pitch screaming and fussiness. By afternoon refused to eat with diarrhea. Took to doctors and was informed to alternate Tylenol and Motrin. Dr. also gave mylicon drops and mylanta. Temperature persisted. On 3/8/2008, child was in pain all over. Parent could not touch without child screaming in pain. Diarrhea still persistent. Child taken to ER where spinal was done. Child transferred by ambulance to another hospital. Blood work, x-rays were performed.  Treated for encephalitis, significant fluid loss, and gastroenteritis.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Patient received the vaccine on 11/8/2017 and came back to pharmacy and report side effects of redness and swelling on left upper arm and a red spot on the left forearm. Patient said she is being seen by Dr. She came back and told us Dr. said it was an allergic reaction.  She was also given Benadryl. Called pt later the afternoon to inquire other health condition to complete this report.  Pt said the redness and swelling has gone down.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site bruising
Clinical narrative: On the same day following the vaccine patient was having trouble moving the arm that received the injection. She is not sure of the exact time it started but knows it wasn't immediately following the shot. The next day patient woke up and arm felt better but a bruise at least 6 inches in circumference was located below the injection site. The bruise is not painful or bothersome to the patient.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever of 101+, heart rate 95+ over the course of 5-6 hours starting about 7 hours after injection.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Amnesia, Chronic inflammatory demyelinating polyradiculoneuropathy, Gait inability, Gastrointestinal tube insertion, Gastrostomy
Clinical narrative: My feet started tingling and then I lost my memory of the next months. Muscle weakness in both legs and unable to walk to end up paralyzed from the nose down.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Muscular weakness, Neuropathy peripheral, Osteonecrosis, Paraesthesia
Clinical narrative: My feet started tingling and then I lost my memory of the next months. Muscle weakness in both legs and unable to walk to end up paralyzed from the nose down.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Paralysis, Plasmapheresis, Sensory loss, Tracheostomy, Transfusion
Clinical narrative: My feet started tingling and then I lost my memory of the next months. Muscle weakness in both legs and unable to walk to end up paralyzed from the nose down.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hypersensitivity, Swelling face
Clinical narrative: Received flu shot on 10/5/2017 and had an allergic reaction 10/5/2017 with signs of swelling on the right face and breathing problem. Staff was  given SOLU-MEDROL, BENADRYL, PEPCID and DUONEB.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Urticaria
Clinical narrative: Pt claims "Hives, stiff neck, pain on left side, including arms. Never felt anything like that before and I had the flu shot multiple times in my life".
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No treatment.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle rupture, Pain in extremity, Scan
Clinical narrative: Pt arm is still in pain into November. She saw her Dr and Dr says something is torn inside.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Dyspnoea, Erythema, Peripheral swelling
Clinical narrative: In November/10/2017 Patient came into the pharmacy and asked for Pneumo shot. I checked the "alert", it did not show she had PRENAR 13 in June/11/2015 at our pharmacy (the Rx # 6401074). According to  CDC, I gave the PNEUMOVAX 23 @ 4pm. She went home and couple hours later, her arm swelling (size of the tennis ball), redness spreading to her elbow. She went to the ER at 8pm and received the "cortisone" shot and Ibuprofen to bring down the swelling. The next day she saw her Dr for her chest pain, and breathing problem (she did mention that this is not doing with the shot), and today November /13 pharmacy received the E scrip for Nitro 0.4mg and Isosorbide mononitrate ER 30mg. I called her today to ask how is she doing: she said she felt much better, the swelling is gone, and she is treated for her chest pain.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Aspiration bone marrow, Fatigue, Full blood count, Headache, Immune thrombocytopenic purpura
Clinical narrative: Immune thrombocytopenia Purpura (initial platelet count of 7,000 which decreased to 5,000 in less than 24 hours), severe fatigue, weight loss, sore throat, headaches, irritability.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Irritability, Metabolic function test, Mononucleosis heterophile test, Oropharyngeal pain, Platelet count decreased
Clinical narrative: Immune thrombocytopenia Purpura (initial platelet count of 7,000 which decreased to 5,000 in less than 24 hours), severe fatigue, weight loss, sore throat, headaches, irritability.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Streptococcus test, Weight decreased
Clinical narrative: Immune thrombocytopenia Purpura (initial platelet count of 7,000 which decreased to 5,000 in less than 24 hours), severe fatigue, weight loss, sore throat, headaches, irritability.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: The patient fainted shortly after receiving the vaccine. She didn't seem to fully lose consciousness, once she was lowered to the floor by her significant other, she was awake. She stayed seated and received water and some candy and after 10-15 minutes of feeling fine, she got up and left the building.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Enlarged red, area spreading to inner arm, which is warm to touch, swollen and a bit sore; chill (for two days); and headache (for two days).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Enlarged red, area spreading to inner arm, which is warm to touch, swollen and a bit sore; chill (for two days); and headache (for two days).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Paraesthesia
Clinical narrative: Patient got vaccine on 11/07/17 and on 11/09/17 in am Patient filling hand numbness and tigling, local redness at site of injection.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swollen upper and lower arms.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Pt called 11/13/17 and explained that her arm is red and has a white spot at the injection site. No pain, itchiness, or pus. I looked at it, and it is lightly red, around 2 inch in diameter. She got the vaccine on 11/12/17 in the afternoon.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Severe soreness/pain in right arm at injection site and surrounding area. Unable to raise arm. This started approx. 6hrs after vaccine was administered. Flu-like symptoms (chills/fever/body aches) started approx. 8hrs after vaccine was administered. Flu shot was also administered the same day as the PPSV23. PPSV23 was given in right arm (same are where soreness was) Flu shot was given in left arm.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Severe soreness/pain in right arm at injection site and surrounding area. Unable to raise arm. This started approx. 6hrs after vaccine was administered. Flu-like symptoms (chills/fever/body aches) started approx. 8hrs after vaccine was administered. Flu shot was also administered the same day as the PPSV23. PPSV23 was given in right arm (same are where soreness was) Flu shot was given in left arm.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: PATIENT REPORTS NORMAL AMOUNT OF PAIN AT INJECTION SITE THAT ABOUT A WEEK LATER SPREAD TO HER SHOULDER AND SHE HAS BEEN EXPERIENCING A DECREASE IN RANGE OF MOTION FOR LAST TWO WEEKS.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Cough, Escherichia infection, Pyrexia, Sepsis
Clinical narrative: 10/28/17 admitted to hosp. for E. coli UTI sepsis, fever, atrial fib new onset, cough. Doctor doesn't think related to HD flu vaccine, but wanted reported.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary tract infection
Clinical narrative: 10/28/17 admitted to hosp. for E. coli UTI sepsis, fever, atrial fib new onset, cough. Doctor doesn't think related to HD flu vaccine, but wanted reported.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient came in for a flu shot on 10/3/17. On 10/5/17, he began to feel pain at the injection site. Patient came in today to state that pain has not gone away. Patient received FLUVIRIN PFS. I suggested that he see his physician as soon as possible.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Discomfort, Swelling
Clinical narrative: C/o swelling and discomfort after imms. Sx decreased by day 3 after imms.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Received GARDASIL vaccine and then passed out.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Burning sensation, Erythema, Pain, Rash erythematous, Rash macular
Clinical narrative: The patient presents today with a complaint of a rash that started Wednesday, October 25, 2017 with redness of the face and swollen bumps across the glabella and right eyebrow. The swollen bumps were quite itchy. The facial skin redness had a burning, stinging sensation. The patient woke up this morning October 26, 2017 noting that the red macular rash spread to involve his arms and torso. Tuesday, October 24, 2017 the patient received a flu shot.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash pruritic
Clinical narrative: The patient presents today with a complaint of a rash that started Wednesday, October 25, 2017 with redness of the face and swollen bumps across the glabella and right eyebrow. The swollen bumps were quite itchy. The facial skin redness had a burning, stinging sensation. The patient woke up this morning October 26, 2017 noting that the red macular rash spread to involve his arms and torso. Tuesday, October 24, 2017 the patient received a flu shot.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Pt still c/o soreness, tenderness on the injection site a month after the shot. There is still visible slight bruising.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: On 11/09/2017 I received the PPV-23 pneumonia shot. Within 12 hours, I had all of the symptoms listed: headache, low grade fever, lightheadedness (brief), soreness at injection site and towards the elbow 4-5 inches, swollen arm, redness from injection sight to elbow. It has been more than 48 hours since injection and no easing of pain or symptoms.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: On 11/09/2017 I received the PPV-23 pneumonia shot. Within 12 hours, I had all of the symptoms listed: headache, low grade fever, lightheadedness (brief), soreness at injection site and towards the elbow 4-5 inches, swollen arm, redness from injection sight to elbow. It has been more than 48 hours since injection and no easing of pain or symptoms.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Limb injury
Clinical narrative: Vaccine administered too high resulting in shoulder injury.
Sex: U
Vaccine: HEP
Symptoms: Needle issue
Clinical narrative: A dose of Hepatitis B vaccine (ENGERIX-B) 10mcg/0.5mL was administered to a newborn by nurse and when nurse removed the syringe from the baby's injection site, found the needle still halfway in the injection site. It was prefilled syringe from manufacturer, the needle was separated from the syringe.
Age: 63.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection site has decreased. Will continue to monitor as needed.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness from deltoid to elbow, swelling, pain.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation
Clinical narrative: Local inflammation.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: Pain in (R) arm that radiated to right jaw x 3 days after injection - resolved - no treatment.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 12 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
Age: 17.0
Sex: F
Vaccine: HEPA, HPVX, HEPA, HPV9
Symptoms: Dizziness, Musculoskeletal stiffness, Neurological examination normal, Posture abnormal, Seizure
Clinical narrative: Immediately following 2nd vaccine administration HPV, as I was putting the BANDAID on sitting pt. she became faint and had about 3 jerks of her arms and her feet extended - only lasted for seconds and she became very pale, but says was feeling fine shortly after. Mother at her side. Had her wait several minutes before leaving office. Called and checked on her at home - Mom said she was tired otherwise fine. HCP notified - orders given to lay down for further IZ's.
Age: 17.0
Sex: F
Vaccine: HEPA, HPVX, HEPA, HPV9
Symptoms: Dizziness, Dyskinesia, Fatigue, Immediate post-injection reaction, Pallor
Clinical narrative: Immediately following 2nd vaccine administration HPV, as I was putting the BANDAID on sitting pt. she became faint and had about 3 jerks of her arms and her feet extended - only lasted for seconds and she became very pale, but says was feeling fine shortly after. Mother at her side. Had her wait several minutes before leaving office. Called and checked on her at home - Mom said she was tired otherwise fine. HCP notified - orders given to lay down for further IZ's.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a pharmacist regarding a 63 year old female patient. The patient was allergic to penicillin. The patient was taking cholesterol medication and blood pressure medication. The patient had no pertinent medical history. On 12-OCT-2017, the patient received an unspecified dose of ZOSTAVAX subcutaneous for prophylaxis (anatomical location, lot number and expiration date were not reported). On the morning of 22-OCT-2017, the patient woke up with mosquito bite-like bumps (4 bumps on 1 finger, 2 above eyebrow, 2 on thumb, and 2 on an unspecified arm) that were itchy and red, with a blister like appearance. The patient did not receive treatment for the adverse events and no lab diagnostics/studies performed; however the patient did call the reporter seeking for medical attention. At the reporting time, the patient was not recovered from the adverse events. The causal relationship between the events mass, erythema and pruritus and therapy with ZOSTAVAX was not reported.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a pharmacist regarding a 63 year old female patient. The patient was allergic to penicillin. The patient was taking cholesterol medication and blood pressure medication. The patient had no pertinent medical history. On 12-OCT-2017, the patient received an unspecified dose of ZOSTAVAX subcutaneous for prophylaxis (anatomical location, lot number and expiration date were not reported). On the morning of 22-OCT-2017, the patient woke up with mosquito bite-like bumps (4 bumps on 1 finger, 2 above eyebrow, 2 on thumb, and 2 on an unspecified arm) that were itchy and red, with a blister like appearance. The patient did not receive treatment for the adverse events and no lab diagnostics/studies performed; however the patient did call the reporter seeking for medical attention. At the reporting time, the patient was not recovered from the adverse events. The causal relationship between the events mass, erythema and pruritus and therapy with ZOSTAVAX was not reported.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Full body rash with bright redness, fever, fatigue.
Age: 73.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Guillain-Barre syndrome, Headache, Intensive care, Nerve conduction studies, Paraesthesia
Clinical narrative: Pt presented to the ED with new onset headache and paresthesias consistent with Guillain-Barre Syndrome, who was then transferred to the neurocritical intensive care unit with deteriorating respiratory status, where she is currently still being treated.
Age: 73.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Respiratory disorder
Clinical narrative: Pt presented to the ED with new onset headache and paresthesias consistent with Guillain-Barre Syndrome, who was then transferred to the neurocritical intensive care unit with deteriorating respiratory status, where she is currently still being treated.
Age: 14.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14-year-old female patient who weighed 224 lbs. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 21-SEP-2017, the patient was vaccinated with an adult dose of VAQTA injection, lot # N016805 with expiration date on 04-SEP-2018 (dose and route of administration were not reported). No adverse effects were reported. Follow up information has been received from a registered nurse on 02-NOV-2017 regarding a 14 year old (also reported as 15 year old) female patient. The patient's medical history included ADD (Attention deficit disorder). It was confirmed that the patient was vaccinated with an adult dose of VAQTA injection, lot # N016805 with expiration date: 04-SEP-2018, intramuscularly in left deltoid on 21-SEP-2017. Other suspect therapies included poliovirus vaccine inactivated (unspecified) (lot # N1A461M), given intramuscularly in right deltoid for prophylaxis. The patient was vaccinated at private doctor's office/hospital and the vaccine was purchased with public funds. It was also confirmed that the medication error was occurred during the preparation for administration.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender on 20-OCT-2017. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 17-OCT-2017, the patient was vaccinated with improperly stored VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # unknown), The vaccines were stored in the range of 6 Farenheit degrees to 14 Farenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. The patient did not experience any adverse events. Digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA014744: US-009507513-1710USA014745: US-009507513-1710USA014746: US-009507513-1710USA014747: US-009507513-1710USA014748: US-009507513-1710USA014749: US-009507513-1709USA007342:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender on 20-OCT-2017. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 15-SEP-2017, the patient was vaccinated with improperly stored VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK) (lot # unknown). The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. The patient did not experience any adverse events. Digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007342: US-009507513-1710USA014743: US-009507513-1710USA014749: US-009507513-1710USA014745: US-009507513-1710USA014746: US-009507513-1710USA014747: US-009507513-1710USA014748.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender on 20-OCT-2017. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 15-SEP-2017, the patient was vaccinated with improperly stored VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # unknown), The vaccines were stored in the range of 6 Farenheit degrees to 14 Farenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. The patient did not experience any adverse events. Digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007342: US-009507513-1710USA014743: US-009507513-1710USA014744: US-009507513-1710USA014746: US-009507513-1710USA014747: US-009507513-1710USA014748: US-009507513-1710USA014749:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender on 20-OCT-2017. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 13-SEP-2017, the patient was vaccinated with improperly stored VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # unknown), The vaccines were stored in the range of 6 Farenheit degrees to 14 Farenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. The patient did not experience any adverse events. Digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007342: US-009507513-1710USA014743: US-009507513-1710USA014744: US-009507513-1710USA014745: US-009507513-1710USA014747: US-009507513-1710USA014748: US-009507513-1710USA014749:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender on 20-OCT-2017. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 27-SEP-2017, the patient was vaccinated with improperly stored VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # unknown), The vaccines were stored in the range of 6 Farenheit degrees to 14 Farenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. The patient did not experience any adverse events. Digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007342: US-009507513-1710USA014743: US-009507513-1710USA014744: US-009507513-1710USA014745: US-009507513-1710USA014746: US-009507513-1710USA014748: US-009507513-1710USA014749:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender on 20-OCT-2017. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 09-OCT-2017, the patient was vaccinated with improperly stored VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK) (lot # unknown). The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. The patient did not experience any adverse events. Digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007342: US-009507513-1710USA014743: US-009507513-1710USA014744: US-009507513-1710USA014745: US-009507513-1710USA014746: US-009507513-1710USA014747: US-009507513-1710USA014749.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender on 20-OCT-2017. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 16-OCT-2017, the patient was vaccinated with improperly stored VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # unknown), The vaccines were stored in the range of 6 Farenheit degrees to 14 Farenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. The patient did not experience any adverse events. igital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007342: US-009507513-1710USA014743: US-009507513-1710USA014744: US-009507513-1710USA014745: US-009507513-1710USA014746: US-009507513-1710USA014747: US-009507513-1710USA014748:
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019 (dosage information and route were not informed). The doses of the vaccine experienced the lowest temperature of 32 degrees Fahrenheit and the highest of 54 degrees Fahrenheit for 49 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from the physician on 16-OCT-2017. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided). The doses of the vaccine experienced the lowest temperature of 47 degrees Fahrenheit and the highest of 49 degrees Fahrenheit for 16 hours. This is one case from several cases received from the same reporter. Follow up information was received from the physician on 16-OCT-2017. The patient was 4 months old. On 16-MAY-2017, the patient was vaccinated with the improperly stored dose of LIQUID PEDVAXHIB (lot # M046140). The patient's and the patient's guardian's identifiers were provided.; Sender's Comments:  US-009507513-1709USA007325:
Age: 1.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 12-month-old female patient. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA007325: