chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patient received improperly stored VARIVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 20-AUG-2019, the patient was vaccinated with vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # r019237 with expiration date on 04-JUL-2020, or S005078 with expiration date on 19-FEB-2021 (dose and route of administration were not reported) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was mixed with properly stored sterile diluent.    The vaccine underwent a temperature excursion of -14 (-9.74 C) to -10 degrees Centigrade. The timeframe was unspecified. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Serum sickness, Skin reaction
Clinical narrative: dimpling; serum sickness; swelling; redness; This spontaneous report was received from a medical assistant and refers to a 75-year-old female patient with hypertension, hyperlipidaemia, hypothyroidism and atrial fibrillation. The patient did not have drug reactions or allergies.   On 25-SEP-2019, the patient was vaccinated intramuscularly with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S021740, expiration date 25-MAR-2021 (exact dose was not reported) for prophylaxis. Concomitant therapies included atorvastatin, diltiazem hydrochloride (DILT XR) and apixaban (ELIQUIS).  On 26-SEP-2019, the patient experienced serum sickness, along with swelling, redness and dimpling at injection site. She sought medical attention. She was treated with prednisone. None lab diagnostics were performed.  The outcome of the events and the relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscular weakness, Myelitis transverse
Clinical narrative: transverse myelitis/progressive lower extremity weakness and numbness of her hands; Information has been received from a lawyer, concerning a case in litigation and referring to a female patient of an unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On or around 09-JUN-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, lot #, expiry date, route and vaccination site were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered progressive lower extremity weakness and numbness of her hands and was diagnosed with transverse myelitis. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality was related.  Upon internal review, the event of transverse myelitis was determined to be medically significant. The event of transverse myelitis was considered to be disabling.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Tenderness at the injection site; Fever; Chills; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2019, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site tenderness, fever, chills and headache. On an unknown date, the outcome of the injection site tenderness, fever, chills and headache were unknown.   It was unknown if the reporter considered the injection site tenderness, fever, chills and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 24 hours ago from the date of reporting.  At the time of this report, the patient was experiencing fever, chills, headache and tenderness at injection site. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Muscular weakness, Peripheral swelling
Clinical narrative: hives, swelling of face and throat, difficulty breathing, fast heartbeat and weakness and swelling and weakness of left arm
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal swelling, Swelling face, Urticaria
Clinical narrative: hives, swelling of face and throat, difficulty breathing, fast heartbeat and weakness and swelling and weakness of left arm
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Back pain, Body temperature increased, Dizziness, Grip strength decreased
Clinical narrative: Pt. started to complain of flu like symptoms, dizziness, body tingling, weakness where he complained he could not grip his pencil in school, temp of 100.2. He was seen in our office where his exam was normal, full strength 5/5 to all extremities, no cerebellar signs. The following day he continued to complain of weakness, numbness and tingling to all extremities, with temp of 101, the symptoms continued and on 5/19/16 and patient was seen by neurology.  He was complaining of weakness, numbness and tingling to his hands and feet, and lower extremities, with headaches, as well as neck and back pain. His exam was normal and a head MRI was ordered at that time. His headaches continued and he was being treated by neurology with Nortriptyline for headaches.  On 5/30/17 patient again c/o muscle weakness, sensory disturbance to his arms and legs and around his waist with headaches at which time he went to Hospital and was transferred to Medical Center to rule out possible GBS, GBS was not diagnosed and patient was discharged.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Hypoaesthesia, Influenza like illness, Laboratory test, Magnetic resonance imaging brain normal
Clinical narrative: Pt. started to complain of flu like symptoms, dizziness, body tingling, weakness where he complained he could not grip his pencil in school, temp of 100.2. He was seen in our office where his exam was normal, full strength 5/5 to all extremities, no cerebellar signs. The following day he continued to complain of weakness, numbness and tingling to all extremities, with temp of 101, the symptoms continued and on 5/19/16 and patient was seen by neurology.  He was complaining of weakness, numbness and tingling to his hands and feet, and lower extremities, with headaches, as well as neck and back pain. His exam was normal and a head MRI was ordered at that time. His headaches continued and he was being treated by neurology with Nortriptyline for headaches.  On 5/30/17 patient again c/o muscle weakness, sensory disturbance to his arms and legs and around his waist with headaches at which time he went to Hospital and was transferred to Medical Center to rule out possible GBS, GBS was not diagnosed and patient was discharged.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Magnetic resonance imaging spinal normal, Muscular weakness, Neck pain, Paraesthesia, Sensory disturbance
Clinical narrative: Pt. started to complain of flu like symptoms, dizziness, body tingling, weakness where he complained he could not grip his pencil in school, temp of 100.2. He was seen in our office where his exam was normal, full strength 5/5 to all extremities, no cerebellar signs. The following day he continued to complain of weakness, numbness and tingling to all extremities, with temp of 101, the symptoms continued and on 5/19/16 and patient was seen by neurology.  He was complaining of weakness, numbness and tingling to his hands and feet, and lower extremities, with headaches, as well as neck and back pain. His exam was normal and a head MRI was ordered at that time. His headaches continued and he was being treated by neurology with Nortriptyline for headaches.  On 5/30/17 patient again c/o muscle weakness, sensory disturbance to his arms and legs and around his waist with headaches at which time he went to Hospital and was transferred to Medical Center to rule out possible GBS, GBS was not diagnosed and patient was discharged.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Condition aggravated, Dyspnoea, Migraine, Neuralgia
Clinical narrative: Increased shortness of breath, joint pain, increase in number of headaches, my right facial nerve is in pain constantly when it usually only when I have a migraine. When I blow my nose, there is blood clots. I have a rash to my back and abdomen.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Thrombosis
Clinical narrative: Increased shortness of breath, joint pain, increase in number of headaches, my right facial nerve is in pain constantly when it usually only when I have a migraine. When I blow my nose, there is blood clots. I have a rash to my back and abdomen.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dyspnoea, Electrocardiogram normal, Palpitations, Productive cough
Clinical narrative: Patient states the next day after her injection she developed diarrhea, felt short of breath and felt palpitations and had a productive cough with yellow sputum
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Sputum discoloured, Wheezing
Clinical narrative: Patient states the next day after her injection she developed diarrhea, felt short of breath and felt palpitations and had a productive cough with yellow sputum
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash
Clinical narrative: had a rash about 1 hour after shot and slight temperature that lasted 2 days
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: On the evening of the 27th had a sore throat which lasted a few days.  Took BetaCarotene and Grapeseed Extract to counteract.   Later in evening started sneezing and runny nose lasting a few days.  On day 3 had horrible bronchial type cough lasting a few days which really hurt when coughing.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: next day developed a rash for 24 hours
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: Muscle pain. Tired - slept most of the day. Headache. Chills. Upset stomach. Fever of 100.3 F.  Lasted 24 hours.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle pain. Tired - slept most of the day. Headache. Chills. Upset stomach. Fever of 100.3 F.  Lasted 24 hours.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA
Symptoms: Wrong product administered
Clinical narrative: Should have been Daptacel
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm that received injection, red, hot and swollen. Took benadryl and claratin and symptoms improved in 5-6 days
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Diaphragmalgia, Dyspnoea, Eye swelling
Clinical narrative: 11/2/19 & 11/3/19 swollen eyes, could not wear any makeup, very sensitive 11/2/19-11/6/19 very achy muscles in buttocks, muscle cramps in feet, very sore knees 11/2/19-11/5/19 extremely tired and weak 11/2/19-11/5-19 could not breath, needed to use Albuterol inhaler multiple times a day, could not breath at night, very sore diaphragm trying to breath I finally connected the dots on 11/5/19 to realize that  all these were side effects, I did not get any paperwork at them time of the shot telling me any side effects, I needed to google it.  Since I have had at least 20 years of flu shots with no side effects it never occured to me that the shot and my symptoms were related.  I called the advice nurse and then had a phone appt with a Dr. They confirmed the reaction, could not tell me how long it would last. Said I was doing the right thing using the Albuterol. No need for an appt unless the symptoms continued a few more days. I am finally feeling better today,11/6/19.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Hyperaesthesia, Muscle spasms, Myalgia
Clinical narrative: 11/2/19 & 11/3/19 swollen eyes, could not wear any makeup, very sensitive 11/2/19-11/6/19 very achy muscles in buttocks, muscle cramps in feet, very sore knees 11/2/19-11/5/19 extremely tired and weak 11/2/19-11/5-19 could not breath, needed to use Albuterol inhaler multiple times a day, could not breath at night, very sore diaphragm trying to breath I finally connected the dots on 11/5/19 to realize that  all these were side effects, I did not get any paperwork at them time of the shot telling me any side effects, I needed to google it.  Since I have had at least 20 years of flu shots with no side effects it never occured to me that the shot and my symptoms were related.  I called the advice nurse and then had a phone appt with a Dr. They confirmed the reaction, could not tell me how long it would last. Said I was doing the right thing using the Albuterol. No need for an appt unless the symptoms continued a few more days. I am finally feeling better today,11/6/19.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swollen Arm; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70-year-old female patient. The patient was a non-smoker. Her medical history included chicken pox (in 1954). Her concomitant medications were not reported.  On 07-JAN-2015, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. On an unknown date, the patient had swollen arm.  The outcome of the event was not reported. The reporter considered swollen arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history and drug reactions/allergies was not reported. Concomitant therapy included sterile diluent.   On 14-OCT-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S015460 with expiration date 20-MAY-2021, dose detail was not reported) via subcutaneous route for prophylaxis. The vaccine experienced improperly stored and was stored at minus 11.5 degree Celsius (C) for 76 hours. There was no previous temperature excursion. The call was because of a data logger involved. It could not be determined if the sterile diluent was properly stored. No adverse effects were reported.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects noted; One of the vaccinations given was supposed to be Prevnar, but instead Gardasil or Gardasil 9 was given; One of the vaccinations given was supposed to be Prevnar, but instead Gardasil or Gardasil 9 was given; This spontaneous report was received from a consumer, concerning her 2 month old grandson. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported.       On 29-OCT-2019 at approximately 15:00, the patient received immunizations with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as "Dtap injection", which the reporter believed immunized the patient to polio and hepatitis B); a hib conj vaccine (reported as "HIB injection"), and rotavirus g1 p1 vaccine live (89-12) (ROTARIX) (or possibly rotavirus g1 g2 g3 g4 p1 reassortant vaccine live (human-bovine)(ROTATEQ)) oral vaccination. The patient was also supposed to receive a pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) injection, but instead he received either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), administered in the patient's tight (dose, route of administration, lot number and expiration date were not reported) No adverse effects were noted.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling, Loss of consciousness, Swelling face
Clinical narrative: The bottom of her face is swollen; Area where the band-aid was applied is inflamed and risen; Risen area; Knocked out; This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient experienced shingles in November 2018). Concomitant products included Herpes zoster (Shingrix).   On 27th October 2019, the patient received the 2nd dose of Shingrix. On 28th October 2019, 1 days after receiving Shingrix, the patient experienced loss of consciousness (serious criteria GSK medically significant). On 29th October 2019, the patient experienced facial swelling, injection site inflammation and injection site swelling. On an unknown date, the outcome of the loss of consciousness and facial swelling were unknown and the outcome of the injection site inflammation and injection site swelling were not recovered/not resolved.   The reporter considered the loss of consciousness, facial swelling, injection site inflammation and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient could not remember the date of her first dose but guesses three months. The patient received 2nd dose of Shingrix which knocked her out. Next morning, the bottom of her face is swollen. The area where the band-aid was applied is inflamed and risen. The reporter did not consent to follow-up.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Abdominal pain, Chills, Pyrexia, Vaccination complication
Clinical narrative: Patient received vaccines at 2:30pm 10-29-19. Approximately 8:00 am on 10-30-19 began to have abdominal pain. The pain worsened throughout the day and patient also developed fever and chills. Patient went to ED and was told by ED doctor the symptoms were most likely due to an adverse reaction to vaccines. Patient was not admitted and all symptoms are resolved at this time.
Age: 7.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Erythema, Pharyngeal disorder
Clinical narrative: The patient came into the office for a Influenza vaccine. Patient received the vaccine in the right arm, abut 8 minutes after the influenza vaccine, the child started saying that he could not breathe, his arms were red and he was clutching his throat. Patients primary care physician, requested for crash bag, and Epinephrine 0.3mg IM. Epinephrine given, per physician order. EMS was called to transport to Emergency Department. Patient was responding, smiling, conscious, and talking after Epinephrine was given.
Age: 7.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Allergy test positive, Anaphylactic reaction
Clinical narrative: The patient came into the office for a Influenza vaccine. Patient received the vaccine in the right arm, abut 8 minutes after the influenza vaccine, the child started saying that he could not breathe, his arms were red and he was clutching his throat. Patients primary care physician, requested for crash bag, and Epinephrine 0.3mg IM. Epinephrine given, per physician order. EMS was called to transport to Emergency Department. Patient was responding, smiling, conscious, and talking after Epinephrine was given.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Vomiting
Clinical narrative: syncope episode, vomiting several times over a period of about 1 hour, left clinic, went home, slept, vomited several more times.  went to bed, went to school the next day, appeared to be recovered.
Age: 50.0
Sex: F
Vaccine: FLU4, HEP, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches - all over and fever of 102.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: I was told her reaction is rare and happens in about 5% of children. But she is presenting with the rash portion of the illness no fever or itchiness so far (day 2 of rash)
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Gaze palsy, Hypopnoea, Pallor, Unresponsive to stimuli
Clinical narrative: Student received flu vaccination at 9:07 am. At approximately 9:17 am, she fell off of the bench, eyes rolled back, face and mouth pale, non-responsive, shallow breathing and incontinent urine. Staff called student's parent, medical director and 911. At 9:20 am, student became responsive, sitting up, alert and oriented, still pale. At 9:24 am, color improved, RR stable. At 9:30 am, student transported by  Rescue EMT.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Urinary incontinence
Clinical narrative: Student received flu vaccination at 9:07 am. At approximately 9:17 am, she fell off of the bench, eyes rolled back, face and mouth pale, non-responsive, shallow breathing and incontinent urine. Staff called student's parent, medical director and 911. At 9:20 am, student became responsive, sitting up, alert and oriented, still pale. At 9:24 am, color improved, RR stable. At 9:30 am, student transported by  Rescue EMT.
Age: 35.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Discomfort, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Insomnia
Clinical narrative: She reported she received 2 vaccines that day, one in each arm. At time of vaccination she was sitting and vaccinator was standing. No problems with left arm. Received influenza in her right arm and felt immediate discomfort with numbness in her fingers that lasted only a couple of minutes. Approx 3 hrs later began to experience pain in her right shoulder. Never had pain like this before. Reports that pain continues, interferes with sleep, and problems with overhead motion to include dressing, drying her hair and driving. Pain is described as a sharp shooting pain that is intermittent.   Symptoms: PAIN IN UNSPECIFIED JOINT(M2550).
Age: 35.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Mobility decreased, Pain
Clinical narrative: She reported she received 2 vaccines that day, one in each arm. At time of vaccination she was sitting and vaccinator was standing. No problems with left arm. Received influenza in her right arm and felt immediate discomfort with numbness in her fingers that lasted only a couple of minutes. Approx 3 hrs later began to experience pain in her right shoulder. Never had pain like this before. Reports that pain continues, interferes with sleep, and problems with overhead motion to include dressing, drying her hair and driving. Pain is described as a sharp shooting pain that is intermittent.   Symptoms: PAIN IN UNSPECIFIED JOINT(M2550).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: severe headache, muscle aches, anorexia, nausea and vomiting on an empty stomach that resolved by 5 PM on the next day Aug 28 2019
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Headache, Influenza virus test negative, Malaise, Oropharyngeal pain
Clinical narrative: On 10/31/19 patient developed fevers (Tmax 102.2 on 11/3/19) followed on 11/1/19 with papular/vesicular rash.  Rash was very itchy.  Subsequently developed malaise, sore throat, mild headache and mild cough.  No contacts with rash.  Pt treated herself symptomatically with tylenol for pain and fevers and hydrocortisone for rash.  Patient seen by this provider in the office on 11/4/19, had negative rapid flu test.  Low suspicion for strep throat, testing not performed.   Concern for possible varicella.  Recommended supportive care only and to avoid contacts at risk of varicella infection.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: On 10/31/19 patient developed fevers (Tmax 102.2 on 11/3/19) followed on 11/1/19 with papular/vesicular rash.  Rash was very itchy.  Subsequently developed malaise, sore throat, mild headache and mild cough.  No contacts with rash.  Pt treated herself symptomatically with tylenol for pain and fevers and hydrocortisone for rash.  Patient seen by this provider in the office on 11/4/19, had negative rapid flu test.  Low suspicion for strep throat, testing not performed.   Concern for possible varicella.  Recommended supportive care only and to avoid contacts at risk of varicella infection.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: rash. Benedryl. Patient improving
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient stated her arm swelled and was red. When patient mentioned she had a reaction today upon examination of her arm there was no redness or swelling visible
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Patient arm that received injection was swollen and red and felt hard. Mother noticed the following night
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Hypersensitivity, Pain, Peripheral swelling, Skin induration
Clinical narrative: My 9 year was at his doc for his 9 year check up and only got the flu shot on 11/4/19 later in the evening he said it hurt still. On 11/5/19 after school 3pm I checked his arm because he was complaining I notice it swollen red hard and hot I traced it. On 11/06/19 I was called by school nurse saying he was complaining. I spoke to his doc office and they advised allergic reaction and to check him out of school and give him Benadryl and keep eye on it. I checked my son out 11/06/19 approx 1230 and notice the red is past the first marking and I traced the new area
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt realized soreness, redness and swelling ("size of half a softball") on Left deltoid at injection site on the morning following the vaccination. Mom states area "felt warm", but by the time the child left for school it "no longer felt warm." Had not seen the doctor or applied ice to area or gave child any medication.
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Shock, Urine analysis
Clinical narrative: Patient seem to go into shock. Went to the ER.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia
Clinical narrative: Patient called pharmacy to report "extreme numbness" in her hand on the arm that she received vaccine. Numbness started morning of 10-24-19 right hand
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red and hot w/i 48 hrs of vaccine. Benedryl given.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Haemoglobin decreased, Malaise, Muscular weakness, Transfusion
Clinical narrative: Low HemoglobiN Sickness  patient, received blood TrANsfusion Weak Legs   TX - Ferrous Sulfate, Levaquin  Folic Acid, Dexametasone
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: soreness; Information has been received from a lawyer and a patient on 29-OCT-2019 regarding a currently 71 years old female patient (this case was split from a legal case with case Number 1812USA002747). The patient's concurrent conditions, medical history or concomitant medications were not provided. Historical vaccines included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (unspecified) and zoster vaccine live (Oka/Merck) (ZOSTAVAX). On 09-SEP-2013, the patient was vaccinated for prophylaxis with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (route of administration, anatomical location, dosage regimen, lot number and expiration were not provided) at her physician's office. On an unspecified date, the patient experienced a side effect of soreness. The outcome of the event of soreness was not reported. Causality assessment was not provided.; Sender's Comments:  US-009507513-1812USA002747:
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Injection site pain, Pain
Clinical narrative: Soreness at the injection site; Upset Stomach; A little tired; Achy; This case was reported by a consumer and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, upset stomach, tiredness and pain. On an unknown date, the outcome of the injection site pain, upset stomach, tiredness and pain were unknown.   It was unknown if the reporter considered the injection site pain, upset stomach, tiredness and pain to be related to Shingrix.  Additional case details were reported as follows: The patient reported that there was nothing to horrible. The patient had some soreness at the injection site, and a little bit of an upset stomach. The patient also a little tired and achy, but again, these symptoms were not severe, just mild. The patient enquired how long did the side effects from the initial vaccination last. Also the patient asked how long did the immunity to shingles last after receiving both shots. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin burning sensation
Clinical narrative: Believed to be shingles; Burn on back; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles and burn of unspecified degree of back (any part). On an unknown date, the outcome of the shingles and burn of unspecified degree of back (any part) were unknown.   It was unknown if the reporter considered the shingles and burn of unspecified degree of back (any part) to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The visitor did not provide additional demographics details. The reporter asked the nurse to look at a burn on patient's back which was believed to be Shingles. The reporter knew generally wait until illness/infection resolved but it was not disclosed. The reporter did not disclosed patient's symptoms until after receiving the vaccine. The reporter thought it was a burn but the provider believed it was Shingles. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt bad; This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient date of birth and exact administration date not available at time of reporting. The patient received dose one of Shingrix approximately 2 months ago and felt bad afterwards. The patient declined the second dose. The specialist attempted to further clarify felt bad, and pharmacist stated it was just the normal injection reaction, nothing unusual. The reporter consent to follow up, but stated she does not want to be on any GlaxoSmithKline mailing lists.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: Temperature excursion; Patient received vaccine with temperature excursion; This is a spontaneous report from a contactable Health Care Professional. The Health Care Professional reported similar events for six patients. This is one of six reports.    A 6 months old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot Number: AA7116, Expiry date: 30May2021, NDC number: 0005197101) on 14Oct2019, at 11:37 a.m., intramuscularly, in the left thigh, at 0.5 ml, single dose, for immunization. The patient medical history was not reported. Additional concomitant vaccines administered for immunization, on same date of pneumococcal 13-val conj vac (dipht crm197 protein) (on 14Oct2019) included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL, Lot. UJ013AA, Expiry date: 10Oct2020) intramuscularly, in the left thigh (No of previous doses: 2) and hepatitis B vaccine (Lot. 212B9, Expiry date: 09May2021) intramuscularly, in the right thigh (No of previous doses: 2) and acetaminophen (paracetamol) from an unspecified date, 160 mg/5ml, 2.5 ml dose every 4 hours as needed for fever or discomfort. The patient previously received the following vaccinations: first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot Number: W81743, Expiry date: 30Sep2020) intramuscularly, in the right thigh, on 10Jun2019; second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot Number: X93780, Expiry date: 30Jan2021) intramuscularly, in the right thigh, on 12Aug2019; first and second dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) on 10Jun2019 and on 12Aug2019 respectively; first dose of hepatitis B vaccine given at the hospital (date of vaccination unspecified) and second dose of hepatitis B vaccine on 10Jun2019; all for immunization. The patient received pneumococcal 13-val conj vac (dipht crm197 protein) after temperature excursion, on 14Oct2019, at 11:37 a.m.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019473602 Different patient ,same event /same drug;US-PFIZER INC-2019473642 Different patient ,same event /same drug;US-PFIZER INC-2019473649 Different patient ,same event /same drug;US-PFIZER INC-2019473822 Different patient ,same event /same drug;US-PFIZER INC-2019473739 Same product/event, different patient;US-PFIZER INC-2019474389 Different patient ,same event /same drug;US-PFIZER INC-2019474349 Different patient ,same event /same drug;US-PFIZER INC-2019474448 same drug/event, different patient;US-PFIZER INC-2019473622 same product/event, different patient;US-PFIZER INC-2019473846 Same drug/event, different patient;US-PFIZER INC-2019473602 same product/event, different patient
Sex: U
Vaccine: PNC13
Symptoms: Discomfort, Pyrexia
Clinical narrative: Fever; Discomfort; This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included asplenia. The patient's concomitant medications were not reported. It was reported that the patient experienced fever and discomfort on an unspecified date after given pneumococcal 13-val conj vac (dipht crm197 protein). Outcome of the events was unknown.  Information on the batch number has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Pyrexia, Tremor, Vomiting
Clinical narrative: Pt received vaccine at approximately 2:00pm, within several hours pt began shaking uncontrollably with chills, could barely talk or dial phone, did not have a fever at that time. Shivering continued for several more hours then pt developed a fever of 102, pt took tylenol, vomited, and continued shivering until approximately 12:30am. Two days later these symptoms resolved except soreness at injection site.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pruritus
Clinical narrative: Post vaccination patient had the following symptoms: prolonged Left upper arm pain, limited range of motion, itching at shoulder these symptoms have continues since vaccination date. has improved slightly in last four days
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation
Clinical narrative: Patient reports burning sensation in her spine followed by left hip pain minutes after receiving the vaccine.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Chills, Computerised tomogram head normal
Clinical narrative: Immediately after shot given, lips started to tingle, face got red, and headache started. Chills followed by fever, nausea, and vomiting  started about 4 hours after shot. Also had shallow breathing which worsened, and had trouble breathing and chest pain. Called 911, and brought to Hospital ER.  Zofran, rocephin, aspirin, and acetaminophen given. Also given IV fluids (normal saline). Other tests performed: Chest X-ray, CT scan to r/o brain bleed, blood and urine test performed.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Headache, Hypopnoea, Immediate post-injection reaction
Clinical narrative: Immediately after shot given, lips started to tingle, face got red, and headache started. Chills followed by fever, nausea, and vomiting  started about 4 hours after shot. Also had shallow breathing which worsened, and had trouble breathing and chest pain. Called 911, and brought to Hospital ER.  Zofran, rocephin, aspirin, and acetaminophen given. Also given IV fluids (normal saline). Other tests performed: Chest X-ray, CT scan to r/o brain bleed, blood and urine test performed.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia oral, Pyrexia, Urine analysis normal, Vomiting
Clinical narrative: Immediately after shot given, lips started to tingle, face got red, and headache started. Chills followed by fever, nausea, and vomiting  started about 4 hours after shot. Also had shallow breathing which worsened, and had trouble breathing and chest pain. Called 911, and brought to Hospital ER.  Zofran, rocephin, aspirin, and acetaminophen given. Also given IV fluids (normal saline). Other tests performed: Chest X-ray, CT scan to r/o brain bleed, blood and urine test performed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pain, Swelling, Tendonitis
Clinical narrative: Developed typical local reaction with redness, swelling and pain thereafter injection, but has subsequently had ongoing pain since and appears to have developed a biceps tendonitis as a result
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Pt fainted shortly after the vaccination. She did not lose consciousness. I laid her on the floor and she felt better.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pain, Herpes virus infection, Hypopyon, Intraocular pressure increased, Iris adhesions
Clinical narrative: On 10/22 I felt some pain in my left eye around 3pm On 10/23 Pain worsened during the day.  Redness observed, suspected 'pink eye'. During night of 10/23--10/24 noticed blurriness/cloudiness in left eye On 10/24 presented at Dr.'s clinic.  Diagnosis: uveitis, posterior synechnae causing IOP 43. Mutton fat deposits.  Fibrous mass on lens.   Immediate treatment with Durezol to stop inflammation.  Also Alphagan, Phenylephrine, Cyclopentolate, Cosopt.  Also valtrex since herpes infection suspected. 10/27 Hypopyon clearly visible As of 11/05, synechnae have disappeared and IOP in low 20's.  Inflammation reduced, cloudiness reduced.  11/06 fibrous mass gone from lens.  Keratic precipitates gone.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Lenticular opacities, Ocular hyperaemia, Uveitis, Vision blurred
Clinical narrative: On 10/22 I felt some pain in my left eye around 3pm On 10/23 Pain worsened during the day.  Redness observed, suspected 'pink eye'. During night of 10/23--10/24 noticed blurriness/cloudiness in left eye On 10/24 presented at Dr.'s clinic.  Diagnosis: uveitis, posterior synechnae causing IOP 43. Mutton fat deposits.  Fibrous mass on lens.   Immediate treatment with Durezol to stop inflammation.  Also Alphagan, Phenylephrine, Cyclopentolate, Cosopt.  Also valtrex since herpes infection suspected. 10/27 Hypopyon clearly visible As of 11/05, synechnae have disappeared and IOP in low 20's.  Inflammation reduced, cloudiness reduced.  11/06 fibrous mass gone from lens.  Keratic precipitates gone.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Third dose of hepatitis B was given too early.  1st dose given on 1/17/19 2nd dose given on 3/5/19 3rd dose given on 5/1/19  There had to be 16 weeks between dose one and dose three, but the third dose was given at 14 weeks and 6 days.   Reviewed the Agency information that was printed back on 4/30/19. The Agency information said that the the accelerated date for hepatitis B is 4/30/19, which is incorrect. The right accelerated date was 5/9/19. Confirmed that the Agency was having a bug in their system around Spring/Summer of 2019 and was forecasting wrong accelerated and recommended dates for third dose of hepatitis B vaccine.  RN called the mother and explained what happened. Mother verbalized understanding and agreed to have the patient redo the third dose of hepatitis B on 11/7/19 to ensure immunity.    No adverse reaction has happened from this incident.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Pain
Clinical narrative: patient reported that cellulitis was diagnosed at hospital emergency room. Doxycyline  capsules and prednisone 40 mg prescribed. I spoke to patient on 11/06/2019 and reported improvement and good mobility although sourness was still present. Patient is to see her pCP next day 11/07/2019
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: PT STATES HER ARM FROM SHOULDER TO ELBOW WAS SWOLLEN, RED,  HOT AND PAINFUL FOR 3 DAYS AND SORE FOR A WEEK AFTER. PT STATES SHE TOOK BENADRYL AND ASPIRIN. DID NOT NOTIFY ANYONE UNTIL TODAY WHEN SHE HEARD THAT SHE NEEDED TO ON THE RADIO.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Electromyogram normal, Laboratory test normal, Magnetic resonance imaging spinal normal, Nerve conduction studies normal, Orthosis user
Clinical narrative: toe walking/calf pain PT braces on the legs
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pain in extremity, Scan with contrast, Toe walking
Clinical narrative: toe walking/calf pain PT braces on the legs
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Patient's arm became red, puffy and a little purple at sight.  She went to her provider 11/05 and the swelling was decreasing so no medical treatment was recommended by provider
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Gait disturbance, Synovitis
Clinical narrative: Right hip pain with limp, exam findings consistent with transient synovitis, resolved after 36 hours with scheduled NSAIDs
Age: 25.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: by the end of the day after getting the vaccines, felt soreness to arm; soreness continued into the next day but by the end of the day, noticed redness, warmth, and swelling  along with increasing pain
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: After receiving immunization, patient noticed expected symptoms of myalgia and arm weakness/soreness.  Patient saw the doctor when it was lasting longer than expected, received a steroid shot and physical therapy from her dr, but called to report that she is still experiencing the symptoms at 6 months after her shot.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: increasing soreness over coarse of first two days (so far); injection site sore, red, hard, and hot
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Headache, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Fever from 99 to 102 over a 3 day period, severe arm pain, back, legs, neck and head pain
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: began to get red and swollen night of vaccination. warm to touch.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling  and warmth
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I am unsure if the patient suffered any adverse effects.  She is under 65 years old and received the Prevnar 13 vaccine from her doctor's office.  I noticed this when I entered her flu shot into database for immunizations called agency.  It was on her record being given on 4/30/19.  On our Immunization Consent Form, she marked that she has no health issues.  I believe they inappropriately gave the Prevnar immunization.  Unfortunately, I have noticed this is a widespread issue.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis in the left arm where all three injections were given.  Patient went to emergency room and received antibiotics, which they are still currently taking and were advised to come back to the ER if things get worse.
Age: 90.0
Sex: U
Vaccine: FLU3
Symptoms: Gait inability
Clinical narrative: Vaccine - Fluzone HD  Couldn't walk, legs would not move at all. Called PCP, told this could be an AE. Recovered by 11/1/19.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Patient called back after an hour of being vaccinated saying that she has tingling and numbness of the tongue.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; an improperly stored dose of PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history and drug reactions/allergies was not reported. Concomitant therapy included sterile diluent.  On 17-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# S007069 with expiration date 06-SEP-2020, dose detail was not reported) via subcutaneous route for prophylaxis. The vaccine experienced improperly stored and was stored at minus 11.5 degree Celsius (C) for 76 hours. There was no previous temperature excursion. The call was because of a data logger involved. It could not be verified if the sterile diluent was properly stored. No adverse effects were reported.