chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Pain, Paralysis
Clinical narrative: It's given two of my friends Gillian Beret syndrome: paralyzation and pain.; It's given two of my friends Gillian Beret syndrome: paralyzation and pain.; It's given two of my friends Gillian Beret syndrome: paralyzation and pain.; Initial information was received on 10-Nov-2020 regarding an unsolicited valid serious social media case from a consumer/non-hcp (healthcare professional).  This case involves a patient with unknown demography who experienced guillian beret syndrome: paralyzation and pain (Guillain-Barre syndrome, paralysis and pain), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious gillian beret syndrome: paralyzation and pain. (Guillain-Barre syndrome, paralysis and pain), unknown latency following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of all the events were unknown.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly document case concerns a patient with unknown demography who experienced Guillain-Barre syndrome, paralysis and pain, after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Night sweats, Oropharyngeal pain
Clinical narrative: Night sweats, chills, muscle pain in legs, aching, headache, feeling rundown, throat was sore as well
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Night sweats, chills, muscle pain in legs, aching, headache, feeling rundown, throat was sore as well
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Peripheral swelling
Clinical narrative: Patient states she feels "like I was hit by a Mack Truck." Severe body aches and headaches began within 8 hours of vaccine administration. Additionally, edema in both calves appeared at the same time and had not yet resolved at the time of reporting adverse effects. The body aches and headaches dissipated within 48 hours. Patient made an appointment with her PCP about the edema, who prescribed furosemide 40mg daily, to be used until resolution of edema.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Muscle injury, Muscle spasms, Musculoskeletal discomfort, Pain
Clinical narrative: Employee experiencing increasing pain, spasms and slowly loosing ability to use left shoulder. Discomfort radiating to shoulders and back. Saw Provider at clinic for check up who diagnosed a muscle injury and recommended an MRI and PT.
Age: 24.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Blood pressure decreased, Immediate post-injection reaction, Syncope
Clinical narrative: Client experienced vasovagal syncope immediately following the administration of influenza (administered 1st) and Tdap (administered 2nd). Client described feeling a drop in his blood pressure. Client was seated while being vaccinated and supported from falling by, RN while experiencing syncope. Client remained seated and drinking water for twenty minutes after syncope. Client shared that he had experienced syncope before. RN advised client to share that he has had vasovagal syncope with any immunization provider he sees in the future because he is at risk for falls after immunizations. Client was experiencing no symptoms twenty minutes after vasovagal response.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discolouration, Yellow skin
Clinical narrative: Patients left arm from injection site down to elbow is black and blue (appears to be bruised, possibly hematoma).  Skin has a yellow tinge.  No itching or pain.  No swelling.  Reaction occurred 2 days after vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient reported a rash/hives to our office on 11/15/20 after having shingles vaccine two weeks prior.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Discomfort, Pain in extremity, Sleep disorder
Clinical narrative: arm aches, painful, weakness,     no treatment other than massaging the area, taking Aleve.   Awakens me in the night.  Comes and goes, more uncomfortable at times
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: It was realized after RotaTeq (oral) administration that the vaccine had an expiration of 5 days prior. It was properly stored and still in the refrigerator. I immediately called Merck and spoke with staff who told me that the efficacy of the vaccine has not been compromised. As the storage temperature was maintained that there are no ill effects to this event.  Dr. was notified as was the mother of the infant. She was still in the office with us. States understanding and had no further concerns or questions.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient with right shoulder pain since injection. Seen in PCP office today. Limited ROM, significant pain.
Age: 32.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Neck pain, Neuralgia, Pain in extremity
Clinical narrative: Received message from patient: I think something went seriously wrong with the shots I received yesterday. I woke up in the middle of the night with the most extreme nerve pain I've ever experienced in my life in my left arm (where shots were administered) shooting from my elbow to my neck. I writhed in pain for hours before eventually managing to sleep for a few hours. When I woke up this morning I was still in immense pain and currently cannot move my left arm without severe pain. Hopefully this is just some kind of allergic reaction but I'm worried this is nerve damage of some kind. Please advise RN recommended to seek ED treatment. ED documentation: Musculoskeletal:  Right lower leg: No edema.  Left lower leg: No edema.  Comments: L shoulder and deltoid tender to palpation, full nontender ROM to L elbow and wrist, decreased ROM at shoulder due to pain, no overlying erythema over shoulder joint, compartments soft    Skin: General: Skin is warm and dry.  Comments: 7cmx3cm area of erythema to L deltoid, irregular but well demarcatd borders, no warmth, no fluctuance or induration    This is a 32 Y male who presents to ED with rash and arm pain. On arrival patient's initial triage vitals with tachycardia of 117, in the room patient heart rate below 100. He overall appears comfortable does not appear to be in distress. Left deltoid with well-demarcated area of erythema extending from the injection site, no warmth, no cobble stoning on point-of-care ultrasound, less concerning for cellulitis. Erythema is not overlying the joint, less concerning for septic arthritis. Shoulder x-ray unremarkable, no obvious joint effusion, no effusion noted on point-of-care ultrasound. Patient has 2+ and symmetrical radial pulses, skin is warm and dry, less concerning for acute arterial occlusion. No edema to suggest DVT. Compartments are soft, no recent trauma, compartment syndrome less likely. Suspect likely local inflammatory reaction following flu shot as cause of patient symptoms. Discussed case and imaging with orthopedic surgery with question of need for possible arthrocentesis if flu shot was administered into the joint space. Per Ortho if this is the case treatment would be symptomatic and would not recommend arthrocentesis. Diagnostic testing, findings and plan discussed with patient. Questions answered. Patient discharged home with plan for PCP follow-up and symptom control with Tylenol and ibuprofen.     11/19/2020 Patient sent additional message  They were unable to find the cause of the pain at the ER last night. They took X-rays and performed an ultrasound and I was subsequently released.      As of this morning I am still in pain and have very limited mobility in my left shoulder. Also, there is now a visible red splotch on my left arm around the area where the shots were administered on Tuesday.      I'm not really sure what the next steps are here but I would really like some relief.  RN reviewed with APNP, return message sent to patient with supportive comfort cares and to continue to monitor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm swelling and redness
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Flatulence, Gastrooesophageal reflux disease, Haematochezia
Clinical narrative: persistent colic, gas pain, and reflux since then with 1 episode of blood to stool On amino acid base formula for easier digestion  Probiotic drops to restore GI flora OTC Mylicon and Gripe water as needed for abdominal pain
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Blood test, Cardiac monitoring, Computerised tomogram, Ear disorder
Clinical narrative: Rcvd 2nd shingles vaccine and a week later 9/15 when I woke up my entire left side of my face was numb. Numbness would dissipate but also started experiencing sensitivity in my ear. Around my eyes nose and mouth i am experiencing burning pain. When I layed down I started experiencing numbness in left side of face. During the day the numbness would be mild but there was still stinging pain. Sharp knee pains and tingling,numbness around left side of my face and eyes. Daughter thought I was experiencing Ramsey hunt syndrome. experiences left side headache. I have had tests from my PCP, Cardiologist, neurologist (MRI testing completed), going to see neuro surgeon 11/30, ENT visit where he prescribed prednisone and antibiotic.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Facial pain, Headache, Hypoaesthesia, Hypoaesthesia eye, Magnetic resonance imaging
Clinical narrative: Rcvd 2nd shingles vaccine and a week later 9/15 when I woke up my entire left side of my face was numb. Numbness would dissipate but also started experiencing sensitivity in my ear. Around my eyes nose and mouth i am experiencing burning pain. When I layed down I started experiencing numbness in left side of face. During the day the numbness would be mild but there was still stinging pain. Sharp knee pains and tingling,numbness around left side of my face and eyes. Daughter thought I was experiencing Ramsey hunt syndrome. experiences left side headache. I have had tests from my PCP, Cardiologist, neurologist (MRI testing completed), going to see neuro surgeon 11/30, ENT visit where he prescribed prednisone and antibiotic.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Paraesthesia, Sinus disorder
Clinical narrative: Rcvd 2nd shingles vaccine and a week later 9/15 when I woke up my entire left side of my face was numb. Numbness would dissipate but also started experiencing sensitivity in my ear. Around my eyes nose and mouth i am experiencing burning pain. When I layed down I started experiencing numbness in left side of face. During the day the numbness would be mild but there was still stinging pain. Sharp knee pains and tingling,numbness around left side of my face and eyes. Daughter thought I was experiencing Ramsey hunt syndrome. experiences left side headache. I have had tests from my PCP, Cardiologist, neurologist (MRI testing completed), going to see neuro surgeon 11/30, ENT visit where he prescribed prednisone and antibiotic.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Limb discomfort
Clinical narrative: Chills and headache, fatigue.sore arm   . Relieved with Motrin late at night.   Then woke with chills, fatigue and headache in am.  Took Tylenol. Finally felt better by 2:30pm
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red arm and swelling.   Benadryl 50mg given PO at 1230.  Symptoms improved.  Redness remained around arm on 11/19/2020 but she was feeling better.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: At the time of vaccination, patient was 15 weeks of age. Patient was scheduled for influenza vaccine appointment along with siblings. Patient received influenza vaccine before 6 months of age. Unnecessary dose given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Cough, Rash, Urticaria
Clinical narrative: Mother called in to office triage line within 30 minutes of receiving vaccines concerns with cough and rash. Patient without wheeze but mother states he did sound as if he had stridor. Rash consistent with hives based on photos that were obtained by parent at the time of the event. Mother instructed to administer Benadryl at home. By the time patient presented to the office the rash was resolved.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states that she is suffering  from extreme arm pain since her vaccination on 10/06/2020. The pain is not specific to the injection site, she state the pain is "up and down" her arm.  Patient state she has visited her primary physician and urgent care. She was given instructions to ice and to give 1-2 for the pain to subside per urgent care. Patient says pain is so extreme she has her arm in a sling. I have given advice to patient  to contact primary physician again so that the issue can be further researched.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Pain
Clinical narrative: I started to get chills at 11PM on 11/18/20 that lasted until 12:30AM and only subsided after I took ibuprofen.  I woke up at 5:45AM on 11/19/20 and have had body aches, felt dizzy and have had off and on chills all day,
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Infection
Clinical narrative: Patient had  Shingrix shot done last July. Stated that the injection gave him a lump since that time and subsequently got infected.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Bursitis
Clinical narrative: Left Arm bursitis/shoulder pain since even on 10/14/20.  Slight improvement with time, ibuprofen, ice, Arnica.
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Dry eye, Facial paralysis, Trismus
Clinical narrative: Patient states he starting having symptoms like Bell's Palsy one week after receiving the flu vaccine, Fluad.  He started having  face drooping on the right side of his face, eye is dry and mouth would not close all the way on the right side on 11-17-2020.   Patient said it is not debilitating but noticeable.  He had a phone conference with his dr on 11-19-2020 and he was advised to monitor and be seen if symptoms worsen but should improve.
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthropathy, Influenza like illness, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient's daughter called and said that her mom was having a very severe reaction to the flu shot. She was having fever, flu like symptoms, nausea, felt like vomiting, muscle aches and joint issues
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Vaccination complication
Clinical narrative: Patient's daughter called and said that her mom was having a very severe reaction to the flu shot. She was having fever, flu like symptoms, nausea, felt like vomiting, muscle aches and joint issues
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: The patient developed extreme arm pain at the injection site which  resolved after about 3 days.
Age: 0.25
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: Fluzone was given 3 months earlier than indicated. RN administering thought he was giving a different vaccine. There were no adverse event as a result of this error. Patient was evaluated by a provider immediately following administration. Patient remained asymptomatic throughout. Patient left the clinic without further incident.
Age: 0.25
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Fluzone was given 3 months earlier than indicated. RN administering thought he was giving a different vaccine. There were no adverse event as a result of this error. Patient was evaluated by a provider immediately following administration. Patient remained asymptomatic throughout. Patient left the clinic without further incident.
Age: 49.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Death
Clinical narrative: Flu shot given on 11/17/2020 at 3:10 pm  and patient died on 11/18/2020 at approx. 10:30 am at his home.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Malaise, Pyrexia
Clinical narrative: The patient developed a fever of 103 degrees Fahrenheit on the evening of the vaccine administration. He didn't feel well. His arm was sore, although not terribly so.  By the following day, he was improved.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Confusional state, Fatigue, Injection site warmth, Walking aid user
Clinical narrative: Patient reported on 11/18/2020 that the injection site felt hot later that day and that one week after the injection on 10/13/2020 she became weakened to the point of needing to use her walker to ambulate. The weakness was generalized all over. She felt episodes of confusion and extreme tiredness. She reports that this lasted a month and while it is improving it continues to persist.  She did not seek medical treatment since the injection and came to clinic on 11/18/2020 for an unrelated issue.
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Inflammation, Pain, Pain in extremity, Tenderness
Clinical narrative: pain and inflammation in left deltoid when laying on or golf swing
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: Tightening of throat
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Flu like symptoms, mild fever, headache for one day - unable to conduct normal activities
Age: 27.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Muscular weakness
Clinical narrative: Presented to clinic on 11/19/20 - reports persistent right arm weakness since immunization received 1.5 years ago - declines future immunization due to this reaction. States she spoke with the Nurse Practitioner 2 months after the vaccine and told her she felt right arm weakness. NP recommended follow-up with a primary care provider. She states she did not follow-up due to no health insurance. Today states the generalized weakness in her right arm has persisted and never resolved. States she notices it most when using the computer or playing the guitar. States it is difficult for her to describe the exact changes, but feels her arm has never been the same. Reviewed resource list for primary care provider visit.
Age: 60.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Blood test normal, Cardiac monitoring normal, Cardiac stress test normal, Computerised tomogram normal, Electrocardiogram normal
Clinical narrative: Patient had a syncopal episode while driving, colliding with a telephone pole, flipping the vehicle on it's side.  He was transported to local ER for evaluation, blood work, radiographs, EKG, EEG, CT scan, ultrasound.  He was hospitalized for 24 hours and no other cause for the event was found.  Stress test and cardiac monitoring have also not revealed any other cause.  He continues to be evaluated.
Age: 60.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Electroencephalogram normal, Road traffic accident, Syncope, Ultrasound scan normal, X-ray normal
Clinical narrative: Patient had a syncopal episode while driving, colliding with a telephone pole, flipping the vehicle on it's side.  He was transported to local ER for evaluation, blood work, radiographs, EKG, EEG, CT scan, ultrasound.  He was hospitalized for 24 hours and no other cause for the event was found.  Stress test and cardiac monitoring have also not revealed any other cause.  He continues to be evaluated.
Age: 60.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Loss of consciousness, Road traffic accident, Syncope
Clinical narrative: Patient had a syncopal episode while driving, colliding with a telephone pole, flipping the vehicle on it's side.  He was transported to local ER for evaluation, blood work, radiographs, EKG, EEG, CT scan, ultrasound.  He was hospitalized for 24 hours and no other cause for the event was found.  Stress test and cardiac monitoring have also not revealed any other cause.  He continues to be evaluated.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Dyspnoea, Neck pain, Neuralgic amyotrophy
Clinical narrative: Shoulder, arm, and neck pain. Subsequent shortness of breath and chest pain. Diagnosis of Parsonage-Turner Syndrome secondary to Shingrix Vaccination.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Spinal X-ray
Clinical narrative: Shoulder, arm, and neck pain. Subsequent shortness of breath and chest pain. Diagnosis of Parsonage-Turner Syndrome secondary to Shingrix Vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: pain at injection site, fatigue, fever, severe muscle pain growing most severe between 4 hours until 12 hours after injection
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Unable to move the left arm completely.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Culture negative, Pyrexia, Rash
Clinical narrative: Per mom patient first developed a fever and then a rash all over her body. Patient still has a rash
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling cold, Headache, Malaise
Clinical narrative: At about midnight on the day I got the shot I started feeling feverish and ill. My body kept trembling and I felt extremely cold. Even covering myself up with 5 blankets couldn't stop the feeling of trembling with cold. My body started aching, especially my entire right arm (in which the shot was administered). My right wrist hurt and  felt like it was sprained (even thought it was not). I could not sleep because of the discomfort. I have had a terrible headache ever since then which has not gone away 35 hours later, in spite of taking 1 Acetaminophen tablet (325mg.) every 12 hours.  I also started feeling slightly nauseous about 24 hours after the vaccination was administered. The nauseous feeling comes and goes since then, but I have not vomited.  It is now 50 hours since I was vaccinated, and I still feel unwell with the headache, right arm ache, fatigue and chills.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Tremor
Clinical narrative: At about midnight on the day I got the shot I started feeling feverish and ill. My body kept trembling and I felt extremely cold. Even covering myself up with 5 blankets couldn't stop the feeling of trembling with cold. My body started aching, especially my entire right arm (in which the shot was administered). My right wrist hurt and  felt like it was sprained (even thought it was not). I could not sleep because of the discomfort. I have had a terrible headache ever since then which has not gone away 35 hours later, in spite of taking 1 Acetaminophen tablet (325mg.) every 12 hours.  I also started feeling slightly nauseous about 24 hours after the vaccination was administered. The nauseous feeling comes and goes since then, but I have not vomited.  It is now 50 hours since I was vaccinated, and I still feel unwell with the headache, right arm ache, fatigue and chills.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Joint pain
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pallor, Syncope, Vomiting
Clinical narrative: Shortly after vaccine administration while  administering pharmacist was filling  required documentation and explaining vaccine information, the patient stood up rapidly from the chair and suffered fainting, turned pale, felt nauseous and had a subsequent single episode of vomiting.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fall, Nervousness, Syncope
Clinical narrative: Patient was given immunization and felt dizzy and light-headed like he was going to pass out.  Myself and his mother had him sit in a chair for a minute and then walked him over to a bench area with his brother.  I was getting ready to give the mother her vaccine and the 10 year old patient fainted and fell to the ground.  He woke up immediately and didn't realize what happened.  We sat with him for about 10-15 min until he felt better.  He was able to drink some water and eat a cookie.  He said he was feeling nervous about the shot and this may have led to him passing out.  He seemed fine but a little shaken up and was able to walk on his own power.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Peripheral swelling, Skin mass, Tremor
Clinical narrative: RED CIRCLE ABOUT 2 INCHES ACROSS, EGG-LIKE BUMP UNDER SKIN, SWELLING OF ARM, CHILLS AND TREMORS
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in extremity
Clinical narrative: Pt is complaining about pain going down her arm, into the elbow area and back up into her armpit area. It started about a couple of days after she got the vaccine. Pt did mention that she was picking fruits from a tree about 2 to 3 days before she got the flu shot. She has been getting the flu shot for the past 3 years. Pharmacist did not give the vaccine to high up. It's about 2 weeks now and she is still having pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: PATIENT STILL (11/19/20) EXPERIENCING INJECTION SITE SORENESS
Age: 59.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site discolouration, Neck pain, Pain in extremity
Clinical narrative: patient reported a severe discoloration and a bruising in the left arm?.just a few inches below her left deltoid...  her entire left arm is sore and she can not move her left arm  also , she reported that the left side of her neck feels sore.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Pt called pharmacy and stated she received a flu shot and pneumonia shot on the same day a few days ago.  She stated the arm she received the flu shot in was fine but the arm she received the pnuemonia shot in has swelled up from around her elbow all the way up to her shoulder.  She stated it was red and irriated too. She was counseled to contact her PCP in order to be further evaluated.
Age: 49.0
Sex: M
Vaccine: FLUA4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Pain
Clinical narrative: Patient experience bleeding at the time of injection and when he removed the bandage two days later, he saw the bandage was full of blood. Patient also experience severe pain. He said it almost felt like he had an allergic reaction to the medication similar to the reaction he had with levofloxacin in a prior incident. The pain lasted over several days.
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: Patient lost full range of motion after receiving vaccination. He was unable to lift his arm to dress and was unable to sleep do to the pain.  Pt sought medical from primary care provider and was told the flu shot was administer too high and went into the shoulder joint.  Patient was prescribed pain medication for the pain.  Patient has improved arm function but not back to normal yet.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Malaise, Pain, Pyrexia
Clinical narrative: Fever, diarrhea, body aches, loss of appetite, malaise.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema
Clinical narrative: redness on face,  arms, back, arms, legs and torso.  experiencing deeper breathing
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash pruritic, Skin test
Clinical narrative: rash and scaly skin on arms, chest, legs, neck, and groin swelling in groin and legs itchiness in areas where rash was found
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Warm, red, large swelling one inch below the injection site.(the size of 3 large eggs per patient). and hives all over her body
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Pain in extremity, Swelling
Clinical narrative: Starting about 1 hour after receiving her vaccine, patient called feeling soreness in her left arm.  The next morning, on 11/18/2020, she noted redness of her left upper arm.  She took some ibuprofen and applied some ice.  Redness and soreness persisted throughout that day.  She called our office on 11/18/2020 and reported that the area of redness was about 7 inches long and 4 inches wide.    Some areas of skin looks almost like a blister.  On 11/19/2020, she reported the redness had improved as well as the soreness and swelling.  She still has some swelling just proximal to her left elbow.
Age: 65.0
Sex: F
Vaccine: FLUA4, PNC13
Symptoms: Pain in extremity
Clinical narrative: pain in arm not going away after 2 months of the vaccination
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Skin warm
Clinical narrative: Patient called at 11:20am to notify us that she thought she was having an allergic reaction to her Shingles shot. Her arm was red, warm to the touch, had a white patch in the middle of the redness, and was growing down her arm.
Age: 60.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient complains of sever swelling redness and hot feeling on both arms. More on the arm that the shingrix was administered. Symptoms progressed and showed fully when patient woke up the next day.    Apply a cold compress to the site for approximately 15 minutes if the patient has any inflammation/swelling/or soreness. Recommend an analgesic such as acetaminophen or non-steroid anti-inflammatory drug. An anti-histamine can be used for any swelling make sure to observe and discuss with the patient signs of generalized anaphylaxis
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Full blood count, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Thrombocytopenic purpura. She began presenting with bruises all over her body so we told the doctor and ordered labs.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenopathy, Pruritus, Rash, Tenderness
Clinical narrative: 11/15/20: noticed single firm lymph node in left axilla 11/17/20: in the morning found a large focal mosslike area adjacent to left nipple, red, tender to touch 11/18/20: inflamed area in left breaded increased in size, small adjacent focal spots of redness with small vesicles by end of day 11/19/20: new focal area of erythema adjacent to nipple on right breast, also tender, itchy
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash & swelling to RD  tx with decadron injection & cool pack Mother reports pt received influenza vaccine last year too which caused his arm to be red & swollen took pt to Urgent Care was given steroid injection & rocephin thought it may have been a skin infection, but it was 48 hrs post injection. Influenza Pf 6mo+ given IM in LD Lot 425T2 NDC 58160-896-52 10/10/19.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: PATIENT REPORTED A RASH AT INJECTION SITE THAT SPREAD TO PATIENT'S STOMACH. ISSUE RESOLVED IN APPROXIMATELY 48 HRS
Age: 63.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site pain
Clinical narrative: Stated she has pain in her right shoulder and has to go to physical therapy
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: pt stated she started to have a reaction at 10:30 am at 10-29-20 flu like symptoms, low grade fever. She took tylenol for the pain and fever. Pt also got a red and swollen in the injection site which is the right arm
Sex: F
Vaccine: FLU4
Symptoms: Illness
Clinical narrative: the patient used to be sick all winter after getting a flu shot; Initial information regarding this unsolicited valid non-serious case via regulatory authority (reference number: 00300455) was received from a consumer and transmitted to Sanofi 05-Oct-2020.  This case involved a female patient of unknown age, who used to be sick all winter (illness) after getting a flu shot with vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  Concurrent condition included sensitivity to egg.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that the patient used to be sick all winter (illness) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Final diagnosis was the patient used to be sick all winter after getting a flu shot.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Dyspnoea, Erythema, Eye disorder, Injection site erythema, Injection site swelling
Clinical narrative: had an anaphylactic reaction; This spontaneous report was received from  a medical assistant referring to a 4 years and 6 months old  female patient. The patient's concomitant medication was not reported. The patient's pertinent medical history included abnormal heart valve, unbalanced common AV canal and FONTAN procedure. Concurrent condition included hypoplastic left heart.. The patient's historical vaccine included measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3) (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX). The patient's concomitant medication were not reported. She had no known drug allergies.  On 12-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) one time dose (lot # was S038145 and expiration date was 25-MAY-2021) subcutaneously at left upper thigh for prophylaxis.         On the same day after leaving pediatric office, the patient was at home and lied down in her room and her mother went to go check on her and realized "something wasn't right". The patient had an anaphylactic reaction (severe allergic reaction), her tongue was purple and she was red from head to toe, hives and that her throat was closing up so they transported the consumer to hospital. While at the hospital, the patient was given intravenous epinephrine and oxygen. However, she was not on oxygen for the entire stay at the hospital. She was only in the hospital for 1 day and it was confirmed to be an emergency room visit. The office/healthcare professional felt uncomfortable using any more of the same lot of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The outcome of the event was resolved.  The causality assessment was not provided. The event was considered to be life threatening by the reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Pyrexia, Swelling face, Urticaria
Clinical narrative: had an anaphylactic reaction; This spontaneous report was received from  a medical assistant referring to a 4 years and 6 months old  female patient. The patient's concomitant medication was not reported. The patient's pertinent medical history included abnormal heart valve, unbalanced common AV canal and FONTAN procedure. Concurrent condition included hypoplastic left heart.. The patient's historical vaccine included measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3) (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX). The patient's concomitant medication were not reported. She had no known drug allergies.  On 12-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) one time dose (lot # was S038145 and expiration date was 25-MAY-2021) subcutaneously at left upper thigh for prophylaxis.         On the same day after leaving pediatric office, the patient was at home and lied down in her room and her mother went to go check on her and realized "something wasn't right". The patient had an anaphylactic reaction (severe allergic reaction), her tongue was purple and she was red from head to toe, hives and that her throat was closing up so they transported the consumer to hospital. While at the hospital, the patient was given intravenous epinephrine and oxygen. However, she was not on oxygen for the entire stay at the hospital. She was only in the hospital for 1 day and it was confirmed to be an emergency room visit. The office/healthcare professional felt uncomfortable using any more of the same lot of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The outcome of the event was resolved.  The causality assessment was not provided. The event was considered to be life threatening by the reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Anaphylactic reaction, Erythema, Throat tightness, Tongue discolouration, Urticaria
Clinical narrative: had an anaphylactic reaction; This spontaneous report was received from  a medical assistant referring to a 4 years and 6 months old  female patient. The patient's concomitant medication was not reported. The patient's pertinent medical history included abnormal heart valve, unbalanced common AV canal and FONTAN procedure. Concurrent condition included hypoplastic left heart.. The patient's historical vaccine included measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3) (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX). The patient's concomitant medication were not reported. She had no known drug allergies.  On 12-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) one time dose (lot # was S038145 and expiration date was 25-MAY-2021) subcutaneously at left upper thigh for prophylaxis.         On the same day after leaving pediatric office, the patient was at home and lied down in her room and her mother went to go check on her and realized "something wasn't right". The patient had an anaphylactic reaction (severe allergic reaction), her tongue was purple and she was red from head to toe, hives and that her throat was closing up so they transported the consumer to hospital. While at the hospital, the patient was given intravenous epinephrine and oxygen. However, she was not on oxygen for the entire stay at the hospital. She was only in the hospital for 1 day and it was confirmed to be an emergency room visit. The office/healthcare professional felt uncomfortable using any more of the same lot of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The outcome of the event was resolved.  The causality assessment was not provided. The event was considered to be life threatening by the reporter.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Patient developed infection in the arm from injection site. pt had redness and swelling of the injection site followed by pain. was prescribed augmentin for treatment of infection.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Erythema, Fatigue, Inflammation, Intra-uterine contraceptive device removal
Clinical narrative: Pain in left arm started shortly after vaccine, felt like typical post vaccination soreness. Progressed the next morning to pain all down my left arm and across my upper back. I also was fatigued and and generally felt bad. The next morning my left arm distal to the vaccination sites was red, swollen, and warm. The pain/fatigue got better but the inflammation continues still.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Skin warm, Smear cervix
Clinical narrative: Pain in left arm started shortly after vaccine, felt like typical post vaccination soreness. Progressed the next morning to pain all down my left arm and across my upper back. I also was fatigued and and generally felt bad. The next morning my left arm distal to the vaccination sites was red, swollen, and warm. The pain/fatigue got better but the inflammation continues still.
Age: 67.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal discomfort, Myalgia
Clinical narrative: Muscular pain over entire body Temperature 95.1 Slight upset stomach
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: a patient received an extra dose of PROQUAD on 08/14/2020. Child's previous shot record was received at the office on 10/20/2020 where it was discovered the child had received MMR II and VA.RIV AX on 07/23/2018; This spontaneous report was received from a nurse regarding a 6 years old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not provided.  On 23-JUL-2018, doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, lot # and expiration date# and anatomical location were not reported) were administered to the patient. On 17-AUG-2020, an extra dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) 0.5 ml (strength, lot # and expiration date# and anatomical location were not reported) subcutaneously for immunization was administered to the patient (extra dose administered). The outcome of the event was not provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: There are no additional adverse events; temperature excursion/ dose of PNEUMOVAX 23 had been administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-NOV-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) once, injection, lot # T027110, expiration date: 23-MAR-2022 (exact dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 35 degrees Fahrenheit for 15 hours. Digital data logger was involved. There were no previous excursions reported. There were no additional adverse events to report. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T027110; expirationdate: 23-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Drug ineffective, Vaccination failure
Clinical narrative: patient received most recent dose on 09/08/2020; she has a negative titer; This is an AE for an ineffective vaccination; This is an AE for an ineffective vaccination; This spontaneous report has been received from a pharmacist concerning a currently 30 years old female patient. The patient's concurrent conditions, historical drugs and medical history were not reported. The patient's concomitant therapies were reported as none. The patient has no known drug allergies.  On 03-JUL-2020, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection for prophylaxis (Lot # and expiration date were not reported).   On 08-SEP-2020, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneous injection for prophylaxis (Lot # and expiration date were not reported).   On an unknown date in 2020, the patient still presented a negative titer (antibody test negative) after having the aforementioned 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The pharmacist considered this was an ineffective vaccination (drug ineffective and vaccination failure).    At the time of reporting, the outcome of negative titer, drug ineffective and vaccination failure were not reported. The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the events was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional signs of adverse reaction to receiving the expired vaccine; expired Vaqta administered to a patient; This spontaneous report was received from a pharmacy student, who received the information from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.   On 09-NOV-2020, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) lot # S032660, expiration date 22-OCT-2020, as prophylaxis (expired product administered) (strength, dose, frequency, and route of administration were not provided). No additional signs of adverse reaction to receiving the expired vaccine were reported.   The outcome of the event, and the causal relationship to the suspect vaccine were unknown.