chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Pyrexia
Clinical narrative: Swollen sore arm where injected, headache and fever.  Swollen painful knee. One week after shot, still have trouble walking.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site nodule, Oropharyngeal pain, Pain in extremity
Clinical narrative: Patient received her second dose of Shingrix on 2/13/20 at 3:52pm in her left deltoid. She reported back to pharmacist 20 minutes later that she was feeling fine and left the store. Patient called 3:58pm 2/15/20 to report adverse reactions. Her left arm was a little sore 2/13/20 and grew more sore throughout 2/14/20. There was about half-dollar redness on 2/14/20. When she woke up 2/15/20, her left arm was more sore and had a "golf ball sized knot" where she got the shot, and her left side of her throat was a little sore. There was no discharge from area, no numbness or tingling or anything alarming, just sore. She was advised to watch carefully for those further signs and to seek emergency help if needed; otherwise to use ice and ibuprofen to manage symptoms.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: EMPLOYEE BECAME DIZZY 2 HOURS AFTER RECEIVING  HER FIRST VACCINE AND DIZZINESS LASTED APPROXIMATELY 4 HOURS.
Age: 1.42
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness, swelling and warm to touch around vaccine site to right thigh. Tylenol 100mg given per MD orders and hot compresses.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Pain, Pruritus, Swelling
Clinical narrative: REDNESS, BRUISE, ITCHINESS, SWELLING, SORENESS THAT HAS LASTED 1 WEEK NOT AND STILL BOTHERING HER. SHE TOOK BENADRYL AND THAT HELPED THE ITCHINESS.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: I have had pain in the exact spot of my flu shot since I received it on 11/4/2019. Within a few day I had lost my range of motion and physical strength. I felt like my arm was dead weight. I couldn't pull up my pants, move my arm above my head or carry a gallon of milk. I messaged my Dr who recommended warm compresses. The pain got worse and I made an appt to see my Dr. who recommended physical therapy. After 5 appts and 6 weeks later - I had regained my range of motion but could not get rid of the pain. I went back to the Dr who recommended an MRI and completing physical therapy. I have 2 more appts left. I continue to have pain in any direction I move my arm. I feel it all night and it constantly aches. I don't know if I will have permanent damage at this point. I have lost physical strength in my left arm and it affects my daily life all day long.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Magnetic resonance imaging abnormal, Pain
Clinical narrative: I have had pain in the exact spot of my flu shot since I received it on 11/4/2019. Within a few day I had lost my range of motion and physical strength. I felt like my arm was dead weight. I couldn't pull up my pants, move my arm above my head or carry a gallon of milk. I messaged my Dr who recommended warm compresses. The pain got worse and I made an appt to see my Dr. who recommended physical therapy. After 5 appts and 6 weeks later - I had regained my range of motion but could not get rid of the pain. I went back to the Dr who recommended an MRI and completing physical therapy. I have 2 more appts left. I continue to have pain in any direction I move my arm. I feel it all night and it constantly aches. I don't know if I will have permanent damage at this point. I have lost physical strength in my left arm and it affects my daily life all day long.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: UPON STANDING, PATIENT COMPLAINED OF DIZZINESS AND FEELING FAINT
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Nausea
Clinical narrative: The first three days after vaccine, I suffered headaches, nausea, fever, tenderness and muscle pain (upper left arm).  The pain in my left arm has continued since 12-04-2019. I am unable to do common things that I did painlessly before the vaccine. Severe, sharp shooting pain occurs when I try to reach back and hook a bra. I am completely unable to do this task the way I used to. Also, reaching back from the car driver's seat to grab the seat belt is very, very painful. I am also unable to reach my left arm up to empty the dishwasher and put the glasses, plates and bowls in the upper cabinets. There are times when I lift a full cup of hot coffee/tea  and have to quickly lower the cup so I don't drop it. My arm aches randomly when I'm not using it. My sleep is disturbed when I roll over in bed onto my left side. The pain is so severe that it wakes me up from a sound sleep. I deeply regret my decision to get a shingles vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder, Tenderness
Clinical narrative: The first three days after vaccine, I suffered headaches, nausea, fever, tenderness and muscle pain (upper left arm).  The pain in my left arm has continued since 12-04-2019. I am unable to do common things that I did painlessly before the vaccine. Severe, sharp shooting pain occurs when I try to reach back and hook a bra. I am completely unable to do this task the way I used to. Also, reaching back from the car driver's seat to grab the seat belt is very, very painful. I am also unable to reach my left arm up to empty the dishwasher and put the glasses, plates and bowls in the upper cabinets. There are times when I lift a full cup of hot coffee/tea  and have to quickly lower the cup so I don't drop it. My arm aches randomly when I'm not using it. My sleep is disturbed when I roll over in bed onto my left side. The pain is so severe that it wakes me up from a sound sleep. I deeply regret my decision to get a shingles vaccine.
Age: 13.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt had a Vasovagal syncope response and was directed to the ground, pt lost consciousness, airway was intact and patient was breathing appropriately, blood pressure was 92/44 mmHg while lying down, heart rate was 77, pt given about 4 fluid ounces of orange juice and felt better. Pt recovered quickly and walked out of the pharmacy with her mom after waiting about 15 minutes.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: light headed
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pt came to pharmacy on 2/15/2020 and states that her arm is still sore at the injection site. she states that there is no welt but it just continues to be sore. no redness either
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Fall, Loss of consciousness, Pain
Clinical narrative: PAIN ALL OVER THE BODY AS IF A NEEDLE STICK OVER NIGHT, EXPERIENCED BLACK OUT AND FALL NEXT MORNING . REGAIN THE CONCIOUSNESS  LATER SAME DAY.  NO MEDICAL SERVICE REQUIRED.  BUT SEEN BY PCP 2 DAYS LATER.  NO  MEDICATION PRESCRIBED PER PATIENT.
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Arthritis bacterial, Incisional drainage
Clinical narrative: Patient got flu vaccine & shingles vaccines on 11/27/2019. He was admitted to hospital with a septic right elbow requiring IV antibiotics for weeks. He had the same thing happen 1 year ago after he received his flu shot on 9/17/2018. He had a septic right elbow and was hospitalized with IV antibiotics.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Pain
Clinical narrative: PATIENT RECEIVED A THIRD DOSE OF SHINGRIX ACCIDENTLY.  PATIENT REPORTED TO THE PHARMACY NEXT DAY STATING HE HAS CHILLS, BODY ACHES/SORENESS, AND COLD SWEATS
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: arm sore, chills, fever 100.2
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Red, swollen, hot feeling area approx. 3 in. in across. Noticed morning after vaccine. No change 1.5 days later.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain, Tremor
Clinical narrative: Experience side effects: tiredness, soreness, shakes, headache, nausea. Resolved after 24 hours.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: RedNess, sore Ness ANTibioTic, sTeroid
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Chills, aches, redness, swelling, itching
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antibody test, Arthralgia, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal
Clinical narrative: Developed severe pain in joints/muscles (shoulders/elbows, hips/knees) Limited mobility with illness. Attending physician diagnosed with PRM Polymyalgia Rheumatica.  No relief with treatment so went to Rheumatologist started on Prednisone 10mg for 30 days with decreasing by 1 mg each month  and Cymbalta 60 mg daily with titration in 12 weeks.  Physical therapy for shoulder due to limited mobility.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood uric acid normal, C-reactive protein increased, Mobility decreased, Myalgia, Polymyalgia rheumatica
Clinical narrative: Developed severe pain in joints/muscles (shoulders/elbows, hips/knees) Limited mobility with illness. Attending physician diagnosed with PRM Polymyalgia Rheumatica.  No relief with treatment so went to Rheumatologist started on Prednisone 10mg for 30 days with decreasing by 1 mg each month  and Cymbalta 60 mg daily with titration in 12 weeks.  Physical therapy for shoulder due to limited mobility.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid factor negative, Urine analysis normal
Clinical narrative: Developed severe pain in joints/muscles (shoulders/elbows, hips/knees) Limited mobility with illness. Attending physician diagnosed with PRM Polymyalgia Rheumatica.  No relief with treatment so went to Rheumatologist started on Prednisone 10mg for 30 days with decreasing by 1 mg each month  and Cymbalta 60 mg daily with titration in 12 weeks.  Physical therapy for shoulder due to limited mobility.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Fatigue, Headache, Injection site erythema
Clinical narrative: Symptoms:Moderate pain & redness at injection site; tiredness, muscle pain, headache and shivering. Discomfort sufficient to prevent normal activities.  Treatment: Rest, Ibuproferin Outcome: Recovery after 36+ hours
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Symptoms:Moderate pain & redness at injection site; tiredness, muscle pain, headache and shivering. Discomfort sufficient to prevent normal activities.  Treatment: Rest, Ibuproferin Outcome: Recovery after 36+ hours
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cold sweat, Crying, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Inconsolable crying/screaming starting about 5 hours after vaccines given. Inconsolable crying/screaming lasted 3 hours the first night of oct 30th. Also baby became clammy and diaphoretic. Another episode of inconsolable crying lasting about 2 hours the following evening, and again the evening after that. Treatment included soothing baby, keeping her cool by undressing her, and administering Tylenol 2.5ml as needed. Right thigh was also red and swollen, very sore to the touch. Symptoms seemed to subside within 3 days and baby seemed back to normal after about 5 days after vaccine administration.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site swelling, Screaming
Clinical narrative: Inconsolable crying/screaming starting about 5 hours after vaccines given. Inconsolable crying/screaming lasted 3 hours the first night of oct 30th. Also baby became clammy and diaphoretic. Another episode of inconsolable crying lasting about 2 hours the following evening, and again the evening after that. Treatment included soothing baby, keeping her cool by undressing her, and administering Tylenol 2.5ml as needed. Right thigh was also red and swollen, very sore to the touch. Symptoms seemed to subside within 3 days and baby seemed back to normal after about 5 days after vaccine administration.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Patient developed Bells Palsy 17 days after vaccination
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Facial paralysis
Clinical narrative: Patient developed Bells Palsy 17 days after vaccination
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My Arm Ache not all the time, It been over a  year When I wen to the Dr. She said after a year the pain would go away.  It been over a year and still have pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reports a rash appearing 1 day after vaccination.  The rash is streak on each side of her body, from her armpit to the bottom of her rib cage. The rash does not hurt or itch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Myalgia, Nausea
Clinical narrative: Injection was more painful that the first in the series and my arm was immediately significantly sore.  I woke up sometime past midnight with nausea, headache, and muscle pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Injection was more painful that the first in the series and my arm was immediately significantly sore.  I woke up sometime past midnight with nausea, headache, and muscle pain.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Dizziness, Feeling abnormal, Headache
Clinical narrative: Shingles vaccine #1 (November 26 @ 3pm) gave me flu like symptoms, pain/bruising feeling at site of injection. I just felt awful but was able to go to work, the next day I felt 100% better. Shingles vaccine #2 gave me feelings of fever/chills, nausea, lightheaded and dizzy, extreme thirst, severe headache, achy all over, pain/bruising feeling at sight of injection I couldn't get out of bed without almost passing out.   by 9:30 am I took tylenol and drank water and was able to get out of bed, but still felt very achy and had no energy, still had the headache even after tylenol but lightheadednes and dizziness was better. By 2 I was feeling much better and was able to function, by evening I was feeling much better.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Injection site bruising, Injection site pain, Nausea, Pain
Clinical narrative: Shingles vaccine #1 (November 26 @ 3pm) gave me flu like symptoms, pain/bruising feeling at site of injection. I just felt awful but was able to go to work, the next day I felt 100% better. Shingles vaccine #2 gave me feelings of fever/chills, nausea, lightheaded and dizzy, extreme thirst, severe headache, achy all over, pain/bruising feeling at sight of injection I couldn't get out of bed without almost passing out.   by 9:30 am I took tylenol and drank water and was able to get out of bed, but still felt very achy and had no energy, still had the headache even after tylenol but lightheadednes and dizziness was better. By 2 I was feeling much better and was able to function, by evening I was feeling much better.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Thirst
Clinical narrative: Shingles vaccine #1 (November 26 @ 3pm) gave me flu like symptoms, pain/bruising feeling at site of injection. I just felt awful but was able to go to work, the next day I felt 100% better. Shingles vaccine #2 gave me feelings of fever/chills, nausea, lightheaded and dizzy, extreme thirst, severe headache, achy all over, pain/bruising feeling at sight of injection I couldn't get out of bed without almost passing out.   by 9:30 am I took tylenol and drank water and was able to get out of bed, but still felt very achy and had no energy, still had the headache even after tylenol but lightheadednes and dizziness was better. By 2 I was feeling much better and was able to function, by evening I was feeling much better.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain, Paraesthesia, Peripheral swelling
Clinical narrative: Injection site pain in right arm. Tingling, burning, and numbing sensation in right arm. Swelling in left and right hands. Denies rashes/hives or shortness of breath.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Back pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: 12 hours after administration patient experienced pain down arm into armpit, across back, shoulder, and up neck.  Patient went to ER and was given muscle relaxer and advil and pain went away that evening.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Starting Tuesday noon, starting feeling sick, fever 101 BP 170/60. This lasted 36 hours, then began to subside.  Left arm was red and swollen, very sore and very red and very hot.  This has gone away
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Starting Tuesday noon, starting feeling sick, fever 101 BP 170/60. This lasted 36 hours, then began to subside.  Left arm was red and swollen, very sore and very red and very hot.  This has gone away
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe derm welting and itching all over body.  No specific site reaction.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Hypoaesthesia, Lymph node pain, Musculoskeletal pain
Clinical narrative: - a lot of pain in shoulder/around socket/lymph node/armpit area - complete numbness down entire arm that will last a few minutes before feeling returns
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Fatigue, Feeling abnormal, Hypoaesthesia, Impaired driving ability
Clinical narrative: - a lot of pain in shoulder/around socket/lymph node/armpit area - complete numbness down entire arm that will last a few minutes before feeling returns
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Lymph node pain, Sleep disorder
Clinical narrative: - a lot of pain in shoulder/around socket/lymph node/armpit area - complete numbness down entire arm that will last a few minutes before feeling returns
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Heart rate increased, Hypersomnia, Muscle rigidity, Musculoskeletal stiffness
Clinical narrative: Started with base of my spine being stiff than became very rigid/rapid heart beat/weakness/nausea/fever/uncontrollable shaking from inside out
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Started with base of my spine being stiff than became very rigid/rapid heart beat/weakness/nausea/fever/uncontrollable shaking from inside out
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Patient awoke at 3am with a severe headache the night of the vaccine. The next 2 days she reports that she felt flu-ish symptoms of fever with chills and headache/body aches etc. Those symptoms resolved but then on day 4 she developed a raised red bumpy, itchy rash on the back of her neck and shoulder blades. She treated it with oral diphenhydramine and hydrocortisone cream. It resolved without and further treatment after a few days. She is concerned about an allergy and possibly a more severe reaction with second dose.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient awoke at 3am with a severe headache the night of the vaccine. The next 2 days she reports that she felt flu-ish symptoms of fever with chills and headache/body aches etc. Those symptoms resolved but then on day 4 she developed a raised red bumpy, itchy rash on the back of her neck and shoulder blades. She treated it with oral diphenhydramine and hydrocortisone cream. It resolved without and further treatment after a few days. She is concerned about an allergy and possibly a more severe reaction with second dose.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: -pt describes pain started soon after injection and never sub-sided. mentioned pain level increased and leveled to today at drive-thru pt mentioned range of motion is limited to where she cannot raise arm more than shoulder level and pain is a dull intense pain. Pain shoots from back left shoulder blade and generates pain down arm thru to tingling finger-tips
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: pt was counseled on the use of afluria b/c she marked allergic to eggs but was not sure of reaction and had a flu vaccine from her dr in 2018 with no issue or side effect and was not sure if that was egg free. pt agreed to afluria and was counseled to stay in vaccination area for 15 mins afterwards. pt agreed. Husband reached out on Feb 15, 2020 to report side effect of mild allergic reaction. pt did not go to dr and is fine but husband just wanted to get report in.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Allergy to vaccine, Erythema, Hypersensitivity
Clinical narrative: pt went to urgent care for complains of allergic reaction. Red patches all over the body, concentrated on arms and trunk
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Vertigo
Clinical narrative: Vertigo symptoms
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Anger, Diarrhoea, Dyskinesia, Ear infection, Ear tube insertion
Clinical narrative: Pt experienced the following after receiving the Vitamin K and Hep B shots: 1. Neurologic inconsolable screaming 2. Total body contortions/arching of back and neck 3. Jaundice shortly after birth that lasted over two weeks and required blue light therapy  4. Stopped breathing within 72 hours of receiving vaccines (sent home prior to 72 hour watch period for preemies... received stimulation from Grandma and came to. Called pediatrician after hours and was told it was just a "spell" that happens to babies from time to time. Did not advise to seek further care and claimed it did not happen as a result of the vaccine) 5. Constant ear infections (needed tubes at 2.5 years) 6. Minimal verbalization until age 2, even though his receptive skills displayed full understanding. Used his own signs to communicate needs (Hippocampus is verbal communications center) 7. Qualified for Early On interventions for Speech. Receptive skills were above average, but language skills below.  8. Physical Outbursts 9. Poor nutritionally gut function causing whiteish loose stool. Lacked enzymes needed for proper gut function since enzymes wiped out by vaccines and antibiotics from constant ear infections. 10. Head banging 11. Rocking 12. Eating plastic and other nonfood materials because lacking stomach lining due to loss of enzymes
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Eating disorder, Emotional distress, Enzyme abnormality, Faeces pale, Gastric disorder
Clinical narrative: Pt experienced the following after receiving the Vitamin K and Hep B shots: 1. Neurologic inconsolable screaming 2. Total body contortions/arching of back and neck 3. Jaundice shortly after birth that lasted over two weeks and required blue light therapy  4. Stopped breathing within 72 hours of receiving vaccines (sent home prior to 72 hour watch period for preemies... received stimulation from Grandma and came to. Called pediatrician after hours and was told it was just a "spell" that happens to babies from time to time. Did not advise to seek further care and claimed it did not happen as a result of the vaccine) 5. Constant ear infections (needed tubes at 2.5 years) 6. Minimal verbalization until age 2, even though his receptive skills displayed full understanding. Used his own signs to communicate needs (Hippocampus is verbal communications center) 7. Qualified for Early On interventions for Speech. Receptive skills were above average, but language skills below.  8. Physical Outbursts 9. Poor nutritionally gut function causing whiteish loose stool. Lacked enzymes needed for proper gut function since enzymes wiped out by vaccines and antibiotics from constant ear infections. 10. Head banging 11. Rocking 12. Eating plastic and other nonfood materials because lacking stomach lining due to loss of enzymes
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Head banging, Jaundice neonatal, Opisthotonus, Phototherapy, Premature baby
Clinical narrative: Pt experienced the following after receiving the Vitamin K and Hep B shots: 1. Neurologic inconsolable screaming 2. Total body contortions/arching of back and neck 3. Jaundice shortly after birth that lasted over two weeks and required blue light therapy  4. Stopped breathing within 72 hours of receiving vaccines (sent home prior to 72 hour watch period for preemies... received stimulation from Grandma and came to. Called pediatrician after hours and was told it was just a "spell" that happens to babies from time to time. Did not advise to seek further care and claimed it did not happen as a result of the vaccine) 5. Constant ear infections (needed tubes at 2.5 years) 6. Minimal verbalization until age 2, even though his receptive skills displayed full understanding. Used his own signs to communicate needs (Hippocampus is verbal communications center) 7. Qualified for Early On interventions for Speech. Receptive skills were above average, but language skills below.  8. Physical Outbursts 9. Poor nutritionally gut function causing whiteish loose stool. Lacked enzymes needed for proper gut function since enzymes wiped out by vaccines and antibiotics from constant ear infections. 10. Head banging 11. Rocking 12. Eating plastic and other nonfood materials because lacking stomach lining due to loss of enzymes
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Respiratory arrest, Screaming, Speech disorder developmental, Stereotypy
Clinical narrative: Pt experienced the following after receiving the Vitamin K and Hep B shots: 1. Neurologic inconsolable screaming 2. Total body contortions/arching of back and neck 3. Jaundice shortly after birth that lasted over two weeks and required blue light therapy  4. Stopped breathing within 72 hours of receiving vaccines (sent home prior to 72 hour watch period for preemies... received stimulation from Grandma and came to. Called pediatrician after hours and was told it was just a "spell" that happens to babies from time to time. Did not advise to seek further care and claimed it did not happen as a result of the vaccine) 5. Constant ear infections (needed tubes at 2.5 years) 6. Minimal verbalization until age 2, even though his receptive skills displayed full understanding. Used his own signs to communicate needs (Hippocampus is verbal communications center) 7. Qualified for Early On interventions for Speech. Receptive skills were above average, but language skills below.  8. Physical Outbursts 9. Poor nutritionally gut function causing whiteish loose stool. Lacked enzymes needed for proper gut function since enzymes wiped out by vaccines and antibiotics from constant ear infections. 10. Head banging 11. Rocking 12. Eating plastic and other nonfood materials because lacking stomach lining due to loss of enzymes
Age: 51.0
Sex: U
Vaccine: UNK
Symptoms: Back pain, Injection site bruising, Injection site erythema, Injection site mass, Pain in extremity
Clinical narrative: Given vaccine with aseptic technique on 2-10-20 and she had a red "heart shaped" bruise the following morning but no soreness or other issues. On the 3rd day she went to "workout her arms really well" and on the 4th day she said her arm and back were sore and the red bruise had become dark with a large lump under the injection site.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Gingival swelling, Injection site rash, Pain
Clinical narrative: PATIENT EXPERIENCED SEVERE BODY ACHES, A SIGNIFICANT RASH AT INJECTION SITE, AND SWOLLEN GUMS LASTING FOR SEVERAL DAYS FOLLOWING VACCINATION
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Fever, chills, nausea, headache, pain swelling  itchiness and redness at inection site 2/14/2020-2/16/2020.  Itchiness, swelling, pain, redness still present on 2/16/2020. Fever, chills, nausea and headache subsided by 2/15/2020.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, headache, pain swelling  itchiness and redness at inection site 2/14/2020-2/16/2020.  Itchiness, swelling, pain, redness still present on 2/16/2020. Fever, chills, nausea and headache subsided by 2/15/2020.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Decreased appetite, Fatigue, Incoherent, Influenza virus test negative
Clinical narrative: Fever over 104, vomiting, back pain, not lucid at times, loss of appetite, fatigue.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Streptococcus test negative, Vaccination complication, Vomiting
Clinical narrative: Fever over 104, vomiting, back pain, not lucid at times, loss of appetite, fatigue.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Type III immune complex mediated reaction
Clinical narrative: arthrus reaction- erythema and induration around injection site
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypokinesia, Mood altered, Musculoskeletal pain, Neck pain
Clinical narrative: After getting flu shot, I had upper arm pain that radiated to my neck and shoulder. I endured the pain for more than two months. The pain had greatly reduced my energy level and inhibited my mood and movement. I had to seek medical treatment multiple times to alleviate the pain I suffered.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: After getting flu shot, I had upper arm pain that radiated to my neck and shoulder. I endured the pain for more than two months. The pain had greatly reduced my energy level and inhibited my mood and movement. I had to seek medical treatment multiple times to alleviate the pain I suffered.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient came in several months after administered that she was not going to get her 2nd dose due to the fact that she had a reaction. day 1 she had a fever of 99.2, days 2 9/28 100.8 fever, swollen site size of a baseball, raised hot circular. Day 3 normal temp, still raised and hot and took 2-3 days to go away. Explained to patient, injection site reaction and low grade fever can happen with all vaccinations. She was concerned due to the length of her reaction and asked that we report it.
Age: 45.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Anaphylactic reaction, Presyncope
Clinical narrative: The patient after receiving the three immunizations starting experiencing signs of anaphylaxis and close to faining. 911 was called and Epinephrine 0.3mg IM administered. The police and EMS showed up, monitored him. After about 30 minutes being observed, the patient declined to go to hospital and was released. He was transported home by his wife.
Age: 31.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: patient experienced hives 3 days after receiving vaccine.; This spontaneous report was received from office manager referring to a 31-year-old male patient. The patient's medical history and drug reactions/allergies were not provided. Concomitant medication included armodafinil (NUVIGIL) (250mg, qd, oral).     On 05-APR-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R011630, expiration date 12-DEC-2020, intramuscular in the left deltoid; dose was unknown) for prophylaxis.      On 08-APR-2019 (reported as 3 days after receiving vaccine), the patient experienced hives. Then the patient was received methylprednisolone acetate (DEPO MEDROL) and recommended OTC fexofenadine hydrochloride (ALLEGRA). The outcome of urticaria was unknown. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow up information was received from the office manager on 06-FEB-2020. The information of reporters, patient and vaccine administration was updated. The suspect drug also reported as "GARDASIL" (inconsistent information), but the lot number was still reported as R011630. The outcome of hives was reported as recovered/resolved. The reporter considered the event was attributable to the vaccine.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Injection site pain, Pain in extremity, Pain of skin
Clinical narrative: unable to urinate; burning sensation on his thighs and torso /on and off burning sensation; weak; hard time walking; muscle pain; tingling in his thighs traveled up up his back and around his ribs.; leg buckle; TENDERNESS; Shooting pain; Skin painful to touch; Skin painful to touch; Sore in both thighs / sore arm; Fatigue for 2-3 days; Slight headache; This case was reported by a consumer via call center representative and described the occurrence of unable to urinate in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 12th January 2021) for prophylaxis.   On 25th January 2020, the patient received the 1st dose of Shingrix. On 2nd February 2020, 8 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced touch sensitivity increased, stinging skin, tenderness and shooting pain. On 3rd February 2020, the patient experienced limb discomfort. On 4th February 2020, the patient experienced muscle pain and tingling. On 6th February 2020, the patient experienced unable to urinate (serious criteria GSK medically significant), burning sensation, weakness and walking difficulty. In February 2020, the patient experienced pain in extremity, fatigue and headache. The patient was treated with valaciclovir hydrochloride (Valtrex), gabapentin and tramadol. On 7th February 2020, the outcome of the unable to urinate was recovered/resolved. On an unknown date, the outcome of the pain in extremity, touch sensitivity increased, muscle pain, tingling, weakness, walking difficulty, tenderness and shooting pain were unknown and the outcome of the fatigue, headache and limb discomfort were recovered/resolved and the outcome of the stinging skin was recovering/resolving and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the unable to urinate, pain in extremity, fatigue, touch sensitivity increased, stinging skin, headache, muscle pain, tingling, burning sensation, weakness, walking difficulty, limb discomfort, tenderness and shooting pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 2nd February 2020, the patient experienced pain presented on both thighs.The front, inner and outer area of both thighs is painful to touch and the skin stings. On 3rd February 2020, the reporter stated that, after vaccination the patient had sore arm and fatigue for 2 to 3 days and slight headache presented on and off for 1 to 2 days. The muscle pain and tingling in his thighs has traveled up up his back and around his ribs.  The patient had a shooting pain on the outer side of his right thigh that made his leg buckle, then it resolved. The patient stated that, the stinging pain was little better than yesterday. The patient received valtrex, gabapentin and tramadol as a treatment medication. The patient did not provide many details for the adverse event report because he was angry and wanted an answer.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Blood test normal, Burning sensation, Fatigue, Headache
Clinical narrative: unable to urinate; burning sensation on his thighs and torso /on and off burning sensation; weak; hard time walking; muscle pain; tingling in his thighs traveled up up his back and around his ribs.; leg buckle; TENDERNESS; Shooting pain; Skin painful to touch; Skin painful to touch; Sore in both thighs / sore arm; Fatigue for 2-3 days; Slight headache; This case was reported by a consumer via call center representative and described the occurrence of unable to urinate in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 12th January 2021) for prophylaxis.   On 25th January 2020, the patient received the 1st dose of Shingrix. On 2nd February 2020, 8 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced touch sensitivity increased, stinging skin, tenderness and shooting pain. On 3rd February 2020, the patient experienced limb discomfort. On 4th February 2020, the patient experienced muscle pain and tingling. On 6th February 2020, the patient experienced unable to urinate (serious criteria GSK medically significant), burning sensation, weakness and walking difficulty. In February 2020, the patient experienced pain in extremity, fatigue and headache. The patient was treated with valaciclovir hydrochloride (Valtrex), gabapentin and tramadol. On 7th February 2020, the outcome of the unable to urinate was recovered/resolved. On an unknown date, the outcome of the pain in extremity, touch sensitivity increased, muscle pain, tingling, weakness, walking difficulty, tenderness and shooting pain were unknown and the outcome of the fatigue, headache and limb discomfort were recovered/resolved and the outcome of the stinging skin was recovering/resolving and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the unable to urinate, pain in extremity, fatigue, touch sensitivity increased, stinging skin, headache, muscle pain, tingling, burning sensation, weakness, walking difficulty, limb discomfort, tenderness and shooting pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 2nd February 2020, the patient experienced pain presented on both thighs.The front, inner and outer area of both thighs is painful to touch and the skin stings. On 3rd February 2020, the reporter stated that, after vaccination the patient had sore arm and fatigue for 2 to 3 days and slight headache presented on and off for 1 to 2 days. The muscle pain and tingling in his thighs has traveled up up his back and around his ribs.  The patient had a shooting pain on the outer side of his right thigh that made his leg buckle, then it resolved. The patient stated that, the stinging pain was little better than yesterday. The patient received valtrex, gabapentin and tramadol as a treatment medication. The patient did not provide many details for the adverse event report because he was angry and wanted an answer.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Magnetic resonance imaging normal, Pain in extremity
Clinical narrative: unable to urinate; burning sensation on his thighs and torso /on and off burning sensation; weak; hard time walking; muscle pain; tingling in his thighs traveled up up his back and around his ribs.; leg buckle; TENDERNESS; Shooting pain; Skin painful to touch; Skin painful to touch; Sore in both thighs / sore arm; Fatigue for 2-3 days; Slight headache; This case was reported by a consumer via call center representative and described the occurrence of unable to urinate in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 12th January 2021) for prophylaxis.   On 25th January 2020, the patient received the 1st dose of Shingrix. On 2nd February 2020, 8 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced touch sensitivity increased, stinging skin, tenderness and shooting pain. On 3rd February 2020, the patient experienced limb discomfort. On 4th February 2020, the patient experienced muscle pain and tingling. On 6th February 2020, the patient experienced unable to urinate (serious criteria GSK medically significant), burning sensation, weakness and walking difficulty. In February 2020, the patient experienced pain in extremity, fatigue and headache. The patient was treated with valaciclovir hydrochloride (Valtrex), gabapentin and tramadol. On 7th February 2020, the outcome of the unable to urinate was recovered/resolved. On an unknown date, the outcome of the pain in extremity, touch sensitivity increased, muscle pain, tingling, weakness, walking difficulty, tenderness and shooting pain were unknown and the outcome of the fatigue, headache and limb discomfort were recovered/resolved and the outcome of the stinging skin was recovering/resolving and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the unable to urinate, pain in extremity, fatigue, touch sensitivity increased, stinging skin, headache, muscle pain, tingling, burning sensation, weakness, walking difficulty, limb discomfort, tenderness and shooting pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 2nd February 2020, the patient experienced pain presented on both thighs.The front, inner and outer area of both thighs is painful to touch and the skin stings. On 3rd February 2020, the reporter stated that, after vaccination the patient had sore arm and fatigue for 2 to 3 days and slight headache presented on and off for 1 to 2 days. The muscle pain and tingling in his thighs has traveled up up his back and around his ribs.  The patient had a shooting pain on the outer side of his right thigh that made his leg buckle, then it resolved. The patient stated that, the stinging pain was little better than yesterday. The patient received valtrex, gabapentin and tramadol as a treatment medication. The patient did not provide many details for the adverse event report because he was angry and wanted an answer.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Burning sensation, Fatigue, Gait disturbance, Headache
Clinical narrative: unable to urinate; burning sensation on his thighs and torso /on and off burning sensation; weak; hard time walking; muscle pain; tingling in his thighs traveled up up his back and around his ribs.; leg buckle; TENDERNESS; Shooting pain; Skin painful to touch; Skin painful to touch; Sore in both thighs / sore arm; Fatigue for 2-3 days; Slight headache; This case was reported by a consumer via call center representative and described the occurrence of unable to urinate in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 12th January 2021) for prophylaxis.   On 25th January 2020, the patient received the 1st dose of Shingrix. On 2nd February 2020, 8 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced touch sensitivity increased, stinging skin, tenderness and shooting pain. On 3rd February 2020, the patient experienced limb discomfort. On 4th February 2020, the patient experienced muscle pain and tingling. On 6th February 2020, the patient experienced unable to urinate (serious criteria GSK medically significant), burning sensation, weakness and walking difficulty. In February 2020, the patient experienced pain in extremity, fatigue and headache. The patient was treated with valaciclovir hydrochloride (Valtrex), gabapentin and tramadol. On 7th February 2020, the outcome of the unable to urinate was recovered/resolved. On an unknown date, the outcome of the pain in extremity, touch sensitivity increased, muscle pain, tingling, weakness, walking difficulty, tenderness and shooting pain were unknown and the outcome of the fatigue, headache and limb discomfort were recovered/resolved and the outcome of the stinging skin was recovering/resolving and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the unable to urinate, pain in extremity, fatigue, touch sensitivity increased, stinging skin, headache, muscle pain, tingling, burning sensation, weakness, walking difficulty, limb discomfort, tenderness and shooting pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 2nd February 2020, the patient experienced pain presented on both thighs.The front, inner and outer area of both thighs is painful to touch and the skin stings. On 3rd February 2020, the reporter stated that, after vaccination the patient had sore arm and fatigue for 2 to 3 days and slight headache presented on and off for 1 to 2 days. The muscle pain and tingling in his thighs has traveled up up his back and around his ribs.  The patient had a shooting pain on the outer side of his right thigh that made his leg buckle, then it resolved. The patient stated that, the stinging pain was little better than yesterday. The patient received valtrex, gabapentin and tramadol as a treatment medication. The patient did not provide many details for the adverse event report because he was angry and wanted an answer.