chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Deafness unilateral, Dizziness, Magnetic resonance imaging
Clinical narrative: Dizziness for 11 days beginning day after the injection and 11 days of dizziness starting 2 weeks later. LOSS OF HEARING IN RIGHT EAR.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Asthenia, Blood pressure fluctuation, Erythema, Paraesthesia oral, Pruritus
Clinical narrative: Redness and itching on the patients armpit, back, neck, and lips. Reported tingling lips, vertigo, fluctuating blood pressure, weakness, and sinus congestion. Patient took Tylenol and Benadryl and improved over the next few days.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Sinus congestion, Vertigo
Clinical narrative: Redness and itching on the patients armpit, back, neck, and lips. Reported tingling lips, vertigo, fluctuating blood pressure, weakness, and sinus congestion. Patient took Tylenol and Benadryl and improved over the next few days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Bruxism, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: After receiving my vaccine, and after retiring for the night, I experienced pain in my left arm around 1 AM. I was unable to sleep most of the night. When I woke up initially I just had the pain in my left arm. However by around 10 or 11 AM, I started with severe shivering to the point where my teeth were chattering and I had my teeth clenched, flu like symptoms such as   Fatigue, headache, a lot of bodyaches,  fever, unable to function and had to stay home to rest.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Pyrexia
Clinical narrative: After receiving my vaccine, and after retiring for the night, I experienced pain in my left arm around 1 AM. I was unable to sleep most of the night. When I woke up initially I just had the pain in my left arm. However by around 10 or 11 AM, I started with severe shivering to the point where my teeth were chattering and I had my teeth clenched, flu like symptoms such as   Fatigue, headache, a lot of bodyaches,  fever, unable to function and had to stay home to rest.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Injection site bruising, Injection site reaction, Rash erythematous
Clinical narrative: GENERAL FLU LIKE SYMPTOMS X ABOUT 72-96 HOURS, THEN FLAT, ERYTHEMATOUS RASH ON BACK OF ARM, BELOW THE INJECTION SITE, LIGHT BRUISING AROUND INJECTION SITE. RASH HAS PERSISTED X 5 DAYS AFTER INJECTION
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Headache
Clinical narrative: I had excruciating abdominal pain that lasted for about 10 hours, along with diarrhea that lasted almost 24 hours, and a headache.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Patient reported feeling tingly and itchy shortly after receiving the vaccine.  He did not have any difficulty breathing or hives.  He decline an offer for EpiPen, Benadryl, or calling 911.  He said he took his own Benadryl and was going to go home.  We followed up with him an hour or 2 later and he said the itching and tingling had subsided.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Back pain, Disorientation
Clinical narrative: Severe lower back pain, bloating in abdomen, muscular pain in abdomen, stomach discomfort,  neck pain, tiredness, and feeling of being disoriented.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Neck pain
Clinical narrative: Severe lower back pain, bloating in abdomen, muscular pain in abdomen, stomach discomfort,  neck pain, tiredness, and feeling of being disoriented.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Pyrexia, Swelling face, Tremor
Clinical narrative: swelling of lips and face, fever 103 F, shakes.  No SOB, itching, rash or hives. Treatment: 4 Benadryl 25mg tabs.  Symptoms improved in the next few hours, completely resolved after 48 hours
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Rash
Clinical narrative: Within 2 hrs, not able to breathe, rash on arms, legs, and face. Patient went to the ER and was given steroids, benadryl, asthma treatments
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Eye contusion, Face injury, Headache, Malaise
Clinical narrative: PATIENT SAID THE FIRST DOSE THEY HAD SOME VERTIGO/HEADACHE BUT TOOK SOME MEDICINE AND THEY WERE OK.  I TOLD THEM TO PURCHASE SOME MECLIZINE AND SHE DID.  I DID WARN HER THE SECOND SHOT COULD CAUSE MORE SIDE EFFECTS.  THE PATIENT SAID THE EVENING OF THE SHOT SHE HAD CHILLS AND WAS FEELING UNWELL.  THE NEXT MORNING WHEN SHE GOT UP FROM THE BED SHE FAINTED AND HIT HER FACE ON THE GROUND AND IT CAUSED A BLACK EYE ON HER RIGHT EYE
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Syncope, Vertigo
Clinical narrative: PATIENT SAID THE FIRST DOSE THEY HAD SOME VERTIGO/HEADACHE BUT TOOK SOME MEDICINE AND THEY WERE OK.  I TOLD THEM TO PURCHASE SOME MECLIZINE AND SHE DID.  I DID WARN HER THE SECOND SHOT COULD CAUSE MORE SIDE EFFECTS.  THE PATIENT SAID THE EVENING OF THE SHOT SHE HAD CHILLS AND WAS FEELING UNWELL.  THE NEXT MORNING WHEN SHE GOT UP FROM THE BED SHE FAINTED AND HIT HER FACE ON THE GROUND AND IT CAUSED A BLACK EYE ON HER RIGHT EYE
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Eye contusion, Headache, Loss of consciousness, Pain
Clinical narrative: PATIENT SAID THE FIRST DOSE THEY HAD SOME VERTIGO/HEADACHE BUT TOOK SOME MEDICINE AND THEY WERE OK.  I TOLD THEM TO PURCHASE SOME MECLIZINE AND SHE DID.  I DID WARN HER THE SECOND SHOT COULD CAUSE MORE SIDE EFFECTS.  THE PATIENT SAID THE EVENING OF THE SHOT SHE HAD CHILLS AND WAS FEELING UNWELL.  THE NEXT MORNING WHEN SHE GOT UP FROM THE BED SHE FAINTED AND HIT HER FACE ON THE GROUND AND IT CAUSED A BLACK EYE ON HER RIGHT EYE
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin discolouration
Clinical narrative: PATIENT SAID THE FIRST DOSE THEY HAD SOME VERTIGO/HEADACHE BUT TOOK SOME MEDICINE AND THEY WERE OK.  I TOLD THEM TO PURCHASE SOME MECLIZINE AND SHE DID.  I DID WARN HER THE SECOND SHOT COULD CAUSE MORE SIDE EFFECTS.  THE PATIENT SAID THE EVENING OF THE SHOT SHE HAD CHILLS AND WAS FEELING UNWELL.  THE NEXT MORNING WHEN SHE GOT UP FROM THE BED SHE FAINTED AND HIT HER FACE ON THE GROUND AND IT CAUSED A BLACK EYE ON HER RIGHT EYE
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: MODERATE TO SEVERE  SHOULDER PAIN WHEN SHE MOVES SHOULDER SINCE RECEIVED FLU SHOT. SHE HAS NOT SEEKED ANY MEDICAL TREATMENT
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient reported redness all down her arm and up around her shoulder and collar bone. She reported arm pain that slowly got better over time, but is still present. Redness has resolved.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Joint stiffness, Myalgia, Nerve compression
Clinical narrative: patient is experiencing muscle aches and joint stiffness since receiving the vaccine on 11/05.  patient also experienced a pinched nerve about a week after the flu vaccine and didn't know if it was because of the vaccine.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: unusual soreness and inability to lift arm above shoulder level without pain
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Pain, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Patient had soreness and mild fever day after shot.  3 days after shot patient developed red hot itchy spots on arm and soreness.  Pt went to urgent care and is being treated for cellulitis today.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Skin warm
Clinical narrative: Patient had soreness and mild fever day after shot.  3 days after shot patient developed red hot itchy spots on arm and soreness.  Pt went to urgent care and is being treated for cellulitis today.
Sex: M
Vaccine: FLU3
Symptoms: Inflammation, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: patient is experiencing severe inflammation, joint stiffness, just over stiff.  symptoms keep getting worse over time.  vaccine given 11/05/2019
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Patient experienced low grade fever over several days, severe muscle pain in left arm, bruising, redness, swelling and warmth to touch on second day
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Patient experienced low grade fever over several days, severe muscle pain in left arm, bruising, redness, swelling and warmth to touch on second day
Age: 81.0
Sex: F
Vaccine: FLUR4
Symptoms: Blood test, Computerised tomogram, Influenza like illness, Magnetic resonance imaging, Vaccination complication
Clinical narrative: Flu like symptoms started Wednesday 10/30/19, she was getting worse through the weekend and went to the hospital on Sunday 11/3/19. The doctors at the hospital thought she was having a stroke, but it was determined to be a reaction to the vaccine. She was only given IV fluids and her regular medications at the hospital.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction, Lip dry, Lip swelling, Paraesthesia oral, Swelling face
Clinical narrative: Patient came in to counseling window and informed me she experienced an adverse reaction (possible allergic reaction) to the Fluzone HD immunization staff administered on 11/1/2019.    She states she experienced lip tingling when she left the store when she got in her car. She then states it gotten worse over the next couple of days and had lip and face swelling. I asked if she went to the emergency room or see a physician about it and she said she did not.   I gave her the VIS sheet for Influenza and informed her to call VAERS to report her reaction. I also advised her to let her physician know about what happened. She also stated that she took pictures of the event. She looked well today and only complains about lip dryness. I recommended an OTC lip balm. She took down my name and staff name and left.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: patient has swelling down the arm, patient went to urgent care clinic and was diagnosed with cellulitis. patient was given ceftriaxone 1 g IM at urgent care resulting in basal vagal event. 911 was called and patient was transported to hospital where patient was precribed Keflex 500 mg QID for cellulitis
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called me on Friday, 11/15/19 to inform me that she had a bad reaction to the vaccination she got at our location.  She got a flu shot in her left arm and PPSV23 in her right arm.  She reported having warmth, redness, swelling and soreness at the injection site on her right arm on 11/8/19.  The following day 11/9/19, she said was not eating  well, extremely sleepy, and that she had passed out cold on the floor of her home and was unsure of how long she had been out.  She went in to see her doctor who reported her WBC was high but she said she was not running a fever. He treated her with a week supply of Cephalexin.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness, Somnolence, Vaccination complication, White blood cell count increased
Clinical narrative: Patient called me on Friday, 11/15/19 to inform me that she had a bad reaction to the vaccination she got at our location.  She got a flu shot in her left arm and PPSV23 in her right arm.  She reported having warmth, redness, swelling and soreness at the injection site on her right arm on 11/8/19.  The following day 11/9/19, she said was not eating  well, extremely sleepy, and that she had passed out cold on the floor of her home and was unsure of how long she had been out.  She went in to see her doctor who reported her WBC was high but she said she was not running a fever. He treated her with a week supply of Cephalexin.
Age: 65.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Diarrhoea, Headache, Rash pruritic, Varicella
Clinical narrative: Patient had headache the evening of vaccination. Then 24 hours after headache, she had diarrhea and 2 days later she developed very itchy rashes that look like chicken pox wrapped around her trunk and buttock and the back of her legs.  The patient went seek medical advice and had a prednisone prescribed. Also went see natural medicine doctor. The rashes lasted about 3 weeks and it gets better now.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness and swelling on pt's right hand along with pain. Once pt noticed the symptoms, she called the pharmacy and was told to take some pain reliever, then if it does not get better to seek medical help. Symptoms started to get worse then she had to go to the ER where she was given some IV medications for pain and swelling. Per pt's after visit summary, she was given Benadryl, pepcid and methylprednison in the emergency room.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Shortly after receiving Engerix-B vaccination, the patient was able to communicate she was experiencing mild vasovagal syncope, slight dizziness, and paleness. She indicated beforehand that this reaction might occur but still wanted the vaccination to complete the series. She refused smelling salts, remained talkative, stayed conscious, and drank water. This reaction lasted from 4:20pm until patient completely feeling better around 4:54pm and was able to walk without dizziness or paleness.
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: The next day after patient got the vaccines, patient had fever, chill and feel fatigue. Patient had to stay in bed for the whole day and next day she feels better. Patient is worried about receiving the second dose Shingrix.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Approx 31 hrs after injection, severe  uncontrollable diarrhea, mild stomach pain. Diarrhea 5-6 times over the next 24 hours.  Mild stomach pain continuing 72 hours.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: The next day after vaccination, patient developed red, hot swollen rashes on her upper arm down to elbow. The rashes lasted for 4 days and went away. Patient did not seek medical treatment.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Pruritus, Rash, Scab, Scratch
Clinical narrative: left forearm extremely itchy starting the next morning, extreme itchiness last several days.  all over body itchiness for at least 4 days.  no reaction seen at site of injection.  no rash, although left forearm looked odd, perhaps inflamed and had two inflamed bumps, which may be moles (they ended up getting scratched and currently have scabs on them).
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Within 15-16 hours, soreness at the injection site as well as fever, chills, and myalgia.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Injection site discomfort, Myalgia, Pyrexia
Clinical narrative: Within 15-16 hours, soreness at the injection site as well as fever, chills, and myalgia.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Heart rate increased, Pruritus, Rash
Clinical narrative: Patient stated he had a body rash, burning and itching 30 hours after administration of immunization.  Patient also stated increased heart rate and bp for 7 days after.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reports that in the evening after receiving the vaccine on 11/12, she awoke in the middle of the evening due to arm pain, redness, swelling, and heat.  She reports that the initial affected area was approximately 4" x 4".  She took 3 doses of acetaminophen over the following two days and iced the affected area repeatedly.  As of 11/15, patient reports that the heat, redness, and size of the reaction have all significantly regressed, but she has not completely recovered as of yet. Patient did not seek medical treatment as she did not feel it was necessary.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX, PPV, PPV
Symptoms: Erythema, Influenza like illness, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Developed flu like symptoms and also causing adverse effect of pneumonia shot. Right arm pain, loss range of motion, red welts, swelling lasting entire weekend. Texted allergist and Hospitalist with pics, and paged PCP.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX, PPV, PPV
Symptoms: Urticaria
Clinical narrative: Developed flu like symptoms and also causing adverse effect of pneumonia shot. Right arm pain, loss range of motion, red welts, swelling lasting entire weekend. Texted allergist and Hospitalist with pics, and paged PCP.
Age: 51.0
Sex: F
Vaccine: HEPAB, PPV, TDAP, VARZOS
Symptoms: Burning sensation, Rash, Rash pruritic
Clinical narrative: Five to six days after getting the vaccines, patient had rashes all over her body. The rashes are itchy and burning. Patient went see a doctor and got prescribed hydrocortisone cream and Benadryl.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Patient came into pharmacy to report redness and swelling on her right arm. Patient received an immunization for prevnar on November 10, 2019 and started to experience some redness about two days afterwards.  She opted to watch and to observe if redness will dissipate but ultimately it did not. She presented to pharmacy with a round, red, slightly swollen area on her right arm where she said she received the vaccine. Patient also indicated slight itching.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Headache, fever, and dizziness
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Hypopnoea, Injection site pain, Injection site swelling
Clinical narrative: I was told I was getting a tetanus shot. Developed Nausea that worsened during the night along with fever, headache, swelling and tenderness at injection site.  11/15/19 symptoms improved slightly with OTC meds. However once worn off about 1pm - shallow breathing and tingling of lips - Tylenol taken and focus on breathing and symptoms  improved- Fever spike was 102.1. Gradually improving - 11/17/19 - fatigue and 99 temperature - arm is still swollen and tender.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Paraesthesia oral, Pyrexia
Clinical narrative: I was told I was getting a tetanus shot. Developed Nausea that worsened during the night along with fever, headache, swelling and tenderness at injection site.  11/15/19 symptoms improved slightly with OTC meds. However once worn off about 1pm - shallow breathing and tingling of lips - Tylenol taken and focus on breathing and symptoms  improved- Fever spike was 102.1. Gradually improving - 11/17/19 - fatigue and 99 temperature - arm is still swollen and tender.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Constipation, Gastrointestinal inflammation, Intestinal obstruction
Clinical narrative: Patient states on 10/17/19-10/19/19 he had abdominal pain and aches which abated on 10/20/19.  Then he had constipation but was able to have a bowel movement on 10/21/19.  Later on 10/21/19 he was seen in the ER with a complete bowel obstruction.  He states he is still having issues with abdominal pain and is going to have an upper and lower endoscopy on 11/26/19.  Dr. wanted to wait until then due to patient still having inflammation of his bowels. He was prescribed famotidine 40 mg every night and augmentin 875/125 mg twice a day for 5 days on 10/25/19; then on 10/28/19 he was prescribed pantoprazole 40 mg every morning; on 11/5/19 he was prescribed a suprep bowel kit; on 11/13 he was prescribed VSL #3 probiotics.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Patient complaint of red swollen knot formed at injection site
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Vaccination complication
Clinical narrative: Vaccine was given 9/28/2019. Patient reported to pharmacy 11/16/19 that he had limited range of motion in shoulder. He did not give a specific start date of the problem. He stated has been working with physical therapist and his family doctor and they both agreed the problem is from the flu shot and he has had no previous problems with his shoulder.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Cough, Pruritus, Throat irritation
Clinical narrative: Patient returned to the pharmacy shortly after receiving the vaccine around 12:55 pm. She complained of generalized itching and she was rubbing her throat and mildly coughing. 911 was contacted and a single dose 25 mg Benadryl solution was administered at 1:00 pm. The patients itching increased and she couldn't tell if her throat was swelling. By 1:06 pm, the patient started to calm down and the itching decreased. EMTs arrived by 1:10pm and continued to monitor the patient. No additional medication was given. EMTs left around 1:30 pm and patient left with her husband.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Listless, Myalgia, Nausea
Clinical narrative: Developed adverse symptoms including chills, aching muscles, nausea, listlessness and fatigue within eight hours, and these lasted approximately 36 hours.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Condition aggravated, Depressed mood, Dizziness
Clinical narrative: Shot site very red, swollen and painful. Became EXTREMELY fatigued within 2-2 1/2 hours; had to lay down for 3 hours. Woke up with fever and nausea and dizziness. Lightheaded. Ate dinner. Went to bed. Next morning (11/13/19) couldn?t get out of bed. Weakness in left side of body; body ache; low grade fever; extreme fatigue; very depressed. Next morning I woke up and had nearly no feeling in left side of body; arm, leg, foot, face. I tried to get up and dressed and noticed it was very difficult for me. My whole mouth and cheeks were droopy and my speech was very slurred. I couldn?t smile. My vision was blurry. I then realized these were all signs of a stroke. I called my doctor and she had me call 911 for possible stroke. Was in ER all day. Did 3 CT Scans. Can?t do mri due to metal hardware inside. After several hours of blood tests etc , my symptoms improved and they sent me home. After evaluating at home and recent symptoms since vaccine wondered if it was due to reaction to flu shot.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dysarthria, Fatigue, Hemiparesis, Hypoaesthesia, Injection site erythema
Clinical narrative: Shot site very red, swollen and painful. Became EXTREMELY fatigued within 2-2 1/2 hours; had to lay down for 3 hours. Woke up with fever and nausea and dizziness. Lightheaded. Ate dinner. Went to bed. Next morning (11/13/19) couldn?t get out of bed. Weakness in left side of body; body ache; low grade fever; extreme fatigue; very depressed. Next morning I woke up and had nearly no feeling in left side of body; arm, leg, foot, face. I tried to get up and dressed and noticed it was very difficult for me. My whole mouth and cheeks were droopy and my speech was very slurred. I couldn?t smile. My vision was blurry. I then realized these were all signs of a stroke. I called my doctor and she had me call 911 for possible stroke. Was in ER all day. Did 3 CT Scans. Can?t do mri due to metal hardware inside. After several hours of blood tests etc , my symptoms improved and they sent me home. After evaluating at home and recent symptoms since vaccine wondered if it was due to reaction to flu shot.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: Shot site very red, swollen and painful. Became EXTREMELY fatigued within 2-2 1/2 hours; had to lay down for 3 hours. Woke up with fever and nausea and dizziness. Lightheaded. Ate dinner. Went to bed. Next morning (11/13/19) couldn?t get out of bed. Weakness in left side of body; body ache; low grade fever; extreme fatigue; very depressed. Next morning I woke up and had nearly no feeling in left side of body; arm, leg, foot, face. I tried to get up and dressed and noticed it was very difficult for me. My whole mouth and cheeks were droopy and my speech was very slurred. I couldn?t smile. My vision was blurry. I then realized these were all signs of a stroke. I called my doctor and she had me call 911 for possible stroke. Was in ER all day. Did 3 CT Scans. Can?t do mri due to metal hardware inside. After several hours of blood tests etc , my symptoms improved and they sent me home. After evaluating at home and recent symptoms since vaccine wondered if it was due to reaction to flu shot.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Sensory disturbance, Vision blurred
Clinical narrative: Shot site very red, swollen and painful. Became EXTREMELY fatigued within 2-2 1/2 hours; had to lay down for 3 hours. Woke up with fever and nausea and dizziness. Lightheaded. Ate dinner. Went to bed. Next morning (11/13/19) couldn?t get out of bed. Weakness in left side of body; body ache; low grade fever; extreme fatigue; very depressed. Next morning I woke up and had nearly no feeling in left side of body; arm, leg, foot, face. I tried to get up and dressed and noticed it was very difficult for me. My whole mouth and cheeks were droopy and my speech was very slurred. I couldn?t smile. My vision was blurry. I then realized these were all signs of a stroke. I called my doctor and she had me call 911 for possible stroke. Was in ER all day. Did 3 CT Scans. Can?t do mri due to metal hardware inside. After several hours of blood tests etc , my symptoms improved and they sent me home. After evaluating at home and recent symptoms since vaccine wondered if it was due to reaction to flu shot.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced painful swelling in arm after vaccine administration, pain level prompted pt to see MD, was sent to ER, Dx provided at ER was cellulitis.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fall, Muscular weakness
Clinical narrative: Patient came in for her second dose of shingrix vaccine. Her husband assisted her walking in as she does have mobility issues. After the vaccine patient felt weak, but with the assistance of her husband went home. The next morning patient felt her legs were getting weaker and she even slipped off the toilet. 911 was called, EMT checked her BP and Mental status which checked out okay. She later did go to the emergency room and was admitted. Per patient nothing has been determined, but she is being referred to rehab/PT to build strength.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram head, Eyelid function disorder, Facial paralysis
Clinical narrative: Developed drooping check, crooked mouth, eyelid would not shut; diagnosed with Bells Palsy
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Inflammation, Influenza like illness, Pain
Clinical narrative: Inflammation + flu like symptoms. Pain from top of head to toes. Upset stomach which lasted around 2 days.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Local reaction, Nodule, Tenderness
Clinical narrative: Patient has knot on right arm; local reaction; Tender to touch; Information has been received on request by the Company from FDA (agency # 805483) under the Freedom of Information Act on 04-OCT-2019.  This spontaneous report was received from a registered nurse regarding an unspecified 12-year-old male patient. The patient's concurrent condition included constipation. The patient's concomitant medication included polyethylene glycol (MIRALAX). The patient did not have any allergies to medications, food or other products. The patient's historical conditions or previous medications were not provided.    On 13-AUG-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number R020948 has been verified to be a valid number, expiration date was not reported but upon internal validation established as: 04-MAY-2021 (strength and exact dose were not provided) administered intramuscularly (IM) on right arm for prophylaxis. On the same day, in the afternoon reported as "pm" the patient experienced a "knot on the right arm" (injection site nodule) which was "tender to touch" (tenderness) but there was no redness or warmth, it was a local reaction and there were no signs of infection. On 14-MAR-2019, the medical doctor (MD) saw the patient and instructed " to do symptomatic treatment only". There were no medical tests or laboratory results related to the event. The outcome of the events was unknown.   The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow up information has been received from the registered nurse on 15-NOV-2019. It was reported that the nurse had no way to track the patient.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site nodule, Injection site pain, Local reaction
Clinical narrative: Patient has knot on right arm; local reaction; Tender to touch; Information has been received on request by the Company from FDA (agency # 805483) under the Freedom of Information Act on 04-OCT-2019.  This spontaneous report was received from a registered nurse regarding an unspecified 12-year-old male patient. The patient's concurrent condition included constipation. The patient's concomitant medication included polyethylene glycol (MIRALAX). The patient did not have any allergies to medications, food or other products. The patient's historical conditions or previous medications were not provided.    On 13-AUG-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number R020948 has been verified to be a valid number, expiration date was not reported but upon internal validation established as: 04-MAY-2021 (strength and exact dose were not provided) administered intramuscularly (IM) on right arm for prophylaxis. On the same day, in the afternoon reported as "pm" the patient experienced a "knot on the right arm" (injection site nodule) which was "tender to touch" (tenderness) but there was no redness or warmth, it was a local reaction and there were no signs of infection. On 14-MAR-2019, the medical doctor (MD) saw the patient and instructed " to do symptomatic treatment only". There were no medical tests or laboratory results related to the event. The outcome of the events was unknown.   The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow up information has been received from the registered nurse on 15-NOV-2019. It was reported that the nurse had no way to track the patient.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Headache, Impaired work ability, Insomnia
Clinical narrative: Had fever up to 101; Was in bed for three days; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever and bedridden. On an unknown date, the outcome of the fever and bedridden were unknown.   It was unknown if the reporter considered the fever and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in June 2019 and had fever of 101 and was in bed for three days. The patient stated that, her PCP would not worried about this and he thought it was a very strong immune response. It was not an allergic reaction. The patient stated that some people did have fever afterwards. The patient wanted to get 2nd dose of Shigrix as the time was running out. The patient wanted to ask about her friend who had stage 4 cancer and was taking chemo. Her immunitiny was seriously compromised and her physician has said that those getting flu shots should not have contact with her for one week.The patient asked the pharmacist and got a vague answer. The patient wanted to ask how long after the vaccine could transmit something to someone with very compromised immunities, as her situation was very serious and did not want to take any chances. The patient asked to PCP only got a general answer.      Lab Comments: Lab test performed on an unknown date
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Had fever up to 101; Was in bed for three days; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever and bedridden. On an unknown date, the outcome of the fever and bedridden were unknown.   It was unknown if the reporter considered the fever and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in June 2019 and had fever of 101 and was in bed for three days. The patient stated that, her PCP would not worried about this and he thought it was a very strong immune response. It was not an allergic reaction. The patient stated that some people did have fever afterwards. The patient wanted to get 2nd dose of Shigrix as the time was running out. The patient wanted to ask about her friend who had stage 4 cancer and was taking chemo. Her immunitiny was seriously compromised and her physician has said that those getting flu shots should not have contact with her for one week.The patient asked the pharmacist and got a vague answer. The patient wanted to ask how long after the vaccine could transmit something to someone with very compromised immunities, as her situation was very serious and did not want to take any chances. The patient asked to PCP only got a general answer.      Lab Comments: Lab test performed on an unknown date
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Bedridden, Pyrexia
Clinical narrative: Had fever up to 101; Was in bed for three days; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever and bedridden. On an unknown date, the outcome of the fever and bedridden were unknown.   It was unknown if the reporter considered the fever and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in June 2019 and had fever of 101 and was in bed for three days. The patient stated that, her PCP would not worried about this and he thought it was a very strong immune response. It was not an allergic reaction. The patient stated that some people did have fever afterwards. The patient wanted to get 2nd dose of Shigrix as the time was running out. The patient wanted to ask about her friend who had stage 4 cancer and was taking chemo. Her immunitiny was seriously compromised and her physician has said that those getting flu shots should not have contact with her for one week.The patient asked the pharmacist and got a vague answer. The patient wanted to ask how long after the vaccine could transmit something to someone with very compromised immunities, as her situation was very serious and did not want to take any chances. The patient asked to PCP only got a general answer.      Lab Comments: Lab test performed on an unknown date
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Had fever up to 101; Was in bed for three days; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever and bedridden. On an unknown date, the outcome of the fever and bedridden were unknown.   It was unknown if the reporter considered the fever and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in June 2019 and had fever of 101 and was in bed for three days. The patient stated that, her PCP would not worried about this and he thought it was a very strong immune response. It was not an allergic reaction. The patient stated that some people did have fever afterwards. The patient wanted to get 2nd dose of Shigrix as the time was running out. The patient wanted to ask about her friend who had stage 4 cancer and was taking chemo. Her immunitiny was seriously compromised and her physician has said that those getting flu shots should not have contact with her for one week.The patient asked the pharmacist and got a vague answer. The patient wanted to ask how long after the vaccine could transmit something to someone with very compromised immunities, as her situation was very serious and did not want to take any chances. The patient asked to PCP only got a general answer.      Lab Comments: Lab test performed on an unknown date
Age: 46.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Anger, Feeling abnormal, Headache, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: started out drowsy and weak in the beginning shortly after the vaccinations then I had great strength feeling like the incredible hulk with crazy thoughts like I could kill a million people. Later in the night, I had a severe headache and went back to feeling drowsy. I laid down early because I didn't feel well. I had these severe headaches for several days. I've never had the type of headaches I had before receiving the shot. They were different than any type of headache I've had previously. I also experienced pain in my back and left side. I call and reported my experience to the health department and visited my doctor the next day due to the issues I were having from the vaccines.
Age: 46.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Ovarian disorder
Clinical narrative: started out drowsy and weak in the beginning shortly after the vaccinations then I had great strength feeling like the incredible hulk with crazy thoughts like I could kill a million people. Later in the night, I had a severe headache and went back to feeling drowsy. I laid down early because I didn't feel well. I had these severe headaches for several days. I've never had the type of headaches I had before receiving the shot. They were different than any type of headache I've had previously. I also experienced pain in my back and left side. I call and reported my experience to the health department and visited my doctor the next day due to the issues I were having from the vaccines.
Age: 46.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Asthenia, Blood test, Headache, Malaise, Somnolence
Clinical narrative: started out drowsy and weak in the beginning shortly after the vaccinations then I had great strength feeling like the incredible hulk with crazy thoughts like I could kill a million people. Later in the night, I had a severe headache and went back to feeling drowsy. I laid down early because I didn't feel well. I had these severe headaches for several days. I've never had the type of headaches I had before receiving the shot. They were different than any type of headache I've had previously. I also experienced pain in my back and left side. I call and reported my experience to the health department and visited my doctor the next day due to the issues I were having from the vaccines.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Cellulitis, Chills, Full blood count normal, Injection site erythema, Injection site streaking
Clinical narrative: My daughter received the second dose of the meningococcal B vaccine(unsure of the brand. The practice manager of medical center took weeks to return phone calls and was supposed to call me back after speaking with the doctor and after a month I still have not heard from here).  That evening she got body aches and fever.  The next day she noticed below the injection site redness and what appeared to be swelling which looked like hives.  Benadryl was given at home with no improvement.  My daughter went to see the doctor on Saturday due to the increased redness of her arm. The doctor thought she was having a severe local reaction or infection. Augmentin was started with no improvement by Monday.  Redness increased extending almost down to elbow. She saw the same doctor on Monday who advised her to go to hospital ER where she was admitted to the hospital from Monday to Wednesday for IV antibiotics related to complications from the vaccine.  She went home on 10 days I believe of oral clindamycin.  I am concerned that the cellulitis was related to a component in the vaccine?  The redness started just below the injection site. Pictures were taken for documentation
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain, Pyrexia
Clinical narrative: My daughter received the second dose of the meningococcal B vaccine(unsure of the brand. The practice manager of medical center took weeks to return phone calls and was supposed to call me back after speaking with the doctor and after a month I still have not heard from here).  That evening she got body aches and fever.  The next day she noticed below the injection site redness and what appeared to be swelling which looked like hives.  Benadryl was given at home with no improvement.  My daughter went to see the doctor on Saturday due to the increased redness of her arm. The doctor thought she was having a severe local reaction or infection. Augmentin was started with no improvement by Monday.  Redness increased extending almost down to elbow. She saw the same doctor on Monday who advised her to go to hospital ER where she was admitted to the hospital from Monday to Wednesday for IV antibiotics related to complications from the vaccine.  She went home on 10 days I believe of oral clindamycin.  I am concerned that the cellulitis was related to a component in the vaccine?  The redness started just below the injection site. Pictures were taken for documentation
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood culture negative, Cellulitis, Erythema, Laboratory test, Local reaction
Clinical narrative: My daughter received the second dose of the meningococcal B vaccine(unsure of the brand. The practice manager of medical center took weeks to return phone calls and was supposed to call me back after speaking with the doctor and after a month I still have not heard from here).  That evening she got body aches and fever.  The next day she noticed below the injection site redness and what appeared to be swelling which looked like hives.  Benadryl was given at home with no improvement.  My daughter went to see the doctor on Saturday due to the increased redness of her arm. The doctor thought she was having a severe local reaction or infection. Augmentin was started with no improvement by Monday.  Redness increased extending almost down to elbow. She saw the same doctor on Monday who advised her to go to hospital ER where she was admitted to the hospital from Monday to Wednesday for IV antibiotics related to complications from the vaccine.  She went home on 10 days I believe of oral clindamycin.  I am concerned that the cellulitis was related to a component in the vaccine?  The redness started just below the injection site. Pictures were taken for documentation
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: My daughter received the second dose of the meningococcal B vaccine(unsure of the brand. The practice manager of medical center took weeks to return phone calls and was supposed to call me back after speaking with the doctor and after a month I still have not heard from here).  That evening she got body aches and fever.  The next day she noticed below the injection site redness and what appeared to be swelling which looked like hives.  Benadryl was given at home with no improvement.  My daughter went to see the doctor on Saturday due to the increased redness of her arm. The doctor thought she was having a severe local reaction or infection. Augmentin was started with no improvement by Monday.  Redness increased extending almost down to elbow. She saw the same doctor on Monday who advised her to go to hospital ER where she was admitted to the hospital from Monday to Wednesday for IV antibiotics related to complications from the vaccine.  She went home on 10 days I believe of oral clindamycin.  I am concerned that the cellulitis was related to a component in the vaccine?  The redness started just below the injection site. Pictures were taken for documentation
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: The patient has developed cellulitis after taking PNEUMOVAX 23 injection; This spontaneous report was received from a currently 73-year-old female patient referring to herself. The patient had no pertinent medical history and her previous drug reactions were not reported. The patient's allergies included to horses and cats. Concomitant medications included atorvastatin, carvedilol and sertraline hydrochloride.   On an unspecified date (also reported as September 14 th (year not provided)), the patient was vaccinated at a super market with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) dose and frequency reported as "one shot", into the right upper arm, also reported as route of administration, as prophylaxis (indication reported as pneumonia) (lot number S0122X5 is an invalid lot number for  pneumococcal vaccine, polyvalent (23-valent); expiration date: 09-FEB-2021; strength was not reported).     On an unspecified date (also reported as September 15 th or 16) (year not provided)), it was reported that the patient developed cellulitis. Therefore, she sought medical attention and treatment with cephalexin was provided: 1 capsule, 4 times a day for 10 days. The patient did not require hospitalization and no laboratory diagnostics or studies were performed due to the event.  On an unspecified date (also reported as September 23 rd or 24 th (year not provided)), the patient recovered from the event cellulitis. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the event was not provided.  Upon internal review, cellulitis was determined to be medically significant.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: patient was complaining of severe arm swelling that was affecting the whole arm from the shoulder to the hand. She was not able to hold the pen and write while using affected (right arm).
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysgraphia, Grip strength decreased, Peripheral swelling
Clinical narrative: patient was complaining of severe arm swelling that was affecting the whole arm from the shoulder to the hand. She was not able to hold the pen and write while using affected (right arm).
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: Member got a tattoo placed roughly one inch below scarification site
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Tattoo, Unevaluable event
Clinical narrative: Member got a tattoo placed roughly one inch below scarification site
Age: 55.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Chest discomfort, Urticaria
Clinical narrative: At time of injection O adverse reaction till next day she had weltes itched all over instructed her to go to MD she also was taking antibiotic of some kind.