chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: patient noted soreness in the arm the day off (11/10) during the evening, swelling to the size of a baseball.  But by saturday morning (11/11) the swelling had moved moved down her arm towards her elbow (residing just above the elbow crease under the bicept) and had brusing (approxamately 3x5 inches) and was warm and tender to the touch. Patient came into the pharmacy Sunday 11/12 and stated brusing was slightly lightening and this reporter observed the brusing, no obvious inflamation. Patient reported during the day her arm (above the brusing) has started lightly itching. Patient stated she obtained her vaccination in the standing position
Age: 0.5
Sex: M
Vaccine: COVID19, DTPPVHBHPB, PNC20, RV5
Symptoms: Product preparation error, Pyrexia, Vomiting
Clinical narrative: Patient received undiluted vaccine of the multidose vial (yellow top). Patient and mother were informed. Patient developed a fever of 104 and vomiting but recovered the after administration.
Age: 70.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Muscle mass
Clinical narrative: PATIENT CAME TO THE PHARMACY SAYING HE HAD A LUMP UNDER HIS LEFT PECTORIAL MUSCLE.  HE STATED IT HAPPENED ABOUT TWO WEEKS AFTER AREXVY.  PATIENT LEFT TO GO HAVE IT CHECKED OUT BY HIS PRESCRIBER.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM (THE VACCINE IS COMIRNATY +12) NDC 00069-2392-10
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Child was given 0.5 ml instead of 0.25ml
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blister, Contusion, Phantom limb syndrome, Swelling
Clinical narrative: Patient also received Flu shot at same time in left arm.  11/3/2022.  Reaction in just a few hours - bruising, 2nd degree blistering and swelling the size of an orange.  Took over a month for swelling to subside.  Continues now a year later with phantom pain in that arm. Patient wanted another Covid shot 11/13/2023, given Moderna not Pfizer.    She will report back to office if there is any reaction this time.   RN BSN
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2, UNK
Symptoms: Antinuclear antibody negative, Appetite disorder, Back pain, Blood thyroid stimulating hormone normal, Brain fog
Clinical narrative: Chronic Fatigue, Brain Fog, SOB on exertion, headaches, backaches, body aches, chronic cough, constipation/ diarrhea, appetite varies, large leg blotches when standing, difficulty sleeping. Had a  Bone Marrow Transplant in Nov 2020 and was in remission.Was taking Ninlaro as a maintenance therapy to prevent recurrance of Multiple Myeloma before and after taking Moderna Bivalance dose in November of 2022. Symptoms started with fever, headaches, nausea/vomiting which subsided within 3 days but I felt very tired and unable to do my Activities of Daily living, wanted to stay in bed. Symptoms persisted for months and I  returned to Oncologist to run standard cancer and other tests,  to rule out recurrance of cancer.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2, UNK
Symptoms: C-reactive protein normal, Constipation, Cortisol normal, Cough, Diarrhoea
Clinical narrative: Chronic Fatigue, Brain Fog, SOB on exertion, headaches, backaches, body aches, chronic cough, constipation/ diarrhea, appetite varies, large leg blotches when standing, difficulty sleeping. Had a  Bone Marrow Transplant in Nov 2020 and was in remission.Was taking Ninlaro as a maintenance therapy to prevent recurrance of Multiple Myeloma before and after taking Moderna Bivalance dose in November of 2022. Symptoms started with fever, headaches, nausea/vomiting which subsided within 3 days but I felt very tired and unable to do my Activities of Daily living, wanted to stay in bed. Symptoms persisted for months and I  returned to Oncologist to run standard cancer and other tests,  to rule out recurrance of cancer.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2, UNK
Symptoms: Dyspnoea exertional, Fatigue, Headache, Insomnia, Laboratory test normal
Clinical narrative: Chronic Fatigue, Brain Fog, SOB on exertion, headaches, backaches, body aches, chronic cough, constipation/ diarrhea, appetite varies, large leg blotches when standing, difficulty sleeping. Had a  Bone Marrow Transplant in Nov 2020 and was in remission.Was taking Ninlaro as a maintenance therapy to prevent recurrance of Multiple Myeloma before and after taking Moderna Bivalance dose in November of 2022. Symptoms started with fever, headaches, nausea/vomiting which subsided within 3 days but I felt very tired and unable to do my Activities of Daily living, wanted to stay in bed. Symptoms persisted for months and I  returned to Oncologist to run standard cancer and other tests,  to rule out recurrance of cancer.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2, UNK
Symptoms: Loss of personal independence in daily activities, Nausea, Pain, Pyrexia, Rash macular
Clinical narrative: Chronic Fatigue, Brain Fog, SOB on exertion, headaches, backaches, body aches, chronic cough, constipation/ diarrhea, appetite varies, large leg blotches when standing, difficulty sleeping. Had a  Bone Marrow Transplant in Nov 2020 and was in remission.Was taking Ninlaro as a maintenance therapy to prevent recurrance of Multiple Myeloma before and after taking Moderna Bivalance dose in November of 2022. Symptoms started with fever, headaches, nausea/vomiting which subsided within 3 days but I felt very tired and unable to do my Activities of Daily living, wanted to stay in bed. Symptoms persisted for months and I  returned to Oncologist to run standard cancer and other tests,  to rule out recurrance of cancer.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2, UNK
Symptoms: Thyroxine normal, Tri-iodothyronine normal, Vomiting
Clinical narrative: Chronic Fatigue, Brain Fog, SOB on exertion, headaches, backaches, body aches, chronic cough, constipation/ diarrhea, appetite varies, large leg blotches when standing, difficulty sleeping. Had a  Bone Marrow Transplant in Nov 2020 and was in remission.Was taking Ninlaro as a maintenance therapy to prevent recurrance of Multiple Myeloma before and after taking Moderna Bivalance dose in November of 2022. Symptoms started with fever, headaches, nausea/vomiting which subsided within 3 days but I felt very tired and unable to do my Activities of Daily living, wanted to stay in bed. Symptoms persisted for months and I  returned to Oncologist to run standard cancer and other tests,  to rule out recurrance of cancer.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient had welts/hives show up on his buttock area within 4 days of the vaccine on 11/10/2023. Those cleared up the following day and the reaction then proceeded to move to his scalp and hairline area. He is still reporting itching on and off as off 11/13/2023, Patient is taking benadryl to help lessen the severity of the hives.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: Vaccine was administered too high in the shoulder joint. After an hour, the patient was unable to move her arm and sought medical attention at an urgent care.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose of moderna was given to adult
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: I requested the flu vaccine and was inadvertently given a covid 19 vaccine instead.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: HIV test false positive
Clinical narrative: false positive for hiv
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Expired product administered
Clinical narrative: vaccination administered after expiration date. stock expired on 10/31/23. no symptoms reported by pt and is aware of expired vaccine.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccination administered after expiration date. stock expired on 10/31/23. no symptoms reported by pt and is aware of expired vaccine.
Age: 8.0
Sex: F
Vaccine: COVID19, FLU4, PPV
Symptoms: Blood culture, C-reactive protein increased, Cellulitis, Chest X-ray, Full blood count
Clinical narrative: High fever of 106.1 on 11/9/23 morning.  Evaluation in the ER.  High CRP. Swelling to the Left arm on 11/20/23 Evaluation at office on 11/10/23 with repeat CBC & CRP.  Rocephin given.  Elevated CRP & WBC. Evaluation at office on 11/11/23 with repeat CBC & CRP.  Rocephin given.  Keflex started for cellulitis.
Age: 8.0
Sex: F
Vaccine: COVID19, FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia, Urine analysis, White blood cell count increased
Clinical narrative: High fever of 106.1 on 11/9/23 morning.  Evaluation in the ER.  High CRP. Swelling to the Left arm on 11/20/23 Evaluation at office on 11/10/23 with repeat CBC & CRP.  Rocephin given.  Elevated CRP & WBC. Evaluation at office on 11/11/23 with repeat CBC & CRP.  Rocephin given.  Keflex started for cellulitis.
Age: 33.0
Sex: U
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: IM was administered too high on the shoulder. IM was more painful than others in the past. Pain and decreased ROM have persisted since injection.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt requested and received a second dose of this vaccination today 11/13/2023. She had received a dose of this vaccination on 11/1/2023.  It is possible pt was confused and was requesting an RSV vaccination. No adverse reactions were noted while in the clinic
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Laboratory test normal, Loss of personal independence in daily activities
Clinical narrative: Within two weeks of receiviing my first vaccine I had to go to the emergency room because I was having problems breathing. I had shortness of breath, heart palpatations, that changed my life drastically. Im still suffering from those symptoms and more. I am lightheaded, dizzy, fatigued . Ive been to a cartio, pulmin, endro, gastro, hemoto, had all the tests recomended and the doctors say all test results came back nornal.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Within two weeks of receiviing my first vaccine I had to go to the emergency room because I was having problems breathing. I had shortness of breath, heart palpatations, that changed my life drastically. Im still suffering from those symptoms and more. I am lightheaded, dizzy, fatigued . Ive been to a cartio, pulmin, endro, gastro, hemoto, had all the tests recomended and the doctors say all test results came back nornal.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Arthritis, Back pain, Blood test, Dysstasia
Clinical narrative: I woke up and many of my joints were hurting.  Knees, Hips, shoulders, groin and feet.  It became excruciating  by the time of my daughters wedding which was 11 days later.  My lower back and hips hurt so bad as well as my knees.  I was no longer able to stand more than a few minutes or walk for more than a few minutes.  I can not take pain pills due to liver disease called nash . I had xrays of knees and it showed severe arthritis . had hip xrays that showed arthritis.  Am now awaiting spine mri.  My whole life has come to a halt and I have children.  I now use a walker.  There are no more activities. No walking, no shopping unless I can hold on to a cart. I'm done.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait disturbance, Groin pain, Pain in extremity, Walking aid user, X-ray limb abnormal
Clinical narrative: I woke up and many of my joints were hurting.  Knees, Hips, shoulders, groin and feet.  It became excruciating  by the time of my daughters wedding which was 11 days later.  My lower back and hips hurt so bad as well as my knees.  I was no longer able to stand more than a few minutes or walk for more than a few minutes.  I can not take pain pills due to liver disease called nash . I had xrays of knees and it showed severe arthritis . had hip xrays that showed arthritis.  Am now awaiting spine mri.  My whole life has come to a halt and I have children.  I now use a walker.  There are no more activities. No walking, no shopping unless I can hold on to a cart. I'm done.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: X-ray of pelvis and hip abnormal
Clinical narrative: I woke up and many of my joints were hurting.  Knees, Hips, shoulders, groin and feet.  It became excruciating  by the time of my daughters wedding which was 11 days later.  My lower back and hips hurt so bad as well as my knees.  I was no longer able to stand more than a few minutes or walk for more than a few minutes.  I can not take pain pills due to liver disease called nash . I had xrays of knees and it showed severe arthritis . had hip xrays that showed arthritis.  Am now awaiting spine mri.  My whole life has come to a halt and I have children.  I now use a walker.  There are no more activities. No walking, no shopping unless I can hold on to a cart. I'm done.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Rash on the arm wont go  away since last week
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Injection site paraesthesia, Pain
Clinical narrative: Patient contacted clinic the day following immunization to report that her arm was "really, really sore" indicating that she had never experienced this kind of pain before. Symptomatic therapy with warm packs alternating with ice as well as acetaminophen to use as needed discussed. Patient later noted that one hour after the shot she started to feel tingling in her left arm (site of injection). Within a few hours there was notable pain radiating from elbow to shoulder. There was no swelling, red streaks, or warmth. Described pain October 9 as a "band with one intense point." No changes in mobility, but noted discomfort carrying items weighing less than 5 pounds and with lifting arm overhead as well as repositioning in bed. Seen in clinic 10/12/2023 with pain to left shoulder superior medial area or deltoid. Decreased ROM to 90 degrees. No other abnormalities noted on exam. Prescribed Naproxen 220 mg bid and alternate with acetaminophen as well as initiating physical therapy. After 4th session of physical therapy feels pain may now be improving slightly.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient contacted clinic the day following immunization to report that her arm was "really, really sore" indicating that she had never experienced this kind of pain before. Symptomatic therapy with warm packs alternating with ice as well as acetaminophen to use as needed discussed. Patient later noted that one hour after the shot she started to feel tingling in her left arm (site of injection). Within a few hours there was notable pain radiating from elbow to shoulder. There was no swelling, red streaks, or warmth. Described pain October 9 as a "band with one intense point." No changes in mobility, but noted discomfort carrying items weighing less than 5 pounds and with lifting arm overhead as well as repositioning in bed. Seen in clinic 10/12/2023 with pain to left shoulder superior medial area or deltoid. Decreased ROM to 90 degrees. No other abnormalities noted on exam. Prescribed Naproxen 220 mg bid and alternate with acetaminophen as well as initiating physical therapy. After 4th session of physical therapy feels pain may now be improving slightly.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Fatigue, Headache, Trigeminal neuralgia
Clinical narrative: Headache & exhaustion within 24 hours afterward. Trigeminal neuralgia & Bells Palsy within 3 months afterward.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Auscultation, Heart rate increased
Clinical narrative: Pt arrived back to clinic @ 1700 on 11/13/23 with mother. Mother stated pt's HR was beating too fast, after receiving the flulaval shot earlier today at 1500. This nurse auscultated pt's apical pulse: 400BPM.  Pt denied pain, denied SOB. Dr. came to bedside immediately and ordered a cold compress and cloths to be placed on pt's forehead and abdomen. Pt was transported to emergency department via mom, as she declined an ambulance to save time.  Pt has been admitted to Hospital.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Headache, Pain in extremity, Pyrexia
Clinical narrative: EVENING OF VACCINATION PATIENT FELT WEAK, ARM PAIN, HEADACHE, HIGHFEVER, FELT AS THOUGH HE COULD NOT SPEAK FOR 2 DAYS. THEN CONTINUES TO HAVE A SEVERE HEADACHE ON AND OFF
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Was given the wrong vaccine. pt is 32 and pregnant and was give HD Flu
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site nodule
Clinical narrative: Knot at site, redness in right arm which increased in size of the weekend.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Pneumonia, Product administered to patient of inappropriate age
Clinical narrative: Patient received a high dose vaccine when not age eligible on 10/18/23 and previously on 10/2/23 received a regular flu vaccine. On 10/31, patient was treated for pneumonia by a clinic and the provider at the clinic thought 2 doses of flu vaccine consecutively caused the condition.
Age: 21.0
Sex: M
Vaccine: COVID19, FLU4, TDAP
Symptoms: Dizziness, Hypoaesthesia, Lethargy
Clinical narrative: Pt was given TDAP Vaccine in left arm,  he then received Covid Pfizer Vaccine ( Comirnaty) in right upper arm,  we proceeded to administer his influenza vaccine (fluzone ) in the right upper arm, as the provider finished administering the last vaccine - which was the influenza vaccine, the patient stated, "Uh-Oh,  my fingers are getting numb and I am getting light headed"   The provider proceeded to have him lay down on the exam table. the patient became very lethargic,  he never lost consciousness.  He apologized for getting lightheaded and states he donates blood regularly and has become faint and lightheaded in the past when donating blood.   We had him drink some water, we asked him if he had eaten - he ate about 2 hours before coming to get his vaccines. We watched the patient for  approximately 20 minutes at 7:50 pm , we raised the head of the exam table , at 7:53 pm , he was walking around in the exam room and states he feels fine.  Patient was escorted to his vehicle, gait steady, alert and oriented.
Age: 6.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Nervousness, Syncope
Clinical narrative: MOM WAS WITH PT INSIDE IMZ BOOTH. HE RECEIVED BOTH VACCINES. PT WAS NERVOUS AND MOM HELPED TO CALM HIM DOWN. HIS MOTHER ASKED HIM TO GO TO HIS FATHER. HIS FATHER WAS STANDING OUTSIDE THE IMZ BOOTHE.  HE  WALKED OVER TO HIS FATHER AFTER IMZ. I WAS THEN ABOUT TO GIVE HIS MOM AN IMZ ABOUT A MINUTE LATER WHEN I HEARD A COMMOTION OUTSIDE THE IMZ BOOTH. PT WAS LAYING ON THE FLOOR TRYING TO GET UP. HIS FATHER WAS KNEELING BESIDE HIM TELLING HIM TO STAY ON THE FLOOR. HIS FATHER SAID HE FAINTED. HE ASKED FOR SOMETHING WITH SUGAR. I GAVE THE FATHER A ROOT BEER SODA AND A PACKET OF YOUGURT.  THE FATHER KEPT THE PT ON THE FLOOR FOR ABOUT 10 MINS. HE HAD HIM DRINK SOME OF THE SODA AND CONSUME SOME OF THE YUOGURT.
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: patient complained of sever diarrhea and vomiting, fever, body aches.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Rash pruritic, Urticaria
Clinical narrative: About 12 days after the vaccine I broke out in an itchy rash and hives. My grandmother experienced a very similar Event after receiving her Covid booster, which led me to draw the connection.  I am now on my 3rd day of this persistent, uncomfortable rash and hives, which are moving around my body (torso, neck, legs, back, and now face).   I have never had hives or a rash like this previously. I will visit my primary care doctor this week.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Hypersensitivity, Peripheral swelling, Skin warm
Clinical narrative: Patient received Shingrix and the Flublok on 11/7/2023, she reports that her right arm (Shingrix side) began to swell and become warm the following morning.  She went to Urgent Care today 11/13/2023 and was told she most likley had an allergic reaction to the vaccine and that then turned into Cellulitis.  She was prescribed Cephalexin 500mg q 6 hours for 7 days.   Urgent Care also advised her to use Benadryl before and after all vaccines going forward.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given Proquad but only needed MMR. Error was injecting wrong vaccine.  No symptoms, no signs, no reaction to vaccine.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was given the fluzone high dose in error. due to her age should have received quadrivalent
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Extreme arm pain, some minor muscle aches.  Acetaminophen helps.  Also some possible chest pain that began about a week after vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Headache, Loss of personal independence in daily activities
Clinical narrative: A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions for about 30 hours, severe headache, entire body shutdown arms legs incapable of functioning normally, soreness, aching, dizziness, shortness of breath, chest pains when inhaling.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pain, Painful respiration
Clinical narrative: A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions for about 30 hours, severe headache, entire body shutdown arms legs incapable of functioning normally, soreness, aching, dizziness, shortness of breath, chest pains when inhaling.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: I have been in menopause for over 10 years and no longer have any hot flashes. I had hot flashes during perimenopause. Shortly after the COVID vaccine I started having hot flashes. It took me a few days to realize that is what was happening. It's been 5 weeks since my vaccine and I'm still having hot flashes.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: I accidentally gave a pediatric dose (age 5y -11y) to a 12 year old patient
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Routine 12 month physical today.  I ordered MMR and Var (along with Hep A and flu) to be administered.  Tech administered MMRV and Var (along with Hep A and flu).  As of this evening, the patient has not had an adverse reaction, to my knowledge.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Routine 12 month physical today.  I ordered MMR and Var (along with Hep A and flu) to be administered.  Tech administered MMRV and Var (along with Hep A and flu).  As of this evening, the patient has not had an adverse reaction, to my knowledge.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: I have been dealing with hives since 11/5 that have only mildly responded to Zyrtec, Allegra and pepcid. I have been messaging with my allergist and I see him on Friday 11/17/23 for an in office visit
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills and body aches
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient selected flu shot on his online form for Pharmacy, thinking it was a newer flu vaccine. However, he had already received the high dose flu shot at the clinic on 09/27/2023. Technician confirmed with him that he wanted the flu shot and continued to process it. Insurance did NOT give any hard halt and vaccine was processed through his insurance. In clinic room, Pharmacist verified the name, DOB, and vaccine. During preparation of vaccine site, the name of the High Dose flu vaccine was mentioned and confirmed numerous times and then administered. Only after the patient was sitting in the waiting room he realized that he did not need the Flu vaccine again this season.
Age: 83.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient selected flu shot on her online form for Pharmacy and in-person, thinking she needed the flu vaccine. However, she had already received the high dose flu shot at the clinic on 09/27/2023. Technician confirmed with her that she wanted the flu shot and continued to process it. Insurance did NOT give any hard halt and vaccine was processed through her insurance. In clinic room, Pharmacist verified the name, DOB, and vaccine. During preparation of vaccine site, the name of the High Dose flu vaccine was mentioned and confirmed numerous times and then administered. Only after the patient was getting up and Pharmacist was completing final counseling, did she realize that she did not need the Flu vaccine again this season.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Gait inability, Injection site erythema, Pain
Clinical narrative: Pt developed severe pain on 11/10/23 and was unable to walk until  late on 11/12/23. She continues to  limp as of 3pm on 11/13/23. Symptoms  have not resolved. continued redness  to the injection site
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site vesicles, Pain in extremity
Clinical narrative: Approximately 2 days after vaccination, Pt developed a blister at the injection  site along with right leg pain and body numbness. These symptoms  lasted 2 days and have resolved
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Ear swelling, Electromyogram, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: About 1 and a half weeks after I received the vaccine, my ears swelled and were very painful. Numbness spread down both of my arms to my finger tips and started across my face and stopped finally at the middle of my face. The numbness receded and now I am left with numbness in all of my 10 finger tips and the left side of my face. Last month the numbness in my lower lip started to grow across my bottom lip and the left side of my tongue. Now my whole bottom lip is completely numb and under my chin.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging
Clinical narrative: About 1 and a half weeks after I received the vaccine, my ears swelled and were very painful. Numbness spread down both of my arms to my finger tips and started across my face and stopped finally at the middle of my face. The numbness receded and now I am left with numbness in all of my 10 finger tips and the left side of my face. Last month the numbness in my lower lip started to grow across my bottom lip and the left side of my tongue. Now my whole bottom lip is completely numb and under my chin.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Intense pain at the time of injection. Almost like she either injected it into my nerves or a tendon j stead of my muscle. Pain was worse than after normal Vaccines  (meaning COVID or first shingles shot). Arm was extremely sore and pain didn?t go away. A couple of weeks later pain intensified and grew my bones and joints on my left side started aching terribly. A deep chronic pain. I was traveling (husband and I just retired) so I was taking anti inflammatories that wet otc (which I NEVER take) to try and numb the pain. Finally we went to the ER where they gave me something stronger for the pain and ordered an MRI, which I was able to get. Pain is constant and I am unable to take pain meds because they have given me such bad heartburn. I can?t sleep, I haven?t gotten any deep sleep or REM since I have been in this much pain (I have a ring that measures.). I am exhausted. I don?t know what to do!!
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Sleep disorder
Clinical narrative: Intense pain at the time of injection. Almost like she either injected it into my nerves or a tendon j stead of my muscle. Pain was worse than after normal Vaccines  (meaning COVID or first shingles shot). Arm was extremely sore and pain didn?t go away. A couple of weeks later pain intensified and grew my bones and joints on my left side started aching terribly. A deep chronic pain. I was traveling (husband and I just retired) so I was taking anti inflammatories that wet otc (which I NEVER take) to try and numb the pain. Finally we went to the ER where they gave me something stronger for the pain and ordered an MRI, which I was able to get. Pain is constant and I am unable to take pain meds because they have given me such bad heartburn. I can?t sleep, I haven?t gotten any deep sleep or REM since I have been in this much pain (I have a ring that measures.). I am exhausted. I don?t know what to do!!
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hemiparesis, Injection site pain, Injection site swelling, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Intense pain at the time of injection. Almost like she either injected it into my nerves or a tendon j stead of my muscle. Pain was worse than after normal Vaccines  (meaning COVID or first shingles shot). Arm was extremely sore and pain didn?t go away. A couple of weeks later pain intensified and grew my bones and joints on my left side started aching terribly. A deep chronic pain. I was traveling (husband and I just retired) so I was taking anti inflammatories that wet otc (which I NEVER take) to try and numb the pain. Finally we went to the ER where they gave me something stronger for the pain and ordered an MRI, which I was able to get. Pain is constant and I am unable to take pain meds because they have given me such bad heartburn. I can?t sleep, I haven?t gotten any deep sleep or REM since I have been in this much pain (I have a ring that measures.). I am exhausted. I don?t know what to do!!
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Intense pain at the time of injection. Almost like she either injected it into my nerves or a tendon j stead of my muscle. Pain was worse than after normal Vaccines  (meaning COVID or first shingles shot). Arm was extremely sore and pain didn?t go away. A couple of weeks later pain intensified and grew my bones and joints on my left side started aching terribly. A deep chronic pain. I was traveling (husband and I just retired) so I was taking anti inflammatories that wet otc (which I NEVER take) to try and numb the pain. Finally we went to the ER where they gave me something stronger for the pain and ordered an MRI, which I was able to get. Pain is constant and I am unable to take pain meds because they have given me such bad heartburn. I can?t sleep, I haven?t gotten any deep sleep or REM since I have been in this much pain (I have a ring that measures.). I am exhausted. I don?t know what to do!!
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Bone pain, Fatigue, Injection site pain, Magnetic resonance imaging abnormal
Clinical narrative: Intense pain at the time of injection. Almost like she either injected it into my nerves or a tendon j stead of my muscle. Pain was worse than after normal Vaccines  (meaning COVID or first shingles shot). Arm was extremely sore and pain didn?t go away. A couple of weeks later pain intensified and grew my bones and joints on my left side started aching terribly. A deep chronic pain. I was traveling (husband and I just retired) so I was taking anti inflammatories that wet otc (which I NEVER take) to try and numb the pain. Finally we went to the ER where they gave me something stronger for the pain and ordered an MRI, which I was able to get. Pain is constant and I am unable to take pain meds because they have given me such bad heartburn. I can?t sleep, I haven?t gotten any deep sleep or REM since I have been in this much pain (I have a ring that measures.). I am exhausted. I don?t know what to do!!
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Magnetic resonance imaging joint, Pain, Pain in extremity, Periarthritis, Sleep disorder
Clinical narrative: Intense pain at the time of injection. Almost like she either injected it into my nerves or a tendon j stead of my muscle. Pain was worse than after normal Vaccines  (meaning COVID or first shingles shot). Arm was extremely sore and pain didn?t go away. A couple of weeks later pain intensified and grew my bones and joints on my left side started aching terribly. A deep chronic pain. I was traveling (husband and I just retired) so I was taking anti inflammatories that wet otc (which I NEVER take) to try and numb the pain. Finally we went to the ER where they gave me something stronger for the pain and ordered an MRI, which I was able to get. Pain is constant and I am unable to take pain meds because they have given me such bad heartburn. I can?t sleep, I haven?t gotten any deep sleep or REM since I have been in this much pain (I have a ring that measures.). I am exhausted. I don?t know what to do!!
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Dysphagia, Dyspnoea, Hypertension, Palpitations
Clinical narrative: Blood pressure high; he has had a high amount of anxiety and suffers from regular panic attacks.; anxiety; throat swelling; couldn't breathe; The patient experienced an anaphylactic reaction immediately after the shot was administered.; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3Y7P4) for prophylaxis.   On 31-OCT-2023, the patient received Arexvy (intramuscular). On 31-OCT-2023, immediately after receiving Arexvy, the patient experienced anaphylaxis (Verbatim: The patient experienced an anaphylactic reaction immediately after the shot was administered.) (serious criteria GSK medically significant), throat swelling (Verbatim: throat swelling) and difficulty breathing (Verbatim: couldn't breathe). On 01-NOV-2023, the patient experienced panic attack (Verbatim: he has had a high amount of anxiety and suffers from regular panic attacks.) and anxiety (Verbatim: anxiety). On an unknown date, the patient experienced blood pressure high (Verbatim: Blood pressure high). The patient was treated with epinephrine (Epi Pen). The outcome of the anaphylaxis was unknown and the outcome of the panic attack and anxiety were not resolved and the outcome of the throat swelling and difficulty breathing were resolved and the outcome of the blood pressure high was not reported.   It was unknown if the reporter considered the anaphylaxis, panic attack, anxiety, throat swelling, difficulty breathing and blood pressure high to be related to Arexvy.     It was unknown if the company considered the anaphylaxis, panic attack, anxiety, throat swelling, difficulty breathing and blood pressure high to be related to Arexvy.   Additional Information: GSK Receipt date: 06-NOV-2023 A patient reported that receiving an Arexvy vaccine at a local pharmacy.  The patient experienced an anaphylactic reaction immediately after the shot was administered.  The pharmacist was able to administer an Epi Pen immediately and the patient regained consciousness.  EMS was called and the rescue squad arrived within 2 minutes.  Blood pressure was high 2 times and after 25 minutes, the patient was able to walk out of the store and went home.  The patient reported that since the anaphylaxis event, he had a high amount of anxiety and suffers from regular panic attacks.  The reporter consented to follow up.
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Blood pressure high; he has had a high amount of anxiety and suffers from regular panic attacks.; anxiety; throat swelling; couldn't breathe; The patient experienced an anaphylactic reaction immediately after the shot was administered.; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3Y7P4) for prophylaxis.   On 31-OCT-2023, the patient received Arexvy (intramuscular). On 31-OCT-2023, immediately after receiving Arexvy, the patient experienced anaphylaxis (Verbatim: The patient experienced an anaphylactic reaction immediately after the shot was administered.) (serious criteria GSK medically significant), throat swelling (Verbatim: throat swelling) and difficulty breathing (Verbatim: couldn't breathe). On 01-NOV-2023, the patient experienced panic attack (Verbatim: he has had a high amount of anxiety and suffers from regular panic attacks.) and anxiety (Verbatim: anxiety). On an unknown date, the patient experienced blood pressure high (Verbatim: Blood pressure high). The patient was treated with epinephrine (Epi Pen). The outcome of the anaphylaxis was unknown and the outcome of the panic attack and anxiety were not resolved and the outcome of the throat swelling and difficulty breathing were resolved and the outcome of the blood pressure high was not reported.   It was unknown if the reporter considered the anaphylaxis, panic attack, anxiety, throat swelling, difficulty breathing and blood pressure high to be related to Arexvy.     It was unknown if the company considered the anaphylaxis, panic attack, anxiety, throat swelling, difficulty breathing and blood pressure high to be related to Arexvy.   Additional Information: GSK Receipt date: 06-NOV-2023 A patient reported that receiving an Arexvy vaccine at a local pharmacy.  The patient experienced an anaphylactic reaction immediately after the shot was administered.  The pharmacist was able to administer an Epi Pen immediately and the patient regained consciousness.  EMS was called and the rescue squad arrived within 2 minutes.  Blood pressure was high 2 times and after 25 minutes, the patient was able to walk out of the store and went home.  The patient reported that since the anaphylaxis event, he had a high amount of anxiety and suffers from regular panic attacks.  The reporter consented to follow up.
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Anaphylactic reaction, Anxiety, Blood pressure increased, Dyspnoea, Hypertension
Clinical narrative: Blood pressure high; he has had a high amount of anxiety and suffers from regular panic attacks.; anxiety; throat swelling; couldn't breathe; The patient experienced an anaphylactic reaction immediately after the shot was administered.; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3Y7P4) for prophylaxis.   On 31-OCT-2023, the patient received Arexvy (intramuscular). On 31-OCT-2023, immediately after receiving Arexvy, the patient experienced anaphylaxis (Verbatim: The patient experienced an anaphylactic reaction immediately after the shot was administered.) (serious criteria GSK medically significant), throat swelling (Verbatim: throat swelling) and difficulty breathing (Verbatim: couldn't breathe). On 01-NOV-2023, the patient experienced panic attack (Verbatim: he has had a high amount of anxiety and suffers from regular panic attacks.) and anxiety (Verbatim: anxiety). On an unknown date, the patient experienced blood pressure high (Verbatim: Blood pressure high). The patient was treated with epinephrine (Epi Pen). The outcome of the anaphylaxis was unknown and the outcome of the panic attack and anxiety were not resolved and the outcome of the throat swelling and difficulty breathing were resolved and the outcome of the blood pressure high was not reported.   It was unknown if the reporter considered the anaphylaxis, panic attack, anxiety, throat swelling, difficulty breathing and blood pressure high to be related to Arexvy.     It was unknown if the company considered the anaphylaxis, panic attack, anxiety, throat swelling, difficulty breathing and blood pressure high to be related to Arexvy.   Additional Information: GSK Receipt date: 06-NOV-2023 A patient reported that receiving an Arexvy vaccine at a local pharmacy.  The patient experienced an anaphylactic reaction immediately after the shot was administered.  The pharmacist was able to administer an Epi Pen immediately and the patient regained consciousness.  EMS was called and the rescue squad arrived within 2 minutes.  Blood pressure was high 2 times and after 25 minutes, the patient was able to walk out of the store and went home.  The patient reported that since the anaphylaxis event, he had a high amount of anxiety and suffers from regular panic attacks.  The reporter consented to follow up.
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Immediate post-injection reaction, Loss of consciousness, Panic attack, Pharyngeal swelling
Clinical narrative: Blood pressure high; he has had a high amount of anxiety and suffers from regular panic attacks.; anxiety; throat swelling; couldn't breathe; The patient experienced an anaphylactic reaction immediately after the shot was administered.; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3Y7P4) for prophylaxis.   On 31-OCT-2023, the patient received Arexvy (intramuscular). On 31-OCT-2023, immediately after receiving Arexvy, the patient experienced anaphylaxis (Verbatim: The patient experienced an anaphylactic reaction immediately after the shot was administered.) (serious criteria GSK medically significant), throat swelling (Verbatim: throat swelling) and difficulty breathing (Verbatim: couldn't breathe). On 01-NOV-2023, the patient experienced panic attack (Verbatim: he has had a high amount of anxiety and suffers from regular panic attacks.) and anxiety (Verbatim: anxiety). On an unknown date, the patient experienced blood pressure high (Verbatim: Blood pressure high). The patient was treated with epinephrine (Epi Pen). The outcome of the anaphylaxis was unknown and the outcome of the panic attack and anxiety were not resolved and the outcome of the throat swelling and difficulty breathing were resolved and the outcome of the blood pressure high was not reported.   It was unknown if the reporter considered the anaphylaxis, panic attack, anxiety, throat swelling, difficulty breathing and blood pressure high to be related to Arexvy.     It was unknown if the company considered the anaphylaxis, panic attack, anxiety, throat swelling, difficulty breathing and blood pressure high to be related to Arexvy.   Additional Information: GSK Receipt date: 06-NOV-2023 A patient reported that receiving an Arexvy vaccine at a local pharmacy.  The patient experienced an anaphylactic reaction immediately after the shot was administered.  The pharmacist was able to administer an Epi Pen immediately and the patient regained consciousness.  EMS was called and the rescue squad arrived within 2 minutes.  Blood pressure was high 2 times and after 25 minutes, the patient was able to walk out of the store and went home.  The patient reported that since the anaphylaxis event, he had a high amount of anxiety and suffers from regular panic attacks.  The reporter consented to follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Felt immense pain as fluid was injected; hit a nerve or injured the cartilage surrounding the humerus and went into the radial, and ulnar and stopped/Discomfort remained fixed in the right chest, and the pain in the shoulder; Unable to sleep longer than 2 hours; Nausea; hot watering mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 03Jul2015; LEVOTHYROXINE, start date: 03Jul2015; ALLOPURINOL, start date: 03Jul2015; FERROUS SULFATE, start date: 03Jul2015; SPIRONOLACTON, start date: 03Jul2015. Vaccination history included: bnt162b2 (DOSE 1), administration date: 29Aug2019, for COVID-19 immunization; bnt162b2 (DOSE 2), administration date: 20Aug2020, for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER)), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Nov2023 at 13:30, outcome "recovering", described as "Felt immense pain as fluid was injected"; NAUSEA (non-serious) with onset 03Nov2023 at 13:30, outcome "recovering"; INSOMNIA (non-serious) with onset 03Nov2023 at 13:30, outcome "recovering", described as "Unable to sleep longer than 2 hours"; PAIN (non-serious) with onset 03Nov2023 at 13:30, outcome "recovering", described as "hit a nerve or injured the cartilage surrounding the humerus and went into the radial, and ulnar and stopped/Discomfort remained fixed in the right chest, and the pain in the shoulder"; BURNING SENSATION (non-serious) with onset 03Nov2023 at 13:30, outcome "recovering", described as "hot watering mouth". Therapeutic measures were taken as a result of vaccination site pain, pain, insomnia, nausea, burning sensation. Additional information: there was no redness at the injection site. The patient felt "immense pain as fluid was injected, like it hit a nerve or injured the cartilage surrounding the humerus and went into the radial, and ulnar and stopped." The patient was unable to sleep longer than two hours, and it progressively worsened. The patient also experienced nausea, hot watering mouth, and pain from the injection site radiating from the right arm to the back area through upper scapula and around to the right upper chest area. Discomfort remained fixed in the right chest, and the pain in the shoulder was subdued with "500mg x 2, per four hours." Tylenol relieved the pain, and the patient felt more comfortable.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.