chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: FLUR4
Symptoms: Vitamin B12 normal
Clinical narrative: AIDP - Guillain Barre Syndrome.  Paresthesias began 11/3/23 (Stocking and glove distribution; Ascending motor weakness in lower extremity began 11/12/23;  ICU hospitalization: 11/12/23 - 11/16/23. Treated with IVIG infusions.  Neuro symptoms began to improve during hospitalization.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Shot 4: The following day I had large sections of my chest and arm covered in hives which were raised and red in color. I took Claritin in response to the allergic reaction. The Claritin reduced the majority of the hives. I still felt itchy and had smaller hives on my legs and trunk of my body. The allergic reaction persisted for 4 weeks before I could see a doctor. The doctor suggested that I switch to Allegra. I continued to have smaller sections of hives and was told I could take up to 4 Allegra per day to treat them. I continued to take Allegra until April 2023 where the allergic reaction completely disappeared.
Age: 65.0
Sex: M
Vaccine: COVID19, FLUA4, RSV
Symptoms: Death, Resuscitation
Clinical narrative: Upon entering resident's room, noted resident without signs of life. Instructed STNA to call for assistance, 2nd nurse arrived, crash cart obtained, CPR initiated, 2nd nurse called 911. Code continued. EMS arrived and took over at 0543. EMS continued code until around 0615, EMS made contact with ER physician to call code. Dr notified at 0624, Pronouncement of death made via telephone with order to release remains of body to institution of choice.
Age: 11.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Injection site pain
Clinical narrative: Given necessary vaccination. Pain at injection site as outcome. Monitoring as treatment .
Age: 32.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Computerised tomogram head abnormal, Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient was playing basketball and jumped up and fell backwards, hitting head on cement. Patient lost consciousness for about 20 minutes (witnessed). Patient was feeling dizzy immediately and began vomiting within 5 minutes of presenting to clinic. Patient was taken to hospital.
Age: 32.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Subdural haematoma, Subgaleal haematoma, Vomiting
Clinical narrative: Patient was playing basketball and jumped up and fell backwards, hitting head on cement. Patient lost consciousness for about 20 minutes (witnessed). Patient was feeling dizzy immediately and began vomiting within 5 minutes of presenting to clinic. Patient was taken to hospital.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4.5cm x 3.5cm area of erythema and induration to patient's right thigh.  Area of erythema was marked with a pen.  Mother was advised to watch this and make sure that the redness is not spreading.  Vaccination nurse was advised and will follow-up with the proper protocol moving forward.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Atrial flutter, Cardioversion
Clinical narrative: AFLUTTER
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Eczema, Rash
Clinical narrative: eczema full body rash
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, severe nausea
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site mass, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: ARM NUMBNESS, HARD TIME LIFTING ARM, ARM FEELING HOT, PAINFUL 5-6/10, LUMP AT INJECTION SITE.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pleural effusion
Clinical narrative: Exudative pleural effusion
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: PATIENT CLAIMS THAT SHE HAD BOTH FLU AND COMIRMATY SHOTS ALL ON RIGHT ARM BECAUSE SHE WAS PARALYZED ON THE LEFT ARM DUE TO A STROKE.  SHE SAID SHE HAD A GNAWING PAIN DAY AFTER THE SHOTS BUT THOUGHT IT WAS DUE TO GETTING BOTH SHOTS AT THE SAME TIME.  THE PAIN HOWEVER NEVER GOT BETTER BUT GOT WORSE ESPECIALLY THE LAST COUPLE WEEKS.  PATIENT SAID IT GOT SO BAD THAT SHE COULD HARDLY RAISES HER ARM.  SHE CLAIMED SHE WENT TO HER DOCTOR ALREADY AND IS TAKING PAIN MEDS AND DOING HEAT/COLD COMPRESS AND LIDOCAINE PATCHES, BUT THEY DO NOT HELP. THERE WERE NO REDNESS, RASH OR SWELLING AT THE INJECTION SITE, ONLY PAIN. PATIENT CLAIMED SHE DID EVERYTHING THAT WERE SUGGESTED TO ALLEVIATE THE PAIN, BUT TO NO PREVAIL.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Chest X-ray normal, Costochondritis, Musculoskeletal chest pain
Clinical narrative: Rib pain, probably costocondritis.  I do not know that this was at all related to the vaccine.  I was just requested by you to complete this form.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Myalgia
Clinical narrative: Muscle Aches Chills
Age: 43.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Gastric lavage, Intentional overdose, Suicide attempt
Clinical narrative: Patient attempted suicide by ingesting half bottle of aspirin 325 mg and entire bottle of antihistamine allergy medication (Claritin) on 10/26/2023. Patient was transferred to local hospital. Patient states they pump his stomach in ER.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: injection was ordered per md  at mothers request. given to soon, not due till child was 6 months old, child was observed for  20 minutes ,
Age: 24.0
Sex: M
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diplegia, Pain in extremity
Clinical narrative: Woke up in excruciating pain in my arms and both legs, I could not move. Totally unable to move... pain was severe but I couldn't move because my limbs would not move!  (not just do to pain level) This lasted 4 hours.  later that night, the paralysis happened again but on a lesser degree...it was just in my legs.  That woke e as well and lasted about 4 hours.    5 hours later, it was like a cloud lifted and I was fine.   I continued Moderna but my first booster (Moderna Biv) on 10/15/2023 hit the tops of my arms from the shoulders down to my wrists.   That lasted 3-4  hours.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC15
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No apparent reaction, no action needed to be taken
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear swelling, Injection site swelling, Joint swelling, Rash
Clinical narrative: CLIENT REPORTED 2 DAYS AFTER VACCINATION: EARS BEGAN SWELLING, EYES SWELLED SHUT; JOINTS SWOLLEN AND RED PATCHY RASH WITH THICKENED SKIN ON WRISTS, HANDS, ANKLES, FEET, JAWLINE; R TEMPLE; HEARING LOSS IN L EAR; R ARM SWOLLEN AT VACCINE SITE X 1 WEEK. STILL DEALING WITH SOME OF THESE SYMPTOMS 3 WEEKS LATER.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin hypertrophy, Swelling of eyelid
Clinical narrative: CLIENT REPORTED 2 DAYS AFTER VACCINATION: EARS BEGAN SWELLING, EYES SWELLED SHUT; JOINTS SWOLLEN AND RED PATCHY RASH WITH THICKENED SKIN ON WRISTS, HANDS, ANKLES, FEET, JAWLINE; R TEMPLE; HEARING LOSS IN L EAR; R ARM SWOLLEN AT VACCINE SITE X 1 WEEK. STILL DEALING WITH SOME OF THESE SYMPTOMS 3 WEEKS LATER.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Brain death, Brain herniation, Cerebral haemorrhage, Imaging procedure abnormal, Intraventricular haemorrhage
Clinical narrative: 12/3 - @ 1215, found unresponsive at home with last known well previous evening.  Brain bleed - ICH, IVH, Brain Herniation that progressed to Brain Death.  Pronounced brain dead on 12/5 @ 1240.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Unresponsive to stimuli
Clinical narrative: 12/3 - @ 1215, found unresponsive at home with last known well previous evening.  Brain bleed - ICH, IVH, Brain Herniation that progressed to Brain Death.  Pronounced brain dead on 12/5 @ 1240.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Pain in extremity
Clinical narrative: I am having anxiety but its almost to the level of a panic attack. My arm is in a lot of pain. I am worried about nerve damage. I already have some nerve problems so I don't want this vaccine to affect that.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Decreased appetite, Malaise, Mobility decreased, Myalgia
Clinical narrative: Ice-pick headaches for about 30 hours. Each time I received the vaccine (initial vaccine was Pfizer, other 3 were Moderna), these were a prominent side effect with more severity, and duration, than previous times. The last vaccine ice-pick headaches were severe, debilitating and kept me in bed for days. Other usual side effects were common and anticipated (chills, feverish at times, myalgias, malaise, no appetite). There were no other neuro changes with these severe ice-pick headaches. I've not previously reported this due to length of time this takes, form wouldn't take my email address, the effort seemed excessive in my busy life, then it was out of my thoughts until just now. I was very concerned about the neuro implications this could have given these for progressively worse in intensity and duration.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Primary stabbing headache, Pyrexia
Clinical narrative: Ice-pick headaches for about 30 hours. Each time I received the vaccine (initial vaccine was Pfizer, other 3 were Moderna), these were a prominent side effect with more severity, and duration, than previous times. The last vaccine ice-pick headaches were severe, debilitating and kept me in bed for days. Other usual side effects were common and anticipated (chills, feverish at times, myalgias, malaise, no appetite). There were no other neuro changes with these severe ice-pick headaches. I've not previously reported this due to length of time this takes, form wouldn't take my email address, the effort seemed excessive in my busy life, then it was out of my thoughts until just now. I was very concerned about the neuro implications this could have given these for progressively worse in intensity and duration.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Staring, Urinary incontinence
Clinical narrative: CMA administered the above vaccinations to this patient while she was sitting in a chair. Two minutes after the injections, patient had a blank stare and then had LOC for a couple seconds. CMA assisted patient to the floor safely during this. Patient urinated herself. CMA yelled out for help from the triage nurse's. RN and LPN came to the exam room. Patient is pale and diaphoretic but A&O now. Assisted patient to lay down on the floor with a pillow under her head. Vitals were taken and documented. Patent was monitored. After she was feeling better, we had her sit up and drink an apple juice box. Patient declined crackers. Patient then was able to get back into the chair. Patient was given pants to change into. Dr (pcp) was notified and came into the exam room to evaluate patient. Vitals were checked again. Patient was feeling better and ambulated out of the clinic with her mother.  (Patient was fasting and very anxious prior to these vaccinations.)
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Breast conserving surgery, Breast mass, Death, Mammogram abnormal
Clinical narrative: 8/2/2022 Hospitalized after fainting spell 2/14/2023 Hospitalized again  May 2023 diagnosed with an abnormal mammogram  August 2023 lumpectomy for pre-breast cancer diagnosis August 2023 lumpectomy biopsy  came back aggressive fast growing cancer triple negative  August 2023 double mastectomy November 2023 died complications to cancer
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Mastectomy, Syncope, Triple negative breast cancer
Clinical narrative: 8/2/2022 Hospitalized after fainting spell 2/14/2023 Hospitalized again  May 2023 diagnosed with an abnormal mammogram  August 2023 lumpectomy for pre-breast cancer diagnosis August 2023 lumpectomy biopsy  came back aggressive fast growing cancer triple negative  August 2023 double mastectomy November 2023 died complications to cancer
Age: 86.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered
Clinical narrative: no symptoms or signs
Age: 43.0
Sex: F
Vaccine: HPV9, PNC20
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness, swelling in the arm.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Inflammation, Neutrophil count increased, Palpitations, White blood cell count increased
Clinical narrative: Blood test was performed on 11/14/2023 revealed severe inflammatory condition in blood cells:  Absolute neutrophils 11732 (above normal upper limit of 7800) and While Blood Cell count of 14 (above normal upper limit of 10.8). Increase in heart palpitations. However, no  Guillain?Barré symptoms observed.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: NO adverse reactions noted/reported
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Mobility decreased, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: After 10 days, pain at right shoulder.  In the next few weeks, additional pains in right hip, left hip, left shoulder, left wrist, both hands.  Pains so severe that use of hands was compromised.   Consulted several doctors, finally ended up with rheumatologist.  Have been on prednisone since January 13, 2023, and methotrexate since July 18, 2023.  The medications (especially prednisone) have reduced the pain, not completely eliminated it.
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Rheumatoid factor increased
Clinical narrative: After 10 days, pain at right shoulder.  In the next few weeks, additional pains in right hip, left hip, left shoulder, left wrist, both hands.  Pains so severe that use of hands was compromised.   Consulted several doctors, finally ended up with rheumatologist.  Have been on prednisone since January 13, 2023, and methotrexate since July 18, 2023.  The medications (especially prednisone) have reduced the pain, not completely eliminated it.
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain in extremity, SARS-CoV-2 test
Clinical narrative: After 10 days, pain at right shoulder.  In the next few weeks, additional pains in right hip, left hip, left shoulder, left wrist, both hands.  Pains so severe that use of hands was compromised.   Consulted several doctors, finally ended up with rheumatologist.  Have been on prednisone since January 13, 2023, and methotrexate since July 18, 2023.  The medications (especially prednisone) have reduced the pain, not completely eliminated it.
Age: 1.08
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered
Clinical narrative: Our assistant medical director called the family and explained the patient received a large dose of Polio then normal.  She told them on what to look for and to call our on call provider if any questions arise after hours. Then she called the next day to follow up on how the baby was doing.
Age: 62.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Dry skin, Rash macular, Skin discolouration, Skin necrosis
Clinical narrative: Patient went to the ER on 11/26/23 stating that she received the RSV vaccine on 11/6/23 and has a small circle of necrotic skin, no fever, numbness or weakness.  Er reports right upper deltoid area 1cm of necrotic dry black skin surrounded by several millimeters of red skin with an ink marking around it.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Basophil count normal, Basophil percentage, Eosinophil count normal, Eosinophil percentage decreased, Haematocrit normal
Clinical narrative: Just the elevated white cell count...
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Haemoglobin normal, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal
Clinical narrative: Just the elevated white cell count...
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Mean cell volume normal, Mean platelet volume normal, Monocyte count increased, Monocyte percentage, Neutrophil count increased
Clinical narrative: Just the elevated white cell count...
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Neutrophil percentage increased, Platelet count normal, Red blood cell count normal, Red cell distribution width normal, White blood cell count increased
Clinical narrative: Just the elevated white cell count...
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt. reports the morning after receiving vaccine, the injection site was very sore with an approximate 3" diameter reddened area that was warm to the touch, and lasted 2 weeks. LPN
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD was given instead of Fluzone Quad.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: 1. Any redness or bruising? No 2.C19 like symptoms? No 3. Lack of mobility in the arm with some arm soreness
Age: 76.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Fatigue, Hallucinations, mixed
Clinical narrative: He got both SPIKEVAX and RSV in the same arm, same day. He had extreme fatigue and audio/visual hallucination for a few days post doses
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD was given instead of Fluzone Quad.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD given instead of Fluzone Quad.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dizziness, Glossodynia, Lip blister, Lip swelling
Clinical narrative: Patient called the pharmacy 12/7 and stated that she was allergic  to the Spikevax vaccine she had received on 12/05/2023 at our pharmacy.  She said she slight experienced dizziness the day of the vaccination (12/5), but said she woke up 12/7 experiencing swollen lips (with a blister on lip), dizziness, sore tongue, and sore vaccination arm.  Notified PCP who stated she was allergic to vaccine, then called pharmacy to add to her allergen list.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient called the pharmacy 12/7 and stated that she was allergic  to the Spikevax vaccine she had received on 12/05/2023 at our pharmacy.  She said she slight experienced dizziness the day of the vaccination (12/5), but said she woke up 12/7 experiencing swollen lips (with a blister on lip), dizziness, sore tongue, and sore vaccination arm.  Notified PCP who stated she was allergic to vaccine, then called pharmacy to add to her allergen list.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD given instead of Fluzone Quadrivalent.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient received 2 MMRV, 1 in August and 1 in May where he should have only received 1 MMRV.  Apparently patient was supposed to receive an MMR in May and a varicella in August unfortunately he got the combination vaccine and thus received 2 of them.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Periorbital haematoma
Clinical narrative: hematoma around the eye
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD given instead of Fluzone Quadrivalent
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD given instead of Fluzone Quadrivalent
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, X-ray limb normal
Clinical narrative: I developed pain in the  outside joint of my left elbow a couple days after the vaccine injection.  I?ve taken ibuprofen, Tylenol, tried massage with analgesic ointment, stretching.  Nothing so far has relieved the pain.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction that was swollen, warm, hurt, sore, and started itching really badly. The area involved swelled up to the size of a grapefruit. This lasted for approximately 8 days.
Age: 67.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Diarrhoea, Dizziness, Loss of personal independence in daily activities
Clinical narrative: Feeling like going to pass out when stand longer than 1minute.  Lightheaded.  Unable to cook breakfast. Staying in bed except for watery diarrhea.  Staying hydrated
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: During administration of ProQuad, approximately 50%  (0.25mL) of vaccine was administered when vaccine leaked out from syringe hub due to syringe failure. Phone consult to Dr. Instructed to provide other half of vaccine to complete full dosage of ProQuad. Discussed with mother. Mother agreeable with plan. Second half (0.25 mL) of vaccine administered without difficulty. No adverse effects noted.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Pt reports the next day she had fever, chills and has since felt exhausted. Pt could not remain at the pharmacy while submitted report for additional information, but patient requested the report be submitte.d.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD given instead of Fluzone Quadrivalent
Age: 73.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Blister, Pustule, Viral test
Clinical narrative: disseminated vesicles/pustules through body
Age: 80.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Dizziness, Dyspnoea, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient called and reported pain in her left arm at the injection site, and that she could not move her arm. She reports that her vaccine may have been given too high in the deltoid muscle, but she was unable to specify distance. Patient was also having trouble breathing which is believed to be a panic attack caused by the pain in her arm, and she stated she was worried she might pass out. Patient was advised to call emergency services for further care.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophil count normal, Epstein-Barr virus test negative, Full blood count normal, Mononucleosis heterophile test negative, Urticaria
Clinical narrative: Hives. Started within 24 hours.  Went to hospital x 2.  Giving IV steroid, IV bendaryl.  Went to Student health. Changed to Zyrtec, PO. las, no mono, normal cbc, no change in eosinophils WEnt to Allergist changed to Allegra. Stopped the huge oral steroid taper the ER had given. pt today 12/7 at f/u said 'never helped gave her side effects" stopped when saw allergist - he's local. he didn't know what it was...
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Erythema, Pain in extremity, Swelling
Clinical narrative: Pt presented to Health Center with left arm pain, swelling, and weakness after receiving a COVID vaccine approximately 4 weeks ago.  The swelling, redness, and pain have all gone down, but he has residual discomfort when he tries to lift his arm.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swollen all around site of vaccine. Warm feeling. Sore and painful - all the time. Red skin all around swollen area. Itchy feeling - all the time. "shooting" sharp pain at times.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site warmth
Clinical narrative: Swollen all around site of vaccine. Warm feeling. Sore and painful - all the time. Red skin all around swollen area. Itchy feeling - all the time. "shooting" sharp pain at times.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: The patient developed topical eruptions on the fourth day after inoculation, the patient used Calamine and Atarax to treat the symptoms.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: This was an adult vaccine that was given to a pediatric patient.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash
Clinical narrative: redness and inflammation at site of injection no pain no loss of movement rash at site of injection gradually going down
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Condition aggravated
Clinical narrative: ON 12/7/2023 THE PATIENT CALLED THE PHARMACY TO SAY HER BLOOD PRESSURE INCREASED (176/90) AS A RESULT OF GETTING THE COVID-19 IMMUNIZATION (SPIKEVAX) 12/4/2023 SHE SAID HER PRESSURE IS USUALLY 130/60 SHE WAS TOLD TO GO TO ER OR PRIMARY MD, SHE WENT TO PRIMARY MD AND THEY SENT HER TO ER WHERE THEY ADMITTED THE PATIENT TO THE HOSPITAL FOR FURTHER EVALUATION
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Vomiting
Clinical narrative: Approximately 5 minutes after receiving the injection, the patient came back to the pharmacy and said she was feeling light-headed and may pass out.  I brought her into the counseling room and she sat down immediately.  I asked her if she wanted water and she did so I got her a water.  When I came back into the room with the water, she had thrown up.  She drank some water and started feeling better.  I stayed in the room with her, and she said she has had a couple incidences of passing out recently but never with the administration of a vaccine.  After about 20-30 minutes she said she felt better and could leave.
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Skin swelling
Clinical narrative: red swollen bump
Age: 34.0
Sex: M
Vaccine: RSV, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO adverse event.  The patient was given these vaccines at request of patient wife, as 39 weeks pregnant and was told her husband would not be allow to be in delivery room.  due in <1 week.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: Patient called the pharmacy on 12/7 which was seven days after her immunization on 11/30.  The patient stated she was having slight arm pain and when she moved her arm she said it affected her breathing and that she was having trouble breathing.  The pharmacist told her that it was possible it could be from the immunization but she would have patient call the doctor as they would probably want to evaluate it further as it could be due to other factors.  The patient agreed she would contact the MD when she got off with the pharmacist.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Hypersomnia, Malaise, Mobility decreased
Clinical narrative: Sick for 1 full week. Sweating, no fever, kept smelling a strong medicine smell all day every day weak with body aches, light headed Day after the booster I slept on and off 12 hours. Could not get out of bed except to urinate one time On 4th day went to Urgent Care, all life signs ok, sent me home, but still feeling sick.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Parosmia
Clinical narrative: Sick for 1 full week. Sweating, no fever, kept smelling a strong medicine smell all day every day weak with body aches, light headed Day after the booster I slept on and off 12 hours. Could not get out of bed except to urinate one time On 4th day went to Urgent Care, all life signs ok, sent me home, but still feeling sick.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: patient requested shingles vaccine; was given Spikevax/COVID vaccine
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received influenza vaccine at clinic appointment on 10/19/23. Presented for another office appointment 11/30/23 and influenza vaccine was ordered and administered again. No reported symptoms from duplicate vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Endocrine neoplasm, Renal cancer stage IV
Clinical narrative: Diagnosised July 5, 2023 with  Well-differentiated endocrine tumor and Stage 4 Liver Cancer
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Neuralgia, Paraesthesia, Swelling face
Clinical narrative: Patient reported that she developed shingles on the left side of her face.  No  lesions appeared but she had some nerve pain and tingling.  She visited her provider and she prescribed valacyclovir.  Today, 12/7/23 she still feels swollen and pain (she also has a tooth infection on that side of her face.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Tooth infection
Clinical narrative: Patient reported that she developed shingles on the left side of her face.  No  lesions appeared but she had some nerve pain and tingling.  She visited her provider and she prescribed valacyclovir.  Today, 12/7/23 she still feels swollen and pain (she also has a tooth infection on that side of her face.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Hyperhidrosis, Hypotension, Loss of consciousness, Syncope
Clinical narrative: On Friday, 12/1/23, at the clinic we had a 7-month pregnant woman from another country faint.  I had immunized her with a Spikevax vaccine a few hours prior to her fainting.  I can't be exact on the time frame but it was definitely hours later.  I'm not sure why she hung around the clinic for such a long time but I think it's because she was waiting for her partner to get vaccinated and he wasn't in line with her.  He must have arrived later.  There was lots going on of course so I wasn't paying specific attention to her but I was aware that she was hanging around the room with other migrants.  She was sitting in a chair in the back corner of the room and all of a sudden there was commotion in her direction.  I noticed her partner was fanning her and someone else was talking to her.   I ran over to her to see what was happening and realized she was going to pass out. She was sweaty and shaking and eventually passed out.  I just supported her body, put her legs up on a chair and called for someone to bring the medical bag.  There was a Medical Assistant at the clinic too, I don't know who she works for or her name, but she ran over first with a blood pressure cuff and glucose testing strips.  When the woman came to, she vomited into a garbage can.  Her blood pressure was low but not alarmingly low, I don't remember her specific BP numbers.  Her blood sugar was 78.    In the meantime, someone called emergency services and relayed all the information we had.  With the help of an interpreter, we were able to assess that the woman hadn't eaten all day except for some fruit in the morning so we were able to give her some juice and a cookie however a few minutes later she vomited again.  I believe she fainted because of not eating right that day and the stress her body was under with her travels to this country and her pregnancy not because of the vaccine.  When the paramedics arrived, I let them take over her care.  She refused to be taken to the hospital for further care and signed a document with the paramedics to that effect.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: On Friday, 12/1/23, at the clinic we had a 7-month pregnant woman from another country faint.  I had immunized her with a Spikevax vaccine a few hours prior to her fainting.  I can't be exact on the time frame but it was definitely hours later.  I'm not sure why she hung around the clinic for such a long time but I think it's because she was waiting for her partner to get vaccinated and he wasn't in line with her.  He must have arrived later.  There was lots going on of course so I wasn't paying specific attention to her but I was aware that she was hanging around the room with other migrants.  She was sitting in a chair in the back corner of the room and all of a sudden there was commotion in her direction.  I noticed her partner was fanning her and someone else was talking to her.   I ran over to her to see what was happening and realized she was going to pass out. She was sweaty and shaking and eventually passed out.  I just supported her body, put her legs up on a chair and called for someone to bring the medical bag.  There was a Medical Assistant at the clinic too, I don't know who she works for or her name, but she ran over first with a blood pressure cuff and glucose testing strips.  When the woman came to, she vomited into a garbage can.  Her blood pressure was low but not alarmingly low, I don't remember her specific BP numbers.  Her blood sugar was 78.    In the meantime, someone called emergency services and relayed all the information we had.  With the help of an interpreter, we were able to assess that the woman hadn't eaten all day except for some fruit in the morning so we were able to give her some juice and a cookie however a few minutes later she vomited again.  I believe she fainted because of not eating right that day and the stress her body was under with her travels to this country and her pregnancy not because of the vaccine.  When the paramedics arrived, I let them take over her care.  She refused to be taken to the hospital for further care and signed a document with the paramedics to that effect.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: the technician giving the vaccine did not re-verify vaccines before giving them.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Loss of consciousness
Clinical narrative: within approx 5 minutes after receiving the covid vaccine the pt. became very clammy while sitting in a chair and passed out.  Clinical staff responded and 911 was activated to respond.  Pt eventually regained consciousness and EMS stayed onsite with pt for a period of time.. Pt decided to go against medical advice regarding transport to the hospitalby ambulance and eventually departed the health center in stable condition.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (x019553   1/19/2025) Temperature and Time frame: -9.; This spontaneous report was received from a nurse referred to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 25-OCT-2023, the patient was vaccinated with improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, 1 dose, lot #X019553, expiration date: 19-JAN-2025, as prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse events were reported (No adverse event). Temperature and Time frame was -9.2C for 1 hour 7 minutes and -11.2 C for 31 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (x019553   1/19/2025) Temperature and Time frame: -9.; This spontaneous report was received from a nurse referred to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 06-NOV-2023, the patient was vaccinated with improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, 1 dose, lot #X019553, expiration date: 19-JAN-2025, as prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse events were reported (No adverse event). Temperature and Time frame was -9.2C for 1 hour 7 minutes and -11.2C for 31 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Pharmacist calling to report adverse event regarding the administration of an expired dose of PNEUMOVAX 23.  Pharmacist stated that the PNEUMOVAX 23 dose had a labeled expiration date of 10/20/2023 and was administered on 11/17/2023.  Pharmacist conf; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and historical drugs were not reported.  On 17-NOV-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml, once, lot #W015900, expiration date: 20-OCT-2023, administered for prophylaxis by a Health Professional (strength, anatomical site of administration and route of administration were not provided) (expired product administered ). Pharmacist confirmed there was no report of medical concerns or symptoms from patient involved (no adverse event). No additional information provided regarding this adverse event.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: GAVE A PATIENT FLUMIST AND ONE MONTH LATER THE PATIENT CAUGHT THE FLU; Dr gave a patient FluMist and one month later the patient caught the FLU.; A spontaneous report has been received from a physician. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) once/single administration, via nasal route, on an unknown date.     A UNKNOWN administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced gave a patient flumist and one month later the patient caught the flu (preferred term: Influenza).     Action taken with flumist quadrivalent was not applicable.    The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No adverse event
Clinical narrative: Negative Titer After 2 Doses of Heplisav-B; Initial Report Received on 19-Oct-2023 and 23-Oct-2023  Non-significant follow up report received on 15-Nov-2023 included QA investigation result.  The investigation did not identify a potential lot related issue.  There is no trend and no potential impact to the lot was identified.   A nurse reported that a 73-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history was reported as diabetes, hypertension, arthritis, and asthma.    No relevant concomitant medications were reported.    On 08-Aug-2023, the patient had a negative Hepatitis B titer (Hepatitis B surface Antibody).  On 16-Aug-2023, the patient received the first dose of HEPLISAV-B (Lot #941590, expiration date 31-Aug-2025, NDC # not reported) intramuscularly in the right deltoid.  On 18-Sep-2023, the patient received the second dose of HEPLISAV-B (Lot #941592, expiration date 31-Aug-2025, NDC # not reported) intramuscularly in the right deltoid.  On 17-Oct-2023, 29 days after having been vaccinated with the second dose of HEPLISAV-B, a repeat Hepatitis B Surface Antibody titer was drawn which was negative.  No reactions were reported.  No additional information was reported.   The event was reported as non-serious and the outcome was not reported.   Company Comment:  The company assessed the event as non-serious and immunologically confirmed vaccination failure.; Sender's Comments: The company assessed the event as non-serious and immunologically confirmed vaccination failure.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Ocular shingles; This serious case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 97-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included bevacizumab (Avastin) for wet macular degeneration.   Concurrent medical conditions included wet macular degeneration (age-related (wet) macular degeneration). Concomitant products included valaciclovir hydrochloride (Valacyclovir) and trifluridine.   On 13-NOV-2023, the patient received the 1st dose of Shingrix. On 15-NOV-2023, the patient started Avastin (injection). On 24-NOV-2023, 11 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: Ocular shingles) (serious criteria GSK medically significant). The action taken with Avastin was unknown. The outcome of the ophthalmic herpes zoster was not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.     It was unknown if the company considered the ophthalmic herpes zoster to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-NOV-2023 The patient had received the 1st dose of Shingrix, followed by an eye injection of Avastin. Ocular shingles developed 10 days later, and patient now been treated with oral antivirals and antiviral ophthalmic drops. 9 days after receiving Avastin, the patient experienced ocular shingles. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Avastin. The reporter consented for the follow-up.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Fatigue
Clinical narrative: Joint pain; Tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: Joint pain) and tiredness (Verbatim: Tiredness). The outcome of the joint pain and tiredness were not reported.   It was unknown if the reporter considered the joint pain and tiredness to be related to Arexvy.   It was unknown if the company considered the joint pain and tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-NOV-2023 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient experienced joint pain and tiredness and were worst side effect
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain
Clinical narrative: injection site pain; joint pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site pain) and joint pain (Verbatim: joint pain). The outcome of the injection site pain and joint pain were not reported.   It was unknown if the reporter considered the injection site pain and joint pain to be related to Arexvy.     It was unknown if the company considered the injection site pain and joint pain to be related to Arexvy.   Additional Information: GSK receipt date:29-NOV-2023 This case was reported by a patient via interactive digital media. The patient asked how long will the joint pain and injection site pain remain?  The patient had both types of pain. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: HEP, MMR, PNC
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever; Swelling; This non-serious case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included Mmr Ii for prophylaxis and Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for prophylaxis.   Additional patient notes included had no history of adverse reactions to vaccines.   On an unknown date, the patient received Engerix B adult, Mmr Ii and Prevnar. On an unknown date, an unknown time after receiving Engerix B adult and Prevnar, the patient experienced fever (Verbatim: Fever) and swelling (Verbatim: Swelling). The outcome of the fever and swelling were not reported.   It was unknown if the reporter considered the fever and swelling to be related to Engerix B adult.     It was unknown if the company considered the fever and swelling to be related to Engerix B adult.   Additional Information: GSK receipt date: 29-NOV-2023 The reporter reported that the patient received the Engerix B was co administered with MMRII and Prevnar. The reporter reported that patient had experienced fever and swelling. Reporter not sure about which product caused reaction to the patient. Reporter stated that the patient had no history of adverse reaction to vaccines. It was unknown if the reporter considered the fever and swelling to be related to MMRII and Prevnar. The reporter did not consent to follow up.