chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 57.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Ear pain, Fatigue, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sneezing, sore throat, fever, racing heart, earache, runny nose, sore arm, extreme fatigue, headache
Age: 57.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Palpitations, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing, sore throat, fever, racing heart, earache, runny nose, sore arm, extreme fatigue, headache
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Neuralgia, Pain
Clinical narrative: Patient said she felt really ill and in pain. She felt like she had internal shingles even though she didn't see a rash on her skin, she went to urgent care and got pregabalin and she said it lasted about 6 weeks. A lot of nerve pain
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Extreme pain head to toe/ constant/12 hour duration , fatigue, lessening pain over next 5 days  pain started 4 hours after shot, extreme pain with movement of innoculated arm
Age: 73.0
Sex: U
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Pruritus, Sleep disorder
Clinical narrative: I woke up in the middle of the night to my arm burning and the injection site red and swelled up the size of a softball. The redness continues to spread and my arm burns and itches terribly.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Patient states she started developing a rash around the sides of her neck that looked like a sunburn that starting the following day and was the worst on following night (9-29-22) but is now clearing up.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given incorrect dose of 0.25ml
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy hives appeared approximately 24 hours after flu vaccine administration. Treated by school nurse with Benadryl and hydrocortisone. Symptoms resolved, but returned approximately 5 hours later. Treated with another dose of Benadryl. Symptoms progressed for another 20 minutes, then began to improve.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscular weakness, Neuralgia
Clinical narrative: Next day within 24 hours following pt receiving bivalent moderna covid booster pt had bilateral leg weakness/neuropathy.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: Vertigo
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PT. IS 64 YR OLD. ADMINISTERED FLUZONE HD INSTEAD OF AGE APPROPRIATE FLU VACCINE
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, COVID-19, Colitis, Colonoscopy abnormal, Condition aggravated
Clinical narrative: I got COVID-19 in early February 2022. I had no lingering symptoms. In March of 2022 I started to have symptoms of Crohn's Disease. I began talking to my doctor in mid-March. I was given prednisone that caused side effects. After the cycle of prednisone my Crohn's symptoms were still not better. From March to June 2022, I had not gotten better. In mid-June it was so bad I was unable to work. Lots of pain and frequent urgent bowel movements with dark stools. I had a virtual appointment with rheumatologist. I was advised to go to the ER. I was admitted. They did a colonoscopy and found that my colon was entirely inflamed. I was told it was because COVID-19 and the vaccine messed with my immune system. I was told I was steroid dependent. They had to find a new medication for me. I am still working on a new treatment plan. I am on STELARA now. As of now I am no longer on HUMIRA and prednisone and fluconazole. As needed, I take an oral mouth rinse.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Faeces discoloured, Frequent bowel movements, Impaired work ability, Pain
Clinical narrative: I got COVID-19 in early February 2022. I had no lingering symptoms. In March of 2022 I started to have symptoms of Crohn's Disease. I began talking to my doctor in mid-March. I was given prednisone that caused side effects. After the cycle of prednisone my Crohn's symptoms were still not better. From March to June 2022, I had not gotten better. In mid-June it was so bad I was unable to work. Lots of pain and frequent urgent bowel movements with dark stools. I had a virtual appointment with rheumatologist. I was advised to go to the ER. I was admitted. They did a colonoscopy and found that my colon was entirely inflamed. I was told it was because COVID-19 and the vaccine messed with my immune system. I was told I was steroid dependent. They had to find a new medication for me. I am still working on a new treatment plan. I am on STELARA now. As of now I am no longer on HUMIRA and prednisone and fluconazole. As needed, I take an oral mouth rinse.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Stool analysis abnormal
Clinical narrative: I got COVID-19 in early February 2022. I had no lingering symptoms. In March of 2022 I started to have symptoms of Crohn's Disease. I began talking to my doctor in mid-March. I was given prednisone that caused side effects. After the cycle of prednisone my Crohn's symptoms were still not better. From March to June 2022, I had not gotten better. In mid-June it was so bad I was unable to work. Lots of pain and frequent urgent bowel movements with dark stools. I had a virtual appointment with rheumatologist. I was advised to go to the ER. I was admitted. They did a colonoscopy and found that my colon was entirely inflamed. I was told it was because COVID-19 and the vaccine messed with my immune system. I was told I was steroid dependent. They had to find a new medication for me. I am still working on a new treatment plan. I am on STELARA now. As of now I am no longer on HUMIRA and prednisone and fluconazole. As needed, I take an oral mouth rinse.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Loss of consciousness
Clinical narrative: pt passed out after he left the vaccination room
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 33.0
Sex: M
Vaccine: COVID19-2, SMALLMNK
Symptoms: Atrial fibrillation, Electrocardiogram, X-ray
Clinical narrative: New onset Atrial fibrillation with RVR diagnosed September 27, 2022
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error
Clinical narrative: No adverse events reported, a vaccine administration error
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: An adult patient (who had already received monovalent COViD-19 booster vaccine dose) came in to our clinic to receive their bivalent COViD-19 vaccine booster dose.  A monovalent booster dose was accidentally administered to the patient by a staff MA instead of the bivalent vaccine. Patient was notified of the error. Patient advised to monitor for any adverse symptoms.
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: N/A Wrong vaccine given for age group
Age: 65.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Underdose
Clinical narrative: Vaccinator reports during Intradermal admin of Jynneos pt moved away causing some of the vaccine to squirt into the air.  Pt did not receive the full dose. Per MD advised to revaccinate..  Pt educated and counseled on recommendation then verbalized agreement and understanding.  Pt decided on subcutaneous route of administration.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Sore throat starting about 45 minutes after the shot. Started as a general soreness and now mostly on right side (~7 hours later). Quite painful.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, SARS-CoV-2 test positive
Clinical narrative: I had very mild flu like symptoms. I never had a fever. I tested for COVID-19 at home and was positive. I went to the urgent care and they tested me as well and they came back positive. Then, they directed me to my PCP  who prescribed me Paxlovid. I had little to no symptoms these lasted 8 days.
Age: 59.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Syringe issue
Clinical narrative: vaccinator was administering an intradermal Jynneos vaccine but during administration, vaccinator noticed vaccine leaking of the patient's arm. There was a small bubble present but the majority of the vaccine leaked out. Per policy, patient was given the option to revaccinate with either another intradermal or a subcutaneous dose. Pt preferred SQ and was revaccinated without any further concerns.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dermal filler reaction, Induration, Nodule, Pharyngeal swelling, Swelling face
Clinical narrative: On August 15th the back of my throat was swollen.  The swelling moved from the back of my jaw into the jawline.  It then moved into my smile line in my cheeks.  I was prescribed prednisone.  My doctor and he said that it is not uncommon for this to happen in areas where I receive filler injections.  This type of swelling had never happened before.  The swelling is still there but it is a lot better.  The swelling isn?t freaky, but it is definitely volume added to my face.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Adult patient came in to clinic for a vaccine appointment. Intended to receive the COViD-19 Pfizer bivalent booster. Has already received the monovalent booster >2 months ago. Patient was accidentally administered the monovalent adult booster dose instead of the bivalent dose. Patient was contacted after the fact regarding the incident, and encouraged to report an adverse symptoms.
Age: 25.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Contusion, Epistaxis, Fall, Feeling hot, Haemorrhage
Clinical narrative: Patient received both vaccines, was still sitting in chair and as the pharmacist had her back turned to grab her paperwork, patient passed out and fell face forward out of chair. She hit her head off of the wooden cabinet in front of her and had contusions to face, bleeding from face and nose. There was no sign that patient was feeling sick or going to pass out. This all happened within a five minute period. After coming to, patient said she felt hot and started to see spots while she was sitting in the chair before she blacked out. Patient's mother denied request from pharmacist to call 911 and called later that night to tell me patient was doing fine.
Age: 25.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Head injury, Loss of consciousness, Visual impairment
Clinical narrative: Patient received both vaccines, was still sitting in chair and as the pharmacist had her back turned to grab her paperwork, patient passed out and fell face forward out of chair. She hit her head off of the wooden cabinet in front of her and had contusions to face, bleeding from face and nose. There was no sign that patient was feeling sick or going to pass out. This all happened within a five minute period. After coming to, patient said she felt hot and started to see spots while she was sitting in the chair before she blacked out. Patient's mother denied request from pharmacist to call 911 and called later that night to tell me patient was doing fine.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: woke up with hives on arms, thighs, behind knees, stomach.   took cool shower, which helped.  hives went away after about 30 hours
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patients complains of persistent pain and swelling in arm since vaccination, he has seen and is seeing doctors to treat symptoms.
Age: 45.0
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash papular, Tongue pruritus, Urticaria
Clinical narrative: Received annual flu vaccine approx 10:00 am. (L) deltoid. Approx 1-1 1/2 hours later, c/o itching to back (low back) and (R) side abdomen. Also c/o tongue "itching". No s/s angioedema. No wheezing. Areas with itching with small raised areas, hive in appearance. Self administered an OTC 25 mg Benadryl. Hives disappeared approx 20 mins after Benadryl. Low back and (R) abd less reddened. C/o itching to those areas also lessened.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: Mild headache  Informed patient to monitor self, hydration, rest, and inform medical services if new sxs other than fever, chills, HA, fatigue experienced. Advised patient to go to ER if develops CP, SOB, generalized rash. Advise patient to contact medical services if side effect prolong and not resolve with OTC meds.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given incorrect dose of 0.25ml
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Influenza virus test negative, Mental status changes, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: possible febrile seizure, altered mental status
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given incorrect dose of 0.25ml
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure during pregnancy, Incorrect product formulation administered, Underdose
Clinical narrative: Patient presented in clinic today to see Dr. for a return OB visit. She is 28 weeks and 4 days gestation who was due for Covid booster, Tdap during pregnancy, and Influenza. The doctor okayed patient to retrieve all immunizations during her visit today. MA and Health Center had gotten the vaccinations ready and had them verified by our RN before dispensing them. After giving the three injections I had notice that I gave the Monovalent Moderna Booster age 6-11 Rather than the Omicron Bivalent Moderna for 18 . Patient did not report any issues or concerns and she has been notified with instructions on when to return for the Bivalent.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Maternal exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: Patient presented in clinic today to see Dr. for a return OB visit. She is 28 weeks and 4 days gestation who was due for Covid booster, Tdap during pregnancy, and Influenza. The doctor okayed patient to retrieve all immunizations during her visit today. MA and Health Center had gotten the vaccinations ready and had them verified by our RN before dispensing them. After giving the three injections I had notice that I gave the Monovalent Moderna Booster age 6-11 Rather than the Omicron Bivalent Moderna for 18 . Patient did not report any issues or concerns and she has been notified with instructions on when to return for the Bivalent.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given incorrect dose of 0.25ml
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given incorrect dose of 0.25ml
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received  0.5ml of Pfizer Bivalent Vaccination instead of the 0.3ml.  No symptoms or adverse effects
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given incorrect dose of 0.25ml
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: I had fatigue, cough, sore throat, and fever only at night. I tested positive at home for COVID-19. Then I went to a pharmacy to test again and it came back positive as well. When I spoke to my doctor we decided not to take anything. I am still coughing and still a little tired but getting better.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had fatigue, cough, sore throat, and fever only at night. I tested positive at home for COVID-19. Then I went to a pharmacy to test again and it came back positive as well. When I spoke to my doctor we decided not to take anything. I am still coughing and still a little tired but getting better.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: General symptom
Clinical narrative: patient observed in office 1 hour post injection, diphenhydramine  12.5mg x 1 dose administered without escalation of symptoms
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: patient observed in office 1 hour post injection, diphenhydramine  12.5mg x 1 dose administered without escalation of symptoms
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT GIVEN PRIMARY SERIES INSTEAD OF BOOSTER
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received incorrect vaccine formulation for age. No adverse reactions or events observed 15 minutes post immunization on 09/02/2022 or reported by mother on 09/29/2022.
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Rash
Clinical narrative: Full body rash , starting in legs/arms progressing to trunk neck and face despite taking benedryl 25mg every 6 hours. went to urgent care was prescribed atarax and zyrtec. on wednesday after monday injections. thursday rash in face neck throat, mouth lips and sore throat. went to ER thursday and recieved solumedrol im. symptoms resolving friday , minimal rash noted on monday Oct. 3.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: PATIENT RECEIVED PRIMARY SERIES INSTEAD OF BOOSTER
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT RECEIVED PRIMARY SERIES VACCINE INSTEAD OF BOOSTER
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT RECEIVED PRIMARY SERIES VACCINE INSTEAD OF BOOSTER
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT RECEIVED PRIMARY SERIES VACCINE INSTEAD OF BOOSTER
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Adverse reaction, Hemiplegia, Monoplegia, Muscle spasms, Pain
Clinical narrative: Patient came to pharmacy to report adverse reaction he believes he got from Covid Booster. Patient reported left shoulder paralysis that went from shoulder that shot down to left leg.  I asked if he could at all move his arms or legs at that time, he said he can move however it caused a lot of pain/cramps. Started on 9/26 when he got the shot and resolved and got better today on 10/4 when he came to pharmacy to pick up his prescription. Because it was on left side, also instructed patient to let his cardiologist know about the adverse effects.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Rash developed on opposite side of body 24 hours after vaccination (right side), below right armpit. Tennis ball sized and painful. On Day 4 small blisters developed.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4, PNC20
Symptoms: Asthenia
Clinical narrative: Patient called later stating that about 30 minutes after receiving the vaccines, she was in the store rest room and felt very weak. Husband took her to the hospital. She was there waiting to see a doctor. She will update us if they find anything.  Husband received same vaccines with no problem. She had Moderna before and now Pfizer so she suspected that she might be allergic to Pfizer or since she had 3 vaccines at the same time, it might be too much.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnuitis
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Clinical system was down therefore had to use instore event , the Pfizer  CDC  label on refrigerator and Pfizer box had use by 10/21/2022   the immunization was given  and going to add the immunization in clinical services, it was found the Pfizer Pediatric  immunization  expired 9/30/2022
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary mass, Axillary pain, Breast cancer female, Breast mass, Breast pain
Clinical narrative: Sore and tender lumps in left under armpit and lower left breast.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast tenderness, Mammogram abnormal, Tenderness, Triple negative breast cancer
Clinical narrative: Sore and tender lumps in left under armpit and lower left breast.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of product administration, Injection site bruising
Clinical narrative: Flu shot was administered into the superior most aspect of the right deltoid muscle just distal to the acromion and was incidentally injected into the sub acromial bursa vs rotator cuff tendon. On exam with PCP (myself) had notable bruising at the injection site, which was superior to where IM arm injections should occur. I attempted to contact Pharmacy for further information, but unfortunately all of their phones were down.
Age: 82.0
Sex: F
Vaccine: UNK
Symptoms: Cerebrovascular accident
Clinical narrative: stroke
Age: 55.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Syringe issue
Clinical narrative: At 5:00 pm RN administered 0.1 ml dose of Jynneos vaccine lot FDP00014  exp date 11/25/2022 via intradermal route on left arm to patient age 55  and leakage was observed . RN notified clinic lead nurse Regarding incident and per clinical guidance was instructed to give 2nd attempt on same arm away from first dose.   Patient verbalized understanding. RN re-administered another dose of 0.1 ml of Jynneos lot FDP00014  exp 11/25/2022  a wheal was produced with no leakage observed by patient, nurse or lead.  Patient was educated to observe reactions and wait 15 minutes in observation area.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: I was not aware that the cut off time was 8-31-22.  The patient told me she was going out of town and couldnt wait for the Bivalent to come out.  Again I was not aware of the 8-31-22 cutoff and i even contacted another Pharmacy and they were also giving this shot.  So I did  also.   I was told i was suppose to fill out this form as a single, aggregate report.  there were no adverse effects.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Culture urine negative, Dysuria, Nocturia, Pollakiuria
Clinical narrative: Difficulty and pain with urinating. Multiple trips to bathroom to empty bladder with initial urination only producing a small dribble. Multiple trips to urinate during the night which rarely occurs before this incident. This started about 12 hours after vaccination.  Visit to urologist who made diagnosis of prostatitis. My prostate was very tender when examined. I felt this was likely vaccine related so I didn't use antibiotics. The symptoms abated over the course of 1 week and ended 8 days after onset. I am now back to normal.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Prostate tenderness, Prostatitis, Urinary retention, Urine output decreased
Clinical narrative: Difficulty and pain with urinating. Multiple trips to bathroom to empty bladder with initial urination only producing a small dribble. Multiple trips to urinate during the night which rarely occurs before this incident. This started about 12 hours after vaccination.  Visit to urologist who made diagnosis of prostatitis. My prostate was very tender when examined. I felt this was likely vaccine related so I didn't use antibiotics. The symptoms abated over the course of 1 week and ended 8 days after onset. I am now back to normal.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Rn was administering flu shots in the unit for staff. I sat down and she gave me the shot. my arm got very heavy, achy and extremely painful. I never have had an issue but something was off this time because my arm was in excruciating pain! I could not remove my scrub top off mind you someone had given me an aleve already afterwards. So I went home that morning, woke up and I could barely move my arm. I took the band aid off and she poked first too high up and a piece of my skin was missing! It looked like a burn mark and no it wasn't the band aid, it was where she gave the shot. I waited a few days to see if the achiness would wear, but my arm down to my hand kept piercing such radiating pain that I went to go see my primary and she said she poked me too high and her technique was clearly improper. She completely didn't poke my deltoid area at all.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Skin disorder, Wrong technique in product usage process
Clinical narrative: Rn was administering flu shots in the unit for staff. I sat down and she gave me the shot. my arm got very heavy, achy and extremely painful. I never have had an issue but something was off this time because my arm was in excruciating pain! I could not remove my scrub top off mind you someone had given me an aleve already afterwards. So I went home that morning, woke up and I could barely move my arm. I took the band aid off and she poked first too high up and a piece of my skin was missing! It looked like a burn mark and no it wasn't the band aid, it was where she gave the shot. I waited a few days to see if the achiness would wear, but my arm down to my hand kept piercing such radiating pain that I went to go see my primary and she said she poked me too high and her technique was clearly improper. She completely didn't poke my deltoid area at all.
Age: 27.0
Sex: U
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity
Clinical narrative: received vaccine and immediately had sharp pain down arm and numbness to the fingers. Numbness is gone today 10.4.22 having trouble lifting arm and any ROM of left arm
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Headache, Loss of consciousness, Mobility decreased
Clinical narrative: I passed out on bathroom floor. Felt fatigued, had headache and was dizzy all day. Couldn?t get off couch
Age: 34.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, Injection site discharge, Wrong technique in product usage process
Clinical narrative: At 2:50 PM  RN administered 0.1 ml dose of Jynneos vaccine Lot # FDP000014 exp date 11/25/2022 via intradermal route to left arm to Patient age 34 and a leakage was observed. RN notified clinic co- lead nurse and the lead PHN regarding incident and per clinical guidance was instructed to give a 2nd dose. Patient requested to get 2nd dose on left arm. Educated patient that because leakage was observed, a repeat dose must be placed on same arm away from the 1st dose. Patient verbalized understanding. RN re-administered another dose of 0.1cc of Jynneos Lot #  FDP000014 exp date 10/04/2022 left arm and a wheal was produced. Patient was educated to observe for adverse reactions
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears still. Getting worse over time.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Computerised tomogram thorax abnormal, Electrocardiogram, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: The morning after I got my vaccination I got up to go to the bathroom and start to get ready. Within seconds of getting up to go to the bathroom I felt like my heart was racing and my chest started to hurt so I checked my HR on the pluseox and it said my HR was 158. I immediately went and laid back down. While laying in bed and focusing on my breathing I was able to get my HR down to the 110-130 range. But as soon as I would get up to anything (even just walking to the bathroom) it would shoot back up to the 140-150 range. So later in the morning I called my PCP and they got me an appointment to see me that afternoon. At that appointment they sent me to the ER. At the ER they did EKG, ran a ton of labs, gave me some aspirin and did a CT scan to rule out a PE (they did rule out PE, but did inadvertently find that I have a splenic aneurysm-- totally unrelated to the vaccine). They could not find anything else wrong other than the tachycardia, and by that time was starting to slowly trend back down, so they discharged me to self monitor at home. I had to take it very slow the rest of the weekend and was not able to do normal daily activities for myself without my HR jumping up to 110-120 until Sunday (10/2/2022). And since that Sunday I have been back to normal for the most part. I will follow up with my PCP on Friday 10/7/2022.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Palpitations, Splenic artery aneurysm, Tachycardia
Clinical narrative: The morning after I got my vaccination I got up to go to the bathroom and start to get ready. Within seconds of getting up to go to the bathroom I felt like my heart was racing and my chest started to hurt so I checked my HR on the pluseox and it said my HR was 158. I immediately went and laid back down. While laying in bed and focusing on my breathing I was able to get my HR down to the 110-130 range. But as soon as I would get up to anything (even just walking to the bathroom) it would shoot back up to the 140-150 range. So later in the morning I called my PCP and they got me an appointment to see me that afternoon. At that appointment they sent me to the ER. At the ER they did EKG, ran a ton of labs, gave me some aspirin and did a CT scan to rule out a PE (they did rule out PE, but did inadvertently find that I have a splenic aneurysm-- totally unrelated to the vaccine). They could not find anything else wrong other than the tachycardia, and by that time was starting to slowly trend back down, so they discharged me to self monitor at home. I had to take it very slow the rest of the weekend and was not able to do normal daily activities for myself without my HR jumping up to 110-120 until Sunday (10/2/2022). And since that Sunday I have been back to normal for the most part. I will follow up with my PCP on Friday 10/7/2022.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was 17 years old + 4 months and accidently given the new Bivalent Moderna Booster dose (not needed until 18 years old). She could have received  the Pfizer for her current age group  - but at this time a booster was not indicated. Patient and Parent traveling - they were getting Booster doses for travel preparation.  Called the patient and informed them of the error - the patient has had no known adverse reactions and has no further questions.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Myalgia, Nausea
Clinical narrative: tired  sore body/muscles upset stomach  nausea  dizzy
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: tired  sore body/muscles upset stomach  nausea  dizzy
Age: 92.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient came in and requested to get his flu shot. Flu shot was processed and administered. Patient then mentioned that he received his Covid vaccine 2 weeks ago but the info was not filled out on vaccine card and asked me to up date his card. I reviewed his file and he had actually received his flu shot on 9/20/22 and not his Covid vaccine.  I informed patient and asked him to let us know if he experience any side effects/adverse events.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Rash
Clinical narrative: Rash  and itching all over the body.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Emotional distress, Immediate post-injection reaction, Nausea
Clinical narrative: PATINET RECEIVED THE FIRST DOSE OF PRIMARY SERIES OF COVID 19 VACCINE (MODERNA). HOWEVER, AS SOON AS THE VACCINE WAS ADMINISTERED TO PATIENT, SHE EPXERINECED LIGHTHEADEDNESS, DIZZINESS AND NAUSEA. THE IMMUNIZER CALLED FOR HELP AND THE PHARMACIS WENT OUT TO IMMUNIZATION STATION WITH EPIPEN, BENADRYL, AND OTHER FIRST AID KITS. PATIENT WAS CONSCIOUS AND STABLE. SHE WAS COHERENT AND ANSWERED QUESTIONS. WE OFFERE TO CALL 911 HOWEVER PATIENT REFUSED. PATIENT STATED THAT SHE WAS SO EMBARRASED. PHARMACIST OBSERVED AND MONITORED THE PATIENT FOR 15 MINUTES. NO FURTHER MEDICAL HELP NEEDED.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Feeling abnormal, Gait disturbance
Clinical narrative: The patient reported to me that approximately 8-10 hours after receiving the vaccine, she experienced what she described as "whole body weakness", brain fog, and having an unstable gait. This lasted for approximately 24 hours, and she began to feel better thereafter.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fall, Injury, Joint injury, Loss of control of legs, Muscle disorder
Clinical narrative: Patient reported injury sustained as a result of a fall. She fell on her knees because she having difficulty controlling her leg muscles. She attributed the neurological component to the Moderna bivalent she had received from us. In addition, she also experienced high fever for a couple days post vaccination.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neurological symptom, Pyrexia
Clinical narrative: Patient reported injury sustained as a result of a fall. She fell on her knees because she having difficulty controlling her leg muscles. She attributed the neurological component to the Moderna bivalent she had received from us. In addition, she also experienced high fever for a couple days post vaccination.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Depressed mood, Depression, Dyskinesia
Clinical narrative: Severe Depression Irritability Unstable Mood  Low Mood Lethargy Confusion High Anxiety Muscle spasms/involuntary movement Twitching 2-3 months after receiving the second dose of the Moderna Vaccine it became evident that I was suffering most if not all of the symptoms above. I was unsure at first due to the fact that I have prior diagnoses for mental disorders and I wasn't sure until I started to get a feeling something wasn't right. I wasn't told about any side effects in this category or magnitude.  The most prevalent side effects are irritability, depression and lethargy, but all of these reported we're recognized at the time frame stated above and are all currently affecting me at this time. There haven't been any treatments yet, but I will be making an appointment to see a psychologist for these symptoms.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Irritability, Lethargy, Mood swings, Muscle spasms
Clinical narrative: Severe Depression Irritability Unstable Mood  Low Mood Lethargy Confusion High Anxiety Muscle spasms/involuntary movement Twitching 2-3 months after receiving the second dose of the Moderna Vaccine it became evident that I was suffering most if not all of the symptoms above. I was unsure at first due to the fact that I have prior diagnoses for mental disorders and I wasn't sure until I started to get a feeling something wasn't right. I wasn't told about any side effects in this category or magnitude.  The most prevalent side effects are irritability, depression and lethargy, but all of these reported we're recognized at the time frame stated above and are all currently affecting me at this time. There haven't been any treatments yet, but I will be making an appointment to see a psychologist for these symptoms.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Severe Depression Irritability Unstable Mood  Low Mood Lethargy Confusion High Anxiety Muscle spasms/involuntary movement Twitching 2-3 months after receiving the second dose of the Moderna Vaccine it became evident that I was suffering most if not all of the symptoms above. I was unsure at first due to the fact that I have prior diagnoses for mental disorders and I wasn't sure until I started to get a feeling something wasn't right. I wasn't told about any side effects in this category or magnitude.  The most prevalent side effects are irritability, depression and lethargy, but all of these reported we're recognized at the time frame stated above and are all currently affecting me at this time. There haven't been any treatments yet, but I will be making an appointment to see a psychologist for these symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site urticaria, Pain
Clinical narrative: Chills, aches. Arm pain, large red rock hard welt at injection site  Received at same time as flu vaccine in same arm (left)
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Chills, aches. Arm pain, large red rock hard welt at injection site  Received at same time as flu vaccine in same arm (left)
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood bicarbonate normal, Blood gases, Blood pH normal, Catheter directed thrombolysis
Clinical narrative: ED visit - Bilateral pulmonary embolism EKOS procedure. Patient is a 75 y.o. female presents to hospital for evaluation of Shortness of breath this been going on for a few weeks but suddenly much worse earlier this morning. Patient was afebrile in the emergency department. Saturations were 86% on room air. Arterial blood gas revealed a pH 7.45 PCO2 34 PO2 was 114 bicarbonate was 23. Saturations are 98%. EKG was sinus rhythm with no ST elevation or depression noted. Chest x-ray was negative. CT PE study did reveal bilateral pulmonary emboli with right heart strain. Patient was initiated on a heparin drip. Cardiology was notified in the emergency department and patient Was transferred to a different location for likely EKOS procedure. Bilateral lower Doppler studies were negative for DVT. 2-D echocardiogram did reveal an ejection fraction of 55-60% with mild diastolic dysfunction. Patient remained stable on room air. She improved to the point that she was deemed appropriate for discharge home. She will be discharged home on Lovenox and Coumadin. She is follow-up with primary care and with cardiology in the outpatient setting as previously arranged. She is following with the Coumadin clinic.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Chest X-ray normal, Computerised tomogram thorax abnormal, Diastolic dysfunction, Dyspnoea, Echocardiogram abnormal
Clinical narrative: ED visit - Bilateral pulmonary embolism EKOS procedure. Patient is a 75 y.o. female presents to hospital for evaluation of Shortness of breath this been going on for a few weeks but suddenly much worse earlier this morning. Patient was afebrile in the emergency department. Saturations were 86% on room air. Arterial blood gas revealed a pH 7.45 PCO2 34 PO2 was 114 bicarbonate was 23. Saturations are 98%. EKG was sinus rhythm with no ST elevation or depression noted. Chest x-ray was negative. CT PE study did reveal bilateral pulmonary emboli with right heart strain. Patient was initiated on a heparin drip. Cardiology was notified in the emergency department and patient Was transferred to a different location for likely EKOS procedure. Bilateral lower Doppler studies were negative for DVT. 2-D echocardiogram did reveal an ejection fraction of 55-60% with mild diastolic dysfunction. Patient remained stable on room air. She improved to the point that she was deemed appropriate for discharge home. She will be discharged home on Lovenox and Coumadin. She is follow-up with primary care and with cardiology in the outpatient setting as previously arranged. She is following with the Coumadin clinic.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Ejection fraction normal, Electrocardiogram normal, PCO2 decreased, PO2 increased, Pulmonary embolism
Clinical narrative: ED visit - Bilateral pulmonary embolism EKOS procedure. Patient is a 75 y.o. female presents to hospital for evaluation of Shortness of breath this been going on for a few weeks but suddenly much worse earlier this morning. Patient was afebrile in the emergency department. Saturations were 86% on room air. Arterial blood gas revealed a pH 7.45 PCO2 34 PO2 was 114 bicarbonate was 23. Saturations are 98%. EKG was sinus rhythm with no ST elevation or depression noted. Chest x-ray was negative. CT PE study did reveal bilateral pulmonary emboli with right heart strain. Patient was initiated on a heparin drip. Cardiology was notified in the emergency department and patient Was transferred to a different location for likely EKOS procedure. Bilateral lower Doppler studies were negative for DVT. 2-D echocardiogram did reveal an ejection fraction of 55-60% with mild diastolic dysfunction. Patient remained stable on room air. She improved to the point that she was deemed appropriate for discharge home. She will be discharged home on Lovenox and Coumadin. She is follow-up with primary care and with cardiology in the outpatient setting as previously arranged. She is following with the Coumadin clinic.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Right ventricular dysfunction, Sinus rhythm, Ultrasound Doppler normal
Clinical narrative: ED visit - Bilateral pulmonary embolism EKOS procedure. Patient is a 75 y.o. female presents to hospital for evaluation of Shortness of breath this been going on for a few weeks but suddenly much worse earlier this morning. Patient was afebrile in the emergency department. Saturations were 86% on room air. Arterial blood gas revealed a pH 7.45 PCO2 34 PO2 was 114 bicarbonate was 23. Saturations are 98%. EKG was sinus rhythm with no ST elevation or depression noted. Chest x-ray was negative. CT PE study did reveal bilateral pulmonary emboli with right heart strain. Patient was initiated on a heparin drip. Cardiology was notified in the emergency department and patient Was transferred to a different location for likely EKOS procedure. Bilateral lower Doppler studies were negative for DVT. 2-D echocardiogram did reveal an ejection fraction of 55-60% with mild diastolic dysfunction. Patient remained stable on room air. She improved to the point that she was deemed appropriate for discharge home. She will be discharged home on Lovenox and Coumadin. She is follow-up with primary care and with cardiology in the outpatient setting as previously arranged. She is following with the Coumadin clinic.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Narrative: Reports soreness at injection site for about 3 weeks, fatigue & body aches on day 10
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pruritus, Rash, Urticaria, Wheezing
Clinical narrative: SkinRash, CoughWheeze, Rash & UrticariaPruritus Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Myalgia Severe joint & muscle stiffness especially in hips, knees, elbows & neck. Narrative:
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: POWER OUTAGE, VACCINE NO LONGER VIABLE
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itching at injection site; Rash at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching and injection site rash. On an unknown date, the outcome of the injection site itching and injection site rash were unknown.   It was unknown if the reporter considered the injection site itching and injection site rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022137180   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's comment: The case was self-reported by the patient. The patient received first dose of Shingrix and experienced rash and itching at the injection site. The reporter consented to follow up. Additional supportive information: For tolerance of 2nd dose, refer case US2022137180, reported by same reporter.; Sender's Comments:  US-GSK-US2022137180:Same reporter
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 15:30 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Apr2021 at 17:15 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyper thyroid" (unspecified if ongoing), notes: Other medical history: Hyper thyroid; "breast cancer", start date: 2017 (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. Concomitant medication(s) included: METHIMAZOLE; AROMASIN; PRISTIQ. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Indication: COVID-19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient took treatment of Paxlovid on 19May2022 for Treatment of COVID-19. Symptoms worsened and took longer to recover and another on Paxlovid in the house compared to the person that did not take it. Also, both was good it had rebound cases and the person who didn't take it did not.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Balance disorder, CSF protein increased, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: About 2 weeks later I had horrific pain in my back. A few days later I started to lose feeling in my legs and feet. I also was losing balance. I made 5 trips to the ER before they can even diagnosed. I had a spinal tap. I was diagnosed with Guillain-Barre syndrome. After 5 months of treatment and therapy I am treated.