chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received an EXTRA DOSE of AREXVY; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 81-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number t5232, expiry date 18-AUG-2025) for prophylaxis.   Previously administered products included Arexvy (1st dose received on 5th February 2024).   On 15-AUG-2024, the patient received the 2nd dose of Arexvy. On 15-AUG-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received an EXTRA DOSE of AREXVY). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 15-AUG-2024 The Healthcare professional was the reporter. The reporter called on the day of reporting stating that a male patient received an extra dose of Arexvy which led to extra dose administered. The first dose was administered on 5 February 2024 and the extra dose was administered on 15 August 2024.; Sender's Comments:  US-GSK-US2024101932:Same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash papular
Clinical narrative: red, itchy rash which started at the injection site; red, itchy rash which started at the injection site; red, itchy rash which started at the injection site; Raised rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-DEC-2022, the patient received the 1st dose of Shingrix. On 04-DEC-2022, 1 days after receiving Shingrix, the patient experienced injection site rash (Verbatim: red, itchy rash which started at the injection site), injection site erythema (Verbatim: red, itchy rash which started at the injection site), injection site itching (Verbatim: red, itchy rash which started at the injection site) and raised rash (Verbatim: Raised rash). The outcome of the injection site rash, injection site erythema, injection site itching and raised rash were resolved (duration 10 days).   It was unknown if the reporter considered the injection site rash, injection site erythema, injection site itching and raised rash to be related to Shingrix.     It was unknown if the company considered the injection site rash, injection site erythema, injection site itching and raised rash to be related to Shingrix.   Additional Information: GSK receipt date: 19-AUG-2024 Consumer reported hat she received one dose of Shingrix and she began experiencing a red, itchy rash which started at the injection site, spread to the length of her forearm, then gradually went away over about a 10 day span. She stated there were no pustules, just a red, raised rash.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Unapproved age; Unapproved age; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 18-month-old male patient who received HAV (Havrix 1440 adult) (batch number 2345B, expiry date 02-FEB-2026) for an unknown indication.   On 19-AUG-2024, the patient received the 1st dose of Havrix 1440 adult 1 meq/kg. On 19-AUG-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: Unapproved age) and overdose (Verbatim: Unapproved age). The outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-AUG-2024 Nurse called to reported that so, we gave an 18 months old, the 19 and up Havrix, the 1 mL instead of the 0.5 dosage which led to adult product administered to child and overdose.
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally received Tdap instead of DTap; accidentally received Tdap instead of DTap; accidentally received Tdap instead of DTap; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number C7747, expiry date 20-JUN-2026) for prophylaxis.   On 19-AUG-2024, the patient received Boostrix. On 19-AUG-2024, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: accidentally received Tdap instead of DTap), adult product administered to child (Verbatim: accidentally received Tdap instead of DTap) and accidental overdose (Verbatim: accidentally received Tdap instead of DTap). The outcome of the wrong vaccine administered, adult product administered to child and accidental overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-AUG-2024 A nurse called to inform that earlier on day of reporting, a 3-year-old accidentally received Tdap instead of DTap which led to wrong vaccine administered, adult product administered to child and accidental overdose.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Balance disorder, Clumsiness, Migraine
Clinical narrative: Excruciating body pain to include: legs, arms, back, neck, shoulders; severe migraine that has been medication resistant,  severe sinus congestion, extreme clumsiness/balance, restless sleep; started approximately 5pm day of vaccination and is still continuing w/ pain now more severe.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Poor quality sleep, Sinus congestion
Clinical narrative: Excruciating body pain to include: legs, arms, back, neck, shoulders; severe migraine that has been medication resistant,  severe sinus congestion, extreme clumsiness/balance, restless sleep; started approximately 5pm day of vaccination and is still continuing w/ pain now more severe.
Age: 32.0
Sex: U
Vaccine: SMALLMNK
Symptoms: Acarodermatitis, Skin lesion, Therapeutic product ineffective
Clinical narrative: Several days after receiving the second dose of Jynneos Vaccine began developing a series of lesions similar to those from the disease in question. The lesions have multiplied on forearms, between fingers, on belly, on ankles and breasts. Nurse practitioner seemed to suspect scabies infection, being unfamiliar with Jynneos side effects, and prescribed permethrin. permethrin is currently having no noticeable effect and medical care is at a loss of what to do without further guidance. No tests have been performed without further advisement from higher up.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: My 11-year-old daughter received the vaccine Gardasil (Lot #W008445) on 07/31/2024. The nurses assistant was administering it intermuscular in her left arm, but when she pulled it out, she was still dispensing product, so a significant amount ended up subcutaneously. This cause an intense amount of pain for my daughter, and she was crying with the pain. She was given a hot compress to help it dissolve. A week later, the injection site swelled up again leaving a red and distinctive swelling that was sore to the touch and "pulsed with pain." We visited our doctor again, and they did not offer any assistance other than to recommend further hot compresses. It is now 3 weeks after the initial vaccine, and there is a significant subcutaneous nodule at the injection site that is sore to the touch.
Age: 21.0
Sex: F
Vaccine: HIBV
Symptoms: Injury associated with device, Occupational exposure to product
Clinical narrative: I was seeing a patient for immunizations due, as I was giving the patient the vaccine, I gave the vaccine, as I was trying to retract the needle, I was going to grav the other vaccine, thats when I got my left thumb with the used needle
Sex: U
Vaccine: MMR
Symptoms: Device connection issue
Clinical narrative: Merk diluent luer-lock connector broke and popped off. MMRII lot: X022986 exp date: 06/11/2025 sterile diluent lot: 1973262 exp date: 03/10/2026.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient developed GI upset including nausea, vomiting, diarrhea and significant abdominal pain requiring hospital admission.
Age: 5.0
Sex: F
Vaccine: COVID19, DTAPIPV, HEPA, MMRV
Symptoms: Incorrect dose administered
Clinical narrative: Moderna 0.5 mL was administered to patient instead of the recommended dose of 0.25 mL.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety disorder, Chronic obstructive pulmonary disease, Condition aggravated, Death
Clinical narrative: Death
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Death, Pain, Vascular dementia
Clinical narrative: Death
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pain of skin, Skin warm
Clinical narrative: Severe red burning painful rash extending from the site of injection covering upper left arm.  Used tylenol to relieve pain.  Skin  still very hot  and painful 48 hours later.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Erythematous papular rash at injection site, spread, worsened until seen by me 8/29/2024.  Recommended hydrocortisone cream BID, and referred to Allergy to rule out allergy to vaccine components.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site bruising, Injection site induration, Injection site mass, Injection site pruritus, Injection site scab
Clinical narrative: Pt's mother called RN line and reported that pt had developed a lump at the injection site of DTap. Vaccines given 12 days ago. Site was itchy and had some bruising, and scab due to pt itching it. No redness, no fevers, no difficulty walking, no sign of infection. Pt's mother stated lump is hard. Had provider visit 8/27, prescribed hydrocortisone cream.
Age: 69.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Extra dose administered
Clinical narrative: patient received two flu shots erroneously, one on 8/13/2024 and another of the same on 8/28/2024
Age: 0.5
Sex: M
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient is a healthy, full-term 6 month old male who presented for a 6-month well child check and for travel vaccinations prior to an upcoming prolonged international travel with his mother to visit family. Patient's parent was seeking out and agreeable to travel vaccinations. The CDC vaccine app was referenced and because the MMR and Varicella vaccine links are next to each other, I mistakenly read the travel guidelines for MMR as the recommendations for Varicella. The patient received the MMR and Hepatitis A vaccinations per the CDC travel guidelines, and 6-month old vaccinations Vaxelis and Prevnar 20. The Varicella vaccine was ordered by myself and subsequently administered despite the CDC recommendation to not vaccine any child under 12 months of age prior to international travel. The error was disclosed to the parent. As of today, 8/29/24 at 9:15am the patient has had no adverse reaction.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Myalgia, Pain
Clinical narrative: Donor repots pain at injection site that moves up arm to shoulder (joint) and back to posterior shoulder muscle that increases on movement .
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pain, Skin discharge, Skin discolouration, Skin disorder, Swelling
Clinical narrative: Swelling. pain. Skin Color Change. Sores. Drainage. 08/13/2024
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient was given a pediatric dose of vaccine instead of adult dose. Patient had no adverse symptoms
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site pruritus, Injection site pustule, Injection site swelling
Clinical narrative: Patient reports that the day after injection she had a localized red, warm, and raised area on her deltoid. after the passing of 4 to 5 days she started developing raised pustules that were itchy and would ooze if squeezed. They were all over here arms and trunk. shortly thereafter she developed a total body rash with a red, raw, encompassing rash on her trunk. she reported to pharmacy 8/27/24 after seeing her MD
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash
Clinical narrative: Patient reports that the day after injection she had a localized red, warm, and raised area on her deltoid. after the passing of 4 to 5 days she started developing raised pustules that were itchy and would ooze if squeezed. They were all over here arms and trunk. shortly thereafter she developed a total body rash with a red, raw, encompassing rash on her trunk. she reported to pharmacy 8/27/24 after seeing her MD
Age: 42.0
Sex: F
Vaccine: FLUC4, HEP, MMR, TDAP
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: Diluent used when mixing MMR II vaccine was expired.  Expiration date was 6/26/2024.  Patient has been notified.  Pharmacist is in touch with patient with updates.  Primary care Dr was reached out to three times but have not been able to get in contact with provider or leave a voicemail on number the patient provided.  Patient has bee pregnant 6 times previously, last was 2013, patient did not recall prior birthweights.  Manufacturer (Merck) was contacted.  Per Represenative at Merck, shot is ok if used with an expired diluent.  Patient aware that Dr may want to have her revaccinated in 28 days for the first dose.  As we have not been able to contact Dr., no current update from Dr regarding this.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient was given a pediatric dose instead of an adult dose. No other adverse outcome.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: BODY WIDE HIVES, FACE TRUNK AND UPPER EXTREMITIES WITHIN 12 HOURS OF VACCINE ADMINISTRATION. BENADRYL RESOLVED
Age: 75.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: On 8/29/24, patient called  Department of Health and notified clinic that soon after receiving 4th (final dose) of the Rabies post exposure prophylaxis series on 8/16/24, patient developed a fever of 101.0 degrees Fahrenheit, chills, fatigue, headache, and nausea.  Patient denies developing a rash, facial swelling, vomiting, difficulty breathing. Patient managed symptoms at home with over the county antipyretics and did not visit a medical provider.  Symptoms resolved within 36 hours post vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient received a pediatric dose instead of an adult dose of vaccine. No adverse side effects.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient received a pediatric dose instead of the adult dose. No adverse side effects.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blindness, Dizziness, Fatigue, Laboratory test normal, Muscular weakness
Clinical narrative: The next day (April 2), I almost fainted. I felt severely dizzy and lots my vision for some number of seconds. Following that, starting April 3rd or 4th, I began to experience severe exhaustion and several panic attacks. Then, around April 11th, I began to experience dizziness, severe weakness in my legs, as well as a fear that I was going to collapse.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Panic attack, Syncope
Clinical narrative: The next day (April 2), I almost fainted. I felt severely dizzy and lots my vision for some number of seconds. Following that, starting April 3rd or 4th, I began to experience severe exhaustion and several panic attacks. Then, around April 11th, I began to experience dizziness, severe weakness in my legs, as well as a fear that I was going to collapse.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Patient reports pain at the injection starting time of injection and has continued since injection was given. Patient reports this to our office on 8/23/24.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Cough
Clinical narrative: vaccine administered in Lt thigh- tolerated well- spoke with pt and Dad- child sitting on Dads lap. Choose two stickers and one placed on the band aid and one on the hand. Pt was smiling and talking then went to stand up and started coughing. This happened within a minute of administering the vaccine. He tucked his chin down then started coughing .  No wheezing or stridor assessed but he continued coughing more and his color was red facial and extremities but no hives.. I took him form Dad and tried to get him to say is name and he would only look at me but would not verbalize anything and continued coughing. I called for the other nurses to help with the response.  Pt noted to have cyanosis to lips and child was placed on nonrebreather- oxygen sat between 97-100 percent. BP 102/72; ambulance called ; first responder arrived from Fire department and assisted in the response.  I called our medical director Dr who agreed not to give epi at the time- oral benadryl given as ordered per emergency protocol; oxygen sats continued to be stable; He did spit some of this oral benadryl out; he appeared very tired and started to become diaphoretic but Ambulance showed up to assessed child and later the child's status returned to baseline. Transported to MC for additional monitoring and Father accompanied in ambulance. 10:35 spoke to ER Md to report sequence of events ; 10:45 am spoke with Dad in ER and states child is doing great and back at baseline.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, UNK
Symptoms: Chest X-ray, Dizziness, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: pateint started complaining of light headed and dizziness and visual disturbances. Pt was placed in supine poisiiton with feet elvated above heart. Pt given apple juice and water, patient had not eten around lunchtime. Vital signs obtained. After approx. 45-60 min EMS was called and patient was transported to General Hospital.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, UNK
Symptoms: Troponin T, Urine analysis, Visual impairment
Clinical narrative: pateint started complaining of light headed and dizziness and visual disturbances. Pt was placed in supine poisiiton with feet elvated above heart. Pt given apple juice and water, patient had not eten around lunchtime. Vital signs obtained. After approx. 45-60 min EMS was called and patient was transported to General Hospital.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness
Clinical narrative: patient feeling dizzy/faint/clammy
Age: 27.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient began to feel lightheaded and passed out for 10 seconds. Patient's face also became flushed. Patient then received water, laid down and elevated his feet, blood pressure monitored, 2 5g glucose tablets given. Patient recovered. 30 minute time course.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema
Clinical narrative: Seen for outpatient acute appointment on 8/28/24. Mom had called RN line reporting 2 days of large area of redness on left thigh since 8/28 AM (2 days after vaccine administration in this area). Patient acting appropriately and does not seem bothered by area.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Rash
Clinical narrative: RASH STARTED ALL OVER THE BODY 2 DAYS AFTER ADMINISTRATION. PT STATES HE HAS NEVER HAD A REACTION TO THE FLU SHOT AND RSV IS THE FIRST TIME HE HAS RECEIVED AND FIRST TIME EVER HAVING ANY REACTION. HE DID MENTION HE HAD BLUE LIGHT LASER TREATMENT 2 WEEKS PRIOR TO THE VACCINE AND THINKS IT MAY HAVE CAUSED HIS SKIN TO BE MORE REACTIVE? HE HAS TREATED WITH COLD COMPRESSES, BENADRYL AND HYDROCORTISONE. CURRENTLY 1 WEEK LATER AND PATIENT FEELS RASH IS IMPROVING, BUT APPARENT ON CHEST , ARMS, LEGS, EVERYWHERE
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: DTaP + IPV (Quadracel) vaccine was inadvertently administered to 5 year old patient as the patient's 3rd dose of DTaP and 3rd dose of IPV. Quadracel is licensed and approved as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel, DAPTACEL, and/or VAXELIS. Patient met the minimum intervals for a dose of DTaP and IPV from dose #2 to dose #3. No known adverse events or outcomes came from the inadvertently administered dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: woke up the next day with achiness, headache and low fever
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt dizzy after receiving vaccine and then fainted
Age: 38.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy
Clinical narrative: Pregnant patient came into pharmacy wanting a RSV vaccine.  Arexvy was given which is not approved in pregnancy.  Both patient and provider were notified on 8/27/24  and given information from CDC when the wrong RSV vaccine is given during pregnancy. Patient reported no adverse  at that time.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Dyspnoea, Urticaria
Clinical narrative: 6-8 hrs later developed "heavy breathing" per parent, but was eating and drinking well. no facial or lip swelling. no vomiting or diarrhea. parents also noted erythema at injection sites on both sides. when we woke up this morning, developed hives on both legs.
Age: 59.0
Sex: M
Vaccine: PNC15
Symptoms: Wrong product administered
Clinical narrative: Patient was administered PCV 15 in error.  Provider ordered PCV 20. Please advise as to if patient should receive PCV 20 in 8 weeks or if patient should receive PPSV23 in one year (minimum 8 weeks). Previously immunized with Prevnar 13 0n 1/23/18
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Urticaria
Clinical narrative: Hives developed on b/l lower extremities, began quickly and then began to improve within 15 min without intervention.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Condition aggravated, Electrocardiogram ambulatory, Fatigue, Hypersomnia
Clinical narrative: He got his vaccine, he noticed a few days later that his balance was starting to go off, and also he started sleeping an extra couple of hours a night.  The only other thing is after his first 2 vaccines his blood count dropped.  He knows it was at 12.5 in 2020 and it has dropped off.  He started taking iron pills to boost in back up and at the present time he is listed as slightly anemic.  His blood count got into the 9's and then went back up to 10.3.  The fatigue, sleeping extra hours and it has gotten slightly worse over the past 3 years.  He went to the ER on 8/4/2024 for palpitations and he is now on a heart monitor for 14 days.  He did not know if this reaction was an extension of his high blood pressure.  He has had so many doctors appointments and he has been trying to keep up with that and was thinking it may be old age catching up with him.  He deals with a holistic company and he told him about his symptoms, and he said that a lot of people have had the symptoms he is having from the COVID 19 shot, and that's why he should report his reactions.   He is wondering if his low blood count, loss of balance and ths sleeping extra is due to the COVID vaccines.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: He got his vaccine, he noticed a few days later that his balance was starting to go off, and also he started sleeping an extra couple of hours a night.  The only other thing is after his first 2 vaccines his blood count dropped.  He knows it was at 12.5 in 2020 and it has dropped off.  He started taking iron pills to boost in back up and at the present time he is listed as slightly anemic.  His blood count got into the 9's and then went back up to 10.3.  The fatigue, sleeping extra hours and it has gotten slightly worse over the past 3 years.  He went to the ER on 8/4/2024 for palpitations and he is now on a heart monitor for 14 days.  He did not know if this reaction was an extension of his high blood pressure.  He has had so many doctors appointments and he has been trying to keep up with that and was thinking it may be old age catching up with him.  He deals with a holistic company and he told him about his symptoms, and he said that a lot of people have had the symptoms he is having from the COVID 19 shot, and that's why he should report his reactions.   He is wondering if his low blood count, loss of balance and ths sleeping extra is due to the COVID vaccines.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Administration site swelling, Erythema, Joint swelling, Peripheral swelling, Skin warm
Clinical narrative: Patient presented himself to the pharmacy on 08/29/2024 (2 days after the administration of the vaccine) indicating that his left arm was swollen and red. It tells me that at the site of administration of the vaccine it is not swollen, but it is below the site of administration and also after the elbow. You can see a bulge and redness between the elbow and the wrist. It indicates that it is a little hot. The patient reports that he has take acetaminophen. I recommended taking ibuprofen to help reduce swelling and apply cold to the area. I also suggested seeing a doctor to be evaluated.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Bell's palsy, Hypoaesthesia, Injection site inflammation
Clinical narrative: Pt had Tdap vaccine on Sunday on her left arm.  The next day on Monday she couldn't feel her left side of her face, and inflammation on injection site.  On Wednesday, pt went to ER and got diagnosed with Bell's Palsy.  She picked up her medications today on Thursday . Pt will follow up with her Primary Care Doctor.
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9 MONTH OLD RECEIVED VACCINE THAT IS RECOMMENDED FOR 4-6YR OLD.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Administration site discolouration, Administration site indentation, Administration site reaction, Autoimmune thyroiditis, Biopsy skin abnormal
Clinical narrative: Vaccine administration site never healed, became larger circle, skin faded to lighter color, tissue died and sunk in like a belly button.  Finally had biopsy after more than one year and diagnosed as Morphea.  Within a couple months of the vax, began having dizziness, numbness and tingling sensations.  It kept worsening.  BP starting becoming violently erratic leading to hospitalizations.  Began feeling ill constantly.  I am now miserably sick all the time and rarely get out of bed.  I've now been diagnosed with Hashimotos, Lupus, and Morphea.  Today I woke up with a full blister on my stomach which is now likely  Bullous Pemphigoid and will see rheumatologist again next week.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blister, Blood pressure abnormal, Dizziness, Feeling abnormal, Hypoaesthesia
Clinical narrative: Vaccine administration site never healed, became larger circle, skin faded to lighter color, tissue died and sunk in like a belly button.  Finally had biopsy after more than one year and diagnosed as Morphea.  Within a couple months of the vax, began having dizziness, numbness and tingling sensations.  It kept worsening.  BP starting becoming violently erratic leading to hospitalizations.  Began feeling ill constantly.  I am now miserably sick all the time and rarely get out of bed.  I've now been diagnosed with Hashimotos, Lupus, and Morphea.  Today I woke up with a full blister on my stomach which is now likely  Bullous Pemphigoid and will see rheumatologist again next week.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Impaired healing, Laboratory test, Malaise, Mobility decreased, Morphoea
Clinical narrative: Vaccine administration site never healed, became larger circle, skin faded to lighter color, tissue died and sunk in like a belly button.  Finally had biopsy after more than one year and diagnosed as Morphea.  Within a couple months of the vax, began having dizziness, numbness and tingling sensations.  It kept worsening.  BP starting becoming violently erratic leading to hospitalizations.  Began feeling ill constantly.  I am now miserably sick all the time and rarely get out of bed.  I've now been diagnosed with Hashimotos, Lupus, and Morphea.  Today I woke up with a full blister on my stomach which is now likely  Bullous Pemphigoid and will see rheumatologist again next week.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia, Pemphigoid, Soft tissue necrosis, Systemic lupus erythematosus
Clinical narrative: Vaccine administration site never healed, became larger circle, skin faded to lighter color, tissue died and sunk in like a belly button.  Finally had biopsy after more than one year and diagnosed as Morphea.  Within a couple months of the vax, began having dizziness, numbness and tingling sensations.  It kept worsening.  BP starting becoming violently erratic leading to hospitalizations.  Began feeling ill constantly.  I am now miserably sick all the time and rarely get out of bed.  I've now been diagnosed with Hashimotos, Lupus, and Morphea.  Today I woke up with a full blister on my stomach which is now likely  Bullous Pemphigoid and will see rheumatologist again next week.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema
Clinical narrative: Redness at site of injection.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Pt was given expired MMRII vaccine on 08/29/2024. Vaccine expired on 08/22/2024
Age: 37.0
Sex: F
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Neck pain
Clinical narrative: Client states starting 2 weeks after vaccinations were administered she began to develop generalized neck pain that has been lasting about 5 weeks without resolution. Instructed to go to PCP for evaluation.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Urticaria
Clinical narrative: About 10-15 minutes after vaccination, pt developed hives on forehead and face. No eye or lip swelling. No coughing. Lungs clear and VS wnl. Given diphenhydramine with subsequent resolution of hives.  This was the 2nd Pentacel dose given to patient, the 4th DTAP and 4th HiB. Other doses given with Vaxelis.
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient received his first dose on 07/31/2024. Pharmacists administered IM instead of SQ. Followed up with the patient before administering his second dose and he did not report any adverse reactions.
Age: 1.33
Sex: M
Vaccine: DTAP, MMR, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient did not experience any Adverse event.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Patient is a 4mo male here with mother and father, with C/O post-vaccine "bruising", redness and swelling of a vaccine site, following his most recent vaccination 22 days ago.  The symptoms improved over time, as bruising cleared up, but there is still a nodule at the site.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Paraesthesia
Clinical narrative: still has tingling in the arm
Age: 75.0
Sex: M
Vaccine: TD
Symptoms: Blood glucose normal, Chest discomfort, Electrocardiogram, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Visual changes including "seeing stars" starting approx 1 minute after administration, followed shortly by chest pressure and tingling in mouth and throat. PO Benadryl administered.  EMS was called. They remained stable following incident, symptoms resolved entirely, and were discharged by EMS.
Age: 75.0
Sex: M
Vaccine: TD
Symptoms: Visual impairment
Clinical narrative: Visual changes including "seeing stars" starting approx 1 minute after administration, followed shortly by chest pressure and tingling in mouth and throat. PO Benadryl administered.  EMS was called. They remained stable following incident, symptoms resolved entirely, and were discharged by EMS.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Chest pain, Mobility decreased, Neck pain, Neuropathy peripheral
Clinical narrative: Reduce range of motion, shoulder pain, neuropathy, neck pain, elbow pain, chest pain.
Age: 62.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Patient received both vaccines ( Arexvy and Fluarix) at approximately 9:30 AM  on 08/29/2024.  After receiving the vaccines patient showed no signs of distress or allergic reaction. At approximately 1:30 PM  patient came to pharmacy and stated that he had an allergic reaction to the vaccines and had broken out in hives.  The  rash was visible on the patient. The patient showed no other signs of distress. There was no swelling of the tongue and the patient came to the pharmacy un accompanied.  The patient was administered a single vial of diphenhydramine 50mg intramuscularly.  The patient declined  EMS  (911)  assistance.  After about 20 minutes the patient went home unaccompanied and promised to call the pharmacy if his condition worsens.
Age: 5.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient had fever of 102 the following day.  He had a febrile seizure lasting greater than 9 minutes which required Diastat to be administered by his mother. He has a history of febrile seizures but has not had one after a vaccine.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, IPV, PNC15, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave child two IPV vaccines (one combo, one solo) instead of one IPV (in combo) and one PCV (solo). Administered approximately 4:20pm on 8/29/2024 at City Health District, vaccine clinic on floor 2, exam room 5. Mom and aunt of child were present. Child appeared well, no reported prior vaccine reactions or allergies known. Were given vaccine information statements, consent obtained, explained possible SEs and adverse reactions of vaccines. Administered Vaxelis, IPV and rotavirus. While reviewing, this RN noticed I had accidentally mixed up IPV with PCV. Called supervisor to discuss, who called deputy director MD and Co immunization nurse senior - both said there were no medical concerns from the accidental administration of two IPVs. Discussed my mistake with mom and aunt and apologized profusely, told them what MD and RN imz senior said, and offered to either do PCV vaccine today or another day. They chose to have PCV vaccine today. They had no questions about the additional IPV vaccine given and were understanding of the mistake. Baby appeared well and did well with all vaccines.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local swelling and redness in arm at site of injection. Started 1 day after vaccination
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: An expired flu vaccine was administered to patient. Vaccine expired 06/2024 and it was administered 8/29/2024. Lot number: U8255BA.  Manufacturer: Sanofi Pasteur
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT HAS NOT EXPERIENCED ANY SIDE EFFECTS BUT THIS IS A 1 DOSE VACCINE AND PATIENT RECEIVED IT TWICE. PREVIOUS DOSE WAS  DECEMBER 2023, AND LAST DOSE WAS TODAY, 08/29/24
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anger
Clinical narrative: Anger sudden onset of anger that was beyond normal. Thought process was scary and still is. If a person is not ok this could cause someone to hurt themselves or someone else. I was surprised by the anger and reaction. I almost felt like I had to fight covid myself that was eye inside my body. You call it a virus I call it a eye inside but okay. So far no leg pain from the creatine kanosis symptoms that were present before hand. But I also haven't been around rape users infected with covid making me deal with mold spores and signs of legionairs disease. The hypoxia is not that bad as the Pfizer vaccine . Is the vaccine worked yet to stabilize the nuclear bombs and weapons of mass destruction inside the brain of the head trauma patients with dry drowning. The dry drowning was nit the main cause of death the cranial pressure from plasma increase would be. All these symptoms and then the vaccine effects the mental health region of emotion and messed with serotonin and dopamine to the point of suicide or wanting people gone. I'm not sure that the vaccine is safe unless added to a group of control modules that effect that part of the brain. The program is not right
Age: 17.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chest X-ray normal, Chest pain, Costochondritis, Dyspnoea, Full blood count normal
Clinical narrative: Chest pain and difficulty breathing.  Diagnosed in emergency department with costochrondritis.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity, Pruritus, Skin lesion
Clinical narrative: Second dose was administered at 9 am, by 8:30pm of the same day, stabbing pain and intense itching began on the left ankle, then right ankle and began moving up both legs. Left side of body has been consistently much worse and the ankle/leg has been the primary focal area. Itching & pain were followed by formation of lesions containing clear lymph. Went to urgent care on 08/18/2024, morning with a request for antiviral to treat the shingles. Doctor refused to consider the possibility that it was shingles since it was obviously correlated to the vaccination so he prescribed only an antihistamine which was totally ineffective. Contacted primary care doctor on 08/19/2024 who also declined to consider that it was shingles and urged me to just go back to urgent care. As a result I've had only at-home care and OTC remedies. Active occurrence of new lesions along with severe pain continued through 08/25/2024. As of 08/26/2024, occurrence of new lesions began to slow and pain has diminished somewhat. As of date of reporting, symptoms continue to gradually diminish along with a diminishing number of new lesions each day.
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Clinic unknowingly administered third dose of JYNNEOS. Upon entering administration into system, writer noticed patient had received two doses of JYNNEOS on 9/26/2022 and 10/26/2022. No adverse reactions noted.
Age: 33.0
Sex: M
Vaccine: FLUR4
Symptoms: Dysphagia, Ear discomfort, Headache, Muscle tightness, Oropharyngeal pain
Clinical narrative: 5 Minutes after vaccine patient experienced itchy throat and tightness in neck, after a couple minutes more she had difficulty swallowing. Patient reports taking famotidine after evaluation at ER. Vitals and appearance of throat was okay at hospital. She reports having sore throat, tightness in throat radiating up towards her ear and headache beginning at 2pm on 8/29.  Pt received Flublok trivalent but unable to choose that on drop down.
Age: 33.0
Sex: M
Vaccine: FLUR4
Symptoms: Throat irritation, Throat tightness
Clinical narrative: 5 Minutes after vaccine patient experienced itchy throat and tightness in neck, after a couple minutes more she had difficulty swallowing. Patient reports taking famotidine after evaluation at ER. Vitals and appearance of throat was okay at hospital. She reports having sore throat, tightness in throat radiating up towards her ear and headache beginning at 2pm on 8/29.  Pt received Flublok trivalent but unable to choose that on drop down.
Age: 31.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: Hives, rash, shortness of breath, symptoms got worse from 11am onward, given steroid and Benadryl at hospital
Age: 31.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Hives, rash, shortness of breath, symptoms got worse from 11am onward, given steroid and Benadryl at hospital
Age: 31.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: Per patient, this morning had hives and shortness of breath, went to Medical Center, was d/c with steroids and benadryl
Age: 31.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Per patient, this morning had hives and shortness of breath, went to Medical Center, was d/c with steroids and benadryl
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient has not reported any medical concerns or symptoms after being administered the RECOMBIVAX HB due to staff miscommunication/ No additional AE; administered RECOMBIVAX HB instead of TRUMENBA; administered RECOMBIVAX HB instead of TRUMENBA / already completed their series with RECOMBIVAX HB; staff member confused the TRUMENBA vaccine with "Hepatitis B Vaccine", RECOMBIVAX HB; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 30-JUL-2024, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB), formulation: intramuscular injection, lot # X002469, expiration date: 22-MAY-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis instead of meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA) (drug not administered).  Nurse stated that the error occurred due to confusion in communication with preparing for the patient's appointment, in which the patient was due for a ''Meningitis B Vaccine'', and the staff member confused the meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA) vaccine with ''Hepatitis B Vaccine'', hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (wrong vaccine administered, product confusion). Nurse stated that the patient had already completed their series with hepatitis b vaccine (recombinant)(RECOMBIVAX HB), and confirmed the patient has not reported any medical concerns or symptoms after being administered the hepatitis b vaccine (recombinant)(RECOMBIVAX HB) due to staff miscommunication (extra dose administered). No additional adverse events reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: 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 y004544   8/19/2025 Temperature: -12.13C Time frame:; 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 y004544   8/19/2025 Temperature: -12.13C Time frame:; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-JUL-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) injection (lot #y004544, expiration date: 19-AUG-2025, administered for prophylaxis (dose, strength, and route of administration were not provided).   This vaccine was improperly stored in -12.13 degree Celsius for 19 minutes (Product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Medical assistant reports patient was accidently administered an expired dose of VARIVAX on Aug 12, 2024. Product expired on Aug 10, 2024. Product has one prior temperature excursion. Medical assistant is asking if this dose could still count as vali; Medical assistant reports patient was accidently administered an expired dose of VARIVAX on Aug 12, 2024. Product expired on Aug 10, 2024. Product has one prior temperature excursion.; This spontaneous report was received from a consumer refers to a 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, the patient was vaccinated with expired and an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), formulation: injection, lot # W025277, expiration date: 10-AUG-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.   On 10-AUG-2024, product expired (expired product administered). Administered dose of vaccine was exposed to the temperature excursion of -11 degrees Celsius for 5 hours and 30 minutes on 02-APR-2023 (product storage error). There were no additional adverse events reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Accident at work, Skin laceration, Syringe issue
Clinical narrative: her thumb was bleeding; Occupational injury/injured as a result of the breakage; V-SHAPED SLICE GOING DOWN HER THUMB WITH SKIN FLAP/laceration occurred; V-SHAPED SLICE GOING DOWN HER THUMB WITH SKIN FLAP/laceration occurred; Syringe broken; Injury associated with device; This spontaneous report was received from a nurse and referred to herself who was a 34-year-old female patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 15-AUG-2024, the patient noticed the broken finger flange of syringe was broken (syringe issue). During the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation: injection, strength: 0.5mL, lot#1967338, expire date 26-JAN-2026) to the other, the patient had a V-shaped slice went down her thumb with skin flap and skin laceration occurred (Occupational injury, Injury associated with device). Her thumb was bleeding. The patient was treated with glue and steristrips. At time of reporting, the patient was recovering from skin flap, skin laceration, wound bleeding, Occupational injury.  The casual relationship between skin flap, skin laceration, wound bleeding, Occupational injury and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   This is one of the two reports from the same reporter. ; Sender's Comments:  US-009507513-2408USA005828: