chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was administered with PENTACEL using only the dry component (Hib), reconstituted using sterile water, without the liquid component (DTaP-IPV). with no adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender to whom administered with diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)] using only the dry component (hib), reconstituted using sterile water, without the liquid component (dtap-ipv). with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization and using only the dry component (hib), reconstituted using sterile water, without the liquid component (dtap-ipv). with no adverse event (single component of a two-component product administered) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 83.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Peripheral swelling, Rash, Rhinorrhoea, Skin warm
Clinical narrative: Arm was swollen; Runny nose; Sneezing; Hot; Arm was red; Rash; Patient with allergy to hydrocortisone was administered Fluad Quadrivalent; This spontaneous case was received on 08-Sep-2023 from other non health professional (consumer) via Communications (reference number SEQW23-02109), and concerned an 83-year-old, female patient.  The patient's concurrent conditions included unspecified thyroid disorder and allergy to hydrocortisone. The patient's concomitant medications included unspecified medication for thyroid and cholesterol for unreported indication.  On Wednesday, 06-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) (explicitly coded as 'Contraindicated product administered') for influenza immunization. The batch number was not reported.  On 07-Sep-2023, when the patient got up at 7 am, after vaccination with Fluad Quadrivalent, the patient had runny nose, was sneezing, arm was red and swollen, was hot, and experienced rash. Treatment measures associated with adverse event was reported as Benadryl (diphenhydramine hydrochloride) and allergy pill from Consumer Value Store Pharmacy. The patient stated that she never had an issue with the flu vaccines before.  The reporter assessed the events as related to Fluad Quadrivalent, as reported that the patient took Fluad vaccine and had some reactions to it.  At the time of initial reporting, the patient had not recovered from the events, as reported it was still going.  This case was assessed as non-serious.  Company comment: An 83-year-old patient with allergy to hydrocortisone was vaccinated with the suspect product Fluad Quadrivalent (explicitly coded as 'Contraindicated product administered'). The patient developed swelling, erythema, and hot feeling on arm, as well as rhinorrhoea, sneezing, and rash one day after vaccination. Based on available information causality between the suspect vaccine and all events is assessed as probably related. Contraindicated product administered is assessed as unrelated per company's conventions.; Reporter's Comments: The reporter assessed the events as related to Fluad Quadrivalent, as reported that the patient took Fluad vaccine and had some reactions to it.; Sender's Comments: An 83-year-old patient with allergy to hydrocortisone was vaccinated with the suspect product Fluad Quadrivalent (explicitly coded as 'Contraindicated product administered'). The patient developed swelling, erythema, and hot feeling on arm, as well as rhinorrhoea, sneezing, and rash one day after vaccination. Based on available information causality between the suspect vaccine and all events is assessed as probably related. Contraindicated product administered is assessed as unrelated per company's conventions.
Age: 83.0
Sex: F
Vaccine: FLUA4
Symptoms: Sneezing
Clinical narrative: Arm was swollen; Runny nose; Sneezing; Hot; Arm was red; Rash; Patient with allergy to hydrocortisone was administered Fluad Quadrivalent; This spontaneous case was received on 08-Sep-2023 from other non health professional (consumer) via Communications (reference number SEQW23-02109), and concerned an 83-year-old, female patient.  The patient's concurrent conditions included unspecified thyroid disorder and allergy to hydrocortisone. The patient's concomitant medications included unspecified medication for thyroid and cholesterol for unreported indication.  On Wednesday, 06-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) (explicitly coded as 'Contraindicated product administered') for influenza immunization. The batch number was not reported.  On 07-Sep-2023, when the patient got up at 7 am, after vaccination with Fluad Quadrivalent, the patient had runny nose, was sneezing, arm was red and swollen, was hot, and experienced rash. Treatment measures associated with adverse event was reported as Benadryl (diphenhydramine hydrochloride) and allergy pill from Consumer Value Store Pharmacy. The patient stated that she never had an issue with the flu vaccines before.  The reporter assessed the events as related to Fluad Quadrivalent, as reported that the patient took Fluad vaccine and had some reactions to it.  At the time of initial reporting, the patient had not recovered from the events, as reported it was still going.  This case was assessed as non-serious.  Company comment: An 83-year-old patient with allergy to hydrocortisone was vaccinated with the suspect product Fluad Quadrivalent (explicitly coded as 'Contraindicated product administered'). The patient developed swelling, erythema, and hot feeling on arm, as well as rhinorrhoea, sneezing, and rash one day after vaccination. Based on available information causality between the suspect vaccine and all events is assessed as probably related. Contraindicated product administered is assessed as unrelated per company's conventions.; Reporter's Comments: The reporter assessed the events as related to Fluad Quadrivalent, as reported that the patient took Fluad vaccine and had some reactions to it.; Sender's Comments: An 83-year-old patient with allergy to hydrocortisone was vaccinated with the suspect product Fluad Quadrivalent (explicitly coded as 'Contraindicated product administered'). The patient developed swelling, erythema, and hot feeling on arm, as well as rhinorrhoea, sneezing, and rash one day after vaccination. Based on available information causality between the suspect vaccine and all events is assessed as probably related. Contraindicated product administered is assessed as unrelated per company's conventions.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Magnetic resonance imaging head normal, Seizure
Clinical narrative: Had first-time seizure while at school
Age: 64.0
Sex: F
Vaccine: FLUC4, RSV
Symptoms: Dyspnoea, Myalgia, Nasal congestion, Rash, Respiratory tract congestion
Clinical narrative: The next day significant breathing difficulty gradually reducing as muscular aches, nasal and chest congestion set in.  Followed within 24 hours by a system rash all over the body.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: rx was administered subcutaneously in error it should have been intramuscular, no adverse reactions was reported by patient
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Significant pain and swelling of arm of injection site.  Skin became warm to the touch, and a significant area of spreading redness developed.  This occurred over the course of 48 hours immediately after the vaccine was administered and lasted 96 hours. This was dose #2 of the vaccine.  The reaction subsided after 96 hours. The patient had no similar reaction to the first dose administered in April 2023.  Only reaction to first dose was normal level of tenderness at the injection site.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine was administered subcutaneous instead of recommended intramucular, pt did not report any adverse reaction
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Local reaction, Peripheral swelling, Pruritus
Clinical narrative: The patient came to the pharmacy and reported she had a local reaction to her flu vaccine. The patient's left arm was red, slightly swollen, and according to the patient, itchy. I recommended the patient take Benadryl to help with the inflammation and redness. I recommended that the patient go to urgent care if the redness and itchiness doesn't go away in a day or two. The patient was happy with the recommendation and purchased  a box.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Bone pain, Chills, Headache, Myalgia, Nausea
Clinical narrative: Approximately 13 hours after the injection I experienced severe chills and body (muscle/bone) aches.  I did not take my temperature.   The chills subsided after I got my body warm in bed.  The morning following the injection I experienced headache and nausea.  The body aches continued the day after the injection, albeit somewhat reduced.  The chills did not return the day after the injection.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Pain
Clinical narrative: Approximately 13 hours after the injection I experienced severe chills and body (muscle/bone) aches.  I did not take my temperature.   The chills subsided after I got my body warm in bed.  The morning following the injection I experienced headache and nausea.  The body aches continued the day after the injection, albeit somewhat reduced.  The chills did not return the day after the injection.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm, aches, fever 100 degrees
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site haemorrhage, Loss of consciousness
Clinical narrative: The patient observed blood at the vaccination  site and passed out briefly before regaining consciousness. Subsequently, the patient's father contacted the paramedics, who conducted an assessment of patient's vital signs, all of which were within normal parameters and transported him on a stretcher.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Flushing, Muscle spasms
Clinical narrative: After 15 minutes, patient  presented of major back spasm and flushing. EMS was notified and vital signs were checked. Patients vitals according to personnel were within normal limits and was assessed properly.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine was administered subcutaneously vs intramuscularly pt reported no adverse effect
Age: 13.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Flublok that should have only been given to patient 18 years old and older.  No adverse reaction noted.
Age: 13.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Flublok that should have only been given to patient 18 years old and older.  No adverse reaction noted.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Unsettled stomach/diarrhea   Do not know accurately which RSV vaccine was administered.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Flublok that should have only been given to patient 18 years or older.  Patient had no adverse reactions to vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: The patient received a 2nd dose of bivalent Moderna vaccine without  clarification or verification of any chronic illnesses or immunocompromised or weakened immune sysytem. The PQCF was filled out in a foreign language.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Hypoaesthesia oral, Lip swelling, Oral disorder, Pain
Clinical narrative: DO NOT KNOW BRAND OF RSV VACCINE RECEIVED...........  Reactions:  feeling of liquid in front teeth, numb & swollen lips, tiredness, aches - mild symptoms but mouth symptoms are strange..  Tylenol relieved aches but not mouth problems. Swollen upper lips persisted - still there 2 days later after RSV shot.  This reaction also happens after other vaccinations but this time they are milder.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Sensory disturbance
Clinical narrative: DO NOT KNOW BRAND OF RSV VACCINE RECEIVED...........  Reactions:  feeling of liquid in front teeth, numb & swollen lips, tiredness, aches - mild symptoms but mouth symptoms are strange..  Tylenol relieved aches but not mouth problems. Swollen upper lips persisted - still there 2 days later after RSV shot.  This reaction also happens after other vaccinations but this time they are milder.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Seasonal flu shot, was not told type.  Okay for a few hours, then got very nauseous.  Light-headed.  Fatigue.  Chills.  Two sessions of throwing up/heaving, plus a few instances of watery diarrhea.   Minor headache  overnight and following morning.  Nausea and fatigue still evident, but less so.  Keeping down water and ginger ale and bread.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Retching, Vomiting
Clinical narrative: Seasonal flu shot, was not told type.  Okay for a few hours, then got very nauseous.  Light-headed.  Fatigue.  Chills.  Two sessions of throwing up/heaving, plus a few instances of watery diarrhea.   Minor headache  overnight and following morning.  Nausea and fatigue still evident, but less so.  Keeping down water and ginger ale and bread.
Age: 92.0
Sex: F
Vaccine: RSV
Symptoms: Acute myocardial infarction, Laboratory test, Nausea, Pulmonary oedema, Respiratory distress
Clinical narrative: approx. 4- 6 hrs. after 2 vaccines- RSV & flu Mom developed nausea, vmtg, respiratory distress & urinary incontinence.   911 was notified & she was taken to the ED  where she was diagnosed with severe edema in her lungs and an anterior wall MI.  No symptoms of dyspnea, or chest pain earlier in the day.
Age: 92.0
Sex: F
Vaccine: RSV
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: approx. 4- 6 hrs. after 2 vaccines- RSV & flu Mom developed nausea, vmtg, respiratory distress & urinary incontinence.   911 was notified & she was taken to the ED  where she was diagnosed with severe edema in her lungs and an anterior wall MI.  No symptoms of dyspnea, or chest pain earlier in the day.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given fluzone HD instead of fluzone quadrivalent, patient was notified of this error
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Rash erythematous, Skin swelling, Tenderness
Clinical narrative: two-inch wide, puffy red rash, still painful to slightest touch over 96 hours after injection.
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Pyrexia
Clinical narrative: PATIENTS WIFE CALLED THE NEXT DAY STATING THAT HE RAN 103 FEVER AFTER RECEIVING FLU SHOT AND HE HAS NEVER HAD FLUAD BRAND BEFORE. HE TOOK TYLENOL AND IT CAME DOWN AND HAS BEEN DOWN AT 98.6
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, Cardiac failure congestive, Condition aggravated, Echocardiogram, Electrocardiogram
Clinical narrative: Went to hospital for asthma issues and learned I had CHF.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: 30 mins after event arm was itchy. The following day arm continued to be itchy and a hive developed.  No history of adverse reactions to vaccines or medications.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: pt came back to pharmacy and complained of shortness of breath, arm pain in both arms and leg pain. I called ems and code white. i took her bp which was 120/83 and hr 45. ems got here and she was feeling better and gave her an aspiring. they were going to do a 12 lead. I tried calling pt several times and with no response
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: AS PER PT. SHE SEES LIGHT BUMPS ON BOTH HANDS.  BUT HER HUSBAND AND PHARMACIST DO NOT SEE ANY BUMPS.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine was administered subcutaneously versus the recommended intramuscularly, pt did not report any adverse effects
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Mobility decreased
Clinical narrative: Patient woke up this morning with intense intermittent sharp back pain. Feels like he slept wrong but very intense and growing in intensity and making it difficult to walk and move around.  Patient tried to use a brace but has not provided relief, ibuprofen has also not helped.
Age: 24.0
Sex: M
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Injection site pain, Muscle strain, Pain in extremity
Clinical narrative: Muscle strain, pain at injection site and entire arm, numbness in fingers
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal discomfort, Fatigue, Headache, Photopsia
Clinical narrative: Headache, flashing on left side of left eye, stomach upset, fatigue
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Chills, Headache, Limb discomfort
Clinical narrative: (Have never had the slightes reaction to flu shot before this, including years of hi-dose.) Chills with uncontrollable shaking, severe joint and muscle pain, headache, weakness, heavy limbs, night fever. (Brother had same reaction to hi-dose this yr despite never a problem before.)
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: (Have never had the slightes reaction to flu shot before this, including years of hi-dose.) Chills with uncontrollable shaking, severe joint and muscle pain, headache, weakness, heavy limbs, night fever. (Brother had same reaction to hi-dose this yr despite never a problem before.)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Bloody discharge, Cardiac monitoring, Chest pain, Dizziness
Clinical narrative: Pharmist pulled blood back into the shot vial then pushed shot into my arm hurt immedaitley i felt dizzy he basically pushed me out the door 10 steps away i started feel sideways walking out of pharmacy it is all on video at pharmacy i went outside and someone outside helpe me to juice next door I went home and symptoms got worse chest pain so bad i had large block of ice on my chest for 4 hours flopping like a fish on the back deck of my home while my friends sat and watched cannabis is only thing and ice that go my past this attack. 2 years later purple toes instant blindness many new symptoms i never had before Bloody discharge from ears .
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Immediate post-injection reaction, Otorrhoea, Pain in extremity, Skin discolouration
Clinical narrative: Pharmist pulled blood back into the shot vial then pushed shot into my arm hurt immedaitley i felt dizzy he basically pushed me out the door 10 steps away i started feel sideways walking out of pharmacy it is all on video at pharmacy i went outside and someone outside helpe me to juice next door I went home and symptoms got worse chest pain so bad i had large block of ice on my chest for 4 hours flopping like a fish on the back deck of my home while my friends sat and watched cannabis is only thing and ice that go my past this attack. 2 years later purple toes instant blindness many new symptoms i never had before Bloody discharge from ears .
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Substance use
Clinical narrative: Pharmist pulled blood back into the shot vial then pushed shot into my arm hurt immedaitley i felt dizzy he basically pushed me out the door 10 steps away i started feel sideways walking out of pharmacy it is all on video at pharmacy i went outside and someone outside helpe me to juice next door I went home and symptoms got worse chest pain so bad i had large block of ice on my chest for 4 hours flopping like a fish on the back deck of my home while my friends sat and watched cannabis is only thing and ice that go my past this attack. 2 years later purple toes instant blindness many new symptoms i never had before Bloody discharge from ears .
Age: 44.0
Sex: F
Vaccine: FLUR4, PNC20
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: pt has warm, raised red nodule at injection site
Age: 48.0
Sex: F
Vaccine: PNC20
Symptoms: Chest discomfort, Lip pruritus
Clinical narrative: Patient states lips felt itchy and chest tight.  Patient took some diphenhydramine.  After 35 minutes patient felt better and went home. Followed up with phone call almost 2 hours later.  Patient states feels fine now.  States may have been because she did not eat.  Also stated has anxiety when give immunizations and that could be part of the reaction as well.
Age: 71.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: PATIENT RECEIVED  FLU VACCINE ON 09/02/2023  AND  CAME BACK  TO RECEIVE SHINGRIX BUT WAS GIVEN ANOTHER FLU SHOT. THE ERROR WAS DISCOVERED AND THE PATIENT WAS CONTACTED TO REPORT ANY SYMPTOMS.
Age: 85.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Asthenia, Dyspnoea, Pyrexia, Tremor
Clinical narrative: The immunizations were given at approximately 12:23 pm. The patient states he started having weakness, shaking, difficulty breathing, and fever later that night. As of the next morning 09/16/2023 the patient had not yet seeked medical treatment.
Age: 75.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted approximately 5 minutes after vaccinations. Patient was in a sitting position. Patient reported no previous adverse reactions to immunizations upon screening before administration. After administration he reports that he commonly gets dizzy and lightheaded and sometime passes out after vaccination. Patient came to approximately 5-10 seconds after initially fainting. Monitored for 20 minutes afterward until he was feeling back to normal and stated that he felt that he was ok to leave.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received fluzone HD at our clinic today. insurance rejected stating that patient received fluzone HD at pharmacy on 9/11/23. patient did not report any adverse events at this time
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two flu vaccines in one day.  RPh spoke with patient and she reported no issues 15 min after vaccines were given.  Rph plans to follow up with patient in a few days.
Age: 76.0
Sex: F
Vaccine: FLU4, RSV, VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Patient came back today to show pharmacist her arm; it was red where she received the vaccinations, and it appeared to be a water blistered formed on her arm. Patient has been putting ice on it this morning. Per patient, the blister showed up this morning and has gotten bigger during the day.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Immunisation reaction, Rash pruritic, Urticaria
Clinical narrative: Customer said that early in the morning she woke up with an itchy rash/hives across her belly.   She called the dr, who suspected it was a reaction to the Arexvy.  The rash cleared up by the next day and she is fine now.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea
Clinical narrative: patient states diarrhea started just before midnight the day of the vaccination, approximately 6 hours post-administration. Patient states she still has diarrhea today, but "is not worried about it"
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: patient complained of itching and red rash on shoulder and ankle. The rash has gotten better however. Some is still lingering.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Cough, Malaise, Pain in extremity, Respiratory tract congestion
Clinical narrative: Patient came to the pharmacy stating that she felt very sick after getting the flu shot on 09/12/23. Her arm became sore and It made her feel very sick the next day. She states that she has cough congestion, and felt clammy, but appears to be improving slowly. She denied any redness, rash, or trouble breathing. Patient informed she used Tylenol and OTC cold meds to control her symptoms and it seemed to be helping. Pharmacist advised to monitor her symptoms , and if no improvement to contact provider.
Age: 6.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse events yet, told the mother I would call 9-18-23 to check in if any adverse events.
Age: 56.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: I administered RSV vaccine to 56 years old patient due to not calculating the patient's age based on the date of birth. The vaccine was given at the clinic. I noticed the mistake that I made when I returned to the pharmacy and started to enter the vaccine consent form to the pharmacy system. I call the patient immediately and informed him that I have administered the vaccine that is only approved to individuals above 60 years old with risk factors. At this time, the patient does not have any adverse events. However, I have informed the patient to report it to VAERS when he gets any adverse events from this vaccination.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Red rash at and around injection site. Has since spread down arm, as if flowing down under skin with gravity. Some itching as well.
Age: 76.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Dizziness, Foot fracture, Headache, Laboratory test normal, Loss of consciousness
Clinical narrative: Patient received both her flu and RSV shot on Friday around 4:15pm.  Patient states the next morning that she felt sick to her stomach, had a headache and felt dizzy.  Before her husband could get her to the restroom, she passed out and broke her metatarsal bone.  Patient did go to the ER where she states that they couldn't find any reason why this would have happened.  She then attributed it to her vaccination.  Her husband had the same two shots and was just tired.
Age: 76.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Nausea
Clinical narrative: Patient received both her flu and RSV shot on Friday around 4:15pm.  Patient states the next morning that she felt sick to her stomach, had a headache and felt dizzy.  Before her husband could get her to the restroom, she passed out and broke her metatarsal bone.  Patient did go to the ER where she states that they couldn't find any reason why this would have happened.  She then attributed it to her vaccination.  Her husband had the same two shots and was just tired.
Age: 77.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Headache, Injection site pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: The day after the vaccinations (9/15) the patient experienced a bad headache and fever, which resolved with Tylenol. On 9/16, the patient noticed a red rash from her neck down across her chest which is warm to touch but is not painful or itchy. The patient reports no swelling or redness at the injection sites, only some soreness the day after the vaccine.
Age: 77.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Skin warm
Clinical narrative: The day after the vaccinations (9/15) the patient experienced a bad headache and fever, which resolved with Tylenol. On 9/16, the patient noticed a red rash from her neck down across her chest which is warm to touch but is not painful or itchy. The patient reports no swelling or redness at the injection sites, only some soreness the day after the vaccine.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: age inappropriate
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Loss of consciousness
Clinical narrative: 15 MINS AFTER RECEIVED FLU SHOT, PT PASS OUT IN FRONT OF PARENT. DAD DID HOLD HER BODY. WE CALL EMS, SHOWUP IN 10 MINUTES AND TAKE VITAL SIGN, BP AND BS. EVRY THING BACK TO NORMAL (BP 83/60, BS 113). PARENT FEEL COMFORTABLE AND PARAMEDIC RELEASE PT BACK HOME AROUND 4PM
Age: 66.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram ambulatory, Electrocardiogram normal
Clinical narrative: Frequent PVCs associated with dyspnea, lightheadedness, and chest discomfort. Unrelated temporally to these symptoms, I have noticed new onset of muscle cramping in my legs and forearms. I posted date and time of onset above, but I am not sure of the precise time of onset. Symptoms increased rapidly and peaked on ~Sep 10-11. I saw my cardiologist Mon Sep 11. He felt the PVCs were univocal and he found no urgent or imminently life-threatening signs on exam or EKG. He ordered a 2 -week ambulatory monitor that is currently in progress. I had been on metoprolol titrate 12.5 mg for several years for occasional PVCs with good control; my cardiologist suggested increasing the metoprolol to 25 mg bid. The muscle cramps, PVCs and associated dyspnea, lightheadedness and chest discomfort seemed to have decreased over the last 5 days. I also had malaise and feverish feelings Sep 7.
Age: 66.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Malaise, Muscle spasms, Pyrexia, Ventricular extrasystoles
Clinical narrative: Frequent PVCs associated with dyspnea, lightheadedness, and chest discomfort. Unrelated temporally to these symptoms, I have noticed new onset of muscle cramping in my legs and forearms. I posted date and time of onset above, but I am not sure of the precise time of onset. Symptoms increased rapidly and peaked on ~Sep 10-11. I saw my cardiologist Mon Sep 11. He felt the PVCs were univocal and he found no urgent or imminently life-threatening signs on exam or EKG. He ordered a 2 -week ambulatory monitor that is currently in progress. I had been on metoprolol titrate 12.5 mg for several years for occasional PVCs with good control; my cardiologist suggested increasing the metoprolol to 25 mg bid. The muscle cramps, PVCs and associated dyspnea, lightheadedness and chest discomfort seemed to have decreased over the last 5 days. I also had malaise and feverish feelings Sep 7.
Age: 69.0
Sex: F
Vaccine: PNC15, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: SWELING AND REDNESS ON ARM
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Loss of blood flow in left hand, numbness and pale color in fingers. This lasted for about a hour but got better once heat pad was applied.   Violent shivering and then extreme sweating on and off  for > 24 hours. Extreme exhaustion (self for 13 hours and then another 2 hours later in the day)   Terrible consistent headache, swollen face.   Took Tylenol several times.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Peripheral circulatory failure, Swelling face
Clinical narrative: Loss of blood flow in left hand, numbness and pale color in fingers. This lasted for about a hour but got better once heat pad was applied.   Violent shivering and then extreme sweating on and off  for > 24 hours. Extreme exhaustion (self for 13 hours and then another 2 hours later in the day)   Terrible consistent headache, swollen face.   Took Tylenol several times.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Headache, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Aching feeling in left arm at the site, joints hurting, headache, blurred vision, and body aches. Symptoms occurred on 8-21-2023. He stayed out of school on 8-22-2023 and returned to school on 8-23-2023.  The parent stated her son was OK to return to school on 8-23-2023. The client's mother said she contacted office and was instructed to give her child Tylenol and Motrin and   alternate.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Vision blurred
Clinical narrative: Aching feeling in left arm at the site, joints hurting, headache, blurred vision, and body aches. Symptoms occurred on 8-21-2023. He stayed out of school on 8-22-2023 and returned to school on 8-23-2023.  The parent stated her son was OK to return to school on 8-23-2023. The client's mother said she contacted office and was instructed to give her child Tylenol and Motrin and   alternate.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Consciousness fluctuating, Decreased appetite, Dizziness, Loss of consciousness
Clinical narrative: Patient made it home, then became dizzy and passed out on the floor. She was in and out of consciousness for 48 hours. She can barely eat and remains dizzy
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Achy, tired, fever, cold, headache
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal discomfort, Abdominal pain, Chest discomfort, Chest pain, Headache
Clinical narrative: September 16, approximately 30 hours after receiving the vaccine I experienced upper abdomen and chest discomfort, similar to pressure or indigestion along with muscle pain in my legs and headache.  Upon waking the next day, September 17 my arms and legs felt tingly and the muscle pain was in my lower legs. The abdominal and chest pain described now as burning pain. I had not eaten anything since before this symptom began.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: September 16, approximately 30 hours after receiving the vaccine I experienced upper abdomen and chest discomfort, similar to pressure or indigestion along with muscle pain in my legs and headache.  Upon waking the next day, September 17 my arms and legs felt tingly and the muscle pain was in my lower legs. The abdominal and chest pain described now as burning pain. I had not eaten anything since before this symptom began.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient called and said every time she moves her arm it hurts. When at rest no issues. She said it started after her vaccine in August.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Cough, Malaise, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Cough sneezing runny nose stuffy nose malaise  slight sore throat
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Sneezing
Clinical narrative: Cough sneezing runny nose stuffy nose malaise  slight sore throat
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Cough, Pyrexia, Throat tightness
Clinical narrative: Cough/tightness in throat/slight fever, gradually diminishing from 9/14 to present
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine was administered subcutaneously rather than the recommended intramuscular.  no adverse reaction was reported
Age: 38.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Loss of consciousness, Syncope
Clinical narrative: Patient has a vasovagal syncope after receiving second shot of MMR. Varivax was given first and the MMR. Patient felt light headed, dizzy, and was out for 10 seconds. He then came back and felt very hot and needed to lay down. Was given some water, ice packs and was monitored for 25 minutes. He then was able to sit up and was feeling better. He stayed at the pharmacy for a bit longer and was driven home by a friend. Patient reports feeling back to normal an hour after the vaccination.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine was administered subcutaneously rather than recommended IM, pt did not report any adverse reaction
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Erythema
Clinical narrative: turned bright red and had hard time breathing eyes started to close but this improved within the next 10 minutes and she was fine. She declined EMS, or going to ER or urgent care
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fatigue, Diarrhea, Muscle Pain, Headache, Sore Throat, Nausea/Vomiting lasted for three days. Nausea seems to be hanging on longer. Not sure if this is actually related to the vaccine since the symptoms did not start until more than a week after the injection.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Fatigue, Diarrhea, Muscle Pain, Headache, Sore Throat, Nausea/Vomiting lasted for three days. Nausea seems to be hanging on longer. Not sure if this is actually related to the vaccine since the symptoms did not start until more than a week after the injection.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Musculoskeletal stiffness, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Stiff Neck, Sore Throat, Feeling feverish, Left Arm Pain
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye pruritus, Immediate post-injection reaction, Swelling of eyelid
Clinical narrative: Immediate eye itching and lids swollen almost shut.
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: We processed a prescription for Fluzone Quad but then administered Flublok Quad.
Age: 84.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: itching at sight of Abrysvo vaccine ( right arm) and itching of face that has lasted since 24 hours after vaccine administration ( today is 9-17-2023) Patient states itching is not as bad today as it was. Recomended some cetirzine or loratadine to help with itching.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site inflammation, Injection site swelling, Peripheral swelling
Clinical narrative: Patient presented to pharmacy on 9/22 showing me her swollen arm. She had both Fluzone HD and Arexvy in the same arm. The site of the flu shot was not inflamed only the site of the RSV vaccine. The swelling started near injection site and down near elbow. I referred her to call her primary. She sent them pictures. They recommended she be seen in an Urgent Care. The Urgent care doctor stated this may be an allergic reaction.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine was administered subcutaneously rather than the recommended intramuscular route, pt did not report any adverse effect
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite, Fatigue, Myalgia, Nausea
Clinical narrative: patient has been having nausea, fatigue, muscle ache, losing appetite for days
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Palpitations, Pyrexia, Sinusitis
Clinical narrative: I have received 3 doses Pfizer vaccine against Covid so far.  First dose (April 1, 2021) was uneventful. About 12-15 hours after the second dose 3 weeks later, I developed high fever with continuous sensation of palpitations. I checked my pulse, and noted a premature beat after each 4, or 8, or 12 normal beats. I do not have any cardiac history, and have not had ectopy before. I had some OTC magnesium at home (which I had used in the past very infrequently as an occasional sleep aid), which I took hoping to decrease ectopy - but shortly after that, the ectopy worsened, with doublets and triplets. This subsided over a couple of days, but repeated itself after the 3rd dose of Pfizer vaccine in Dec 2021. I have not had any Covid vaccines since then. The similar episodes of very frequent ectopy have repeated twice, in Jan 2022 and sometime in the spring 2023, when I had a sinusitis with fever, but I did not take a Covid test. I continue sometimes waking up in the morning with palpitations/ ectopic beats, which tend to resolve within less than an hour (and that is why I have checked below that the adverse event did not fully resolve).
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Crying, Injection site pain, Pain, Pain in extremity
Clinical narrative: I received the RVS shot on Sept. 13, and my arm was sore for 4 days.  Late Sept  16 at night, I woke up from sleeping on that side (left side where I received the shot) and moved it.  I immediately felt pain that was more painful than I'd ever felt before at the top of my  my left shoulder down to the injection site..  It made me cry--and I don't do that.  I immediately took 2 Advil tablets, and within a few minutes I fell asleep.  When I woke up at 7:30 a.m., the severe pain was gone, and now it only hurts a little when I move it in one direction.
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Sleep disorder
Clinical narrative: I received the RVS shot on Sept. 13, and my arm was sore for 4 days.  Late Sept  16 at night, I woke up from sleeping on that side (left side where I received the shot) and moved it.  I immediately felt pain that was more painful than I'd ever felt before at the top of my  my left shoulder down to the injection site..  It made me cry--and I don't do that.  I immediately took 2 Advil tablets, and within a few minutes I fell asleep.  When I woke up at 7:30 a.m., the severe pain was gone, and now it only hurts a little when I move it in one direction.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Limb mass
Clinical narrative: While billing patient's insurance for the Shingrix it was discovered that she previously was vaccinated with Shingrix on 10/1/2021 and 12/10/2021 according the Vaccine Registry.  She now has received a third dose of Shingrix.  Upon speaking with patient, she did report a "lump" on her arm.  She received both a Flucelvax 23-24 and the Shingrix in her left deltoid.
Age: 88.0
Sex: M
Vaccine: RSV
Symptoms: Dizziness, Head discomfort
Clinical narrative: Patient received vaccination, proceeded to do some shopping, felt lightheaded so he sat down in the grocery department, was able to walk to the pharmacy saying he still felt lightheaded and had pressure in the back of his head. Had patient sit down right in front of the pharmacy cashier, had him sip some water. Pharmacy management was notified and offered an ambulance but he refused. Patient sat for 30 minutes and had a family member come to take him home. (unclear if medical attention was needed) Tried to follow-up with patient, but had to leave a voice message
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Patient returned to pharmacy on 9/17/23 at approximately 2pm to show a quarter-sized, yellowish-brown bruise, She complained that she had pain and some tingling / numbness all week. She was going to give it another week before seeking treatment. She just wanted us to know that this was from the vaccine and she was demanding names. I assured her that I was required to report her reaction and that she should also report it and seek treatment.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: sore arm, then redness about 2 inches in diameter around the injection site.  lasting about 5 days, before it cleared.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine was administered in error as subcutaneously rather than intramuscular pt did not report any adverse effects
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine was administered subcutaneously rather than recommended IM route pt did not report any adverse reaction
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: vaccine was administered in error as a subcutaneous vaccine rather than the recommended intramuscular vaccine, pt did not report any adverse effects
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain, Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: Developed redness, warm to touch, described as a burning sensation in local area of vaccine. Size of redness on 9/17/2023 is 10cm by 16cm approx. She took tylenol and stated that helped with pain. Previously, with shingrix pt recalled redness extending down entire arm to fingers for shot one making it painful to wear rings. Shot 2 in shingrix series was less severe. Based on previous reaction to shingrix patient expects redness to subside over next week.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site warmth
Clinical narrative: Developed redness, warm to touch, described as a burning sensation in local area of vaccine. Size of redness on 9/17/2023 is 10cm by 16cm approx. She took tylenol and stated that helped with pain. Previously, with shingrix pt recalled redness extending down entire arm to fingers for shot one making it painful to wear rings. Shot 2 in shingrix series was less severe. Based on previous reaction to shingrix patient expects redness to subside over next week.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Erythema, Lip blister, Lip erythema, Lip swelling
Clinical narrative: First Shingrix May 21, 2023. Second Shingrix July 22, 2023. August 12th, a few weeks after vaccination, patient developed a burning rash/red blisters on her lips that became swollen. A few days later her whole face was broken out in red, burning splotches. She went to the ER 8/14th and was given Prednisone. Follow up with PCP on 8/18th and required more prednisone. Even now (September), she has burning splotches under both eyes and her lips remain slightly swollen. She states that nothing else changed (no new moisturizer, sunscreen, makeup, detergent, etc.)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral discomfort, Skin burning sensation
Clinical narrative: First Shingrix May 21, 2023. Second Shingrix July 22, 2023. August 12th, a few weeks after vaccination, patient developed a burning rash/red blisters on her lips that became swollen. A few days later her whole face was broken out in red, burning splotches. She went to the ER 8/14th and was given Prednisone. Follow up with PCP on 8/18th and required more prednisone. Even now (September), she has burning splotches under both eyes and her lips remain slightly swollen. She states that nothing else changed (no new moisturizer, sunscreen, makeup, detergent, etc.)
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site, slightly raised large red circle around injection site, arm is warm to the touch, fatigue, headache.  This started the day of vaccine and has continued every day since. It has been 6 days since patient was vaccinated.   She has been taking Advil and Tylenol for pain.