chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired dose of Shingrix was administered to a patient/ patient received an expired second dose of shingrix inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired dose of Shingrix was administered to a patient/ patient received an expired second dose of shingrix inadvertently). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-NOV-2023 The reporter asked about the side effect if given expired shingrix to patient. The vaccine administration facility was the same as primary reporter. Office manager stated patient received an expired second dose of Shingrix inadvertently. The reporter confirmed an expired dose of Shingrix was administered to a patient, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling hot, Hyperaesthesia, Hypoaesthesia, Loss of consciousness
Clinical narrative: He has passed out from these attacks; burning in feet; his skin becomes very sensitive to the point that he cannot stand for anything to touch it.; numbness in face; his body overheats to the extreme; sensitive to touch; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced passed out (Verbatim: He has passed out from these attacks) (serious criteria GSK medically significant), burning foot (Verbatim: burning in feet), sensitive skin (Verbatim: his skin becomes very sensitive to the point that he cannot stand for anything to touch it.), numbness facial (Verbatim: numbness in face), feeling hot (Verbatim: his body overheats to the extreme) and touch sensitivity increased (Verbatim: sensitive to touch). The outcome of the passed out, burning foot, sensitive skin, numbness facial and feeling hot were unknown and the outcome of the touch sensitivity increased was not reported.   It was unknown if the reporter considered the passed out, burning foot, sensitive skin, numbness facial, feeling hot and touch sensitivity increased to be related to Shingrix.     It was unknown if the company considered the passed out, burning foot, sensitive skin, numbness facial, feeling hot and touch sensitivity increased to be related to Shingrix.   Additional Information: GSK Receipt date: 10-NOV-2023 A reporter reported that his brother received 2nd Shingrix dose in April of 2023, Since that time he had been experiencing numbness in his face and his body overheats to the extreme.  When the overheating happens, his skin becomes very sensitive to the point that he cannot stand for anything to touch it.  These attacks seem to be worse when he sleeps or was very relaxed.  She explained that the attacks begin at his feet and radiate upward until it is throughout his whole body and he had passed out from these attacks.  He had seen doctors and had been to multiple Emergency Departments but had not received a diagnosis.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: He has passed out from these attacks; burning in feet; his skin becomes very sensitive to the point that he cannot stand for anything to touch it.; numbness in face; his body overheats to the extreme; sensitive to touch; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced passed out (Verbatim: He has passed out from these attacks) (serious criteria GSK medically significant), burning foot (Verbatim: burning in feet), sensitive skin (Verbatim: his skin becomes very sensitive to the point that he cannot stand for anything to touch it.), numbness facial (Verbatim: numbness in face), feeling hot (Verbatim: his body overheats to the extreme) and touch sensitivity increased (Verbatim: sensitive to touch). The outcome of the passed out, burning foot, sensitive skin, numbness facial and feeling hot were unknown and the outcome of the touch sensitivity increased was not reported.   It was unknown if the reporter considered the passed out, burning foot, sensitive skin, numbness facial, feeling hot and touch sensitivity increased to be related to Shingrix.     It was unknown if the company considered the passed out, burning foot, sensitive skin, numbness facial, feeling hot and touch sensitivity increased to be related to Shingrix.   Additional Information: GSK Receipt date: 10-NOV-2023 A reporter reported that his brother received 2nd Shingrix dose in April of 2023, Since that time he had been experiencing numbness in his face and his body overheats to the extreme.  When the overheating happens, his skin becomes very sensitive to the point that he cannot stand for anything to touch it.  These attacks seem to be worse when he sleeps or was very relaxed.  She explained that the attacks begin at his feet and radiate upward until it is throughout his whole body and he had passed out from these attacks.  He had seen doctors and had been to multiple Emergency Departments but had not received a diagnosis.  The reporter did not consent to follow-up.
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Malaise, Rash, Respiratory tract congestion, Sinusitis
Clinical narrative: exhausted; broke out in rash; sinus infection; congestion in chest; really sick; Initial information received on 07-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA352986(CLUSTER).  This case involves Elderly male patient who was exhausted, broke out in rash, sinus infection, congestion in chest and really sick after receiving vaccine Influenza Vaccine.  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 dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, form, dose, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date about 10 days later the patient developed exhausted (fatigue), broke out in rash (rash), sinus infection (sinusitis), congestion in chest (respiratory tract congestion) and really sick (illness) following the administration of INFLUENZA VACCINE.  It was reported "patient is a truck driver hence prescriber not sure if rash was a result of irritation from sitting all day or flu injection or something else."  Action taken: not applicable.  Prescribed a cream and rash is now better was a corrective treatment for the event (broke out in rash). It was not reported if the patient received a corrective treatment for the events (exhausted, sinus infection, congestion in chest, really sick).  At time of reporting, the outcome was Unknown for the events.
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: rash; she is itching in every joint; Initial information received on 06-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves Elderly female patient who experienced rash and she is itching in every joint after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past vaccination(s) included COVID 19 VACCINE. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date in 2023, the patient received an unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (Frequency: once) (Strength: Standard) (with an unknown formulation, expiry date and lot number) via unknown route in unknown administration site for immunization.  On an unknown date in 2023, the patient developed events of rash and she is itching in every joint (pruritus) (unknown latency).  It was reported, Consumer called stating that she has always gotten the flu shot and starting last year, she got the FLUZONE HD QIV. This year, the FLUZONE HD QIV has caused her to have a rash, the same as the rash she got when she had the COVID-19 vaccine. She was asking of there is anything that they put in the COVID vaccine that is also in the FLUZONE HD QIV. She said that she has been getting the flu shot for a very long time and this time, she is itching in every joint of her body. Consumer said she had the vaccine done at the pharmacy. She said she does not have allergies and she always eat eggs, so she is not sure what was put in the vaccine that caused her to have a rash. Consumer stated that she turned 65 last year which is why she started using the FLUZONE HD QIV. She was upset that the information has to go through an HCP or pharmacist, but she agreed to have them call on her behalf. She said that manufacturers have to let the consumers know what is in the vaccines. The only thing that her pharmacist told her is that there is a new flu variant in this year's vaccine. Consumer was frustrated with the vaccines that she stated she will never take the COVID-19 vaccine again or the FLUZONE HD QIV if it is what's causing her rash.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: temperature excursion vaccine administered by patient with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA352408.  This case involves an unknown age and unknown gender patient who was administered temperature excursion vaccine IPV (VERO) [IPOL] with no reported 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 unknown dose of temperature excursion vaccine IPV (VERO) with no reported adverse event (poor quality product administered) (latency: same day) (Suspension for injection) (lot number and expiry date not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.   It was reported that "Nurse asks for stability information following a temperature excursion which lasted for a total of 5 days. Reason: Refrigerator issue Max/low temperature reached: NEGATIVE 1.6 Celsius Human error? No. was the product administered to a patient? Yes."   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: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Erythema, Fatigue, Headache, Pain in extremity
Clinical narrative: Pain, redness and swelling in arm. Chills, headache and fatigue. Trouble sleeping.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Sleep disorder
Clinical narrative: Pain, redness and swelling in arm. Chills, headache and fatigue. Trouble sleeping.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Tachycardia, Throat irritation
Clinical narrative: tachycardia, chest tightness, trouble breathing, throat itching
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness unilateral, Therapeutic product ineffective, Tinnitus
Clinical narrative: FLU SHOT CAUSED ME TO LOSE HEARING IN MY RIGHT EAR AND CAUSED SEVERE TINNITUS IN MY RIGHT EAR.  I DO NOT KNOW THE EXACT VACCINE OR MANUFACTURER.  IT WAS THE OVER 65 YEARS OLD DOSE OF FLU SHOT.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Lethargy, Muscular weakness
Clinical narrative: Pronounced weakness in both hands, especially pinky and ring fingers, difficulty holding and manipulating objects, lethargy, unusual joint pain.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Multiple sclerosis relapse
Clinical narrative: EVENT: I have a roller coaster with fatigue. I do too much and I can just pass out and be down for days. Like right now. Pt reported allergic rx to Moderna which caused a flare up of MS, she was hospitalized. This was with her first vaccine did not provide date but according to allergies it was initially documented in 2021.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Acute respiratory failure, Culture negative, General physical health deterioration, Rales, Sepsis
Clinical narrative: The patient is a 24w3d male infant with pulmonary hemorrhage, cerebellar bleed, and bronchopulmonary dysplasia who was intubated at birth, with extubation on 8/10/23, however required re-intubation on 8/24/23 in the setting of apnea, bradycardia, and desaturation events. On 10/26/23, the patient was due for enteral rotavirus vaccine, which was ordered with the route as "oral" and "Give via NG tube" written in the administration instructions. However, administration was documented as being given via mouth that morning. Prior to vaccine administration, the patient's oxygen requirements appeared largely stable, with 52% oxygen documented the morning of 10/26/23. The patient experienced a clinical decompensation 10/26/23 afternoon, with coarse crackles noted in bilateral lung fields, oxygen requirements up to 100%, and initiation of sedation and paralysis. Empiric antibiotics were initiation on 10/26/23 as well for suspected sepsis. On 10/27/23, the patient was weaned back to 52% oxygen, and antibiotics were discontinued on 10/28/23 due to negative cultures, with notes indicating that the clinical exam was reassuring with more stable clinical status after the respiratory decompensation event. The patient was eventually transferred to another hospital for ongoing care on 11/6/23.
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery dissection
Clinical narrative: pt had covid vaccine and 3 days later had dissection of coronary artery
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Chills, Confusional state, Dizziness, Euphoric mood
Clinical narrative: As expected, patient experienced chills, myalgias, headache, mild fever, and exhaustion for about 36 hours after vaccination. As those symptoms subsided, patient noted continued feeling of "brain fog" described as dizziness, light-headedness, feelings of being far away inside her head, discombobulated, and generally foggy.  This symptom has persisted since onset about 3-days post-vaccination and is continuing today.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: As expected, patient experienced chills, myalgias, headache, mild fever, and exhaustion for about 36 hours after vaccination. As those symptoms subsided, patient noted continued feeling of "brain fog" described as dizziness, light-headedness, feelings of being far away inside her head, discombobulated, and generally foggy.  This symptom has persisted since onset about 3-days post-vaccination and is continuing today.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event occured. We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given
Age: 14.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Syncope
Clinical narrative: At 11:19 am Client was extremely anxious prior to vaccination. After vaccination client had a syncope episode in the chair, head lowered feet elevated. VS taken, after a few seconds client was responsive juice and food provided. Client did not eat or drink for the day. VS monitored until completely oriented. escorted to waiting area with parents. Left at approximately 1pm  in good health.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule
Clinical narrative: Pt. reports, "hen egg size knot" at injection site.
Age: 2.92
Sex: M
Vaccine: UNK, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event occured We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given.
Age: 2.92
Sex: M
Vaccine: UNK, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event occured. We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Neck pain, Procedural pain, Spinal pain
Clinical narrative: I had had back surgery in August, recovering well, Day after vaccine began having pain at right SI joint which was surgical site, then progressed up my spine into my neck with complete spasm and pain unrelieved by any meds or therapy. Absolutely complete systemic inflammatory response after the vaccine.  This lasted for 2 weeks, saw my ortho in followup and prescribed Medrol dose pack.  Within 24hurs, pain started to subside and back to baseline discomfort by end of dosepack.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic inflammatory response syndrome
Clinical narrative: I had had back surgery in August, recovering well, Day after vaccine began having pain at right SI joint which was surgical site, then progressed up my spine into my neck with complete spasm and pain unrelieved by any meds or therapy. Absolutely complete systemic inflammatory response after the vaccine.  This lasted for 2 weeks, saw my ortho in followup and prescribed Medrol dose pack.  Within 24hurs, pain started to subside and back to baseline discomfort by end of dosepack.
Age: 1.75
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event occured.  We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt is an Adult female but received a pediatric dose of the covid vaccine
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The shot was in my upped left arm, possibly muscular? Severe swelling at the site of the shot and surrounding area, went down gradually over about 5-7 days. Itchiness of the same area on and off while it was swollen, cortisone cream relieved the itchiness for a while. Pain when sleeping on that side for about 4 or 5 days.
Age: 51.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Abdominal discomfort, Chills, Pain in extremity
Clinical narrative: Shivering and upset stomach upon waking of the morning of 11/16/2023; symptoms persisted until mid afternoon (about 2:00 - 3:00 pm).  Both arms are still slightly sore as of this morning (11/17/2023), but pain has subsided considerably since the previous day
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Tendon disorder
Clinical narrative: L shoulder pain progressed to inability to move/abduct/rotate, now improving 1.5 months later however not at baseline, seems rotator cuff tendonopathy related
Age: 20.0
Sex: F
Vaccine: FLU4, HEP, HEPA, TDAP
Symptoms: Wrong product administered
Clinical narrative: Client was administered a Hepatitis A vaccine, instead of Hepatitis B vaccine. Client was immediately notified to return to receive the Hepatitis B vaccine. The client did return and did receive the Hepatitis B vaccine.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Biopsy skin, Granuloma annulare, Rash, Rash pruritic
Clinical narrative: Rash on both lower legs and feet, doctor called it Granuloma annulare. Very itchy and spread around legs and ankles. I have been on clobetasol 0.05% ointment for one week with some but not complete clearing, advised to use it for at least another week.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Feeling abnormal, Gastrointestinal pain, Pyrexia, Rash
Clinical narrative: 24 hours post-injection, developed intestinal cramping and diarrhea, which resolved after taking Imodium.  Also felt feverish and generally poor for another c. 30 hours.  Then after about a week developed a very itchy rash on my chest which has not yet fully resolved.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Rash pruritic
Clinical narrative: 24 hours post-injection, developed intestinal cramping and diarrhea, which resolved after taking Imodium.  Also felt feverish and generally poor for another c. 30 hours.  Then after about a week developed a very itchy rash on my chest which has not yet fully resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Mom came to the health department at 8:30am on 11/17/23 stating her childs left arm was red, ,swollen, and warm to the touch. Also stated child had been scratching at injection site the night before and that morning.  Upon assessment, the swelling had spread down from the site of injection, but contained to the upper arm. Left deltoid was warm to the touch, red, and swollen. The patient stated that it hurt when she moved her arm and when it was touched. I asked her to rate her pain, but she was unable to do so. Mom asked her if it "hurt real bad". Child shook her head no. Denied any breathing difficulty and no signs of breathing difficulty. I advised the mom to call the childs PCP. Mom stated she had called the PCP and child couldn't be seen today, but that she would try the walk-in clinic.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site warmth, Pain, Peripheral swelling, Scratch, Skin warm
Clinical narrative: Mom came to the health department at 8:30am on 11/17/23 stating her childs left arm was red, ,swollen, and warm to the touch. Also stated child had been scratching at injection site the night before and that morning.  Upon assessment, the swelling had spread down from the site of injection, but contained to the upper arm. Left deltoid was warm to the touch, red, and swollen. The patient stated that it hurt when she moved her arm and when it was touched. I asked her to rate her pain, but she was unable to do so. Mom asked her if it "hurt real bad". Child shook her head no. Denied any breathing difficulty and no signs of breathing difficulty. I advised the mom to call the childs PCP. Mom stated she had called the PCP and child couldn't be seen today, but that she would try the walk-in clinic.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt received GSK influenza quad inj Lot# 79XR9 on 10/04/2023 subsequently received an additional dose of the above vaccine at the school flu clinic on 11/02/2023. Parent erred in not notifying the school nurse the pt had previously received vaccine on 10/04/2023. If that had been done the pt consent form would have been pulled and this incident would not have happened.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain of skin, Pyrexia
Clinical narrative: PT returned to clinic 11/16 with complaints of redness, swelling with pain at injection site. This began on 11/16 .Pt had fever on 11/16 .None on day of visits. seen by Dr. Documented tricep area 10 cm erythematous skin, tender warm with induration. ORdered Keflex 500 mg 1 capsule 4 x a day for 10 days. to follow up with pcp in 1 week. If worsening symptoms to return to clinic.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Skin induration
Clinical narrative: PT returned to clinic 11/16 with complaints of redness, swelling with pain at injection site. This began on 11/16 .Pt had fever on 11/16 .None on day of visits. seen by Dr. Documented tricep area 10 cm erythematous skin, tender warm with induration. ORdered Keflex 500 mg 1 capsule 4 x a day for 10 days. to follow up with pcp in 1 week. If worsening symptoms to return to clinic.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, VARCEL
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Within approximately 2 minutes of receiving the vaccine, patient passed out. He was given an ice pack and responded to gentle stimuli within 1-2 minutes.  Patient then verbalized he felt like he might vomit, mom reports he did not eat breakfast this morning. He was given crackers and a sprite and was monitored for an additional 20 minutes. Patient fully recovered.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in during a flu shot clinic and stated he was getting the flu shot. After patient left staff realized he had gotten two flu shots and needed COVID vaccine instead. Patient had declined information sheet when he left the clinic. No reactions at this time.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Developed painful red rash one day following vaccine., about 4cm in diameter. It gradually expanded while becoming less bright red, and then became itchy and then went away within 3 days total.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt received GSK Influenza Quad Inj P Lot# 79XR9 on 10/05/2023 subsequently received an additional dose of the above vaccine at the school flu clinic on 11/02/2023. Parent erred in not notifying the school nurse the pt. had previously received vaccine on 10/05/2023. If that had been done the pt. consent form would have been pulled and this incident would not have happened.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No Adverse event occured. We realzed on 11/16/23 that we administered full vial instad of 0.25ml. Therefore, 0.5ml was given.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Immediate post-injection reaction, Injected limb mobility decreased, Pain
Clinical narrative: Patient stated that right after vaccine she felt like they had hit a nerve and felt weak and light headed. Sat around for a few and felt well enough to go home. But has felt weak and had severe pain when moving her arm and can not raise it above her shoulder.  She told me she is going to be seen by a doctor to assess her arm.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Cough, Dizziness, Headache
Clinical narrative: Immediately after vaccine, the arm was sore, which was consistent with the shot.  The following day the soreness spread through the arm and shoulder and kept progressing with each day throughout the body.  Friday morning (11/10/23), the headache and photosensitivity were added to the list of symptoms and by Monday 11/13/23, I was unable to get out of bed unassisted.  The symptoms were very consistent with a very bad case of flu, such as body aches, dizziness, photosensitivity, headache, weakness, dry hacking cough,  dizziness.  Unable to get out of bed unassisted.    Negative fever. Negative for influenza A/B and COVID (rapid and PCR). Oral hydration and symptom management with: Ibuprofen, acetaminophen, fluticasone nasal, fexofenadine.    On 11/17/23 symptoms began to subside, but not enough to regain full function.  Lost 5 days of work,
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Impaired work ability, Influenza A virus test negative, Influenza like illness, Influenza virus test
Clinical narrative: Immediately after vaccine, the arm was sore, which was consistent with the shot.  The following day the soreness spread through the arm and shoulder and kept progressing with each day throughout the body.  Friday morning (11/10/23), the headache and photosensitivity were added to the list of symptoms and by Monday 11/13/23, I was unable to get out of bed unassisted.  The symptoms were very consistent with a very bad case of flu, such as body aches, dizziness, photosensitivity, headache, weakness, dry hacking cough,  dizziness.  Unable to get out of bed unassisted.    Negative fever. Negative for influenza A/B and COVID (rapid and PCR). Oral hydration and symptom management with: Ibuprofen, acetaminophen, fluticasone nasal, fexofenadine.    On 11/17/23 symptoms began to subside, but not enough to regain full function.  Lost 5 days of work,
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test negative, Mobility decreased, Pain, Pain in extremity, Photosensitivity reaction
Clinical narrative: Immediately after vaccine, the arm was sore, which was consistent with the shot.  The following day the soreness spread through the arm and shoulder and kept progressing with each day throughout the body.  Friday morning (11/10/23), the headache and photosensitivity were added to the list of symptoms and by Monday 11/13/23, I was unable to get out of bed unassisted.  The symptoms were very consistent with a very bad case of flu, such as body aches, dizziness, photosensitivity, headache, weakness, dry hacking cough,  dizziness.  Unable to get out of bed unassisted.    Negative fever. Negative for influenza A/B and COVID (rapid and PCR). Oral hydration and symptom management with: Ibuprofen, acetaminophen, fluticasone nasal, fexofenadine.    On 11/17/23 symptoms began to subside, but not enough to regain full function.  Lost 5 days of work,
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative, Viral infection
Clinical narrative: Immediately after vaccine, the arm was sore, which was consistent with the shot.  The following day the soreness spread through the arm and shoulder and kept progressing with each day throughout the body.  Friday morning (11/10/23), the headache and photosensitivity were added to the list of symptoms and by Monday 11/13/23, I was unable to get out of bed unassisted.  The symptoms were very consistent with a very bad case of flu, such as body aches, dizziness, photosensitivity, headache, weakness, dry hacking cough,  dizziness.  Unable to get out of bed unassisted.    Negative fever. Negative for influenza A/B and COVID (rapid and PCR). Oral hydration and symptom management with: Ibuprofen, acetaminophen, fluticasone nasal, fexofenadine.    On 11/17/23 symptoms began to subside, but not enough to regain full function.  Lost 5 days of work,
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient asked to get a pneumonia immunization at the pharmacy. We checked the state database to see which pneumonia vaccine he was due for, and after checking, it showed he already received all of the vaccines needed for pneumonia. After looking over the rest of his vaccines on the database, it appeared that he had not yet received the newest Covid 19 booster so we recommended that. Patient thought that he received the vaccine already, but agreed to fill out the consent form and receive this vaccine. Once the vaccine was already given, and the person administering the vaccine was going to fill out his covid vaccine card, we noticed he already received the vaccine a month prior. Our system automatically updates the state database to show vaccines, so there was a glitch in the system somehow that didn't show the covid 19 vaccine was administered.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: PATIENTS MOTHER CALLED APPROX 1 HOUR AFTER VACCINE GIVEN.  PATIENT DEVELOPED A RASH ALL OVER TRUNK OF BODY APPROX 45 MINUTES AFTER VACCINE GIVEN.  PATIENT WAS GIVEN 50MG BENADRYL.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Within 5 minutes after vaccination, Client had gotten up and stated he needed to use the restroom. As the client was walking towards the door, he began saying. " I feel like im going to pass out". Client was assisted to the chair. Cool rags were applied to the clients forehead. Client VS include BP 104/64 and HR 80. Client remained seated  for another 5-10 minutes. Client reported feeling better quickly after he sat down and was able to stand up and walk without  feeling lightheaded. Client was provided with crackers and juice. Client denied SOB, tightness in chest,or feeling like his tongue was swelling.  No cyanosis, or swelling of the face noted.  No rash noted.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt. recipient Glaxosmithkline Influenza Qaud Inj P Lot# NT2M9 on 10/24/2023 at PCP office. Pt. subsequently received an additional influenza vaccine (info above) at school flu clinic. Pt. recipient parent neglected to notify school nurse child had received flu vaccine on 10/24/2023. If that had been done the school consent form would have been pulled and the incident would not have occurred.
Age: 13.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Cyanosis, Loss of consciousness, Nausea, Seizure
Clinical narrative: Family consisting of mom and two sons scheduled to get seasonal immunization at the pharmacy on 11-16-23.  13 year old male had appointments for two shots - one spikevax and one fluzone quad immunization.    following second immunization patient briefly passed out and had a brief seizure event.  the event only lasted about 10 seconds.  mom stated that patient has history of passing out at sight of blood but never with immunizations.  patient regained consciousness after about 10 seconds , white in facial color and lips slightly blue.   patient stated felt a little nausea upon sitting up.  patient was offered water and started to regain color and decreased nausea symptom.   patient  remained in immunization room for another 30 minutes and then left with mom and brother for some electrolyte drink and to go home.  mom was  going to follow up with doctor in the morning.
Age: 15.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: First Hepatitis A vaccine administration medication did not properly enter vaccination site due to faulty needle tip/hub. Client immediately contacted to return to receive a second dose of Hepatitis A vaccine. Client did return, and did receive a second Hepatitis A vaccine in alternate intramuscular site.
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Hypersomnia, Muscular weakness, Pyrexia
Clinical narrative: Patient reports when she stands, her knees and ankles give out. She is also reporting sleeping more than usual. Lastly, she reports developing a fever of 101F.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: I get a numb tingly feeling just like when your hand goes to sleep. It's under my left arm and reaches over to the side of my left breast and it doesn't last long but it comes and goes throughout the day.
Age: 71.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Body temperature increased, Central venous catheterisation, Cerebrovascular accident, Dyspnoea, Feeling abnormal
Clinical narrative: He got his vaccines, everything was fine.  His wife had gone to bed early.  Around 11:00 PM he woke up his wife, was vomiting, and stated that he was feeling terrible.  The next morning she got up and he had been sleeping, he had been in and out of bed all night vomiting.  She had to go to work, she brought him some gatorade, water and put it next to the bed.  She asked her son to check on him, and he said that he was fine.  About an hour later she asked her son to check on him, and he could not get him up.  He had a temperature of 105, and they could not wake him up.  They took him to the ER and told them what was going on and said that he had MRSA.  Wife states that he was unconscious still.  He was taken to the I ICU, and his breathing was so hard trying to breath and they told him that he was compensating that his kidney were going to go into failure.  She decided to put him on a respiratore.  They decided that he had a stroke, did not know if it was at the time of the inputting on the respiratory.  The blood that was being pushed out from the heart, he had 100 little strokes on his brain.  He does not think there will be any long-term affects as they were minor.  He is now in rehab as he is having problems with his left leg.    He was taken to Hospital.    He has a big wound on his right arm, and infectious disease is watching it, and if it had gotten any worse he would have to have had surgery to remove the skin around it.  He was then removed to rehab right now and admitted there on 10/31/23.  He will be in there for at least the first week in December.  He has a PICC line receiving antibiotics and will be there due to that.  There was nothing wrong with his valve as he was sent for 2 different tests, and they will have to watch that for a year.    He does go for pain management due to a work related incident in his 40s.  Dr. is his PM doctor.
Age: 71.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Intensive care, Laboratory test, Limb injury, Loss of consciousness, Mechanical ventilation
Clinical narrative: He got his vaccines, everything was fine.  His wife had gone to bed early.  Around 11:00 PM he woke up his wife, was vomiting, and stated that he was feeling terrible.  The next morning she got up and he had been sleeping, he had been in and out of bed all night vomiting.  She had to go to work, she brought him some gatorade, water and put it next to the bed.  She asked her son to check on him, and he said that he was fine.  About an hour later she asked her son to check on him, and he could not get him up.  He had a temperature of 105, and they could not wake him up.  They took him to the ER and told them what was going on and said that he had MRSA.  Wife states that he was unconscious still.  He was taken to the I ICU, and his breathing was so hard trying to breath and they told him that he was compensating that his kidney were going to go into failure.  She decided to put him on a respiratore.  They decided that he had a stroke, did not know if it was at the time of the inputting on the respiratory.  The blood that was being pushed out from the heart, he had 100 little strokes on his brain.  He does not think there will be any long-term affects as they were minor.  He is now in rehab as he is having problems with his left leg.    He was taken to Hospital.    He has a big wound on his right arm, and infectious disease is watching it, and if it had gotten any worse he would have to have had surgery to remove the skin around it.  He was then removed to rehab right now and admitted there on 10/31/23.  He will be in there for at least the first week in December.  He has a PICC line receiving antibiotics and will be there due to that.  There was nothing wrong with his valve as he was sent for 2 different tests, and they will have to watch that for a year.    He does go for pain management due to a work related incident in his 40s.  Dr. is his PM doctor.
Age: 71.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Musculoskeletal disorder, Pain management, Renal failure, Sleep disorder, Somnolence
Clinical narrative: He got his vaccines, everything was fine.  His wife had gone to bed early.  Around 11:00 PM he woke up his wife, was vomiting, and stated that he was feeling terrible.  The next morning she got up and he had been sleeping, he had been in and out of bed all night vomiting.  She had to go to work, she brought him some gatorade, water and put it next to the bed.  She asked her son to check on him, and he said that he was fine.  About an hour later she asked her son to check on him, and he could not get him up.  He had a temperature of 105, and they could not wake him up.  They took him to the ER and told them what was going on and said that he had MRSA.  Wife states that he was unconscious still.  He was taken to the I ICU, and his breathing was so hard trying to breath and they told him that he was compensating that his kidney were going to go into failure.  She decided to put him on a respiratore.  They decided that he had a stroke, did not know if it was at the time of the inputting on the respiratory.  The blood that was being pushed out from the heart, he had 100 little strokes on his brain.  He does not think there will be any long-term affects as they were minor.  He is now in rehab as he is having problems with his left leg.    He was taken to Hospital.    He has a big wound on his right arm, and infectious disease is watching it, and if it had gotten any worse he would have to have had surgery to remove the skin around it.  He was then removed to rehab right now and admitted there on 10/31/23.  He will be in there for at least the first week in December.  He has a PICC line receiving antibiotics and will be there due to that.  There was nothing wrong with his valve as he was sent for 2 different tests, and they will have to watch that for a year.    He does go for pain management due to a work related incident in his 40s.  Dr. is his PM doctor.
Age: 71.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Staphylococcal infection, Transient ischaemic attack, Vomiting
Clinical narrative: He got his vaccines, everything was fine.  His wife had gone to bed early.  Around 11:00 PM he woke up his wife, was vomiting, and stated that he was feeling terrible.  The next morning she got up and he had been sleeping, he had been in and out of bed all night vomiting.  She had to go to work, she brought him some gatorade, water and put it next to the bed.  She asked her son to check on him, and he said that he was fine.  About an hour later she asked her son to check on him, and he could not get him up.  He had a temperature of 105, and they could not wake him up.  They took him to the ER and told them what was going on and said that he had MRSA.  Wife states that he was unconscious still.  He was taken to the I ICU, and his breathing was so hard trying to breath and they told him that he was compensating that his kidney were going to go into failure.  She decided to put him on a respiratore.  They decided that he had a stroke, did not know if it was at the time of the inputting on the respiratory.  The blood that was being pushed out from the heart, he had 100 little strokes on his brain.  He does not think there will be any long-term affects as they were minor.  He is now in rehab as he is having problems with his left leg.    He was taken to Hospital.    He has a big wound on his right arm, and infectious disease is watching it, and if it had gotten any worse he would have to have had surgery to remove the skin around it.  He was then removed to rehab right now and admitted there on 10/31/23.  He will be in there for at least the first week in December.  He has a PICC line receiving antibiotics and will be there due to that.  There was nothing wrong with his valve as he was sent for 2 different tests, and they will have to watch that for a year.    He does go for pain management due to a work related incident in his 40s.  Dr. is his PM doctor.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event occured. We realzed on 11/16/23 that we administered full vial instead of 0.25ml. Therefoer, 0.5ml was given.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Hypertension
Clinical narrative: Extreme hypertension  Needed to add more hypertensive meds to bring down BP BP finally back to baseline on 11/17/23
Age: 51.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Patient developed significant right deltoid pain making it difficult to do daily tasks and move arm. The pain has persisted for 3 and a half weeks so far, and is still ongoing, though it is starting to improve.
Age: 1.75
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adversse event occured. We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event occured. We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Flushing, Malaise, Nausea
Clinical narrative: Patient developed sudden onset of facial flushing/redness, palpitations, nausea, dizziness following vaccination for influenza.  Vaccination was given with Fluarix Quadrivalent Vaccine by GSK.  Within the first five minutes of receiving the vaccine she began feeling ill.  Patient was given IM bendaryl 25 mg and symptoms resolved.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations
Clinical narrative: Patient developed sudden onset of facial flushing/redness, palpitations, nausea, dizziness following vaccination for influenza.  Vaccination was given with Fluarix Quadrivalent Vaccine by GSK.  Within the first five minutes of receiving the vaccine she began feeling ill.  Patient was given IM bendaryl 25 mg and symptoms resolved.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV1
Symptoms: Unevaluable event
Clinical narrative: Asked for help on what is the correct vaccine was told 50mg instead of 100mg.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: shivers, body aches, headache. no treatment.  went away after 12 hours.
Age: 31.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: Growing Rash, Swelling at injection site. Arm hurting
Age: 31.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Fatigue, Injection site pain, Pain, Pain in extremity, Rash
Clinical narrative: Growing Rash, Swelling at injection site. Arm hurting
Age: 31.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Rash papular, Swelling, Tenderness
Clinical narrative: Growing Rash, Swelling at injection site. Arm hurting
Age: 31.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: She got her vaccines, and had no reaction.  Then around 6:00 AM she woke up with a really sore arm to the point that it was painful to move.  It started to subside and hurts when anything it touching her skin.  There is a rash 1" wide and 3" long across her arm.  It is bulging, swollen, hurts from the injection site all the way down to her wrist, index finger and her thumb.  She did take a Hydrocodone for her back pain and that is not helping with the pain in her arm.  She talked to the pharmacist who gave her the injection, but told her to call her doctor if she got worse and told her to report to us.  She is also extremely tired.
Age: 31.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Fatigue, Injection site pain, Pain, Pain in extremity, Rash
Clinical narrative: She got her vaccines, and had no reaction.  Then around 6:00 AM she woke up with a really sore arm to the point that it was painful to move.  It started to subside and hurts when anything it touching her skin.  There is a rash 1" wide and 3" long across her arm.  It is bulging, swollen, hurts from the injection site all the way down to her wrist, index finger and her thumb.  She did take a Hydrocodone for her back pain and that is not helping with the pain in her arm.  She talked to the pharmacist who gave her the injection, but told her to call her doctor if she got worse and told her to report to us.  She is also extremely tired.