chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: a person may have been administered FLUZONE NP subcutaneously instead of intramuscularly (with no reported adverse event); Initial information received on 04-Nov-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of unknown age and gender who may have been administered influenza USP trival A-B subvirion no preservative vaccine [Fluzone] subcutaneously instead of intramuscularly (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 may have been administered a dose of 0.5 ml of suspect influenza USP trival A-B subvirion no preservative vaccine (Suspension for injection) (strength; lot number; expiry date not reported) subcutaneously instead of intramuscularly (with no reported adverse event) in unknown administration site (incorrect route of product administration) (latency: same day).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence will not be available.  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: 35.0
Sex: M
Vaccine: UNK
Symptoms: Brain fog, Fatigue, Memory impairment
Clinical narrative: Foggy brain; Forgetfulness; Exhausted; Slept for 10 hours straight without waking up once; This spontaneous case, initially received on 24-Oct-2024, was reported by a health professional and concerns an adult male patient.  Medical History and Concomitant Medications reported as unknown.  Administration of company suspect drug: On 15-Oct-2024, the patient received Flucelvax (TIV) for influenza immunization, dose: Unknown, route of administration: Not reported, Anatomical Location: Left deltoid, Lot number: 391315 (CSL Seqirus Batch number unable to be matched).  No additional suspect drugs.  Adverse reactions/events and outcomes: On 15-Oct-2024, the patient experienced Foggy brain (outcome: Unknown), Forgetfulness (outcome: Unknown), Exhausted (outcome: Unknown), Slept for 10 hours straight without waking up once (outcome: Unknown).  Pharmacist reported that he had some odd things happen to him after he was vaccinated with Flucelvax. He reported the onset occurred 15 minutes after vaccine administration, and that this has never happened to him after any other flu shot in the past (all egg-based), and he reported he received a flu shot annually.  The symptoms included Foggy brain, Forgetfulness: a patient came in to the hospital and clearly stated why they were there. When he went to go type that in to the computer and summarize what was said, he was unable to remember what the patient said. He also reported he was forgetting what he was saying in the middle of his sentences. Patient drove home and said he was okay to drive, but he was so exhausted that he unknowingly fell asleep around 6pm and slept for 10 hours straight without waking up once, and was shocked to see it was 3am.  Treatment measures associated with event reported as unknown.  Flucelvax (TIV) action taken: Not Applicable  Reporters' assessment: The reporter considers the events as non-serious and did not provide the causality assessment.; Reporter's Comments: All events are related.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Swelling face, Urticaria
Clinical narrative: Hives covering entire body, abdominal burning, facial swelling. Hives since 10/26/24. Treated with prenidsone, allegra, and benardyl.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these fluarix were given after the temperature excursion which led to incorrect product storage error. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128774:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128750:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128747:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128740:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128736:same reporter/different patient
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix early second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number D5ap5, expiry date 10-AUG-2026) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 06-SEP-2024, the patient received the 2nd dose of Shingrix. On 16-SEP-2024, 10 days after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix early second dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that an early second dose of Shingrix was given to an immunocompetent patient. The patient received 2nd dose of Shingrix vaccine earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: UNK
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Whilst administering the dose leaked on patient's arm; Vaccine leaked on the arm of the patient and had to re-administer product; damage syringe underneath needle connection; This spontaneous case, initially received on 06-Nov-2024, with additional information on 07-Nov-2024, was reported by a non health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug(s): On an unknown date, the patient received Fluad (TIV) for not reported indication, route of administration and anatomical location was not reported. Lot number: No batch number available and will be requested upon follow-up.   No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Whilst administering the dose leaked on patient's arm (outcome: Not Reported), Vaccine leaked on the arm of the patient and had to re-administer product (outcome: Not Reported), damage syringe underneath needle connection (outcome: Not Reported).  The defect was noted during use. Plunger was not depressed. Needle was inside patient's arm, and the needle appeared tightly attached. Product was storage on original packing in 41 degrees F. Vaccine leaked on the arm of the patient and had to re-administer product. Syringe was damaged underneath needle connection. Vaccine was stored in 41 degree f temperature conditions.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide a serious or causality opinion.; Reporter's Comments: All events were considered not related.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: third dose has not been administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 20-MAR-2024) and Twinrix (received 2nd dose on 17-APR-2024).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: third dose has not been administered). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-OCT-2024 The reporter was ask if the third dose could be administered on the day of reporting. The nurse was not sure if the third dose should be 6 months from the first dose or 6 months from the second dose. The reporter planned to administer third dose on the day of reporting. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these fluarix were given after the temperature excursion which led to incorrect product storage error. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128767:same reporter/different patient
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 84-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy.    On 20-Oct-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 20-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.            Patient did not any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not have no known drug allergy. No concomitant medication was reported.  No treatment information was reported.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Influenza virus test negative, Injection site erythema, Injection site swelling, Injection site warmth, Nasopharyngitis
Clinical narrative: Left thigh with swelling, erythema and warmth on anterior aspect extending from upper thigh to above knees. Spares posterior thigh. 2 cm induration over injection site. No tenderness to palpation. No pain with ambulation. Benadryl given on 11/13/24. Cold compress applied. Redness and swelling improved on 11/14/24. Fever of 100 on 11/13/24 and 101.5 on 11/14/24.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Left thigh with swelling, erythema and warmth on anterior aspect extending from upper thigh to above knees. Spares posterior thigh. 2 cm induration over injection site. No tenderness to palpation. No pain with ambulation. Benadryl given on 11/13/24. Cold compress applied. Redness and swelling improved on 11/14/24. Fever of 100 on 11/13/24 and 101.5 on 11/14/24.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Gingival pruritus, Gingival swelling, Oral pruritus, Pharyngeal swelling
Clinical narrative: Shot was administered in left arm. Scratchy feeling on tongue, cheeks and gums started about 10 minutes after the shot. Inner cheeks, tongue, gums and throat started to swell and tightened. EMS was called and patient was given two tablets of benadryl. In the ambulance the patient was given epinephrine and solumedrol. Patient continued to be monitored in the ER. An hour after of onset symptoms resolved.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Throat tightness, Tongue pruritus
Clinical narrative: Shot was administered in left arm. Scratchy feeling on tongue, cheeks and gums started about 10 minutes after the shot. Inner cheeks, tongue, gums and throat started to swell and tightened. EMS was called and patient was given two tablets of benadryl. In the ambulance the patient was given epinephrine and solumedrol. Patient continued to be monitored in the ER. An hour after of onset symptoms resolved.
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Communication disorder, Confusional state, Magnetic resonance imaging head abnormal
Clinical narrative: 10042244---STROKE Received the updated 2023-2024 COVID vaccine on 7/29/24. On 8/1/24, patient developed confusion, difficulty following commands and deteriorating communication. Underwent MRI which showed a left frontotemporal subacute CVA. Per the CDC, serious adverse events regardless of whether the reporter thinks the vaccine caused the adverse event should be reported to VAERS.
Sex: U
Vaccine: RAB
Symptoms: Physical product label issue
Clinical narrative: RabAvert (rabies vaccine) vials do not have a scannable barcode on the vials for medication administration in the system. The barcode configuration on the vials makes them almost impossible to scan. the information in the barcodes on the vials does not contain the lot or exp information. The barcode on the exterior of the box does contain the NDC, lot, menu and exp, however the lot, menu and exp are not formatted correctly, so our system is unable to fill in the information automatically like it does on other vaccines. It is only able to detect the NCD. Examples: NDC: 50632-010-01 Manu: BAVARIANN NORDIC RABAVERT (PF) Box Vial: 0100350632010015218413151145 SN: 8413151145 Exp: 11-2027 Lot: FDP00552 Scan: data matrix on vial is not able to be detected by scanned 0100350632010015213785831696 SN: 3758531696 Exp: 12-2027 Lot: FDP00553 Scan: 350632010015 0100350632010015214009531088 SN: 4009531088 Exp: 11-2027 Lot: FDP00571 Scan: 1727113010FDP00571 This puts our nurses at risk for medication errors and transcription errors that flow to system and error out resulting in incomplete vaccine records with the state.
Age: 30.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site rash, Rash
Clinical narrative: Pt received first dose of Jynneos on 10/8/24. Pt reports a painful rash that was localized to the injection site 2 to 3 days after. The rash rapidly progressed to involve the deltoid area, pectoral area and scapular area. Pt went to an urgent care and was diagnosed as singles and pt took valacyclovir. The patient presented to clinic on 10/29 and the rash had progressed but was not crrusting and appeared to be healing.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Was getting Flucelvax vaccination ready for the patient for administration. when pushing the air out of the syringe the liquid started spilling out of the side of the syringe where the need is inserted. checked to make sure needle was not loose. No visible damage to need or prefilled syringe.
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Gave Flulaval injection. Serum leaked out, unsure how much vaccine was given, provider decided not to revaccinate at this time. Device failed; Device malfunction - that is, the device did not do what is was supposed to do;
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Device connection issue
Clinical narrative: LPN (license practical nurse) prepared flu vaccine for administration and ensured syringe was securely attached to needle. Upon adminsitration of vaccine, it ran out around the need hub. LPN looked at the syringe/needle again and noted the syringe hub was crooked with the needle placed. Patient needed 2nd stick for vaccination.What was the original intended procedure?: flu vaccination What problem did the user have:Device failed (e.g broke, couldn't get it to work or stopped working) ; Device malfunction - that is, the device did not di what it was supposed to do;
Sex: U
Vaccine: PNC20
Symptoms: Product preparation issue, Product storage error
Clinical narrative: LPN in an outlying community clinic received an order for Pneumococcal 20-valent conjugate vaccine. LPN retrieved vaccine from the refrigerator and identified white-colored clumping within the vaccine. LPN reports she both swirled and vigorously shook the vaccine, in accordance with the manufacturer recommendations, but the clump within the vaccine would not resuspend. The LPN left the vaccine at room temperature for a short time but the clump within the vaccine would still not resuspend. The LPN discarded the vaccine and administered a different syringe to the patient that did not have the clumping issue. Continuous temperature monitoring for the previous 5 weeks from that medication refrigerator did not identify and temperatures out of range that would have indicated the vaccine froze while in the refrigerator. Lot number was not provided by the reporter and so do not have this information. Patient identifiers were also not provided, however the vaccine in question was discarded and not administered to any patient.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dental discomfort, Pain in jaw
Clinical narrative: On 8/19/2024 I got my second dose of Shingrix 0.5 ml IM injection. First dose was 6/19/2024. a few hours later I tried to drink a cup of hot coffee. I immediately felt a severe pain in my left lower jaw, which felt similar to a herpes simplex exacerbation in my right facial nerve distribution several years earlier. I called my dentist who at my request prescribed a methylprednisolone 4 mg. dose pak, which I completed as directed. I also started taking Acyclovir 800 mg. bid, which I took for 2 days. The pain improved and I started taking Aleve twice a day for the pain. I saw my doctor on 8/28 who referred me to an ENT but said I didn't have to go if pain went away. I stopped taking the Aleve after a few days. I have very mild discomfort in my L lower molar when I brush my teeth. Despite no being able to find reports of this, I believe that it was a reactivation of Zoster virus caused by the Shingrix.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Urticaria, Vomiting
Clinical narrative: Pt developed hives and experienced severe nausea and vomiting
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hepatic failure, Laboratory test, Loss of consciousness, Scan
Clinical narrative: Have a severe confirmed peg allergy. Reaction is severe quick and lips swell throat closes anaphylaxis occurs and carry epi pen and had to use it a lot. Covid shot anaphylaxis reaction in less then a minute had ultrasound. Don't understand and they refuse to look while they want to pump me full of medications and my throat closes. Thank g-d for epi pen they came up and out of nowhere liver failure. Don't drink don't have hepatitis there are clinical trials of patients having exact out of blue liver failure all with peg allergy and a reversal with steroids. All like myself have confirmed peg allergy and they pump me full of medications a mile long that when administered have anaphylactic shock reaction. They won't listen and last week had reaction to over the counter adult Benadryl with peg o. Emergency room throat closing they said no and 4 hour wait. I called primary dr picked up epi pen and saved myself. Now yesterday and 4 th time I was at bank and collapsed I unconscious in care and again tell them check dye. It's contra indicated and molecular weigh peg with low content I can in emergency get through with bags of I tell them its a serious allergy and notes in my chart. Clinical trial patients had reversal with medication protocol. All of this started with reaction to iron infusion and Moderna Covid shot that hit floor in seconds. They are all not the same. Moderna Pfizer peg. Others not. Had I have been told they are not the same and peg allergy that is severe quick and fatal and they are asking me how to spell peg and sit it on my tray and it will be potentially fatal it's only the short version but hospital is harming me and think I am mental and it's a made up allergy. Drs say never heard of that and are angry I refuse anything with peg but yesterday so out of it they gave me contrast and hours later throat closed and epi pen. These possible fatal adverse reaction due to lack of knowledge and refusal to listen and read is left for me and my epi pen to save my life. Have had so many tests scans lab work but confirmed by dr and the at least 5-10 reactions would need to get my records to see dates and results.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Throat tightness, Ultrasound scan
Clinical narrative: Have a severe confirmed peg allergy. Reaction is severe quick and lips swell throat closes anaphylaxis occurs and carry epi pen and had to use it a lot. Covid shot anaphylaxis reaction in less then a minute had ultrasound. Don't understand and they refuse to look while they want to pump me full of medications and my throat closes. Thank g-d for epi pen they came up and out of nowhere liver failure. Don't drink don't have hepatitis there are clinical trials of patients having exact out of blue liver failure all with peg allergy and a reversal with steroids. All like myself have confirmed peg allergy and they pump me full of medications a mile long that when administered have anaphylactic shock reaction. They won't listen and last week had reaction to over the counter adult Benadryl with peg o. Emergency room throat closing they said no and 4 hour wait. I called primary dr picked up epi pen and saved myself. Now yesterday and 4 th time I was at bank and collapsed I unconscious in care and again tell them check dye. It's contra indicated and molecular weigh peg with low content I can in emergency get through with bags of I tell them its a serious allergy and notes in my chart. Clinical trial patients had reversal with medication protocol. All of this started with reaction to iron infusion and Moderna Covid shot that hit floor in seconds. They are all not the same. Moderna Pfizer peg. Others not. Had I have been told they are not the same and peg allergy that is severe quick and fatal and they are asking me how to spell peg and sit it on my tray and it will be potentially fatal it's only the short version but hospital is harming me and think I am mental and it's a made up allergy. Drs say never heard of that and are angry I refuse anything with peg but yesterday so out of it they gave me contrast and hours later throat closed and epi pen. These possible fatal adverse reaction due to lack of knowledge and refusal to listen and read is left for me and my epi pen to save my life. Have had so many tests scans lab work but confirmed by dr and the at least 5-10 reactions would need to get my records to see dates and results.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Condition aggravated, Headache, Pain, Pyrexia
Clinical narrative: Patient woke up with chills in the middle of the night with a severe body ache and a headache, when I approached her she had a high fever that was hot to the touch. Symptoms went on for the duration of the next day
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Skin warm
Clinical narrative: Patient woke up with chills in the middle of the night with a severe body ache and a headache, when I approached her she had a high fever that was hot to the touch. Symptoms went on for the duration of the next day
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives scattered on epidermis
Age: 0.58
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Extra Vaccine Given
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia
Clinical narrative: Tachycardia of over 120 bpm for hours after injection that I could not lower.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Paraesthesia, Sensitive skin
Clinical narrative: Patient called clinic 11/13/2024 at 4:20 p.m. and spoke with this nurse. Patient reports that she came to clinic 11/13/2024 and received flu vaccine in left arm at approximately 2:20 p.m.  Patient states that 1-2 hours after receiving vaccine that she began "having nerve pain, tingling, and skin sensitivity from left eye to left knee." Denies any other symptoms other than nerve pain, tingling, and skin sensitivity along left side of body. Patient does not have PCP. Patient was referred to local health department.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Biopsy small intestine normal, Enema administration, Gastrointestinal necrosis, Haematochezia, Infant irritability
Clinical narrative: Patient presented to ED with fussy poor feeding, had a bloody stool in ED.  Confirmed intussusseption by ultrasound and unable to reduce by pediatric surgery team with barium enema. Required laprascopy and 10cm of small bowel removed due to necrosis.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Intussusception, Laparoscopic surgery, Poor feeding infant, Small intestinal resection, Ultrasound abdomen abnormal
Clinical narrative: Patient presented to ED with fussy poor feeding, had a bloody stool in ED.  Confirmed intussusseption by ultrasound and unable to reduce by pediatric surgery team with barium enema. Required laprascopy and 10cm of small bowel removed due to necrosis.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Client came in for catch up immunizations. He had eight vaccines due without the option of multi-immunization vaccines available. Parents and RN planned to give three that day, pcv20, Dtap, and Hib. RN drew up the wrong vaccine, giving the client an additional dose of IPV when the series was already complete. It was noticed immediately. This was discussed with the parents who decided to go ahead and get the PCV20 anyhow. There were no adverse reactions because of the additional IPV vaccine.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Dysstasia, Fall, Gait disturbance, Laboratory test normal, Loss of personal independence in daily activities
Clinical narrative: Three days after receiving this flu shot my husband suddenly could barely walk or stand up.  He fell and was unable to get up. He needed help dressing and getting up stairs.  He needed a walker. Prior to these symptoms he walked over a mile independently four times a week and went to the gym and drove.  I took him to the ER and all test came out negative even two brain scans.  I believe he is experiencing a weakened version of Guillain Barre Syndrome even though he does not have the classic symptoms other than sudden onset of severe weakness in legs.  He is gradually recovering and is about 80%  back to normal.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Walking aid user
Clinical narrative: Three days after receiving this flu shot my husband suddenly could barely walk or stand up.  He fell and was unable to get up. He needed help dressing and getting up stairs.  He needed a walker. Prior to these symptoms he walked over a mile independently four times a week and went to the gym and drove.  I took him to the ER and all test came out negative even two brain scans.  I believe he is experiencing a weakened version of Guillain Barre Syndrome even though he does not have the classic symptoms other than sudden onset of severe weakness in legs.  He is gradually recovering and is about 80%  back to normal.
Age: 61.0
Sex: M
Vaccine: COVID19, FLU3, PNC20, RSV
Symptoms: Tinnitus
Clinical narrative: Constant ringing in ears.  Tinnitus.  This began the morning after the vaccinations and has been non-stop since.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Head discomfort, Headache
Clinical narrative: WORST headache of my life.I am not exaggerating when I say i thought I was going to die. the pain was that severe for several hours straight. Nothing helped.  Literally felt like my head would explode. It felt like every single blood vessel in my head was pushing toward my skull. Pounding headache with on and off again chills.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness, swelling and itching started about 3 days after the vaccine, continued to spread and covers a portion of the left arm.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Lip swelling
Clinical narrative: SWELLING OF UPPER LIP
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Immediately after receiving the Pfizer COVID-19 vaccine I could taste a metallic taste on the roof of my mouth and could feel it up my nasal passage. I could describe it as tasting like a nickel. The symptom is still currently presenting.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient received 5-11 yr old covid vaccine instead of 12+. There were no reported side effects but the dose is lower than was indicated by their age.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a duplicate flu vaccine. She received one dose in September and another in November. Our database showed she was still due for a flu vaccine and the patient did not question it. She has been counseled and is not having any adverse events.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Patient received the Pentacel vaccine on 11/13/24 and the vaccine expired on 11/10/24.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: New onset A Fib requiring hospitalization, new medications
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Immediate post-injection reaction
Clinical narrative: burning sensation immediately following vaccine, stopped but then came back a few minutes post vaccination and then again around midnight evening of vaccine
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Magnetic resonance imaging abnormal, Pain, Tendon injury
Clinical narrative: On 10/9/2023, employee reported ongoing pain in her left arm with movement.  Employee was referred to the Occ Med clinic for medical evaluation.  Employee was advised by the medical provider on conservative treatment at home, such as ice/heat and NSAID's.  Employee was seen for a follow-up appointment on 10/19/2024 and was discharged from care.  On 10/30/2024, employee contacted this RN to report she continued to have ongoing pain in her left shoulder x 1 year since the date of vaccination.  Employee stated she had an MRI completed per her PCP on 10/24/2024 that showed a tear in the supraspinatus tendon related to flu vaccine administration 1 year prior.  Employee was referred to Orthopedics on 11/5/2024 and was advised that surgery is recommended.  Date of surgery is pending at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was administered post vaccine freezer excursion and was deemed unviable by Health Dept and the Moderna manufacturer.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Employee contact Occupational Health on 10/7/2024 to report ongoing pain in her right shoulder after receiving a seasonal influenza vaccine on 9/24/2024.  Employee was referred to the Occ Med clinic for medical evaluation.  Employee was treated with a course of steroids and instructed on home treatment measures, such as ice/heat and NSAID's.  Employee is scheduled for a follow-up appointment on 11/15/2024, status pending at the time of this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test negative
Clinical narrative: Loss of taste and smell three to four weeks after Covid shot. Smell and taste have NOT YET RETURNED.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, FLU3
Symptoms: Dermatitis atopic, Urticaria
Clinical narrative: Delayed-onset urticaria on both elbows. New onset of atopic dermatitis on back of head/top of neck.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: Delayed-onset urticaria on both elbows. New onset of atopic dermatitis on back of head/top of neck.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Skin warm
Clinical narrative: Patient came to pharmacy on 11/14 to report that approx 8 hours after receiving the vaccine she suffered from severe knee pain, swelling and heat. This lasted about 36 hours. The reaction was on her knee that she had replaced about 7 months ago.
Age: 33.0
Sex: M
Vaccine: HPV9
Symptoms: Burning sensation, Neuropathy peripheral, Paraesthesia
Clinical narrative: Patient is experiencing neuropathy/tingling sensations in hands and feet.  It travels up into his calves. States that it feels like 'fire'.  Started the day after the vaccine. No issues with the first vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The vaccine clinic organizer reached out to us via email stating patient's arm (her deltoid and bicep area where she got the flu injection) is still sore and it limits her movement and range of motion and she's never experience this before from any of her influenza vaccine in the past.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: When I was being injected with the flu shot, I felt intense pressure that I have never experienced with any shot before, my husband was with me, had the flu shot as well by same nurse and did not have this experience, a few hours later my arm and shoulder were so painful, I couldn t pick it up, so different from shots in the past, it was much worse when I layed down to sleep and couldn t really sleep, this went well beyond the normal 24-48 hours. I kept thinking every day that it would be better but it wasn t . After 2 weeks of being sleep deprived and in pain, my PCP added me on as she agreed this wasn t normal.. She didn t know what was wrong, put me on a muscle relaxer at bedtime and Tylenol 2x daily for 5 days and requested that I go to the walk in Orthopedic clinic that Saturday, which I did. ( the muscle relaxer and Tylenol did not help the pain) I saw the Ortho PA, he did an x-ray to rule out infection, after a full exam he said I had Rotor Curr Tendinitis due to flu shot placement, SIRVA. He started me on Prenisolone pack for 6 days to calm down the inflammation and pain, started exercise at home to stretch, he said if I m very stiff and if I didn t start move it the arm I would have frozen shoulder. As of today 6 days from this, the meds are done an the pain is starting to return. I m to see him in 6 weeks for injections if the issue hasn t resolved. He said he sees 1-3 patients per year with this. I am so disheartened by all of this, my arm was fine prior to this and I m reading online that this can last for a long time and possibly cause damage in the future.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome, Shoulder injury related to vaccine administration, X-ray normal
Clinical narrative: When I was being injected with the flu shot, I felt intense pressure that I have never experienced with any shot before, my husband was with me, had the flu shot as well by same nurse and did not have this experience, a few hours later my arm and shoulder were so painful, I couldn t pick it up, so different from shots in the past, it was much worse when I layed down to sleep and couldn t really sleep, this went well beyond the normal 24-48 hours. I kept thinking every day that it would be better but it wasn t . After 2 weeks of being sleep deprived and in pain, my PCP added me on as she agreed this wasn t normal.. She didn t know what was wrong, put me on a muscle relaxer at bedtime and Tylenol 2x daily for 5 days and requested that I go to the walk in Orthopedic clinic that Saturday, which I did. ( the muscle relaxer and Tylenol did not help the pain) I saw the Ortho PA, he did an x-ray to rule out infection, after a full exam he said I had Rotor Curr Tendinitis due to flu shot placement, SIRVA. He started me on Prenisolone pack for 6 days to calm down the inflammation and pain, started exercise at home to stretch, he said if I m very stiff and if I didn t start move it the arm I would have frozen shoulder. As of today 6 days from this, the meds are done an the pain is starting to return. I m to see him in 6 weeks for injections if the issue hasn t resolved. He said he sees 1-3 patients per year with this. I am so disheartened by all of this, my arm was fine prior to this and I m reading online that this can last for a long time and possibly cause damage in the future.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, FLU3, TDAP
Symptoms: Underdose
Clinical narrative: Administered Moderna vaccine for 6-11yo to an adult instead of Spikevax. Per CDC, able to give additional Moderna dose on same clinical day. Identified issue and second "lower" dose COVID vaccine adminsitered.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC20, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Mother presented to health department today Nov 14 20224 stating that her son received vaccines on April 23 2024 and 5 days later he had a febrile seizure.  Mother took child to ER and followed up with a nurse practitioner at clinic.  Mother was told by nurse practitioner at clinic that even though the febrile seizure happened 5 days later it had to have been caused by the vaccines he received.  Mother was told by NP at pediatric clinic to come back to the health today to get a Medical Exemption and for health department to do a VAERS report.  Child has had no other medical problems since febrile seizure in April. Explained to mother that the Pediatric office would have to give her a Medical Exemption for her sons vaccines.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test normal, Brain fog, Chest discomfort, Cough
Clinical narrative: Fatigue, debilitating, cannot work Brain fog Chest sensations/cardiac changes, shown ion ekg Colon activation, explosive stools Dermatitis eye, repeated, multiple styles too Inability to regulate body temperature cough with talking/fatigueHistamine sensation/allergic Post exercise exhaustion
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eczema eyelids, Electrocardiogram abnormal, Exercise tolerance decreased, Fatigue
Clinical narrative: Fatigue, debilitating, cannot work Brain fog Chest sensations/cardiac changes, shown ion ekg Colon activation, explosive stools Dermatitis eye, repeated, multiple styles too Inability to regulate body temperature cough with talking/fatigueHistamine sensation/allergic Post exercise exhaustion
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Histamine intolerance, Impaired work ability, Laboratory test normal, Stool analysis normal, Temperature regulation disorder
Clinical narrative: Fatigue, debilitating, cannot work Brain fog Chest sensations/cardiac changes, shown ion ekg Colon activation, explosive stools Dermatitis eye, repeated, multiple styles too Inability to regulate body temperature cough with talking/fatigueHistamine sensation/allergic Post exercise exhaustion
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Patient reporting severe headache times 2 days post injection followed by approximately 8-10 more days of dull headache with some relief provided by acetaminophen. This seemed to affect activity tolerance throughout the day and duration of the symptoms
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray limb normal
Clinical narrative: Patient was given immunizations at his well child check. Immunizations were given by a highly trained registered nurse, RN. The immunizations were given using aseptic techniques after identifying landmarks using the deltoid location. There was nothing atypical regarding the care and all CDC vaccine practices utilized. Patient began to complain of pain in the left arm (Meningitis B) site on the same day and pain has persisted for greater than a week and now has decreased range of motion. He was seen in the office and I started anti-inflammatory medication and physical therapy ordered and referred to orthopedics. He was showing some improvement with anti-inflammatory medication but given history I am concerned for SIRVA.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Start feeling ill, thenlose consciousness for an indeterinate period of time
Age: 12.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Erythema, Mobility decreased, Peripheral swelling, Rotator cuff syndrome
Clinical narrative: Patient presented with worsening and distally expanding right arm swelling and erythema after receiving Covid/flu vaccine. Absence of diffuse pain or recent trauma. Neurovascularly intact. Patient experienced point tenderness to anterior shoulder, decreased abduction due to proximal shoulder pain, with positive impingement testing. Focal shoulder findings most likely due to mass effect from swelling. Patient improvement with diphenhydramine administration.
Age: 12.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Tenderness
Clinical narrative: Patient presented with worsening and distally expanding right arm swelling and erythema after receiving Covid/flu vaccine. Absence of diffuse pain or recent trauma. Neurovascularly intact. Patient experienced point tenderness to anterior shoulder, decreased abduction due to proximal shoulder pain, with positive impingement testing. Focal shoulder findings most likely due to mass effect from swelling. Patient improvement with diphenhydramine administration.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling of right thigh approximately 12 x 8 cm in diameter
Age: 68.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Vertigo
Clinical narrative: Vertigo, being treated with physical therapist. Earliest appointment available with ENT scheduled in December.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Patient was given RSV vaccine (Abrysvo) outside of recommended window for pregnant women (32-36 weeks). Patient was scheduled to be given TDap but RSV vaccine was given instead. Patient is 30+1 weeks pregnant, estimated date of delivery is 1/20/2025. No adverse effects were observed and patient and provider were notified of error.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Feeding disorder, Gastrooesophageal reflux disease
Clinical narrative: 12hrs of vomiting, pain all over, fatigue, not being able to eat or drink = lasted 2 days; the next week I still had little appetite with bad acid reflux and slowly regaining strength.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: 12hrs of vomiting, pain all over, fatigue, not being able to eat or drink = lasted 2 days; the next week I still had little appetite with bad acid reflux and slowly regaining strength.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: PT STATES SHE HAD A FEVER OF 100, AREA WAS RED, RAISED AND 4 INCHES IN DIAMETER.  TODAY THE AREA WAS RED, WARM TO THE TOUCH, RAISED AND 3 INCHES IN DIAMETER.  PT STATES SHE TOOK TYLENOL THIS MORNING AND SHE DID NOT HAVE A FEVER IN CLINIC.
Age: 1.25
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient immunized with full 1ml 1440u dose instead of correct 0.5ml 720U dose. This was not caught until processing inventory 2 weeks later. Documented in patient chart, reached out to guardian and left multiple voice mails.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: pt states she initially had some itching but then a red welp developed at the injection site that is warm to the touch. It is 2 inches wide and 3 inches long.  She had chills. She contacted her doctors office and was told to apply cortisone cream to it and to come in if she continued to have any other symptoms. Today the redness is some better but it continues to be itchy and irritated so she is still using the cortisone cream.