chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: RSV plus Covid-19; RSV plus Covid-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 03Dec2023, outcome "unknown" and all described as "RSV plus Covid-19". The patient underwent the following laboratory tests and procedures: Body temperature: High, notes: she experienced a high temperature; SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient took Paxlovid for two days and was diagnosed with RSV plus Covid-19 last Sunday. The patient experienced a high temperature and had to be admitted.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: was administered with PENTACEL for the supposed to be 5th dose of the DTaP vaccination series instead of QUADRACEL with no reported adverse event; Initial information received on 08-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] for the supposed to be 5th dose of the dtap vaccination series instead of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (proquad) for Prophylactic vaccination.  On 08-Dec-2023, the patient received  0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ957AB) (Expiry date: 01-Jun-2024) (Strength: standard) (Frequency: once) via intramuscular route in the right thigh for immunization.  On 08-Dec-2023, the patient was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] for the supposed to be 5th dose of the dtap vaccination series instead of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] with no reported adverse event (wrong product administered) (latency: same day).  It was reported, Caller calls in to inform that they have a 4-year-old patient that was administered with PENTACEL for the supposed to be 5th dose of the DTaP vaccination series instead of quadracel. They are calling to ask whether the DTaP-IPV component is valid or the patient needs to be revaccinated. See transfer screen for more details. This situation is pre-assessed as a medication error/an inappropriate use due to administration of pentacel instead of quadracel for dtap-ipv   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: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Haematochezia
Clinical narrative: Blood in his stool / a lot of blood in his stool; This spontaneous case was received on 08-Dec-2023 from a pharmacist (reference number: SEQW23-04751) and concerned a 65-year-old, male patient.  The patient's concurrent conditions included hypertension and constipation. The patient's past medical history included pain. The patient's concomitant medications included Lasix (furosemide), olmesartan, Hydrocodone/Acetaminophen (hydrocodone bitartrate; paracetamol), and Stool softener (docusate sodium), all used for unreported indication.  On 07-Dec-2023, at 08:38, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 371627, and expiry date was 30-Jun-2024.  On 08-Dec-2023, one day after receiving Fluad Quadrivalent, the patient experienced blood in stool. The patient had a lot of blood in stool.  At the time of initial reporting, on 08-Dec-2023, the patient had not recovered from the event of 'blood in stool'. As reported, ongoing.  The reporter did not provide causality assessment.   The event of 'blood in stool' was considered to be medically significant by a Physician within Seqirus's Regulatory Authority.  Company comment: A 65-year-old male patient with a medical history of constipation experienced haematochezia one day after the vaccination with Fluad Quadrivalent. Causality is confounded by concomitantly used therapy (furosemide; hydrocodone/acetaminophen). Relevant laboratory and diagnostic results were not provided. Due to lack of above-mentioned information, casuality for haematochezia is unassessable.; Sender's Comments: A 65-year-old male patient with a medical history of constipation experienced haematochezia one day after the vaccination with Fluad Quadrivalent. Causality is confounded by concomitantly used therapy (furosemide; hydrocodone/acetaminophen). Relevant laboratory and diagnostic results were not provided. Due to lack of above-mentioned information, casuality for haematochezia is unassessable.
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: patient has no signs or symptoms; HCP report that the patient was supposed to receive VARIVAX today 12/11/2023, but received SHINGRIX instead; HCP report that the patient was supposed to receive VARIVAX today 12/11/2023, but received SHINGRIX instead; HCP report that the patient was supposed to receive VARIVAX today 12/11/2023, but received SHINGRIX instead; This spontaneous report was received from a nurse referring to a 40 year old female patient. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  The reporter stated that on 11-DEC-2023, at 07:40 hours the patient was vaccinated inadvertently and mistakenly with varicella zoster vaccine rge (cho)(SHINGRIX) Lot Number: 274YD, expiration date:15-SEP-2025 (strength, dose, route, frequency, indication and anatomical location were not provided); The patient was supposed to receive varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, dose number, route, frequency, lot number and expiration date were not reported) for prophylaxis, but received varicella zoster vaccine rge (cho)(SHINGRIX) instead, as a new nurse in the practice confused the 2 products (interchange of vaccine products, product confusion and wrong product administered).  The primary reporter stated that the new nurse believed she was giving a varicella containing product when she gave the varicella zoster vaccine rge (cho)(SHINGRIX) vaccine, and that the new nurse mixed up the varicella zoster vaccine rge (cho)(SHINGRIX) and the varicella virus vaccine live (oka/merck)(VARIVAX) vaccines.   It was mentioned that the patient was due for varicella virus vaccine live (oka/merck)(VARIVAX) related to a prior lab test (unspecified), that was completed on an unspecified date, showing that the patient was non-immune to varicella. It was unspecified if that patient had had a pervious dose of varicella virus vaccine live (oka/merck)(VARIVAX).  No adverse events, signs or symptoms reported.
Age: 0.67
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: age wrong; extra dose: 06-NOV-2000; age wrong; age wrong; age wrong; This case was split from a legal case (2311USA004702) regarding an 8-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were in case 2311USA004702.  On 02-MAY-2000 (product administered to patient of inappropriate age), 29-AUG-2000 (product administered to patient of inappropriate age, Inappropriate schedule of vaccine administered) and 06-NOV-2000 (product administered to patient of inappropriate age, extra dose administered), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2311USA004702:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: the patient had chills; the patient had fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (the patient had chills) and PYREXIA (the patient had fever) in a 57-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (the patient had chills) and PYREXIA (the patient had fever). At the time of the report, CHILLS (the patient had chills) and PYREXIA (the patient had fever) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that, starting with the second dose the patient got the chills and the fever the same night that he had the vaccine. That was true with the second shot and after each booster dose.  No treatment information was reported.   This case was linked to MOD-2023-753714, MOD-2023-753718 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blood test, Myalgia
Clinical narrative: polymyalgia; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (polymyalgia) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Previously administered products included for Product used for unknown indication: COVID-19 vaccine (dose 1 (lot number 014M20A)) on 26-Feb-2021, COVID-19 vaccine (dose 2 (lot number 008B21A)) on 26-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (dose 3 (lot number GJ6739)) on 20-Oct-2022. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 28-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2023, the patient experienced MYALGIA (polymyalgia). The patient was treated with PREDNISONE in 2023 at a dose of 20 for 15 days then went to 10 for 5 days. At the time of the report, MYALGIA (polymyalgia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Blood test: seds were elevated..         The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. 1.5 weeks after the shot the patient had a blood test. The patient was put on a prednisone taper 20 for 15 days then went to 10 for 5 days. The prednisone was whacking afib into the heart from it. 1 week ago the patient was weened off of prednisone. Currently the patient was unable to get up, get dressed, or get out of bed at night.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: injection site arm was sore; feeling tired, fatigued; headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site arm was sore), CHILLS (Chills), PYREXIA (Fever), FATIGUE (feeling tired, fatigued) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Dec-2023, the patient experienced VACCINATION SITE PAIN (injection site arm was sore), FATIGUE (feeling tired, fatigued) and HEADACHE (headache). In December 2023, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 14-Dec-2023, FATIGUE (feeling tired, fatigued) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (injection site arm was sore) had not resolved and CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The concomitant medication was not reported by reporter.   Dosage text for suspect product was reported as unknown.  The patient received his first Moderna Covid-19 vaccine in 2021 probably March or April, second Moderna Covid-19 vaccine at an unknown date in 2021. The patient had Moderna booster every 6 months with the last shot being in Dec 2022 until 11 Dec 2023, when the patient received Spikevax 2023 2024. He had reactions of feeling tired, fatigued, the next morning he had a slight headache and that that evening he felt tired and fatigued. His injection site arm was sore. By 14 Dec 2023 he had no side effects except for if he touches his injection site arm it was slightly sore.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-753718, US-MODERNATX, INC.-MOD-2023-753719.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Scab, Wound
Clinical narrative: 6 days after, pt came in with a scab/wound on right shoulder
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: left arm pain in shoulder and elbow with less movement with weekness
Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Magnetic resonance imaging, X-ray limb
Clinical narrative: (1) Very sore prolonged at injection site on upper Rt arm, (2) infringment of Rt arm muscle/nerve causing Restriction of movement - 1 & 2 increased so that I have informed my PCP; gone to the ED; saw an Orthopedist, Begn PT, had a MRI of shoulder
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium decreased, Chest X-ray, Dyspnoea, Electrocardiogram, Full blood count
Clinical narrative: I took covid booster on 19th and 2 days later suddenly I started experiencing palpitations and my heart rate was recorded as 168. Added with that I had shortness of breath. So, we immediately rushed to emergency. There they have took the CBC blood tests, chest X ray and ECG. They were not sure if it was due to booster and told that I have low potassium levels. Hence, they gave me potassium pills and asked me to take the medicines for 5 days and I did that. The heart rate didn't completely get normal, like some days especially in the mornings after getting up it would be 130-120 and averagely around 100 all the day for no reason. Today, again in the evening suddenly I experienced shortness of breath so I went to urgent care and there the doctor suggested me to come here and get checked with d-dimer test and lungs ct scan and some thyroid test. She insisted that this heart rate is not normal so asked me to get cleared with this problem as soon as possible. I was given propranalol and anxiety medicine for one year after this. I had no history of anxiety. As the reports used to be normal they have kept me under anxiety medicine. I was on medication from jan 2022 to december 2022. Now again after 8 months from october I am experiencing these symptoms with more intensity. Moderna booster destroyed my life. I took two doses of astra zeneca in another country. I had absolutely no issues. All started after taking the moderna. I need an answer for this. Please help!
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate abnormal, Impaired quality of life, Palpitations
Clinical narrative: I took covid booster on 19th and 2 days later suddenly I started experiencing palpitations and my heart rate was recorded as 168. Added with that I had shortness of breath. So, we immediately rushed to emergency. There they have took the CBC blood tests, chest X ray and ECG. They were not sure if it was due to booster and told that I have low potassium levels. Hence, they gave me potassium pills and asked me to take the medicines for 5 days and I did that. The heart rate didn't completely get normal, like some days especially in the mornings after getting up it would be 130-120 and averagely around 100 all the day for no reason. Today, again in the evening suddenly I experienced shortness of breath so I went to urgent care and there the doctor suggested me to come here and get checked with d-dimer test and lungs ct scan and some thyroid test. She insisted that this heart rate is not normal so asked me to get cleared with this problem as soon as possible. I was given propranalol and anxiety medicine for one year after this. I had no history of anxiety. As the reports used to be normal they have kept me under anxiety medicine. I was on medication from jan 2022 to december 2022. Now again after 8 months from october I am experiencing these symptoms with more intensity. Moderna booster destroyed my life. I took two doses of astra zeneca in another country. I had absolutely no issues. All started after taking the moderna. I need an answer for this. Please help!
Sex: U
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Influenza vaccine administered in the tendons of my rotator cuff rather than in my deltoid. It hurt instantly and I lost full range of motion for about 3 weeks. I would wake in pain when rolling over on it at night. Currently it's been 5 weeks and my shoulder is better but it still hurts when I raise it in certain ways. I knew right away that influenza vaccine wasn't properly administered. My deltoid is very easy to see and the hole was significantly above the muscle in the tendon spot The MA should have located the deltoid and injected into it
Sex: U
Vaccine: FLUX
Symptoms: Product administered at inappropriate site, Sleep disorder
Clinical narrative: Influenza vaccine administered in the tendons of my rotator cuff rather than in my deltoid. It hurt instantly and I lost full range of motion for about 3 weeks. I would wake in pain when rolling over on it at night. Currently it's been 5 weeks and my shoulder is better but it still hurts when I raise it in certain ways. I knew right away that influenza vaccine wasn't properly administered. My deltoid is very easy to see and the hole was significantly above the muscle in the tendon spot The MA should have located the deltoid and injected into it
Sex: U
Vaccine: HPVX
Symptoms: Malaise, Product administration error
Clinical narrative: During annual routine well check, the 1st nurse asked if we would like the flu, covid, or HPV shot for my child. I state no and signed the documented paperwork stating I DID NOT want my child to have those shots. After speaking to the doctor he understood what my concerns were but stated my child did need the TDAP and meningo shot for school. I advise those shots for school were ok. The 2nd nurse then came in to administer his shots and said there are 3 shots. As I was reading the shot record I mentioned he was NOT to have the HPV and her response was "oops... I have already gave it to him, its just habit". The Doctor heard the conversation as walking by and ran in and was very upset with the nurse and said "that shot was not ordered, why was it given?" She then said "its just habit to give kids this age this shot". Now my child is having ill symptoms from this shot that was given to him and there is nothing we can do about it!
Sex: U
Vaccine: COVID19-2
Symptoms: Injection site discharge, Injection site erythema, Injection site inflammation, Injection site pain, Product administered at inappropriate site
Clinical narrative: On July 3, 2023, I went to the Pharmacy for my second bivalent COVID-19 vaccine booster (Moderna Lot #AS7643E). The pharmacy technician who administered the vaccine stood next to me, instead of sitting down, and she injected the vaccine into the top of my left shoulder instead of into my left deltoid. The insertion of the needle was very painful because it went into a bony area of my shoulder rather than in my deltoid muscle. The vaccine itself ran down my arm and the technician had to wipe it up with cotton balls. Within 12 hours or so, a large area of the top of my shoulder became red and inflamed. It was painful but not like the usual muscle soreness after an intramuscular vaccination. The inflammation and pain lasted for almost a week. I knew immediately that the vaccination had been administered into the wrong site. I also knew immediately that I had not gotten the full dose of the vaccine because it ran down my arm. I think the pharmacy technician should have been better trained. Also, the pharmacy seemed to be very busy that day and I think she was in a rush to do the vaccine and get back to filling prescriptions.
Sex: U
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: On July 3, 2023, I went to the Pharmacy for my second bivalent COVID-19 vaccine booster (Moderna Lot #AS7643E). The pharmacy technician who administered the vaccine stood next to me, instead of sitting down, and she injected the vaccine into the top of my left shoulder instead of into my left deltoid. The insertion of the needle was very painful because it went into a bony area of my shoulder rather than in my deltoid muscle. The vaccine itself ran down my arm and the technician had to wipe it up with cotton balls. Within 12 hours or so, a large area of the top of my shoulder became red and inflamed. It was painful but not like the usual muscle soreness after an intramuscular vaccination. The inflammation and pain lasted for almost a week. I knew immediately that the vaccination had been administered into the wrong site. I also knew immediately that I had not gotten the full dose of the vaccine because it ran down my arm. I think the pharmacy technician should have been better trained. Also, the pharmacy seemed to be very busy that day and I think she was in a rush to do the vaccine and get back to filling prescriptions.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cognitive test, Connective tissue disorder, Laboratory test, Magnetic resonance imaging, Magnetic resonance imaging head
Clinical narrative: Last dose 11/2/22, prior dose  4/22/22, which was Moderna due to administration error.   Starting in June 2022, developed leg pain. Initial physical exam diagnosed it as join inflammation and cortisol injection given.  6 months later pain had returned and again was injected. Pain returned 3 months later and in August 2023 again returned to Orthopedic doctor. Work up, including Hip and upper leg MRI, followed by ultrasound.  Findings were a nerve sheath tumor in right leg and  degeneration of muscle and connective tissue between buttocks and thigh creating severe area pain.    Additionally, in 2022, November began noticing being forgetful. This increased over the next months until I too medical leave for work up. Continuing on medical leave with no real reason.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Memory impairment, Muscle atrophy, Nervous system neoplasm, Pain in extremity, Product administration error
Clinical narrative: Last dose 11/2/22, prior dose  4/22/22, which was Moderna due to administration error.   Starting in June 2022, developed leg pain. Initial physical exam diagnosed it as join inflammation and cortisol injection given.  6 months later pain had returned and again was injected. Pain returned 3 months later and in August 2023 again returned to Orthopedic doctor. Work up, including Hip and upper leg MRI, followed by ultrasound.  Findings were a nerve sheath tumor in right leg and  degeneration of muscle and connective tissue between buttocks and thigh creating severe area pain.    Additionally, in 2022, November began noticing being forgetful. This increased over the next months until I too medical leave for work up. Continuing on medical leave with no real reason.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: Last dose 11/2/22, prior dose  4/22/22, which was Moderna due to administration error.   Starting in June 2022, developed leg pain. Initial physical exam diagnosed it as join inflammation and cortisol injection given.  6 months later pain had returned and again was injected. Pain returned 3 months later and in August 2023 again returned to Orthopedic doctor. Work up, including Hip and upper leg MRI, followed by ultrasound.  Findings were a nerve sheath tumor in right leg and  degeneration of muscle and connective tissue between buttocks and thigh creating severe area pain.    Additionally, in 2022, November began noticing being forgetful. This increased over the next months until I too medical leave for work up. Continuing on medical leave with no real reason.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Fatigue, Headache, Mobility decreased, Pain
Clinical narrative: L shoulder hurt by 7 p.m. I took tylenol (2 tabs) at 9:30. Bed at 10:30. Could not sleep on L shoulder. Pruritis got me up for lotions and an Rx 1 pill. Woke up and every pore on my body and head hurts; tired, difficulty moving at times; slight swelling both cheeks; headache.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Pruritus, Sleep disorder, Swelling face
Clinical narrative: L shoulder hurt by 7 p.m. I took tylenol (2 tabs) at 9:30. Bed at 10:30. Could not sleep on L shoulder. Pruritis got me up for lotions and an Rx 1 pill. Woke up and every pore on my body and head hurts; tired, difficulty moving at times; slight swelling both cheeks; headache.
Age: 60.0
Sex: F
Vaccine: FLUC4, RSV, TDAP
Symptoms: Asthenopia, Chills, Headache, Nasal pruritus, Swelling of eyelid
Clinical narrative: I felt fine, I went and got the 3, and about 7:30 that evening, I started with the chills, I had a low grade temp of 99. Then my eyes felt heavy, I had like heavy eyes,  and then I woke up in the morning, my eyes were like all swollen, no pink eye, almost like swollen shut. It wasnt itchy, just around the bridge of my nose, and I had a massive headache. I took tylenol , but the fever would not go away. It was a low grade fever, so I wasnt really worried about that. So then I took, benadryl, tagamat, allegra. I started a medrol pack, a steroid. Then I put Ice on my eyes to bring the swelling down. Saturday I called the ER, they called me back Saturday night . It's a little better now, it's getting there slowly but surely. My vision was never effected.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Third dose of MMR vaccine given in error
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, Condition aggravated, Cough
Clinical narrative: Pt presented to PCP on 11/3/22 reporting cough that had started since 10/24/22. Pt also reported that she had an asthma attach after her booster on 10/23/22 and was using expired albuterol. Pt diagnosed w/ mild intermittent asthma with acute exacerbation. pt prescribed levalbuterol PRN and prednisone 40 mg daily x 5 days. PCP deemed trigger of asthma attach unclear.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROEN INSTEAD OF REFRIGERATED
Age: 23.0
Sex: F
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertently administered Covid-19 MOD - Spikevax past BUD date of 12/15/23.    Client does not c/o any adverse s/e from vaccine at this time.   Client has been informed to return to clinic to receive current updated Covid-19 MOD Spikevax  2023 vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROE NSTEAD OF REFRIGERATED
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Immediate post-injection reaction, Malaise, Skin discolouration
Clinical narrative: Immediately following administration, I began to gasp for air and felt like I was dying. My legs turned black and I had to take charcoal before my symptoms improved. My son had similar symptoms. Upon returning home, our dog (that we've had for 10 years) is now being aggressive against us and bit my son.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Erythema, Feeling hot, Flushing
Clinical narrative: On Sunday 12/17/23 evening patient experience nausea, achey chills, and a very sore arm to the touch.  patient took ibuprofen that evening to combat symptoms. On Monday 12/18/23 at approx. 12pm noon patient experienced sharp pain in sternum, nausea, rushing of heat around face and neck. felt tingly/facial flushing. within 2 minutes bright pink all over face and a little onto neck area. patient took cetirizine chewable. .. immediately took shower thereafter
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia, Tenderness
Clinical narrative: On Sunday 12/17/23 evening patient experience nausea, achey chills, and a very sore arm to the touch.  patient took ibuprofen that evening to combat symptoms. On Monday 12/18/23 at approx. 12pm noon patient experienced sharp pain in sternum, nausea, rushing of heat around face and neck. felt tingly/facial flushing. within 2 minutes bright pink all over face and a little onto neck area. patient took cetirizine chewable. .. immediately took shower thereafter
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received the wrong dose of COVID-19 vaccine- He was given the 6 month-4 year COVID-19 vaccine, instead of the 5-11 year COVID-19 vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Pyrexia
Clinical narrative: Fever and chills started at about 11PM and continued for about 6 hours. Also had heaviness in arm.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness, Swelling
Clinical narrative: On 12/19/2023, he was still having muscle aches and pain at the site, could not turn his head, and some swelling was noted on the right side of the body. (Per phone conversation with this nurse)
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered
Clinical narrative: Vaccine was given and second check done but expiration was missed and wrong date for expiration was written on the vaccine board.  Vaccine was expired.
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: I administered Tdap instead of D-tap  Given Sep 2023 and as of today there is no reaction. Provider aware spoke to patient parent knows and discuss no symptom's from child .
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hyperhidrosis, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chill, fever, headache, sweats
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRGERATED
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product selection error
Clinical narrative: I pulled Pfizer Covid vaccine from stock instead of stock. There was no Pfizer, vaccine pulled by mistake. Lot # HH3897,-EXP 3/31/2025.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: PATIENT CAME INTO OFFICE ON 12/14/2023  TO GET 6 MONTH VACCINE. PATIENT WAS CRYING BEFORE VACCINE WAS ADMINSTERED. THE PERSON ADMINSTERING THE VACCINES FOLLOWED OFFICE WHEN GIVING THE PROPER VACCCINES.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 65.0
Sex: F
Vaccine: PNC15
Symptoms: Immediate post-injection reaction, Injection site pain, Myalgia, Pain
Clinical narrative: Message received from patient: Still recovering from pneumo vaccine at facility following mammo on Dec 6. When nurse injected vaccine she asked if I could pull sleeve up further. I told her I didn?t want vaccine close to shoulder bone. She said she goes down finger width from that. When she started pushing the vaccine in I felt a heavy sensation along with slight burn of vaccine. I felt sensation with each push. I grabbed my lower arm because I asked why does it feel like that? She asked if I was alright. I said yes but it felt different from any vaccine I had. She said there?s nerves there and could be that. I?m sure when I grabbed arm I tensed up. I got muscle ache from the vaccine but more intense. It is Dec.19 and I still have muscle pain in the site area and pain when lifting up over my head.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Nausea, Pyrexia
Clinical narrative: Severe stomach pain, nausea, fever, chills
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Wrong product administered
Clinical narrative: patient requested Pfizer   covid vaccine (comirnaty ) and she mistakenly got spikevax(moderna vaccine , Now patient stated that she had vertigo form the vaccine.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given flu vaccine when it was not indicated at this time. Patient parent notified and parent wanted VAERS report submitted. Otherwise, patient tolerated well and no ill symptoms at this time.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU4, HPV9, MENB, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: COVID vaccine pt received was a dose for 5-11yr olds. Pt is 17yrs old. Found the error during vaccine reconciliation 12/19/23. Parent will be notified and pt offered the correct dose of vaccine
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient here for 1 year vaccinations.  REceiving 5 shots this visit.   Clint received two flu shots instead of the Havrix.  Appointment was at 2:00.  Mother called two times to inform, messages left.  She didn't return call.  State Dept. called to report.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction. Pt is 4 years old and received the 12 and older formulation/dose
Age: 44.0
Sex: F
Vaccine: PNC15, TDAP
Symptoms: Feeling hot, Musculoskeletal discomfort, Pain in jaw
Clinical narrative: PCV 15 given in left arm by this nurse.  Patient mmediately stated that she felt a "thunk" while vaccine was injected.  Fluzone was then injected to the lateral side  of PCV a little lower in the left arm.  Again, patient stated that she felt a "thunk' and stated she can feel something "weird " going up her neck, under her left ear and then along her left jaw line to her chin.  She states it feels hot, the discomfort is going up in her ear and her ear feels hot.  No sob of breath or increased swelling to area noted.  NP was notiifed of status  immediately and did come to room to examine patient.  Patient continued to state that she was ok, it just felt hot.   NP advised taking ibuprofen and applying heat to the area.  Patient voiced understanding, got up from table. Was able to bear weight without difficulty and denied dizziness or lightheadedness.  NP asked her to call back by 5 pm to advise how she was doing and if she should start feeling any different to call immediately call.  Patient did voice understanding.    at 4:08 PM following injection:   Called and spoke with patient.  She stated that her left ear no longer felt like it was "burning  hot".  The area under her left ear under the jaw line to her chin is still sore, but no longer burns or causing her discomfort.  She denies any other pain or discomfort
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema, Eye pruritus, Nasal pruritus, Rash
Clinical narrative: Moderna Booster shot. Developed hives and rash 10 days later. Started on the neck and moved to everywhere on the body. Bulls eye rings on palms of the hands developed. Contact dermatitis symptoms and Itchy eyes and nose as well. Antibiotics and steroid from urgent care gave no relief. Hives waxed and waned for month and turned into eczema patches all over body. Started dupixent. Still have breakthrough eczema.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test negative, Urticaria
Clinical narrative: Moderna Booster shot. Developed hives and rash 10 days later. Started on the neck and moved to everywhere on the body. Bulls eye rings on palms of the hands developed. Contact dermatitis symptoms and Itchy eyes and nose as well. Antibiotics and steroid from urgent care gave no relief. Hives waxed and waned for month and turned into eczema patches all over body. Started dupixent. Still have breakthrough eczema.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Swollen left leg from hip to knee, hives/rash on left leg covering an area of approximately 3x5 inches, limping
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Dysgeusia, Feeling hot, Flushing, Headache, Sluggishness
Clinical narrative: She got her vaccine, all of a sudden felt hot/flushed which continued off and on during the day.  Then she noticed a headache, and those were the main things.  She did not take anything for her symptoms as it would come and go.  Feels like she should have waited until she saw her new doctor to get their recommendations.  She has not had a headache, and had some sluggishness.  She does have a strange funny taste in her mother, bitter taste that has been there for about 24 hours.  She felt a little flushed this morning as well.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 15 minutes after vaccine patient developed numbness and tingling in her hands and feet.  Symptoms resolved, but then returned the next day. They have continued, and worsened up until today.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Confusional state, Dyspnoea, Electrocardiogram normal, Muscular weakness, Pain in extremity
Clinical narrative: Pt reported about 2 hours after receiving the vaccine she experienced aching in her legs as well as weakness.  She then started having some shortness of breath and she thought some confusion.  She presented to a local ER about 9 hours after the start of symptoms.  She was observed overnight and discharged the next day with albuterol inhaler, steroids.  No fever, productive cough, N/V/D.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Platelet count decreased
Clinical narrative: Pt reported about 2 hours after receiving the vaccine she experienced aching in her legs as well as weakness.  She then started having some shortness of breath and she thought some confusion.  She presented to a local ER about 9 hours after the start of symptoms.  She was observed overnight and discharged the next day with albuterol inhaler, steroids.  No fever, productive cough, N/V/D.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Immediate pain in her shoulder, difficulty ranging the shoulder afterwords with persistent aching pain since given
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypertension, Loss of personal independence in daily activities, Magnetic resonance imaging normal, Menopausal symptoms
Clinical narrative: Since the vaccine I have debilitating pain in my knees which prevent from exercising and running. Since the vaccine; my menopausal symptoms have gotten worse and I have high blood pressure since the vaccine.  I am experiencing an intense amount of pain in my joints all over my body. I have gone to the Drs and have MRI's but there is nothing that is found to explain my constant pain all over my body including my shoulders; hips and knees. My joints feel like they are popping out of my skin.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient inadvertently received a vaccine that expired on 12/9/23. Manufacture did not have any data on an extension past the posted date on the bottle. Recommendation is to give new dose. Recommended that to patient come back to get another dose of boostrix. He declined coming back today as he got 3 others already.
Age: 60.0
Sex: F
Vaccine: COVID19, RSV, VARZOS
Symptoms: Abdominal pain, Axillary pain, Diarrhoea, Feeling cold, Headache
Clinical narrative: 12/17/23 approx 8pm Woke up from nap, couldn?t get warm Body aches Headache Injection site left arm red swollen 12/18/23 2am Woke up to get ready for work Headache worse Left armpit painful, no swelling  Extreme fatigue  12/19/23 2am Posterior left side neck painful/stiff Loose stool Abdominal cramping when eating  Headache still present
Age: 60.0
Sex: F
Vaccine: COVID19, RSV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: 12/17/23 approx 8pm Woke up from nap, couldn?t get warm Body aches Headache Injection site left arm red swollen 12/18/23 2am Woke up to get ready for work Headache worse Left armpit painful, no swelling  Extreme fatigue  12/19/23 2am Posterior left side neck painful/stiff Loose stool Abdominal cramping when eating  Headache still present
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN NSTEAD OF REFRIGERATED
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: EDD:03/05/2024
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received HD fluzone on 10/25/2023. On 12/19, patient presented to report that he had already received a dose of flu vaccine previously. On review, patient received flu vaccine on 10/17 at another facility.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling and pain at injection site. This was most painful between day 1 and day 3 after injection. It all went away after four days.  In addition, in the middle of the night (within 12 hours of the injection) there was an experience of strong chills and shivering which lasted about 30 minutes.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: there was not a reaction.  Just give the dual dose by accident.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Moderna vaccine on 10/28 and Cominarty on 12/17. No issues from the patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Musculoskeletal disorder
Clinical narrative: left atm doesnt work
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Swelling
Clinical narrative: Soreness started in the evening of the vaccine administration. Swelling was noticeable on the 10th of December and the swelling got worse the next day and then stayed the same the next couple days and then went down.
Age: 12.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: 10:28 AM, APPROXIMATELY 1 MINUTE AFTER LAST VACCINE (GARDASIL), PATIENT LOSS CONSCIOUSNESS.  EMERGENCY PROTOCOL INITIATED.  PATIENT AWAKENED APPROX. 15 SECONDS LATER.  WAS CONTINUOUSLY MONITORED BY NURSES ON SITE.   1029--BP INITIALLY WAS 137/92, HR 88.  LAST BP AT 10:39 WAS 115/84, HR 77.  PARENT REPORTS WILL CONTINUE TO MONITOR AT HOME FOR ANY ADVERSE EFFECTS.  PATIENT AMBULATED WITHOUT ASSISTANCE WITH PARENT OUT OF CLINIC.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Swelling
Clinical narrative: Pain/soreness started on the date of administration, a few hours after receiving. Swelling started about 10/27, got worse the next day, and then subsided 6-7 days later
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 95.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea
Clinical narrative: Diarrhea lasting several hours
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Myalgia, Pain, Pain in extremity
Clinical narrative: soreness in deltoid muscle; pinching sensation with certain movements that starts at the wrist and travels up the arm to the flu injection site
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Pyrexia
Clinical narrative: Mom stated that pt was fine just a slight fever and fussy.
Age: 72.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Pt administered a 3rd MenQuadfi dose in error. MD & patient made aware
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED