chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PNC15
Symptoms: Lethargy, Pyrexia
Clinical narrative: fever; lethargic; her infant may have received a vaccine that was recalled caller advised the vaccine was VAXNEUVANCE; This spontaneous report was received from a consumer referring to her child, a male infant patient of unknown age and gender (conflicting information, the patient was also reported as a child). The patisnt's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 26-JUL-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (lot#: X011332, expiration date was not reported but upon internal validation indicated as 01-JAN-2025; strength, dose, and route of administration were not reported) for prophylaxis.  On an unknown date after the first vaccination in 2023, the patient had a fever and was lethargic. The reporter was informed that the product might have been recalled in 2023 (recalled product administered). The outcome of the events, and the causal relationship between the events above and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) were not provided.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: patient had no adverse events; shattered barrel, broken plunger side of syringe; after I administered the PCV15 vaccine to a baby/patient did receive a dose of the VAXNEUVANCE; This spontaneous report was received from a medical assistant and refers to an infant (baby between 2 and 6 months old; exact age was not provided) patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JAN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe, lot # reported and confirmed as: W021510, expiration date: 08-OCT-2023 (exact dose, dose number, site and route of administration were not provided) administered for prophylaxis. The barrel of syringe was shattered and plunger side of syringe was broken (syringe issue; poor quality device used) which caused severe injury to medical assistant administering the vaccine (captured in #2301USA007946). However, there were no issues with this administration to the pediatric patient. The reporter stated the patient did receive the full dose and had no adverse events (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA007946:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area; He was also very tired; sore arm; headache; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 33-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient was healthy.  Previously administered products included for Product used for unknown indication: Flu Vaccine on 01-Nov-2023, Pfizer (previously had 4 Pfizer shots.), Pfizer (previously had 4 Pfizer shots.), Pfizer (previously had 4 Pfizer shots.) and Pfizer (previously had 4 Pfizer shots.). Past adverse reactions to the above products included No adverse event with Flu Vaccine, Pfizer, Pfizer, Pfizer and Pfizer.    On 30-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Dec-2023, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced PAIN (he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area) and FATIGUE (He was also very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Dec-2023, PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PAIN (he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area) and FATIGUE (He was also very tired) had resolved.            The concomitant medication was not reported by reporter. It was reported that on 04-DEC-2023, patient was perfectly fine. Over the weekend, on Saturday, the headache went away. But then he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area. It was as if someone was pinching him in a split second and then it would go away. Then he would scratch the area. But there was nothing physically observable on the skin. He stated whatever it was, It felt like pinching. The next two days after the vaccination, he was pretty tired. The very next day, he was in bed. The following day, he didn't have to be in bed, but was still tired like he couldn't do a lot.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area; He was also very tired; sore arm; headache; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 33-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient was healthy.  Previously administered products included for Product used for unknown indication: Flu Vaccine on 01-Nov-2023, Pfizer (previously had 4 Pfizer shots.), Pfizer (previously had 4 Pfizer shots.), Pfizer (previously had 4 Pfizer shots.) and Pfizer (previously had 4 Pfizer shots.). Past adverse reactions to the above products included No adverse event with Flu Vaccine, Pfizer, Pfizer, Pfizer and Pfizer.    On 30-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Dec-2023, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced PAIN (he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area) and FATIGUE (He was also very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Dec-2023, PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PAIN (he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area) and FATIGUE (He was also very tired) had resolved.            The concomitant medication was not reported by reporter. It was reported that on 04-DEC-2023, patient was perfectly fine. Over the weekend, on Saturday, the headache went away. But then he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area. It was as if someone was pinching him in a split second and then it would go away. Then he would scratch the area. But there was nothing physically observable on the skin. He stated whatever it was, It felt like pinching. The next two days after the vaccination, he was pretty tired. The very next day, he was in bed. The following day, he didn't have to be in bed, but was still tired like he couldn't do a lot.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea
Clinical narrative: Nausea; Cold like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and NASOPHARYNGITIS (Cold like symptoms) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 01-Dec-2023, the patient experienced NAUSEA (Nausea) and NASOPHARYNGITIS (Cold like symptoms). At the time of the report, NAUSEA (Nausea) and NASOPHARYNGITIS (Cold like symptoms) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medication was not reported.  It was unknown if the patient experienced any additional symptoms or events.   Treatment medication was not reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Immune thrombocytopenia
Clinical narrative: Immune Thrombocytopenia
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Eye haemorrhage, Ocular hyperaemia
Clinical narrative: Burst Blood vessel in one Eye. This has happened immediately following the last 3 doses I have received. Vaccine one day, next morning wake up with bloodshot eye. Eye is completely blood red for about a week, then clears up. I am concerned that if vessels are bursting repeatedly in the eye, what about in the brain!
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Biopsy muscle abnormal, Muscle atrophy, Neuropathic muscular atrophy
Clinical narrative: I have developed muscle atrophy  Skeletal muscle, left vastus lateralis, biopsy:  1) Definite denervation atrophy and probable reinnervation; and  2) Preferential type 2 atrophy.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Pyrexia, Tremor
Clinical narrative: Body tremors at 2:10 AM and lasted for 30 minutes on December 7th, 2023. I was tired on December 6th, 2023 at 5 and 7 PM respectively. Got a fever at 3:10 AM which I am currently have right now. Already recover from body tremors. My previous three vaccinations were Pfizer in which the first one I got a fever on April 16th, 2021 and had to do zoom for school instead of attending school.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Reported a 24-year-old patient received their first dose of GARDASIL 9 "years ago" and just received their second dose two months ago; This spontaneous report was received from a pharmacist referring to a 24-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date (reported as "years ago"), the patient was received her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On an unknown date in September 2023 (reported as "two months ago"), the patient received her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired PNEUMOVAX 23 which was administered to a patient. Vaccine expired on 30SEP2023 and was administered 05DEC2023.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 05-DEC-2023, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection (lot#: W019533, expiration date: 30-SEP-2023; strength, dose, and route of administration were not reported) by a health professional for prophylaxis (expired product administered). The vaccine had no previous temperature excursions. No side effects were reported (no adverse event).
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: this was the second injection and that it was being administered earlier than the 2 year timeframe with no reported adverse event; expired TYPHIM was given to a 47 year old patient with no reported adverse event; Initial information received on 30-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 47 years old female patient to whom this was the second Typhoid VI Polysaccharide Vaccine [Typhim VI] injection and that it was being administered earlier than the 2 year timeframe which was also expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Multiple sclerosis.   On an unknown date, the patient received a dose 2 of suspect Typhoid VI Polysaccharide Vaccine Solution for injection (lot number, strength, dose, expiry date not reported) via unknown route in unknown administration site as Prophylactic vaccination was being administered earlier than the 2 year timeframe and also expired with no reported adverse event (inappropriate schedule of product administration) (expired product administered) (latency: same day).   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 Regulatory Authority 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: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Illness, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: COVID-19; All of the Moderna shots caused pain at site of shot and made me sick for one day; All of the Moderna shots caused paint at site of shot and made me sick for one day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (All of the Moderna shots caused paint at site of shot and made me sick for one day), COVID-19 (COVID-19) and VACCINATION SITE PAIN (All of the Moderna shots caused pain at site of shot and made me sick for one day) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) for an unknown indication.    The patient's past medical history included Knee replacement on 25-Feb-2020. Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal, Hot flashes and Asthma. Concomitant products included AMLODIPINE and ROSUVASTATIN for Blood cholesterol abnormal, HYDROCHLOROTHIAZIDE for Blood pressure abnormal, GABAPENTIN for Hot flashes.   In November 2023, the patient received dose of FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Sep-2023, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ILLNESS (All of the Moderna shots caused paint at site of shot and made me sick for one day) and VACCINATION SITE PAIN (All of the Moderna shots caused pain at site of shot and made me sick for one day). At the time of the report, ILLNESS (All of the Moderna shots caused paint at site of shot and made me sick for one day), COVID-19 (COVID-19) and VACCINATION SITE PAIN (All of the Moderna shots caused pain at site of shot and made me sick for one day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2023, SARS-CoV-2 test: Positive.         It was reported that, all of the Moderna shots, caused pain at the site of shot and made the patient sick for one day. The patient was exposed to COVID over and over and never got it. The booster that the patient got with Pfizer did not cause any reaction or made her sick, then the patient did catch COVID and said that it did not work.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion
Clinical narrative: The patient felt that the covid-19 vaccine caused the Pacemaker; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC PACEMAKER INSERTION (The patient felt that the covid-19 vaccine caused the Pacemaker) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC PACEMAKER INSERTION (The patient felt that the covid-19 vaccine caused the Pacemaker). At the time of the report, CARDIAC PACEMAKER INSERTION (The patient felt that the covid-19 vaccine caused the Pacemaker) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CARDIAC PACEMAKER INSERTION (The patient felt that the covid-19 vaccine caused the Pacemaker) to be related.    Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that the patient felt that the covid-19 vaccine caused the Pacemaker and was advising others not to receive their Moderna Covid-19 vaccines.   This case was linked to US-MODERNATX, INC.-MOD-2023-752079 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752079:Same Reporter Different Patient
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Approximately 15 minutes after vaccine administration he developed red, flat patches on cheek. Respiratory statues was normal and no itching. Dr. noticed no other hives anywhere. Dr gave 3.75ml of Benadryl and observed for 30 minutes. Pt fell asleep and was discharged with no other skin hives.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Pediarix and Engerix B.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Lt upper arm red and swollen and hot to the touch. Reddness and swelling is localized, but spanning the size roughly of a tennis ball.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient was given the entire vial of the Pfizer Covid vaccine 6mo - <5 years. The vial was supposed to be diluted with 1.1mL sodium chloride 0.9%, and the vial contained 3 doses.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient was given the entire vial of the Pfizer 6month - <5 years covid vaccine. The vial was supposed to be diluted with 1.1mL of sodium chloride 0.9% liquid. The vial contained 3 doses of vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site urticaria, Pain
Clinical narrative: From chart review: The following day she had soreness at the site, firmness as well and pain. About 24 hours after the vaccine, she broke out in hives on her face, trunk and on the arms. The family took her quickly to urgent care and by the time the family got there, the hives had started to go away. No fevers, no joint swelling, no vomiting, no trouble breathing. About 4-6 weeks later, she developed a hive at the site of the injection -she reported some itchiness and also reported pain at the site. Benadryl or Cetirizine was given and the hive improved, but the site did remain pretty sore for a few days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: From chart review: The following day she had soreness at the site, firmness as well and pain. About 24 hours after the vaccine, she broke out in hives on her face, trunk and on the arms. The family took her quickly to urgent care and by the time the family got there, the hives had started to go away. No fevers, no joint swelling, no vomiting, no trouble breathing. About 4-6 weeks later, she developed a hive at the site of the injection -she reported some itchiness and also reported pain at the site. Benadryl or Cetirizine was given and the hive improved, but the site did remain pretty sore for a few days.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Hordeolum, Paraesthesia oral, Peripheral swelling, Skin discolouration
Clinical narrative: Sores in the mouth; Swollen fingers on right hand; purple and swollen right eye and developed a stye; continued blurry vision in right eye; headache; tingling in lips
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Stomatitis, Swelling of eyelid, Vision blurred
Clinical narrative: Sores in the mouth; Swollen fingers on right hand; purple and swollen right eye and developed a stye; continued blurry vision in right eye; headache; tingling in lips
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram normal, Exercise tolerance decreased, Laboratory test normal, Palpitations
Clinical narrative: Within two days of Moderna booster on Oct 6, brisk walk made heart pound heavily, what said it was 202. Had many other instances were heart rate over 170 with a simple brisk walk when I'm a very, very physically fit person (run, tennis, lift weights).   I had 4 Pfizer vaxes, then a Moderna #067M22A 5/16/23 before a trip, then latest Moderna booster on 10/6/23 before another trip.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Hives, rash
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Patient given bivalent COVID 9/12/23, right after EUA was pulled from market. had no reaction
Age: 1.08
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Both thighs turned bright red
Age: 103.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient expired on 11/30/23. Patient had other comorbidities and was on Hospice care prior to receiving the  COVID-19, mRNA, LNP-S, PF, 50 mcg/0.5 mL vaccine.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Chills, Dry mouth, Dry throat, Fatigue
Clinical narrative: dry mouth and throat, headache, fatigue, 2 x5 inch lump at injection site, fever, chills, extreme body and joint pain and high fever (103 degrees).
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Injection site mass, Pain, Pyrexia
Clinical narrative: dry mouth and throat, headache, fatigue, 2 x5 inch lump at injection site, fever, chills, extreme body and joint pain and high fever (103 degrees).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Rash, Rash erythematous
Clinical narrative: Patient received a Shringrix vaccination (NDC 58160-0823-11, LOT: 71A92, EXP: 09/29/25) in the left deltoid on 11/29/23. The following day on 11/30/23, the patient reports experiencing itchiness, pain and redness at the site of injection. On 12/01/23, the patient reported visualizing a raised bump on her right arm at the elbow. She reports she sent a staff message on 12/01/23 to notify her provider and she went to pharmacy to consult a pharmacist, whom recommended using hydrocortisone cream. Patient reports the hydrocortisone did not help at all. She reports she also used zinc oxide cream, which also did not help. Over the weekend, the rash spread to the left side of her arm as well. On 12/04/23, the patient went to urgent care and was prescribed triamcinolone cream and valacyclovir to help with her symptoms. VAERS also filled to document this event.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: Patient received a Shringrix vaccination (NDC 58160-0823-11, LOT: 71A92, EXP: 09/29/25) in the left deltoid on 11/29/23. The following day on 11/30/23, the patient reports experiencing itchiness, pain and redness at the site of injection. On 12/01/23, the patient reported visualizing a raised bump on her right arm at the elbow. She reports she sent a staff message on 12/01/23 to notify her provider and she went to pharmacy to consult a pharmacist, whom recommended using hydrocortisone cream. Patient reports the hydrocortisone did not help at all. She reports she also used zinc oxide cream, which also did not help. Over the weekend, the rash spread to the left side of her arm as well. On 12/04/23, the patient went to urgent care and was prescribed triamcinolone cream and valacyclovir to help with her symptoms. VAERS also filled to document this event.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Blood test, Cardiac therapeutic procedure, Coagulation test, Computerised tomogram, Echocardiogram
Clinical narrative: Developed a blood clot in left kidney and was admitted to local hospital on 12/04/2023. No history of blood clots previously.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Renal vascular thrombosis
Clinical narrative: Developed a blood clot in left kidney and was admitted to local hospital on 12/04/2023. No history of blood clots previously.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Chills
Clinical narrative: Chills
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dental caries, Injection site urticaria, Injection site warmth, Tooth restoration
Clinical narrative: My left upper arm just started breaking out in hives about 20-30 minutes ago near the site of injection. The area is warm to the touch as well. So far, I'm just monitoring it. I had a cavity filled on the left side of my mouth two days ago, but feel that this is unrelated.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: COVID vaccine administered on 12/6/23, out of freezer expiration date 11/30/23.  No adverse reaction from expired vaccine reported.
Age: 91.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Wrong product administered
Clinical narrative: Accidently gave Fluad instead of Comirnaty.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diplopia, Myasthenia gravis, Vision blurred
Clinical narrative: I got the vaccine on 9/26/23. I had the normal symptoms. I'll be honest, it wasn't until 9:30 until I started having double vision. I started having eye problems, where I couldnt see clearly. That happen at 9:30. Later on it did occur to me that it was close to the vaccine. My first symptom was blurred vision, it would come and go over the next few days. I went to my normal doctor, and he just didn't have a clue. Dr. is the that properly diagnosed me. I was diagnosis is Myasthenia gravis.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt received Fluzone 0.5 mL on 10/4/23 by another provider. I gave Fluzone on 11/18/23. I verified name, DOB, and expected vaccine with parent, however I did not check to see if the patient recently received the vaccine. I called patient's parent today to notify them of the error but there was no answer.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pt needed her 2nd MMR and first varicella to be able to start school but pt has had no reactions or any concerns at this time
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring, Dizziness, Electrocardiogram, Electrocardiogram ambulatory, Heart sounds
Clinical narrative: Light headedness Cardiac dysrhythmia (Nonconducted PACs) Hypotension
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Supraventricular extrasystoles
Clinical narrative: Light headedness Cardiac dysrhythmia (Nonconducted PACs) Hypotension
Age: 71.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Pain
Clinical narrative: Patient reports having left shoulder pain immediately following shingles vaccine, and persisting until 12/07/2023. He says it hurts to lift his arm, and wanted to delay receiving second dose of the shingles vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, Nausea, Pain, Pain in extremity, Rash macular
Clinical narrative: Patient noticed hives on lower back yesterday evening, worse this morning - spread to greater area on back.  Red splotches, raised, Nausea noted today 12/7/23 and patient generally "doesn't feel well".  Also noted shooting pain down her right arm.  No fever noted.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Swelling, Urticaria
Clinical narrative: Patient noticed hives on lower back yesterday evening, worse this morning - spread to greater area on back.  Red splotches, raised, Nausea noted today 12/7/23 and patient generally "doesn't feel well".  Also noted shooting pain down her right arm.  No fever noted.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Cervical cord compression, Dyspnoea, Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care
Clinical narrative: Guillain Barré syndrome  Admitted to hospital and started IVIG 35 g daily on 12/5 transferred to critical care unit on 12/7 for closer monitoring due to increased dyspea and respiratory muscle involvement
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Lumbar puncture abnormal, Magnetic resonance imaging spinal abnormal, Use of accessory respiratory muscles
Clinical narrative: Guillain Barré syndrome  Admitted to hospital and started IVIG 35 g daily on 12/5 transferred to critical care unit on 12/7 for closer monitoring due to increased dyspea and respiratory muscle involvement
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC20
Symptoms: Condition aggravated, Eczema, Erythema, Periorbital swelling, Pruritus
Clinical narrative: 2 days after vaccination, mom states pt had flare up of his eczema with swelling around his eyes, intense erythema and itching. The mom took to the Hospital ER who treated pt with 5 days of oral steroid.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest X-ray, Chest pain, Condition aggravated, Diabetes mellitus, Diabetes mellitus inadequate control
Clinical narrative: Fever-Chills; Constant chest pain; blood sugar spikes, uncontrollable by prescription max at 294  on 12/03/2023 at 7PM. Went to hospital
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Differential white blood cell count, Electrocardiogram, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Fever-Chills; Constant chest pain; blood sugar spikes, uncontrollable by prescription max at 294  on 12/03/2023 at 7PM. Went to hospital
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever-Chills; Constant chest pain; blood sugar spikes, uncontrollable by prescription max at 294  on 12/03/2023 at 7PM. Went to hospital
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Myalgia, Nausea
Clinical narrative: C/O body aches, fever, h/a, chills, nausea, arm pain and chest muscle pain
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: C/O body aches, fever, h/a, chills, nausea, arm pain and chest muscle pain
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was administered 0.5ml the Moderna Covid 6mos-11yrs 2023-2024 formulation instead of >12yrs old formulation.
Age: 7.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Hyperhidrosis, Loss of consciousness, Muscle twitching, Pallor, Syncope
Clinical narrative: Per Emergency Repose Team provider's documentation:  "Called to ERT for momentary syncope after flu/covid vaccines  7 yo o/w healthy female received 2 vaccines and shortly after became pale, sweaty, and passed out on bench (no fall or injury), mild twitching noted. Was lifted by team to position and returned to consciousness in less than 10 seconds without any postictal state. Initial BP was mildly elevated, team believed she was moving her arm. On arrival she was supine on the bed, alert/oriented, pale and a little sweaty. Denied any nausea, sob or mouth symptoms. No rash. Repeat BP normalized. Pt indicated resolution of symptoms and had return of normal color to face. She was allowed to sit up (did so quickly and without issue). After a few moments, repeat BP was normal and HR in 70-80s. Father confirmed she looked like she was 'herself' again. Pt stood and observed for a minute w/o return of symptoms. Released to routine post vax observation period."
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Blister, Hypersensitivity, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: pt called and said she developed an allergic rxn 3 days after getting her flu shot here. her symptoms were rash all over body, itching and blisters , redness and swelling around inj site. pt had to go er get steriod shot , now her SX are better but blisters start scaling . she wanted to repot the rxn, counselled pt to consult her Dr about that and in future to get all her IMZ at a clinic setting incase of anaphylaxis. pt said she has been getting flu shots regularly every year and not sure what happened. She confirms that rash was severe around injection site that's why suspecting allergic rxn from the shot. I will report to VARES as well as the pt
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash
Clinical narrative: pt called and said she developed an allergic rxn 3 days after getting her flu shot here. her symptoms were rash all over body, itching and blisters , redness and swelling around inj site. pt had to go er get steriod shot , now her SX are better but blisters start scaling . she wanted to repot the rxn, counselled pt to consult her Dr about that and in future to get all her IMZ at a clinic setting incase of anaphylaxis. pt said she has been getting flu shots regularly every year and not sure what happened. She confirms that rash was severe around injection site that's why suspecting allergic rxn from the shot. I will report to VARES as well as the pt
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Coordination abnormal, Dyspnoea, Muscular weakness, Pain
Clinical narrative: The patient is taking Sinemet and entacapone for Parkinson's disease. She states the RSV vaccine has made her medications less effective. She has muscle weakness in the legs, worsening tremors, difficulty walking due to pain, and loss of coordination. All adverse effects started 1 day after the vaccine and continue to day 2 after receiving the vaccine.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Parkinson's disease, Tremor
Clinical narrative: The patient is taking Sinemet and entacapone for Parkinson's disease. She states the RSV vaccine has made her medications less effective. She has muscle weakness in the legs, worsening tremors, difficulty walking due to pain, and loss of coordination. All adverse effects started 1 day after the vaccine and continue to day 2 after receiving the vaccine.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: None. Dose administered too soon.
Age: 20.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: No adverse event
Clinical narrative: pt came into clinic needing her Hep B #2. pt then reported she needed MMR and Varicella. pt was given Engerix-B and ProQuad to cover. pt is having no reaction side effects or concerns. per Merck this will be counted as a vaild dose and no need to repeat vaccines.
Age: 20.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: pt came into clinic needing her Hep B #2. pt then reported she needed MMR and Varicella. pt was given Engerix-B and ProQuad to cover. pt is having no reaction side effects or concerns. per Merck this will be counted as a vaild dose and no need to repeat vaccines.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Immunisation reaction
Clinical narrative: PATIENT RECIEVED AREXVY VACCINE ON 12/2/23. PATIENT REPORTED ADVERSE REACTION TO US ON 12/6, PATIENT STATES THEY WENT TO URGENT CARE FOR THE REACTION (WHICH STARTED ON 12/3/23) AND WAS PRESCRIBED CEPHALEXIN ANTIBIOTIC (FILLED AT OTHER PHARMACY).
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pregnant patient erroneously received Arexvy instead of Abrysvo RSV vaccine.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was administered 0.5ml of Moderna Covid 2023-2024 6mos -11y/o formulation instead of Moderna  Spikevax for 12 years and older.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Face oedema, Injection site induration, Injection site urticaria
Clinical narrative: Urticaria and induration of 3x3 cm on the Right arm (deltoid area) where the Men B vaccine was given. Also had Facial edema. Parent gave Benadryl and cool compresses. Will avoid the booster for now.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting, not able to keep fluids or food down. Patient to take 4mg of Zofran and if that does not help patient to come in office for IV fluids.
Age: 44.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pregnant patient erroneously received Arexvy instead of Abrysvo
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: He got his vaccine in his left buttock, he had immediate burning in his bottom, heavy sweating, tremors went crazy, they were thinking he was having a seizure, energy level dropped to 0, white face and almost passing over.  When they tried to turn him over it hurt like crazy.  They called for help, 3 nurses and then they called the doctor from upstairs.  Once the doctor came in she asked what happened, and asking him how he felt, getting an evaluation from the nurses.  They got him a heat pad for his bad, elevated his legs and they tried to elevate his back up to see if he could drink some water.  He was out of it for a few minutes.  He was there for about an hour and a half.  They took several attempts to take his as he was shaking too bad, and then shot up to 126 on them, and they told him that if he did not get better within 20 minutes then he would be a no code.  He informed them that he needed some time to recover from this experience.  They tried to sit him up, was extremely dizzy and had to lay him back down.  From there it was a waiting time, he was given a graham cracker, and he is allergic to apples and they only had apple juice, drank some water and then was able to sit up.  He was able to walk a little bit, enough to sit in a wheelchair.  He had droven himself to the clinic, and they ended up calling his son-in-law to the hospital to pick him up.  They informed him if he had any problems the next day to contact the CDC/VAERS.  He is feeling better, slightly dizzy, butt is still sore, and has no fever.  He feels that today will be recovery day.  They are sending his information to his PCP so that he can determine if he gets his 2nd shingles vaccine.    The doctor believed him that he did not want to go to the ER, just time to recover from it.  His son-in-law took him home, stayed with him for 20 minutes, and took a long nap.  He was able to eat oatmeal, drink water, some weakness, and just not feeling like himself.  He feels about 4-5/10 and is going to wait until he feels better to do anything else, feeling fatigued and just going to take it easy today.   Felt like he had a non-fever flu-bug.    He normally gets his injections in his buttock as if he gets one in his arm he will immediately pass out.  He had a flu vaccine and pneumonia vaccine about 1 1/2 to 2 months ago and had no reaction other than some fatigue and his buttocks hurting and was able to drive himself to and from the clniic.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Musculoskeletal pain, Pain, Pallor
Clinical narrative: He got his vaccine in his left buttock, he had immediate burning in his bottom, heavy sweating, tremors went crazy, they were thinking he was having a seizure, energy level dropped to 0, white face and almost passing over.  When they tried to turn him over it hurt like crazy.  They called for help, 3 nurses and then they called the doctor from upstairs.  Once the doctor came in she asked what happened, and asking him how he felt, getting an evaluation from the nurses.  They got him a heat pad for his bad, elevated his legs and they tried to elevate his back up to see if he could drink some water.  He was out of it for a few minutes.  He was there for about an hour and a half.  They took several attempts to take his as he was shaking too bad, and then shot up to 126 on them, and they told him that if he did not get better within 20 minutes then he would be a no code.  He informed them that he needed some time to recover from this experience.  They tried to sit him up, was extremely dizzy and had to lay him back down.  From there it was a waiting time, he was given a graham cracker, and he is allergic to apples and they only had apple juice, drank some water and then was able to sit up.  He was able to walk a little bit, enough to sit in a wheelchair.  He had droven himself to the clinic, and they ended up calling his son-in-law to the hospital to pick him up.  They informed him if he had any problems the next day to contact the CDC/VAERS.  He is feeling better, slightly dizzy, butt is still sore, and has no fever.  He feels that today will be recovery day.  They are sending his information to his PCP so that he can determine if he gets his 2nd shingles vaccine.    The doctor believed him that he did not want to go to the ER, just time to recover from it.  His son-in-law took him home, stayed with him for 20 minutes, and took a long nap.  He was able to eat oatmeal, drink water, some weakness, and just not feeling like himself.  He feels about 4-5/10 and is going to wait until he feels better to do anything else, feeling fatigued and just going to take it easy today.   Felt like he had a non-fever flu-bug.    He normally gets his injections in his buttock as if he gets one in his arm he will immediately pass out.  He had a flu vaccine and pneumonia vaccine about 1 1/2 to 2 months ago and had no reaction other than some fatigue and his buttocks hurting and was able to drive himself to and from the clniic.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: He got his vaccine in his left buttock, he had immediate burning in his bottom, heavy sweating, tremors went crazy, they were thinking he was having a seizure, energy level dropped to 0, white face and almost passing over.  When they tried to turn him over it hurt like crazy.  They called for help, 3 nurses and then they called the doctor from upstairs.  Once the doctor came in she asked what happened, and asking him how he felt, getting an evaluation from the nurses.  They got him a heat pad for his bad, elevated his legs and they tried to elevate his back up to see if he could drink some water.  He was out of it for a few minutes.  He was there for about an hour and a half.  They took several attempts to take his as he was shaking too bad, and then shot up to 126 on them, and they told him that if he did not get better within 20 minutes then he would be a no code.  He informed them that he needed some time to recover from this experience.  They tried to sit him up, was extremely dizzy and had to lay him back down.  From there it was a waiting time, he was given a graham cracker, and he is allergic to apples and they only had apple juice, drank some water and then was able to sit up.  He was able to walk a little bit, enough to sit in a wheelchair.  He had droven himself to the clinic, and they ended up calling his son-in-law to the hospital to pick him up.  They informed him if he had any problems the next day to contact the CDC/VAERS.  He is feeling better, slightly dizzy, butt is still sore, and has no fever.  He feels that today will be recovery day.  They are sending his information to his PCP so that he can determine if he gets his 2nd shingles vaccine.    The doctor believed him that he did not want to go to the ER, just time to recover from it.  His son-in-law took him home, stayed with him for 20 minutes, and took a long nap.  He was able to eat oatmeal, drink water, some weakness, and just not feeling like himself.  He feels about 4-5/10 and is going to wait until he feels better to do anything else, feeling fatigued and just going to take it easy today.   Felt like he had a non-fever flu-bug.    He normally gets his injections in his buttock as if he gets one in his arm he will immediately pass out.  He had a flu vaccine and pneumonia vaccine about 1 1/2 to 2 months ago and had no reaction other than some fatigue and his buttocks hurting and was able to drive himself to and from the clniic.
Age: 6.0
Sex: M
Vaccine: FLU4, HEPA, MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: MMR was given 25 days after Varivax so dose is invalid.  There were no side effects reported.
Age: 14.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no adverse events reported.
Age: 66.0
Sex: M
Vaccine: COVID19, FLUA4, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received the 6m-11y dose of Moderna; not the appropriate dose of 12y and up.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Pt. began feeling tired. She has complained of being tired every single day since she received the vaccine shot. This is still going on.
Age: 45.0
Sex: M
Vaccine: FLUR4
Symptoms: Blood thyroid stimulating hormone normal, Computerised tomogram head normal, Full blood count normal, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: AIDP - Guillain Barre Syndrome.  Paresthesias began 11/3/23 (Stocking and glove distribution; Ascending motor weakness in lower extremity began 11/12/23;  ICU hospitalization: 11/12/23 - 11/16/23. Treated with IVIG infusions.  Neuro symptoms began to improve during hospitalization.
Age: 45.0
Sex: M
Vaccine: FLUR4
Symptoms: Intensive care, Lumbar puncture abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Metabolic function test normal
Clinical narrative: AIDP - Guillain Barre Syndrome.  Paresthesias began 11/3/23 (Stocking and glove distribution; Ascending motor weakness in lower extremity began 11/12/23;  ICU hospitalization: 11/12/23 - 11/16/23. Treated with IVIG infusions.  Neuro symptoms began to improve during hospitalization.
Age: 45.0
Sex: M
Vaccine: FLUR4
Symptoms: Muscular weakness, Neurological symptom, Paraesthesia, Prothrombin level normal, Prothrombin time normal
Clinical narrative: AIDP - Guillain Barre Syndrome.  Paresthesias began 11/3/23 (Stocking and glove distribution; Ascending motor weakness in lower extremity began 11/12/23;  ICU hospitalization: 11/12/23 - 11/16/23. Treated with IVIG infusions.  Neuro symptoms began to improve during hospitalization.