chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RSV
Symptoms: Chills, Hyperhidrosis, Myalgia, Sleep disorder
Clinical narrative: chills; sweats; severe muscle pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 10-JAN-2023, the patient received Arexvy. In JAN-2023, less than a day after receiving Arexvy, the patient experienced chills (Verbatim: chills), sweating (Verbatim: sweats) and muscle pain (Verbatim: severe muscle pain). The outcome of the chills, sweating and muscle pain were unknown.   It was unknown if the reporter considered the chills, sweating and muscle pain to be related to Arexvy.     It was unknown if the company considered the chills, sweating and muscle pain to be related to Arexvy.   Additional Information: GSK receipt date: 11-JAN-2024 The husband had the RSV vaccine yesterday (the day before reporting), and woke in the middle of the night with chills and sweats, severe muscle pain. Follow-up not possible as no contact details provided.
Sex: M
Vaccine: RVX
Symptoms: Chest pain
Clinical narrative: chest pain; This non-serious case was reported by a other health professional via sales rep and described the occurrence of chest pain in a adult male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 23-DEC-2023, the patient received RSV vaccine. On an unknown date, 2 days after receiving RSV vaccine, the patient experienced chest pain (Verbatim: chest pain). The outcome of the chest pain was not reported.   It was unknown if the reporter considered the chest pain to be related to RSV vaccine.     It was unknown if the company considered the chest pain to be related to RSV vaccine.   Additional Information: GSK Receipt date: 10-JAN-2024 The health care provider reported that the approximately age 64 year of patient called day before of reporting and reported the chest pain, was referred to urgent care. Patient reported that he received RSV (unknown if received Arexvy or not) around the 23rd, December 2023, started experiencing chest pain 2 to 3 days after. The reporter did not consent to follow-up.
Sex: M
Vaccine: FLUX, RVX
Symptoms: Flushing, Hyperhidrosis, Musculoskeletal disorder
Clinical narrative: legs quit working; sweating; flushing; This non-serious case was reported by a other health professional via sales rep and described the occurrence of leg discomfort in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On 25-OCT-2023, the patient received RSV vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced leg discomfort (Verbatim: legs quit working), sweating (Verbatim: sweating) and flushing (Verbatim: flushing). The outcome of the leg discomfort, sweating and flushing were resolved.   It was unknown if the reporter considered the leg discomfort, sweating and flushing to be related to RSV vaccine.     It was unknown if the company considered the leg discomfort, sweating and flushing to be related to RSV vaccine.   Additional Information: GSK receipt date:09-JAN-2024 The reporter was GlaxoSmithKline representative. On the behalf of an health care professional(office manager)who received an email from a email from a pharmacy stating that a patient received a flu vaccine and RSV vaccine from a local pharmacy on 25th October 2023. The patient was going to the car when he became flushed and sweaty. He made it back inside and his legs quit working. The patient's vitals were okay and after sitting for 15-20 minutes, the patient was okay. Unknown if RSV vaccine was Arexvy. It was unknown if the reporter considered the leg discomfort, sweating and flushing to be related to influenza vaccine.    The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed a case of shingles; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed a case of shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 10-JAN-2024 Sales rep submitted would like to knew what to do with Shingrix in this scenario.  The patient received 2 doses of Shingrix and 1 year later they developed a case of shingles.  The reporter asked if recommendation to revaccinate the patient with another 2 doses series of Shingrix. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: The patient says all her joints have pain; The patient also reports that she has pain that started in her left arm, moved across her chest and back, into her right arm, her shoulders, the tops of her legs, and her left knee; Chest pain; back pain; Injection Hurt; Pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included cortisone for product used for unknown indication.   Concurrent medical conditions included unspecified disorder of knee joint, migraine (since 1973) and restless legs syndrome (Restless Feet Syndrome). Concomitant products included tramadol.   On 27-DEC-2023, the patient received Arexvy (left arm) and cortisone. On 27-DEC-2023, less than a day after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection Hurt) and pain in arm (Verbatim: Pain). On an unknown date, the patient experienced joint pain (Verbatim: The patient says all her joints have pain), radiating pain (Verbatim: The patient also reports that she has pain that started in her left arm, moved across her chest and back, into her right arm, her shoulders, the tops of her legs, and her left knee), chest pain (Verbatim: Chest pain) and back pain (Verbatim: back pain). The action taken with cortisone was unknown. The outcome of the injection site pain, pain in arm, joint pain, radiating pain, chest pain and back pain were not resolved.   It was unknown if the reporter considered the injection site pain, pain in arm, joint pain, radiating pain, chest pain and back pain to be related to Arexvy.     It was unknown if the company considered the injection site pain, pain in arm, joint pain, radiating pain, chest pain and back pain to be related to Arexvy.   Additional Information: GSK receipt date: 11-JAN-2024 The reporter was a female patient calling to report adverse reactions after receiving a RSV Vaccine. The patient reported that the injection hurt really bad when she received the vaccine.  The patient reported that the injection site still hurts today (at the time of reporting).  The patient also reported that she had pain that started in her left arm, moved across her chest and back, into her right arm, her shoulders,  the tops of her legs, and her left knee.  The patient said all her joints had pain.  The pain in her left arm started the day she received the vaccine.  The pain everywhere but her left arm just started in the last day or two.  The patient also reported that she received a Cortisone shot in her left knee the same day as receiving the RSV vaccine.  The patient reported in the last day or 2 she was getting worse instead of better. T The patient also takes Tramadol (unknown product information) 50mg or 100mg (unconfirmed strength or dosage) 1 to 2 tablets once or twice a day for Restless Feet Syndrome. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: an adult dose of Havrix was administered to a pediatric patient.; an adult dose of Havrix was administered to a pediatric patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-month-old female patient who received HAV (Havrix 1440 adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 11-JAN-2024, the patient received the 2nd dose of Havrix 1440 adult. On 11-JAN-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: an adult dose of Havrix was administered to a pediatric patient.) and adult product administered to child (Verbatim: an adult dose of Havrix was administered to a pediatric patient.). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-JAN-2024 The health care professional (HCP) stated an adult dose of Havrix was administered to a pediatric patient, which led to overdose and adult product administered to child.  The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a first first dose of Havrix on 25-JAN-2022 and the second dose on 14-JUL-2022; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old patient who received HAV (Havrix) (batch number yg7yj, expiry date 03-FEB-2023) for prophylaxis.   Previously administered products included Havrix (received  1st dose on 25th January 2022).   On 14-JUL-2022, the patient received Havrix. On 14-JUL-2022, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: received a first first dose of Havrix on 25-JAN-2022 and the second dose on 14-JUL-2022). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-JAN-2024 The nurse stated that a patient received a first dose of Havrix and the second dose.  The early dose was caught in a chart audit. The patient received the 2nd dose early, which led to shortening of vaccination schedule.  The reporter did not consent to follow-up.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Needle issue, Underdose
Clinical narrative: leaked out of the needle during administration; leaked out of the needle during administration; leaked out of the needle during administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 81-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G75S4, expiry date 05-JUL-2025) for prophylaxis.   On 11-JAN-2024, the patient received Arexvy. On 11-JAN-2024, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: leaked out of the needle during administration). On an unknown date, the patient experienced needle issue (Verbatim: leaked out of the needle during administration) and pharmaceutical product complaint (Verbatim: leaked out of the needle during administration). The outcome of the accidental underdose, needle issue and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 11-JAN-2024 A pharmacist reported that a patient received a dose of Arexvy that leaked out of the needle during administration, which led to accidental under dose, needle issue and pharmaceutical product complaint. The reporter consented to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: receive a havrix vaccine vaccine 11 days early; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a child patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: receive a havrix vaccine vaccine 11 days early). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JAN-2024 A field representative said that they had a child who received a havrix vaccine 11 days early last year for his 18 month vaccines, which led to shortening of vaccine schedule. The reporter was double checking that if they need to complete a booster or something or what they need to do. The reporter consented to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Benign fasciculation syndrome, Muscle spasms, Muscle twitching, Paraesthesia
Clinical narrative: benign fasciculation syndrome; experiencing strange muscle twitching; Pins and needle type sensation; Cramping; This non-serious case was reported by a consumer via call center representative and described the occurrence of benign fasciculation syndrome in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-OCT-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced benign fasciculation syndrome (Verbatim: benign fasciculation syndrome), muscle twitching (Verbatim: experiencing strange muscle twitching), paresthesia (Verbatim: Pins and needle type sensation) and muscle cramp (Verbatim: Cramping). The outcome of the benign fasciculation syndrome, muscle twitching, paresthesia and muscle cramp were not resolved.   It was unknown if the reporter considered the benign fasciculation syndrome, muscle twitching, paresthesia and muscle cramp to be related to Shingrix.     It was unknown if the company considered the benign fasciculation syndrome, muscle twitching, paresthesia and muscle cramp to be related to Shingrix.   Additional Information: GSK receipt date: 11-JAN-2024 The reporter was patient's husband.  The reported that she got Shingrix and since then, been experiencing strange muscle twitching and cramping and pins-and-needle type sensations.  She had seen a few physician and specialists who had all said that it was benign fasciculation syndrome. The reporter believed she got the shot at her physician's office but he did not had the information in front of him.  The reporter's wife was not with him at the time of the report therefore he did not had her physician's contact information in front of him and lot number. The reporter was fine with GSK safety sending him a letter or an email requesting her MD contact information.         The reporter consented to follow up
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Pain in extremity
Clinical narrative: and his arm was sore; he was sick for a day; Chills; Headache; Fatigue; Not feeling well; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2022, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: and his arm was sore), sickness (Verbatim: he was sick for a day), chills (Verbatim: Chills), headache (Verbatim: Headache), fatigue (Verbatim: Fatigue) and feeling unwell (Verbatim: Not feeling well). The outcome of the pain in arm was unknown and the outcome of the sickness, chills, headache, fatigue and feeling unwell were resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm, sickness, chills, headache, fatigue and feeling unwell to be related to Shingrix.     It was unknown if the company considered the pain in arm, sickness, chills, headache, fatigue and feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR006452   Additional Information: GSK receipt date: 11-JAN-2024 The reporter was the wife calling on behalf of her husband and reported that her husband received the 1st dose of Shingrix within 3 days of 27th April 2022 (no specific date provided), and his arm was sore, he was sick for a day with chills, headache, fatigue, and did not felt well at all.  The reporter also reported that her husband received the 2nd dose of Shingrix three months later in his left arm, and complained that he was more sore and more sick after the 2nd dose.  The reporter had reported all the information the reporter provided about these events. The consent to follow up with health care professional (HCP) was not asked as the patient was not on the phone. The case linked with US2024AMR006452, by same reporter.; Sender's Comments:  US-GSK-US2024AMR006452:same patient / sameproduct
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered a dose of Boostrix to a 65 year old male patient on 11Jan2024 from lot number 7ZD7L, which had an expiration date of 09Dec2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 65-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7ZD7L, expiry date 09-DEC-2023) for prophylaxis.   On 11-JAN-2024, the patient received Boostrix. On 11-JAN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Boostrix to a 65 year old male patient on 11Jan2024 from lot number 7ZD7L, which had an expiration date of 09Dec2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-JAN-2024 The Pharmacist reported one if the pharmacy technicians administered a dose of expired Boostrix to patient , which led to expired vaccine used. At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: inadvertently given a pediatric dose; Nurse Practitioner states a male adult patient was inadvertently given a pediatric dose today; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 42-year-old male patient who received HAV (Havrix pediatric) (batch number BR2GD, expiry date 16-MAY-2025) for prophylaxis.   On 12-JAN-2024, the patient received Havrix pediatric (intramuscular). On 12-JAN-2024, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: inadvertently given a pediatric dose) and adult use of a child product (Verbatim: Nurse Practitioner states a male adult patient was inadvertently given a pediatric dose today). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-JAN-2024 The Vaccine Administration Facility was the same as Primary Reporter Nurse Practitioner stated a male adult patient was inadvertently given a pediatric dose today (on the day of reporting), as dose one in the Havrix series, which led to accidental underdose and adult use of child product. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: they did not receive the second dose until November 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In March 2022, received first dose).   In NOV-2023, the patient received the 2nd dose of Shingrix. In NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: they did not receive the second dose until November 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 12-JAN-2024 The reporter had a resident who get their first Shingrix dose in March 2022 and they did not received the second dose until November 2023. Reporter asked a question that did they need another dose. The reporter was unable to provide any vaccine or patient details. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain in extremity
Clinical narrative: Sore arm; development of fever blister approximately 36 hours after receiving injection.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID vaccine breakthrough case
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Me and my kids got the first Covid Shot then we went back and got the second one on 10/05/2021 , I remember because thats an important date and as the months went by my son kept complaining about his legs hurting,  then on March 18th, I get the worse call of my life while I am at work that my son is laying on my kitchen floor and can't move his legs so I advised my daughter to call 911 and the rest can be found in his medical charts my kids has been a healthy and kid but I blame myself because I took him to get that shot and now his dreams of becoming a police officer are down the drain , my son played football since he was 5 .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Immediate post-injection reaction, Immunisation reaction, Optic neuritis
Clinical narrative: I received the second dose on 10/05/2021 and immediately  after my right eye began to burn and itch real bad so I got dry eye drops from store and when I woke up on the next day my right eye had a black spot covering it I could not see anything out that eye I went to several ER wake med unc and they kept prescribing stuff that wasn't working then unc said I had optic neurotic that was caused by the Covid shot.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Visual field defect
Clinical narrative: I received the second dose on 10/05/2021 and immediately  after my right eye began to burn and itch real bad so I got dry eye drops from store and when I woke up on the next day my right eye had a black spot covering it I could not see anything out that eye I went to several ER wake med unc and they kept prescribing stuff that wasn't working then unc said I had optic neurotic that was caused by the Covid shot.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Rotator cuff syndrome
Clinical narrative: possible SIRVA - worsening rotator cuff dysfunction within days after administration in patient with prior rotator cuff disorder
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Injection site pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Soreness at site, headache, stomach ache, fever, sore throat, respiratory congestion
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory tract congestion
Clinical narrative: Soreness at site, headache, stomach ache, fever, sore throat, respiratory congestion
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Hypoaesthesia, Laboratory test normal, Pain in extremity
Clinical narrative: Arm pain, arm numbness, and chest pain.  Patient went to the ER & said the test all came back good.  She is following up with her Dr.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Influenza virus test negative, Injection site pain, Myalgia
Clinical narrative: 1/13/24 EVENING: FEVER OF 102, MUSCLE AND BODY ACHES, LOCALIZED PAIN AT INJECTION SITE. 1/14/24 EXTREME FATIGUE AND SEVERE HEADACHE. 1/15/24 RUNNY NOSE, SNEEZING, SORE THROAT. PATIENT WAS SEEN BY PRIMARY CARE ON TUESDAY AND TESTED FOR BOTH FLU AND COVID BUT BOTH WERE NEGATIVE. PATIENT TREATING WITH OTC MEDICATIONS AT THIS TIME FOR SYMPTOMS STATED ABOVE. FEVER HAS COME DOWN, PAIN AT INJECTION SITE RESOLVED, BODY ACHES RESOLVED BUT ALL COLD SYMPTOMS AND SEVERE HEADACHE STILL PRESENT.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: 1/13/24 EVENING: FEVER OF 102, MUSCLE AND BODY ACHES, LOCALIZED PAIN AT INJECTION SITE. 1/14/24 EXTREME FATIGUE AND SEVERE HEADACHE. 1/15/24 RUNNY NOSE, SNEEZING, SORE THROAT. PATIENT WAS SEEN BY PRIMARY CARE ON TUESDAY AND TESTED FOR BOTH FLU AND COVID BUT BOTH WERE NEGATIVE. PATIENT TREATING WITH OTC MEDICATIONS AT THIS TIME FOR SYMPTOMS STATED ABOVE. FEVER HAS COME DOWN, PAIN AT INJECTION SITE RESOLVED, BODY ACHES RESOLVED BUT ALL COLD SYMPTOMS AND SEVERE HEADACHE STILL PRESENT.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, Sneezing
Clinical narrative: 1/13/24 EVENING: FEVER OF 102, MUSCLE AND BODY ACHES, LOCALIZED PAIN AT INJECTION SITE. 1/14/24 EXTREME FATIGUE AND SEVERE HEADACHE. 1/15/24 RUNNY NOSE, SNEEZING, SORE THROAT. PATIENT WAS SEEN BY PRIMARY CARE ON TUESDAY AND TESTED FOR BOTH FLU AND COVID BUT BOTH WERE NEGATIVE. PATIENT TREATING WITH OTC MEDICATIONS AT THIS TIME FOR SYMPTOMS STATED ABOVE. FEVER HAS COME DOWN, PAIN AT INJECTION SITE RESOLVED, BODY ACHES RESOLVED BUT ALL COLD SYMPTOMS AND SEVERE HEADACHE STILL PRESENT.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Fall
Clinical narrative: Patient was seated during administration. When he went to stand up to put his sweatshirt back on, fell backward into the exam table and had complaints of feeling dizzy and not remembering falling over. Provider was in the room with patient already and immediately elevated his legs. Nurse came in right after and placed cool wash cloth on the back of his neck and fanned him .
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Mom states last night had a couple of small mosquito like bumps that turned into one big spot at injection site. Eventually went away after giving Tylenol and applying Benadryl topical ointment. 1/17/24 upper arm swollen again, red, firm and warm to the touch. Reviewed symptoms with Dr., informed mom to apply cold compress and give Tylenol for soreness.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Bursitis, Cervical radiculopathy, Immediate post-injection reaction, Injection site pain
Clinical narrative: Subjective Chief Complaint Patient presents with   Left Shoulder - Pain    Log out History of Present Illness: Ms. is a 66 y.o. female who presents to clinic for initial evaluation of left shoulder pain. Patient reports that on 12/19/23, she had a pneumonia vaccine administered in her left lateral shoulder at Pharmacy, causing immediate, severe pain in the area of injection. She later noted having pain at night since then as well as some swelling and reduced ROM of the shoulder. Patient went to a walk-in clinic on 12/22/23, who did x-rays and gave her an IM Toradol injection. She kept having pain and went to the ER on 12/26/23, who gave her a steroid and IM Ketorolac injection, as well as prescribed Medrol Dosepak and hydrocodone. Patient had a Toradol shot done at the ER and was given a Medrol Dosepak. She visited her PCP on 12/28/23, who referred her to me. Patient also describes some radiating pain into her dorsal wrist ano hand, consistent with her history of cervical DJD. Today, her pain is described as a 5 out of ten on a pain scale, aching in sensation. She has increased pain when trying to elevate her shoulder. Of note, she is on amitriptyline and Gabapentin. Past History: Current Outpatient Medications:   ALBUTEROL SULFATE INHL, Inhale., Disp.   Assessment/Plan 1. Osteoarthritis of spine with radiculopathy, cervical region 2. Acute pain of left shoulder 3. Shoulder impingement syndrome, left 4. Acute bursitis of left shoulder 5. Adhesive capsulitis of left shoulder Plan: After lengthy discussion, Ms. would like to proceed with conservative treatment for her left shoulder subacromial bursitis, left shoulder impingement and cervical DJD. I ordered PT left shoulder and lumbar spine. I administered a left shoulder subacromial bursa steroid injection which she tolerated well. Patient reports that she ahs been given Meloxicam in the past but has not taken it. I advised beginning use of Meloxicam once a day for pain relief. I will reassess her in 4-6 weeks. Procedure Consent Consent was obtained after extensive discussion of risks such as bleeding, infection, skin changes, etc as well as verification that they have no allergies to medications or supplies used. The patient wished to proceed and provided verbal consent. Large Joint Arthrocentesis: L subacromial
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Joint range of motion decreased, Pain, Pain in extremity, Periarthritis
Clinical narrative: Subjective Chief Complaint Patient presents with   Left Shoulder - Pain    Log out History of Present Illness: Ms. is a 66 y.o. female who presents to clinic for initial evaluation of left shoulder pain. Patient reports that on 12/19/23, she had a pneumonia vaccine administered in her left lateral shoulder at Pharmacy, causing immediate, severe pain in the area of injection. She later noted having pain at night since then as well as some swelling and reduced ROM of the shoulder. Patient went to a walk-in clinic on 12/22/23, who did x-rays and gave her an IM Toradol injection. She kept having pain and went to the ER on 12/26/23, who gave her a steroid and IM Ketorolac injection, as well as prescribed Medrol Dosepak and hydrocodone. Patient had a Toradol shot done at the ER and was given a Medrol Dosepak. She visited her PCP on 12/28/23, who referred her to me. Patient also describes some radiating pain into her dorsal wrist ano hand, consistent with her history of cervical DJD. Today, her pain is described as a 5 out of ten on a pain scale, aching in sensation. She has increased pain when trying to elevate her shoulder. Of note, she is on amitriptyline and Gabapentin. Past History: Current Outpatient Medications:   ALBUTEROL SULFATE INHL, Inhale., Disp.   Assessment/Plan 1. Osteoarthritis of spine with radiculopathy, cervical region 2. Acute pain of left shoulder 3. Shoulder impingement syndrome, left 4. Acute bursitis of left shoulder 5. Adhesive capsulitis of left shoulder Plan: After lengthy discussion, Ms. would like to proceed with conservative treatment for her left shoulder subacromial bursitis, left shoulder impingement and cervical DJD. I ordered PT left shoulder and lumbar spine. I administered a left shoulder subacromial bursa steroid injection which she tolerated well. Patient reports that she ahs been given Meloxicam in the past but has not taken it. I advised beginning use of Meloxicam once a day for pain relief. I will reassess her in 4-6 weeks. Procedure Consent Consent was obtained after extensive discussion of risks such as bleeding, infection, skin changes, etc as well as verification that they have no allergies to medications or supplies used. The patient wished to proceed and provided verbal consent. Large Joint Arthrocentesis: L subacromial
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rotator cuff syndrome, X-ray limb abnormal
Clinical narrative: Subjective Chief Complaint Patient presents with   Left Shoulder - Pain    Log out History of Present Illness: Ms. is a 66 y.o. female who presents to clinic for initial evaluation of left shoulder pain. Patient reports that on 12/19/23, she had a pneumonia vaccine administered in her left lateral shoulder at Pharmacy, causing immediate, severe pain in the area of injection. She later noted having pain at night since then as well as some swelling and reduced ROM of the shoulder. Patient went to a walk-in clinic on 12/22/23, who did x-rays and gave her an IM Toradol injection. She kept having pain and went to the ER on 12/26/23, who gave her a steroid and IM Ketorolac injection, as well as prescribed Medrol Dosepak and hydrocodone. Patient had a Toradol shot done at the ER and was given a Medrol Dosepak. She visited her PCP on 12/28/23, who referred her to me. Patient also describes some radiating pain into her dorsal wrist ano hand, consistent with her history of cervical DJD. Today, her pain is described as a 5 out of ten on a pain scale, aching in sensation. She has increased pain when trying to elevate her shoulder. Of note, she is on amitriptyline and Gabapentin. Past History: Current Outpatient Medications:   ALBUTEROL SULFATE INHL, Inhale., Disp.   Assessment/Plan 1. Osteoarthritis of spine with radiculopathy, cervical region 2. Acute pain of left shoulder 3. Shoulder impingement syndrome, left 4. Acute bursitis of left shoulder 5. Adhesive capsulitis of left shoulder Plan: After lengthy discussion, Ms. would like to proceed with conservative treatment for her left shoulder subacromial bursitis, left shoulder impingement and cervical DJD. I ordered PT left shoulder and lumbar spine. I administered a left shoulder subacromial bursa steroid injection which she tolerated well. Patient reports that she ahs been given Meloxicam in the past but has not taken it. I advised beginning use of Meloxicam once a day for pain relief. I will reassess her in 4-6 weeks. Procedure Consent Consent was obtained after extensive discussion of risks such as bleeding, infection, skin changes, etc as well as verification that they have no allergies to medications or supplies used. The patient wished to proceed and provided verbal consent. Large Joint Arthrocentesis: L subacromial
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Inadvertently received wrong COVID-19 vaccine product. No adverse symptom or signs reported by patient.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: I got the SPIKEVAX on Jan. 12th, and every night since then I've had profuse NIGHT SWEATS around my chest and shoulders. I've had sweats before, but not to the same degree and frequency.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Diarrhoea, Exposure during pregnancy, Nausea, Vomiting
Clinical narrative: Normal uncomplicated pregnancy in third trimester and 31 weeks gestation of pregnancy, multigravida of advanced maternal age, second pregnancy, estimated delivery date March 15/2024, Blood Pressure 113/59, BMI 36.31 Weight 205 lb (93 kg) Immunizations Given:  tetanus diphtheria pertussis (Tdap) vaccine, age 7+ yr (ADACEL, BOOSTRIX), adverse reaction NAUSEA, DIARRHEA, VOMITING
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Injection site nodule
Clinical narrative: nodule in thigh at injection site.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient given Spikevax Moderna vaccine which is for 12 & older. Patient has not reported with adverse reaction.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Skin mass
Clinical narrative: subcutaneous nodule ~2cm  with minor overlaying skin color changes remain two weeks out from vaccine administration (no longer has pain, swelling, erythema)
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Extreme nausea;  extreme fatigue, headaches,  rt  arm hurt x?s 1 week after inj.   No tx;   Lasted x?s 1 wk ;
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient returned to the pharmacy 01/09/2024 and expressed much concern about significant bruising (approx 2 inches in diameter), hard and warm lumps under the injection site, location of vaccine administration, and pain and swelling surrounding the injection site. The injection appeared to be administered much lower than the appropriate and recommended deltoid site per injection technique guidelines. The patient also stated she is medically trained and is aware of proper injection technique.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Product administered at inappropriate site
Clinical narrative: Patient returned to the pharmacy 01/09/2024 and expressed much concern about significant bruising (approx 2 inches in diameter), hard and warm lumps under the injection site, location of vaccine administration, and pain and swelling surrounding the injection site. The injection appeared to be administered much lower than the appropriate and recommended deltoid site per injection technique guidelines. The patient also stated she is medically trained and is aware of proper injection technique.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: C-reactive protein, Febrile convulsion, Full blood count normal, Urine analysis normal
Clinical narrative: Febrile seizure
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Chest discomfort, Dizziness, Dyspnoea, Fatigue
Clinical narrative: tightness in chest, trouble breathing, dizziness, tiredness, weakness
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives generally all over the body and coughing right after injection. Provider entered room and IM decadron was administered to the patient. He was sent to the ER and monitored. ER administered benadryl and sent the patient home
Age: 79.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Condition aggravated, Multiple sclerosis, Paralysis
Clinical narrative: PATIENT EXPERIENCE MS FLARE WITH TOTAL PARALYSIS THE NIGHT AFTER COADMINISTRATION OF VACCINES. SYMPTOMS RESOLVE WITHIN 24 HOURS.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: DTaP + IPV (Kinrix) was given.  Patient was 7 years of age and should have gotten, Tdap and seperate IPV.
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Heart rate increased
Clinical narrative: DIARRHEA, RAPID HEART RATE, DIARRHEA SINCE 1/4/2024
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: DTaP + IPV (Kinrix) was given when patient was 7 years of age. Child should have received Tdap and IPV seperately.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Pt experienced bruising and swelling at injection site. Bruising still visible today (1/17/2024). Pt states she did not have pain initially and noticed the bruising at her annual physical on 1/10/2024
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Hot flush, Nasopharyngitis, Pain
Clinical narrative: Pt states they had aches/pains/ cold symptoms for about 2 days but has had hot flashes on and off every since receiving the vaccine
Age: 15.0
Sex: M
Vaccine: HPV9, IPV, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives scattered on upper body starting Sunday night January 14th, 2024. He visited the health center 1pm on Monday January 15th.  Our Director of the Health Center started hi mon Zyrtec 180mg po x 1 tablet twice a day for 7 days. On Tuesday January 16th he visited the health center and no longer had hives.
Age: 64.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was given a dose of Shingrix vaccine despite already finishing the 2-dose series in 2021
Age: 35.0
Sex: M
Vaccine: COVID19-2, HPV9
Symptoms: Dizziness, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Patient passed out immediately after receiving both vaccines (Covid19 vaccine was first given followed by the HPV). He was unresponsive for about  3 to 4 seconds. He was helped to lie on his back with his legs elevated for about 30 to 40 minutes. He complaint of feeling a little dizzy but completely recovered after an additional 20 minutes.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Induration, Localised infection, Malaise
Clinical narrative: Patient came to pharmacy on Wednesday and presented with a large red area on left arm. She stated area was hard and hot. Night of injection (Monday) felt body hurting and burning on arm. On Tuesday, was sick all day. On Wednesday, had appointment with dermatologist who stated was an infection. She was prescribed a steroid cream and antibiotics.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Skin warm
Clinical narrative: Patient came to pharmacy on Wednesday and presented with a large red area on left arm. She stated area was hard and hot. Night of injection (Monday) felt body hurting and burning on arm. On Tuesday, was sick all day. On Wednesday, had appointment with dermatologist who stated was an infection. She was prescribed a steroid cream and antibiotics.
Age: 57.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered outside of manufacturer and CDC guidelines
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired vaccine
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: Hives that appear out of nowhere.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Diplopia, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: Sudden onset of double vision.  Dr. performed eye exam and ordered labs and MRI.  MRI and labs showed no abnormalities.  Double vision lasted until 12/26/2023 when it suddenly resolved.  No recurrence to date.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Constipation, Heart rate irregular, Palpitations, Sleep disorder
Clinical narrative: She got her vaccine she was fine at that time.  She was fine the rest of the day.  She then was awakened at 1:00 AM due to palpitations, and tried to go back to sleep but was awakened as they were constant.  She was taking her pulse and there were a little skip.  When she was awake in the morning she had some palpitations. She went to the gym and told them that she was having palpitations and she told them were the machine was.  By that evening she was starting to slow down and not have the palpitations.  That evening around 10:00 PM she was OK and they had gone away.  She has a history of having palpitations in the past but has never showed anything significant.  She has not notified her doctor of this as of yet and she is going to notify her through EMR.   2 days later she took some magnesium for constipation and took an extra one and had some palpitations ,but then they went away and has not had any since.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCNE FROZEN INSTEAD OF REFRIGERATED.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered two Prevnar20 vaccines within 6 months of each other. The first was given on 7-19-2023 and the second on 1/2/2024. Pt reported no adverse outcomes at office visit on 1/17/24. Error was discovered on review of chart prior to patient appointment.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN ISTEAD OF REFRIGERATED
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Product distribution issue, Product storage error
Clinical narrative: Pt was seen in clinic on 1/16/24.  He received a TDAP vaccine out of a shipment that had been received on that day.  Sanofi notified the clinic later that day  that they could not verify that the shipment had not been out of temperature due to the length of time in transit.  Pt was advised to receive another dose as soon as possible.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Product distribution issue, Product storage error
Clinical narrative: Pt was seen in clinic on 1/16/24.  She received a TDAP vaccine out of a shipment that had been received on that day.  Sanofi notified the clinic later that day  that they could not verify that the shipment had not been out of temperature due to the length of time in transit.  Pt was advised to receive another dose as soon as possible.
Age: 1.25
Sex: F
Vaccine: COVID19, HEPA, MMR, PNC20
Symptoms: Product preparation issue
Clinical narrative: Did not dilute vaccine with dilution and only gave 0.3 of the vaccine
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: She got her vaccine and it was sore and then it started to itch and took cold pack and Tylenol.  Then did that everyday after that.  She could not take the itching anymore and Saturday 12/30/2023 she started putting Cortisone 10 on it, and by then she had a patch on her arm that was all red, like 2 x 4 patch.  It went a couple of inches over and a couple of inches down from the area of the injection.  She continued after that to take Tylenol, put ice on it and take the Cortisone.  She stopped doing that regimen and on Monday, 1/1/24 she only began putting the cortisone cream on once a day as the itching had calmed down to about once a day and it kept it under control  She did not want to put too much on as she felt it might interfere with the shot.  On 1/6/24 was the last time she put Cortisone on it.  Now if she looks at her arm she can still a slight discoloration of that patch of itchiness on her arm, but it has not bothered her.   It may about 1-2 times a day that she may itch but it?s not bad and the itching does not last long.  She rubs it a little bit and then it goes away.   She had all of the COVID shots and did not have any problems other than the last one she had some itching.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Did not dilute vaccine with dilution and only gave 0.3 of the vaccine
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Covid-related death
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac tamponade, Catheterisation cardiac, Echocardiogram, Electrocardiogram, Pericarditis
Clinical narrative: Pt experienced Pericarditis that ultimately resulted in Cardiac Tamponade which was successfully treated
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Pt experienced Pericarditis that ultimately resulted in Cardiac Tamponade which was successfully treated
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Limb mass, Mobility decreased, Myalgia
Clinical narrative: Patient called and stated that she has a small lump in her right arm and muscle soreness (hard to life things like milk jugs)