chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: unable to stand or eat; unable to stand or eat; It felt similar to an extreme hangover; Diarrhea; I woke up, it was dark, and I immediately vomited into my trash can; headache; fever; My joints hurt; This spontaneous case was reported by a patient and describes the occurrence of DYSSTASIA (unable to stand or eat), FEEDING DISORDER (unable to stand or eat), HANGOVER (It felt similar to an extreme hangover), DIARRHOEA (Diarrhea) and VOMITING (I woke up, it was dark, and I immediately vomited into my trash can) in a 37-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032680) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2024 at 12:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. In February 2024, the patient experienced DYSSTASIA (unable to stand or eat), FEEDING DISORDER (unable to stand or eat), HANGOVER (It felt similar to an extreme hangover), DIARRHOEA (Diarrhea), VOMITING (I woke up, it was dark, and I immediately vomited into my trash can), HEADACHE (headache), PYREXIA (fever) and ARTHRALGIA (My joints hurt). At the time of the report, DYSSTASIA (unable to stand or eat), FEEDING DISORDER (unable to stand or eat), DIARRHOEA (Diarrhea) and ARTHRALGIA (My joints hurt) outcome was unknown and HANGOVER (It felt similar to an extreme hangover), VOMITING (I woke up, it was dark, and I immediately vomited into my trash can), HEADACHE (headache) and PYREXIA (fever) was resolving.            Concomitant and treatment medications were not reported.  Patient had the vaccine administered at 12:30 pm, then went to sleep at 2:30pm. When patient woke up, it was dark, and he immediately vomited into his trash can. Patient had a splitting headache, his joints hurt, patient had a fever and diarrhea. Over the next several hours (patient don't know how many), patient vomited 8 times, visited the bathroom 6 times and was unable to stand or eat. Patient literally had to crawl across the floor to get to the bathroom. It felt similar to an extreme hangover.  It was unknown if the patient experienced any additional symptoms/events and medication Details and reason for taking the medicine.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2024, the patient received the 1st dose of Shingrix. In JAN-2024, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Extreme fatigue). The outcome of the fatigue was not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: GSK receipt date: 08-FEB-2024 The patient self-reported this case. The patient age was 80 years in April. The patient got the first Shingrix shot a few weeks ago around the 8th of January 2024. since then, was experiencing extreme fatigue like never before. The patient asked was it possible that after receiving the first Shingrix shop, it could cause fatigue.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; 1 patient after product was involved in a temperature excursion; This spontaneous report has been received from a nurse, regarding a patient with unknown age and gender. The patient's concurrent condition, pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) occurred temperature excursions. On 12-FEB-2024, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot number X010531 has been verified to be a valid lot number and expiration date was 11-APR-2025, frequency, route of administration and anatomical location were not provided) for prophylaxis (product storage error).   The temperature was reported as 16.5 Fahrenheit degree (F). The Time frame was reported as 14 F to 46 F for 24 hours 0 minutes 0 seconds, 6 F to 14 F for 54 hours 45 minutes 0 seconds. The previous temperature excursion did not occur. No patient symptoms have been reported. No additional adverse event (AE) (no adverse event).
Sex: F
Vaccine: RSV
Symptoms: Injection site vesicles
Clinical narrative: Blister at injection site; This non-serious case was reported by a physician via patient support programs and described the occurrence of injection site blisters in a 60-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On an unknown date, the patient received the 1st dose of Arexvy (left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site blisters (Verbatim: Blister at injection site). The outcome of the injection site blisters was not resolved.   The reporter considered the injection site blisters to be related to Arexvy.     The company considered the injection site blisters to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-FEB-2024 The patient was diabetic. The physician reported that, the patient received 1st dose of arexvy. The patient had blisters at injection site.
Sex: U
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling; heat; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 3 days after receiving Arexvy, the patient experienced swelling (Verbatim: Swelling) and feeling hot (Verbatim: heat). The outcome of the swelling and feeling hot were not reported.   It was unknown if the reporter considered the swelling and feeling hot to be related to Arexvy.     It was unknown if the company considered the swelling and feeling hot to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-FEB-2024  The case was received from the patient via (AE monitoring database) interactive digital media. The patient was reporter The reporter reported that he had swelling and heat and a large area around the vax site 3 days after the vaccination. The reporter asked it that concerning. The follow-up would not be possible as no contact details were available.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received Arexvy on AUG-2023 and a second dose on 29-SEP-2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 93pd7, expiry date 22-OCT-2024) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 29-SEP-2023, the patient received the 2nd dose of Arexvy. On 29-SEP-2023, an unknown time after receiving Arexvy and an unknown time after receiving AREXVY, the patient experienced extra dose administered (Verbatim: Patient received Arexvy on AUG-2023 and a second dose on 29-SEP-2023.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2024 The pharmacist reported patient received second dose of Arexvy, which led to extra dose administered. The pharmacy discovered error a week ago when insurance called back regarding 2 claims. The pharmacist could not confirm if the patient got the second dose but could assume. The reporter consented to follow up.
Sex: M
Vaccine: RVX
Symptoms: Discomfort, Pain in extremity, Sleep disorder, Social avoidant behaviour
Clinical narrative: very uncomfortable; keeps me up at night at times; Pain in arm; Shy; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a 85-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 30-JAN-2024, the patient received RSV vaccine. On 30-JAN-2024, less than a day after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Pain in arm) and shyness (Verbatim: Shy). On an unknown date, the patient experienced discomfort (Verbatim: very uncomfortable) and sleeplessness (Verbatim: keeps me up at night at times). The outcome of the pain in arm and shyness were not resolved and the outcome of the discomfort and sleeplessness were not reported.   It was unknown if the reporter considered the pain in arm, shyness, discomfort and sleeplessness to be related to RSV vaccine.     It was unknown if the company considered the pain in arm, shyness, discomfort and sleeplessness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 12-FEB-2024 The patient stated that she had every vaccination recommended and had no problems. This time the pain has gotten very uncomfortable and even keeps me up at night at times. (Pain in arm and shy). The symptoms were not treated. The reporter consented to follow up.
Sex: U
Vaccine: RVX
Symptoms: Headache
Clinical narrative: headaches; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in an unspecified number of patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced headache (Verbatim: headaches). The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to RSV vaccine.     It was unknown if the company considered the headache to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 08-FEB-2024 A consumer stated that her Physical Therapist told her that they had seen several patients suffering with headaches after receiving the RSV vaccine (manufacturer not specified). The reporter did not consent to follow up. The case is linked with US2024017861, same reporter.; Sender's Comments:  US-GSK-US2024017861:1 of 2 report
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Administration after exposure to frozen temperatures; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number B2L4G, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: Administration after exposure to frozen temperatures). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-FEB-2024 The reporter was a medical assistant. The reporter called to report that their doses of FluLaval were exposed to temperatures as low as 29.7 degrees Fahrenheit to multiple excursion and would like to know how to proceed, which led to incorrect storage of vaccine. No information about patients was provided, nor events, but it was given for the vaccines. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 35.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 35 year-old patient mistakenly receive Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-FEB-2024, the patient received Arexvy. On 09-FEB-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 35 year-old patient mistakenly receive Arexvy). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2024 A pharmacist reported that a 35 year-old patient mistakenly receive Arexvy, which led to inappropriate age at vaccine administration. The healthcare professional asked for safety information. Lot number and expiration date were not provided by the reporter. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to pediatric patient; Adult dose given to pediatric patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 2-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 25-OCT-2023, the patient received the 2nd dose of Havrix 1440 adult. On 25-OCT-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: Adult dose given to pediatric patient) and overdose (Verbatim: Adult dose given to pediatric patient). The outcome of the adult product administered to child and overdose 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-FEB-2024 A Pharmacist contacted GlaxoSmithKline via phone inquiring about Havrix and what information was available about the administration of an adult dose to a 2 year old female which led to adult product administered to child and overdose. They provided data about the vaccine, patient, event. The reporter consented to receive follow up. The vaccine administration facility is the same as primary reporter. This case is linked with US2024018937, same reporter.; Sender's Comments:  US-GSK-US2024018937:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: DESTROYED MY LIFE WITH YOUR COVID VACCINE; This spontaneous report received from a patient via social media and it was unknown if it was an J&J managed social media site concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose series:1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced destroyed life with covid vaccine and stated that Jannsen knows all about it. Has it from the beginning and stated covid vaccine ruined life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of destroyed my life with your covid vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: report pain with a flu shot; Initial information received on 06-Feb-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2024SA045767(CLUSTER).  This case involves an unknown age female patient who experienced report pain while receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number, dosage, route, administration site, expiration date and strength not reported) for immunization  On an unknown date (unknown latency) the patient had developed non-serious event of pain (vaccination site pain) following the administration of Influenza Vaccine.  Action taken: Unknown.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Angiogram cerebral, Bell's palsy, Blood test, Cerebral haemorrhage, Chest X-ray
Clinical narrative: Facial droop right side, brain bleed, Bell's Palsy
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Computerised tomogram head, Computerised tomogram thorax, Electrocardiogram, Electroencephalogram, Facial paralysis
Clinical narrative: Facial droop right side, brain bleed, Bell's Palsy
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging neck, Magnetic resonance imaging spinal
Clinical narrative: Facial droop right side, brain bleed, Bell's Palsy
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Decreased appetite, Feeding disorder, Injection site rash, Pyrexia
Clinical narrative: Hib on 1-11-2024 Pedvaxhib V029145 fever and loss of appetite, unable to eat. rash at the single shot sight
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Flu shot was given as an extra shot. Patient originally got the first flu shot in 09/2023 and patient could not remember and it was not showing up on my computer that he got it. Second(extra) shot was given today 02/15/2024. Patient was made aware and tolerated injection well in office and left clinic without any difficulties. No treatment or further work up needed
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: low grade fever 100.3 taken at 11am. Hives were noticed around 6:40pm, predominantly on his left leg (injection site) from ankle up to left hip, with a few on his left arm and right leg as well.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Pain, Tenderness
Clinical narrative: Feeling run down and weakness, Sensitive to touch,  and Taking Ibuprofen for pain
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site movement impairment, Injection site pain, Magnetic resonance imaging abnormal, Muscle strain
Clinical narrative: Intense pain and burning reported at time of IM injection right deltoid on 11/21/2023. On 12/08/2023, pain described as deep aching/burning which radiates down to elbow. Unable to abduct shoulder. Pain is worse with use of the arm and nothing relieves the pain. Tried Ibuprofen with some effect. Exam confirmed tenderness over right anterior deltoid and limited shoulder abduction ability secondary to pain. Gabapentin prescribed for neuropathic pain. Advised to continue NSAIDs. Ultrasound performed 12/8/2023, which showed no sonographic abnormality in the area of concern. MRI performed 01/06/2024, which showed a Grade 1 teres minor muscle strain versus contusion. Referral to pain clinic provided 01/16/2024.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pain, Ultrasound scan normal
Clinical narrative: Intense pain and burning reported at time of IM injection right deltoid on 11/21/2023. On 12/08/2023, pain described as deep aching/burning which radiates down to elbow. Unable to abduct shoulder. Pain is worse with use of the arm and nothing relieves the pain. Tried Ibuprofen with some effect. Exam confirmed tenderness over right anterior deltoid and limited shoulder abduction ability secondary to pain. Gabapentin prescribed for neuropathic pain. Advised to continue NSAIDs. Ultrasound performed 12/8/2023, which showed no sonographic abnormality in the area of concern. MRI performed 01/06/2024, which showed a Grade 1 teres minor muscle strain versus contusion. Referral to pain clinic provided 01/16/2024.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Decreased appetite, Injection site swelling
Clinical narrative: MOM TO PATIENT TO ER ON EVENING HE HAD VACCINES WITH CONCERNS OF UPPER AND LOWER LEG SWELLING AND DECREASED APPETITE. BY THE TIME THEY HAD GOTTEN TO ER THE SWELLING HAD RESOLVED PER ER NOTE.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia
Clinical narrative: Pt was given spikevax 11/28, since then has been having hyperglycemia. Prior to this covid injection, his blood sugars were extremely well controlled.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia
Clinical narrative: Pt was given Moderna spikevax, after vaccine, pt has had severe hyperglycemia. Prior to vaccine, diabetes was very well controlled.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage within 48 hours
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: This was a dose for the 5y->12y & the correct dose for his age group of 12y+.  Grandmother & patient informed & apologized to immediately when happened.  No adverse affects noted.
Age: 1.25
Sex: F
Vaccine: PNC20
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Mother messaged clinic about Large red rash surrounding injection site. Image provided by mother.  Mother denied any fever or other symptoms present.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Dyskinesia, Hyperhidrosis, Loss of consciousness
Clinical narrative: Right after the 4 vaccines given @4:55pm patient was pale sweat, started to both extremities' jerky and loss of consciousness. The jerky and loss of conscious lasted 4 seconds. The patient is weak, felt dizzy, nausea, vomited a few ml white clear liquid. Check BP 88/44 P54 @4:57PM; BP 84/49 P57, SPO2 99% @5:01PM; bp 99/66 P58, SPO2 99% @5:07PM; BP 95/62 P67 SPO2 98% @5:30PM.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Nausea, Pallor, Vomiting
Clinical narrative: Right after the 4 vaccines given @4:55pm patient was pale sweat, started to both extremities' jerky and loss of consciousness. The jerky and loss of conscious lasted 4 seconds. The patient is weak, felt dizzy, nausea, vomited a few ml white clear liquid. Check BP 88/44 P54 @4:57PM; BP 84/49 P57, SPO2 99% @5:01PM; bp 99/66 P58, SPO2 99% @5:07PM; BP 95/62 P67 SPO2 98% @5:30PM.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: vaccination site-swollen, erythematous and itchy
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV, TDAP
Symptoms: Arthralgia, Culture, Hepatomegaly, Laboratory test, Magnetic resonance imaging normal
Clinical narrative: 2/7/2024 Family calls today saying they went to urgent care because child had pain in her left hip and doctor told her it could be from the polio vaccine and to contact us. I saw pt. in clinic and both arms have no redness, swelling, bruising or any trauma. In fact, you cannot tell if there were shots given. Family states she started complaining of left hip and thigh area pain on Saturday (3 days after vaccines). On the exam I see what looks like an entry point on the lateral left hip area? spider bite, exactly where she points to where the pain is. The left thigh seems somewhat tight and warmer than the right. There is no redness or streaking that I can see. Directed family to ER to be evaluated and treated, made it clear this is what needs to be done. I also told them I do not believe this is from the shots we gave her 1 week ago. Told family to call me after ER visit to update me, they stated they would. 2/8/24 LVM ? no answer 2/9/24 @ 11 am ? Spoke with Uncle, student was admitted to hospital. Per uncle, x-rays showed nothing so doing MRI of lower body. Uncle states fever for 3 days in am and pm. Cultures were done also. No diagnosis yet. Uncle states pain in hip getting worse. Asked about the puncture area on left hip ? where her pain is - and Uncle stated doctor said that was nothing. 2/9/2024@130pm ? no answer 2/13/24 LVM to have family call us to let us know how pt. is doing. 2/14/24 Aunt calls and states pt. has no more pain and can walk. Doctors think it was a post viral problem, MRI and x-rays all normal. Still waiting for lab work. Aunt also states her liver was enlarged. Aunt states no shots in other country. Rheumatologist suggest to hold off on vaccines until mid to late March, I will contact school nurse.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV, TDAP
Symptoms: Pain in extremity, Pyrexia, Skin warm, Viral infection, X-ray normal
Clinical narrative: 2/7/2024 Family calls today saying they went to urgent care because child had pain in her left hip and doctor told her it could be from the polio vaccine and to contact us. I saw pt. in clinic and both arms have no redness, swelling, bruising or any trauma. In fact, you cannot tell if there were shots given. Family states she started complaining of left hip and thigh area pain on Saturday (3 days after vaccines). On the exam I see what looks like an entry point on the lateral left hip area? spider bite, exactly where she points to where the pain is. The left thigh seems somewhat tight and warmer than the right. There is no redness or streaking that I can see. Directed family to ER to be evaluated and treated, made it clear this is what needs to be done. I also told them I do not believe this is from the shots we gave her 1 week ago. Told family to call me after ER visit to update me, they stated they would. 2/8/24 LVM ? no answer 2/9/24 @ 11 am ? Spoke with Uncle, student was admitted to hospital. Per uncle, x-rays showed nothing so doing MRI of lower body. Uncle states fever for 3 days in am and pm. Cultures were done also. No diagnosis yet. Uncle states pain in hip getting worse. Asked about the puncture area on left hip ? where her pain is - and Uncle stated doctor said that was nothing. 2/9/2024@130pm ? no answer 2/13/24 LVM to have family call us to let us know how pt. is doing. 2/14/24 Aunt calls and states pt. has no more pain and can walk. Doctors think it was a post viral problem, MRI and x-rays all normal. Still waiting for lab work. Aunt also states her liver was enlarged. Aunt states no shots in other country. Rheumatologist suggest to hold off on vaccines until mid to late March, I will contact school nurse.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported, just a duplicate vaccine. Patient requested an Abrysvo injection and received it on 2/1/24 after already getting an Arexvy injection on 12/14/23.  The computer did NOT show a previous Arexvy when the Abrysvo was completed.
Age: 1.58
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: pt was given ActHIB, this vaccine was two days out of date, there are no adverse reactions as of this time
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Pregnant patient was prescribed Recombivax but was administered Heplisav.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Fatigue, Headache, Hypertension
Clinical narrative: MODERNA #1 4/5/2021 MODERNA #2  5/4/2021 SHORTLY LATER IN MAY 2021 DEVELOPED HYPERTENSION HEADACHES DIZZINESS TACHYCARDIA FATIGUE MALAISE
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Malaise, Tachycardia
Clinical narrative: MODERNA #1 4/5/2021 MODERNA #2  5/4/2021 SHORTLY LATER IN MAY 2021 DEVELOPED HYPERTENSION HEADACHES DIZZINESS TACHYCARDIA FATIGUE MALAISE
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: At the injection site, I have a large red spot, twice as big as a silver dollar, and it is a hard lump in there. And I have had an ongoing headache. Just a general feeling of lethargy and just not feeling quite right. I have taken vaccines before and I have never had a reaction to any of them like this before. It's still ongoing. It hasn't calm down very much so I thought I report it to you. The outcome has not happened yet, I have been treating it with benadryl both pills and topical lotion, and compress's that were all instructed by the pharmacist. I have taken Excedrin for the headaches. It's calm down a little bit, but it's not gone away yet.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Lethargy
Clinical narrative: At the injection site, I have a large red spot, twice as big as a silver dollar, and it is a hard lump in there. And I have had an ongoing headache. Just a general feeling of lethargy and just not feeling quite right. I have taken vaccines before and I have never had a reaction to any of them like this before. It's still ongoing. It hasn't calm down very much so I thought I report it to you. The outcome has not happened yet, I have been treating it with benadryl both pills and topical lotion, and compress's that were all instructed by the pharmacist. I have taken Excedrin for the headaches. It's calm down a little bit, but it's not gone away yet.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient reports soreness at the site of injection and has continued for several months post-vaccine
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eye discharge, Eye inflammation, Eye pain, Eye pruritus, Laboratory test
Clinical narrative: My eyes became bloodshot. Red, ichy and runny. Looked like pink eye. Painful. Waited a week to see if it would go away on its own.  It did not.  Consulted with Urgent Care and was given drops which did not help. Made a Drs. appt. with my primary. She prescribed me steroid drops which did help and told me to see my Eye Dr. for additional tests. With Dr., did every test imaginable. Eyes were inflammed and I developed a prominent floater. In addition, my eye sight got worse.  My contacts and eyeglasses were no longer strong enough.  Had to invest in new contacts and glasses. Went from 6.50L / 5.75R to 7.00L / 6.50R.  After multiple visits and many tests, I took drops that helped, but to this day I do not feel like my eyes are as healthy as they once were.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Ocular hyperaemia, Visual impairment, Vitreous floaters
Clinical narrative: My eyes became bloodshot. Red, ichy and runny. Looked like pink eye. Painful. Waited a week to see if it would go away on its own.  It did not.  Consulted with Urgent Care and was given drops which did not help. Made a Drs. appt. with my primary. She prescribed me steroid drops which did help and told me to see my Eye Dr. for additional tests. With Dr., did every test imaginable. Eyes were inflammed and I developed a prominent floater. In addition, my eye sight got worse.  My contacts and eyeglasses were no longer strong enough.  Had to invest in new contacts and glasses. Went from 6.50L / 5.75R to 7.00L / 6.50R.  After multiple visits and many tests, I took drops that helped, but to this day I do not feel like my eyes are as healthy as they once were.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Loss of consciousness
Clinical narrative: vaccine administered without issue and pt had exited the immunization room, RPh was made aware of a customer that had passed out in the vestibule, arrived to find pt sitting in chair her son was holding her jacket and a CNA was checking her pulse (good and strong).  EMTs arrived and took over care and pt was alert to  name, date and location, pt was transported to the emergency room
Age: 0.33
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was given the 1 vail dose of Menveo instead of 2 vial dose
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong dosage formulation
Clinical narrative: This was the wrong formulation given to patient.
Age: 73.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Mechanical ventilation, Neurological symptom
Clinical narrative: Per MD the patient was put on a vent and Guillain-Barré is the working diagnosis provided by the hospital treating the patient and symptoms began 11 days after the vaccination occurred.
Age: 73.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Per MD the patient was put on a vent and Guillain-Barré is the working diagnosis provided by the hospital treating the patient and symptoms began 11 days after the vaccination occurred.
Age: 73.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Per MD the patient was put on a vent and Guillain-Barré is the working diagnosis provided by the hospital treating the patient and symptoms began 11 days after the vaccination occurred.
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Mechanical ventilation, Neurological symptom
Clinical narrative: Guillain Barre syndrome; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-JAN-2024, the patient received the 1st dose of Arexvy. On 05-FEB-2024, 12 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization, GSK medically significant and life threatening). The outcome of the guillain barre syndrome was not resolved.   The reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-FEB-2024 The reporter reported that patient had Guillain barre syndrome after receiving Arexvy vaccine. Guillain barre syndrome was reported as worsened. The reporter consented to follow-up.
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-JAN-2024, the patient received the 1st dose of Arexvy. On 05-FEB-2024, 12 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization, GSK medically significant and life threatening). The outcome of the guillain barre syndrome was not resolved.   The reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-FEB-2024 The reporter reported that patient had Guillain barre syndrome after receiving Arexvy vaccine. Guillain barre syndrome was reported as worsened. The reporter consented to follow-up.
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-JAN-2024, the patient received the 1st dose of Arexvy. On 05-FEB-2024, 12 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization, GSK medically significant and life threatening). The outcome of the guillain barre syndrome was not resolved.   The reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-FEB-2024 The reporter reported that patient had Guillain barre syndrome after receiving Arexvy vaccine. Guillain barre syndrome was reported as worsened. The reporter consented to follow-up.
Age: 73.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Mechanical ventilation, Neurological symptom
Clinical narrative: RSV vaccine brand and other details unknown. Patient developed Guillain-Barré syndrome and needed hospitalization on  02/04/2024. He passed away on 02/15/2024
Age: 73.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: RSV vaccine brand and other details unknown. Patient developed Guillain-Barré syndrome and needed hospitalization on  02/04/2024. He passed away on 02/15/2024
Age: 73.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: RSV vaccine brand and other details unknown. Patient developed Guillain-Barré syndrome and needed hospitalization on  02/04/2024. He passed away on 02/15/2024
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at injection site increased
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine was administered. Bexsero was ordered, but Boostrix was administered.  Pt reported possible fever after receiving Boostrix but no other symptoms.
Age: 0.67
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was coming in for her 6 months old Vaccines , she is currently 8 months 14 days.  i drew up vaccines and including the Rota vaccine with LOT: X020936 EXP: 12/19/2024 . after given i reviewed that she was out of the range to receive the Rota vaccine which should be only 2-8 months when started at 2 months, i spoke to our Provider and i have spoken to Mother.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chondrosarcoma, Pain in extremity, Pathology test
Clinical narrative: Pt reports arm soreness ever since second COVID19 vaccine administration, later diagnosed with chondrosarcoma as of 2/2024 at the same site
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Biopsy skin abnormal, Blood creatine phosphokinase increased, Chest pain, Condition aggravated
Clinical narrative: Within 2 weeks I had a reactivation of  HSV in new location, coccyx. Had biopsied. Was on suppressive therapy and had to take bolus doses.  Serrum Fe+ harsh decline and symtompatic, Muscle weakness, instability, extreme fatigue and exhaustion. Activation of long dormant sleep disorders, Idiopathic Hypersomnia and Klein Levin Syndrome (undiagnosised). onslaught of SARCOIDOSIS joint /muscle pain and new cutaneous lesions.  Decrease in athletic performance (elite) Worsening night sweats. Idiopathic chest pain with change in Blood Pressures and radiating R side facial pain and numbness.  Symptoms have been one year and sarcoidosis is in a Flare. Have now had 5 sarcoidosis related excisions, last diagnosis of Prurigo Nodule.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Facial pain, Fatigue, Gait disturbance, Hypersomnia, Hypersomnia-bulimia syndrome
Clinical narrative: Within 2 weeks I had a reactivation of  HSV in new location, coccyx. Had biopsied. Was on suppressive therapy and had to take bolus doses.  Serrum Fe+ harsh decline and symtompatic, Muscle weakness, instability, extreme fatigue and exhaustion. Activation of long dormant sleep disorders, Idiopathic Hypersomnia and Klein Levin Syndrome (undiagnosised). onslaught of SARCOIDOSIS joint /muscle pain and new cutaneous lesions.  Decrease in athletic performance (elite) Worsening night sweats. Idiopathic chest pain with change in Blood Pressures and radiating R side facial pain and numbness.  Symptoms have been one year and sarcoidosis is in a Flare. Have now had 5 sarcoidosis related excisions, last diagnosis of Prurigo Nodule.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Lesion excision, Muscular weakness, Myalgia, Neurodermatitis
Clinical narrative: Within 2 weeks I had a reactivation of  HSV in new location, coccyx. Had biopsied. Was on suppressive therapy and had to take bolus doses.  Serrum Fe+ harsh decline and symtompatic, Muscle weakness, instability, extreme fatigue and exhaustion. Activation of long dormant sleep disorders, Idiopathic Hypersomnia and Klein Levin Syndrome (undiagnosised). onslaught of SARCOIDOSIS joint /muscle pain and new cutaneous lesions.  Decrease in athletic performance (elite) Worsening night sweats. Idiopathic chest pain with change in Blood Pressures and radiating R side facial pain and numbness.  Symptoms have been one year and sarcoidosis is in a Flare. Have now had 5 sarcoidosis related excisions, last diagnosis of Prurigo Nodule.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Night sweats, Pain, Sarcoidosis, Serum ferritin decreased, Skin lesion
Clinical narrative: Within 2 weeks I had a reactivation of  HSV in new location, coccyx. Had biopsied. Was on suppressive therapy and had to take bolus doses.  Serrum Fe+ harsh decline and symtompatic, Muscle weakness, instability, extreme fatigue and exhaustion. Activation of long dormant sleep disorders, Idiopathic Hypersomnia and Klein Levin Syndrome (undiagnosised). onslaught of SARCOIDOSIS joint /muscle pain and new cutaneous lesions.  Decrease in athletic performance (elite) Worsening night sweats. Idiopathic chest pain with change in Blood Pressures and radiating R side facial pain and numbness.  Symptoms have been one year and sarcoidosis is in a Flare. Have now had 5 sarcoidosis related excisions, last diagnosis of Prurigo Nodule.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sleep disorder
Clinical narrative: Within 2 weeks I had a reactivation of  HSV in new location, coccyx. Had biopsied. Was on suppressive therapy and had to take bolus doses.  Serrum Fe+ harsh decline and symtompatic, Muscle weakness, instability, extreme fatigue and exhaustion. Activation of long dormant sleep disorders, Idiopathic Hypersomnia and Klein Levin Syndrome (undiagnosised). onslaught of SARCOIDOSIS joint /muscle pain and new cutaneous lesions.  Decrease in athletic performance (elite) Worsening night sweats. Idiopathic chest pain with change in Blood Pressures and radiating R side facial pain and numbness.  Symptoms have been one year and sarcoidosis is in a Flare. Have now had 5 sarcoidosis related excisions, last diagnosis of Prurigo Nodule.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness at site of injection one day after receiving injection. Vaccine given 2/12, reaction began 2/13. Was seen in office on 2/14 with symptom improvement. Does not appear allergic. No hives present.  Plan to use ibuprofen x1-2 days. Before 2nd dose, can give ibuprofen and zyrtec x48h.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event occurred.  infant received  first dose of Rotateq at age 6 mos, which should not have been given due to his age
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia
Clinical narrative: Muscle aches in arms, hands, legs, and feet, not necessarily all at once. Muscle aches occur most often at night and have been present every day (or at least 99% of the time) since 12/14/23. Began taking magnesium glycinate on 1/20/24. Initial dose was 200 mg a day and then increased to 400 mg a day about 2/1/24.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, RV5
Symptoms: Wrong product administered
Clinical narrative: by accident patient received Vaxelis instead of Vaxneuvance yesterday in clinic.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Arthralgia, Ear pain, Electromyogram normal
Clinical narrative: I had zero reaction to the first two shots, also Pfizer.  From the moment I had the third shot, I immediately experienced pain down the entire left side of my body.  From behind my left ear all the way to my left foot.  My left pinky and ring finger also have numbness.  And on the same two toes. The pain is especially concentrated in my left shoulder and hip, but generally down the whole left side. I have seen a multitude of doctors, and have had no relief - over two years later. Doctors I have seen include: Dr. (Sports Medicine), (Pain Management), (PT), Dr. (Rheumatologist), Dr. (Neurologist), (Acupuncturist), Dr. (OMM/DO), (PT, Cellular Health Specialist), Dr. (Neurologist), Dr. (Pain Management). No matter what, nothing has worked, and overall my tests are all "normal".  I have tried many many things and spent thousands of dollars trying to find relief.  I know the pain started as soon as the third shot occurred. I am NOT an anti-vaxxer by any means! My life has changed drastically in the last two years as I physically cannot do the things that I used to be able to do - from working out to general lifting of basic objects. I have basically given up trying to fix it because I simply cannot afford to anymore - treatment at this point is generally out of pocket. I'm beyond frustrated. I'm basically told nothing is wrong with me, and I'm tired of it. It's been almost two and a half years and I still have extreme pain and nothing I've tried has given me relief. I have refused any further covid or even flu vaccines.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Immediate post-injection reaction, Intervertebral disc protrusion, Loss of personal independence in daily activities
Clinical narrative: I had zero reaction to the first two shots, also Pfizer.  From the moment I had the third shot, I immediately experienced pain down the entire left side of my body.  From behind my left ear all the way to my left foot.  My left pinky and ring finger also have numbness.  And on the same two toes. The pain is especially concentrated in my left shoulder and hip, but generally down the whole left side. I have seen a multitude of doctors, and have had no relief - over two years later. Doctors I have seen include: Dr. (Sports Medicine), (Pain Management), (PT), Dr. (Rheumatologist), Dr. (Neurologist), (Acupuncturist), Dr. (OMM/DO), (PT, Cellular Health Specialist), Dr. (Neurologist), Dr. (Pain Management). No matter what, nothing has worked, and overall my tests are all "normal".  I have tried many many things and spent thousands of dollars trying to find relief.  I know the pain started as soon as the third shot occurred. I am NOT an anti-vaxxer by any means! My life has changed drastically in the last two years as I physically cannot do the things that I used to be able to do - from working out to general lifting of basic objects. I have basically given up trying to fix it because I simply cannot afford to anymore - treatment at this point is generally out of pocket. I'm beyond frustrated. I'm basically told nothing is wrong with me, and I'm tired of it. It's been almost two and a half years and I still have extreme pain and nothing I've tried has given me relief. I have refused any further covid or even flu vaccines.