chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Night sweats, I woke-up wet and sweating, hair wet, top & bottom sheets, pillow; just like I had been in the shower; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 2, single (Lot number: EM9810) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose, Lot# EL3249), administration date: 21Jan2021, when the patient was 75-year-old, for COVID-19 immunisation, reaction(s): "Blood pressure increased", "Night sweats", "Insomnia", "Vaginal discharge", "Feeling cold", "Asthenia", "Fatigue", "Restlessness", "Weight gain", "Cold", "Flu", "Hot flashes". The following information was reported: NIGHT SWEATS (non-serious), outcome "unknown", described as "Night sweats, I woke-up wet and sweating, hair wet, top & bottom sheets, pillow; just like I had been in the shower".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350709 same patient/drug, different drug dose/event.;
Age: 1.67
Sex: F
Vaccine: MNQ, PNC15
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE REACTIONS NOTED - IT WAS AN ADMINISTRATION ERROR
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site induration, Injection site pain
Clinical narrative: L arm pain and induration at injection site lasting >2 months post injection
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure immeasurable, Cardio-respiratory arrest, Computerised tomogram, Discomfort, Electrocardiogram
Clinical narrative: I had a vaccine in October of 23. this was my 4th vaccine. I was diagnosed with Pericarditis. They can find no other reason for this, other than i have had 4 covid shots and they are seeing an increase in  Pericarditis from people that have been vaccinated. It has been almost 2 weeks, they have changed treatment twice and i am still suffering from pain and discomfort. I am fatigued and can only work 4 hours a day, per the Doctor. I was treated with several medications and at 1 point lost blood pressure and coded.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Laboratory test, Magnetic resonance imaging, Pain
Clinical narrative: I had a vaccine in October of 23. this was my 4th vaccine. I was diagnosed with Pericarditis. They can find no other reason for this, other than i have had 4 covid shots and they are seeing an increase in  Pericarditis from people that have been vaccinated. It has been almost 2 weeks, they have changed treatment twice and i am still suffering from pain and discomfort. I am fatigued and can only work 4 hours a day, per the Doctor. I was treated with several medications and at 1 point lost blood pressure and coded.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Ultrasound scan, X-ray
Clinical narrative: I had a vaccine in October of 23. this was my 4th vaccine. I was diagnosed with Pericarditis. They can find no other reason for this, other than i have had 4 covid shots and they are seeing an increase in  Pericarditis from people that have been vaccinated. It has been almost 2 weeks, they have changed treatment twice and i am still suffering from pain and discomfort. I am fatigued and can only work 4 hours a day, per the Doctor. I was treated with several medications and at 1 point lost blood pressure and coded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Autoimmune thyroiditis, Autonomic nervous system imbalance, Blood test abnormal, Cytokine storm
Clinical narrative: Excessive Menstural Bleeding for 18 months. Migraines ongoing for almost 3 years. Pots and Dysutonomia. Tachycardia. Hashimoto's and autoimmune flare up. Cytokine storm. ongoing.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Magnetic resonance imaging abnormal, Migraine, Postural orthostatic tachycardia syndrome, Tachycardia
Clinical narrative: Excessive Menstural Bleeding for 18 months. Migraines ongoing for almost 3 years. Pots and Dysutonomia. Tachycardia. Hashimoto's and autoimmune flare up. Cytokine storm. ongoing.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: Excessive Menstural Bleeding for 18 months. Migraines ongoing for almost 3 years. Pots and Dysutonomia. Tachycardia. Hashimoto's and autoimmune flare up. Cytokine storm. ongoing.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Skin discolouration
Clinical narrative: Her upper left deltoid got a rash and discolored. She states that it doesn't hurt and she has been icing it.
Age: 42.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Aortic dissection, Cardiac operation, Transfusion
Clinical narrative: Class-A aortic dissection  repaired through open heart surgery. I survived, but only because I got to the hospital in time. I had no symptoms before, and previous echocardiograms were normal.
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: Client was given Arexvy on 12/1/23.  Client was 32 weeks gestation. This is client's 3rd pregnancy. Date of delivery at 39 weeks.  Client denies any side effects or complications after administration of injection.  Client denies any complications with pregnancy, labor/delivery or birth.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Computerised tomogram abnormal, Lymphocyte count increased, Magnetic resonance imaging abnormal, Waldenstrom's macroglobulinaemia
Clinical narrative: Bloodwork prior to Moderna Covid vaccines was unremarkable for decades.  Two months after the 2nd Moderna dose, ABS Lymphocytes doubled--from about 2500 to 5,000. Other normal bloodwork markers suddenly went out of range through 2022..  In the spring of 2023, I was diagnosed with Waldenstrom's Macroglobulimenia.
Age: 15.0
Sex: F
Vaccine: COVID19, FLU4, HEPA, HPV9, IPV, MMR, MNQ, VARCEL
Symptoms: Lip dry, Loss of personal independence in daily activities, Pallor, Posture abnormal, Retching
Clinical narrative: I was vaccinating a 15 year old female client with her father present in vaccine room. She received 8 vaccinations and within about 2 minutes after receiving them, started to appear pale and some green general coloration of her skin on her face. I immediately had her elevate her feet on a nearby stool and had her dad support her on her right side, with his arms. She stayed upright the entire time. Father stood next to her the entire time. I asked her if she was ok, and she said yes. I left the room to grab some apple juice for her to drink. She was having difficulty poking the straw through the hole of the juice box, and started to appear to close her eyes and drop her head slightly. I grabbed her juice box for her, poked the straw in and brought it to her lips to drink. Her lips looked dry, ashen and pale. She took a sip and immediately her face turned a light red as her circulation seemed to be improving. Then she made a gagging motion with her mouth and I brought a trash can close and she vomited twice. I gave her water next, and instructed her to take small slow sips.  She vomited again and then stopped. She was conscious the entire time, no vitals were taken. She was responsive to all my verbal commands. She rested with me for another 10 minutes. All her color returned to her face. I explained the vaccine record to her father, gave him an Resource Guide and how to get resources and walked her and her father to the lobby. After I walked the client to the lobby and left her to hand-off with Registration staff. I advised she did not need to stay in the clinic any longer. I confirmed they had no more questions, father and daughter verbalized understanding and I walked away. Client appeared alert and verbal when I left.
Age: 15.0
Sex: F
Vaccine: COVID19, FLU4, HEPA, HPV9, IPV, MMR, MNQ, VARCEL
Symptoms: Skin discolouration, Vomiting
Clinical narrative: I was vaccinating a 15 year old female client with her father present in vaccine room. She received 8 vaccinations and within about 2 minutes after receiving them, started to appear pale and some green general coloration of her skin on her face. I immediately had her elevate her feet on a nearby stool and had her dad support her on her right side, with his arms. She stayed upright the entire time. Father stood next to her the entire time. I asked her if she was ok, and she said yes. I left the room to grab some apple juice for her to drink. She was having difficulty poking the straw through the hole of the juice box, and started to appear to close her eyes and drop her head slightly. I grabbed her juice box for her, poked the straw in and brought it to her lips to drink. Her lips looked dry, ashen and pale. She took a sip and immediately her face turned a light red as her circulation seemed to be improving. Then she made a gagging motion with her mouth and I brought a trash can close and she vomited twice. I gave her water next, and instructed her to take small slow sips.  She vomited again and then stopped. She was conscious the entire time, no vitals were taken. She was responsive to all my verbal commands. She rested with me for another 10 minutes. All her color returned to her face. I explained the vaccine record to her father, gave him an Resource Guide and how to get resources and walked her and her father to the lobby. After I walked the client to the lobby and left her to hand-off with Registration staff. I advised she did not need to stay in the clinic any longer. I confirmed they had no more questions, father and daughter verbalized understanding and I walked away. Client appeared alert and verbal when I left.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: lightheaded next morning,naseau, inection site swollen and red
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: AREXVY VACCINE WAS GIVEN TO PATIENT WHEN SHE WAS 59 YEARS OLD, INSTEAD OF 60 YEARS OLD; NO OTHER ADVERSE EVENTS
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rubra pilaris
Clinical narrative: I have contracted Pityriasis Rubra Pilaris (PRP)
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient received meningococcal vaccine in left upper arm IM after seasonal flu vaccine. Pt got off of bed and sat on his grandma's lap, stated he felt dizzy and then had a syncopal episode. Woke up after 30 seconds after being safely lowered to floor. Mom then remembered patient had previous history of vasovagal with blood draws. Pt in Trendelenburg position on floor with nurse, ice applied to neck and forehead and v/s stable. MD  made aware. Pt able to safely get up into seated position where he was provided water and cookies. Patient discharged home to mom and grandma, steady on feet and able to walk fine after 20 minutes waiting in office.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Chronic sinusitis, Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Injection site reaction-Hot, red area below injection site and bruising at injection site.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Joint swelling, Magnetic resonance imaging normal, Weight bearing difficulty
Clinical narrative: Within a couple of hours of receiving the vaccine, the patient?s knee swelled up and became painful. It has been three weeks and she is still in a lot of pain  and unable to put weight on it. X-Rays, an MRI, have not shown any injury. She was sitting on the couch when the knee began to swell.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb normal
Clinical narrative: Within a couple of hours of receiving the vaccine, the patient?s knee swelled up and became painful. It has been three weeks and she is still in a lot of pain  and unable to put weight on it. X-Rays, an MRI, have not shown any injury. She was sitting on the couch when the knee began to swell.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Chest X-ray, Electrocardiogram, Fibrin D dimer, Full blood count
Clinical narrative: New onset SVT (Supraventricular tachycardia) in an otherwise healthy adult with no underlying cardiac history. ER visit - IV adenosine.  Resolved and placed on cardiac medication for SVT control
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Supraventricular tachycardia, Troponin, Ultrasound Doppler
Clinical narrative: New onset SVT (Supraventricular tachycardia) in an otherwise healthy adult with no underlying cardiac history. ER visit - IV adenosine.  Resolved and placed on cardiac medication for SVT control
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Initial redness and swelling noted to injection site. Complained of pain for several days.  Began to notice I had to repeat myself several times. Began to notice volume going up on TV and radio.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Patient given Shingrix vaccine SQ. Should have been given IM. Diffent brand used previously and this was to be given SQ. Computers were down and very busy trying to take care of patient needs with suboptimal resources.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Coagulopathy, Eating disorder, Fatigue, Feeling hot
Clinical narrative: After the vaccine, pt. felt tired and then slept for 3 months, with serious muscle aches, serious nausea to the point where sh could not eat for at least 8 hours, fatigue, serious brain fog, at times unable to life her body to use the restroom. Tired when walking from one room to another. It has been 2 years, and the recovery has been slow. There were signs of liver damage and micro clotting in her first lab results. At present pt. has movement for about 1 hour a day. Her arms and legs regularly get hot then cold, causing shooting pains. Brain fog and fatigue is still a serious issue, and the nausea comes and goes with spates of not eating to bulk eating.  There are days where pt. is still too tired to get out of bed. She has lost contact with her friends, and has not attended school full time since the vaccine reaction.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hypersomnia, Laboratory test abnormal, Liver injury, Loss of personal independence in daily activities
Clinical narrative: After the vaccine, pt. felt tired and then slept for 3 months, with serious muscle aches, serious nausea to the point where sh could not eat for at least 8 hours, fatigue, serious brain fog, at times unable to life her body to use the restroom. Tired when walking from one room to another. It has been 2 years, and the recovery has been slow. There were signs of liver damage and micro clotting in her first lab results. At present pt. has movement for about 1 hour a day. Her arms and legs regularly get hot then cold, causing shooting pains. Brain fog and fatigue is still a serious issue, and the nausea comes and goes with spates of not eating to bulk eating.  There are days where pt. is still too tired to get out of bed. She has lost contact with her friends, and has not attended school full time since the vaccine reaction.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Nausea, Pain, Peripheral coldness
Clinical narrative: After the vaccine, pt. felt tired and then slept for 3 months, with serious muscle aches, serious nausea to the point where sh could not eat for at least 8 hours, fatigue, serious brain fog, at times unable to life her body to use the restroom. Tired when walking from one room to another. It has been 2 years, and the recovery has been slow. There were signs of liver damage and micro clotting in her first lab results. At present pt. has movement for about 1 hour a day. Her arms and legs regularly get hot then cold, causing shooting pains. Brain fog and fatigue is still a serious issue, and the nausea comes and goes with spates of not eating to bulk eating.  There are days where pt. is still too tired to get out of bed. She has lost contact with her friends, and has not attended school full time since the vaccine reaction.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Social problem
Clinical narrative: After the vaccine, pt. felt tired and then slept for 3 months, with serious muscle aches, serious nausea to the point where sh could not eat for at least 8 hours, fatigue, serious brain fog, at times unable to life her body to use the restroom. Tired when walking from one room to another. It has been 2 years, and the recovery has been slow. There were signs of liver damage and micro clotting in her first lab results. At present pt. has movement for about 1 hour a day. Her arms and legs regularly get hot then cold, causing shooting pains. Brain fog and fatigue is still a serious issue, and the nausea comes and goes with spates of not eating to bulk eating.  There are days where pt. is still too tired to get out of bed. She has lost contact with her friends, and has not attended school full time since the vaccine reaction.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dysarthria, Dyspnoea, Feeling abnormal
Clinical narrative: Reported Symptoms: 10008479:CHEST PAIN; 10847984:WEIRD FEELING; 10047924:WHEEZING; Narrative: 10/5/23 developed SOB and decreased 02 sat after immunization. Was given Epi due to possible allergic reaction to immunization Other Relevant HX: 10/5/23 Approximately 4 mins after receiving Spikevax Covid vaccine: patient is seen grabbing his chest when asked if he was ok, patient is hardly able to speak; asking if this is normal after the injection. Patient is complaining of feeling funny, tighting of chest and throat . Wheezing noted. Nurse mgr. called to assist. Oxygen level noted to 76% on RA. Emergency kit opened and Epi Pen Auto Injector of 0.3mg given at 1125am in the Right thigh while Nurse Mgr. called 911. BP: 214/79 HR 73. 5 min post EPI: BP: 190/90 HR 66 Pulse OX 97%; patient reporting feeling much better. Breathing was unlabored and no wheezing noted. 10 mins post Epi: BP: 183/84 Hr 68 Pulse Ox: 97% Ambulance arrives at 1145 and transfer of care given. Patient notified not to receive any additional doses of the COVID Vaccine. Added to Allergy List. 10/6/2023 Patient stops by clinic to follow up on ED visit. Patient was in immunization clinic 10/5/23 developed SOB and decreased 02 sat after immunization. Was given Epi due to possible allergic reaction to immunization. Patient was sent to ED per EMS to be evaluated. Patient states he feels fine and states he felt fine after initial reaction yesterday. Patient gives this writer ED record to review. He states he was told all labs and tests were WNL and they had no answer to what had happened.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Oxygen saturation decreased, Throat tightness, Wheezing
Clinical narrative: Reported Symptoms: 10008479:CHEST PAIN; 10847984:WEIRD FEELING; 10047924:WHEEZING; Narrative: 10/5/23 developed SOB and decreased 02 sat after immunization. Was given Epi due to possible allergic reaction to immunization Other Relevant HX: 10/5/23 Approximately 4 mins after receiving Spikevax Covid vaccine: patient is seen grabbing his chest when asked if he was ok, patient is hardly able to speak; asking if this is normal after the injection. Patient is complaining of feeling funny, tighting of chest and throat . Wheezing noted. Nurse mgr. called to assist. Oxygen level noted to 76% on RA. Emergency kit opened and Epi Pen Auto Injector of 0.3mg given at 1125am in the Right thigh while Nurse Mgr. called 911. BP: 214/79 HR 73. 5 min post EPI: BP: 190/90 HR 66 Pulse OX 97%; patient reporting feeling much better. Breathing was unlabored and no wheezing noted. 10 mins post Epi: BP: 183/84 Hr 68 Pulse Ox: 97% Ambulance arrives at 1145 and transfer of care given. Patient notified not to receive any additional doses of the COVID Vaccine. Added to Allergy List. 10/6/2023 Patient stops by clinic to follow up on ED visit. Patient was in immunization clinic 10/5/23 developed SOB and decreased 02 sat after immunization. Was given Epi due to possible allergic reaction to immunization. Patient was sent to ED per EMS to be evaluated. Patient states he feels fine and states he felt fine after initial reaction yesterday. Patient gives this writer ED record to review. He states he was told all labs and tests were WNL and they had no answer to what had happened.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: Admitted to the Hospital on 10/07/2023 for an Acute Pulmonary Embolism.; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Admitted to the Hospital on 10/07/2023 for an Acute Pulmonary Embolism.) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7646C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Sep-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 5 milliliter. On 22-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PULMONARY EMBOLISM (Admitted to the Hospital on 10/07/2023 for an Acute Pulmonary Embolism.) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 07-Oct-2023 due to PULMONARY EMBOLISM. The patient was treated with WARFARIN SODIUM (WARFARIN [WARFARIN SODIUM]) ongoing since an unknown date for Pulmonary embolism, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Admitted to the Hospital on 10/07/2023 for an Acute Pulmonary Embolism.) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments.   Patient medical history included, statins . It was reported that, Shortness of breath started three weeks after vaccine administration .  It was unknown if the patient experienced any additional symptoms/events. No concomitant medication was reported. Company comment: This spontaneous case concerns a 65-year-old male patient, with no medical history reported, who experienced the serious (hospitalization and medically significant) and unexpected AESI of PULMONARY EMBOLISM, 21 days after an unspecified dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) vaccine. She experienced shortness of breath and received WARFARIN SODIUM at an unspecified dose and frequency as treatment. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) vaccine is not affected by this report.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: the second GARDASIL 9 dose hurt/ injection site pain during GARDASIL 9; This spontaneous report was received from a registered nurse, via company representative, referring to herself as a "mid" adult female patient, who currently was 44-year-old.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (doses, vaccination scheme, strengths, lot numbers, expiration dates, injection sites and routes of administration were not provided).  On an unknown date, the patient experienced injection site pain (vaccination site pain) during hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), she mentioned that second dose hurted. The outcome of the event was unknown.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2402USA002287:MSD
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a patient at 3 years and 7 months old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Concomitant products included Vaxelis.   On 13-FEB-2024, the patient received Kinrix. On 13-FEB-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a patient at 3 years and 7 months old). The outcome of the inappropriate age at vaccine administration 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: 15-FEB-2024 The medical assistant reported Kinrix was ordered for a patient and administered.  Afterwards she realized the patient was only 3 years and 7 months old, instead of the approved age of 4 years, which led to inappropriate age at vaccine administration.  Prior to the Kinrix dose, the patient had 1 prior DTaP and IPV dose (Vaxelis) on 21-JAN-2024. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given Infanrix to a 4 days old infant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-day-old female patient who received DTPa (Infanrix) (batch number TX77L, expiry date 01-DEC-2025) for prophylaxis.   On 15-FEB-2024, the patient received the 1st dose of Infanrix. On 15-FEB-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: given Infanrix to a 4 days old infant). The outcome of the inappropriate age at vaccine administration 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: 16-FEB-2024 The Infanrix vaccine (first DTAP vaccine) was given to an infant (patient) yesterday (day before reporting), which led to an inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: Chronic kidney stones; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Chronic kidney stones) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 02-Aug-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEPHROLITHIASIS (Chronic kidney stones) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (Chronic kidney stones) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.  Company Comment This is an spontaneous case concerning in a patient of a 58-year-old female patient with no medical history reported who experienced the unexpected seriousness criteria medically significant event of nephrolithiasis approximately 2 years and 4 months after a dose of mRNA-1273 vaccine. Concomitant medication nor Treatment details were reported. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac stress test abnormal, Chills, Echocardiogram, Heart rate increased
Clinical narrative: Same day I had elevated HR, fever, chills, weakness. The symptoms that continued was tachycardia at rest.  At rest I would have around HR of 130bpm. With exercise, would reach 190bpm. I was seen by cardiologists and diagnosed with POTS after after COVID vaccine. Postural orthostatic tachycardia syndrome.  I still have the symptoms.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Postural orthostatic tachycardia syndrome, Pyrexia, Tachycardia
Clinical narrative: Same day I had elevated HR, fever, chills, weakness. The symptoms that continued was tachycardia at rest.  At rest I would have around HR of 130bpm. With exercise, would reach 190bpm. I was seen by cardiologists and diagnosed with POTS after after COVID vaccine. Postural orthostatic tachycardia syndrome.  I still have the symptoms.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration
Clinical narrative: local reaction with erythema and induration
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myofascial pain syndrome, Trigger points
Clinical narrative: Persistent myofascial pain/trigger point that was referred to extensor tendons that required trigger injection and repeat 2 weeks later. Improved significantly after injections with mild pain disappearing after 4months. No prior history of similar events with any injections.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improperly stored vaccine was administered to the patient; This spontaneous report was received from a medical assistant concerning a 2-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.  On 04-DEC-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# X003664, expiration date: 10-NOV-2025) was stored at 54.3 degree Fahrenheit (F) for 9 hour 32 minutes and 0 seconds; on 05-DEC-2023, at 57.7F for 15 hours 30 minutes 0 seconds; on 06-DEC-2023, at 50.2F for 5 hours 43 minutes 0 seconds; on 07-DEC-2023, at 30.6F for 1 hour 55 minutes 0 seconds and 52.7F for 11 hours 3 minutes 0 seconds; on 11-DEC-2023, at 48.4F for 1 hour 47 minutes 0 seconds. There was no other reported current or previous temperature excursions.  On 16-JAN-2024, the patient was vaccinated with the improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (0.5 ml once, strength, anatomical location, and route of administration not provided) for prophylaxis (product storage error). The patient did not report any adverse issues or side effects from the administration. No other adverse event (AE) information was able to be provided during the call.    This is one of 28 cases from the same reporter.; Sender's Comments:  US-009507513-2401USA015454: US-009507513-2401USA015432: US-009507513-2401USA015463: US-009507513-2401USA015310: US-009507513-2401USA015363: US-009507513-2401USA015367: US-009507513-2401USA015453: US-009507513-2401USA015498: US-009507513-2401USA015507: US-009507513-2401USA015517: US-009507513-2401USA015537: US-009507513-2401USA015540: US-009507513-2401USA015557: US-009507513-2401USA015591: US-009507513-2401USA015605: US-009507513-2401USA015622: US-009507513-2401USA015627: US-009507513-2401USA015649: US-009507513-2401USA015651: US-009507513-2401USA015674: US-009507513-2401USA015687: US-009507513-2401USA015695: US-009507513-2401USA015699: US-009507513-2401USA015710: US-009507513-2401USA015731: US-009507513-2401USA015739: US-009507513-2401USA015760: US-009507513-2401USA015762:
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered on 10-02-2024 and was expired on 18-01-2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594, expiry date 18-JAN-2024) for prophylaxis.   On 10-FEB-2024, the patient received Boostrix. On 10-FEB-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered on 10-02-2024 and was expired on 18-01-2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2024 The certified medical assistant (CMA) stated that the expired dose of Boostrix vaccine was administered to a patient, which led to expired vaccine used. She believed that it was a booster dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Gout
Clinical narrative: Developed gout flare within 48 hours after vaccine.  Had gout once in right great toe 15 years prior, without relapse, without meds, with normal uric acid levels since, treated with diet and exercise. Gout flared in left great toe, was previously asymptomatic. Resolved after 48 hours after steroid injection into joint and ibuprofen.  Asymptomatic since for 2 years, no meds.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACTHIB was administered to a patient using sterile water instead of the diluent, with no reported adverse event; Initial information was received on 14-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who was administrated HIB (PRP/T) Vaccine [ACT-HIB] using sterile water instead of the diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.  On 13-Feb-2024, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) Vaccine  (Powder and solvent for solution for injection) (lot UK021AA,Expiry date : 28-Feb-2025, strength was unknown) via intramuscular route in the left thigh for Prophylactic vaccination(Immunization) and acthib was administered to a patient using sterile water instead of the diluent, with no reported adverse event (product preparation error) (latency : same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received their first dose of IMOVAX on Friday/was set up to have their second dose today but would not have IMOVAX until Monday, with no reported adverse event.; Initial information was received on 16-Feb-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 32 years old male patient who received their first dose of rabies (HDC) vaccine [Imovax rabies] on friday/was set up to have their second dose today but would not have imovax until monday, with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect rabies (HDC) vaccine (Powder and solvent for suspension for injection) (lot number, expiry date was unknown, strength: standard) via unknown route in unknown administration site for Immunization and patient received their first dose of imovax on friday/was set up to have their second dose today but would not have imovax until monday, with no reported adverse event (Inappropriate schedule of product administration) (unknown latency). The information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Bronchial hyperreactivity, Bundle branch block right, Chest X-ray abnormal, Chest pain
Clinical narrative: Reported Symptoms:  10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19;    Narrative: Patient presented to ED with chest pain and worsening pulmonary symptoms. Was inpatient for 2 days (remdesivir and dexamethasone daily) then discharged home on 12/28/23.  Other Relevant HX:  PMH:  CAD, COPD, T2DM, HTN, HLD, OSA on CPAP, morbid obesity   Admitted for COVID-19 infection and EKG changes (discordant T-waves w/ RBBB) possibly due to ischemia   Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Electrocardiogram T wave abnormal, Electrocardiogram abnormal, Lung hyperinflation
Clinical narrative: Reported Symptoms:  10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19;    Narrative: Patient presented to ED with chest pain and worsening pulmonary symptoms. Was inpatient for 2 days (remdesivir and dexamethasone daily) then discharged home on 12/28/23.  Other Relevant HX:  PMH:  CAD, COPD, T2DM, HTN, HLD, OSA on CPAP, morbid obesity   Admitted for COVID-19 infection and EKG changes (discordant T-waves w/ RBBB) possibly due to ischemia   Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory symptom, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Reported Symptoms:  10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19;    Narrative: Patient presented to ED with chest pain and worsening pulmonary symptoms. Was inpatient for 2 days (remdesivir and dexamethasone daily) then discharged home on 12/28/23.  Other Relevant HX:  PMH:  CAD, COPD, T2DM, HTN, HLD, OSA on CPAP, morbid obesity   Admitted for COVID-19 infection and EKG changes (discordant T-waves w/ RBBB) possibly due to ischemia   Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Feeling hot, Infection, Limb discomfort, Lip swelling
Clinical narrative: Reported Symptoms:  10042674:SWELLING;    Narrative: Patient went to the ER for swelling, discomfort and warmth in both hands. Had swollen lips and a swollen eye.    Suspect reaction to vaccine or perhaps secondary to viral infection.    Other Relevant HX:   Other:  swelling
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling, Swelling, Viral infection
Clinical narrative: Reported Symptoms:  10042674:SWELLING;    Narrative: Patient went to the ER for swelling, discomfort and warmth in both hands. Had swollen lips and a swollen eye.    Suspect reaction to vaccine or perhaps secondary to viral infection.    Other Relevant HX:   Other:  swelling
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Reported Symptoms: 10028813:NAUSEA; 1004770:VOMITING; NARRATIVE: Other Relevant HX: Other: NAUSEA AND VOMITING
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nasal congestion
Clinical narrative: Reported Symptoms: 10016256:FATIGUE; 10028735;NASAL CONGESTION; 10047862:WEAKNESS; Narrative: Other Relevant HX: Other: FATIGUE; WEAKNESS: NASAL CONGESTION
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Reported Symptoms:  10013911:DYSGEUSIA;     Narrative:   Other Relevant HX:  Other:  chronic dysgeusia
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Breakthrough COVID-19, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Computerised tomogram thorax abnormal
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted and treated throughout hospital stay for COPD, diarrhea, kidney failure, acute encephalopathy, T2DM, sepsis with septic shock, 2/2 acute hypoxic respiratory failure, COVID 19 PNA with secondary MSSA PNA, as well as severe necrotizing pneumonia 2/2 Pseudomonas and MSSA. Patient received treatment with remdesivir, tocilizumab, dexamethasone, hydrocortisone for COVID-19 as well as antibiotics for bacterial pneumonia. Patient worsened over the course of admission, required intubation, and passed while in the hospital. Other Relevant HX: PMH significant for OUD (previously on suboxone; now in remission), DM2, PAD s/p right femoral endarterectomy (2021), CAD with MI 2003 and PCI with stent to RCA, hypothyroidism, HTN, depression, PTSD, COPD, dyslipidemia, and TIA Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death, Diarrhoea, Echocardiogram abnormal, Ejection fraction decreased, Encephalopathy
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted and treated throughout hospital stay for COPD, diarrhea, kidney failure, acute encephalopathy, T2DM, sepsis with septic shock, 2/2 acute hypoxic respiratory failure, COVID 19 PNA with secondary MSSA PNA, as well as severe necrotizing pneumonia 2/2 Pseudomonas and MSSA. Patient received treatment with remdesivir, tocilizumab, dexamethasone, hydrocortisone for COVID-19 as well as antibiotics for bacterial pneumonia. Patient worsened over the course of admission, required intubation, and passed while in the hospital. Other Relevant HX: PMH significant for OUD (previously on suboxone; now in remission), DM2, PAD s/p right femoral endarterectomy (2021), CAD with MI 2003 and PCI with stent to RCA, hypothyroidism, HTN, depression, PTSD, COPD, dyslipidemia, and TIA Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Endotracheal intubation, General physical health deterioration, Lung consolidation, Lung opacity, Pleural effusion
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted and treated throughout hospital stay for COPD, diarrhea, kidney failure, acute encephalopathy, T2DM, sepsis with septic shock, 2/2 acute hypoxic respiratory failure, COVID 19 PNA with secondary MSSA PNA, as well as severe necrotizing pneumonia 2/2 Pseudomonas and MSSA. Patient received treatment with remdesivir, tocilizumab, dexamethasone, hydrocortisone for COVID-19 as well as antibiotics for bacterial pneumonia. Patient worsened over the course of admission, required intubation, and passed while in the hospital. Other Relevant HX: PMH significant for OUD (previously on suboxone; now in remission), DM2, PAD s/p right femoral endarterectomy (2021), CAD with MI 2003 and PCI with stent to RCA, hypothyroidism, HTN, depression, PTSD, COPD, dyslipidemia, and TIA Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pneumonia, Pneumonia bacterial, Pneumonia necrotising, Pneumonia staphylococcal, Pseudomonas infection
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted and treated throughout hospital stay for COPD, diarrhea, kidney failure, acute encephalopathy, T2DM, sepsis with septic shock, 2/2 acute hypoxic respiratory failure, COVID 19 PNA with secondary MSSA PNA, as well as severe necrotizing pneumonia 2/2 Pseudomonas and MSSA. Patient received treatment with remdesivir, tocilizumab, dexamethasone, hydrocortisone for COVID-19 as well as antibiotics for bacterial pneumonia. Patient worsened over the course of admission, required intubation, and passed while in the hospital. Other Relevant HX: PMH significant for OUD (previously on suboxone; now in remission), DM2, PAD s/p right femoral endarterectomy (2021), CAD with MI 2003 and PCI with stent to RCA, hypothyroidism, HTN, depression, PTSD, COPD, dyslipidemia, and TIA Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pulmonary mass, Renal failure, SARS-CoV-2 test positive, Sepsis, Septic shock
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted and treated throughout hospital stay for COPD, diarrhea, kidney failure, acute encephalopathy, T2DM, sepsis with septic shock, 2/2 acute hypoxic respiratory failure, COVID 19 PNA with secondary MSSA PNA, as well as severe necrotizing pneumonia 2/2 Pseudomonas and MSSA. Patient received treatment with remdesivir, tocilizumab, dexamethasone, hydrocortisone for COVID-19 as well as antibiotics for bacterial pneumonia. Patient worsened over the course of admission, required intubation, and passed while in the hospital. Other Relevant HX: PMH significant for OUD (previously on suboxone; now in remission), DM2, PAD s/p right femoral endarterectomy (2021), CAD with MI 2003 and PCI with stent to RCA, hypothyroidism, HTN, depression, PTSD, COPD, dyslipidemia, and TIA Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Staphylococcal infection, Type 2 diabetes mellitus, Vaccine breakthrough infection
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted and treated throughout hospital stay for COPD, diarrhea, kidney failure, acute encephalopathy, T2DM, sepsis with septic shock, 2/2 acute hypoxic respiratory failure, COVID 19 PNA with secondary MSSA PNA, as well as severe necrotizing pneumonia 2/2 Pseudomonas and MSSA. Patient received treatment with remdesivir, tocilizumab, dexamethasone, hydrocortisone for COVID-19 as well as antibiotics for bacterial pneumonia. Patient worsened over the course of admission, required intubation, and passed while in the hospital. Other Relevant HX: PMH significant for OUD (previously on suboxone; now in remission), DM2, PAD s/p right femoral endarterectomy (2021), CAD with MI 2003 and PCI with stent to RCA, hypothyroidism, HTN, depression, PTSD, COPD, dyslipidemia, and TIA Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination