chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: PNC20
Symptoms: Full blood count, Injection site haemorrhage, Metabolic function test, Platelet count
Clinical narrative: About 16 hours after the injection, the resident was identified to have bleeding at the site of the injection that was moderate amount. We could not get the bleeding to stop, it saturated the dressing a couple of times. We sent to the ER. The following morning, the site continued to bleed.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: DTAP-IPV given subQ instead of IM, pt unharmed, provider notified, per CDC, ok to count as valid and not reinject.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Extra dose administered, Throat irritation, Urticaria
Clinical narrative: Patient was given two combination vaccines - Dtap / Ipol and MMRV. Patient has had all these vaccines before, just not in this combination. Patient has had Pentacel in the past, but has not had Quadracel.  The patient has also had MMR and Varicella seperately but this was the first time for the combination MMRV.      Patient was given vaccines and 10 minutes after started to develop small hives around waste. Patient started coughing and complaining of itchy throat. Vitals were taken at 12pm 95% ox plus 124. Attempted to give benadryl patient spit most of it out. Physician choose to give patient .18 epi. Called EMS, squad came to transport. While in ambulance choose to allow mom to transport child because he was responding well to the medication.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Arrhythmia, Chest discomfort, Condition aggravated, Extrasystoles, Sleep disorder
Clinical narrative: At approximately 2:30 am, 15 hours after receiving the RSV VACCINE, I was awakened I experienced minor chest discomfort and noticed a heart arrhythmia  (Skipped/Extra heart beats).   I went back to sleep and at 8am when I awakened my heart beat was back to normal Sinus Rhythm.  It has since been five plus years since my last encounter with skipped heart beats.  I am experiencing other flu like symptoms after vaccination
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia, Rash, Tachycardia
Clinical narrative: RASH TACHYCARDIA FEVER DIFFICULTY BREATHING
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: I have always had extremely regular menstrual cycles. After the first round of vaccines rolled out 2021, my cycle started getting further and further apart. I first suspected I was in perimenopause but I was only in my early 30s so it seemed young but bloodwork came back normal. However, after contracting COVID in January 2023, I did not receive another booster until November. During that time my cycle started to slowly return back to normal and 4 months I was at my exact 28-29 day cycle UNTIL my booster in November. Since then they have slowly started to spread further apart again.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV
Symptoms: C-reactive protein increased, Giant cell arteritis, Inflammatory marker increased, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: I was told it was okay to have all three shots at once. Since having the shots, starting in early October, I experienced symptoms of what I thought was a sinus infection and subsequently an arthritis flareup due to inactivity.  However, it has recently been determined that I have developed polymyalgia rheumatica and possibly giant cell arteritis (referral for temporal artery biopsy has been made.) There is no proof of causal relationship between the vaccines and my diagnosis, but I am suspicious and wanted to report it just in case.  I will NOT do multiple vaccinations on the same day in the future. I have been on multiple doses of antibiotics and steroids and seen multiple doctors (PCP, chiropractor, osteopath, ENT, allergist) trying to determine what's going on.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Dizziness, Headache, Injection site pain, Vertigo
Clinical narrative: Sore arm at injection site,  Dizziness / Vertigo.  Headache
Sex: F
Vaccine: UNK
Symptoms: Laboratory test normal, Rash, Rash erythematous, Roseolovirus test, Streptococcus test negative
Clinical narrative: Patient received MMR, DTaP, and Hib vaccines on 10/10/23 at the health department. She had urticaria on her legs that night. Rash resolved the following day but appeared again that night. Rash resolved and patient was clear until 10/23/23 when she developed a fine red rash that is primarily on the torso. She was treated with Benadryl effectively. No adverse outcome, but allergy testing was recommended.
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Patient received MMR, DTaP, and Hib vaccines on 10/10/23 at the health department. She had urticaria on her legs that night. Rash resolved the following day but appeared again that night. Rash resolved and patient was clear until 10/23/23 when she developed a fine red rash that is primarily on the torso. She was treated with Benadryl effectively. No adverse outcome, but allergy testing was recommended.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a Flu vaccine at 4 months old. There have been no reported signs and symptoms.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chills, Cough, Diarrhoea
Clinical narrative: severe vomiting, diarrhea, chills, fever, body sweats - hand and feet ice cold, body aches, severe cough, congestion, mucus
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral coldness, Pyrexia, Respiratory tract congestion, Secretion discharge
Clinical narrative: severe vomiting, diarrhea, chills, fever, body sweats - hand and feet ice cold, body aches, severe cough, congestion, mucus
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe vomiting, diarrhea, chills, fever, body sweats - hand and feet ice cold, body aches, severe cough, congestion, mucus
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling of the left hand. Rings hand to be cut off ring finger of left hand
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Kinrix vaccine was given in error instead of Dtap. The patients parents were notified and denied any adverse effects or concerns.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry mouth, Headache, Heart rate increased
Clinical narrative: Headache, dry mouth, pulse rate over 100 when it's usually not above 70
Age: 84.0
Sex: M
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Cardiac monitoring, Computerised tomogram, Echocardiogram, Magnetic resonance imaging, Transient ischaemic attack
Clinical narrative: I was told it was okay to have all three shots at once. On September 30, 2024, I experienced a very short lived TIA that affected my left side for less than 5 minutes in duration. I have not had any symptoms since but subsequently read an article that said there's some evidence that having Covid and Flu 65+ shots at the same time increases risk of stroke, so I wanted to report this.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Faeces discoloured, Melaena, Occult blood positive
Clinical narrative: Developed black tarry "strips" within normal appearing stool x 3 stools on 1/14/23. No fussiness, fever, vomiting, Normal appetite. Dark specks in the stool noted once on 1/15. Since then, normal appearing stools.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Peripheral swelling, Rash
Clinical narrative: Patient said 3 days later the arm began to swell and a rash appeared.  Lasted for 2 to 2 1/2 months.  It still is difficult to move or use.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Severe headache, body aches, fatigue, nausea, fever, chills, runny nose, ringing in ears
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Tinnitus
Clinical narrative: Severe headache, body aches, fatigue, nausea, fever, chills, runny nose, ringing in ears
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dental caries, Eyelid disorder, Injection site pain, Injection site swelling, Lip swelling
Clinical narrative: By Friday evening (01/12/2024), I had my usual reaction to the Covid vaccine -- i.e., injection site felt a bit swollen and was painful if I leaned against a wall on that shoulder.  When I woke up on Tuesday (01/16/2024), I had small itchy nodules across my lower back, which I assumed were due to needles used there at end of an extremely strenuous Physical Therapy session on Monday afternoon.  After getting a minor cavity filled by my dentist, by 10 a.m., I had  what looked like hives (which I have never had before) around the front of my legs -- so, PT needles were not the issue.  I applied Cortisone cream and the existing wheals began fading, but new ones appeared further around my groin. By 3:00 p.m. that afternoon, the dental anesthetic had worn off and I thought I was just becoming aware of my lower lip again; however, my lip had swollen to 4-5X normal size.  My dentist said the procedure sometimes caused such swelling and prescribed prednisone, for which I took my first dose around 4 pm.  As of 9:00 p.m. (01/16/2024), my lip swelling had reduced to only 2-3x normal; however, my right eyelid was droopy with swelling.  Also, the original wheals around my hips/groin had largely vanished, although some surface penile swelling had appeared.  I found medical information papers that indicate these symptoms have been associated at a low rate with Covid vaccinations, and that treatment included options like allergy medications and montelukast.  I began taking montelukast and loratadine at night and the prednisone in the morning.  As of today (01/19/2024), all of the hives/bumps are gone, the lower lip is almost back to normal size, and all other swelling aside from possibly in the eyelids is gone.  My last dose of prednisone will be tomorrow morning.  My Physical Therapy is strongly focused on improving Core strength in the hip region.  All of the hives/bumps occurred in that area.  They began in approximately the same positions as where the PT needles were inserted the day before and slowly progressed around the hips and then down the front of the legs to the crotch region.  Swelling in that region then occurred in the scrotum and the surface tissue of the penis.  The dental cavity that was filled was in the back molar on my right lower jaw.  Swelling on the face first appeared in the lower lip, beginning the right side and progressing to the entire lower lip.  Later, swelling began in the right eyelid.  Finally, swelling began on the left eyelid.  As such, I hypothesize that my symptoms were triggered by an interaction between the immune response to the Covid shot and the two physical traumas (intense PT and dental work) which would have resulted in inflammatory responses in those regions of my body.  As such, while the symptoms were alarming and unpleasant, I am not especially worried that they will occur again with any subsequent Covid vaccinations.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Local anaesthesia, Penile swelling, Pruritus, Scrotal swelling, Skin mass
Clinical narrative: By Friday evening (01/12/2024), I had my usual reaction to the Covid vaccine -- i.e., injection site felt a bit swollen and was painful if I leaned against a wall on that shoulder.  When I woke up on Tuesday (01/16/2024), I had small itchy nodules across my lower back, which I assumed were due to needles used there at end of an extremely strenuous Physical Therapy session on Monday afternoon.  After getting a minor cavity filled by my dentist, by 10 a.m., I had  what looked like hives (which I have never had before) around the front of my legs -- so, PT needles were not the issue.  I applied Cortisone cream and the existing wheals began fading, but new ones appeared further around my groin. By 3:00 p.m. that afternoon, the dental anesthetic had worn off and I thought I was just becoming aware of my lower lip again; however, my lip had swollen to 4-5X normal size.  My dentist said the procedure sometimes caused such swelling and prescribed prednisone, for which I took my first dose around 4 pm.  As of 9:00 p.m. (01/16/2024), my lip swelling had reduced to only 2-3x normal; however, my right eyelid was droopy with swelling.  Also, the original wheals around my hips/groin had largely vanished, although some surface penile swelling had appeared.  I found medical information papers that indicate these symptoms have been associated at a low rate with Covid vaccinations, and that treatment included options like allergy medications and montelukast.  I began taking montelukast and loratadine at night and the prednisone in the morning.  As of today (01/19/2024), all of the hives/bumps are gone, the lower lip is almost back to normal size, and all other swelling aside from possibly in the eyelids is gone.  My last dose of prednisone will be tomorrow morning.  My Physical Therapy is strongly focused on improving Core strength in the hip region.  All of the hives/bumps occurred in that area.  They began in approximately the same positions as where the PT needles were inserted the day before and slowly progressed around the hips and then down the front of the legs to the crotch region.  Swelling in that region then occurred in the scrotum and the surface tissue of the penis.  The dental cavity that was filled was in the back molar on my right lower jaw.  Swelling on the face first appeared in the lower lip, beginning the right side and progressing to the entire lower lip.  Later, swelling began in the right eyelid.  Finally, swelling began on the left eyelid.  As such, I hypothesize that my symptoms were triggered by an interaction between the immune response to the Covid shot and the two physical traumas (intense PT and dental work) which would have resulted in inflammatory responses in those regions of my body.  As such, while the symptoms were alarming and unpleasant, I am not especially worried that they will occur again with any subsequent Covid vaccinations.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: By Friday evening (01/12/2024), I had my usual reaction to the Covid vaccine -- i.e., injection site felt a bit swollen and was painful if I leaned against a wall on that shoulder.  When I woke up on Tuesday (01/16/2024), I had small itchy nodules across my lower back, which I assumed were due to needles used there at end of an extremely strenuous Physical Therapy session on Monday afternoon.  After getting a minor cavity filled by my dentist, by 10 a.m., I had  what looked like hives (which I have never had before) around the front of my legs -- so, PT needles were not the issue.  I applied Cortisone cream and the existing wheals began fading, but new ones appeared further around my groin. By 3:00 p.m. that afternoon, the dental anesthetic had worn off and I thought I was just becoming aware of my lower lip again; however, my lip had swollen to 4-5X normal size.  My dentist said the procedure sometimes caused such swelling and prescribed prednisone, for which I took my first dose around 4 pm.  As of 9:00 p.m. (01/16/2024), my lip swelling had reduced to only 2-3x normal; however, my right eyelid was droopy with swelling.  Also, the original wheals around my hips/groin had largely vanished, although some surface penile swelling had appeared.  I found medical information papers that indicate these symptoms have been associated at a low rate with Covid vaccinations, and that treatment included options like allergy medications and montelukast.  I began taking montelukast and loratadine at night and the prednisone in the morning.  As of today (01/19/2024), all of the hives/bumps are gone, the lower lip is almost back to normal size, and all other swelling aside from possibly in the eyelids is gone.  My last dose of prednisone will be tomorrow morning.  My Physical Therapy is strongly focused on improving Core strength in the hip region.  All of the hives/bumps occurred in that area.  They began in approximately the same positions as where the PT needles were inserted the day before and slowly progressed around the hips and then down the front of the legs to the crotch region.  Swelling in that region then occurred in the scrotum and the surface tissue of the penis.  The dental cavity that was filled was in the back molar on my right lower jaw.  Swelling on the face first appeared in the lower lip, beginning the right side and progressing to the entire lower lip.  Later, swelling began in the right eyelid.  Finally, swelling began on the left eyelid.  As such, I hypothesize that my symptoms were triggered by an interaction between the immune response to the Covid shot and the two physical traumas (intense PT and dental work) which would have resulted in inflammatory responses in those regions of my body.  As such, while the symptoms were alarming and unpleasant, I am not especially worried that they will occur again with any subsequent Covid vaccinations.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Loss of hearing
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: patient was given a training sample. .
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED EXPIRED SPIKEVAX VACCINE. IT EXPIRED 1/09/2024 AND PATIENT RECEIVED IT ON 1/11/2024.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED SPIKEVAX 2 DAYS AFTER IT EXPIRED. IT EXPIRED 1/09/2024 AND WAS GIVEN VACCINE ON 1/11/2024
Age: 79.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Erythema, Fatigue, Headache, Hunger, Limb mass
Clinical narrative: On 12/8/23 she got the first vaccine around 11:00 AM.  She noticed that she had a weird sensation when she got the vaccine of a tingling sensation in her body.  That went away and then her arm was itching, and then when she rubbed it to itch it she noticed there was a lump on the back of her arm.  She went into the bathroom to look in the mirror and she had a raised welted area that was 1/2" wide and it went down her arm about 3-3 1/2 ".  That's when she first noticed it.  The 2nd day it was worse, darker red.  The third day it was similar, and the 4th day it faded and by the 5th day it was gone.  She was still left with a lump on the  back of her arm and then it did go away.  She got the booster yesterday and last night she noticed it red again, but it is a different shape.  She has a big knot/lump in the back of her arm and it s itching.  She does not know how big it was.  The raised welt in the back of her left arm is more circular, it looks like 2-2 ½  long and 1  wide, more round in nature.  It is warm to touch and it has a lump in it.   She went to the doctor yesterday and she told her about it and told her that she was going to get the booster for monkey pox, but the county said there were more outbreaks and they were giving out these shots so she went to get one.   Yesterday she got the same overall tingling feeling from her head down to her torso that she did like the first one, and then it goes away.  The 2nd thing was the redness and welt on the back of the arm, but this time this morning she woke up with a headache at 6:00 AM.  She is a person that never has headaches, and she felt that maybe she didn t sleep very well.  She had the redness that was sore, swollen and itchy.  Then she had to take her car to the dealership and when she got home she was really tired, a little hungry and then got the tingly feeling again.  She has not taken anything for the headache which continues as she does not take anything for headaches.  She decided to get the paperwork out to see about the reactions and got our phone # to call us.   She did call the NP office and left a message for the MA and left a message and waiting for her to CB.
Age: 79.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Nodule, Pain in extremity, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: On 12/8/23 she got the first vaccine around 11:00 AM.  She noticed that she had a weird sensation when she got the vaccine of a tingling sensation in her body.  That went away and then her arm was itching, and then when she rubbed it to itch it she noticed there was a lump on the back of her arm.  She went into the bathroom to look in the mirror and she had a raised welted area that was 1/2" wide and it went down her arm about 3-3 1/2 ".  That's when she first noticed it.  The 2nd day it was worse, darker red.  The third day it was similar, and the 4th day it faded and by the 5th day it was gone.  She was still left with a lump on the  back of her arm and then it did go away.  She got the booster yesterday and last night she noticed it red again, but it is a different shape.  She has a big knot/lump in the back of her arm and it s itching.  She does not know how big it was.  The raised welt in the back of her left arm is more circular, it looks like 2-2 ½  long and 1  wide, more round in nature.  It is warm to touch and it has a lump in it.   She went to the doctor yesterday and she told her about it and told her that she was going to get the booster for monkey pox, but the county said there were more outbreaks and they were giving out these shots so she went to get one.   Yesterday she got the same overall tingling feeling from her head down to her torso that she did like the first one, and then it goes away.  The 2nd thing was the redness and welt on the back of the arm, but this time this morning she woke up with a headache at 6:00 AM.  She is a person that never has headaches, and she felt that maybe she didn t sleep very well.  She had the redness that was sore, swollen and itchy.  Then she had to take her car to the dealership and when she got home she was really tired, a little hungry and then got the tingly feeling again.  She has not taken anything for the headache which continues as she does not take anything for headaches.  She decided to get the paperwork out to see about the reactions and got our phone # to call us.   She did call the NP office and left a message for the MA and left a message and waiting for her to CB.
Age: 79.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Sensory disturbance, Skin warm, Urticaria
Clinical narrative: On 12/8/23 she got the first vaccine around 11:00 AM.  She noticed that she had a weird sensation when she got the vaccine of a tingling sensation in her body.  That went away and then her arm was itching, and then when she rubbed it to itch it she noticed there was a lump on the back of her arm.  She went into the bathroom to look in the mirror and she had a raised welted area that was 1/2" wide and it went down her arm about 3-3 1/2 ".  That's when she first noticed it.  The 2nd day it was worse, darker red.  The third day it was similar, and the 4th day it faded and by the 5th day it was gone.  She was still left with a lump on the  back of her arm and then it did go away.  She got the booster yesterday and last night she noticed it red again, but it is a different shape.  She has a big knot/lump in the back of her arm and it s itching.  She does not know how big it was.  The raised welt in the back of her left arm is more circular, it looks like 2-2 ½  long and 1  wide, more round in nature.  It is warm to touch and it has a lump in it.   She went to the doctor yesterday and she told her about it and told her that she was going to get the booster for monkey pox, but the county said there were more outbreaks and they were giving out these shots so she went to get one.   Yesterday she got the same overall tingling feeling from her head down to her torso that she did like the first one, and then it goes away.  The 2nd thing was the redness and welt on the back of the arm, but this time this morning she woke up with a headache at 6:00 AM.  She is a person that never has headaches, and she felt that maybe she didn t sleep very well.  She had the redness that was sore, swollen and itchy.  Then she had to take her car to the dealership and when she got home she was really tired, a little hungry and then got the tingly feeling again.  She has not taken anything for the headache which continues as she does not take anything for headaches.  She decided to get the paperwork out to see about the reactions and got our phone # to call us.   She did call the NP office and left a message for the MA and left a message and waiting for her to CB.
Age: 67.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Arthralgia, Back pain, Nausea, Oedema peripheral
Clinical narrative: swelling under arm (lower armpit area), joint pain, back pain, nausea
Age: 70.0
Sex: M
Vaccine: FLUA4, TDAP, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: After administration of the vaccines, it was determined that the Boostrix vaccine used was expired at the time of administration.  Expiration date on product was 12/9/2023.  The patient was contacted immediately and he reported no adverse events at this time.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Injection site rash, Skin reaction
Clinical narrative: Patient went to the ER on 11/10/2023 for a rash on the right thigh. The ER diagnosis as localized reaction at the injection site. The mom was instructed to give infants Tylenol every 6 hours.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Injection site rash, Local reaction
Clinical narrative: Patient went to the ER on 11/10/2023 for a rash on the right thigh. The ER diagnosis as localized reaction at the injection site. The mom was instructed to give infants Tylenol every 6 hours.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Decreased appetite, Electrocardiogram normal, Epigastric discomfort, Influenza virus test negative
Clinical narrative: I experienced mild upper gastric discomfort in the weeks following my third COVID booster. But the symptoms became very severe 2.5 weeks after the 3rd booster.  At this time, I experienced severe pain and vomiting for 12 hours, resulting in syncope and complete loss of consciousness.  Complete work up was done in ER, diagnosed with severe gastritis. IV fluids and medications helped mitigate the severe symptoms. At present, decreased appetite persists and mild discomfort following meals.  I have never had GI issues before this.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of consciousness, Pain, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Syncope
Clinical narrative: I experienced mild upper gastric discomfort in the weeks following my third COVID booster. But the symptoms became very severe 2.5 weeks after the 3rd booster.  At this time, I experienced severe pain and vomiting for 12 hours, resulting in syncope and complete loss of consciousness.  Complete work up was done in ER, diagnosed with severe gastritis. IV fluids and medications helped mitigate the severe symptoms. At present, decreased appetite persists and mild discomfort following meals.  I have never had GI issues before this.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: I experienced mild upper gastric discomfort in the weeks following my third COVID booster. But the symptoms became very severe 2.5 weeks after the 3rd booster.  At this time, I experienced severe pain and vomiting for 12 hours, resulting in syncope and complete loss of consciousness.  Complete work up was done in ER, diagnosed with severe gastritis. IV fluids and medications helped mitigate the severe symptoms. At present, decreased appetite persists and mild discomfort following meals.  I have never had GI issues before this.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Muscular weakness, Pain
Clinical narrative: 39yo F NICU nurse received her flu shot in the left deltoid at imms clinic on 30 NOV. She reports that the shot seemed to hurt more than usual while being injected, but otherwise for the next week just had the typical post-vaccine muscle soreness in the area around the injection. Around 7-10 days she reports starting to have shooting pains that went all the way down to her fingers. Those shooting pains have since resolved. She also reports that she had some numbness and tingling sensation in the arm, which is also now largely resolved, but she still gets infrequently. However, she also reports gradual onset of pain in the left shoulder and upper arm, which continues to the present. She reports that the pain is focused in the posterior shoulder around the joint line, with an uncomfortable rubbing sensation in that area. Pain is generally absent at rest, but brought on by lifting with the affected shoulder or with abducting her arm above the horizontal. She also describes weakness in the affected arm due to the pain.   She denies any prior medical problems with the affected shoulder. No significant PMH except for anxiety treated with Zoloft. No surgeries to the affected extremity. Allergic to sulfa. She reports that the pain does not impair her ability to do her job as a NICU nurse, and that it has been getting better on its own.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: 39yo F NICU nurse received her flu shot in the left deltoid at imms clinic on 30 NOV. She reports that the shot seemed to hurt more than usual while being injected, but otherwise for the next week just had the typical post-vaccine muscle soreness in the area around the injection. Around 7-10 days she reports starting to have shooting pains that went all the way down to her fingers. Those shooting pains have since resolved. She also reports that she had some numbness and tingling sensation in the arm, which is also now largely resolved, but she still gets infrequently. However, she also reports gradual onset of pain in the left shoulder and upper arm, which continues to the present. She reports that the pain is focused in the posterior shoulder around the joint line, with an uncomfortable rubbing sensation in that area. Pain is generally absent at rest, but brought on by lifting with the affected shoulder or with abducting her arm above the horizontal. She also describes weakness in the affected arm due to the pain.   She denies any prior medical problems with the affected shoulder. No significant PMH except for anxiety treated with Zoloft. No surgeries to the affected extremity. Allergic to sulfa. She reports that the pain does not impair her ability to do her job as a NICU nurse, and that it has been getting better on its own.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Borrelia test negative, Brain fog, Cough, Cytokine test
Clinical narrative: Nausea (1 day),  abdominal pain (2/28/21 - 3/3/21 and frequent flare-ups afterward)  severe chronic fatigue and exercise intolerance (started 2/28/21 and is continuing) persistent cough, tinnitus, heat intolerance vertigo (started 2/27/21 and is on-going) Brain fog on-going
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Exercise tolerance decreased, Fatigue, Granulocyte count decreased
Clinical narrative: Nausea (1 day),  abdominal pain (2/28/21 - 3/3/21 and frequent flare-ups afterward)  severe chronic fatigue and exercise intolerance (started 2/28/21 and is continuing) persistent cough, tinnitus, heat intolerance vertigo (started 2/27/21 and is on-going) Brain fog on-going
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Temperature intolerance, Tinnitus, Vascular endothelial growth factor assay, Vertigo
Clinical narrative: Nausea (1 day),  abdominal pain (2/28/21 - 3/3/21 and frequent flare-ups afterward)  severe chronic fatigue and exercise intolerance (started 2/28/21 and is continuing) persistent cough, tinnitus, heat intolerance vertigo (started 2/27/21 and is on-going) Brain fog on-going
Age: 69.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Anxiety, Fatigue, Heart rate irregular, Palpitations
Clinical narrative: felt fatigue, irregular heart beat, anxiety, heart palpitations.
Age: 69.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Atrial flutter, Atrioventricular block, Blood potassium normal, Cardioversion, Condition aggravated
Clinical narrative: felt fatigue, irregular heart beat, anxiety, heart palpitations.
Age: 69.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Electrocardiogram abnormal, Heart rate increased, Laboratory test normal, Palpitations, Sinus rhythm
Clinical narrative: felt fatigue, irregular heart beat, anxiety, heart palpitations.
Age: 69.0
Sex: M
Vaccine: RSV, RSV
Symptoms: White blood cell count increased
Clinical narrative: felt fatigue, irregular heart beat, anxiety, heart palpitations.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: RASH AND SWELLING AT IMMUNIZATION SITE
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Metamorphopsia, Vision blurred
Clinical narrative: PATIENT REPORTED BLURRY AND SKEWED VISION, THE DAY AFTER VACCINATION, HE STATED HE WAS SEEING TWO LINES CROSSING, HAD TO CLOSE ONE EYE TO READ HIS NEWSPAPER, THE SECOND DAY AFTER VACCINATION, HE SAID HIS VISION GOT WORSE AND THE LINES STARTED TO SQUARE UP. TODAY HE SAID HE HAS BLURRY VISION.
Age: 7.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: RN inadvertently administered Tdap vaccine too soon. RN misread parameters in vaccine schedule.
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Sudden death
Clinical narrative: PATIENT DIED APPROXIMATELY 45 MINUTES AFTER RECEIVING THEIR FLU SHOT, PATIENTS WIFE SAID THAT AFTER THEY GOT HOME AND HE WENT OUT TO START THEIR SNOW MOBILE AND SUDDENLY DIED.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: Patient was given 2nd MMRII vaccine 6 days after previous MMR vaccine. Patient was intended to receive Varicella vaccine.  As of now there has been no adverse effects.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Herpes zoster, Rash
Clinical narrative: Developed shingles on 1/10/2024. Started with a small rash on my upper left back and spread down to my left hand and up mt arm. Started antiviral medication on 1/14/2024 after visiting urgent care. 37 weeks pregnant at the time, have not delivered yet.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired 12/9/23 and was administered on 1/6/24.  No adverse event occurred as the result of this.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: She came to fill her new Rx on 1-17-24. She was told us that after the COVID vaccine her arm felt "frizzle" arm through to her fingers and her fingers are numbed. Her doctor told her to see the neurologist. Also, her doctor told her that the numbness might come back or might not.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Thrombosis
Clinical narrative: blood clot redeveloped after vaccination.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Human papillomavirus infection; This spontaneous report was received from a nurse referred to a 26-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 30-JAN-2014, the patient was vaccinated the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, lot #1696AA, expiration date was not reported, but upon internal validation established as 12-SEP-2014, administered intramuscularly for prophylaxis (dose, strength was not provided). On 07-APR-2014, the patient was vaccinated the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, lot # J010395, expiration date was not reported, but upon internal validation established as 29-APR-2016(dose, strength was not provided). On 07-OCT-2014, the patient was vaccinated the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, lot # J013324, expiration date was not reported, but upon internal validation established as 12-FEB-2016 (dose, strength was not provided).   On an unknown date, the patient contracted human papillomavirus infection (HPV) after receiving full quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) series. Genotyping was not done on the lesions, so it was unknown if the patient was infected by a HPV type included in the original vaccination (papilloma viral infection). It was unknown whether the treatment was given for the event. At the time of reporting, the outcome of the event papilloma viral infection was unknown. The action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) regarding papilloma viral infection was reported as Not Applicable.   The causal relationship between papilloma viral infection and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had all the shingle shots and got them twice since the shots/Suspected vaccination failure; I had all the shingle shots and got them twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had all the shingle shots and got them twice since the shots/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had all the shingle shots and got them twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JAN-2024 This case was reported by a patient via interactive digital media. The patient had all the shingle shots and got them twice since the shots Follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: FLUX, RVX, UNK
Symptoms: Dyspnoea, Injection site pruritus
Clinical narrative: experienced shortness of breath; slight site of administration itchiness; This non-serious case was reported by a consumer via patient support programs and described the occurrence of shortness of breath in a female patient who received cabotegravir, rilpivirine (Cabenuva) suspension for injection for drug use for unknown indication.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis and Influenza vaccine for prophylaxis.   Additional patient notes included Other conditions not provided..   On 06-DEC-2023, the patient started Cabenuva. On 01-DEC-2023, the patient received RSV vaccine and Influenza vaccine. On 06-DEC-2023, less than a day after starting Cabenuva, less than a day after starting Cabenuva and 5 days after receiving RSV vaccine, the patient experienced shortness of breath (Verbatim: experienced shortness of breath) and injection site itching (Verbatim: slight site of administration itchiness). The action taken with Cabenuva was unknown. The outcome of the shortness of breath was resolved and the outcome of the injection site itching was not resolved.   The reporter considered the shortness of breath to be unrelated to Cabenuva, Cabenuva Syringe Device, Cabenuva Needle Device and Cabenuva Vial Adaptor Device. It was unknown if the reporter considered the injection site itching to be related to Cabenuva, Cabenuva Syringe Device, Cabenuva Needle Device and Cabenuva Vial Adaptor Device. It was unknown if the reporter considered the shortness of breath to be related to RSV vaccine.     The company considered the shortness of breath to be unrelated to Cabenuva, Cabenuva Syringe Device, Cabenuva Needle Device and Cabenuva Vial Adaptor Device. It was unknown if the company considered the injection site itching to be related to Cabenuva, Cabenuva Syringe Device, Cabenuva Needle Device and Cabenuva Vial Adaptor Device. It was unknown if the company considered the shortness of breath to be related to RSV vaccine.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   GSK Receipt Date: 08-JAN-2024 This case as received from consumer via regulatory authority. Patient was calling and does not have lot number. Other products were not provided. Patient experienced shortness of breath and slight site of administration itchiness following 06 Dec 2023 injection. Completed by the prescriber themselves instead of normal registered nurse. Recently had injections for Respiratory syncytial virus or Flu on 01 Dec 2023 and was unsure if that may had an effect with the 06 Dec 2023 injections. Patient advised itchiness was typically normal but wanted to just check to see if it was normal. Patient did mention injection seemed to be in a spot 2 to 3 inches off from where it was normally given. Next injection was set around February 2024 but Patient did not remember exact date. It was unknown if the reporter considered the shortness of breath to be related to Influenza vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold, Influenza like illness, Insomnia, Pain
Clinical narrative: Unable to sleep; Body is aching from the top of my head to my feet/ hurting./; truck hit me; Freezing cold/ cold; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of insomnia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced insomnia (Verbatim: Unable to sleep), general body pain (Verbatim: Body is aching from the top of my head to my feet/ hurting./), feeling abnormal (Verbatim: truck hit me) and feeling cold (Verbatim: Freezing cold/ cold). The patient was treated with paracetamol (Tylenol). The outcome of the insomnia, general body pain, feeling abnormal and feeling cold were unknown.   It was unknown if the reporter considered the insomnia, general body pain, feeling abnormal and feeling cold to be related to Shingrix.     It was unknown if the company considered the insomnia, general body pain, feeling abnormal and feeling cold to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-Jan-2024 The reporter reported that yesterday the patient received Shingrix vaccine and experienced could not sleep all night even after took 2 sleeping pills. The patient received Tylenol as a treatment for his or her body was aching from the top of his or her head to his or her feet, everything was hurting. The reporter asked the girl is this the same one Shingrix vaccine you gave me the first time as she stated yes. The reporter stated that the first time he or she did not had any effects. Today the patient was felt like a truck hit him or her, he or she got freezing cold, patient was cold, hurting. The reporter did not know what to do, was it normal to do that,  It was like a heavy flu or what.
Sex: F
Vaccine: RSV
Symptoms: Dysgeusia
Clinical narrative: funny taste in mouth; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of taste peculiar in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced taste peculiar (Verbatim: funny taste in mouth). The outcome of the taste peculiar was resolved.   The reporter considered the taste peculiar to be possibly related to Arexvy.     The company considered the taste peculiar to be possibly related to Arexvy.   Additional Information: GSK Receipt Date: 13-JAN-2024 The case was received from the patient via interactive digital media. The patient and her husband both got the shot of Arexvy (RSV shot). The patient had funny taste in her mouth nothing else they were both fine no side effects. The reporter thought that the event might had been related to the product.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: received expired dose of Hiberix on 08Jan2024 the vaccine expired on 30Dec2023; 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 6-month-old male patient who received Hib (Hiberix) (batch number 74YN7, expiry date 30-DEC-2023) for prophylaxis.   On 08-JAN-2024, the patient received the 3rd dose of Hiberix. On 08-JAN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: received expired dose of Hiberix on 08Jan2024 the vaccine expired on 30Dec2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2024. A medical assistant reported that a male patient received an expired dose of Hiberix which led to expired vaccine used. No symptoms were reported.  The reporter consented to follow up.