chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Lymphadenopathy, Menstrual disorder, Polymenorrhoea, Pyrexia
Clinical narrative: 1st Vaccine Moderna 8/14/21 Pharmacy #3583 - Flu like symptoms the next night 24 hours later, rash at injection stie then no issues until a week later- Covid Arm- raised hot huge rash bump that went away in 3-4 days.  My menstruation cycle was due in two weeks and was a few days late.  2nd dose Moderna 9/11/21 at Pharmacy #3583 Fever that very night and swollen lymph nodes only on right side groin, armpit, ithy large rash developed and saw my Dr via telehealth call prescribed high dose steroid for three days.  My menstruation cycle the next few months September, October and November were sooner and sooner so the 28 day cycle closed down to 23 days. Then in February my cycle did not come and in March 2022 I have no been on a constant bleeding, heavy cycle, spotting and only 4-5 days here and there maybe 3 times in the last 4 months of not a lot of bleeding. I have talked to my Dr about it but no one seems to realize there is an issue with the shots and cycles this extreme. As of today June 5 2022 I am on the search for a new gyno that will listen to me and figure out how to reverse this damage.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash papular, Rash pruritic, Skin swelling, Skin warm
Clinical narrative: 1st Vaccine Moderna 8/14/21 Pharmacy #3583 - Flu like symptoms the next night 24 hours later, rash at injection stie then no issues until a week later- Covid Arm- raised hot huge rash bump that went away in 3-4 days.  My menstruation cycle was due in two weeks and was a few days late.  2nd dose Moderna 9/11/21 at Pharmacy #3583 Fever that very night and swollen lymph nodes only on right side groin, armpit, ithy large rash developed and saw my Dr via telehealth call prescribed high dose steroid for three days.  My menstruation cycle the next few months September, October and November were sooner and sooner so the 28 day cycle closed down to 23 days. Then in February my cycle did not come and in March 2022 I have no been on a constant bleeding, heavy cycle, spotting and only 4-5 days here and there maybe 3 times in the last 4 months of not a lot of bleeding. I have talked to my Dr about it but no one seems to realize there is an issue with the shots and cycles this extreme. As of today June 5 2022 I am on the search for a new gyno that will listen to me and figure out how to reverse this damage.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Dyspnoea, Emotional distress
Clinical narrative: Several minutes after administering a Pneumovax 23 to a patient she began to have severe difficulty breathing and chest pain. We called EMS, and a code and I administered 1 dose of epinephrine 0.3mg to the patient. Patient remained conscious and sitting in the chair but was clearly in distress.  EMS came shortly after, assessed the patient, and took her to hospital for evaluation/treatment.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Heart rate increased, Heart rate irregular, Hypertension
Clinical narrative: Hypertension  Rapid heart beat Aggressive heart beats Chest tightness
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test abnormal
Clinical narrative: Hypertension  Rapid heart beat Aggressive heart beats Chest tightness
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever of up to 103; vomiting.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain, Peripheral swelling, Pyrexia, Skin irritation
Clinical narrative: Chills, fever, body aches, swollen and irritated arm  54 hours so far
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: severe dizziness
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Hypoaesthesia, Pain, Paraesthesia, Small fibre neuropathy
Clinical narrative: Idiopathic small fiber neuropathy diagnosed via skin biopsies. No known cause was found. Symptoms started three days after second dose, then they went away. They returned about a month after my third dose (first booster).   Symptoms include tingling, numbness and some pain, especially in my left foot, but also in hands, arm, face, and tongue.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction. Vaccine temperature excursion. Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Ageusia, Anosmia, Condition aggravated, Dyspnoea
Clinical narrative: Since after I got the vaccine (both doses) I noticed that my body bruises (without hitting against anything), I even noticed a blood spot in my eye most recently (but I haven?t poked my eye or anything!)and my heart rate increases at certain times without change of activity, my blood pressure is higher than the normal range it used to be before vaccination.. and healing from any infection takes too long (I have been having a recurrent yeast infection that doesn?t seem to go away although I have taken prescribed anti fungal 4 times already ) and wounds healing is slower than prior to getting vaccinated.  Since receiving the vaccine I have been bloated and my body had been swollen for no reason and it?s not going away.. I get nauseous easily. I had been infected by Covid prior to receiving the vaccine , it caused me loss of taste and smell, which I started gaining back. But when I got the vaccine I lost them again and I am barely able to taste or smell.  Also right after I got the vaccines I have been having shortness of breath more than normal.. it was worse during the first 2 months after vaccine.. but since my oxygen levels were good and I wasn?t hospitalized you didn?t care to call me about it.. I have been reporting all of this through the portal!  I have a very strong immune system that prior to the vaccine I would normally heal fast from anything but since after the vaccine I have been struggling with that! I am not happy about all of this and I am afraid this will be a forever change.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Fungal infection, Heart rate increased, Hypertension, Impaired healing
Clinical narrative: Since after I got the vaccine (both doses) I noticed that my body bruises (without hitting against anything), I even noticed a blood spot in my eye most recently (but I haven?t poked my eye or anything!)and my heart rate increases at certain times without change of activity, my blood pressure is higher than the normal range it used to be before vaccination.. and healing from any infection takes too long (I have been having a recurrent yeast infection that doesn?t seem to go away although I have taken prescribed anti fungal 4 times already ) and wounds healing is slower than prior to getting vaccinated.  Since receiving the vaccine I have been bloated and my body had been swollen for no reason and it?s not going away.. I get nauseous easily. I had been infected by Covid prior to receiving the vaccine , it caused me loss of taste and smell, which I started gaining back. But when I got the vaccine I lost them again and I am barely able to taste or smell.  Also right after I got the vaccines I have been having shortness of breath more than normal.. it was worse during the first 2 months after vaccine.. but since my oxygen levels were good and I wasn?t hospitalized you didn?t care to call me about it.. I have been reporting all of this through the portal!  I have a very strong immune system that prior to the vaccine I would normally heal fast from anything but since after the vaccine I have been struggling with that! I am not happy about all of this and I am afraid this will be a forever change.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Increased tendency to bruise, Nausea, Swelling, Treatment failure
Clinical narrative: Since after I got the vaccine (both doses) I noticed that my body bruises (without hitting against anything), I even noticed a blood spot in my eye most recently (but I haven?t poked my eye or anything!)and my heart rate increases at certain times without change of activity, my blood pressure is higher than the normal range it used to be before vaccination.. and healing from any infection takes too long (I have been having a recurrent yeast infection that doesn?t seem to go away although I have taken prescribed anti fungal 4 times already ) and wounds healing is slower than prior to getting vaccinated.  Since receiving the vaccine I have been bloated and my body had been swollen for no reason and it?s not going away.. I get nauseous easily. I had been infected by Covid prior to receiving the vaccine , it caused me loss of taste and smell, which I started gaining back. But when I got the vaccine I lost them again and I am barely able to taste or smell.  Also right after I got the vaccines I have been having shortness of breath more than normal.. it was worse during the first 2 months after vaccine.. but since my oxygen levels were good and I wasn?t hospitalized you didn?t care to call me about it.. I have been reporting all of this through the portal!  I have a very strong immune system that prior to the vaccine I would normally heal fast from anything but since after the vaccine I have been struggling with that! I am not happy about all of this and I am afraid this will be a forever change.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Tested positive, Cough. Fever, Running nose.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Electric shock sensation, Headache, Hypersomnia, Mobility decreased
Clinical narrative: All of my joints, muscles and nerves felt like they were connected to an electric switch in the on position.  I had a very severe headache, couldn?t control my hands to hold phone or push buttons to call an ambulance, could not control my legs to get on my feet, could not completely wake up, it was as though I had been drugged an would go back to sleep, was confused when I would wake up because the pains were so severe.  When I did wake up after about 24 hrs all of the pains were completely gone as though the electric switch was turned off.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: All of my joints, muscles and nerves felt like they were connected to an electric switch in the on position.  I had a very severe headache, couldn?t control my hands to hold phone or push buttons to call an ambulance, could not control my legs to get on my feet, could not completely wake up, it was as though I had been drugged an would go back to sleep, was confused when I would wake up because the pains were so severe.  When I did wake up after about 24 hrs all of the pains were completely gone as though the electric switch was turned off.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Foaming at mouth, Laboratory test, Mobility decreased, Nausea, Pain
Clinical narrative: I got my first shot on 3.30.21, I went home, i was fine. Woke up, my arm was sore, I started getting nausea, but then I started throwing up. I thought it was normal, but then I was throwing up all day. Next day, I started throwing up white foam. Then my hand was hurting like some one spanked it. On the third day, I woke up and my vomiting was more aggressive, and my right hand was was in pain, I could not use it. If I tried to do something, it just hurt the whole hand. I called the clinic and told them that I was having a bad reaction to the shot, told them that my vomiting wont stop and my right hand is hurting. They made me an appointment. So I was back and fourth in the clinic. Those 3 weeks, it's getting worse. Clinic/NP was just giving me nausea medicine and acid reflux mediation. And wanted to give me a shot to take the pain away from my hand. But I said no more shots. The second shot, I was suppose to get it out of her clinic. I couldnt use my hand at all. Right before I got the shot, I had to get her advice. She gives me a shot, and gave me vomiting meds again and sent me for the second covid shot. I went because she's my doctor.   Went to Hospital.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: I got my first shot on 3.30.21, I went home, i was fine. Woke up, my arm was sore, I started getting nausea, but then I started throwing up. I thought it was normal, but then I was throwing up all day. Next day, I started throwing up white foam. Then my hand was hurting like some one spanked it. On the third day, I woke up and my vomiting was more aggressive, and my right hand was was in pain, I could not use it. If I tried to do something, it just hurt the whole hand. I called the clinic and told them that I was having a bad reaction to the shot, told them that my vomiting wont stop and my right hand is hurting. They made me an appointment. So I was back and fourth in the clinic. Those 3 weeks, it's getting worse. Clinic/NP was just giving me nausea medicine and acid reflux mediation. And wanted to give me a shot to take the pain away from my hand. But I said no more shots. The second shot, I was suppose to get it out of her clinic. I couldnt use my hand at all. Right before I got the shot, I had to get her advice. She gives me a shot, and gave me vomiting meds again and sent me for the second covid shot. I went because she's my doctor.   Went to Hospital.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: (12/28) PAIN AT THE INJECTION SITE. LEFT ARM IMMOBILE, HEADACHE, DIFFICULTY SWALLOWING TROUBLE BREATHING, CHEST HURT, HEART POUNDING, FATIGUE, NAUSEA, FEVER, CHILLS. (12/29) STOMACH PAIN, FATIGUE, CHILLS (12/30) TROUBLE SLEEPING; FEELING SICK (12/31) NIGHTTIME CHILLS (1/1) CHEST HURT, HEADACHES (1/2) NAUSEA, HEADACHES (1/4) TREMORS IN BOTH HANDS AND BACK (SENSED AND VISIBLE), RAPID HEART RATE  (1/5) FEELING AWFUL, FATIGUE  (1/6) SEVERE NAUSEA (1/9) NAUSEA, SEVERE FATIGUE, SLEPT MOST THE DAY, BELL'S PALSY IN RIGHT face (1/10) STOMACH PAIN, FATIGUE, FEVER RAPID HEART RATE, PAIN IN BACK, SHOULDER, HEADACHES, NAUSEA, STOMACH PAIN
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Injected limb mobility decreased, Laboratory test
Clinical narrative: (12/28) PAIN AT THE INJECTION SITE. LEFT ARM IMMOBILE, HEADACHE, DIFFICULTY SWALLOWING TROUBLE BREATHING, CHEST HURT, HEART POUNDING, FATIGUE, NAUSEA, FEVER, CHILLS. (12/29) STOMACH PAIN, FATIGUE, CHILLS (12/30) TROUBLE SLEEPING; FEELING SICK (12/31) NIGHTTIME CHILLS (1/1) CHEST HURT, HEADACHES (1/2) NAUSEA, HEADACHES (1/4) TREMORS IN BOTH HANDS AND BACK (SENSED AND VISIBLE), RAPID HEART RATE  (1/5) FEELING AWFUL, FATIGUE  (1/6) SEVERE NAUSEA (1/9) NAUSEA, SEVERE FATIGUE, SLEPT MOST THE DAY, BELL'S PALSY IN RIGHT face (1/10) STOMACH PAIN, FATIGUE, FEVER RAPID HEART RATE, PAIN IN BACK, SHOULDER, HEADACHES, NAUSEA, STOMACH PAIN
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: (12/28) PAIN AT THE INJECTION SITE. LEFT ARM IMMOBILE, HEADACHE, DIFFICULTY SWALLOWING TROUBLE BREATHING, CHEST HURT, HEART POUNDING, FATIGUE, NAUSEA, FEVER, CHILLS. (12/29) STOMACH PAIN, FATIGUE, CHILLS (12/30) TROUBLE SLEEPING; FEELING SICK (12/31) NIGHTTIME CHILLS (1/1) CHEST HURT, HEADACHES (1/2) NAUSEA, HEADACHES (1/4) TREMORS IN BOTH HANDS AND BACK (SENSED AND VISIBLE), RAPID HEART RATE  (1/5) FEELING AWFUL, FATIGUE  (1/6) SEVERE NAUSEA (1/9) NAUSEA, SEVERE FATIGUE, SLEPT MOST THE DAY, BELL'S PALSY IN RIGHT face (1/10) STOMACH PAIN, FATIGUE, FEVER RAPID HEART RATE, PAIN IN BACK, SHOULDER, HEADACHES, NAUSEA, STOMACH PAIN
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Bell's palsy, Chest pain
Clinical narrative: (12/28) PAIN AT THE INJECTION SITE. LEFT ARM IMMOBILE, HEADACHE, DIFFICULTY SWALLOWING TROUBLE BREATHING, CHEST HURT, HEART POUNDING, FATIGUE, NAUSEA, FEVER, CHILLS. (12/29) STOMACH PAIN, FATIGUE, CHILLS (12/30) TROUBLE SLEEPING; FEELING SICK (12/31) NIGHTTIME CHILLS (1/1) CHEST HURT, HEADACHES (1/2) NAUSEA, HEADACHES (1/4) TREMORS IN BOTH HANDS AND BACK (SENSED AND VISIBLE), RAPID HEART RATE  (1/5) FEELING AWFUL, FATIGUE  (1/6) SEVERE NAUSEA (1/9) NAUSEA, SEVERE FATIGUE, SLEPT MOST THE DAY, BELL'S PALSY IN RIGHT face (1/10) STOMACH PAIN, FATIGUE, FEVER RAPID HEART RATE, PAIN IN BACK, SHOULDER, HEADACHES, NAUSEA, STOMACH PAIN
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Defect conduction intraventricular, Dysphagia, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: (12/28) PAIN AT THE INJECTION SITE. LEFT ARM IMMOBILE, HEADACHE, DIFFICULTY SWALLOWING TROUBLE BREATHING, CHEST HURT, HEART POUNDING, FATIGUE, NAUSEA, FEVER, CHILLS. (12/29) STOMACH PAIN, FATIGUE, CHILLS (12/30) TROUBLE SLEEPING; FEELING SICK (12/31) NIGHTTIME CHILLS (1/1) CHEST HURT, HEADACHES (1/2) NAUSEA, HEADACHES (1/4) TREMORS IN BOTH HANDS AND BACK (SENSED AND VISIBLE), RAPID HEART RATE  (1/5) FEELING AWFUL, FATIGUE  (1/6) SEVERE NAUSEA (1/9) NAUSEA, SEVERE FATIGUE, SLEPT MOST THE DAY, BELL'S PALSY IN RIGHT face (1/10) STOMACH PAIN, FATIGUE, FEVER RAPID HEART RATE, PAIN IN BACK, SHOULDER, HEADACHES, NAUSEA, STOMACH PAIN
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Heart rate increased, Hypersomnia
Clinical narrative: (12/28) PAIN AT THE INJECTION SITE. LEFT ARM IMMOBILE, HEADACHE, DIFFICULTY SWALLOWING TROUBLE BREATHING, CHEST HURT, HEART POUNDING, FATIGUE, NAUSEA, FEVER, CHILLS. (12/29) STOMACH PAIN, FATIGUE, CHILLS (12/30) TROUBLE SLEEPING; FEELING SICK (12/31) NIGHTTIME CHILLS (1/1) CHEST HURT, HEADACHES (1/2) NAUSEA, HEADACHES (1/4) TREMORS IN BOTH HANDS AND BACK (SENSED AND VISIBLE), RAPID HEART RATE  (1/5) FEELING AWFUL, FATIGUE  (1/6) SEVERE NAUSEA (1/9) NAUSEA, SEVERE FATIGUE, SLEPT MOST THE DAY, BELL'S PALSY IN RIGHT face (1/10) STOMACH PAIN, FATIGUE, FEVER RAPID HEART RATE, PAIN IN BACK, SHOULDER, HEADACHES, NAUSEA, STOMACH PAIN
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Malaise, Nausea
Clinical narrative: (12/28) PAIN AT THE INJECTION SITE. LEFT ARM IMMOBILE, HEADACHE, DIFFICULTY SWALLOWING TROUBLE BREATHING, CHEST HURT, HEART POUNDING, FATIGUE, NAUSEA, FEVER, CHILLS. (12/29) STOMACH PAIN, FATIGUE, CHILLS (12/30) TROUBLE SLEEPING; FEELING SICK (12/31) NIGHTTIME CHILLS (1/1) CHEST HURT, HEADACHES (1/2) NAUSEA, HEADACHES (1/4) TREMORS IN BOTH HANDS AND BACK (SENSED AND VISIBLE), RAPID HEART RATE  (1/5) FEELING AWFUL, FATIGUE  (1/6) SEVERE NAUSEA (1/9) NAUSEA, SEVERE FATIGUE, SLEPT MOST THE DAY, BELL'S PALSY IN RIGHT face (1/10) STOMACH PAIN, FATIGUE, FEVER RAPID HEART RATE, PAIN IN BACK, SHOULDER, HEADACHES, NAUSEA, STOMACH PAIN
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pyrexia, Sinus arrhythmia, Tremor
Clinical narrative: (12/28) PAIN AT THE INJECTION SITE. LEFT ARM IMMOBILE, HEADACHE, DIFFICULTY SWALLOWING TROUBLE BREATHING, CHEST HURT, HEART POUNDING, FATIGUE, NAUSEA, FEVER, CHILLS. (12/29) STOMACH PAIN, FATIGUE, CHILLS (12/30) TROUBLE SLEEPING; FEELING SICK (12/31) NIGHTTIME CHILLS (1/1) CHEST HURT, HEADACHES (1/2) NAUSEA, HEADACHES (1/4) TREMORS IN BOTH HANDS AND BACK (SENSED AND VISIBLE), RAPID HEART RATE  (1/5) FEELING AWFUL, FATIGUE  (1/6) SEVERE NAUSEA (1/9) NAUSEA, SEVERE FATIGUE, SLEPT MOST THE DAY, BELL'S PALSY IN RIGHT face (1/10) STOMACH PAIN, FATIGUE, FEVER RAPID HEART RATE, PAIN IN BACK, SHOULDER, HEADACHES, NAUSEA, STOMACH PAIN
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Lip swelling, Throat irritation, Tongue pruritus
Clinical narrative: Patient informed vaccinator that she has a history of allergic reactions to vaccines and asked if an epi-pen might be available in case. Patient was vaccinate at 2:35PM and monitored by clinical staff. Patient began experiencing a minor allergic reaction with swelling around 10-15 minutes after injection. She self-administered Benadryl and felt normal by the time she left. She was driven home by her husband.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Patient informed vaccinator that she has a history of allergic reactions to vaccines and asked if an epi-pen might be available in case. Patient was vaccinate at 2:35PM and monitored by clinical staff. Patient began experiencing a minor allergic reaction with swelling around 10-15 minutes after injection. She self-administered Benadryl and felt normal by the time she left. She was driven home by her husband.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Vaccination error
Clinical narrative: Received 4th shot as system was not updated to show that patient had already received booster. Mother handed vaccine card  to LPN and three vaccines were listed
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Received 4th shot as system was not updated to show that patient had already received booster. Mother handed vaccine card  to LPN and three vaccines were listed
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Concomitant administration of VARIVAX and PROQUAD to a one year old patient.; This spontaneous report was received from a medical assistant concerning a 1-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.   On 13-MAY-2022, the patient was vaccinated concomitantly with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (ml), lot # U030162, expiration date 28-SEP-2023, and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml, lot # U0315694, expiration date 06-APR-2023, for prophylaxis (route of administration and anatomical location was not reported) (Overdose). No additional information was provided.   Lot number U0315694 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). Lot number U0315694 does not match any Company product as confirmed by Lot Verification team.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX802AA, expiry date February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 27th May 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 31-May-2022 Reporter's comment: The health care provider called to report that the patient received an expired dose of Bexsero. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: medication error due to a patient being administered only the DTAP-IPV liquid component of the PENTACEL vaccine, with no reported adverse event; Initial information on 19-May-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 2 months old male patient who had medication error due to a patient being administered only the dtap-ipv liquid component of the pentacel vaccine, with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (Hepatitis B Vaccine); Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar); And Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) all for prophylactic vaccination.  On 06-May-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine, frequency: once, dose number 1st (route, strength, formulation: unknown) lot uj531aaa, expiry date: 22-Jul-2022 via intramuscular route in the thigh nos for prophylactic vaccination.  On 06-MAY-2022 the patient developed a non-serious event medication error due to a patient being administered only the dtap-ipv liquid component of the pentacel vaccine, with no reported adverse event (Incorrect product formulation administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with was not applicable.  It was not reported if the patient received a corrective treatment for the event (Incorrect product formulation administered).  At time of reporting, the outcome was Unknown for the event Incorrect product formulation administered.   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.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Vaccine expired 4/22/2022 and was administered on 5/11/2022, with no reported adverse event; Initial information received on 12-May-2022 regarding an unsolicited valid  non-serious courtesy case received from a consumer/non-hcp.    This case involves an unknown demographic patient whose vaccine expired 4/22/2022 and was administered on 5/11/2022, with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-May-2022, the patient received a  dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine suspension for injection unknown strength lot C5732AA expiration date 22-Apr-2022 via unknown route in unknown administration site for prophylactic vaccination.  Vaccine expired 4/22/2022 and was administered on 5/11/2022, with no reported adverse event (expired product administered) (same day).  Action taken: Not applicable  Outcome: Unknown    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: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 16 month old was given 2 doses of Hib, given Acthib when he already got a dose of Pentacel with no reported adverse event; Initial information was received on 16-May-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.   This case involves a 16 months old male patient who experienced 16 month old was given 2 doses of hib, given acthib when he already got a dose of pentacel with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included prevnar and pentacel for Prophylactic vaccination.  On 16-May-2022, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine (lot UJ521AA and expiry- 22-JUL-2023 ) (strength and formulation: unknown) via intramuscular route in the left upper thigh for immunization.  On 16-MAY-2022 the patient developed a non-serious 16 month old was given 2 doses of hib, given acthib when he already got a dose of pentacel with no reported adverse event (extra dose administered) (latency same day) following the administration of HIB (PRP/T) vaccine.  Action taken:  not applicable.  At time of reporting, the outcome was Unknown for the event 16 month old was given 2 doses of hib, given acthib when he already got a dose of pentacel with no reported adverse event.  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 guidelines. 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: 1.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Product preparation issue
Clinical narrative: administered the vaccine but it was reconstituted with sterile water instead of the supplied diluent with no reported adverse event; Initial information received on 17-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old female patient who administered the vaccine but it was reconstituted with sterile water instead of the supplied diluent with no reported adverse event while receiving vaccines DTAP and HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-May-2022, the patient received a 3rd series of 0.5ml dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (lot: uj635aa, expiry: 27-Jan-2023) via intramuscular route in the right thigh for Immunization.  On an unknown date, the patient received a dose of suspect DTAP not produced by Sanofi Pasteur (strength, form, dose, route, lot number, expiry not reported) on an unknown administration site for Prophylactic vaccination.  On 12-May-2022 the patient experienced administered the vaccine but it was reconstituted with sterile water instead of the supplied diluent with no reported adverse event (product preparation error) (Latency: same day with respect of HIB (PRP/T)  vaccine and unknown for DTAP)  Action taken: not applicable for both the suspects.  Outcome: Unknown   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.
Sex: M
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 14 day old infant was erroneously administered ActHIB today, 18May2022 on the right thigh; Initial information received  on 18-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 14 days old male patient who was erroneously administered acthib today,18may2022 on the right thigh while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for immunisation; and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix) for Immunisation.  On 18-May-2022, the patient received a  0.5 ml dose of suspect HIB (PRP/T) Vaccine (batch lot :UJ614AB)(Expiry date :12-Mar-2023)(unknown strength and formulation) via unknown route in the right thigh for immunization.  On 18-May-2022 (latency : same day) the patient developed a non-serious event of  a 14 day old infant was erroneously administered acthib today, 18may2022 on the right thigh (product administered to patient of inappropriate age) following the administration of HIB (PRP/T) VACCINE.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event .  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 guidelines. 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Expired pentacel was administered with no reported adverse event; Initial information received on 20-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender and it was reported expired pentacel was administered with no reported adverse event , while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2022, the patient received an unknown  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, ( lot : UJ433AA; expiry date: 17-May-2022)  in unknown administration site for prophylactic vaccination.  It was reported that  expired pentacel was administered on 20-May-2022 and it expired 3 days prior (expired product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken : not applicable.  Outcome: unknown  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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was administered to a patient after the expiration date with no reported adverse event; Initial information was received on 20-May-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 65years old male patient to whom vaccine was administered to a patient after the expiration date with no reported adverse event while receiving vaccine Typhoid VI Polysaccharide Vaccine [Typhim VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Toxoid, Vaccine Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) for Immunisation.  On 20-May-2022, the patient received 0.5ml dose of suspect Typhoid VI Polysaccharide Vaccine (batch/lot number: T2a371m) (formulation, strength, expiration date: unknown) via unknown route in unknown administration site for immunization after the expiration date with no reported adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event (expired product administered).  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 guidelines. 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.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine may have been administered post excursion with no reported adverse event; Initial information received on 20-May-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown age and gender to whom  vaccine may have been administered post excursion with no reported adverse event, while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It  was reported that there was a temperature excursion on unopened IPOL due to refrigerator malfunction (not human error). The time of excursion was 38 hours and 15 minutes and the temperature for excursion was -1.1 C.  On an unknown date, the patient received an unknown  dose of suspect IPV (VERO) (lot : V1A121M ; expiry date: not reported) for prophylactic vaccination.  It was stated that  vaccines may have been administered post excursion with no reported adverse event (Product temperature excursion issue) (onset date: unknown) (latency: same day)  following the administration of IPV (VERO).  Action taken: not applicable.  Outcome:  unknown  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 guidelines. 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: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient who was given expired dose of ACTHIB (14 days after it has been expired) with no reported adverse event.; Initial information received on 20-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old female patient who was given expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (14 days after it has been expired) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2022, the patient received expired dose of 0.5 ml suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection (lot UJ661AAA, Expiration date: 06-May-2022) via unknown route in unknown administration site for immunization 14 days after it has been expired with no reported adverse event (expired product administered). It was asked "what are the side effects, what to look for and what to do to a patient who was given expired dose of ACTHIB (14 days after it has been expired)"  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event patient who was given expired dose of acthib (14 days after it has been expired) with no reported adverse event.   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 guidelines. 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: pentacel was administered and expired 3 days prior with no reported adverse event; Initial information received on 20-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves an unknown age and unknown gender patient who experienced pentacel was administered and expired 3 days prior with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect  diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t)(PRP/T) vaccine(unknown batch lot number, dosage, strength, formulation) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed non-serious event of  pentacel was administered and expired 3 days prior with no reported adverse event (expired product administered) ( latency :same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event pentacel was administered and expired 3 days prior with no reported adverse event.   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 guidelines. 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: 39.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired ACTHIB being administered to a patient with no reported adverse event; Initial information received on 23-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 39 years old male patient to whom expired acthib being administered to a patient with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine polysacch 23V (Pneumovax) for Immunisation.  On 23-May-2022, the patient received suspect HIB (PRP/T) vaccine at a dose of 0.5 ml total (lot UJ661AA , expiry date: 06-May-2022, form, strength: not reported) via intramuscular route in the left deltoid for immunisation.  On 23-May-2022, expired acthib being administered to a patient with no reported adverse event (expired product administered, latency: same day) following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable.  Outcome: Unknown    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 guidelines. 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.