chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Swollen tongue
Clinical narrative: Swollen tongue/Tongue swelling did not go away; Anaphylactic reaction/rushed to the hospital; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue/Tongue swelling did not go away) and ANAPHYLACTIC REACTION (Anaphylactic reaction/rushed to the hospital) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced SWOLLEN TONGUE (Swollen tongue/Tongue swelling did not go away) (seriousness criteria hospitalization and life threatening) and ANAPHYLACTIC REACTION (Anaphylactic reaction/rushed to the hospital) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on 07-Apr-2021 due to ANAPHYLACTIC REACTION. At the time of the report, SWOLLEN TONGUE (Swollen tongue/Tongue swelling did not go away) had not resolved and ANAPHYLACTIC REACTION (Anaphylactic reaction/rushed to the hospital) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: Sick (Kidney Problems); This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Sick (Kidney Problems)) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder (kidney problems (no dialysis)).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced RENAL DISORDER (Sick (Kidney Problems)) (seriousness criterion hospitalization). At the time of the report, RENAL DISORDER (Sick (Kidney Problems)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About two weeks after vaccination the patient became sick  and was hospitalized. The patient was sent to a  convalescent home from the hospital and then back to the hospital for 2 months then back to the convalescent home again. The patient had spent March, April and May 2021 in those facilities. On 27-May-2021, the patient came back home.  No concomitant medications and treatment information reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. However, the previous history of Kidney disorder is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. However, the previous history of Kidney disorder is a confounder.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory bowel disease, Vaccination complication
Clinical narrative: inflammatory bowel disease; severe response to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATORY BOWEL DISEASE (inflammatory bowel disease) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATORY BOWEL DISEASE (inflammatory bowel disease) (seriousness criterion medically significant) and VACCINATION COMPLICATION (severe response to the vaccine). At the time of the report, INFLAMMATORY BOWEL DISEASE (inflammatory bowel disease) and VACCINATION COMPLICATION (severe response to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, the previous history of inflammatory bowel disease is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, the previous history of inflammatory bowel disease is a confounder.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: Bleeding after the 2nd shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding after the 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding after the 2nd shot) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (Bleeding after the 2nd shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Very limited information regarding this event (hemorrhage) has been provided at this time. Details regarding vaccination date and the type of bleeding are required for further assessment.; Sender's Comments: Very limited information regarding this event (hemorrhage) has been provided at this time. Details regarding vaccination date and the type of bleeding are required for further assessment.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication or treatment were reported by the reporter.  Company Comment: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.   This case was linked to MOD-2021-102410 (Patient Link).; Sender's Comments: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Headache, Myalgia
Clinical narrative: Right deltoid muscle ache began within 1 hour after injection and resolved within 24 hours. Muscle and joint pain in entire body began on 6/2/2021 at about 3 a.m. and resolved on 6/3/2021 at about 8 a.m. Headache, chills, fever, and a dry cough began on 6/2/2021 at 4 a.m. The fever fluctuated between 99.5 degrees F and 101.3 degrees F. The chills and fever resolved on 6/2/2021 at 10 p.m. The headache resolved on 6/3/2021 at 10 a.m. The headache was frontal type pain in the forehead with sensitivity to light. The dry cough is still ongoing right now on 6/4/2021 at approximately 6:15 a.m. It is a dry, non-productive cough, worse during the day and less at night.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Right deltoid muscle ache began within 1 hour after injection and resolved within 24 hours. Muscle and joint pain in entire body began on 6/2/2021 at about 3 a.m. and resolved on 6/3/2021 at about 8 a.m. Headache, chills, fever, and a dry cough began on 6/2/2021 at 4 a.m. The fever fluctuated between 99.5 degrees F and 101.3 degrees F. The chills and fever resolved on 6/2/2021 at 10 p.m. The headache resolved on 6/3/2021 at 10 a.m. The headache was frontal type pain in the forehead with sensitivity to light. The dry cough is still ongoing right now on 6/4/2021 at approximately 6:15 a.m. It is a dry, non-productive cough, worse during the day and less at night.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Confusional state, Dizziness, Fall, Fatigue
Clinical narrative: started getting dizzy about a week after the shot. about two weeks after the shot the dizziness is worse. I fell at work when I was just standing by my desk when I suddenly became extremely dizzy. At home I am having to hold onto things to help with balance. I am also having headaches, tinnitus, confusion, some mild congestion, and extreme tiredness. The vaccine is the only thing thing that is different the last couple of months. None of my medications have changed. I am due for the second shot next week, but I am not getting it due to the side effects I am experiencing.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Respiratory tract congestion, Tinnitus
Clinical narrative: started getting dizzy about a week after the shot. about two weeks after the shot the dizziness is worse. I fell at work when I was just standing by my desk when I suddenly became extremely dizzy. At home I am having to hold onto things to help with balance. I am also having headaches, tinnitus, confusion, some mild congestion, and extreme tiredness. The vaccine is the only thing thing that is different the last couple of months. None of my medications have changed. I am due for the second shot next week, but I am not getting it due to the side effects I am experiencing.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Paraesthesia, Shoulder injury related to vaccine administration
Clinical narrative: Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on left chest/back
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Product formulation issue
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flushing, Hyperhidrosis, Pyrexia
Clinical narrative: Systemic: Chills-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: na
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperaesthesia, Pain, Paraesthesia
Clinical narrative: I am 23 weeks pregnant and due on or around September 27, 2021. The evening on the same day of the vaccine (my second dose), I felt very touchy, almost tingly, sore, body aches, and fatigue.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood test, Blood urine, Carbon dioxide increased, Chest X-ray
Clinical narrative: High fever developed 2-3 days after shot (104.7).  Now 12 days with a fever in range 102-104.7 degrees.    Rapid COVID test day 1 of fever - negative  Doctor visit day 3 - (5/27) Rapid COVID test - negative Antibiotics prescribed 5/27   Back to doctor 6/1 (day 8 of fever - antibiotics not helping) PCR COVID test sent out (result - negative) High protein in urine - sent to ER at CHOP  ER at CHOP: Performed EKG, chest x-ray, full blood workup, tested for Mono, Epstein Barr, etc.  Results normal, other than elevated glucose, asparatame aminotransferase, and carbon dioxide in blood.  Sent home to return for repeat testing and full body scan/imaging if fever still present after 14 days.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: High fever developed 2-3 days after shot (104.7).  Now 12 days with a fever in range 102-104.7 degrees.    Rapid COVID test day 1 of fever - negative  Doctor visit day 3 - (5/27) Rapid COVID test - negative Antibiotics prescribed 5/27   Back to doctor 6/1 (day 8 of fever - antibiotics not helping) PCR COVID test sent out (result - negative) High protein in urine - sent to ER at CHOP  ER at CHOP: Performed EKG, chest x-ray, full blood workup, tested for Mono, Epstein Barr, etc.  Results normal, other than elevated glucose, asparatame aminotransferase, and carbon dioxide in blood.  Sent home to return for repeat testing and full body scan/imaging if fever still present after 14 days.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness neurosensory, Deafness unilateral, Magnetic resonance imaging head
Clinical narrative: Sudden onset sensorineural hearing loss in left ear
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Confusional state, Fatigue, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Nausea-Mild, Additional Details: Patient felt light headed, nauseaous with abdominal cramping and little confusion. He felt exhausted. Called ambulance and paramedics monitored the patient's vitals and send him after he felt better
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Flushing, Pyrexia
Clinical narrative: Mild joint achiness, face flushed/feverish for several hours. Some fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring normal, Cardiac stress test normal, Chest pain, Chills, Electrocardiogram normal
Clinical narrative: Within 4 hours I had chills, fever, body aches, severe headache, nausea, vomiting, and a racing heart rate. At rest my normal heart rate is 55; but that night at rest it was 108 bmp
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Palpitations, Pyrexia
Clinical narrative: Within 4 hours I had chills, fever, body aches, severe headache, nausea, vomiting, and a racing heart rate. At rest my normal heart rate is 55; but that night at rest it was 108 bmp
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Within 4 hours I had chills, fever, body aches, severe headache, nausea, vomiting, and a racing heart rate. At rest my normal heart rate is 55; but that night at rest it was 108 bmp
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea, Dizziness, Hypotension
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Additional Details: during the 15 minutes waiting time patient complained of lightheadednes and dizzines. i helped patient to lay on the floor and mesured her bloodpressure and it was normal , after about 5 minutes patient is not feeling any better and her blood pressure dropped . after 5 more minutes patient was still struggling with her low blood pressure and starting to have stomach issues and felt anurge to have a bowel movement.911 operator advised agianst any food, water or meds untill emt arrives.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremities)-Medium.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Got the shot at 12:30PM on Thursday. Started feeling fever, chills, fatigue, muscle and joint pain, and slight headache at 3:10AM. Recorded temperature of 100.7 degrees with an ear thermometer. Took Tylenol, drank 32oz of cold water, put a cold wash cloth on forehead. After an hour my temperature dropped to 98.8. Felt less achy but still warm.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Skin warm
Clinical narrative: Got the shot at 12:30PM on Thursday. Started feeling fever, chills, fatigue, muscle and joint pain, and slight headache at 3:10AM. Recorded temperature of 100.7 degrees with an ear thermometer. Took Tylenol, drank 32oz of cold water, put a cold wash cloth on forehead. After an hour my temperature dropped to 98.8. Felt less achy but still warm.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Dizziness, Dyskinesia, Hypoaesthesia
Clinical narrative: It started with body ache, fever, chills and dizziness.  Patient went to ER where she was given Toradol y Relafen.  Se continued to feel dizzies  and headaches started for a whole week.  Then she began to have involuntary movements of the left hand and her mouth twisted to the left.  Eventually the symptoms subsided but  she started to feel numbness of the fingers and tingling on the neck .  She went back to the ER and was given Pepcid, antibiotics and a COVID-19 test (PCR) which result was negative (04/18/2021).  The symptoms persisted so she visited an ER again where a CT was performed and results were normal.  Her primary physician gave a referral to the an ER of a healthcare facility where a contrast CT was performed and was given Vistaril and Morphine.  In this last ER visits she started to tremble.  The results of this last test and lab results were normal.   She finally was referred to a neurologist who gave klonopin and is pending further tests.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: It started with body ache, fever, chills and dizziness.  Patient went to ER where she was given Toradol y Relafen.  Se continued to feel dizzies  and headaches started for a whole week.  Then she began to have involuntary movements of the left hand and her mouth twisted to the left.  Eventually the symptoms subsided but  she started to feel numbness of the fingers and tingling on the neck .  She went back to the ER and was given Pepcid, antibiotics and a COVID-19 test (PCR) which result was negative (04/18/2021).  The symptoms persisted so she visited an ER again where a CT was performed and results were normal.  Her primary physician gave a referral to the an ER of a healthcare facility where a contrast CT was performed and was given Vistaril and Morphine.  In this last ER visits she started to tremble.  The results of this last test and lab results were normal.   She finally was referred to a neurologist who gave klonopin and is pending further tests.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Lymphadenopathy, Night sweats, Pain
Clinical narrative: Severe headache lasted 1 week, took Tylenol.  Body aches, night sweats, upset stomach  lasted 1 week, then, enlarged  lymph node in groin, lasted 2 weeks,  soreness still in that leg.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe headache lasted 1 week, took Tylenol.  Body aches, night sweats, upset stomach  lasted 1 week, then, enlarged  lymph node in groin, lasted 2 weeks,  soreness still in that leg.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Injection site pain, Nausea, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm where shot was given
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Seizure
Clinical narrative: I received my COVID vaccine on may 25 the next day i went for dialysis and had what they told me a seizure. So we stopped the treatment and continued it on Friday and literally 6 minutes into my treatment i went in to cardiac arrest. Was rushed to the hospital and they said my heart was not the problem and they don?t know what happened.  So i am assuming its the vaccine because I?ve been downing dialysis now for 3 month and never had a problem.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient reported throat closure about 9 hours after Pfizer COVID injection. He did not seek medical treatment and it resolved. He called it an anaphylactic reaction. I did not administer the second dose of Pfizer vaccine as a precaution. I told him to seek advice from his doctor and if he chooses to get the second dose, he should get it at a medical facility or doctor's office.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Paraesthesia, Tachycardia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder
Clinical narrative: Right after vaccine was given, patient felt lightheaded. Pharmacist gave a bottle of water and ice pack, while his wife attended to him and waited for his recovery. Meanwhile his eyes rolled few times. His wife asked me to call 911. Medic came within 15 minutes and took him to hospital while he was still conscious.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient received 1st dose of pfizer vaccine. Less than 1 minute later patients mother alerted us that the patient had lost consciousness. She was immediately laid down and gained consciousness within 10 seconds. She stated feeling lightheaded, sweaty, looked pale and felt like she was in a trance. 1st BP reading (111/67), 2nd BP reading done 15 min later (106/59 & HR 65). After 30 min of monitoring patient was able to leave.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient received 1st dose of pfizer vaccine. Less than 1 minute later patients mother alerted us that the patient had lost consciousness. She was immediately laid down and gained consciousness within 10 seconds. She stated feeling lightheaded, sweaty, looked pale and felt like she was in a trance. 1st BP reading (111/67), 2nd BP reading done 15 min later (106/59 & HR 65). After 30 min of monitoring patient was able to leave.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Feeling hot, Head discomfort
Clinical narrative: Sensation that moved up my jaw to my neck and then to my brain and head then jaw and neck pain  tingling in my whole  head and brain with pressure. Blurred vision   the the next morning have  facial numbness. Dizziness  vertigo  leg tingling. And pain. While Arm pain in injection side. Pain in side of body with injection     Muscle twitching in injection arm  throat tightness and swelling me coughing   Sinus pain  and headache  tiredness feeling unwell. Felling hot all over
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Malaise, Muscle twitching, Neck pain
Clinical narrative: Sensation that moved up my jaw to my neck and then to my brain and head then jaw and neck pain  tingling in my whole  head and brain with pressure. Blurred vision   the the next morning have  facial numbness. Dizziness  vertigo  leg tingling. And pain. While Arm pain in injection side. Pain in side of body with injection     Muscle twitching in injection arm  throat tightness and swelling me coughing   Sinus pain  and headache  tiredness feeling unwell. Felling hot all over
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Pharyngeal swelling, Sensory disturbance
Clinical narrative: Sensation that moved up my jaw to my neck and then to my brain and head then jaw and neck pain  tingling in my whole  head and brain with pressure. Blurred vision   the the next morning have  facial numbness. Dizziness  vertigo  leg tingling. And pain. While Arm pain in injection side. Pain in side of body with injection     Muscle twitching in injection arm  throat tightness and swelling me coughing   Sinus pain  and headache  tiredness feeling unwell. Felling hot all over
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain, Throat tightness, Vertigo, Vision blurred
Clinical narrative: Sensation that moved up my jaw to my neck and then to my brain and head then jaw and neck pain  tingling in my whole  head and brain with pressure. Blurred vision   the the next morning have  facial numbness. Dizziness  vertigo  leg tingling. And pain. While Arm pain in injection side. Pain in side of body with injection     Muscle twitching in injection arm  throat tightness and swelling me coughing   Sinus pain  and headache  tiredness feeling unwell. Felling hot all over
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 1.17
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Depressed level of consciousness, Disorientation, Hyperventilation, Lethargy, Pyrexia
Clinical narrative: After her appointment she was fine and smiley, she took a nap on the car ride home. 2 hours after her shots, we noticed she was breathing heavily and had spiked a fever, she was incredibly lethargic. We brought her into urgent care and had a pulse of 177. The nurse kept checking and said she didn't want to chart it that high, however, it was always above 160 even when she was sleeping. We saw the doctor and he said she would be fine. We left, it is now the next day and she isnt waking up, it extremely disoriented and has a 102 fever still.
Sex: U
Vaccine: HEPA, HEPA, HIBV, HPV9, MMRV, PPV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion; No additional adverse effect; This spontaneous non-valid report was received from a health care professional and refers to unknown patients. No information regarding the patients pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 06-MAY-2021, vaccines experienced the temperature excursion of above 9 degrees Celsius (C) (16.3 C) for 5 minutes for Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and hepatitis A vaccine, inactivated (VAQTA); from -14 C to -10 C (-14.2 C) for 30 minutes for measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX). The event was reported due to digital data logger. There were no previous temperature excursions.  On unknown dates, patients were vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1691302; expiration date: 23-JAN-2022); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T008151; expiration date: 21-JUN-2022); hepatitis A vaccine, inactivated (VAQTA) (lot # T008698; expiration date: 04-JUN-2021; lot # T033519, expiration date: 11-DEC-2021); haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T005737; expiration date reported as unknown, but upon internal validation confirmed as 10-JUN-2022); measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T012418; expiration date: 10-JUN-2021; lot # T029100; expiration date: 23-FEB-2022; lot # T007395; expiration date: 29-AUG-2021;lot # reported as T012537; expiration date reported as: 17-OCT-2021); Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T024557; expiration date: 15-MAR-2022 (reported as 15-MAR-2021)) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot #T021826; expiration date: 25-JUN-2022; lot # T002843; expiration date: 23-JAN-2022; lot # T025942; expiration date: 30-JUL-2022; lot # T000344; expiration date: 01-MAY-2022; lot # T028309; expiration date: 20-AUG-2022) (doses and route of administration were not provided); all for prophylaxis. There were no additional adverse events reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lethargy, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer as part of litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant therapy were not reported. On or about 31-AUG-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) by a healthcare provider at a pharmacy (dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, patient was treated by a physician for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia
Clinical narrative: very dizzy and could not stand up
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Non raised rash at injection area, torso and groin.  Noticed this morning 6/4/2021
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Rabavert has not been given at this time; Case reference number US-BN-2021-001682 is a spontaneous case report initially received on 10-May-2021 from a pharmacist via Agency (reference number: USBAV21-0206) and concerned a 32-year-old male patient.   The patient's medical history was not reported.  The patient's concomitant medication included HRIG (immunoglobulin human anti-rabies) for post-exposure.  On unspecified date, the patient was supposed to receive Rabavert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: not reported) at unknown dose for post-exposure, but the vaccine was not given (explicitly coded as 'Product dose omission issue').  The reporter did not give consent for further follow-up.  This case is linked to the case US-BN-2021-001681 (the same reporter).   No further information was provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received only HRIG for post-exposure and RabAvert was not administered. That is considered to be missed dose. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received only HRIG for post-exposure and RabAvert was not administered. That is considered to be missed dose. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Sharp chest pain near heart, difficulty breathing, shortness of breath
Sex: M
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: it was given in the same location as the HRIG; This case was reported by a pharmacist via licensee and described the occurrence of vaccine administered at inappropriate site in a male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included IMMUNOGLOBULIN HUMAN ANTI-RABIES (HRIG).   On 30th November 2020, the patient received RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 30th November 2020, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site 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 details were provided as follows: The age at vaccination was not reported. The patient had a bite to the face. 3ml of Immunoglobulins were given at the site of the injury and 2ml were given in the deltoid. Then the Rabavert was given about 1 half 2 inch away from the HRIG injection site. Should the vaccine be given again if it was given in the same location as the HRIG.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Miscarriage-Severe, Additional Details: Pt had miscarriage after first dose of Pfizer vaccination. Bleeding started hours after shot.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Moderate ringing in ears, more noticeable in last week or two. Started noticing about three weeks after last dose.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died 2/26/2021
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Vaccination failure
Clinical narrative: I got the Shingles shot a couple years ago & I still came down with them/ Suspect vaccination failure; I still came down with them/still have a few that still bothers me.; A few that still bothers me; This case was reported by a consumer via media and described the occurrence of suspected 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and discomfort. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. A couple years ago, the patient received Shingles vaccine and still came down with shingles. The patient stated that it had been 8 weeks so far and most of them had disappeared but still had a few that still bothers him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Fatigue, Pruritus, Swelling face, Swelling of eyelid
Clinical narrative: Angioedema ? large hives, swelling of face and eyes, itching and fatigue
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Angioedema ? large hives, swelling of face and eyes, itching and fatigue
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dysphagia, Dyspnoea, Eye swelling
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: patient was given shot. about 5 minutes after she was complaining of chest tightness and difficulty breathing. i took BP at 208pm 177/22 - pulse 99. I spoke to the patient't nephrology nurse, she said patient has many allergies and to start our protocol. At 223pm BP was assesed with a manual device and still high at 170/120, patient still complaining of difficulty breathing and chest tightness, 1 dose of epinephrine 0.3mg was administered intramuscularly in left thigh.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hyperhidrosis, Hypertension, Mouth swelling, Swelling face
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: patient was given shot. about 5 minutes after she was complaining of chest tightness and difficulty breathing. i took BP at 208pm 177/22 - pulse 99. I spoke to the patient't nephrology nurse, she said patient has many allergies and to start our protocol. At 223pm BP was assesed with a manual device and still high at 170/120, patient still complaining of difficulty breathing and chest tightness, 1 dose of epinephrine 0.3mg was administered intramuscularly in left thigh.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: patient was given shot. about 5 minutes after she was complaining of chest tightness and difficulty breathing. i took BP at 208pm 177/22 - pulse 99. I spoke to the patient't nephrology nurse, she said patient has many allergies and to start our protocol. At 223pm BP was assesed with a manual device and still high at 170/120, patient still complaining of difficulty breathing and chest tightness, 1 dose of epinephrine 0.3mg was administered intramuscularly in left thigh.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: patient was given shot. about 5 minutes after she was complaining of chest tightness and difficulty breathing. i took BP at 208pm 177/22 - pulse 99. I spoke to the patient't nephrology nurse, she said patient has many allergies and to start our protocol. At 223pm BP was assesed with a manual device and still high at 170/120, patient still complaining of difficulty breathing and chest tightness, 1 dose of epinephrine 0.3mg was administered intramuscularly in left thigh.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Flushing
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: fast heartrate-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: patient was not feeling well sitting, so he laid on ground. went to check up on him, he felt clammy sweaty, but responsive. mom was there but not terrible concerned, declined 911 call. gave patient water and he was okay half hour later
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Lethargy
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: fast heartrate-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: patient was not feeling well sitting, so he laid on ground. went to check up on him, he felt clammy sweaty, but responsive. mom was there but not terrible concerned, declined 911 call. gave patient water and he was okay half hour later
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Death
Clinical narrative: death N17.9 - Acute renal failure, unspecified acute renal failure type
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shingles shot / I got shingles/ Suspected Vaccination failure; I got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient got the Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dizziness, Feeling hot, Hypoaesthesia
Clinical narrative: Dizziness Numbness in legs and feet Vomit  diarrhea  Extreme chest pain Warm legs to touch  Cannot drive anymore
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Vomiting
Clinical narrative: Dizziness Numbness in legs and feet Vomit  diarrhea  Extreme chest pain Warm legs to touch  Cannot drive anymore
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Dyspnoea, Flushing
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: <5 min post dose patient noted feeling short of breath, numbness, dizzy, sweaty, shaky and then lost consiousness. I was able to catch her head so she didnt hit a hard surface. Patient was unresponsive for 10 seconds. She started to seize and her eyes rolled to the back of her head. After she regained consciousness she was moved into the pharmacy and laid down. Pt was given a cool towel and water.1st BP (112/70 & HR74), 2nd BP 15min later (110/70 & HR 84). After 45 min pt left with family member
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Gaze palsy, Hyperhidrosis, Hypoaesthesia, Loss of consciousness, Paraesthesia
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: <5 min post dose patient noted feeling short of breath, numbness, dizzy, sweaty, shaky and then lost consiousness. I was able to catch her head so she didnt hit a hard surface. Patient was unresponsive for 10 seconds. She started to seize and her eyes rolled to the back of her head. After she regained consciousness she was moved into the pharmacy and laid down. Pt was given a cool towel and water.1st BP (112/70 & HR74), 2nd BP 15min later (110/70 & HR 84). After 45 min pt left with family member