chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: There was no adverse events whatsoever.  Patient mis-represented her vaccine history and told us she was getting her 2nd pfizer vaccine.  Her first was at another facility.  Later it was discovered that we administered the 3rd dose which was not appoved at the time.  Patient admitted that she fully intended to get her 3rd dose and that's why she told us of only 1 prior dose.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse events whatsoever.  Patient mis-represented her vaccine history and told us she was getting her 2nd pfizer vaccine.  Her first was at another facility.  Later it was discovered that we administered the 3rd dose which was not appoved at the time.  Patient admitted that she fully intended to get her 3rd dose and that's why she told us of only 1 prior dose.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Chest pain, Confusional state, Cough, Electrocardiogram abnormal
Clinical narrative: COVID vaccine breakthrough case
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus arrhythmia
Clinical narrative: COVID vaccine breakthrough case
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amniocentesis, Cardiac arrest, Cardioversion, Echocardiogram abnormal, Ejection fraction
Clinical narrative: Employee apparently tolerated second Pfizer vaccination but was found unresponsive and in V-fib at home four days later.  Was revived and transferred to hospital for care.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Hypothermia, Immunoglobulin therapy, Infusion, Resuscitation
Clinical narrative: Employee apparently tolerated second Pfizer vaccination but was found unresponsive and in V-fib at home four days later.  Was revived and transferred to hospital for care.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular fibrillation
Clinical narrative: Employee apparently tolerated second Pfizer vaccination but was found unresponsive and in V-fib at home four days later.  Was revived and transferred to hospital for care.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Resuscitation, Ultrasound scan abnormal, Unresponsive to stimuli, Ventricular fibrillation
Clinical narrative: Employee apparently tolerated second Pfizer vaccination but was found unresponsive and in V-fib at home four days later.  Was revived and transferred to hospital for care.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Inmate had a fall on 09-15-2021 required CPR ; 3 shocks; was sent to outside hospital and was pronounced there at 1700
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardioversion, Death, Fall, Resuscitation
Clinical narrative: Inmate had a fall on 09-15-2021 required CPR ; 3 shocks; was sent to outside hospital and was pronounced there at 1700
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal blistering, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: Approximately 1.5 hours after receiving shot I felt a sore throat coming on.  It continued to feel that way for the next few days.  Then on the afternoon of 9/14/21 my mouth and throat started to blister and became very painful.  I immediately started to drink ice water to help with the pain.  The pain persisted for hours until I fell asleep.  I woke up the next morning and the sores seemed to have resolved for the most part, but was unsure of whether or not to receive a second dose.  I made an appointment with a doctor to look at and she stated most of it had resolved but noticed some irritation.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral mucosal blistering, Oral pain, Oropharyngeal blistering, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: Approximately 1.5 hours after receiving shot I felt a sore throat coming on.  It continued to feel that way for the next few days.  Then on the afternoon of 9/14/21 my mouth and throat started to blister and became very painful.  I immediately started to drink ice water to help with the pain.  The pain persisted for hours until I fell asleep.  I woke up the next morning and the sores seemed to have resolved for the most part, but was unsure of whether or not to receive a second dose.  I made an appointment with a doctor to look at and she stated most of it had resolved but noticed some irritation.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stomatitis, Throat irritation
Clinical narrative: Approximately 1.5 hours after receiving shot I felt a sore throat coming on.  It continued to feel that way for the next few days.  Then on the afternoon of 9/14/21 my mouth and throat started to blister and became very painful.  I immediately started to drink ice water to help with the pain.  The pain persisted for hours until I fell asleep.  I woke up the next morning and the sores seemed to have resolved for the most part, but was unsure of whether or not to receive a second dose.  I made an appointment with a doctor to look at and she stated most of it had resolved but noticed some irritation.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Paraesthesia
Clinical narrative: Heart fluttering, tightness in chest,  mild shortness of breath,  major headache, fatigue, significant brain fog lasting over 6 days
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Chest discomfort, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Heart fluttering, tightness in chest,  mild shortness of breath,  major headache, fatigue, significant brain fog lasting over 6 days
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: Heart fluttering, tightness in chest,  mild shortness of breath,  major headache, fatigue, significant brain fog lasting over 6 days
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: After injecting Dilutent into vial - waited 15 minutes and injected 1.8cc into right arm of student.  Realized it was a multidose vial.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: After injecting Dilutent into vial - waited 15 minutes and injected 1.8cc into right arm of student.  Realized it was a multidose vial.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration to unauthorized age group. Accidental/unintentional administration.  5 days muscle aches, headaches, subjective fever, hot flashes, nausea with emesis x 1.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hot flush, Myalgia, Nausea, Product administered to patient of inappropriate age
Clinical narrative: Administration to unauthorized age group. Accidental/unintentional administration.  5 days muscle aches, headaches, subjective fever, hot flashes, nausea with emesis x 1.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Administration to unauthorized age group. Accidental/unintentional administration.  5 days muscle aches, headaches, subjective fever, hot flashes, nausea with emesis x 1.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Administration to unauthorized age group. Accidental/unintentional administration.  5 days muscle aches, headaches, subjective fever, hot flashes, nausea with emesis x 1.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: Patient was monitored for 30 minutes instead of 15 due to her previous reaction of hives to an MMR. At 28 minutes after the vaccine was administered the patient got extremely foggy headed and thought she was going to pass out. I put a pulse ox on her  (oxygen saturation was 99 and pulse was 84) and gave her an orange juice.  I then took her blood pressure and it was 154/104mmHg. She says it normally runs 120/80mmHg. I took it with a different machine and cuff. It was 152/104mmHg. I let her sit a few more minutes, took her blood pressure on the opposite arm, it was 148/102mmHg. I asked the patient if she had a doctor, she said no. I asked her if I could call EMS. She said yes, she had no one else to help her. EMS arrived 5 minutes later and she was taken to hospital for further evaluation.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Patient was monitored for 30 minutes instead of 15 due to her previous reaction of hives to an MMR. At 28 minutes after the vaccine was administered the patient got extremely foggy headed and thought she was going to pass out. I put a pulse ox on her  (oxygen saturation was 99 and pulse was 84) and gave her an orange juice.  I then took her blood pressure and it was 154/104mmHg. She says it normally runs 120/80mmHg. I took it with a different machine and cuff. It was 152/104mmHg. I let her sit a few more minutes, took her blood pressure on the opposite arm, it was 148/102mmHg. I asked the patient if she had a doctor, she said no. I asked her if I could call EMS. She said yes, she had no one else to help her. EMS arrived 5 minutes later and she was taken to hospital for further evaluation.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Feeling abnormal
Clinical narrative: Patient was monitored for 30 minutes instead of 15 due to her previous reaction of hives to an MMR. At 28 minutes after the vaccine was administered the patient got extremely foggy headed and thought she was going to pass out. I put a pulse ox on her  (oxygen saturation was 99 and pulse was 84) and gave her an orange juice.  I then took her blood pressure and it was 154/104mmHg. She says it normally runs 120/80mmHg. I took it with a different machine and cuff. It was 152/104mmHg. I let her sit a few more minutes, took her blood pressure on the opposite arm, it was 148/102mmHg. I asked the patient if she had a doctor, she said no. I asked her if I could call EMS. She said yes, she had no one else to help her. EMS arrived 5 minutes later and she was taken to hospital for further evaluation.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Paraesthesia, Skin discolouration
Clinical narrative: Onset of cheeks, lips, and throat numbness 20-30 minutes after leaving office (left office at 1007 after 15 minute wait).  Seen at dentist at 12:00pm and was having bronchospasms, vomiting mucus and diaphoretic.  Advised to go to urgent care.  Seen at Urgent care and transported via ambulance to the Emergency Room.  Treated and released, no admission for anaphylaxis.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchospasm, Hyperhidrosis, Hypoaesthesia, Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: Onset of cheeks, lips, and throat numbness 20-30 minutes after leaving office (left office at 1007 after 15 minute wait).  Seen at dentist at 12:00pm and was having bronchospasms, vomiting mucus and diaphoretic.  Advised to go to urgent care.  Seen at Urgent care and transported via ambulance to the Emergency Room.  Treated and released, no admission for anaphylaxis.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Onset of cheeks, lips, and throat numbness 20-30 minutes after leaving office (left office at 1007 after 15 minute wait).  Seen at dentist at 12:00pm and was having bronchospasms, vomiting mucus and diaphoretic.  Advised to go to urgent care.  Seen at Urgent care and transported via ambulance to the Emergency Room.  Treated and released, no admission for anaphylaxis.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Almost immediate anaphylactic reaction.  Epi-pen administered in clinic, then transported to ER. I received steroids and Benadryl by an IV.  After monitoring, I was allowed to go home. After 3 day dosage of steroids ended, reactions increased.  My face was numb from eyes to jawline.  I felt as if I had a megadose of novacaine.  At the same time I would have attacks to my lungs, as if a foreign monster had entered my body.  These attacks are a sudden and fast as an anaphylactic reaction.   I have been trying to control reactions with Benedryl.  Attacks appear to be lessening, but still occurring, without advance notice.  After a month of feeling like a zombie from the Benadryl, I requested, from my doctor to go on steroids.  I am presently on a 10 day, 20mg dose of prednisone.  I also use my Advair and Ventolin inhalers daily to help my lungs survive the attacks.  I have also needed  a 12mg tablet most days to control help control the attacks. I still have mildnessnumbness in my sinuses and mouth. SCIENCE AND MEDICINE NEEDS TO DO BETTER!!! I am very worried about the damage being cause to my lungs and heart.  I have requested scans on both when this (hopefully) subsides.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Hypoaesthesia, Lung disorder
Clinical narrative: Almost immediate anaphylactic reaction.  Epi-pen administered in clinic, then transported to ER. I received steroids and Benadryl by an IV.  After monitoring, I was allowed to go home. After 3 day dosage of steroids ended, reactions increased.  My face was numb from eyes to jawline.  I felt as if I had a megadose of novacaine.  At the same time I would have attacks to my lungs, as if a foreign monster had entered my body.  These attacks are a sudden and fast as an anaphylactic reaction.   I have been trying to control reactions with Benedryl.  Attacks appear to be lessening, but still occurring, without advance notice.  After a month of feeling like a zombie from the Benadryl, I requested, from my doctor to go on steroids.  I am presently on a 10 day, 20mg dose of prednisone.  I also use my Advair and Ventolin inhalers daily to help my lungs survive the attacks.  I have also needed  a 12mg tablet most days to control help control the attacks. I still have mildnessnumbness in my sinuses and mouth. SCIENCE AND MEDICINE NEEDS TO DO BETTER!!! I am very worried about the damage being cause to my lungs and heart.  I have requested scans on both when this (hopefully) subsides.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: My 4yo was mistakenly administered 3ml of the pfizer covid vaccine at the pharmacy when we went in for a flu shot. she did not experience any adverse side effects and it's been 48 hours after the fact. I wanted to report this as it was an adult dose and obviously emergency authorization has not been granted
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: My 4yo was mistakenly administered 3ml of the pfizer covid vaccine at the pharmacy when we went in for a flu shot. she did not experience any adverse side effects and it's been 48 hours after the fact. I wanted to report this as it was an adult dose and obviously emergency authorization has not been granted
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm 5 days; This case was reported by a consumer and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included defibrillator/pacemaker insertion (has had defibrillator placed back in 1994).   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 28th July 2021, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself. The patient received a dose of Shingrix in left arm and later on that evening had a sore left arm for 5 days. Referred patient to health care professional and provided CDC website. The reporter did not consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Headache, Myalgia, Pain
Clinical narrative: Killing pain; Third dose was administered; Pain all over body feels electrocution, feels like lungs are being pulled out; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Killing pain), EXTRA DOSE ADMINISTERED (Third dose was administered), MYALGIA (Pain all over body feels electrocution, feels like lungs are being pulled out), HEADACHE (Headache) and CHILLS (Chills) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LITHIUM for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (Killing pain), EXTRA DOSE ADMINISTERED (Third dose was administered), MYALGIA (Pain all over body feels electrocution, feels like lungs are being pulled out), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 16-Aug-2021, EXTRA DOSE ADMINISTERED (Third dose was administered) had resolved. At the time of the report, PAIN (Killing pain), MYALGIA (Pain all over body feels electrocution, feels like lungs are being pulled out), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: 9 patients received MENACTRA post-excursion at negative 0.7 degree Celsius for 5 minutes/ no AE;Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00750950) and transmitted to Sanofi on 01-Sep-2021.   This case is linked to case Id: 2021SA293642 (CLUSTER).  This case involves 9 patients (unknown demographics) who had received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6951AA, expiry date 06-Jun-2022) post-excursion at negative 0.7 degree Celsius for 5 minutes (product storage error) via unknown route at an unknown administration site on 25-Aug-2021 for prophylactic vaccination.  It was a case of potential medication error due to product storage error temperature too low (latency was on same day).  At the time of report, no adverse event reported.  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: FLU4
Symptoms: Blood urine present, Cystitis
Clinical narrative: developed a severe bladder infection; her husband was peeing blood; Initial information was received on 10-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (Reference number- 00764114) and transmitted to Sanofi on 10-Sep-2021.  This case involves a 92-year-old male patient who experienced severe bladder infection (Cystitis) and peeing blood (Blood urine present) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. At the time of the event, the patient had ongoing Chronic kidney disease and Cardiac failure congestive.  On 16-Sep-2020, the patient received a (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed non-serious severe bladder infection (Cystitis) peeing blood (Blood urine present) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, "Her husband received the FLUZONE HIGH-DOSE QUADRIVALENT vaccine last year on 16SEP2020 and developed a severe bladder infection that required an ER visit on 18SEP2020. Caller states that her husband was peeing blood when taken to the ER. Caller states that her husband has chronic kidney disease with a GFR of 34 or 35 in addition to congestive heart failure and asked how FLUZONE HIGH-DOSE QUADRIVALENT was metabolized. Caller states that her husband has never had a reaction like this before. Caller asked for a comparison of Sanofi flu vaccines to see if the FLUZONE HIGH-DOSE QUADRIVALENT was "too strong for her husband".Caller states that pharmacist could not locate any information on the metabolism of FLUZONE HIGH-DOSE QUADRIVALENT and suggested that she contact Medical Information".  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, patient had recovered from the events.  There will be no information available on batch number for this case.ea
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: soar arm at injection site - unable to lift arm above shoulder - treated with Tylenol -
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: body aches / fever of 101.5 for 48 hours / tired / headache / unable to move from bed without help / chills / nausea / loss of appetite  received the vaccine on a Tuesday (9-7-21) - went to bed the evening after the vaccine at 6:00 pm - missed school the two next days -  stayed in bed until Friday morning and was able to go to school but didn't feel fully recovered until Saturday.  Gave Tylenol and Advil alternating every 4-8 hours to help with symptoms -
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pain, Pyrexia
Clinical narrative: body aches / fever of 101.5 for 48 hours / tired / headache / unable to move from bed without help / chills / nausea / loss of appetite  received the vaccine on a Tuesday (9-7-21) - went to bed the evening after the vaccine at 6:00 pm - missed school the two next days -  stayed in bed until Friday morning and was able to go to school but didn't feel fully recovered until Saturday.  Gave Tylenol and Advil alternating every 4-8 hours to help with symptoms -
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Computerised tomogram normal, Condition aggravated, Dizziness
Clinical narrative: Feeling fatigued, difficulty breathing and chest discomfort, heart palpitations, irregular heart beat with lightheadedness. Early period after vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Haemangioma of liver, Heart rate irregular
Clinical narrative: Feeling fatigued, difficulty breathing and chest discomfort, heart palpitations, irregular heart beat with lightheadedness. Early period after vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Ventricular extrasystoles
Clinical narrative: Feeling fatigued, difficulty breathing and chest discomfort, heart palpitations, irregular heart beat with lightheadedness. Early period after vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Lung opacity, Malaise, SARS-CoV-2 test positive
Clinical narrative: Admitted to hospital for covid symptoms but not hypoxic.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Admitted to hospital for covid symptoms but not hypoxic.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospital employee was fully vaccinated with Pfizer vaccine but came down Covid + on 09/18/21 First dose: 01/08/21 lot#EJ1686 2nd dose: 02/08/21 lot#EL8289
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heavy menstrual bleeding, Hypoaesthesia, Injection site pain, Menstrual disorder
Clinical narrative: Spontaneous menstrual cycle within 1-2 hours of injection; abnormal in nature with heavier flow than normal cycles. Cycle lasted approximately 7 days. Numbness extending from forearm to left cheek; started within 12 hours, lasted 12 hours. Tenderness at injection site within 4 hours, lasted 24 hours. Fever 101 degrees and chills; started approximately 16-20 hours post injection,  lasted approximately 12-16 hours.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Spontaneous menstrual cycle within 1-2 hours of injection; abnormal in nature with heavier flow than normal cycles. Cycle lasted approximately 7 days. Numbness extending from forearm to left cheek; started within 12 hours, lasted 12 hours. Tenderness at injection site within 4 hours, lasted 24 hours. Fever 101 degrees and chills; started approximately 16-20 hours post injection,  lasted approximately 12-16 hours.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Muscle spasms, Pain
Clinical narrative: Menstrual irregularities/painful cramps after vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear pain, Hyperhidrosis, Migraine
Clinical narrative: migraine headache, severe neck pain, nausea, sinus issues, ear pain, joint pain, chills, sweating . symptoms started on 9/14/2021 and are still ongoing with just sinus issues and chest congestion that just started. Worst of symptoms occurred for 5 days.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pulmonary congestion, Sinus disorder
Clinical narrative: migraine headache, severe neck pain, nausea, sinus issues, ear pain, joint pain, chills, sweating . symptoms started on 9/14/2021 and are still ongoing with just sinus issues and chest congestion that just started. Worst of symptoms occurred for 5 days.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Capillary nail refill test abnormal, Cyanosis, Dyspnoea, Feeling cold, Flushing
Clinical narrative: Arrived home from work on 9/14/2021. Sat down. He had been chilled all day. Face was flushed he started to drip with sweat. Stated " I can't breath". VS 114/78,89 T unreadable due to sweat. RR 22, Spo2 91% Room air.  Red, peticial rash noted on chest and abdomen. He quickly became centrally cyanotic. Cap refill to fingers delayed. Lips dusky. Dr called.  Medicated with Benadryl 50mg (chewed), Pepcid 20mg PO, Zyrtec 10mg, Prednisone 20mg PO.  After about 10 minutes his fingers started to pink. Cap refill  slowly improved. The central cyanosis didn't resolve for about an hour. Prednisone taper obtained from pharmacy. An additional Prednisone 40mg PO given for a total of 60mg. After the additional 40mg given the rash resolved.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Petechiae, Rash, Rash erythematous
Clinical narrative: Arrived home from work on 9/14/2021. Sat down. He had been chilled all day. Face was flushed he started to drip with sweat. Stated " I can't breath". VS 114/78,89 T unreadable due to sweat. RR 22, Spo2 91% Room air.  Red, peticial rash noted on chest and abdomen. He quickly became centrally cyanotic. Cap refill to fingers delayed. Lips dusky. Dr called.  Medicated with Benadryl 50mg (chewed), Pepcid 20mg PO, Zyrtec 10mg, Prednisone 20mg PO.  After about 10 minutes his fingers started to pink. Cap refill  slowly improved. The central cyanosis didn't resolve for about an hour. Prednisone taper obtained from pharmacy. An additional Prednisone 40mg PO given for a total of 60mg. After the additional 40mg given the rash resolved.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Stiffness and soreness of shoulder
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Light sensitivity which turned into serious adverse reaction to being in sunlight. Caused severe shakiness, sweating, diarrhea, vomiting, nausea, severe ongoing headache that wouldn?t respond to medications. Sunlight caused majority of symptoms. Face numbness and inability to function as normal in sun. Vision changes. Loss of appetite. Swelling of right side of lips.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Lip swelling, Nausea, Photophobia
Clinical narrative: Light sensitivity which turned into serious adverse reaction to being in sunlight. Caused severe shakiness, sweating, diarrhea, vomiting, nausea, severe ongoing headache that wouldn?t respond to medications. Sunlight caused majority of symptoms. Face numbness and inability to function as normal in sun. Vision changes. Loss of appetite. Swelling of right side of lips.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Visual impairment, Vomiting
Clinical narrative: Light sensitivity which turned into serious adverse reaction to being in sunlight. Caused severe shakiness, sweating, diarrhea, vomiting, nausea, severe ongoing headache that wouldn?t respond to medications. Sunlight caused majority of symptoms. Face numbness and inability to function as normal in sun. Vision changes. Loss of appetite. Swelling of right side of lips.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Pacemaker generated rhythm
Clinical narrative: Heart Attack 3 hours after receiving the 2nd Moderna vaccination for C19. Pacemaker went off at least 5-6 times causing more damage to an already 20% functioning heart.kk
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Fall, Lower limb fracture, Skin laceration
Clinical narrative: confusion trimmers weakness fell and broke her leg
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: confusion trimmers weakness fell and broke her leg
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: Has been seizure free for 4-6 months (longest she?s been seizure free). The week of the 1st dose she had pretty significant seizures.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular
Clinical narrative: Missed and late periods starting june 8 period  cycle was 51 days  - no period since July 29? day 53 .  Previous cycles were regular 28-33 days.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Considerable worsening of existing tinnitus. Extreme rushing sounds. Hearing music. Much much worse than before vaccine
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Vertigo which started around 1/30/21, 4 days after receiving 2nd dose of Pfizer vaccine. I almost felt to the ground at work while bending over to lock a crash cart. That night I had a few additional episodes, one time, I felt like I was going to pass out. Episodes of dizziness, lightheadedness, and intermittent nausea were frequent and became worse during the first week, and eventually faded out after 2.5 months.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse inadvertently administered 2nd dose to patient, 1 day short of her 12th birthday. Patient monitored for 15 minutes, post vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vision blurred, Visual impairment
Clinical narrative: The next morning body fatigue, joint pains, it felt like a film over my eyes and I was seeing white spots. The first day (9-3) the white spots were constant, the second day they became less severe, It lasted for 3 days.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Injection site pain
Clinical narrative: After about 26 hours post injection started with pain in injection site, left axillary pain, left axillary lymphadenopathy, fatigue, chills, arthralgias. I have taken 2 doses of Ibuprofen 600 mg.  At 48 hours I continue with pain in injection site, left axillary pain, left axillary lymphadenopathy.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: After about 26 hours post injection started with pain in injection site, left axillary pain, left axillary lymphadenopathy, fatigue, chills, arthralgias. I have taken 2 doses of Ibuprofen 600 mg.  At 48 hours I continue with pain in injection site, left axillary pain, left axillary lymphadenopathy.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Pain in extremity, Swelling
Clinical narrative: Chest pain and arm pain. The chest pain is closer to the arm pit feels like a something is swollen. Right arm/right chest. The shot was given in that arm.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Exposure during pregnancy, Fatigue, Injection site pain
Clinical narrative: 22 weeks pregnant, estimated delivery date 01/15/2022.  Around 26 hours post injection presented fatigue, pain in injection site, and left axillary pain. I have taken one dose of acetaminophen 500 mg.  At 48 hours post injection I still have pain in injection site and left axillary pain.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Bruxism, Heavy menstrual bleeding, Nervousness, Panic attack
Clinical narrative: Onset of menstruation on day 11 of cycle, heavy bleeding for 12 days. Previous decade of cycles had been regular/26-28 days, bleeding lasting 3-4 days.   Onset of chronic general anxiety, and almost daily panic attacks for the next 3 weeks.  Jaw clenching and shaky feelings continue still at 6 weeks
Age: 36.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Burning sensation, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Immediate onset of pain and burning to left upper arm. Burning sensation went away within 24 hours. Pain has continued for greater than 90+ days at the time of report submission requiring the daily administration of oral NSAIDs to control pain. Pain continues regardless of use/rest. Seen by clinic staff twice via appointment without resolution of symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Bloody stool with mucous/ change in bowel habits for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bloody stool with mucous/ change in bowel habits for 5 days) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced HAEMATOCHEZIA (Bloody stool with mucous/ change in bowel habits for 5 days) (seriousness criterion medically significant). On 13-Sep-2021, HAEMATOCHEZIA (Bloody stool with mucous/ change in bowel habits for 5 days) had not resolved. Not Provided          No concomitant medications were reported.  No treatment information was provided.  Company comment- This case concerns a 37 year-old, female subject with no relevant medical history, who experienced the unexpected event of Haematochezia. The event occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown as there's no information available about the first dose.  The benefit-risk relationship of Spikevax is not affected by this report. Event Haematochezia was automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite it was reported as non-serious.; Sender's Comments: This case concerns a 37 year-old, female subject with no relevant medical history, who experienced the unexpected event of Haematochezia. The event occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown as there's no information available about the first dose.  The benefit-risk relationship of Spikevax is not affected by this report. Event Haematochezia was automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite it was reported as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Oedema peripheral, Swelling
Clinical narrative: swelling under left arm pit; This case was reported by a consumer via Shingrix GSK and described the occurrence of local swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional details were provided a follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she just had second dose of Shingles shot and had most of the normal side effects but also had swelling under left arm pit. No other information available as contact to follow up details not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: feel very ill!; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a 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 illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.  Additional details were provided as follows: This patient-self reported this case. The age at vaccination was not reported. The patient received the shingles shot that made him/ her feel very ill. The patient stated that it was better than getting shingles. This case was linked with US2021AMR196890, reporter by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196890:same reporter (reporter case)
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: made us feel very ill!; This case was reported by a consumer via interactive digital media and described the occurrence of illness in an unspecified number of patients 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 illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients received the shingles shot that made them feel very ill. The reporter stated that it was better than getting shingles. This case was linked with US2021AMR196890, reporter by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196879:same reporter (reporter case)
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.   On 26-AUG-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931844, 20210931982, 20210932593, 20210932036, 20210932567, 20210931951, 20210932240 and 20210932874.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscle spasms, Rash macular, Screaming
Clinical narrative: pinkish spot across from the injection site, not on it/red spot on her; leg cramp; needle hurt so bad; screamed; This spontaneous case was reported by a consumer and describes the occurrence of SCREAMING (screamed), RASH MACULAR (pinkish spot across from the injection site, not on it/red spot on her), MUSCLE SPASMS (leg cramp) and INJECTION SITE PAIN (needle hurt so bad) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No medication history information was provided.  Concomitant products included VITAMINS NOS for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced SCREAMING (screamed) and INJECTION SITE PAIN (needle hurt so bad). On an unknown date, the patient experienced RASH MACULAR (pinkish spot across from the injection site, not on it/red spot on her) and MUSCLE SPASMS (leg cramp). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Leg cramps, at an unspecified dose and frequency. At the time of the report, SCREAMING (screamed), MUSCLE SPASMS (leg cramp) and INJECTION SITE PAIN (needle hurt so bad) outcome was unknown and RASH MACULAR (pinkish spot across from the injection site, not on it/red spot on her) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also includes unspecified supplements.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Near death experience
Clinical narrative: almost died; developed COVID severely; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (almost died) and COVID-19 (developed COVID severely) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (almost died) (seriousness criterion medically significant) and COVID-19 (developed COVID severely) (seriousness criterion medically significant). At the time of the report, NEAR DEATH EXPERIENCE (almost died) and COVID-19 (developed COVID severely) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medical information were reported.  No treatment information was reported.  Company comment: Based on biological implausibility, causal association between the Covid-19 and the administration of mRNA-1273 is assessed as unlikely.  There is not enough information to assess the event of nearly died as the clinical presentation, signs and symptoms of the event was not provided.  I addition, the dates of vaccine administration is lacking.  Additional information has been requested.; Sender's Comments: Based on biological implausibility, causal association between the Covid-19 and the administration of mRNA-1273 is assessed as unlikely.  There is not enough information to assess the event of nearly died as the clinical presentation, signs and symptoms of the event was not provided.  I addition, the dates of vaccine administration is lacking.  Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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 VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.   Reporter did not allow further contact
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-314573, MOD-2021-314517, MOD-2021-314793, MOD-2021-314545, MOD-2021-314805, MOD-2021-314570, MOD-2021-314810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow Up received : Possible No new information.