chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error
Clinical narrative: The patient received an expired dose of the vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Regulatory Authority (RA) (Reference number- 00870596) and transmitted on 23-Nov-2021..  This case involves a 65 year old male patient who was received an expired dose of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 22-Nov-2021, the patient received a 0.7 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ537AB, expiry: July2021, formulation: pre-filled syringe (PFS)) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Registered Pharmacist (RPH) calling in on FLUZONE high dose (HD) PFS. Caller states that a patient received an expired dose of the vaccine and would like to know if they should revaccinate? Caller also asked what information should they provide to the patient? Patient mistakenly received expired FLUZONE HD from last year."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired dose of ADACEL with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via regulatory agency (Reference number- 00871802) and transmitted to Sanofi on 24-Nov-2021.  This case involves an unknown demographic patient who received expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 16-Nov-2021, the patient received a 0.5 mL (once) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5661AA, expiry date: 8-Aug-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired product administered (latency: same day).  At time of reporting, 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Cough, Fear, Headache
Clinical narrative: This spontaneous case that was received on 27-Oct-2021 from other non-healthcare professional (reference number: SEQW21-04690) and concerned a 68-year-old, female patient.  The patient's concurrent conditions included asthma. The patient's concomitant medications were not reported. The patient's historical vaccine included Fluad vaccine (unknown if trivalent or quadrivalent) after which the patient had no issues.  On 15-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: left arm and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 312849, expiration date: 08-Jun-2022.  On the same day, right after receiving the vaccine, the patient experienced a sore arm. The patient was afraid that she received a COVID vaccine instead of a flu vaccine because the pharmacy was very busy that day and a lot of people were in the waiting room for a COVID dose.  It was confirmed that lot number provided by her, corresponded to a Fluad lot number.  On 16-Oct-2021, one day after administration of Fluad Quadrivalent, the pain worsened and started to radiate up to her neck above her left collarbone, extending to the side and back. The patient stated that the left side of her head also hurt. She also developed a deep, raspy, dry cough during this time she had never experienced before.  On 17-Oct-2021, the patient states that the symptoms began to lessen.  On 18-Oct-2021, the patient stated that most of the adverse reactions had gone away, but she did experience a sore arm, back pain and pain up the neck. The patient stated that she still had left shoulder and neck pain that extends to the top of the back, and every once in a while, she would experience a "burst" where there will be a spot on her collarbone that "sends a jolt up her neck". No corrective treatment was given for the reactions.   On the same day, the patient recovered from the events of 'headache', 'dry cough' and 'painful arm'.  On an unspecified date in Oct-2021, the patient was nervous about getting Fluad again.  The outcome of the events of 'nervous' and 'fear' was not reported.  At the time of initial reporting on 27-Oct-2021, the patient had not recovered from the events of 'shoulder pain', 'neck pain' and 'back pain'.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: One day after administration of Fluad Quadrivalent, the pain developed pain in arm, neck pain, back pain, headache and dry cough. The events are assessed as possibly related to the Fluad Quadrivalent, due to suggestive time relationship.; Sender's Comments: One day after administration of Fluad Quadrivalent, the pain developed pain in arm, neck pain, back pain, headache and dry cough. The events are assessed as possibly related to the Fluad Quadrivalent, due to suggestive time relationship.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Neck pain, Nervousness, Pain, Pain in extremity
Clinical narrative: This spontaneous case that was received on 27-Oct-2021 from other non-healthcare professional (reference number: SEQW21-04690) and concerned a 68-year-old, female patient.  The patient's concurrent conditions included asthma. The patient's concomitant medications were not reported. The patient's historical vaccine included Fluad vaccine (unknown if trivalent or quadrivalent) after which the patient had no issues.  On 15-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: left arm and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 312849, expiration date: 08-Jun-2022.  On the same day, right after receiving the vaccine, the patient experienced a sore arm. The patient was afraid that she received a COVID vaccine instead of a flu vaccine because the pharmacy was very busy that day and a lot of people were in the waiting room for a COVID dose.  It was confirmed that lot number provided by her, corresponded to a Fluad lot number.  On 16-Oct-2021, one day after administration of Fluad Quadrivalent, the pain worsened and started to radiate up to her neck above her left collarbone, extending to the side and back. The patient stated that the left side of her head also hurt. She also developed a deep, raspy, dry cough during this time she had never experienced before.  On 17-Oct-2021, the patient states that the symptoms began to lessen.  On 18-Oct-2021, the patient stated that most of the adverse reactions had gone away, but she did experience a sore arm, back pain and pain up the neck. The patient stated that she still had left shoulder and neck pain that extends to the top of the back, and every once in a while, she would experience a "burst" where there will be a spot on her collarbone that "sends a jolt up her neck". No corrective treatment was given for the reactions.   On the same day, the patient recovered from the events of 'headache', 'dry cough' and 'painful arm'.  On an unspecified date in Oct-2021, the patient was nervous about getting Fluad again.  The outcome of the events of 'nervous' and 'fear' was not reported.  At the time of initial reporting on 27-Oct-2021, the patient had not recovered from the events of 'shoulder pain', 'neck pain' and 'back pain'.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: One day after administration of Fluad Quadrivalent, the pain developed pain in arm, neck pain, back pain, headache and dry cough. The events are assessed as possibly related to the Fluad Quadrivalent, due to suggestive time relationship.; Sender's Comments: One day after administration of Fluad Quadrivalent, the pain developed pain in arm, neck pain, back pain, headache and dry cough. The events are assessed as possibly related to the Fluad Quadrivalent, due to suggestive time relationship.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Muscle rigidity, Pallor
Clinical narrative: Child passed out / lost consciousness temporarily and entire body seized rigid for a moment (less than one minute).  Took approximately fifteen minutes before she was able to consistently maintain consciousness without eye rolling or lolling in and out of semi consciousness.  Unable to maintain continuous conversation.  Face very pale and lips white - about 20-25 minutes before fully regained normal color and the woozy feeling started to subside.  This reaction was worse and consciousness issues were more prolonged than initial reaction to first dose at the same facility on 11/11/2021.  Her body did not seize rigid during the first dose and she was also to recover more quickly / easily from the loss of consciousness without repeated eye rolling / lolling.  First dose was maybe 5-10 minutes to recover.  Benedryl was administered within a few minutes by the pharmacist after the reaction to the first pfizer vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Extra dose administered, Injection site pain
Clinical narrative: received booster shot at 0715 and around 1615 started to have soreness at injection site and abdominal cramping
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Condition aggravated, Cough, Cystitis
Clinical narrative: 100-101° temperature and night, and on/off the next day. shivers, constantly cold, really bad bodyaches, ear aches, cough which has worsened,, migraine,
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Feeling cold, Migraine, Pain, Urine analysis abnormal
Clinical narrative: 100-101° temperature and night, and on/off the next day. shivers, constantly cold, really bad bodyaches, ear aches, cough which has worsened,, migraine,
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, Lip swelling, Swelling face
Clinical narrative: Swollen upper lip and swollen nose from Moderna booster shot. My previous two doses were from Pfizer and this did not happen.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Hypoaesthesia, Impaired work ability, Injection site erythema
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Pt was given vaccine too high in the arm and developed tingling and numbness, nerve damage, bursa as diagnosed with an MRI by the doctor. She has had many doctor appointments and has to have physical therapy for months as well as missing work for doctor appointments.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Limb injury, Nerve injury, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Pt was given vaccine too high in the arm and developed tingling and numbness, nerve damage, bursa as diagnosed with an MRI by the doctor. She has had many doctor appointments and has to have physical therapy for months as well as missing work for doctor appointments.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperventilation, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fall, Fatigue, Lethargy
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: fell out of bed -- called ED but ems did not take to hospital she said bc vitals were normal
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Cellulitis, Exposure to toxic agent, Extra dose administered, Infection
Clinical narrative: On 10/31/21, two days after my 3rd, booster vaccine (given 10/28/21) I was both bitten by insects and exposed to poison ivy on my left, injection arm.    I scratched until both sites scabbed and then infection and swelling set in on that arm.  This was  not centered around the injection site, but rather around the insect bite/poison ivy sites.  Two weeks later I was prescribed antibiotics for a suspected case of cellulitis by my doctor but did not take them, as the infection was beginning to clear on its own.  As of 12/4/21 I still have a slight rash and itching on my left arm.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Scab, Scratch, Swelling
Clinical narrative: On 10/31/21, two days after my 3rd, booster vaccine (given 10/28/21) I was both bitten by insects and exposed to poison ivy on my left, injection arm.    I scratched until both sites scabbed and then infection and swelling set in on that arm.  This was  not centered around the injection site, but rather around the insect bite/poison ivy sites.  Two weeks later I was prescribed antibiotics for a suspected case of cellulitis by my doctor but did not take them, as the infection was beginning to clear on its own.  As of 12/4/21 I still have a slight rash and itching on my left arm.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash papular
Clinical narrative: Itchy skin, raised bumps/rash, various parts of the body: arms, legs, back, scalp, behind ears, near hair lines
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted within one minute of receiving vaccine. He was monitored and asked to lay down flat on floor with feet elevated on chair. He immediately regained consciousness and was okay after some observation and fluids.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Hypertension
Clinical narrative: Systemic: chest pain and high blood pressure-Mild, Systemic: Hypertension-Mild
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: 2-3 minutes after the Moderna booster vaccine, patient felt woozy, and states she saw black. patient was immediately laid down VS 84/58, HR 63, POX 96%, blood sugar 117. Patient was monitored for 45  minutes, last set of VS: BP 98/68, HR 78, POX 100%, patient denies dizziness, flushing, Patient states this has happened to her before during vaccination administration.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: 2-3 minutes after the Moderna booster vaccine, patient felt woozy, and states she saw black. patient was immediately laid down VS 84/58, HR 63, POX 96%, blood sugar 117. Patient was monitored for 45  minutes, last set of VS: BP 98/68, HR 78, POX 100%, patient denies dizziness, flushing, Patient states this has happened to her before during vaccination administration.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration, Vitiligo
Clinical narrative: Approximately a week after the second dose, we noticed white discoloration on knees, elbows, spine, ankles, wrists.  The discoloration spread over the next few weeks.  He was diagnosed with vitiligo and seen by his pediatrician, dermatologist, and integrative doctor.  Though no one is sure that the onset of the vitiligo was caused by the vaccine, all of the healthcare professionals said it could be possible.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Pruritus, Urticaria
Clinical narrative: ON FRIDAY 12/3/2021 MY CHILD RECEIVED HIS SECOND DOSE OF COVID19 VACCINE AT 5:46PM. DEVELOPED AN URTICARIAL RASH 30 MINUTES AFTER INJECTION STARTING ON VACCINE SITE AND CHIN, LATER COVERING MOST OF HIS BODY. TOOK MY CHILD TO THE EMERGENCY ROOM AT ALMOST MIDNIGHT AND DISCHARGED HOME AT 2:30AM.  SINCE THE URTICARIA IS STILL COVERING MOST OF HIS BODY, I TOOK HIM TO HIS PEDIATRICIAN AL 8AM TODAY, SATURDAY 12/4/2021. GIVEN NEW MEDICATION BUT HE IS STILL COMPLAINING OF ITCHING ALL OVER.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Lethargy
Clinical narrative: Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Big bump in vaccination side (left arm). Pain
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 2nd day hard swollen red patch at injection site, half dollar size. Muscle aches and joint pain. 3rd day redness spread on arm. Rash under breasts.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: 2nd day hard swollen red patch at injection site, half dollar size. Muscle aches and joint pain. 3rd day redness spread on arm. Rash under breasts.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Fatigue, Headache, Pyrexia
Clinical narrative: Fluttering heart (main symptom being reported)  Fever  Headache  Shortness of breath   Fatigue
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chills, Dizziness, Dyspnoea, Fall
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Additional Details: Patient fell over in chair after given vaccine.  Another customer found patient and called for pharmacy staff.  Needed 2 pharmacist to help pick up patient.  Patient was lethargic, labored breathing and was not able to sit upright in chair.  Patient was nauseated and threw up in trash can.  911 was called and patient denied treatment from them.  Patient eventually recovered and walked out of store on own.  Also had front store type up incident report
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Additional Details: Patient fell over in chair after given vaccine.  Another customer found patient and called for pharmacy staff.  Needed 2 pharmacist to help pick up patient.  Patient was lethargic, labored breathing and was not able to sit upright in chair.  Patient was nauseated and threw up in trash can.  911 was called and patient denied treatment from them.  Patient eventually recovered and walked out of store on own.  Also had front store type up incident report
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Additional Details: Patient fell over in chair after given vaccine.  Another customer found patient and called for pharmacy staff.  Needed 2 pharmacist to help pick up patient.  Patient was lethargic, labored breathing and was not able to sit upright in chair.  Patient was nauseated and threw up in trash can.  911 was called and patient denied treatment from them.  Patient eventually recovered and walked out of store on own.  Also had front store type up incident report
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Vomiting-Mild
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue, achy all over, low grade fever, headache, chills.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Chills for 8 hours; Headache for 6 hours; Low grade fever for 6 hours; Arm soreness at injection site (non-debilitating) 1 day
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Injection site extravasation, Puncture site reaction, Underdose
Clinical narrative: When the shot was administered, some of the liquid leaked out of the arm and ran down his arm to the elbow.  The immunizer  was unable to determine how much of the shot was injected. She conferred with the pharmacy manager who said that it was okay and that nothing more could be done.  The next day, I called the pharmacy and spoke to the immunizer who said that it leaked out after she took out the syringe and that at least two drops came out. She thinks that more than half went in but can't be sure. She was not sure why it happened. The following day, I called again and spoke to the manager who stated that it is too hard to estimate how many drops are in a full dose of .2mL and that generally they don't give another half shot or full shot to complete the dosage. He suggested that I could get an antibody test, but that they would not cover the cost of that expense.  He said that he was "pretty sure" that he got enough of the shot, but he was not present at the time of the administration of the shot.    I called the Health Department and the medical director stated, ?If there is a lower than authorized dose, it would be repeated. It's hard to know how much leaked out so I can't recommend if they should repeat and would defer to the person who administered. The rule of thumb had been if more than half leaked out to repeat but the new guidelines are less clear.  If I had administered and a substantial portion had leaked (even if less than half), I would repeat but I don?t have an understanding of the amount.  For example, if it?s a drop and you repeat, you would then provide a larger than authorized dose."  The patient did not experience any of the side effects that he experience after the first dose - no arm soreness, fatigue, low fever, etc.  He did have  large, circular bruise on his arm for 6 days and a puncture hole for 2 days.  This was not present after receiving the first shot.  My suspicion is that the immunizer injected him too quickly and with too much pressure, then depressed the plunger too quickly and it leaked when she pulled out.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: 12 hours after the shot I had chills, fever and muscular aches. Went to bed with extra blankets. At 7:00 am Dec. 4 with aches and temp 98.3.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Body aches, headache, fever, chills, severe fatigue and nausea.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches, headache, fever, chills, severe fatigue and nausea.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain
Clinical narrative: Swollen painful lump in left armpit.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Headache, Pyrexia
Clinical narrative: Chills began at 1 am.   Very, very weak, throwing up, slight fever, stomach pain, headache.  I had these same symptoms with my first and second shot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Chills began at 1 am.   Very, very weak, throwing up, slight fever, stomach pain, headache.  I had these same symptoms with my first and second shot.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac abnormal, Chest pain, Coronary arterial stent insertion, Dyspnoea, Echocardiogram
Clinical narrative: Began getting chest pains and shortness of breath  within a month of receiving the vaccine injections.  The symptoms continued to get worse.  Had difficulty walking and with any exertion.   Had an echocardiogram on 8-25-21. Had a heart catheterization on 9-10-21 in which a stent was placed in a coronary artery.   The symptoms improved somewhat with the stent but still very short of breath and have difficulty with walking and exertion.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance
Clinical narrative: Began getting chest pains and shortness of breath  within a month of receiving the vaccine injections.  The symptoms continued to get worse.  Had difficulty walking and with any exertion.   Had an echocardiogram on 8-25-21. Had a heart catheterization on 9-10-21 in which a stent was placed in a coronary artery.   The symptoms improved somewhat with the stent but still very short of breath and have difficulty with walking and exertion.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen armpit node in arm where vaccine booster received.  Right arm.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Weight decreased
Clinical narrative: Not for nothing, but six weeks after I had my second Moderna shot on February 27, 2021, (Lot 001A21A) I became violently ill on the first week of April with stomach pain, loss of appetite, headache, chills, vomiting, diarrhea, and I  lost seven pounds in four days of hell.   Six weeks after I received my Moderna booster shot (Lot 037C21A) on October 20, 2021 ( which is half the dose ), I have had very similar symptoms but not as bad. None of the vomiting nor diarrhea and I only lost three pounds.  I find this curious and was wondering if this was an expected side effect.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antiacetylcholine receptor antibody positive, Asthenia, Computerised tomogram thorax normal, Dysarthria, Dyspnoea
Clinical narrative: myasthenia gravis symptoms began 3 weeks after the second dose.  Severe weakness in chewing muscles and neck.  Inability to chew.  Inability to speak without slurring.  Severe weakness in shoulders, neck, chest, and legs.  Two weeks after adverse event, problems breathing were added to list of issues.   Blood work concluded elevated antibodies related to myasthenia gravis.  Follow up CT scan did not show any abnormal Thymus gland as is common in patients.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mastication disorder, Muscular weakness, Myasthenia gravis
Clinical narrative: myasthenia gravis symptoms began 3 weeks after the second dose.  Severe weakness in chewing muscles and neck.  Inability to chew.  Inability to speak without slurring.  Severe weakness in shoulders, neck, chest, and legs.  Two weeks after adverse event, problems breathing were added to list of issues.   Blood work concluded elevated antibodies related to myasthenia gravis.  Follow up CT scan did not show any abnormal Thymus gland as is common in patients.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site rash
Clinical narrative: 4 hours after shot: Arm soreness 10:30 am on 12/1 : headache, body ache, body chills and fatigue  3:30 pm on 12/1: continuation of previous symptoms.  Nausea, joint pain red rash at injection site with a streak of red going toward bicep 7am on 12/2: minor body fatigue injection site sore red rash still present 7 am on 12/3 slight body fatigue and joint pain, red rash still present, injection site sore ringing in my ears is noticed 8am on 12/4: rash is still present but very faint, injection site and rash site sore, ringing in ears present  7 am
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Rash erythematous, Tinnitus
Clinical narrative: 4 hours after shot: Arm soreness 10:30 am on 12/1 : headache, body ache, body chills and fatigue  3:30 pm on 12/1: continuation of previous symptoms.  Nausea, joint pain red rash at injection site with a streak of red going toward bicep 7am on 12/2: minor body fatigue injection site sore red rash still present 7 am on 12/3 slight body fatigue and joint pain, red rash still present, injection site sore ringing in my ears is noticed 8am on 12/4: rash is still present but very faint, injection site and rash site sore, ringing in ears present  7 am
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Intermenstrual bleeding, Vaccine positive rechallenge
Clinical narrative: Metrorragia (Gyn bleeding) , moderate. Actually happened on both previous moderna COVID-19 vaccine received but I hadn?t correlated it and did not report then
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: I experienced soreness in the injection area and around into my shoulder within an hour of the vacation.  Starting several hours after I began to feel a slight low grade fever and fatigue.  After going to bed around 11pm I  continued to wake through the night feeling uncomfortable and body ache.  Around 3:00 am my fever persisted  along with headaches and left shoulder pain and increased body aches.  I gradually started to feel better around 11: 00 am and felt mostly back to a normal by that evening.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: I experienced soreness in the injection area and around into my shoulder within an hour of the vacation.  Starting several hours after I began to feel a slight low grade fever and fatigue.  After going to bed around 11pm I  continued to wake through the night feeling uncomfortable and body ache.  Around 3:00 am my fever persisted  along with headaches and left shoulder pain and increased body aches.  I gradually started to feel better around 11: 00 am and felt mostly back to a normal by that evening.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was age 11 when she received her first Pfizer Pediatric covid vaccination, but turned 12 before her second dose of covid vaccine.  She was administered a second pediatric dose of Pfizer Pediatric vaccine instead of receiving the adult dosage given her new age onset of 12.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm became sore late evening, 3 am was wakened with severe headache, migraine level and fever. Body aches increased throughout the day. Tylenol to reduce fever as much as possible. Low grade fever persists throughout- Saturday morning still have headache and muscle soreness
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Arm became sore late evening, 3 am was wakened with severe headache, migraine level and fever. Body aches increased throughout the day. Tylenol to reduce fever as much as possible. Low grade fever persists throughout- Saturday morning still have headache and muscle soreness
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Dizziness, Headache, Injection site bruising
Clinical narrative: Woke up at around 3 am with headache and pain in  left arm, neck and upper back.  Got up to walk to bathroom and was weak and dizzy...nearly passed out. Walked to bathroom and became nauseous and then dry heaved.  Had to lie on the floor for 15 minutes from dizziness.  Had low grade fever 99.8.  Took Tylenol and went back to bed.   Improved over the course of the day and felt back to normal by evening except for a very sore arm and bruising at the injection site. Arm soreness lasted for 3 days.  Bruising is still there.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity, Presyncope, Pyrexia
Clinical narrative: Woke up at around 3 am with headache and pain in  left arm, neck and upper back.  Got up to walk to bathroom and was weak and dizzy...nearly passed out. Walked to bathroom and became nauseous and then dry heaved.  Had to lie on the floor for 15 minutes from dizziness.  Had low grade fever 99.8.  Took Tylenol and went back to bed.   Improved over the course of the day and felt back to normal by evening except for a very sore arm and bruising at the injection site. Arm soreness lasted for 3 days.  Bruising is still there.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Sleep disorder
Clinical narrative: Woke up at around 3 am with headache and pain in  left arm, neck and upper back.  Got up to walk to bathroom and was weak and dizzy...nearly passed out. Walked to bathroom and became nauseous and then dry heaved.  Had to lie on the floor for 15 minutes from dizziness.  Had low grade fever 99.8.  Took Tylenol and went back to bed.   Improved over the course of the day and felt back to normal by evening except for a very sore arm and bruising at the injection site. Arm soreness lasted for 3 days.  Bruising is still there.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Dizziness, Fatigue, Fear
Clinical narrative: About 4 hours after the 2nd vaccine, I started to feel like I was getting a serious head cold and buzzy like I had taken original strength Sudafed. Over the course of the afternoon, I started to feel more lightheaded.  After work, I went to bed immediately. The next day I felt worse: worse versions of the previous day?s reactions plus a  fever ~99.0, chills, body aches and just general discomfort. Fearing these symptoms would get worse, I messaged my doctor?s office at noon (~28 hours after the vaccine) and her partner on duty that day immediately got back to me and assured me I could take tylenol to relieve those flu - like symptoms. I took 1000mg of extra strength tylenol. I felt more comfortable. The body aches stopped after a few days.  I felt out of it and fatigued for about a week. I don?t know if this is related, but 2 months (April 22, 2021) later I had a severe migraine. It was much worse than the first migraine I had 5 years before. I went to urgent care and was referred to a neurologist, who diagnosed the severe migraine a week later. Since the severe migraine in April, I have had 1 more with similar symptoms (numbness in arms and hands, etc)  in October.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Influenza like illness, Migraine, Nasopharyngitis
Clinical narrative: About 4 hours after the 2nd vaccine, I started to feel like I was getting a serious head cold and buzzy like I had taken original strength Sudafed. Over the course of the afternoon, I started to feel more lightheaded.  After work, I went to bed immediately. The next day I felt worse: worse versions of the previous day?s reactions plus a  fever ~99.0, chills, body aches and just general discomfort. Fearing these symptoms would get worse, I messaged my doctor?s office at noon (~28 hours after the vaccine) and her partner on duty that day immediately got back to me and assured me I could take tylenol to relieve those flu - like symptoms. I took 1000mg of extra strength tylenol. I felt more comfortable. The body aches stopped after a few days.  I felt out of it and fatigued for about a week. I don?t know if this is related, but 2 months (April 22, 2021) later I had a severe migraine. It was much worse than the first migraine I had 5 years before. I went to urgent care and was referred to a neurologist, who diagnosed the severe migraine a week later. Since the severe migraine in April, I have had 1 more with similar symptoms (numbness in arms and hands, etc)  in October.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: About 4 hours after the 2nd vaccine, I started to feel like I was getting a serious head cold and buzzy like I had taken original strength Sudafed. Over the course of the afternoon, I started to feel more lightheaded.  After work, I went to bed immediately. The next day I felt worse: worse versions of the previous day?s reactions plus a  fever ~99.0, chills, body aches and just general discomfort. Fearing these symptoms would get worse, I messaged my doctor?s office at noon (~28 hours after the vaccine) and her partner on duty that day immediately got back to me and assured me I could take tylenol to relieve those flu - like symptoms. I took 1000mg of extra strength tylenol. I felt more comfortable. The body aches stopped after a few days.  I felt out of it and fatigued for about a week. I don?t know if this is related, but 2 months (April 22, 2021) later I had a severe migraine. It was much worse than the first migraine I had 5 years before. I went to urgent care and was referred to a neurologist, who diagnosed the severe migraine a week later. Since the severe migraine in April, I have had 1 more with similar symptoms (numbness in arms and hands, etc)  in October.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Headache, Induration, Injected limb mobility decreased
Clinical narrative: Booster shot administered around 11:45 am 01Dec2021.  Onset of headache by 4 pm 01Dec2021. Headache continued through 18:00 on 02Dec2021 (ibuprofen used to manage pain).  Swelling of lymph nodes in left armpit (injection site, left shoulder) observed around 9 am 02Dec2021.  Swelling on scale of softball. Consistent aching pain/discomfort (~7 on a 1-10 scale) with occasional sharp spikes. Difficulty lifting/moving arm. Lymph node can easily be located and is very firm. Pain/swelling persists as of this report.  Red rash/hives on neck observed around 8 am 03Dec2021. Worsened and spread to chest throughout the day. Itchy and hot. Benadryl used to manage itch. The rash was 95% cleared by 8:30 am 04Dec2021.  I experienced all three of the above reactions after my second dose as well, so they were not entirely unexpected. I am reporting for informational purposes. If my lymph node swelling does not go down in a week I will follow up with a doctor.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Booster shot administered around 11:45 am 01Dec2021.  Onset of headache by 4 pm 01Dec2021. Headache continued through 18:00 on 02Dec2021 (ibuprofen used to manage pain).  Swelling of lymph nodes in left armpit (injection site, left shoulder) observed around 9 am 02Dec2021.  Swelling on scale of softball. Consistent aching pain/discomfort (~7 on a 1-10 scale) with occasional sharp spikes. Difficulty lifting/moving arm. Lymph node can easily be located and is very firm. Pain/swelling persists as of this report.  Red rash/hives on neck observed around 8 am 03Dec2021. Worsened and spread to chest throughout the day. Itchy and hot. Benadryl used to manage itch. The rash was 95% cleared by 8:30 am 04Dec2021.  I experienced all three of the above reactions after my second dose as well, so they were not entirely unexpected. I am reporting for informational purposes. If my lymph node swelling does not go down in a week I will follow up with a doctor.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Urticaria
Clinical narrative: Booster shot administered around 11:45 am 01Dec2021.  Onset of headache by 4 pm 01Dec2021. Headache continued through 18:00 on 02Dec2021 (ibuprofen used to manage pain).  Swelling of lymph nodes in left armpit (injection site, left shoulder) observed around 9 am 02Dec2021.  Swelling on scale of softball. Consistent aching pain/discomfort (~7 on a 1-10 scale) with occasional sharp spikes. Difficulty lifting/moving arm. Lymph node can easily be located and is very firm. Pain/swelling persists as of this report.  Red rash/hives on neck observed around 8 am 03Dec2021. Worsened and spread to chest throughout the day. Itchy and hot. Benadryl used to manage itch. The rash was 95% cleared by 8:30 am 04Dec2021.  I experienced all three of the above reactions after my second dose as well, so they were not entirely unexpected. I am reporting for informational purposes. If my lymph node swelling does not go down in a week I will follow up with a doctor.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspepsia, Malaise, Nausea
Clinical narrative: Lightheadedness, heartburn, nausea, general sick feeling.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT IS 17YEARS AND 3 MONTHS.  THE NURSE ADMINISTERED THE MODERNA VACCINE WHICH IS TO BE ADMINISTERED TO PATIENTS 18YEARS AND OLDER.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Fatigue, Herpes zoster, Nausea, Pain in extremity
Clinical narrative: At the moment I got a sore arms (left) in the evening I was having nausea and I was very energized, It seemed like I was given energy drink and I couldn't stop moving. the next day I was fatigue all day and after that I was with a sore day for almost a week, in that same week after the vaccination I got shingles I made appointment with MD, PhD he prescribed Acyclovir 800MG 4 daily for 40 days, Gabapentin 300MG daily for 40 days. on the 2nd week after the vaccination I went to My primary doctor at health center let him know about the shingles and I was advised to continue taking my medication I was prescribed my the two previous doctors.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Feeling abnormal, Headache, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: After receiving my booster vaccine, I started to have all of the symptoms of COVID 19 - congestion throughout my chest to my head, a slamming headache, brain fog, and notable, loss of taste!
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Interchange of vaccine products, Pruritus, Skin tightness
Clinical narrative: My original vaccinations were Moderna back in April and May of 2021. Decided to have the Pfizer booster shot. One day following the Pfizer booster shot, started itching on the right side of my body (chest, arm, and scalp). Booster was given in right arm. Also, blisters, similar to poison ivy, developed on the right side of my nose. Now, four days later, blisters are very pronounced and itchy. Scalp and chest still a little itchy. Right side of nose feels "tight" - probably due to the blisters.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Nephrolithiasis
Clinical narrative: 4 mm and 6 mm kidney stones passed 2 weeks and 4 Weeks after vaccine.   (This also happened after doses 1 and 2.)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes
Age: 36.0
Sex: F
Vaccine: COVID19, FLU4, TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, chills, fever
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea, Vaginal haemorrhage
Clinical narrative: My period ended about a week before getting the first dose of the Pfizer vaccine at the local pharmacy . I have prior infection and my serology revealed  that my antibodies level was extremely high . My job announced that it made to be vaccinated by 10/7/21 since I work in a home care agency as a clerk and due to fear to lose my job , I went after work to take the first dose On 10/6/21. On 10/12/21, I started bleeding while at work . My period came back . It last for about four days .  On 10/27/21, I went to take the second dose at my local pharmacy . The next day, I started bleeding again . My period last for about 5 days . I told my colleague , called my doctor doctor but office was closed . I reported to the PA  and one of the nurses director at my job what I was experiencing.I didn?t go to the hospital because I knew they was nothing they would have done for me . Last month November I bled twice . Today is 12/4/21, I have not gotten my period yet . Not sure why this happening to me . A nurse who works at my agency instructed me to re
Sex: U
Vaccine: COVID19
Symptoms: Angiogram normal, Apnoea, Blood glucose decreased, Coma scale, Computerised tomogram head normal
Clinical narrative: Family found patient unresponsive in recliner.  EMS arrived and found his glucose was 55.   GCS 9.  Incomprehensible speech.   Not following commands.  In ED, patient observed with full body rigidity.   Upon admission to Neuro ICU patient had roving eye movements.  Apneic breathing,  patient intubated.   Patient unable to move all 4 extremities except for flickers of muscle.
Sex: U
Vaccine: COVID19
Symptoms: Electroencephalogram normal, Endotracheal intubation, Eye movement disorder, Intensive care, Magnetic resonance imaging normal
Clinical narrative: Family found patient unresponsive in recliner.  EMS arrived and found his glucose was 55.   GCS 9.  Incomprehensible speech.   Not following commands.  In ED, patient observed with full body rigidity.   Upon admission to Neuro ICU patient had roving eye movements.  Apneic breathing,  patient intubated.   Patient unable to move all 4 extremities except for flickers of muscle.
Sex: U
Vaccine: COVID19
Symptoms: Movement disorder, Muscle rigidity, Speech disorder, Unresponsive to stimuli
Clinical narrative: Family found patient unresponsive in recliner.  EMS arrived and found his glucose was 55.   GCS 9.  Incomprehensible speech.   Not following commands.  In ED, patient observed with full body rigidity.   Upon admission to Neuro ICU patient had roving eye movements.  Apneic breathing,  patient intubated.   Patient unable to move all 4 extremities except for flickers of muscle.