chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Retching
Clinical narrative: Moderna Dry Heaves, just 1 session. temperature, body ached all over, tired, headache.  Side effect only lasted from 3am 3-5 -21 until 3 am 3-6-21.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Low grade fever, muscle aches, chills lasted until about midnight. Felt fine next morning
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site red, itchy, sore, and swollen 9 days after injection.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms, fever, chills, body aches, headache, fatigue
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms, fever, chills, body aches, headache, fatigue
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: The patient complains of tingling in the left arm from elbow to wrist following injection.  She was place under additional observation for 15 min.  The patient has no medical problems, takes no meds, and she is not allergic to any meds.  Following the additional observation subject stated the symptoms were no longer present.  The patient was released at this point.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: I developed a headache, body aches, fatigue, chills, nausea and 101.4 fever.  I started with the headache on 3/5/2021 and I had the other symptoms when I woke up on 3/6/2021.  My fever broke at 6:00 PM on 3/6/2021 and I felt much better after that.  Woke up on 3/7/2021 with fatigue only.  Felt normal on 3/8/2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I developed a headache, body aches, fatigue, chills, nausea and 101.4 fever.  I started with the headache on 3/5/2021 and I had the other symptoms when I woke up on 3/6/2021.  My fever broke at 6:00 PM on 3/6/2021 and I felt much better after that.  Woke up on 3/7/2021 with fatigue only.  Felt normal on 3/8/2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Scar
Clinical narrative: 48 hours after vaccination, developed mild (non-painful) case of shingles on right breast.  Consulted family (retired nurse) and friend (active physician) and texted picture.  Saw Dr. physician assistant on 2/1/2021.  Received second Moderna dose on 2/25/21 at same location.  No major adverse effects following injection (other than normal soreness at injection site). Some (temporary?) scarring still remains.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Ongoing low grade fever (as high as 100.6) and fatigue for 13 days so far after 2nd COVID-19 vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle spasms, Muscle twitching, Muscular weakness
Clinical narrative: Muscle spasms/twitching in left arm (arm of injection), left breast area, and left side of abdomen beginning in the afternoon of March 1 and continuing until date of report (3/9/21); not constant, but frequent (more than 10x a day); each twitch episode lasting no more than 10 seconds.  Elbow joint pain and fatigue beginning afternoon of injection and continuing until 3/7/21; ongoing and constant, but worsening at night. Muscle weakness in left arm bicep beginning March 3, 2021, and continuing until date of report (3/9/21). Constant and ongoing; very little, if any improvement.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna vaccine however should have received Pfizer.  To note the patient is 17, however will be 18 in 3 days.  No adverse reaction noted.  Reported to physician and no concerns medically for patient.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Moderna COVID-19Vaccine EUA
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Decreased appetite, Headache, Myalgia, Nausea
Clinical narrative: Severe muscle pains, cold hands, acne, nausea, loss of appetite, headache, sleepiness, mucus was clear, now yellow and orange
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Secretion discharge, Somnolence
Clinical narrative: Severe muscle pains, cold hands, acne, nausea, loss of appetite, headache, sleepiness, mucus was clear, now yellow and orange
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Immediate post-injection reaction, Neck pain, Paraesthesia oral
Clinical narrative: Immediate lips/tongue tingling, right neck started to hurt, had benadryl 50mg po, progressively worse, trouble clearing throat, had epi and IM benadryl and sent by EMS to hospital, SOB, wheezing, EC- epi, Decadron, admitted and  then intubated and had epi infusion.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Wheezing
Clinical narrative: Immediate lips/tongue tingling, right neck started to hurt, had benadryl 50mg po, progressively worse, trouble clearing throat, had epi and IM benadryl and sent by EMS to hospital, SOB, wheezing, EC- epi, Decadron, admitted and  then intubated and had epi infusion.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram, Dizziness, Dysarthria
Clinical narrative: PI   Patient is a 67 year old male who presents with dizziness and left facial droop.  The patient reports that he woke up this morning and felt very unsteady on his feet and dizzy.  That has since subsided.  However, he noted some slurred speech and left facial droop.  He woke up at 7:30 AM.  He went to bed last night at 11 PM.  Last known well is 11 PM, as he woke up with his symptoms.  He reports some weakness of the left upper extremity and left lower extremity.  Acute left arm, leg, face weakness, slurred speech and buring eyes.  Symptoms came and went over 42 hour period.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electroencephalogram, Eye irritation, Facial paralysis, Feeling abnormal
Clinical narrative: PI   Patient is a 67 year old male who presents with dizziness and left facial droop.  The patient reports that he woke up this morning and felt very unsteady on his feet and dizzy.  That has since subsided.  However, he noted some slurred speech and left facial droop.  He woke up at 7:30 AM.  He went to bed last night at 11 PM.  Last known well is 11 PM, as he woke up with his symptoms.  He reports some weakness of the left upper extremity and left lower extremity.  Acute left arm, leg, face weakness, slurred speech and buring eyes.  Symptoms came and went over 42 hour period.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: PI   Patient is a 67 year old male who presents with dizziness and left facial droop.  The patient reports that he woke up this morning and felt very unsteady on his feet and dizzy.  That has since subsided.  However, he noted some slurred speech and left facial droop.  He woke up at 7:30 AM.  He went to bed last night at 11 PM.  Last known well is 11 PM, as he woke up with his symptoms.  He reports some weakness of the left upper extremity and left lower extremity.  Acute left arm, leg, face weakness, slurred speech and buring eyes.  Symptoms came and went over 42 hour period.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Oral herpes, Pain
Clinical narrative: Extreme fatigue, high fever (101), chills , body aches, diarrhea.  Started about 14 hours after injection. Lasted approximately 36 hours. Tylenol helped. .onset of fever blister about 5 days after injection.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue, high fever (101), chills , body aches, diarrhea.  Started about 14 hours after injection. Lasted approximately 36 hours. Tylenol helped. .onset of fever blister about 5 days after injection.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness (4"x6" about 2" below injection site) started 2/26/2021. Noted swelling and warmth but denied pain. Tried benadryl and other creams with no improvement. Ibuprofen seemed to help.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After 15 min observation pt felt dizzy, drank water waited an additional 15 minutes and felt better
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Two days after getting the first vaccine dose, I started to experience fever, chills, body aches, extreme fatigue, headache, dizziness. It stopped after 36 hours, but started again the next day. I'm currently still experiencing extreme fatigue and weakness.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Two days after getting the first vaccine dose, I started to experience fever, chills, body aches, extreme fatigue, headache, dizziness. It stopped after 36 hours, but started again the next day. I'm currently still experiencing extreme fatigue and weakness.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, fever, aches lasting  48 hrs
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Airway patency device insertion, Blood glucose increased, Cardiac arrest, Cardiac assistance device user, Cardiac disorder
Clinical narrative: EMS reported sudden onset of shortness of breath, patient grabbed his chest and collapsed. He stopped breathing. Wife began CPR with chest compressions at 5:00. Fire dept. arrived resumed CPR and attached AED but there was no shock advise. They placed an OPA as well (inserted an airway) and started ventilation. Asystole was confirmed, they continued CPR. After 5:25 they gave 3 rounds Epineferin and ended CPR at 5:46. They also checked his blood sugar and it was 136. Possible reaction to covid vaccine. Possible death due to history of cardiac issues. His PCP is requesting an autopsy
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Death, Dyspnoea, Mechanical ventilation, Respiratory arrest
Clinical narrative: EMS reported sudden onset of shortness of breath, patient grabbed his chest and collapsed. He stopped breathing. Wife began CPR with chest compressions at 5:00. Fire dept. arrived resumed CPR and attached AED but there was no shock advise. They placed an OPA as well (inserted an airway) and started ventilation. Asystole was confirmed, they continued CPR. After 5:25 they gave 3 rounds Epineferin and ended CPR at 5:46. They also checked his blood sugar and it was 136. Possible reaction to covid vaccine. Possible death due to history of cardiac issues. His PCP is requesting an autopsy
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Resuscitation, Syncope
Clinical narrative: EMS reported sudden onset of shortness of breath, patient grabbed his chest and collapsed. He stopped breathing. Wife began CPR with chest compressions at 5:00. Fire dept. arrived resumed CPR and attached AED but there was no shock advise. They placed an OPA as well (inserted an airway) and started ventilation. Asystole was confirmed, they continued CPR. After 5:25 they gave 3 rounds Epineferin and ended CPR at 5:46. They also checked his blood sugar and it was 136. Possible reaction to covid vaccine. Possible death due to history of cardiac issues. His PCP is requesting an autopsy
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Unresponsive to stimuli
Clinical narrative: EMS reported sudden onset of shortness of breath, patient grabbed his chest and collapsed. He stopped breathing. Wife began CPR with chest compressions at 5:00. Fire dept. arrived resumed CPR and attached AED but there was no shock advise. They placed an OPA as well (inserted an airway) and started ventilation. Asystole was confirmed, they continued CPR. After 5:25 they gave 3 rounds Epineferin and ended CPR at 5:46. They also checked his blood sugar and it was 136. Possible reaction to covid vaccine. Possible death due to history of cardiac issues. His PCP is requesting an autopsy
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Patient vaccinated. Shortly after patient complained of itchiness in throat. A focused exam was gone on the patient. No noted swelling in patients oral cavity. Patient able to talk and swallow. Patient given 10mg of cetirizine. Patient states that itchiness resolved during observation period. Patient refused further treatment and decided to return to work.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Unevaluable event
Clinical narrative: This was an administration error, drawn into syringe and not given. patient had no visible symptoms.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Electrocardiogram, Incontinence, Nausea
Clinical narrative: Exactly 14 minutes after injection, felt dizzy and nauseous. Fainted, had convulsive syncope for 1 minute, lost voluntary control of bodily function (urinated), woke up, and vomited multiple times. Vomiting lasted from 10:35am - 1:10pm.  Also had diarrhea twice in between vomiting, and was shaking occasionally.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: Exactly 14 minutes after injection, felt dizzy and nauseous. Fainted, had convulsive syncope for 1 minute, lost voluntary control of bodily function (urinated), woke up, and vomited multiple times. Vomiting lasted from 10:35am - 1:10pm.  Also had diarrhea twice in between vomiting, and was shaking occasionally.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Nasopharyngitis, Pyrexia
Clinical narrative: Very cold chills, fever, fatigue,  weak,  this started in the early morning the next day.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe explosive diarrhea cannot control. I have been taking up to ^ imodiums a day  gas ex and charcoal tablets.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: patient is 7 days from 2nd covid 19 vaccine. patient has upper lip swelling and stated the day prior her lower lip was swollen. states face feels funny and has wondered if it was a bells palsy reaction? no changes in home or new foods/medications.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient reported that she felt "dizzy." This had never happened to her before. She had breakfast this morning. She was on no medications and reported no allergies. Orthostatic BPs were as follows: Lying-95/50, Sitting-103/71, Standing-101/69. She remained alert and oriented x 3. She was given water and juice. Able to ambulate without incident before discharge.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysarthria
Clinical narrative: Patient reports having slurred speech beginning 2000 the evening following vaccination. She presented to the ER on 02/11/2021 and admitted to hospital for Acute  CVA. Discharged on 02/14/2021. Patient's PCP recommended completion of series.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I felt like my brain and brain stem were swollen.  It took at least a week before my brain began to feel normal.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood thyroid stimulating hormone, Cardiac monitoring, Dizziness, Full blood count
Clinical narrative: Since the beginning of February, 1 week post vaccine, I have had 3 separate instances where I awake in the middle of the night out of a dead sleep with a racing heart and feel like I'm going to vomit or pass out. It usually subsides within 10 minutes.  I have also been having spells of dizziness during the day, usually 3-5 days each week. I have seen my primary care MD, that diagnosed me with vertigo. I have also been to the ER, who then diagnosed me with anxiety and explained my waking up in the middle of the night as a panic attack. I have never had these feelings with physical symptoms prior to my vaccine. I have never had the COVID-19 virus to my knowledge.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Palpitations, Panic attack, Sleep disorder
Clinical narrative: Since the beginning of February, 1 week post vaccine, I have had 3 separate instances where I awake in the middle of the night out of a dead sleep with a racing heart and feel like I'm going to vomit or pass out. It usually subsides within 10 minutes.  I have also been having spells of dizziness during the day, usually 3-5 days each week. I have seen my primary care MD, that diagnosed me with vertigo. I have also been to the ER, who then diagnosed me with anxiety and explained my waking up in the middle of the night as a panic attack. I have never had these feelings with physical symptoms prior to my vaccine. I have never had the COVID-19 virus to my knowledge.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vertigo
Clinical narrative: Since the beginning of February, 1 week post vaccine, I have had 3 separate instances where I awake in the middle of the night out of a dead sleep with a racing heart and feel like I'm going to vomit or pass out. It usually subsides within 10 minutes.  I have also been having spells of dizziness during the day, usually 3-5 days each week. I have seen my primary care MD, that diagnosed me with vertigo. I have also been to the ER, who then diagnosed me with anxiety and explained my waking up in the middle of the night as a panic attack. I have never had these feelings with physical symptoms prior to my vaccine. I have never had the COVID-19 virus to my knowledge.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and body pain
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Migraine
Clinical narrative: Migraine, chills, diarrhea, vomiting, sore muscles, fatigue. Weak
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Vomiting
Clinical narrative: Migraine, chills, diarrhea, vomiting, sore muscles, fatigue. Weak
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Ageusia, Anosmia, Arthralgia
Clinical narrative: hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain,  vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and  taste, tingly limbs gone but severe pain  behind right knee, ruled out blood clot, smell back, taste  not all the way returned, pain continuous
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Burning sensation, Chest pain, Computerised tomogram abdomen, Computerised tomogram pelvis
Clinical narrative: hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain,  vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and  taste, tingly limbs gone but severe pain  behind right knee, ruled out blood clot, smell back, taste  not all the way returned, pain continuous
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Electrocardiogram, Metabolic function test, Paraesthesia, Ultrasound biliary tract
Clinical narrative: hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain,  vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and  taste, tingly limbs gone but severe pain  behind right knee, ruled out blood clot, smell back, taste  not all the way returned, pain continuous
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain,  vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and  taste, tingly limbs gone but severe pain  behind right knee, ruled out blood clot, smell back, taste  not all the way returned, pain continuous
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Burning feet syndrome, Chest discomfort
Clinical narrative: hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain,  vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and  taste, tingly limbs gone but severe pain  behind right knee, ruled out blood clot, smell back, taste  not all the way returned, pain continuous
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Dehydration, Electrocardiogram, Paraesthesia, SARS-CoV-2 test
Clinical narrative: hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain,  vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and  taste, tingly limbs gone but severe pain  behind right knee, ruled out blood clot, smell back, taste  not all the way returned, pain continuous
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound biliary tract
Clinical narrative: hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain,  vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and  taste, tingly limbs gone but severe pain  behind right knee, ruled out blood clot, smell back, taste  not all the way returned, pain continuous
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Large portion of dose leaked out; A spontaneous report was received from a healthcare professional (pharmacist) concerning a unknown age of unknown gender patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced large portion of dose leaked out. The patient's medical history, was not provided by the reporter. Concomitant medications were not reported. On unknown date, prior to  the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On unknown date , the patient reported large portion of dose leaked out. Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The events,large portion of dose leaked out was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate dose administered for mRNA-1273 (Lot number: unknown) with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired vaccine dose; A spontaneous report was received from a Consumer concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced received an expired vaccine dose.  The patient had no adverse event in the medical history. No relevant concomitant medications were reported.  On 13 Feb, 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient was acknowledged by her neighbor that her neighbor received expired vaccine dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, received an expired vaccine dose, was resolved on 13 Feb 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 043L20A)  with no associated AEs reported.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Menactra was administered two days after the expiration date, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via agency (Reference number- 00495741) and transmitted to Sanofi on 26-Feb-2021.  This case involves a 24 years old female patient who was vaccinated 0.5 ml second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], solution for injection (lot number- U6543AB, expiration date- 23-FEB-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 25-FEB-2021 and reported that Menactra was administered two days after the expiration date (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medications were given to the patient.  It was a case of actual medication error due to expired vaccine used (same day latency). Also reported that the caller would like to know how to proceed in caring for the patient. MIA (Manufacturing and/or importation activities) transferred Health Care Professional who asked for appropriate follow-up after expired Menactra was given.   It was not reported whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: On the 8th day. I developed a big lump at site of injection. Hot itchy. The day before I developed pain in right shoulder joint.   I have itchy burning pain in site and also right hip. Burning  itchy pain. I can?t see anything. Site is hot.  Not I can?t lift my shoulder on right arm.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: On the 8th day. I developed a big lump at site of injection. Hot itchy. The day before I developed pain in right shoulder joint.   I have itchy burning pain in site and also right hip. Burning  itchy pain. I can?t see anything. Site is hot.  Not I can?t lift my shoulder on right arm.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Body aches, headache , fatigue, sore throat,
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood gases, Chest X-ray, Computerised tomogram thorax, Condition aggravated
Clinical narrative: Exacerbation of myasthenia gravis that had been stable for 10 years. Increasing weakness and respiratory difficulties within 72 hours of vaccination. Required intubation and mechanical ventilation which continues
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Endotracheal intubation, Mechanical ventilation, Myasthenia gravis, Respiratory disorder
Clinical narrative: Exacerbation of myasthenia gravis that had been stable for 10 years. Increasing weakness and respiratory difficulties within 72 hours of vaccination. Required intubation and mechanical ventilation which continues
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Flank pain, Pain, Pain in extremity
Clinical narrative: From Feb. 21 thru approx. Mar. 3 (day 8 - day 18 after vaccaination dose 1), I experienced pain / achiness  as itemized below; first part no unusual, second part unusual (two parts overlapped): Part 1: Feb. 21 thru Feb. 28 (day 8 - day 15): pain / achiness in lower back / kidney area; preceded by some pain in all joints; this time period marks start of needing to take Ibuprofen (either whole tablet or half tablet) to reduce pain, lasting thru Feb. 24. Part 2: Feb. 27 thru approx. Mar. 3 (day 14 - day 18): LOWER LEGS / SHINS / ANKLES PAIN AND SORENESS, needed to rub / massage to reduce pain; pain was at a signficant level and several day duration that surprised and even alarmed me; I considered calling my doctor, but assuming it was a temporary symptom caused by the vaccine, so I did not call, did not take more Ibuprofen, and gradually the pain reduced and petered out. I had not read of any such symptom.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hyperhidrosis, Injection site muscle weakness, Injection site pain
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it was administered had following symptoms: Weak, Tender, Muscle Pain, Warm to Touch, and overall achy/sore. The day after my whole body felt weak, lethargic, feverish, sweaty and tired. I ended up sleeping for 14+  hours as well.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Lethargy, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it was administered had following symptoms: Weak, Tender, Muscle Pain, Warm to Touch, and overall achy/sore. The day after my whole body felt weak, lethargic, feverish, sweaty and tired. I ended up sleeping for 14+  hours as well.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it was administered had following symptoms: Weak, Tender, Muscle Pain, Warm to Touch, and overall achy/sore. The day after my whole body felt weak, lethargic, feverish, sweaty and tired. I ended up sleeping for 14+  hours as well.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: 10 minutes post vaccine pt felt nauseous. Drank water and was encouraged to relax and sit in propped up position
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache, diarrhea, leg and body aches, fever
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Brain stem infarction
Clinical narrative: Per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Moderna on 3/4 and 2/4. Patient is admitted for left pontine acute infarction ?
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Dysphagia, Dyspnoea, Immediate post-injection reaction, Injection site reaction
Clinical narrative: This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swollen tongue
Clinical narrative: This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Asthenia, Chills, Dizziness, Heart rate increased
Clinical narrative: At 9:15 am I started to get sweats and chills and feel week.  9:30 started to notice throat was swelling.  9:45 am I reported to the nurse because throat was swelling to point I had no voice and felt weak.  I was given Benedryl and sat down.  My pulse was taken and blood pressure was taken.  My pulse was high and so was blood pressure.  I felt weak and dizzy.  Pulse and blood pressure remained high.   After Benedryl and 30 minutes, the swelling started to go down in throat and voice returned.  Pulse and blood pressure started to go down also. After 3 weeks I felt normal.  The weakness and dizziness, sore throat from the swelling and the blood pressure were finally back to normal.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: At 9:15 am I started to get sweats and chills and feel week.  9:30 started to notice throat was swelling.  9:45 am I reported to the nurse because throat was swelling to point I had no voice and felt weak.  I was given Benedryl and sat down.  My pulse was taken and blood pressure was taken.  My pulse was high and so was blood pressure.  I felt weak and dizzy.  Pulse and blood pressure remained high.   After Benedryl and 30 minutes, the swelling started to go down in throat and voice returned.  Pulse and blood pressure started to go down also. After 3 weeks I felt normal.  The weakness and dizziness, sore throat from the swelling and the blood pressure were finally back to normal.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort
Clinical narrative: The patient has a history of asthma. She complains of sinus pressure that spread to behind her ears. The patient was placed on 15 min secondary observation after which she stated the pressure was still present but refused to be seen in the ED at the present time. The patient was released to go home.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Approximately 12 hours after the vaccine I developed a headache and became VERY tired. Approximately 14 hours after the vaccine I developed a fever. As of 9:00 am everything is back to normal.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Nausea, Pain
Clinical narrative: headache, nausea, aching, chilling
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: My tongue swelled up three times its normal size 6 hours after the vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On day 8 post vaccination, had head ache, intense fatigue, and an area around 4-5 inches surrounding injection site became intensely pruritic,swollen, warm to touch.  Symptoms still ongoing two day s later
Age: 32.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Lymphadenopathy
Clinical narrative: swelling in armpit tiredness chill
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination complication
Clinical narrative: 5 days after patient received 1st dose of vaccine, a red rash started on patient's back. By noon the rash moved to patient's arms. Throughout the day rash went to thighs and backs of legs, stopped at ankles. Patient went to  ER at 10:45pm on 3/2/2021. Patient was given Prednisone 10mg twice daily for 5 days.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Pruritus, Rash macular, Respiratory tract congestion
Clinical narrative: Approximately 25 minutes after vaccination, recipient complained of hives and itching. Redness noted on both cheeks and nose and forehead. watm to touch. No shortness of breath, hoarseness to voice, cenied sore throat. No redness or swelling to tongue in throat. breath sounds clear. denied abdominal pain or nausea. Small macular red rash noted on arms. Vital signs stable.  Recipient was being observed for 30 minutes due to history of anaphylaxis with bee stings, multiple allergies to antibiotics and  is asthmatic.  When questioned in observation area, she did recall having anaphylaxis with an injectable drug which she had not mentioned in the prevaccination questionnaire.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Urticaria
Clinical narrative: Approximately 25 minutes after vaccination, recipient complained of hives and itching. Redness noted on both cheeks and nose and forehead. watm to touch. No shortness of breath, hoarseness to voice, cenied sore throat. No redness or swelling to tongue in throat. breath sounds clear. denied abdominal pain or nausea. Small macular red rash noted on arms. Vital signs stable.  Recipient was being observed for 30 minutes due to history of anaphylaxis with bee stings, multiple allergies to antibiotics and  is asthmatic.  When questioned in observation area, she did recall having anaphylaxis with an injectable drug which she had not mentioned in the prevaccination questionnaire.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysarthria, Echocardiogram, Electrocardiogram, Facial paralysis
Clinical narrative: Woke up at 2 a.m. felt tightness in throat went bathroom right side of face was drooping by mouth and speech was very slurred went to hospital an had various tests done
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Throat tightness
Clinical narrative: Woke up at 2 a.m. felt tightness in throat went bathroom right side of face was drooping by mouth and speech was very slurred went to hospital an had various tests done
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: NAUSEA/VOMITING BEGAN 03/05/2021 IN THE PM
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: Patient stated that her heart was racing  and her feeling shaking in her limbs. Vitals were BP 135/80, HR 90, RR.14. Patient denied any other symptoms. After about 15 minutes patient stated that she felt better, Denies any medical history and instructed to follow up with her PCP. Patient stated that she wanted to return to work and denied any further medical treatment.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Rash, Throat tightness, Urticaria, Wheezing
Clinical narrative: 12 hours after receiving vaccine, rash appeared on lower legs with raised welts. This lasted 9 days. 16 hours after vaccine, wheezing, chest tightness and throat tightness which improved after 4 days using Benadryl and Pepcid. Visited Dr. on 2/12/2021 and was prescribed an Epi pen, oral and topical steroids.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Janssen COVID-19 Vaccine EUA. Injection site on arm hurt immediately after injection and upper arm is still sore today (3 days later). Approx 7 hours after receiving vaccine I experienced a sudden onset of overall body aches and joint pain specifically in my knees. It was kind of severe- even my skin was hurting when I got goosebumps. A fever came on after that and I was shivering, cold, sweaty. Approx 11 hours after injection I began to experience a severe headache and sleepiness. Symptoms continued overnight and disturbed my sleep, but were relieved somewhat by taking ibuprofen. By the next morning (after sleeping 14 hours) I was only feeling tired, arm soreness, and headache (no more fever, chills, body aches). All symptoms except arm soreness cleared up rather suddenly, approx 24 hours after they came on (which was approx 31 hours after injection).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain, Limb discomfort, Nasopharyngitis, Pain
Clinical narrative: Janssen COVID-19 Vaccine EUA. Injection site on arm hurt immediately after injection and upper arm is still sore today (3 days later). Approx 7 hours after receiving vaccine I experienced a sudden onset of overall body aches and joint pain specifically in my knees. It was kind of severe- even my skin was hurting when I got goosebumps. A fever came on after that and I was shivering, cold, sweaty. Approx 11 hours after injection I began to experience a severe headache and sleepiness. Symptoms continued overnight and disturbed my sleep, but were relieved somewhat by taking ibuprofen. By the next morning (after sleeping 14 hours) I was only feeling tired, arm soreness, and headache (no more fever, chills, body aches). All symptoms except arm soreness cleared up rather suddenly, approx 24 hours after they came on (which was approx 31 hours after injection).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Somnolence
Clinical narrative: Janssen COVID-19 Vaccine EUA. Injection site on arm hurt immediately after injection and upper arm is still sore today (3 days later). Approx 7 hours after receiving vaccine I experienced a sudden onset of overall body aches and joint pain specifically in my knees. It was kind of severe- even my skin was hurting when I got goosebumps. A fever came on after that and I was shivering, cold, sweaty. Approx 11 hours after injection I began to experience a severe headache and sleepiness. Symptoms continued overnight and disturbed my sleep, but were relieved somewhat by taking ibuprofen. By the next morning (after sleeping 14 hours) I was only feeling tired, arm soreness, and headache (no more fever, chills, body aches). All symptoms except arm soreness cleared up rather suddenly, approx 24 hours after they came on (which was approx 31 hours after injection).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: 7 inches rash around the injection site  Can forward picture  Should I take my second shot due 3/24/21
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation
Clinical narrative: He was doing well for a couple of days after he received the vaccine, then he started noticing a decline in his mental health.  He became agitated, irate, nothing did anything to provoke his reaction.  The voices that he normally hears became louder, and nothing changed except the vaccine.  This increased his mental health issues and psychiatrist wanted to admit him to a mental institute and then changed his mind when he realized he had the vaccine.  His agitation became 10X worse than his baseline.   His psychiatrist believes that the vaccination cancelled out his medications.  His doctor is adjusting his medications and advised against taking the 2nd vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Hypersomnia, Vomiting
Clinical narrative: wanted to let someone know my symptoms developed a week and two days after the second Moderna vaccine.  Severe dizziness, vomiting and tired.  I slept for 36 hours straight and did not eat or drink during that time.   My issues are resolving on day five today I only have a slight amount of dizziness.  Thought it was odd it took so long to get the symptoms after the shot.  I had no ear issues and my blood pressure was normal.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Enlarged uvula, Pharyngeal swelling
Clinical narrative: throat was swollen, difficult to swallow, no compromised airway, uvula swollen, TX: Patient given decadron IM and oral prednisone taper, patient responded to treatment and doing better
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy post vaccine
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Urticaria
Clinical narrative: pt states after he got 2nd dose he became hot, itchy and developed small hives that merged together that became a rash that went from his legs to his arms and eventually his mouth around the lips.  Pt is taking Prednisone 20 mg and fluocinonide 10% and triamcinolone cream which is helping about 50-80%.  Pt will continue to take this meds until he sees his PCP on 3/12/2021.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Began menstrual cycle 2 weeks early, with extreme cramps and heavy period flow. Patient has normal cycles and never bleeds between periods. Bleeding started the morning after receiving the first dose of COVID-19 vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Somnolence
Clinical narrative: Drowsy, SOB, lightheadedness. Evaluated by EMS-Transported to Emergency room/department or urgent care.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Hypersensitivity, Nausea
Clinical narrative: Approximately 10 hours after receiving the injection, I experienced extreme chills, nausea, elevated heart rate. The last time I experienced symptoms like this was on the first day I started chemotherapy and had an allergic reaction to one of the chemo drugs (bleomycin). I had a delayed reaction hours later and went to the ER. It was determined it was an allergy. So I took Claritin D 24 H and saw the symptoms I was experiencing last night dissipate.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to 17 year old patient outside of the recommended/approved age guidelines
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gastrointestinal inflammation, Pain, Palpitations
Clinical narrative: Within 24 hrs from  1st vaccine :Low grade fever ,  chills , aches  Within 2 weeks from 1st vaccine - . multi system inflammation since vaccine ( intestinal, sinus) , dizziness , chills on off , episode of heart palpitations not occurring prior to vaccine
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus inflammation, Pyrexia
Clinical narrative: Within 24 hrs from  1st vaccine :Low grade fever ,  chills , aches  Within 2 weeks from 1st vaccine - . multi system inflammation since vaccine ( intestinal, sinus) , dizziness , chills on off , episode of heart palpitations not occurring prior to vaccine
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Feeling hot, Hyperhidrosis, Injection site pain
Clinical narrative: Approximately 12 hours after receiving the shot (~7:00PM), I began experiencing severe body ache starting in my spine and spreading to my other joints. Throughout the night I experienced chills followed by overheating/sweating.  The body aches and low-grade fever persisted until 3:00PM 8 Mar 2021. I treated myself with rest and ibuprofen and noticed improvements. As with the first short, injection site swelling and soreness was prevalent for a few days.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Pain, Pyrexia, Spinal pain
Clinical narrative: Approximately 12 hours after receiving the shot (~7:00PM), I began experiencing severe body ache starting in my spine and spreading to my other joints. Throughout the night I experienced chills followed by overheating/sweating.  The body aches and low-grade fever persisted until 3:00PM 8 Mar 2021. I treated myself with rest and ibuprofen and noticed improvements. As with the first short, injection site swelling and soreness was prevalent for a few days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Heart rate increased, Pain
Clinical narrative: Fever 101, severe aches, swelling of face, fast heartbeat, bad rash all over body, dizziness and weakness, headache