chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Cellulitis; arm was painful; COVID arm; raised bumps; hives; little bit of swelling / arm was very swollen; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MASS (raised bumps), VACCINATION SITE URTICARIA (hives) and VACCINATION SITE SWELLING (little bit of swelling / arm was very swollen). On 02-May-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and VACCINATION SITE PAIN (arm was painful). At the time of the report, CELLULITIS (Cellulitis), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MASS (raised bumps), VACCINATION SITE URTICARIA (hives), VACCINATION SITE SWELLING (little bit of swelling / arm was very swollen) and VACCINATION SITE PAIN (arm was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment included antibiotics. As per reporter, the patient has not yet started therapy, at the time of report.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Speech disorder, Walking disability
Clinical narrative: brain hemorrhage; Can not  Walk; Can not speak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (brain hemorrhage), WALKING DISABILITY (Can not  Walk) and SPEECH DISORDER (Can not speak) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced CEREBRAL HAEMORRHAGE (brain hemorrhage) (seriousness criterion hospitalization). On 30-Apr-2021, the patient experienced WALKING DISABILITY (Can not  Walk) (seriousness criterion intervention required) and SPEECH DISORDER (Can not speak) (seriousness criterion intervention required). The patient was hospitalized on sometime in April 2021 due to CEREBRAL HAEMORRHAGE. At the time of the report, CEREBRAL HAEMORRHAGE (brain hemorrhage), WALKING DISABILITY (Can not  Walk) and SPEECH DISORDER (Can not speak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient ended up going to Hospital by ambulance and underwent t emergency surgery. She stayed in ICU and in at the time of report, she was still hospitalized.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Limb discomfort, Myalgia
Clinical narrative: Trachea blocked; could not breathe; current in arm that went down the arm and towards the chest; Dizziness; Cough; her arm hurts and her forearm hurts; This spontaneous case was reported by a consumer and describes the occurrence of TRACHEAL OBSTRUCTION (Trachea blocked) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced TRACHEAL OBSTRUCTION (Trachea blocked) (seriousness criterion medically significant), DYSPNOEA (could not breathe), LIMB DISCOMFORT (current in arm that went down the arm and towards the chest), DIZZINESS (Dizziness), COUGH (Cough) and MYALGIA (her arm hurts and her forearm hurts). At the time of the report, TRACHEAL OBSTRUCTION (Trachea blocked), DYSPNOEA (could not breathe), LIMB DISCOMFORT (current in arm that went down the arm and towards the chest), DIZZINESS (Dizziness), COUGH (Cough) and MYALGIA (her arm hurts and her forearm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Diphenhydramine. The patient was in ER (interpreted as Emergency Room) from 10.30 to 20.30 on 28-Apr-2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-101774 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-101774:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tracheal obstruction
Clinical narrative: Trachea blocked; could not breathe; current in arm that went down the arm and towards the chest; Dizziness; Cough; her arm hurts and her forearm hurts; This spontaneous case was reported by a consumer and describes the occurrence of TRACHEAL OBSTRUCTION (Trachea blocked) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced TRACHEAL OBSTRUCTION (Trachea blocked) (seriousness criterion medically significant), DYSPNOEA (could not breathe), LIMB DISCOMFORT (current in arm that went down the arm and towards the chest), DIZZINESS (Dizziness), COUGH (Cough) and MYALGIA (her arm hurts and her forearm hurts). At the time of the report, TRACHEAL OBSTRUCTION (Trachea blocked), DYSPNOEA (could not breathe), LIMB DISCOMFORT (current in arm that went down the arm and towards the chest), DIZZINESS (Dizziness), COUGH (Cough) and MYALGIA (her arm hurts and her forearm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Diphenhydramine. The patient was in ER (interpreted as Emergency Room) from 10.30 to 20.30 on 28-Apr-2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-101774 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-101774:
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: possible erectile disfunction; This spontaneous case was reported by a non-health professional and describes the occurrence of ERECTILE DYSFUNCTION (possible erectile disfunction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERECTILE DYSFUNCTION (possible erectile disfunction) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (possible erectile disfunction) outcome was unknown. Not Provided          Concomitant medication information not provided. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Coma, Dehydration, Diarrhoea
Clinical narrative: Coma; blood sugar decreased; diarrhea; nausea; Sickness; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of COMA (Coma) and BLOOD GLUCOSE DECREASED (blood sugar decreased) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus and Vitamin B12 deficiency.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION COMPLICATION (Sickness), DEHYDRATION (dehydration) and NAUSEA (nausea). On 31-Mar-2021, the patient experienced COMA (Coma) (seriousness criteria hospitalization, medically significant and life threatening), BLOOD GLUCOSE DECREASED (blood sugar decreased) (seriousness criterion hospitalization) and DIARRHOEA (diarrhea). The patient was hospitalized from 31-Mar-2021 to 03-Apr-2021 due to BLOOD GLUCOSE DECREASED and COMA. On 03-Apr-2021, COMA (Coma) and DIARRHOEA (diarrhea) had resolved. At the time of the report, BLOOD GLUCOSE DECREASED (blood sugar decreased), VACCINATION COMPLICATION (Sickness), DEHYDRATION (dehydration) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood glucose: decreased (Low) Decreased.         Treatment for the events were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-102981 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination complication
Clinical narrative: Coma; blood sugar decreased; diarrhea; nausea; Sickness; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of COMA (Coma) and BLOOD GLUCOSE DECREASED (blood sugar decreased) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus and Vitamin B12 deficiency.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION COMPLICATION (Sickness), DEHYDRATION (dehydration) and NAUSEA (nausea). On 31-Mar-2021, the patient experienced COMA (Coma) (seriousness criteria hospitalization, medically significant and life threatening), BLOOD GLUCOSE DECREASED (blood sugar decreased) (seriousness criterion hospitalization) and DIARRHOEA (diarrhea). The patient was hospitalized from 31-Mar-2021 to 03-Apr-2021 due to BLOOD GLUCOSE DECREASED and COMA. On 03-Apr-2021, COMA (Coma) and DIARRHOEA (diarrhea) had resolved. At the time of the report, BLOOD GLUCOSE DECREASED (blood sugar decreased), VACCINATION COMPLICATION (Sickness), DEHYDRATION (dehydration) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood glucose: decreased (Low) Decreased.         Treatment for the events were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-102981 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hyponatraemia, Pyrexia
Clinical narrative: Hyponatremia; Fever; This case was received via  (Reference number: 21k-163-3866645-00) on 23-Apr-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of HYPONATRAEMIA (Hyponatremia) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENETOCLAX ABBVIE) tablet for Acute myeloid leukemia.    Patient's medical history was not provided by the reporter.  Concomitant products included ALLOPURINOL, HYDROXYUREA, INSULIN DETEMIR (LEVEMIR), ROSUVASTATIN, GABAPENTIN, LEVOTHYROXINE, VALSARTAN and PARACETAMOL (TYLENOL) for an unknown indication.   On 02-Apr-2021, the patient started VENETOCLAX (VENETOCLAX ABBVIE) (Oral) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPONATRAEMIA (Hyponatremia) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization). The patient was hospitalized on sometime in April 2021 due to HYPONATRAEMIA and PYREXIA. At the time of the report, HYPONATRAEMIA (Hyponatremia) and PYREXIA (Fever) had not resolved.            No treatment information was provided.  Very limited information regarding the events has been provided at this time. Additional information regarding name of the vaccine and date of administration, and date of onset for the events are required for further evaluation.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information regarding name of the vaccine and date of administration, and date of onset for the events are required for further evaluation.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Antibody test, Cyanosis, Decreased appetite, Depressed mood
Clinical narrative: My issues initially started about an hour after the vaccine.  I became very subdued, no appetite and "foggy" for a lack of better words.  I attributed this to what others stated were "typical reactions" and did not make a fuss over it.   The following day I was VERY tired and stayed in bed and then about half way thru day 3, I became alert and resumed normal activity.  At day 13 I began to have upper thigh pain in my left leg and began to feel winded as I was would walk up steps and do housework which had not happened previously ever..  On 4/14/21 I requested an appointment with my primary care doctor, however he was booked for 2 weeks and I was referred to an associated PA  where I received a virtual consult.  He told me that I was "over the age" of the women that were having reactions ,even though I had requested a Doppler.  He only ran bloodwork, and in fact never even called me back on the bloodwork, and just posted it in the online profile.  My ankles are VERY swollen and have bluish pitting and my feet do have considerable pain.  I do have right side abdominal pain everyday since the 13th of April.  I now need to find a doctor that will run diagnostics and respect my concerns
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Dyspnoea, Fatigue, Feeling abnormal, Full blood count
Clinical narrative: My issues initially started about an hour after the vaccine.  I became very subdued, no appetite and "foggy" for a lack of better words.  I attributed this to what others stated were "typical reactions" and did not make a fuss over it.   The following day I was VERY tired and stayed in bed and then about half way thru day 3, I became alert and resumed normal activity.  At day 13 I began to have upper thigh pain in my left leg and began to feel winded as I was would walk up steps and do housework which had not happened previously ever..  On 4/14/21 I requested an appointment with my primary care doctor, however he was booked for 2 weeks and I was referred to an associated PA  where I received a virtual consult.  He told me that I was "over the age" of the women that were having reactions ,even though I had requested a Doppler.  He only ran bloodwork, and in fact never even called me back on the bloodwork, and just posted it in the online profile.  My ankles are VERY swollen and have bluish pitting and my feet do have considerable pain.  I do have right side abdominal pain everyday since the 13th of April.  I now need to find a doctor that will run diagnostics and respect my concerns
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Oedema, Pain in extremity
Clinical narrative: My issues initially started about an hour after the vaccine.  I became very subdued, no appetite and "foggy" for a lack of better words.  I attributed this to what others stated were "typical reactions" and did not make a fuss over it.   The following day I was VERY tired and stayed in bed and then about half way thru day 3, I became alert and resumed normal activity.  At day 13 I began to have upper thigh pain in my left leg and began to feel winded as I was would walk up steps and do housework which had not happened previously ever..  On 4/14/21 I requested an appointment with my primary care doctor, however he was booked for 2 weeks and I was referred to an associated PA  where I received a virtual consult.  He told me that I was "over the age" of the women that were having reactions ,even though I had requested a Doppler.  He only ran bloodwork, and in fact never even called me back on the bloodwork, and just posted it in the online profile.  My ankles are VERY swollen and have bluish pitting and my feet do have considerable pain.  I do have right side abdominal pain everyday since the 13th of April.  I now need to find a doctor that will run diagnostics and respect my concerns
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Product preparation issue
Clinical narrative: mixing error occurred, patient may have received only diluent. patient was revaccinated 05/05
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Condition aggravated, Dyspnoea, Electrocardiogram
Clinical narrative: After 1St vaccine.  Chest pains, difficulty breathing, like breathing through a straw.  Saw cardiologist doctor,  and was seen at ER. Sent home with Aspirin and colchicine scripts. To this day still having severe chest Pain and difficulty breathing.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: After 1St vaccine.  Chest pains, difficulty breathing, like breathing through a straw.  Saw cardiologist doctor,  and was seen at ER. Sent home with Aspirin and colchicine scripts. To this day still having severe chest Pain and difficulty breathing.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The injection site is red and swollen. The swelling has moved around the front of my forearm and into my inner arm towards my armpit with bruising around the swelling. From pictures I've seen online, it resembles COVID arm.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Acidosis, Acute kidney injury, Acute myocardial infarction, Arthralgia
Clinical narrative: symtptoms started evening of vaccine dose. Felt fine in am.  found on floor by family brought to hosp by EMS, seizure disorder; didn't have the strength to get to bed due to fatigue, which is history. Also abd pain and diarrhea and myalgias. Mottled reticular rash diagnosis identified: Abdominal pain; Acidemia; Acute kidney injury; Lactic acidosis; Mottled skin; NSTEMI (non-ST elevated myocardial infarction); Right hip pain; Tachypnea; Weakness
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Diarrhoea, Fatigue, Lactic acidosis
Clinical narrative: symtptoms started evening of vaccine dose. Felt fine in am.  found on floor by family brought to hosp by EMS, seizure disorder; didn't have the strength to get to bed due to fatigue, which is history. Also abd pain and diarrhea and myalgias. Mottled reticular rash diagnosis identified: Abdominal pain; Acidemia; Acute kidney injury; Lactic acidosis; Mottled skin; NSTEMI (non-ST elevated myocardial infarction); Right hip pain; Tachypnea; Weakness
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Livedo reticularis, Myalgia, Tachypnoea
Clinical narrative: symtptoms started evening of vaccine dose. Felt fine in am.  found on floor by family brought to hosp by EMS, seizure disorder; didn't have the strength to get to bed due to fatigue, which is history. Also abd pain and diarrhea and myalgias. Mottled reticular rash diagnosis identified: Abdominal pain; Acidemia; Acute kidney injury; Lactic acidosis; Mottled skin; NSTEMI (non-ST elevated myocardial infarction); Right hip pain; Tachypnea; Weakness
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Hallucination, Migraine, Mobility decreased
Clinical narrative: I was unable to move out of bed for 4 days. Hallucinating. My bones felt like they were breaking.  Severe migraine and I get migraine all the time. These were unbearable.  My vision was completely blurry.   It's been almost 4 weeks and my vision is still blurry. I'm going to eye Doctor next week.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: I was unable to move out of bed for 4 days. Hallucinating. My bones felt like they were breaking.  Severe migraine and I get migraine all the time. These were unbearable.  My vision was completely blurry.   It's been almost 4 weeks and my vision is still blurry. I'm going to eye Doctor next week.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haemoglobin normal, Malaise, Somnolence, Weight decreased
Clinical narrative: fatigue, sleepiness, not feeling well, weight loss
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: In reviewing patient information, she marked she has fainted in the past from vaccines. She clarified during the pre-examination that she fainted after getting a flu shot  2 years ago. She said she has not gotten a flu shot since and she had not had one prior to that since childhood. She said he thinks she fainted because she did not wait to be monitored after her shot and left immediately. She was informed that she should wait 30 minutes after her COVID vaccine to have proper monitoring. Patient received shot at 5pm, sat out in the waiting area outside pharmacy. Pharmacist checked on patient at 5:09pm and she was slumped over against the body of her friend. Pharmacist asked if she was okay and friend said she is beginning to faint. Friend was advised to lay friend on the ground, legs elevated, and a cold compress pack was giving to apply to patient's neck and face.  At 5:14pm, patient was awake and alert. She remained seated on the ground for the remainder of her 30 minutes of monitoring. Patient left alert and well.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Moderate to severe pain at injection site, fever, chills, headache, extreme fatigue, GI upset, decreased appetite. All started the day after the 2nd injection and lasted for approximately 48 hours. OTC medications and oral fluids at home were the only treatments.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Moderate to severe pain at injection site, fever, chills, headache, extreme fatigue, GI upset, decreased appetite. All started the day after the 2nd injection and lasted for approximately 48 hours. OTC medications and oral fluids at home were the only treatments.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Headache, severe cold chills, weak breath, loss of energy, weak limbs, vomiting, diharea
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Vomiting
Clinical narrative: Headache, severe cold chills, weak breath, loss of energy, weak limbs, vomiting, diharea
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Condition aggravated, Headache, Pyrexia, Tinnitus
Clinical narrative: Normal for the 2nd - fever, chills, headache.  The reason I'm writing is because I've had a huge increase in Tinnitus.  Saw ENT today (5/6/21) who said it was most likely due to the vaccine. They are seeing many patients with this issue.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Product preparation issue
Clinical narrative: Mixing error occurred, patient may have received only diluent. Patient was revaccinated 05/05.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Patient reported dizziness. Elevated blood pressure at 148/93 mmHg. Heart rate and temp were within normal limits. 5 minutes after vaccine administration, patient reported feeling better. She denies numbness, tingling, pain, and headache. Blood pressure was 148/84 mmg.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Pain, Rash
Clinical narrative: I went from a COMPLETELY healthy individual to thinking I strained a muscle shoveling snow for the zillionth day in a row, how weird.  Then the headache began, the pain on the right side of my ribs, front to back, got excruciatingly more painful over the weekend.  Finally Monday night the stupid rash developed. About 5 days after the pain began.  Telehealth nurses said what they thought it was but said I should visit a live person who did it as shingles within a out half a second.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Insomnia
Clinical narrative: I had the injection site pain; pain in the arm; muscle pain; tired; slight headache; slight chills; slightly below my normal capacity to get out and do things; I didn't sleep that night; This is a spontaneous report received from a contactable consumer (patient). An 81-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date and dose 2 of BNT162B2 (lot number EN6203) on 04Apr2021 in midafternoon; both via unspecified routes of administration as single doses for COVID-19 immunization. Medical history and concomitant medications were not reported. With both doses of BNT162B2 the patient had the same reactions. The first 24 hours the patient had injection site pain, pain in the arm, muscle pain, and she didn't sleep that night. Within the 24 hours she was a little more tired than usual with a slight headache, slight chills, and no other adverse reaction. The patient had no fever, no swelling, no nausea. She felt okay but slightly below her normal capacity to get out and do things. The outcomes of injection site pain, pain in the arm, muscle pain, didn't sleep that night, a little more tired than usual, slight headache, slight chills, and slightly below her normal capacity to get out and do things were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: I had the injection site pain; pain in the arm; muscle pain; tired; slight headache; slight chills; slightly below my normal capacity to get out and do things; I didn't sleep that night; This is a spontaneous report received from a contactable consumer (patient). An 81-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date and dose 2 of BNT162B2 (lot number EN6203) on 04Apr2021 in midafternoon; both via unspecified routes of administration as single doses for COVID-19 immunization. Medical history and concomitant medications were not reported. With both doses of BNT162B2 the patient had the same reactions. The first 24 hours the patient had injection site pain, pain in the arm, muscle pain, and she didn't sleep that night. Within the 24 hours she was a little more tired than usual with a slight headache, slight chills, and no other adverse reaction. The patient had no fever, no swelling, no nausea. She felt okay but slightly below her normal capacity to get out and do things. The outcomes of injection site pain, pain in the arm, muscle pain, didn't sleep that night, a little more tired than usual, slight headache, slight chills, and slightly below her normal capacity to get out and do things were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever (~100.5), chills, and nausea starting around 9PM day of vaccination. No treatment, just went to bed.  2:30 AM woke with continued fever (~101.6), chills, and nausea with one round of vomiting.  Again no treatment, just went back to bed. 5:30AM woke with fever (~101.5), chills, and nausea again, no vomiting, no treatment. 9:30AM woke with no nausea just fever (~100.5) and headache, took Tylenol.  Rested most of the day and took Tylenol again in afternoon which kept temp under 100.  Next morning no fever or headache.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Haematochezia, Reaction to previous exposure to any vaccine
Clinical narrative: Approximately 2 - 2.5 weeks after each injection I had bleeding from the urinary tract.  The first time there was light blood on toilet paper after urination, urine was cloudy, then a few days later, urine was bright red. (I do not eat beets.) Symptoms went away after a week or so.  Then returned about 2.5 weeks after second shot. Noticed what appeared to be small blood clots in toilet.  Symptoms continued for several  weeks then suddenly disappeared.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Death
Clinical narrative: Five days post vaccine patient had a massive cerebral hemorrhage resulting in death.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Patient reported swelling of bottom lip about 24 hours after receiving the vaccine. Patient took a Benadryl and appeared to be fine the following day.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Neurological symptom, Paraesthesia
Clinical narrative: Patient stated that she had numbness on her right side from her face to her toes.  She felt dizzy. and tingling in her whole side.  She said that she had a neurological reaction to a previous dose and has been see a neurologist.  Vitals were checked and all were stable.  Went to the er with the paramedics however.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives / rash started a week or so after the injection (3/28).  I don't really remember what date it started on, as it was minor at first (The start date above is an estimate.) It got progressively worse each day, and was severe by 4/13.  It was doubling in size and severity each day.  I finally went to a dermatologist on 4/14, and began a two week Prednisone taper to stop it.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Cough, Dyspnoea, Fatigue
Clinical narrative: feel like I am in a fog; my chest was tight; my throat almost like a frog in my throat, like congested to try and cough and clear it up; cough; A little difficult breath, shortness of breath; I feel tired; on and off feeling bad/ I just don't feel like it or like doing anything; my back is tight; not feeling good enough to do anything/ I just don't feel good./haven't felt good at all; energy wise/I feel weak; This is a spontaneous report from non-contactable consumer (patient). A 60-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced on and off feeling bad, her back was tight, not feeling good enough to do anything or to exert herself energy-wise. Sometimes she went to the gym after work; she didn't feel like it or like doing anything. She didn't think she could get up and go to work. She just didn't feel good. She didn't know if it was the vaccine that was giving her a "rollercoaster ride." She did weights and cardio workouts. She worked out pretty hard but she had not done it like she used to. On 05Apr2021 she woke up in the morning and her chest was tight. Her throat almost like a frog in her throat like congested to try and cough and clear it up. A little difficult breath, shortness of breath but not real bad. Her breathing was okay now, tightness in her back and she felt tired. She was not the type of person that liked to sit around; it was like she was fighting it, and she didn't know what she was fighting. On 06Apr2021, she almost felt like she was in a fog; feeling like a fog started today (06Apr2021) and she stayed in bed until 10am. The patient stated "he" had a bad cold and was fine now. She was feeling kind of bad but not as bad as "he" was. She had only time, first time shortness of breath yesterday (05Apr2021). She had not felt good at all on and off since the vaccine. She was thinking pollen. She felt weak and did not feel good. The outcomes of on and off feeling bad, not feeling good enough to do anything, chest was tight, throat congested, cough, shortness of breath, tightness in her back, and feeling in a fog were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Muscle tightness, Upper respiratory tract congestion
Clinical narrative: feel like I am in a fog; my chest was tight; my throat almost like a frog in my throat, like congested to try and cough and clear it up; cough; A little difficult breath, shortness of breath; I feel tired; on and off feeling bad/ I just don't feel like it or like doing anything; my back is tight; not feeling good enough to do anything/ I just don't feel good./haven't felt good at all; energy wise/I feel weak; This is a spontaneous report from non-contactable consumer (patient). A 60-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced on and off feeling bad, her back was tight, not feeling good enough to do anything or to exert herself energy-wise. Sometimes she went to the gym after work; she didn't feel like it or like doing anything. She didn't think she could get up and go to work. She just didn't feel good. She didn't know if it was the vaccine that was giving her a "rollercoaster ride." She did weights and cardio workouts. She worked out pretty hard but she had not done it like she used to. On 05Apr2021 she woke up in the morning and her chest was tight. Her throat almost like a frog in her throat like congested to try and cough and clear it up. A little difficult breath, shortness of breath but not real bad. Her breathing was okay now, tightness in her back and she felt tired. She was not the type of person that liked to sit around; it was like she was fighting it, and she didn't know what she was fighting. On 06Apr2021, she almost felt like she was in a fog; feeling like a fog started today (06Apr2021) and she stayed in bed until 10am. The patient stated "he" had a bad cold and was fine now. She was feeling kind of bad but not as bad as "he" was. She had only time, first time shortness of breath yesterday (05Apr2021). She had not felt good at all on and off since the vaccine. She was thinking pollen. She felt weak and did not feel good. The outcomes of on and off feeling bad, not feeling good enough to do anything, chest was tight, throat congested, cough, shortness of breath, tightness in her back, and feeling in a fog were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Nausea, Paraesthesia
Clinical narrative: Pt states he has pressure behind the tear by temple, has been feeling nauseas, and has tinging in arm.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Immediate post-injection reaction, Pallor, Paraesthesia
Clinical narrative: At around 4:30 PM patient had a syncope episode immediately after receiving first Covid dose of Pfizer. Vaccinating nurse guided patient from chair to the floor with legs elevated, as patient verbalized feeling he was going to pass out. Patient verbalized he had both hands tingling and feeling numb. Patient also stated he was cold and appeared pale. Patient vitals b/p 140/92, pulse 89, O2 sat 100%. Patient was provided sweater and started to feel warm per patient. Symptoms began to resolve naturally and patient stated he was ready to sit up. Patient sat up against wall, and 5 minutes later sat up and transferred back into chair. Patient verbalized feeling well and no longer experiencing tingling/numbness in both hands. Pale skin was no longer observed.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: At around 4:30 PM patient had a syncope episode immediately after receiving first Covid dose of Pfizer. Vaccinating nurse guided patient from chair to the floor with legs elevated, as patient verbalized feeling he was going to pass out. Patient verbalized he had both hands tingling and feeling numb. Patient also stated he was cold and appeared pale. Patient vitals b/p 140/92, pulse 89, O2 sat 100%. Patient was provided sweater and started to feel warm per patient. Symptoms began to resolve naturally and patient stated he was ready to sit up. Patient sat up against wall, and 5 minutes later sat up and transferred back into chair. Patient verbalized feeling well and no longer experiencing tingling/numbness in both hands. Pale skin was no longer observed.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Cough, Insomnia, Nausea
Clinical narrative: 102 fever Cough Nausea and vomiting Body aches Chills Insomnia
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: 102 fever Cough Nausea and vomiting Body aches Chills Insomnia
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Stool analysis normal
Clinical narrative: had diarrhea for 3 weeks
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Patient fainted for 1 to 2mins after receiving the vaccination.  This happened 5 to 6 mins after the injection. The patient was sitting down, so I approached to see if it was an allergic reaction or not. I checked for breathing and had another patient call 911.  Patient woke back up while we had the 911 operator on the phone.  He asked for some water and he felt light headed.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness & swelling at injection site; Redness & swelling at injection site; Dizziness; Hot & cold sweats; Hot & cold sweats; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 30Mar2021 (at the age of 86-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization. On the second or third day after receiving the vaccine, the patient experienced redness and swelling at injection site, dizziness, hot and cold sweats. The event were reported as non-serious. The outcomes of redness and swelling at injection site, dizziness, hot and cold sweats were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Fatigue, Feeling abnormal, Hypoacusis
Clinical narrative: Started getting reduced hearing on both ears, worse on right hand side, shortly after 1st dose received on 4/2/2021. Hearing deteriorated even further after second dose received 5/4/2021. Right hand side ear worse than left.  No pain associated with hearing loss, but clouded mind, and extreme tiredness due to impaired hearing. Especially if in noisy locations like a grocery store.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Throat tightness, Urticaria
Clinical narrative: within 15 minutes my throat started to get tight.  After 15 more minutes it was harder to swallow.  The nurses looked  at me and noticed hives on my chest, back, neck and up my face.  They drove me to the ER where they did an intramuscular shot of benedryl since they could not get an IV into my veins.  They tried 8 times between both arms and even had another nurse attempt.  Neither were successful.  They discharged me 3 hours or so later with prescribing me benedryl 25mg twice a day for three days.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Confusional state, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: 3/31 stroke like symptoms ED with admission for testing  4/20 stroke like symptoms ED with admission for testing  4/27 seizure  4/28 seizure during MRV confirmed no stroke  5/2 15 seizures ED visit to stop seizure activity 5/3 19 seizures, admission for LP and EEG study  5/4 4 seizures discharged, tests inconclusive  5/5 2 seizures 5/6 2 seizures All are accompanied by severe headache, blurred vision, confusion
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Gene mutation identification test negative, Headache, Lumbar puncture normal, Magnetic resonance imaging normal, Neurological symptom
Clinical narrative: 3/31 stroke like symptoms ED with admission for testing  4/20 stroke like symptoms ED with admission for testing  4/27 seizure  4/28 seizure during MRV confirmed no stroke  5/2 15 seizures ED visit to stop seizure activity 5/3 19 seizures, admission for LP and EEG study  5/4 4 seizures discharged, tests inconclusive  5/5 2 seizures 5/6 2 seizures All are accompanied by severe headache, blurred vision, confusion
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast normal, Seizure, Venogram normal, Vision blurred
Clinical narrative: 3/31 stroke like symptoms ED with admission for testing  4/20 stroke like symptoms ED with admission for testing  4/27 seizure  4/28 seizure during MRV confirmed no stroke  5/2 15 seizures ED visit to stop seizure activity 5/3 19 seizures, admission for LP and EEG study  5/4 4 seizures discharged, tests inconclusive  5/5 2 seizures 5/6 2 seizures All are accompanied by severe headache, blurred vision, confusion
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had developed shingles after taking the first dose of the Pfizer COVID-19 vaccine. Last Thursday (01Apr2021), the patient went to a walk-in clinic because the presentation of her illness was not typical of shingles but the doctor confirmed that it was shingles (on an unspecified date in 2021). She was prescribed with valaciclovir (VALTREX) and the antiviral therapy was started on an unspecified date (reported as this weekend). The outcome of the event was unknown.   It was stated that there had been conflicting recommendations by the doctors on whether the patient should go ahead with both the antiviral medication and the Pfizer COVID-19 vaccine. Reporter wanted to know if there would be more information about an active case of shingles while taking the Pfizer COVID-19 vaccine and also wanted to know if there would be interactions with antiviral therapy (ex. Valtrex) and antibiotics with the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: The person received the first Moderna vaccine by accident.  Per the CDC guidance, the second Moderna was provided as off-label use.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Colectomy, Colostomy, Computerised tomogram abdomen abnormal, Diverticulitis intestinal perforated
Clinical narrative: Admitted to hospital for severe diverticulitis with perforation
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthma, Chest discomfort, Diarrhoea, Dyspnoea
Clinical narrative: On day three after my Covid vaccine, after experiencing mostly mild side effects for the first two days, I experienced a severe episode of tachycardia while walking uphill. This is a walk I do three times a week and have never felt this way before. I couldn't catch my breath, and my heart rate remained abnormally elevated for another fifteen minutes. I walked down the hill and spoke to my doctor, who said it was likely a vaccine side effect and I should rest for the day. I continued to experience episodes of tachycardia, with heart rate in the 130s, throughout the rest of the day. I was short of breath just walking to the bathroom. My doctor had me come in and performed an EKG, which was normal. I continued having these symptoms the rest of the day, until eventually my heart rate stabilized  after 9pm. The next day I felt very tired, but no longer experienced the tachycardia. I had a follow up at my clinic and another normal EKG. Then yesterday evening, which was day 5 after the vaccine (technically day 6 maybe), I was walking my dog on a flat surface, taking my time, and I became short of breath, with pressure and tightness in my chest. I was unable to get a deep breath for another 30 minutes. Today, day 6/7 after my vaccine, I am fatigued, and continue to feel pressure and tightness in my chest throughout the day. I have asthma, and this feels different, though I have been using my inhaler to try to open up the tightness I'm experiencing. I also continue to have stomach pain and diarrhea since day one after receiving the vaccine. I also had that with the first vaccine three weeks ago--stomach pain and diarrhea.