chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: approximately 11 hours after the vaccination was given, I would go from freezing to hot, could not get comfortable in bed, super tired.   the hot to cold went on for almost 24 hours.  When I woke up on the second day after receiving the vaccine, I woke up with a great amount of pressure in my head and a massive headache.  On the 3rd day after the vaccine, I got up and ready for work.  about 45 minutes into work, I was short of breath and light headed.    I did have a positive Covid result on Dec 31 so I still have the antibodies.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: approximately 11 hours after the vaccination was given, I would go from freezing to hot, could not get comfortable in bed, super tired.   the hot to cold went on for almost 24 hours.  When I woke up on the second day after receiving the vaccine, I woke up with a great amount of pressure in my head and a massive headache.  On the 3rd day after the vaccine, I got up and ready for work.  about 45 minutes into work, I was short of breath and light headed.    I did have a positive Covid result on Dec 31 so I still have the antibodies.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head
Clinical narrative: Bells Palsy, treatment started 3/8/21 with prednisone
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Localized area of erythema, warmth, swelling, and tenderness 12 days post injection
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: Red rash a litte swollen and feverish 6 inches long.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Throat irritation
Clinical narrative: At 1:20pm pt. C/o scratch throat,SOB and chest tightness and asked for water to drink.Dr. at chairside. V/s163/94 pulse 85 resp 20 o2 sat 98%RA   1:38 team alert activated 1:41 EMS activated 1:42 epi pen given 0.3mg subq  1:49 ambulance arrived unit 586 report given to EMT. V/s before transported 156/86 pulse 84 resp 20 98% o2 sat RA Pt. Requested to be transported to the nearest/ED hospital
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFIB  reoccurred after being. gone for two years
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Injection site mass, Injection site swelling, Injection site warmth, X-ray
Clinical narrative: Swelling, fever near injection. Knot larger than softball around the area of injection. Hot to touch. Severe infection in shoulder, arm down to hand. Infection had spread to back.of my arm and down into my elbow. Have photos if needed. This was my 2nd injection
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Covid arm comes and goes, itchy, rash
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Nausea, Vomiting
Clinical narrative: at approximately 5:35pm, the patient states that he felt hot and nauseous.  He vomited and was able to take Banophen 50mg.  A few minutes later, the patient stated he felt fine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Malaise
Clinical narrative: Sudden onset flushness, warm, and 'not quite right'  Vital Signs: BP 118/80 HR 68 O2Sat 98 Skin Signs: Warm and dry  Vitals taken. Continued observation.  At 15:44 HR 74 O2Sat 94 Continued observation  BP 126/78 HR 71 O2Sat 96 Pt released by medical staff  Disposition: Home by Self
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: rash on left arm at injection site
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram spine, Electrocardiogram, Laboratory test
Clinical narrative: pt became nauseated and vomiting 1 day after getting vaccine,  reported on Mon  2/22/21 but states was getting better,  received call from sister on 2/25/21 that pt could not get out of bed on own -  was sent to ER at that time
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Vomiting, X-ray limb
Clinical narrative: pt became nauseated and vomiting 1 day after getting vaccine,  reported on Mon  2/22/21 but states was getting better,  received call from sister on 2/25/21 that pt could not get out of bed on own -  was sent to ER at that time
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, fatigue, nausea, muscle aches
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash erythematous, Vaccination complication
Clinical narrative: What has now been label as Covid Arm. Itching at the injection site began approximately four days after injection. I have had a red rash in a circular shape. As of today, twelve days later, it is mildly red and still itches. I am due for my second Moderna on March 31. At this time, it is doubtful I will get the second shot. I had no treatment.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Injection site pain, Paraesthesia, Pruritus, Rash
Clinical narrative: I took one Aleve for my arm Pain near the injection site. Then I got a Rash and itch that traveled down my left side, my throat started to feel funny so I took a Benedryl. Then my cheeks felt like they were hot and tingly.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: I took one Aleve for my arm Pain near the injection site. Then I got a Rash and itch that traveled down my left side, my throat started to feel funny so I took a Benedryl. Then my cheeks felt like they were hot and tingly.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Bacterial test positive, Blood electrolytes normal, Blood lactic acid normal, Brain natriuretic peptide increased
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose.  Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide increased, Cardiomegaly, Chest X-ray abnormal, Chills, Cough
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose.  Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Fibrin D dimer normal, Gastrointestinal haemorrhage, Haematocrit decreased
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose.  Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Headache, Heart rate irregular, Lung opacity, Micturition urgency
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose.  Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pneumonia, Pollakiuria, Pulmonary oedema, Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose.  Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rales, Red blood cells urine positive, SARS-CoV-2 test negative, Troponin normal, Urinary tract infection
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose.  Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count normal, White blood cells urine positive
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose.  Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash over shoulders, back , arms and scalp
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Inappropriate schedule of product administration, Pruritus, Rash, Rash erythematous
Clinical narrative: The rash she has now / is very itchy/rash presented on her torso and back.; feel very tired; The rash she has now / is more like red dots/rash presented on her torso and back.; receive her first dose in November 2020/ received her second dose 1/11/2021; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (started on 19th January 2019), skin lesion (on her stomach and back) and blister (large). Concurrent medical conditions included celiac disease and diabetes. Concomitant products included Herpes zoster (Shingrix).   On 11th January 2021, the patient received the 2nd dose of Shingrix. On 11th January 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. In February 2021, the patient experienced itchy rash, tiredness and red rash. On an unknown date, the outcome of the itchy rash, tiredness and red rash were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the itchy rash, tiredness and red rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however could be 57 or 58 years. In November 2020, the patient received 1st dose of Shingrix. On approximately 18th February or 19th February 2021, five weeks after receiving 2nd dose of shingrix vaccine, a rash presented on patient's torso and back. The patient also started to feel very tired. The rash she had was similar but not as bad and the rash was more like red dots not full blisters but it was very itchy. The patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule. The patient declined to answer any further questions. The reporter did not consent to follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Heart rate increased, Hypertension, Oropharyngeal discomfort, Pharyngeal swelling
Clinical narrative: Tongue and throat swelled to the point that she couldn't swallow her own saliva; Tongue and throat swelled to the point that she couldn't swallow her own saliva; Heart rate went pretty high up; Blood pressure went pretty high up; Shaking; Tickle in my throat; Couldn't stop coughing as throat was so irritated; Couldn't stop coughing as throat was so irritated; A spontaneous report (United States) was received from a consumer concerning a 36-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tongue and throat swelled to the point that she couldn't swallow her own saliva, heart rate went pretty high up, blood pressure went pretty high up, shaking, tickle in my throat, couldn't stop coughing as throat was so irritated.  The patient's medical history was not provided. The patient was allergic to shellfish, all nuts besides pistachios and cashews, a lot of raw fruits and vegetables, sulfa drugs, latex, Macrobid, and MRI contrast. No relevant concomitant medications were reported.  On 13 Jan 2021 at 08:00 PM, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, 3-4minutes after vaccination, the patient's tongue and throat swelled to the point that she couldn't swallow her own saliva, her heart rate and blood pressure went pretty high up, she was also shaking. Patient was at hospital during this time hence she was wheeled to the ER. She adds that she had a tickle in her throat, so she couldn't stop coughing because her throat was so irritated. Patient didn't get any medication for event even as they were busy hence they patient didn't get her epinephrine. Patient also confirmed that she had never had a severe reaction to any type of immunization. Treatment for the event included diphenhydramine before she got to the emergency room. She was supposed to take more of treatment medication and loratadine on 14 Jan 2021 by 11AM as her tongue started swelled up again.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events tongue and throat swelled to the point that she couldn't swallow her own saliva, heart rate went pretty high up, blood pressure went pretty high up, shaking, tickle in my throat, couldn't stop coughing as throat was so irritated were not reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product (LOT 041L20A) and the start date of the events within 3-4 minutes after vaccination, a causal relationship cannot be excluded. Patient's has known hx to allergy to shellfish, all nuts besides pistachios and cashews, a lot of raw fruits and vegetables, sulfa drugs, latex, Macrobid, and MRI contrast. Further information has been requested
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat irritation, Tremor
Clinical narrative: Tongue and throat swelled to the point that she couldn't swallow her own saliva; Tongue and throat swelled to the point that she couldn't swallow her own saliva; Heart rate went pretty high up; Blood pressure went pretty high up; Shaking; Tickle in my throat; Couldn't stop coughing as throat was so irritated; Couldn't stop coughing as throat was so irritated; A spontaneous report (United States) was received from a consumer concerning a 36-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tongue and throat swelled to the point that she couldn't swallow her own saliva, heart rate went pretty high up, blood pressure went pretty high up, shaking, tickle in my throat, couldn't stop coughing as throat was so irritated.  The patient's medical history was not provided. The patient was allergic to shellfish, all nuts besides pistachios and cashews, a lot of raw fruits and vegetables, sulfa drugs, latex, Macrobid, and MRI contrast. No relevant concomitant medications were reported.  On 13 Jan 2021 at 08:00 PM, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, 3-4minutes after vaccination, the patient's tongue and throat swelled to the point that she couldn't swallow her own saliva, her heart rate and blood pressure went pretty high up, she was also shaking. Patient was at hospital during this time hence she was wheeled to the ER. She adds that she had a tickle in her throat, so she couldn't stop coughing because her throat was so irritated. Patient didn't get any medication for event even as they were busy hence they patient didn't get her epinephrine. Patient also confirmed that she had never had a severe reaction to any type of immunization. Treatment for the event included diphenhydramine before she got to the emergency room. She was supposed to take more of treatment medication and loratadine on 14 Jan 2021 by 11AM as her tongue started swelled up again.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events tongue and throat swelled to the point that she couldn't swallow her own saliva, heart rate went pretty high up, blood pressure went pretty high up, shaking, tickle in my throat, couldn't stop coughing as throat was so irritated were not reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product (LOT 041L20A) and the start date of the events within 3-4 minutes after vaccination, a causal relationship cannot be excluded. Patient's has known hx to allergy to shellfish, all nuts besides pistachios and cashews, a lot of raw fruits and vegetables, sulfa drugs, latex, Macrobid, and MRI contrast. Further information has been requested
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arterial catheterisation normal, Chest pain, Feeling abnormal, Pain in extremity
Clinical narrative: felt so bad; severe chest pain; Chest pain and arm pain; A spontaneous report was received from a consumer concerning her husband, a 71-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced abnormal feeling, severe chest pain,  and arm pain.   The patient's medical history, as provided by the reporter, included the patient had a heart attack on 26 May 2020 and on October 2020 the patient had five bypass, two arteries they took. Since October the patient's condition was stated to be great. Concomitant medications reported included Insulin Bovine, Multivitamins [vitamins Nos], acetylsalicylic acid and Medication related to patient's heart attack.  On 12 Feb 2021, unspecified days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021, post receiving mRNA-1273, the patient had no reaction and did not feel bad.  On unspecified day in Feb 2021 one week prior to the reporting the events, the patient experienced chest pain and arm pain, minimum that lasted for 10 minutes. 3 or 4 night prior reporting the event, the patient was feeling abnormal, went to ER and was hospitalized with severe chest pain. The patient was in a regular room and was transferred to ICU. Next day, Cardiac catheterization was performed to see the patient's heart and found that 3 arteries in the original surgery were failing.  Treatment for the event, severe chest pain included morphine.  Action taken with mRNA-1273 in response to the events was not reported.   The event of arm pain was considered Recovered/Resolved.  The events, abnormal feeling, severe chest pain were considered as unknown. The patient is still hospitalized.; Reporter's Comments: This case concerns a 71-year-old, male patient, who experienced severe chest pain, feeling abnormal. Cardiac catheterization was performed which showed that 3 arteries in the original surgery were failing. Very limited information regarding this event has been provided at this time. The patient's medical history of heart attack (May 2020) and bypass (October 2020) confounds the causality. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic; A spontaneous report was received from a nurse concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction.  The patient's medical history was provided by the reporter. Concomitant medication included Gabapentin used for unknown indication.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical Location for prophylaxis of COVID-19 infection.  On an unknown date, after receiving the first dose of mRNA-1273, the patient had a significant reaction, anaphylactic. The patient was on gabapentin.  No treatment information was provided. No relevant laboratory details were included.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysphagia, Feeling hot, Fluid retention, Flushing
Clinical narrative: Allergic reaction; Tongue felt full; Did not feel well; Puffiness; Trouble swalloing; rash; Swollen glands; Blood pressure high/ changes in blood pressure; Felt faintness; Feeling hot; Fluid accumulation; Turned a dark, pinkish color/ flushed; Changes in heart rate/ heart was racing; A spontaneous report was received from a health care professional concerning a 68-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergic reaction/ hypersensitivity, feeling hot, fluid retention, flushing, presyncope, heart rate abnormal, swelling face, tongue felt full/ swollen tongue, hypertension, dysphagia, not feeling well/ malaise, rash, and lymphadenopathy.  The patient's medical history, as provided by the reporter, included anaphylaxis to Keflex, lisinopril and sulfa drugs. Concomitant medications reported included HCTZ, diltiazem, rosuvastatin, isosorbide mono, metoprolol and pepcid.   On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On the same day patient experienced allergic reactions, feeling hot, fluid retention, flushing, presyncope, high blood pressure, swollen glands. On 26 Jan 2021, the patient was taken into the hospital and kept there for 6 hours.  On 29 Jan 2021, the patient still had faintness. Her heart was racing and she did not feel well.  On 04 Feb 2021, her tongue felt full and something did not feel right. The patient's vital signs included blood pressure 190/98 and later 140/80.  Treatment details included Benadryl, EpiPen, Ativan, Solumedrol, steroids, and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, feeling hot, fluid retention, lymphadenopathy, and rash were considered recovered/resolved on an unknown date. The outcome of the events, flushing, and presyncope, was considered not recovered/not resolved. The outcome of the events, allergic reaction, hypertension, heart rate abnormal, swelling face, swollen tongue, malaise, and dysphagia, was not provided.; Reporter's Comments: This case concerns a 68 Y/O F who had serious unexpected hypersensitivity along with unexpected BP high, heart rate abnormal, presyncope, dysphagia, face swelling, swollen tongue, flushing, feeling hot, malaise, fluid retention, and expected rash, lymphadenopathy.  Event onset the same day as first dose mRNA-1273. Treated with Benadryl, EpiPen, steroids. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Hypersensitivity, Hypertension, Lymphadenopathy, Malaise
Clinical narrative: Allergic reaction; Tongue felt full; Did not feel well; Puffiness; Trouble swalloing; rash; Swollen glands; Blood pressure high/ changes in blood pressure; Felt faintness; Feeling hot; Fluid accumulation; Turned a dark, pinkish color/ flushed; Changes in heart rate/ heart was racing; A spontaneous report was received from a health care professional concerning a 68-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergic reaction/ hypersensitivity, feeling hot, fluid retention, flushing, presyncope, heart rate abnormal, swelling face, tongue felt full/ swollen tongue, hypertension, dysphagia, not feeling well/ malaise, rash, and lymphadenopathy.  The patient's medical history, as provided by the reporter, included anaphylaxis to Keflex, lisinopril and sulfa drugs. Concomitant medications reported included HCTZ, diltiazem, rosuvastatin, isosorbide mono, metoprolol and pepcid.   On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On the same day patient experienced allergic reactions, feeling hot, fluid retention, flushing, presyncope, high blood pressure, swollen glands. On 26 Jan 2021, the patient was taken into the hospital and kept there for 6 hours.  On 29 Jan 2021, the patient still had faintness. Her heart was racing and she did not feel well.  On 04 Feb 2021, her tongue felt full and something did not feel right. The patient's vital signs included blood pressure 190/98 and later 140/80.  Treatment details included Benadryl, EpiPen, Ativan, Solumedrol, steroids, and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, feeling hot, fluid retention, lymphadenopathy, and rash were considered recovered/resolved on an unknown date. The outcome of the events, flushing, and presyncope, was considered not recovered/not resolved. The outcome of the events, allergic reaction, hypertension, heart rate abnormal, swelling face, swollen tongue, malaise, and dysphagia, was not provided.; Reporter's Comments: This case concerns a 68 Y/O F who had serious unexpected hypersensitivity along with unexpected BP high, heart rate abnormal, presyncope, dysphagia, face swelling, swollen tongue, flushing, feeling hot, malaise, fluid retention, and expected rash, lymphadenopathy.  Event onset the same day as first dose mRNA-1273. Treated with Benadryl, EpiPen, steroids. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Rash, Swelling face, Swollen tongue
Clinical narrative: Allergic reaction; Tongue felt full; Did not feel well; Puffiness; Trouble swalloing; rash; Swollen glands; Blood pressure high/ changes in blood pressure; Felt faintness; Feeling hot; Fluid accumulation; Turned a dark, pinkish color/ flushed; Changes in heart rate/ heart was racing; A spontaneous report was received from a health care professional concerning a 68-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergic reaction/ hypersensitivity, feeling hot, fluid retention, flushing, presyncope, heart rate abnormal, swelling face, tongue felt full/ swollen tongue, hypertension, dysphagia, not feeling well/ malaise, rash, and lymphadenopathy.  The patient's medical history, as provided by the reporter, included anaphylaxis to Keflex, lisinopril and sulfa drugs. Concomitant medications reported included HCTZ, diltiazem, rosuvastatin, isosorbide mono, metoprolol and pepcid.   On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On the same day patient experienced allergic reactions, feeling hot, fluid retention, flushing, presyncope, high blood pressure, swollen glands. On 26 Jan 2021, the patient was taken into the hospital and kept there for 6 hours.  On 29 Jan 2021, the patient still had faintness. Her heart was racing and she did not feel well.  On 04 Feb 2021, her tongue felt full and something did not feel right. The patient's vital signs included blood pressure 190/98 and later 140/80.  Treatment details included Benadryl, EpiPen, Ativan, Solumedrol, steroids, and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, feeling hot, fluid retention, lymphadenopathy, and rash were considered recovered/resolved on an unknown date. The outcome of the events, flushing, and presyncope, was considered not recovered/not resolved. The outcome of the events, allergic reaction, hypertension, heart rate abnormal, swelling face, swollen tongue, malaise, and dysphagia, was not provided.; Reporter's Comments: This case concerns a 68 Y/O F who had serious unexpected hypersensitivity along with unexpected BP high, heart rate abnormal, presyncope, dysphagia, face swelling, swollen tongue, flushing, feeling hot, malaise, fluid retention, and expected rash, lymphadenopathy.  Event onset the same day as first dose mRNA-1273. Treated with Benadryl, EpiPen, steroids. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Pain in extremity
Clinical narrative: my arm hurts; slight headache; cold sweat; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: unknown), via an unspecified route of administration in the right arm on 26Jan2021 at 14:45 ( at the age of 40-year-old) as a single dose for COVID-19 immunisation at workplace clinic. Medical history included penicillin allergy (childhood). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. On 27Jan2021, at 12:00 the patient experienced my arm hurts, slight headache and cold sweat and did not last long at all (as reported). The patient did not receive any treatment for the events. The events were reported as non-serious. The outcome of the events my arm hurts, slight headache and cold sweat was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Insomnia
Clinical narrative: I have been having excruciating stabbing pain between T5 and T 6 on the right side of my back.; have not slept for two days; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-year-old female patient (Patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249, Expiry date: unknown) via an unspecified route of administration on 08Jan2021 on left arm at single dose for covid-19 immunisation. Medical history included High blood pressure. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included latanoprost, timolol maleate (LATANAPROST) Eye Drops, levothyroxine (LEVOTHYROXINE), amlodipine (AMLODIPINE). The patient previously took first dose of BNT162B2 (lot number: eK5730, Expiry date: unknown) on 18Dec2020 at 11:00 AM at a single dose for covid-19 immunisation. The patient stated I have been having excruciating stabbing pain between T5 and T 6 on the right side of my back on 26Jan2021 at 06:15 PM. It is a constant stabbing pain have not slept for two days. Ice helps a little nothing else. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Burning around my R breast where there is an implant. This burning was INTENSE and lasted 5 days after my 2nd shot.; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 39-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1283, Expiry date: unknown), via an unspecified route of administration on 09Jan2021 at 09:00 am (at the age of 39-years-old) on left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included citalopram (CITALOPRAM), cyanocobalamin (VIT B12), ergocalciferol (VIT D), ascorbic acid (VIT C). The patient previously took first dose of BNT162B2 (Lot number: EH9899, Expiry date: unknown) on 19Dec2020 at 09:00 am (at the age of 39-years-old) on left arm at single dose for covid-19 immunisation. The patient stated that, burning around my r breast where there is an implant. this burning was intense and lasted 5 days after my 2nd shot on 10Jan2021 at 09:00 am. The patient recovered from the event burning around my r breast where there is an implant on 14Jan2021. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the adverse event.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dry throat, Rhinorrhoea, Vaccination site pain
Clinical narrative: Soreness in upper left arm at injection site; Runny nose; dry throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of bnt162b2 (Solution for injection, Lot number: Not reported) via unspecified route of administration on left arm at 10:30, on 28Jan2021 at single dose for COVID-19 immunization at workplace clinic. The patient relevant medical history was none. The patient concomitant medication included finasteride from an unknown date in 2021 (received within 2 weeks of vaccination). On 28Jan2021, the patient experienced soreness in upper left arm at injection site, runny nose, and dry throat. The patient did not receive treatment for the events. The patient hand did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The seriousness of the events was reported as non-serious. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash all over my stomach by the end of the day it was on my legs, chest, back, neck and arms.; This is a spontaneous report from a contactable other health care professional (patient, self-reported). A 38-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3246, expiry date was unknown), via an unspecified route of administration, in Arm Left, on 19Jan2021 at 17:00, as single dose for COVID-19 immunization. Medical history included Slight anemic and slight Vit. D deficiency. Concomitant medication included ethinylestradiol, levonorgestrel (VIENVA) as birth control (in two weeks of vaccine). Patient previously took sulfamethoxazole, trimethoprim (BACTRIM), ibuprofen (MOTRIN) and Ibuprofen; had known allergies with these medications. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19 post vaccination. Patient reported that day after vaccine (20Jan2021, 06:00) got a very itchy rash all over my stomach by the end of the day it was on my legs, chest, back, neck and arms. Events resulted in doctor or other healthcare professional office/clinic visit. Patient was prescribed anti-histamine and steroid cream. Outcome of the event was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: 48hours and still have fatigue and joint pain; 48hours and still have fatigue and joint pain; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on the left arm on 28Jan2021 at 09:00 AM at a single dose for COVID-19 immunisation. The patient medical history was none. There were no allergies to medications, food, or other products. Concomitant medications included rosuvastatin calcium (CRESTOR) at 5mg, vitamin D and zinc. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced fatigue and joint pain on 28Jan2021 at 14:00 and after 48 hours also, was experiencing the events. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir.; This is a spontaneous report from a contactable nurse. A 59-year-old female patient  received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK4176, intramuscular in the left arm, on 22Jan2021 15:00 at SINGLE DOSE for covid-19 immunization. Medical history included depression, SEM, Herpes Simplex 3 and BET.  Concomitant medications included sertraline, clonazepam and propranolol. The patient also had thiomersal allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 25Jan2021, the patient experienced breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir. The outcome of event was recovered.  Follow-up attempts are completed. The information on the batch/lot number has been obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Mammogram, Pyrexia
Clinical narrative: arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM  (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Ultrasound scan, Vaccination site pain
Clinical narrative: arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM  (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Influenza like illness
Clinical narrative: flu like symptoms (headache, body aches); feels weak and woozy; feels weak and woozy; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that an 82-year-old female patient started to receive bnt162b2 (manufacturer not specified), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced flu like symptoms (headache, body aches) yesterday she was feeling better but now feels weak and woozy The final outcome of events was reported as unknown.    Information on the Lot/Batch number has been requested.