chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Hypersensitivity, Hypertension
Clinical narrative: Patient described having lightheadedness, the began to experience dyspnea saying her breathing felt strange.  This began approximately 5 minutes after her dose was administered.  We had her sit down in our injection room and began to monitor her symptoms.    I immediately got out our protocol for Treatment of an Allergic Reaction as part of our vaccination program protocol.   the patient remained conscious and responsive throughout the encounter.  A pulse oximeter was placed on her left pointer finger.  Her heart rate fluctuated in the 110s to 130s during the encounter.  Her pulse ox remained 97% throughout the encounter.  Patient reported having a history of hypertension treated with lisinopril.  We placed a blood pressure monitor on her left wrist to take her blood pressure.  Her initial blood pressure was 164/105, which she reported was "just a little bit over normal" for her.  After taking the initial blood pressure, she described that her symptoms were beginning to subside a bit.  We discussed the signs/symptoms that we would be looking for in an anaphylaxis type reaction, some of which were present (i.e. tachycardia, dyspnea) and some of which were not (i.e. hives, swelling of the face/lips, throat, etc.).  We then began to take her blood pressure again.  The second blood pressure measurement was 156/104.  Shortly after taking the second blood pressure, she described having feelings of dyspnea again.  At that time, I notified another staff member to contact EMS/call 911 and let them know we potentially had an allergic reaction to the second dose of Moderna COVID-19 vaccine.  When the symptoms came back for the second time, I got out the Epipen Two Pack in the case that we would need to administer a dose.  We continued to monitor her symptoms and kept her responsive over the next few minutes, until the first set of EMS arrived from the local fire department.  The EMS staff began taking her vitals and took over care of that patient at that point.  Patient was still responsive and describing only dyspnea and having clinical symptoms of tachycardia and hypertension.  Patient got nauseated around 10 minutes after the first set of EMS arrived, and experienced a bit of vomiting.  About 10-15 minutes after the first set of EMS arrived and took over care of the patient, the ambulance and second set of EMS arrived and took over care.  They began monitoring the patients symptoms and placed an IV line.  The patient was then transported to the local Emergency Department.  At around 5PM, the patient called the pharmacy to report that the physicians at the emergency department had ruled that she had experienced an allergic, non-anaphylactic reaction to the dose of Moderna COVID-19 vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tachycardia, Vomiting
Clinical narrative: Patient described having lightheadedness, the began to experience dyspnea saying her breathing felt strange.  This began approximately 5 minutes after her dose was administered.  We had her sit down in our injection room and began to monitor her symptoms.    I immediately got out our protocol for Treatment of an Allergic Reaction as part of our vaccination program protocol.   the patient remained conscious and responsive throughout the encounter.  A pulse oximeter was placed on her left pointer finger.  Her heart rate fluctuated in the 110s to 130s during the encounter.  Her pulse ox remained 97% throughout the encounter.  Patient reported having a history of hypertension treated with lisinopril.  We placed a blood pressure monitor on her left wrist to take her blood pressure.  Her initial blood pressure was 164/105, which she reported was "just a little bit over normal" for her.  After taking the initial blood pressure, she described that her symptoms were beginning to subside a bit.  We discussed the signs/symptoms that we would be looking for in an anaphylaxis type reaction, some of which were present (i.e. tachycardia, dyspnea) and some of which were not (i.e. hives, swelling of the face/lips, throat, etc.).  We then began to take her blood pressure again.  The second blood pressure measurement was 156/104.  Shortly after taking the second blood pressure, she described having feelings of dyspnea again.  At that time, I notified another staff member to contact EMS/call 911 and let them know we potentially had an allergic reaction to the second dose of Moderna COVID-19 vaccine.  When the symptoms came back for the second time, I got out the Epipen Two Pack in the case that we would need to administer a dose.  We continued to monitor her symptoms and kept her responsive over the next few minutes, until the first set of EMS arrived from the local fire department.  The EMS staff began taking her vitals and took over care of that patient at that point.  Patient was still responsive and describing only dyspnea and having clinical symptoms of tachycardia and hypertension.  Patient got nauseated around 10 minutes after the first set of EMS arrived, and experienced a bit of vomiting.  About 10-15 minutes after the first set of EMS arrived and took over care of the patient, the ambulance and second set of EMS arrived and took over care.  They began monitoring the patients symptoms and placed an IV line.  The patient was then transported to the local Emergency Department.  At around 5PM, the patient called the pharmacy to report that the physicians at the emergency department had ruled that she had experienced an allergic, non-anaphylactic reaction to the dose of Moderna COVID-19 vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain
Clinical narrative: Fine first day - body aches the second day. Nothing serious - just achy on arm and all over.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis, Hypoaesthesia, Paraesthesia oral, Swelling of eyelid
Clinical narrative: within 24 hours had unusual tongue sensation, then left side of face numbness, eyelid swelling,  left sided facial droop. Diagnosed with Bell's Palsy at office visit 3/31/21
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: The Pfizer COVID-19 Vaccine vials were reconstituted with 1.6mL vs. 1.8mL of normal saline.  This resulted in the patient receiving 33mcg of active vaccine component in the 0.3mL dose instead of the  labeled 30mcg.  This has been disclosed to the patient.  Patient reports feeling fine, no adverse side effects.  Reporting through VAERS is required  given the increase in dose administered.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Severe muscle and joint aches, with a fever of 101
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: The Pfizer COVID-19 Vaccine vials were reconstituted with 1.6mL vs. 1.8mL of normal saline.  This resulted in the patient receiving 33mcg of active vaccine component in the 0.3mL dose instead of the EUA labeled 30mcg.  This has been disclosed to the Department of health and the patient.  Patient reports feeling fine, no adverse side effects.  Reporting through VAERS is required by the Department of health given the increase in dose administered.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: 3/25/2021 THURS 5:30pm  Dizzy, achy, tired. runny nose, congestion, cough. restless night hard to sleep with coughing                                                hard to breathe 3/26/2021    called off work. could not function. same as above... general malaise . by far worst day! weight on chest just want to sleep 3/27/2021    general malaise eased up. less tired...BUT late in day low grade fever and chills. super tired want to sleep 3/28/2021    general malaise lifts a bit. The fever and chills are gone. still stuffed up coughing/hacking up. productive cough with                                 mucus/sputum . 3/29.2021   MONDAY  back to work. still feel "not right"  congestin and coughing BUT feel better energy wise.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Impaired work ability, Insomnia, Malaise
Clinical narrative: 3/25/2021 THURS 5:30pm  Dizzy, achy, tired. runny nose, congestion, cough. restless night hard to sleep with coughing                                                hard to breathe 3/26/2021    called off work. could not function. same as above... general malaise . by far worst day! weight on chest just want to sleep 3/27/2021    general malaise eased up. less tired...BUT late in day low grade fever and chills. super tired want to sleep 3/28/2021    general malaise lifts a bit. The fever and chills are gone. still stuffed up coughing/hacking up. productive cough with                                 mucus/sputum . 3/29.2021   MONDAY  back to work. still feel "not right"  congestin and coughing BUT feel better energy wise.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Productive cough, Pyrexia, Restlessness
Clinical narrative: 3/25/2021 THURS 5:30pm  Dizzy, achy, tired. runny nose, congestion, cough. restless night hard to sleep with coughing                                                hard to breathe 3/26/2021    called off work. could not function. same as above... general malaise . by far worst day! weight on chest just want to sleep 3/27/2021    general malaise eased up. less tired...BUT late in day low grade fever and chills. super tired want to sleep 3/28/2021    general malaise lifts a bit. The fever and chills are gone. still stuffed up coughing/hacking up. productive cough with                                 mucus/sputum . 3/29.2021   MONDAY  back to work. still feel "not right"  congestin and coughing BUT feel better energy wise.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Secretion discharge
Clinical narrative: 3/25/2021 THURS 5:30pm  Dizzy, achy, tired. runny nose, congestion, cough. restless night hard to sleep with coughing                                                hard to breathe 3/26/2021    called off work. could not function. same as above... general malaise . by far worst day! weight on chest just want to sleep 3/27/2021    general malaise eased up. less tired...BUT late in day low grade fever and chills. super tired want to sleep 3/28/2021    general malaise lifts a bit. The fever and chills are gone. still stuffed up coughing/hacking up. productive cough with                                 mucus/sputum . 3/29.2021   MONDAY  back to work. still feel "not right"  congestin and coughing BUT feel better energy wise.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headed and dizziness occurred about 30 minutes after injection.  Given water, some food, and laid down for 45 minutes and symptoms went away.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient complained about nubness in her face. No complaints with the 1st dose.  Onsite EMS was called vitals BP 153/118 HR 103 BG 198. She was given 25 mg Benedryl orally given. She was released to go home.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Nausea, Retching
Clinical narrative: Had first dose of COVID vaccine Wednesday 3/24 Thursday started with chills , could not get warm , slight nausea, headache 10/10 - took Excedrin and that helped  Friday same symptoms as Thursday  but did vomit x 2  Afebrile  Has had headaches daily since vaccine but has managed them with Excedrin Saturday thought she was getting better, dizziness and nausea that started later in the day, slight chills  Sunday - nausea, dry heaves- , freezing all day  Was unable to keep anything down - tried crackers and water  Tried Dramamine due to the dizziness and nausea - helps a little  States she is still using Dramamine and it is helpful Monday and Tuesday still having waves of nausea and dry heaves States she is able to eat and drink and keep things down, and is "taking it easy with the food"  Stated constantly feels like a weight is sitting on her throat Describes as pressure, burning and feeling like a weight is sitting there constantly - area of the chin, down her throat to the breastbone in center of chest between her breasts Stated this has been present for 3 days and has been a constant feeling Rates this discomfort as 8/10   Patient referred for ER for assessment today
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vomiting
Clinical narrative: Had first dose of COVID vaccine Wednesday 3/24 Thursday started with chills , could not get warm , slight nausea, headache 10/10 - took Excedrin and that helped  Friday same symptoms as Thursday  but did vomit x 2  Afebrile  Has had headaches daily since vaccine but has managed them with Excedrin Saturday thought she was getting better, dizziness and nausea that started later in the day, slight chills  Sunday - nausea, dry heaves- , freezing all day  Was unable to keep anything down - tried crackers and water  Tried Dramamine due to the dizziness and nausea - helps a little  States she is still using Dramamine and it is helpful Monday and Tuesday still having waves of nausea and dry heaves States she is able to eat and drink and keep things down, and is "taking it easy with the food"  Stated constantly feels like a weight is sitting on her throat Describes as pressure, burning and feeling like a weight is sitting there constantly - area of the chin, down her throat to the breastbone in center of chest between her breasts Stated this has been present for 3 days and has been a constant feeling Rates this discomfort as 8/10   Patient referred for ER for assessment today
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Drug hypersensitivity, Throat tightness
Clinical narrative: throat "tight" - no skin rash;  no swelling of tongue;  no difficulty swallowing / talking.  TX: removal of mask, fresh air & bottle of water to drink per request - drank 1/3 of bottle initially without difficulty and reported improvement of SX immediately.  Remained in observation lot entire wait time & further issues.     Allergy PCN;  DM.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Chills, Pyrexia, Taste disorder
Clinical narrative: In addition to fever, chills and body aches i had lost a sense of teste or in better words everything tastes different, dull maybe, or no taste. Maybe I should describe it as instead of coffee taste i tasted clay
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Drug eruption, Rash pruritic, Skin abrasion
Clinical narrative: Reason for Visit on 3/30/2021: rash and itching x 2days.  Skin Comment: multiple excorations, erythem papules, few ecchymoses.  ? due to Janssen vaccine.  Take hydroxyzine 25mg bid.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Received 2nd dose of Pfizer COVID vaccine 1/29/2021. On 3/25/2021 developed chills, body aches, cough, and rhinorrhea. Tested positive for COVID.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Moderna first vaccine shot. Red, swollen, slightly painful at injection site. Swollen lymph nodes in left armpit.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Muscular weakness, Pallor
Clinical narrative: At 3:15 patient received Moderna Vaccine. Approximately five minutes after receiving Vaccine patient began to feel chills throughout his body and began to feel very dizzy. Staff & Observer walks over to the patient and notices patient's face is completely pale and lips have no color. Staff notifies the clinical group supervisor and she takes patient's vitals. Patient can barely keep his head up, and is weak. Patients vitals at 15:29 44 67/42 96. We lay him on the floor with his feet on a chair. Staff calls paramedics at 3:29. At 15:37 48 78/42 97. At 15:40 55 98/64 96. At 15:46 54 98/64 96. Paramedics arrived at 15:51 and his vitals are 57 82/62 97. Patient is stable. Paramedics clear him.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Dizziness, Nausea
Clinical narrative: Woke up at 12:35 AM with a fever, chills, body aches, and nausea. chills in the morning that went away, nausea was on and off and had an on and off headache. Started having intense chest pain around 10 AM- felt like pressure on my chest and almost squeezing, it kind of shot out and I could feel it in my throat and in my headache. It was still happening around 1 PM so I went to the ER after calling urgent care but the pain subsided once I was at the ER. Nausea, dizziness, haziness, and headache were on and off the rest of the day, subsiding around 6 PM.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain, Pyrexia, Vision blurred
Clinical narrative: Woke up at 12:35 AM with a fever, chills, body aches, and nausea. chills in the morning that went away, nausea was on and off and had an on and off headache. Started having intense chest pain around 10 AM- felt like pressure on my chest and almost squeezing, it kind of shot out and I could feel it in my throat and in my headache. It was still happening around 1 PM so I went to the ER after calling urgent care but the pain subsided once I was at the ER. Nausea, dizziness, haziness, and headache were on and off the rest of the day, subsiding around 6 PM.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis, Eczema, Herpes zoster, Post herpetic neuralgia
Clinical narrative: dermatitis; eczema; postherpetic neuralgia; herpes zoster; Information has been received from a lawyer and a consumer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After being vaccinated, the pt suffered dermatitis, eczema, herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the pt's use of the defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations, not present prior to using the company's product. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of the conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the claimed events was not recovered, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered dermatitis, eczema, herpes zoster and postherpetic neuralgia to be disabling events.
Sex: M
Vaccine: COVID19
Symptoms: Hydronephrosis, Renal pain
Clinical narrative: Right kidney feels like its getting swelling (bigger) more than left; Right bother me a lot/ felt something in kidneys after two days; A spontaneous report was received from a consumer concerning (himself), a 83-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events right kidney feels like its getting swelling (bigger) more than left and right bother me a lot/ felt something in kidneys after two days (Hydronephrosis and Renal pain).   The consumer's medical history was not provided.   Relevant concomitant medication was reported as esomeprazole sodium (nexium).  On 28-FEB-2021, prior to the onset of the events the consumer received their first of two planned doses of mRNA-1273 (lot/batch: 025A21A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 02-MAR-2021, the consumer experienced the events right kidney feels like it was getting swelled (bigger) more than left and right bother him  a lot/ felt something in kidneys after two days.  No treatment information for the events was provided.   Action taken with mRNA-1273 in response to the event s was unknown.  On an unknown date, the outcome of events, events right kidney feels like it was getting swelled (bigger) more than left and right bother him  a lot/ felt something in kidneys after two days was resolved.; Reporter's Comments: This case concerns an 83 Y/O M with serious unexpected events of hydronephrosis and nonserious unexpected renal pain. Event onset 6 days after first dose mRNA-1273. Events resolved. 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling hot, Headache, Loss of consciousness
Clinical narrative: Found on unconscious on the floor, I have no memory of coming of bathroom; I felt weak and hot; I felt shaking extremely cold; I felt weak and hot; I felt shaking extremely cold; Nausea; Headaches; Soreness to left arm; A spontaneous report  was received from a consumer who was also a 82-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who was found on unconscious on the floor/loss of consciousness, hit me like a ton of bricks, soreness to left arm/pain in extremity/, I felt shaking extremely cold/feeling cold, I felt weak and hot/feeling hot; asthenia, I felt shaking extremely cold/tremor, nausea and headaches.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, vitamin D, calcium and senior vitamin not specified.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) on 06 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Feb 2021, patient experienced sore arms which was resolved on 08 Feb 2021.  On 06 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021 the patient experienced headaches, nausea, felt shaking extremely cold, hot and weak, the patient was found unconscious, hitting patient with a ton of bricks and was taken to emergency room on an ambulance.  Treatment for the event included hydration fluids, tylenol and aspirin.  The action taken with the drug in response to the events was not applicable.  The all events were recovered except tiredness which was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor, Vaccination site pain
Clinical narrative: Found on unconscious on the floor, I have no memory of coming of bathroom; I felt weak and hot; I felt shaking extremely cold; I felt weak and hot; I felt shaking extremely cold; Nausea; Headaches; Soreness to left arm; A spontaneous report  was received from a consumer who was also a 82-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who was found on unconscious on the floor/loss of consciousness, hit me like a ton of bricks, soreness to left arm/pain in extremity/, I felt shaking extremely cold/feeling cold, I felt weak and hot/feeling hot; asthenia, I felt shaking extremely cold/tremor, nausea and headaches.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, vitamin D, calcium and senior vitamin not specified.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) on 06 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Feb 2021, patient experienced sore arms which was resolved on 08 Feb 2021.  On 06 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021 the patient experienced headaches, nausea, felt shaking extremely cold, hot and weak, the patient was found unconscious, hitting patient with a ton of bricks and was taken to emergency room on an ambulance.  Treatment for the event included hydration fluids, tylenol and aspirin.  The action taken with the drug in response to the events was not applicable.  The all events were recovered except tiredness which was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Paraesthesia oral
Clinical narrative: blackout for short time; slit feeling at tip of tounge; Fell down; Weird feeling; A spontaneous report was received from a consumer concerning an 73 year old, male patient who experienced blackout for short time/loss of consciousness , slit feeling at tip of tongue/paraesthesia oral, fell down/fall and weird feeling/feeling abnormal.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The current condition included was blood pressure abnormal.  On 11 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 Batch no: 048A21A for prophylaxis of COVID-19 infection.  On 11 Mar 2021, the patient was fell down, blackout for short time and that was very strange and weird feeling. The patient experienced his tip of tounge is felt like its slit  Treatment information was included Benadryl and He used cold compressor and started feeling good  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event of blackout for short time was considered Resolved 11 Mar 2021 and slit feeling at tip of tongue was considered resolved on 12 Mar 2021.  The outcome of event fall was unknown and for event feeling abnormal was recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder, Urticaria chronic
Clinical narrative: Autoimmune skin disorder; Chronic urticaria; A spontaneous report was received from a consumer concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, autoimmune skin disorder/autoimmune disorder and chronic urticaria/ urticaria chronic.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date in 2021, prior to the onset of the symptoms, the patient received the unknown dose of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date in 2021, it was reported that the patient developed autoimmune skin disorder and chronic urticaria. The event autoimmune skin disorder was considered medically significant. No treatment details were provided.  Action taken with mRNA-1273 in response to the events were not provided.  At the time of this report, the outcome of the events autoimmune skin disorder and chronic urticaria were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Bedridden, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: struggled to get out of bed and stayed in bed all day; no appetite; vaccination site pain; Felt miserable; Felt knocked out; Short term memory feels affected more once again; A spontaneous report was received from a consumer concerning 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt knocked out/ loss of consciousness, felt miserable/ feeling abnormal, struggled to get out of bed and stayed in bed all day / bedridden, short term memory feels affected more once again/ amnesia, no appetite/ decreased appetite.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included lisinopril, levothyroxine sodium, omeprazole.  On 22 Feb 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 001A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, patient experienced arm sore for a few days. On 25 Feb 2021, patient had experienced hurting all over body and couldn't do anything for 5 days (very painful). Short term feels affected.  On 22 Mar 2021, prior to the onset of the event, the patient received second of their two planned doses of mRNA-1273 (Lot number: 037A21A) through unknown route at right arm for prophylaxis of COVID-19 infection.  On 22 Mar 2021 in the evening after second dose, patient felt knocked out and miserable and struggled to get out of bed. She had short term memory feels affected more once again. On 23 Mar 2021 patient stayed in bed all day and had no appetite. On 24 Mar 2021, patient was feeling a lot better.  The event patient felt knocked out was a medically significant condition.  Treatment activities for event was done with paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, felt knocked out, felt miserable, struggled to get out of bed and stayed in bed all day, short term memory feels affected more once again, no appetite was recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056390:Dose 1
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: struggled to get out of bed and stayed in bed all day; no appetite; vaccination site pain; Felt miserable; Felt knocked out; Short term memory feels affected more once again; A spontaneous report was received from a consumer concerning 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt knocked out/ loss of consciousness, felt miserable/ feeling abnormal, struggled to get out of bed and stayed in bed all day / bedridden, short term memory feels affected more once again/ amnesia, no appetite/ decreased appetite.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included lisinopril, levothyroxine sodium, omeprazole.  On 22 Feb 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 001A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, patient experienced arm sore for a few days. On 25 Feb 2021, patient had experienced hurting all over body and couldn't do anything for 5 days (very painful). Short term feels affected.  On 22 Mar 2021, prior to the onset of the event, the patient received second of their two planned doses of mRNA-1273 (Lot number: 037A21A) through unknown route at right arm for prophylaxis of COVID-19 infection.  On 22 Mar 2021 in the evening after second dose, patient felt knocked out and miserable and struggled to get out of bed. She had short term memory feels affected more once again. On 23 Mar 2021 patient stayed in bed all day and had no appetite. On 24 Mar 2021, patient was feeling a lot better.  The event patient felt knocked out was a medically significant condition.  Treatment activities for event was done with paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, felt knocked out, felt miserable, struggled to get out of bed and stayed in bed all day, short term memory feels affected more once again, no appetite was recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056390:Dose 1
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site; This is a spontaneous report from a contactable consumer reported for himself. A 68-year-old male patient received bnt162b2 (Solution for injection), via an unspecified route of administration, administered in arm right on 27Jan2021 17:00 as for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jan2021 17:45 patient had ore injection site. There was no treatment for the event. The outcome of the event recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of the lymph node in left axilla; This is a spontaneous report from a contactable nurse (patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number:EK4176 Exp Date: not reported), via an unspecified route of administration on an unspecified date (at the age of  43-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. It was also reported that prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced swelling of the lymph node in left axilla on 27Jan2021. The patient has not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Head ache; arm pain; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL92962, expiration date not reported), via an unspecified route of administration, administered on the left arm on 27Jan2021 12:15 (at the age of 55-years-old) at a single dose for COVID-19 immunisation.  The patient's medical history was not reported. Concomitant medication included levothyroxine (manufacturer unknown) taken for an unspecified indication.  The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Health Clinic. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced head ache and arm pain on 27Jan2021 16:45. Events were assessed as non-serious. Treatment was not received for the events.The outcome of events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Fever; chills; soreness/body aches; muscle aches; feeling tired; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL9261) via unknown route at left arm on 27Jan2021 06:45 at single dose for covid-19 immunization. Medical history reported as none. Concomitant medication included pregabalin; cetirizine hydrochloride (ALLERTEC). The patient had no allergy. the patient not-receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination includes Pregabalin, Allertec. On 27Jan2021, patient had fever, chills, soreness, muscle aches, body aches, feeling tired. There was no treatment received for the adverse events. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Very sore arm; Very tired; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 27Jan2021 at 08:00 (at the age of 47-years-old) as a single dose for covid-19 immunisation. The patient had no allergies to medications, food, or other products and other medical history was none. 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 patient received allergy medicine within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, at 17:00 pm the patient had very sore arm and very, very tired. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Jan2021.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: pain; swelling; itching; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 19Jan2021 10:45 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history included HTN (hypertension), osteoporosis and Allergies to sulfa. Concomitant medication(s) included macrogol 3350 (MIRALAX); metoprolol; hctz; donepezil; alendronate sodium (ALENDRONATE) all was taken for an unspecified indication. The patient previously took hydrocodone and experienced allergies. on 27Jan2021 05:00 patient experienced pain, swelling, itching. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, was the patient did not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. Outcome of the events was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Moderate to severe fatigue; I have trouble staying awake during the day, especially early evening.  I need more and longer naps than usual.  Because I have leukemia, I do have fatigue normally.; Moderate to severe fatigue; I have trouble staying awake during the day, especially early evening.  I need more and longer naps than usual.  Because I have leukemia, I do have fatigue normally.; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 19Jan2021 09:00 (Batch/Lot Number: EL3249) as single dose for Covid-19 immunization. Medical history included ongoing leukaemia, chronic pain, gastritis, colitis, supraventricular tachycardia, depression, xerostomia, afibrillation, migraines, fatigue, and others. Concomitant medication included ibrutinib (IBRUTINIB) taken for leukaemia. The patient previously had Known allergies for drugs Bactrim, Belladonna, Diclofenac, DMannose, IV contrast media, Mobic, Metoclopramide, Metoprolol, Protonix, and Pyridium. Patient not had other vaccine in four weeks, Other medications in two weeks includes Ibrutinib (for leukemia). On 19Jan2021 on 13:00, patient had Moderate to severe fatigue; "I have trouble staying awake during the day, especially early evening. I need more and longer naps than usual. Because I have leukemia, I do have fatigue normally, but it has gotten Much worse". Patient not had COVID prior vaccination; patient not tested COVID post vaccination. There was no treatment received for the adverse events. Th outcome of the events was not recovered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Pyrexia
Clinical narrative: fever; Cough; headache; This is a spontaneous report from a contactable consumer (Patient). A 29-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN 5318), via an unspecified route of administration, administered in Arm Right on 26Jan2021 13:15 as single dose at Workplace clinic for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Jan2021 13:30, the patient experienced fever, cough and Headache. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was Recovering.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experienced headache after second COVID-19 vaccine; This is a spontaneous report from a non-contactable physician.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route on unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache after second COVID-19 vaccine on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: fever 100.5; chills; fatigue; headache; nausea; This is a spontaneous report from a contactable Other Health Professional (patient). A 59-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EL3246), via an unspecified route of administration, in the arm right on 25Jan2021 at 07:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization, at hospital. Medical history was not reported. Patient received unspecified concomitant medications (within 2 weeks of vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the right arm on 07Jan2021 at unknown time (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient did not have allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 25Jan2021, the patient experienced fever 100.5, chills, fatigue, headache and nausea. The patient did not receive any treatment for the adverse events. The clinical outcome for the reactions fever 100.5, chills, fatigue, headache and nausea was reported as recovered/resolved in 2021.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever 100.5; chills; fatigue; headache; nausea; This is a spontaneous report from a contactable Other Health Professional (patient). A 59-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EL3246), via an unspecified route of administration, in the arm right on 25Jan2021 at 07:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization, at hospital. Medical history was not reported. Patient received unspecified concomitant medications (within 2 weeks of vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the right arm on 07Jan2021 at unknown time (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient did not have allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 25Jan2021, the patient experienced fever 100.5, chills, fatigue, headache and nausea. The patient did not receive any treatment for the adverse events. The clinical outcome for the reactions fever 100.5, chills, fatigue, headache and nausea was reported as recovered/resolved in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: body aches; chills; like having the flu; This is a spontaneous report from a contactable consumer reporting for a female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 Immunization. The patient's medical history included first dose of COVID vaccine. Concomitant medication was not reported. On an unknown date patient experienced body aches and chills, would not have able to go to work, like having the flu. The patient treatment reported as unknown. The event assessed as non-serious by the reporter. The outcome for the event was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Lethargy, Pain
Clinical narrative: fever; chills; body aches; lethargy; sweats; headache; This is a spontaneous report from a contactable consumer (patient). A 41-year-old consumer of an unspecified gender received first dose of BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection) on 21Jan2021 01:15 PM to left arm at single dose for Covid-19 immunization. The patient's medical history included thyroidectomy. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included liothyronine sodium (CYTOMEL) and levothyroxine sodium (TIROSINT) which were received within two weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Jan2021 05:00 PM, the patient experienced fever, chills, body aches, lethargy, sweats and headache. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had tested for Covid-19 by polymerase chain reaction (PCR) test. On 30Jan2021, Covid tests post vaccination included nasal swab and PCR, which showed negative. The patient received antibiotics (doctor thought that the patient had Covid) as the treatment for the events. Outcome of the event was recovering. Vaccine Facility information and ethnicity information was available.  Information on the lot/batch number has been requested.