chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest X-ray, Condition aggravated, Hypoaesthesia, Muscular weakness
Clinical narrative: numberless shoulder/extends numbness left leg weak when stood( felt numb)/numbness; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2, also reported as Pfizer-BioNTech COVID-19), via an unspecified route of administration on 18Dec2020 13:15, single dose (dose number 1) in left arm, for immunization. Medical history included allergies to food, perfumes, fragrance, smoke and residual odor. Other medical history includes asthma, OSA (obstructive sleep apnea), borderline DM, anxiety and depression. The patient previously took VICODIN and had drug hypersensitivity.  She had no other vaccines in four weeks but had other medications (unspecified) in two weeks. The patient reported that on 18Dec2020 at 13:30 she experienced left arm lateral numberless shoulder- last 3 finger, extended numb to pointer finger, extends numbness shoulder up left neck to lips midpoint the complete lips extended to right side of face and neck and then to right temporal, ear and down to clavicle; left leg weak when stood( felt numb). She developed asthma exacerbation by 0900 and started to resolve in ER. About 0018 numbness now in lips, around lips, tongue, and starting down neck. Treatment for the event were Epinephrine IM, Benadryl, Dexamethasone, ab. She also had CXR (chest x-ray), no results reported. The outcome of events was recovered with Sequel.   Information on the lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell?s Palsy to the left side of my face. Woke up Wednesday morning with symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasal congestion, Oropharyngeal pain, Productive cough
Clinical narrative: Increased congestion about 12 hours after receiving the vaccine. Congestion in back of throat and feeling like I need to clear my throat often.; When I clear my throat there is phlegm; Slight nasal congestion; Slight itching and soreness of the throat; Slight itching and soreness of the throat; coughing once through the night; pain and swelling of the injection site; pain and swelling of the injection site; fatigue; This is a spontaneous report from a contactable consumer.   A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 18-DEC-2020 09:00 AM (at the age of 36-years-old) at an unspecified dose in the left arm for COVID-19 vaccination.  Medical history was reported as "None" and the patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination.The patient was administered the vaccine in the hospital. Concomitant medication included zolpidem tartrate (AMBIEN), clonazepam (KLONOPIN) and "MVI" (not further specified). The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 18Dec2020 at 17:00, the patient experienced increased congestion "about 12 hours" after receiving the vaccine as well as congestion in back of throat which she described as  "feeling like I need to clear my throat often"  and "when I clear my throat there is phlegm." Further, on 18Dec2020 at 17:00 the patient also experienced slight nasal congestion, slight itching and soreness of the throat that lasted for about 30 minutes and she woke up coughing once through the night. Additionally, on 18Dec2020 at 17:00 the patient experienced pain and swelling of the vaccination site and fatigue. The patient did not receive any treatment for the events. The clinical outcomes of congestion in back of throat, phlegm, nasal congestion, sore throat, itchy throat, coughing, vaccination site pain, vaccination site swelling and fatigue were not recovered.  It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Throat clearing, Throat irritation, Upper respiratory tract congestion, Vaccination site pain, Vaccination site swelling
Clinical narrative: Increased congestion about 12 hours after receiving the vaccine. Congestion in back of throat and feeling like I need to clear my throat often.; When I clear my throat there is phlegm; Slight nasal congestion; Slight itching and soreness of the throat; Slight itching and soreness of the throat; coughing once through the night; pain and swelling of the injection site; pain and swelling of the injection site; fatigue; This is a spontaneous report from a contactable consumer.   A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 18-DEC-2020 09:00 AM (at the age of 36-years-old) at an unspecified dose in the left arm for COVID-19 vaccination.  Medical history was reported as "None" and the patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination.The patient was administered the vaccine in the hospital. Concomitant medication included zolpidem tartrate (AMBIEN), clonazepam (KLONOPIN) and "MVI" (not further specified). The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 18Dec2020 at 17:00, the patient experienced increased congestion "about 12 hours" after receiving the vaccine as well as congestion in back of throat which she described as  "feeling like I need to clear my throat often"  and "when I clear my throat there is phlegm." Further, on 18Dec2020 at 17:00 the patient also experienced slight nasal congestion, slight itching and soreness of the throat that lasted for about 30 minutes and she woke up coughing once through the night. Additionally, on 18Dec2020 at 17:00 the patient experienced pain and swelling of the vaccination site and fatigue. The patient did not receive any treatment for the events. The clinical outcomes of congestion in back of throat, phlegm, nasal congestion, sore throat, itchy throat, coughing, vaccination site pain, vaccination site swelling and fatigue were not recovered.  It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Employee reports he developed tinnitus 8 hours after injection and has remained 4 days post injection with no history of tinnitus.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Nasal congestion, Peripheral swelling, Swelling of eyelid
Clinical narrative: Eyelid and nasal bridge swelling; Eyelid and nasal bridge swelling; Swelling of hands and wrists; Swelling of hands and wrists; This is a spontaneous report from a contactable physician. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EJ1685), via intramuscular route of administration (right arm) on 18Dec2020 18:15 at a single dose for COVID-19 immunisation. Relevant medical history included depression, hay fever and acne. Concomitant medication included escitalopram, fexofenadine hydrochloride (ALLEGRA) and doxycycline. The patient was allergic to nickel and fragrance. On 19Dec2020 07:00, patient experienced eyelid and nasal bridge swelling; and swelling of hands and wrists. Patient received allegra due to the event. Outcome of the events was reported as recovering/resolving.   Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia
Clinical narrative: Joint pain started in right hand, then right arm, to right shoulder and eventually across back to left shoulder.; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EH9899) on 16Dec2020, via an unspecified route of administration, at a single dose in the left arm, for COVID-19 immunization. The patient had history of positive antinuclear antibody (ANA) without diagnosis. She had known allergies to penicillin. Concomitant medications received in two weeks included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE), acetylsalicylic acid (ASA), melatonin (MELATONIN). The patient did not receive other vaccine in the past four weeks. She had not had ever been diagnosed with COVID-19 prior the vaccination, not tested for COVID-19 post the vaccination. On 17Dec2020, the patient experienced joint pain which started in right hand, then right arm, to right shoulder and eventually across back to left shoulder. The event was non-serious. The patient did not receive any treatment for the event. The event was not resolved.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Soreness; Headache; This is a spontaneous report from a contactable Healthcare Professional reporting for herself.  A 53-years-old female patient received first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: ER5730, by intramuscular route in right arm, in Hospital, on 17Dec2020 at 08:45, at single dose for COVID-19 immunization. The patient had no known allergies and no relevant medical history. Concomitant medications were taken, but they were unspecified. On 17Dec2020 at 15:00 the patient experienced soreness and headache, both assessed as non-serious and resolved on an unknown date in Dec2020 without any treatment.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Product administered at inappropriate site, Sleep disorder
Clinical narrative: unable to lift arm in active range of motion; difficulty sleeping; administered too high on the arm into the subacromial space; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Eh9899), via an unspecified route of administration at the left arm on 18Dec2020 at 15:00 (03:00 PM) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient 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 the patient has not been tested for COVID-19 since the vaccination. The patient's medical history was not reported (other medical history: yes). The patient had no known allergies. Concomitant medication included other unspecified medications received within 2 weeks of vaccination. The patient reported that the injection was given and she thought that it was administered too high on the arm into the subacromial space. By end of day, she was unable to lift arm in active range of motion, and had difficulty sleeping. Following day, still unable to lift arm. The events unable to lift arm in active range of motion, and had difficulty sleeping started on 18Dec2020 at 16:00 (04:00 PM). The clinical outcome of the events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Syncope
Clinical narrative: Developed dizziness, lightheadedness, warmth, sweaty and had a syncopal episode at 8:45pm.  All symptoms resolved then within 15 minutes of laying down in bed and having a cold compress on forehead
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: red splotchy itchy face; red splotchy itchy face; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 17Dec2020 at 16:00 (at the age of 29-years-old) as a single dose for Covid-19 vaccination. Medical history included Premenstrual dysphoric depression syndrome from an unknown date. The patient did not have any allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications included citalopram (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Dec2020 at 21:00, the patient experienced red splotchy itchy face. Therapeutic measures were taken for the red splotchy itchy face which included allergy medicine (unspecified). The clinical outcome of the events red splotchy itchy face was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever 103F, Shaking Chills Responded to Tylenol.  Afebrile 12 hours later
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Rash, Rash pruritic
Clinical narrative: 12/27/2020  intense pain at injection site. 12/28/2020 bumpy rash, very itchy both arms and hand, chest, stomach, under the armpits, shoulders, both legs. Triamcinolone Acetonide Cream, some relief to rash; rash still persists.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dry mouth, Dyspnoea, Fatigue
Clinical narrative: After vaccine my mouth started to get dry while I was driving home. 1/2 body sore and chest pain felt like heart burn and I was having a heard time breathing. injection site started hurting all the way up to my shoulder. I started getting chills and tired.  i started feeling better last night but I did not sleep well. I still have body aches and my chest is feeling better. If I do not feel better in the next 24 hours i will be contacting my HCP.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: After vaccine my mouth started to get dry while I was driving home. 1/2 body sore and chest pain felt like heart burn and I was having a heard time breathing. injection site started hurting all the way up to my shoulder. I started getting chills and tired.  i started feeling better last night but I did not sleep well. I still have body aches and my chest is feeling better. If I do not feel better in the next 24 hours i will be contacting my HCP.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Hypertension
Clinical narrative: High blood pressure; heart rate in the 100's/High heart rate; light headed and dizzy; This is a spontaneous report from a non-contactable nurse(patient). This female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on Dec2020 (reported as on Thursday) for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient received the vaccine on Thursday and within 15 to 20 minutes, she got light headed and dizzy with high blood pressure with a heart rate in the 100's. She went to the ER and was sent home, but her blood pressure continues to be high. Her primary care physician wanted to start her on some blood pressure medication due to continuous high blood pressure. The reporter was asking if high blood pressure and high heart rate had been reported as an adverse event for the Covid vaccine. Outcome of High blood pressure was not resolved. Outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT 162B2 and the events blood pressure increased, dizziness, and heart rate increased cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: diaphoretic; dizzy; This is a spontaneous report from a contactable nurse. A 51-year-old female patient (not pregnant) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ek5730) at single dose on 21Dec2020 11:00 AM intramuscular on left arm for Covid-19 immunization. Medical history included known allergies with codeine. Patient reported similar reaction of diaphoretic and dizzy to giving blood. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. Concomitant drug was not provided. Patient became diaphoretic and dizzy approximately 11:15 AM on 21Dec2020 (also reported as 8 min after injection). The adverse event result in doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment reported as patient was laid down with feet up, cool compress applied, drank some juice. The events were reported as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events diaphoresis and dizziness cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash and Hives
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal rigidity, Chills, Pain in extremity
Clinical narrative: Extremely painful legs; abdomen spasms; abdomen spasms and cramps; severe chills; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient (not pregnant at the time of vaccination) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 17Dec2020 04:00 PM Intramuscular in Right arm (also reported Arm Left) for Covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Medical history included hypothyroidism, hypotension, obesity, and allergies to onions. There were no other vaccines received in four weeks; however other medications received in two weeks. Patient experienced extremely painful legs and abdomen spasms and cramps, severe chills on 17Dec2020 09:00 PM. Patient applied arnica 35% on the affected area and it helped. Since the vaccination, patient had not been tested for COVID-19. Outcome of the events was resolving.  The events were reported as non-serious.       Information on lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of extremely painful legs, abdomen spasms and cramps, and severe chills cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain in extremity, Paraesthesia
Clinical narrative: respiratory distress with dyspnea and increased work; respiratory distress with dyspnea and increased work; rapid progression of symptoms; lightheadedness; tingling to right upper and lower arm; pain to mid forearm; generalized weakness; This is a spontaneous report from a non-contactable health care professional. A 72-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot_number= HE9899) at single dose on 18Dec2020 10:00 AM intramuscular in the right deltoid muscle for Covid-19 immunization. Medical history and concomitant drug were not provided. She denied any history of previous adverse reactions to vaccines. Concomitant drug was not provided.  During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and tingling to right upper and lower arm. Also complain of pain to mid forearm. She denied hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, itching and tongue swelling.When walking to the emergency bay reported some lightheadedness and generalized weakness, patient denies facial drooping or weakness. No loss of strength and normal ROM to hand and arms. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Patient was monitored for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea and increased work. The events were reported as non-serious. Outcome of the events was unknown.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and reported serious events cannot be excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chest X-ray normal, Fatigue, Feeling abnormal
Clinical narrative: I received my first dose of Moderna vaccine at around 9:45 am on Dec 24 and I was fine for like 4 hrs after receiving it, until I started feeling similarly to the way I felt when I tested positive for Covid and had it at the beginning of November (feverish, headache, body ache, stuffy mucusless nose, fatigue, hangover sensation like nauseated and weird, etc...) Things got a little bit worse when all of a sudden I started feeling feverish and my heart started beating so fast I could hear it myself. I had to stop doing what I was doing and called (my insurance/MCD) because I was getting anxious and started hyperventilating, which did not allow me to breathe normal. They told me to take Tylenol which I did and little by little my fever started decreasing; it must have been almost 100 F at that moment. Then once again like 5 hrs after I had taken Tylenol I started getting fever again and this time I got extremely cold also and I was shaking so much and felt so weak I had to lay down and call  once again; they told me to have someone take me to their urgent care center and I went there and they retested me for Covid but it was negative this time. Since I had taken Tylenol (2nd time same day, 6 hrs apart) just before I left, my fever was not that high when I showed up there. They told me studies have showed some people experience similar symptoms but when they get the 2nd not the 1st dose; however, they thought it could happen too. I had fever nonstop for almost 48 hrs; it was so high (101.7- highest reached). The rest of the time?at night when I was trying to sleep, obviously I could not take my temperature, I was half awake, half sleep hallucinating, shaking, cold, then hot and sweating a lot and speaking non sense in my sleep (according to my spouse)- this happened both nights. On Dec 26 I woke up feeling not great but definitely better but had a little headache and still felt somewhat nauseated. My last dose of Tylenol I took at 8 pm on Dec 25. I have been feeling better for the past two days but I still feel a little bit tired and not back to my normal self.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hallucination, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: I received my first dose of Moderna vaccine at around 9:45 am on Dec 24 and I was fine for like 4 hrs after receiving it, until I started feeling similarly to the way I felt when I tested positive for Covid and had it at the beginning of November (feverish, headache, body ache, stuffy mucusless nose, fatigue, hangover sensation like nauseated and weird, etc...) Things got a little bit worse when all of a sudden I started feeling feverish and my heart started beating so fast I could hear it myself. I had to stop doing what I was doing and called (my insurance/MCD) because I was getting anxious and started hyperventilating, which did not allow me to breathe normal. They told me to take Tylenol which I did and little by little my fever started decreasing; it must have been almost 100 F at that moment. Then once again like 5 hrs after I had taken Tylenol I started getting fever again and this time I got extremely cold also and I was shaking so much and felt so weak I had to lay down and call  once again; they told me to have someone take me to their urgent care center and I went there and they retested me for Covid but it was negative this time. Since I had taken Tylenol (2nd time same day, 6 hrs apart) just before I left, my fever was not that high when I showed up there. They told me studies have showed some people experience similar symptoms but when they get the 2nd not the 1st dose; however, they thought it could happen too. I had fever nonstop for almost 48 hrs; it was so high (101.7- highest reached). The rest of the time?at night when I was trying to sleep, obviously I could not take my temperature, I was half awake, half sleep hallucinating, shaking, cold, then hot and sweating a lot and speaking non sense in my sleep (according to my spouse)- this happened both nights. On Dec 26 I woke up feeling not great but definitely better but had a little headache and still felt somewhat nauseated. My last dose of Tylenol I took at 8 pm on Dec 25. I have been feeling better for the past two days but I still feel a little bit tired and not back to my normal self.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperventilation, Incoherent, Nasal congestion, Nasal dryness, Nausea
Clinical narrative: I received my first dose of Moderna vaccine at around 9:45 am on Dec 24 and I was fine for like 4 hrs after receiving it, until I started feeling similarly to the way I felt when I tested positive for Covid and had it at the beginning of November (feverish, headache, body ache, stuffy mucusless nose, fatigue, hangover sensation like nauseated and weird, etc...) Things got a little bit worse when all of a sudden I started feeling feverish and my heart started beating so fast I could hear it myself. I had to stop doing what I was doing and called (my insurance/MCD) because I was getting anxious and started hyperventilating, which did not allow me to breathe normal. They told me to take Tylenol which I did and little by little my fever started decreasing; it must have been almost 100 F at that moment. Then once again like 5 hrs after I had taken Tylenol I started getting fever again and this time I got extremely cold also and I was shaking so much and felt so weak I had to lay down and call  once again; they told me to have someone take me to their urgent care center and I went there and they retested me for Covid but it was negative this time. Since I had taken Tylenol (2nd time same day, 6 hrs apart) just before I left, my fever was not that high when I showed up there. They told me studies have showed some people experience similar symptoms but when they get the 2nd not the 1st dose; however, they thought it could happen too. I had fever nonstop for almost 48 hrs; it was so high (101.7- highest reached). The rest of the time?at night when I was trying to sleep, obviously I could not take my temperature, I was half awake, half sleep hallucinating, shaking, cold, then hot and sweating a lot and speaking non sense in my sleep (according to my spouse)- this happened both nights. On Dec 26 I woke up feeling not great but definitely better but had a little headache and still felt somewhat nauseated. My last dose of Tylenol I took at 8 pm on Dec 25. I have been feeling better for the past two days but I still feel a little bit tired and not back to my normal self.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiration abnormal, SARS-CoV-2 test negative, Tremor
Clinical narrative: I received my first dose of Moderna vaccine at around 9:45 am on Dec 24 and I was fine for like 4 hrs after receiving it, until I started feeling similarly to the way I felt when I tested positive for Covid and had it at the beginning of November (feverish, headache, body ache, stuffy mucusless nose, fatigue, hangover sensation like nauseated and weird, etc...) Things got a little bit worse when all of a sudden I started feeling feverish and my heart started beating so fast I could hear it myself. I had to stop doing what I was doing and called (my insurance/MCD) because I was getting anxious and started hyperventilating, which did not allow me to breathe normal. They told me to take Tylenol which I did and little by little my fever started decreasing; it must have been almost 100 F at that moment. Then once again like 5 hrs after I had taken Tylenol I started getting fever again and this time I got extremely cold also and I was shaking so much and felt so weak I had to lay down and call  once again; they told me to have someone take me to their urgent care center and I went there and they retested me for Covid but it was negative this time. Since I had taken Tylenol (2nd time same day, 6 hrs apart) just before I left, my fever was not that high when I showed up there. They told me studies have showed some people experience similar symptoms but when they get the 2nd not the 1st dose; however, they thought it could happen too. I had fever nonstop for almost 48 hrs; it was so high (101.7- highest reached). The rest of the time?at night when I was trying to sleep, obviously I could not take my temperature, I was half awake, half sleep hallucinating, shaking, cold, then hot and sweating a lot and speaking non sense in my sleep (according to my spouse)- this happened both nights. On Dec 26 I woke up feeling not great but definitely better but had a little headache and still felt somewhat nauseated. My last dose of Tylenol I took at 8 pm on Dec 25. I have been feeling better for the past two days but I still feel a little bit tired and not back to my normal self.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: bells palsy; This is a spontaneous report from a Pfizer-sponsored program.  A Consumer reported for herself.   A 75-years-old female patient  received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient previously took mercury and experienced drug hypersensitivity.  The patient experienced Bells palsy  on an unspecified date with outcome of unknown.    The patient is wondering if Bells palsy may be an adverse reaction to the vaccine.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate increased, Hyperhidrosis, Malaise
Clinical narrative: Low grade fever; fast heart rate; she sweated so much; she has body aches still; This is a spontaneous report from a contactable nurse (patient). This 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/lot number: EH9899) via an unspecified route of administration on 20Dec2020 10:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient took COVID vaccine because she was exposure in hospital. Patient said she experienced reaction from the first dose of COVID vaccine. The patient got the first dose of vaccine by injection once on 20Dec2020, later clarified as COVID vaccine, and overnight she had a low grade fever on 20Dec2020, and she checked her heart rate from her Watch, and it said 108 to like low 100s, stated not her usual resting heart rate, and she woke at 4AM and felt a fast heartbeat, other than that, she thought it was from fever. Low grade fever was right before going to bed around 10PM: she had body aches, headache, she was not feeling well, she was very hot, At 4AM, she thought to sleep it off, as her whole body ached, and she couldn't really move, and she looked at her Watch to check and her heart rate was 103 resting, and she didn't take her temperature again, but she sweated so much, and she turned down the temperature and as of today, she has body aches still, and a little bit of fast heart rate. Outcome of the events was unknown. Reporter seriousness for Low grade fever and fast heart rate was medically significant. Primary Source Reporter assessed Low grade fever and fast heart rate related by Method.; Sender's Comments: A causal association between BNT162B2 and the events pyrexia and heart rate increased cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Occupational exposure to SARS-CoV-2, Pain, Pyrexia
Clinical narrative: Low grade fever; fast heart rate; she sweated so much; she has body aches still; This is a spontaneous report from a contactable nurse (patient). This 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/lot number: EH9899) via an unspecified route of administration on 20Dec2020 10:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient took COVID vaccine because she was exposure in hospital. Patient said she experienced reaction from the first dose of COVID vaccine. The patient got the first dose of vaccine by injection once on 20Dec2020, later clarified as COVID vaccine, and overnight she had a low grade fever on 20Dec2020, and she checked her heart rate from her Watch, and it said 108 to like low 100s, stated not her usual resting heart rate, and she woke at 4AM and felt a fast heartbeat, other than that, she thought it was from fever. Low grade fever was right before going to bed around 10PM: she had body aches, headache, she was not feeling well, she was very hot, At 4AM, she thought to sleep it off, as her whole body ached, and she couldn't really move, and she looked at her Watch to check and her heart rate was 103 resting, and she didn't take her temperature again, but she sweated so much, and she turned down the temperature and as of today, she has body aches still, and a little bit of fast heart rate. Outcome of the events was unknown. Reporter seriousness for Low grade fever and fast heart rate was medically significant. Primary Source Reporter assessed Low grade fever and fast heart rate related by Method.; Sender's Comments: A causal association between BNT162B2 and the events pyrexia and heart rate increased cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Tonsillitis
Clinical narrative: Severe sore throat and tonsillitis, head ache
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation, Vomiting
Clinical narrative: Vomit; Coughing; Felt like Throat was itchy; This is a spontaneous report from a Non-contactable Nurse. A 41-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899) intramuscular on Left arm on 21Dec2020 16:30 at single dose for COVID-19 immunization. Medical history included allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020, 10 minutes after the vaccine the patient began to vomit, felt like throat was itchy, and began coughing. Events resulted that she was taken to the ER (Emergency room). She received Epinephrine, Dexamethasone as treatment for events. Events outcome was recovered on 21Dec2020.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events vomiting, cough, and itchy throat cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Hypoaesthesia, Pain in extremity, Pulmonary pain
Clinical narrative: Arm soreness, 18 hours after vaccine with SOB, CP, fever 99. took Ibuprofen. Numbness to left side of face and hand approx. 36 hours post vaccine, that resolved in 10 hours approx. 48 hours after the vaccine. Lung pain resolved within 72 hours of the vaccine
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Arm soreness, 18 hours after vaccine with SOB, CP, fever 99. took Ibuprofen. Numbness to left side of face and hand approx. 36 hours post vaccine, that resolved in 10 hours approx. 48 hours after the vaccine. Lung pain resolved within 72 hours of the vaccine
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Pain, Painful respiration, Pleuritic pain
Clinical narrative: Arm soreness, 18 hours after vaccine with SOB, CP, fever 99. took Ibuprofen. Numbness to left side of face and hand approx. 36 hours post vaccine, that resolved in 10 hours approx. 48 hours after the vaccine. Lung pain resolved within 72 hours of the vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Heart rate increased, Hot flush, Hyperhidrosis
Clinical narrative: I elevated heart rate  to 159, I was hot, flush, sweating, elevated BP 154/94 which is high for me. I stayed 15 more minutes and everything was back to normal. The next morning I had a headache. By noon, I had vomiting. I went for a COVID 19 test.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: I elevated heart rate  to 159, I was hot, flush, sweating, elevated BP 154/94 which is high for me. I stayed 15 more minutes and everything was back to normal. The next morning I had a headache. By noon, I had vomiting. I went for a COVID 19 test.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disorientation, Dizziness, Fatigue, Feeling hot
Clinical narrative: 10:30am -  Received the Vaccine Shot 11:30am- Warmth throughout face, then right had went all tingly, then numb and swollen. The numbness crept up the arm to the elbow. Then the nose started to get tingly and numb followed by the lips and gums.   12:00pm - Started to not be able to speak a sentence.  The words were coming out of my moth very jumbled even though in my mind I knew what I was trying to say. Still numb in right hand, and on right side of face.  12:10 pm- Could not see fully out of the right peripheral of my eye as well to the other symptoms of not being able to speak a full sentence. I was able to speak less words than I had about 10 min prior. Numbness in my hand went away at this time. 1:15pm- I was able to speak mostly full sentences again.  I got a pounding headache on the front to left side of my head and felt fatigues. 1:40pm- Finally able to speak full sentences again, I could feel my hand and all the parts of my face.  Felt weak, still had headache and felt nauseous and dizzy. 2:15pm- Took 1 advil, fell asleep 4:00pm- Woke up, felt weak, disoriented, still had a headache. 8:00pm- Only a small headache left and a sore arm
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Intranasal hypoaesthesia, Nasal discomfort
Clinical narrative: 10:30am -  Received the Vaccine Shot 11:30am- Warmth throughout face, then right had went all tingly, then numb and swollen. The numbness crept up the arm to the elbow. Then the nose started to get tingly and numb followed by the lips and gums.   12:00pm - Started to not be able to speak a sentence.  The words were coming out of my moth very jumbled even though in my mind I knew what I was trying to say. Still numb in right hand, and on right side of face.  12:10 pm- Could not see fully out of the right peripheral of my eye as well to the other symptoms of not being able to speak a full sentence. I was able to speak less words than I had about 10 min prior. Numbness in my hand went away at this time. 1:15pm- I was able to speak mostly full sentences again.  I got a pounding headache on the front to left side of my head and felt fatigues. 1:40pm- Finally able to speak full sentences again, I could feel my hand and all the parts of my face.  Felt weak, still had headache and felt nauseous and dizzy. 2:15pm- Took 1 advil, fell asleep 4:00pm- Woke up, felt weak, disoriented, still had a headache. 8:00pm- Only a small headache left and a sore arm
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia, Paraesthesia oral, Speech disorder
Clinical narrative: 10:30am -  Received the Vaccine Shot 11:30am- Warmth throughout face, then right had went all tingly, then numb and swollen. The numbness crept up the arm to the elbow. Then the nose started to get tingly and numb followed by the lips and gums.   12:00pm - Started to not be able to speak a sentence.  The words were coming out of my moth very jumbled even though in my mind I knew what I was trying to say. Still numb in right hand, and on right side of face.  12:10 pm- Could not see fully out of the right peripheral of my eye as well to the other symptoms of not being able to speak a full sentence. I was able to speak less words than I had about 10 min prior. Numbness in my hand went away at this time. 1:15pm- I was able to speak mostly full sentences again.  I got a pounding headache on the front to left side of my head and felt fatigues. 1:40pm- Finally able to speak full sentences again, I could feel my hand and all the parts of my face.  Felt weak, still had headache and felt nauseous and dizzy. 2:15pm- Took 1 advil, fell asleep 4:00pm- Woke up, felt weak, disoriented, still had a headache. 8:00pm- Only a small headache left and a sore arm
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Visual field defect
Clinical narrative: 10:30am -  Received the Vaccine Shot 11:30am- Warmth throughout face, then right had went all tingly, then numb and swollen. The numbness crept up the arm to the elbow. Then the nose started to get tingly and numb followed by the lips and gums.   12:00pm - Started to not be able to speak a sentence.  The words were coming out of my moth very jumbled even though in my mind I knew what I was trying to say. Still numb in right hand, and on right side of face.  12:10 pm- Could not see fully out of the right peripheral of my eye as well to the other symptoms of not being able to speak a full sentence. I was able to speak less words than I had about 10 min prior. Numbness in my hand went away at this time. 1:15pm- I was able to speak mostly full sentences again.  I got a pounding headache on the front to left side of my head and felt fatigues. 1:40pm- Finally able to speak full sentences again, I could feel my hand and all the parts of my face.  Felt weak, still had headache and felt nauseous and dizzy. 2:15pm- Took 1 advil, fell asleep 4:00pm- Woke up, felt weak, disoriented, still had a headache. 8:00pm- Only a small headache left and a sore arm
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report from a contactable Other HCP reported for self. This 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 via intramuscular at single dose (Lot # EH9899) for Covid 19 vaccine. None medical history and concomitant medications included. She got the first Covid 19 vaccine yesterday (20Dec2020) and got migraine one hour after on 20Dec2020. Stated that it has not gone away. Was not sure if specific course of action for headache since it did not occur until after 15 minutes. Outcome of the event was not recovered. Event assessed as serious (Other medically important condition).; Sender's Comments: The reported migraine was possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Trismus
Clinical narrative: Reporting on behalf of patient. He self reported to the Medication Safety Coordinator, that he was woken up from his sleep the night after receiving the vaccination, with his jaw moving side to side uncontrollably. This lasted for a couple seconds, would stop, and then would happen again. This occurred about 3 times total. He also felt twitching in his forehead a couple times. These episodes self resolved and did not happen again.