chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Headache; Hypertension; Face flushed; Extremely tired; Slow Motion; Slurred Speech; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscularly on 29Dec2020 08:00 at left arm at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications were not reported. Patient previously took metronidazole (FLAGYL) and experienced allergy. Patient experienced headache, hypertension, face flushed, extremely tired, slow motion, and slurred speech on 29Dec2020 09:30. Treatment was not received for these events. Outcome of the events was resolving.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Sensation of foreign body
Clinical narrative: Describes feeling 'weird".  dizzy, slightly SOB, felt large lump in back of throat- felt similar to when she has experienced an allergic reaction.  she did not report it to observers but later reported to me after arriving home and still not feeling 100% back to baseline.  she stayed in observation area for 40 minutes post vaccine.  Reports that she will consult her medical provider to decide if she should take the 2nd dose.
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Toothache
Clinical narrative: I need a root canal, I have pain; a little bit of sour stomach; This is a spontaneous report from a non-contactable Other Health Professional for herself.  A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose number 1, via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Patient asked can she now take amoxicillin a week after getting first dose? Patient received the first dose on 23Dec2020. Patient though she needs a root canal, she had pain. Patient had a little bit of sour stomach after receiving the COVID 19 vaccine. Patient heard some people got more of a dose than they should have and wound up in the hospital. Action taken in response to the events for BNT162B2 was not applicable. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on legs and arms developed 12-24 hours after vaccine administered. Lasted one day. Treated with OTC medication.; This is a spontaneous report from a contactable consumer. This consumer reported for a 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 23Dec2020 at single dose in left arm for covid-19 immunization. Medical history was not reported. Concomitant drug was Spironolactone in two weeks. It was reported that patient experienced Rash on legs and arms developed 12-24 hours after vaccine administered on 23Dec2020. Lasted one day with outcome was recovered. Treated with OTC medication. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. No Allergies to medications, food, or other products.  No follow up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Also c/o tingling in hands and feet; dizziness; This is a spontaneous report from a non-contactable other HCP. This other HCP reported for a 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) Intramuscular on 18Dec2020 at single dose in Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minutes waiting period after the injection, the patient began to experience dizziness. Also c/o tingling in hands and feet. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Treatment included water, granola bar, and rest. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Circumoral oedema, Eyelids pruritus, Nasal congestion, Pharyngitis, Swelling of eyelid
Clinical narrative: Symptoms: eyelids swelling/itching, nasal/sinus swelling, nasopharyngeal swelling, circumoral swelling-around mouth and lips, not inside mouth. Administered nasal Flonase 2 pumps each nare and 50 mg Benadryl at 2230. At 0430 next morning 12/29, swelling decreased, eyelids remained swollen and minimal swelling in nasal/sinus area. Continued Benadryl 50 mg every 6 hours x 3 doses, by 1900 on 12/29 swelling resolved
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Symptoms: eyelids swelling/itching, nasal/sinus swelling, nasopharyngeal swelling, circumoral swelling-around mouth and lips, not inside mouth. Administered nasal Flonase 2 pumps each nare and 50 mg Benadryl at 2230. At 0430 next morning 12/29, swelling decreased, eyelids remained swollen and minimal swelling in nasal/sinus area. Continued Benadryl 50 mg every 6 hours x 3 doses, by 1900 on 12/29 swelling resolved
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Paranasal sinus discomfort, Swelling of eyelid
Clinical narrative: Symptoms: eyelids swelling/itching, nasal/sinus swelling, nasopharyngeal swelling, circumoral swelling-around mouth and lips, not inside mouth. Administered nasal Flonase 2 pumps each nare and 50 mg Benadryl at 2230. At 0430 next morning 12/29, swelling decreased, eyelids remained swollen and minimal swelling in nasal/sinus area. Continued Benadryl 50 mg every 6 hours x 3 doses, by 1900 on 12/29 swelling resolved
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; This is a spontaneous report from a contactable Other Health Professional for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685) dose number 1, intramuscularly on 26Dec2020 15:30 at single dose on arm Left for COVID-19 immunization. Medical history included irritable bowel syndrome, chicken allergy and COVID-19.  Concomitant medications received within 2 weeks of vaccination included clonazepam, spironolactone and melatonin, all from unknown date for unknown indication.  Onset of symptoms began roughly 9hrs post vaccine. Lasted roughly 24 hours (28Dec2020). Body aches, low grade fever, chills, shivering, headache, nausea, stiff/sore arm. Adverse event start date: 27Dec2020 00:00. No treatment was received for the events. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was resolved on 28Dec2020.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; This is a spontaneous report from a contactable Other Health Professional for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685) dose number 1, intramuscularly on 26Dec2020 15:30 at single dose on arm Left for COVID-19 immunization. Medical history included irritable bowel syndrome, chicken allergy and COVID-19.  Concomitant medications received within 2 weeks of vaccination included clonazepam, spironolactone and melatonin, all from unknown date for unknown indication.  Onset of symptoms began roughly 9hrs post vaccine. Lasted roughly 24 hours (28Dec2020). Body aches, low grade fever, chills, shivering, headache, nausea, stiff/sore arm. Adverse event start date: 27Dec2020 00:00. No treatment was received for the events. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was resolved on 28Dec2020.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.; During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.; This is a spontaneous report from a non-contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) dose number 1, intramuscularly on an unspecified date at single dose on left arm (left deltoid muscle) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She had no history of previous hypersensitivity reactions to immunizations. During her 15 minutes waiting period after the injection, the patient began to experience dizziness, anxiety. She denied rash, hives, difficulty breathing, difficulty swallowing, throat tightness, hoarseness, itching, facial swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, vomiting and abdominal pain. Planned action included: observation, serial examination. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was unknown. Assessment by reporter: transient anxiety associated with COVID vaccine administration.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test negative, Injection site erythema, Myalgia, Pain, Pyrexia
Clinical narrative: Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was tested for covid-19, flu, and a urinalysis was performed. All tests gave negative results. Ibuprofen was recommended for symptom management.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was tested for covid-19, flu, and a urinalysis was performed. All tests gave negative results. Ibuprofen was recommended for symptom management.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Paraesthesia, Paraesthesia oral
Clinical narrative: feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on the Right side of shoulder and up into neck and ear; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; pain in right shoulder and back of neck into back of head; This is a spontaneous report from a contactable nurse for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), intramuscular on 30Dec2020 10:15 at single dose on right arm for covid-19 immunisation. Medical history included hypothyroid, migraines and sulfa allergy. Concomitant medications included propranolol, topiramate (TOPAMAX), levothyroxine, bupropion hydrochloride (WELLBUTRIN) and levocetirizine dihydrochloride (XYZAL), all from unknown date for unknown indication. At 10:30 on 30Dec2020 (also reported as "about 5 minutes after shot"), patient started feeling tingling on right side of tongue and part of inside of mouth. Felt some light tingling on the Right side of shoulder and up into neck and ear. The tingling resolved, but few hours after the shot, have pain in right shoulder and back of neck into back of head. No treatment was received for the events. Action taken in response to the event was not applicable. Outcome of feeling tingling on right side of tongue and part of inside of mouth, felt some light tingling on the Right side of shoulder and up into neck and ear was resolved. Outcome of pain in right shoulder and back of neck into back of head was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose normal, Blood magnesium normal, Differential white blood cell count normal, Dizziness
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am  and about 3 minutes later, experienced nausea, dizziness and weakness. Patient was brought to ED to be evaluated @ 07:35 am.  Ondansetron  4mg inj was given at 8:29am and NS 1000 mL was given over 2 hrs at 8:30am.  Patient felt better and tolerating oral at 09:19 am and discharged at 9:25am.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Full blood count normal, Metabolic function test normal, Nausea, Troponin I normal
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am  and about 3 minutes later, experienced nausea, dizziness and weakness. Patient was brought to ED to be evaluated @ 07:35 am.  Ondansetron  4mg inj was given at 8:29am and NS 1000 mL was given over 2 hrs at 8:30am.  Patient felt better and tolerating oral at 09:19 am and discharged at 9:25am.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Vomiting
Clinical narrative: she had a slight headache that turned into a bad headache; threw up/ vomited; Nausea; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER5730) via unspecified route on right upper arm single dose for COVID-19 immunization on 30Dec2020 before 10:30AM, at 49-year-old. Medical history and concomitant medication were not reported. On 30Dec2020, 20 minutes after getting the vaccine, the patient had a slight headache that turned into a bad headache by 11AM. Then she went to lunch at 11:30, and after she ate something, she took ibuprofen, then got back from lunch, worked an hour, and threw up. She vomited between 1 and 1:30PM, and vomited a few times and was done, but could still feel a little nausea, but was not going to go throw up. She checked her temperature but didn't have one. Action taken for BNT162B2 was not appliable. Outcome of the event headache was resolving, outcome of the event threw up/ vomited was resolved on 30Dec2020, outcome of the other event was unknown. It was reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tachycardia
Clinical narrative: Tachycardia; Tingling in the tongue; This is a spontaneous report from a Pfizer-sponsored program. A contactable female physician (patient) of unspecified age reported herself received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 21Dec2020. Medical history and concomitant medication were not reported. 2-3 hours after the vaccination (21Dec2020), the patient experienced tachycardia. She took diphenhydramine (BENADRYL) 25 IM. It went up and down before it settled down. She also had experienced tingling in the tongue on 21Dec2020. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown. It was reported as non-serious.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Fatigue, Feeling cold
Clinical narrative: 12 hours after administration of the vaccination (1 am) I awakened in the middle of the night with teeth chattering chills, I felt extremely cold (hard to warm up), my hands were numb (especially the left hand, but I got the shot in the right arm) .   I had severe muscle aches, it was hard to walk.  i felt extremely thirsty and my lips were dry.  13-14 hours after the shot.  I still felt cold but was less shaky and teeth no longer chattering.  hard to walk, felt wobbly, I was a little dizzy.  I felt like I was having muscle spasms even in my pelvic floor.  still thrirsty.    17 hours felt warm and sweaty, but not having feverish feelings. very tired  19 hours sore and very tired. 28 hours finally felt more normal and less tired.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Gait disturbance, Hyperhidrosis, Hypoaesthesia, Lip dry
Clinical narrative: 12 hours after administration of the vaccination (1 am) I awakened in the middle of the night with teeth chattering chills, I felt extremely cold (hard to warm up), my hands were numb (especially the left hand, but I got the shot in the right arm) .   I had severe muscle aches, it was hard to walk.  i felt extremely thirsty and my lips were dry.  13-14 hours after the shot.  I still felt cold but was less shaky and teeth no longer chattering.  hard to walk, felt wobbly, I was a little dizzy.  I felt like I was having muscle spasms even in my pelvic floor.  still thrirsty.    17 hours felt warm and sweaty, but not having feverish feelings. very tired  19 hours sore and very tired. 28 hours finally felt more normal and less tired.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Pain, Sleep disorder, Thirst
Clinical narrative: 12 hours after administration of the vaccination (1 am) I awakened in the middle of the night with teeth chattering chills, I felt extremely cold (hard to warm up), my hands were numb (especially the left hand, but I got the shot in the right arm) .   I had severe muscle aches, it was hard to walk.  i felt extremely thirsty and my lips were dry.  13-14 hours after the shot.  I still felt cold but was less shaky and teeth no longer chattering.  hard to walk, felt wobbly, I was a little dizzy.  I felt like I was having muscle spasms even in my pelvic floor.  still thrirsty.    17 hours felt warm and sweaty, but not having feverish feelings. very tired  19 hours sore and very tired. 28 hours finally felt more normal and less tired.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Hypertonia, Parosmia, Vaccination site pain
Clinical narrative: having a brief, weird sense of smell; she felt lightheaded; having an arm slightly sored; facial tension; anxiety; This is a spontaneous report from a contactable nurse (patient). This (age: 62; unit: unknown) female nurse reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Nurse stated receiving the COVID-19 vaccine last Monday (21Dec2020), after which she experienced immediate and random side effects. She explained having a brief, weird sense of smell, then within three minutes, she felt lightheaded which was strong for 15 minutes and went away within 30 minutes. She specified that the lightheadedness didn't feel like anxiety. She mentioned having an arm slightly sored and a facial tension which also occurred within that 30 minutes period. She added having an other symptom, but didn't specify it, saying that she wasn't certain if her symptoms were related to the vaccine or to anxiety. She expressed being reluctant to receiving the second dose of the vaccine. She then asked if her symptoms were commonly reported side effects of the COVID-19 vaccines. It was reported as non-serious. Outcome of events weird sense of smell and lightheaded was recovered, and the rest of events was unknown.   Information on lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Burning sensation, Chest discomfort, Fatigue
Clinical narrative: Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR elevated at 110bpm; Severe allergic reaction with symptoms that include/ rash all over his body including his throat, chest, and inner legs.; Right side of neck was swollen and sore; Right side of neck was swollen and sore; his neck was stiff to turn; he feels "really weak and tired"; he feels "really weak and tired"; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19. The patient's medical history and concomitant medications were not reported. Patient is a 46y/o male certified nursing assistant (CNA).  He received his first dose of Pfizer-Biontech Covid19 vaccine, yesterday 29Dec2020. On an unspecified date in Dec2020, patient experienced severe allergic reaction with symptoms that include: felt like his whole body was on fire, chest tightness, BP of 170/104, HR elevated at 110 bpm, rash all over his body including his throat, chest, and inner legs. Right side of neck was swollen and sore. Both sides are swollen, today, and his neck was stiff to turn, he feels "really weak and tired".  Patient was taken by ambulance to the emergency room.  Patient then asked if he should get the second dose of the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of severe allergic reaction with multiple symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: Heart rate increased, Hypersensitivity, Musculoskeletal stiffness, Neck pain, Rash
Clinical narrative: Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR elevated at 110bpm; Severe allergic reaction with symptoms that include/ rash all over his body including his throat, chest, and inner legs.; Right side of neck was swollen and sore; Right side of neck was swollen and sore; his neck was stiff to turn; he feels "really weak and tired"; he feels "really weak and tired"; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19. The patient's medical history and concomitant medications were not reported. Patient is a 46y/o male certified nursing assistant (CNA).  He received his first dose of Pfizer-Biontech Covid19 vaccine, yesterday 29Dec2020. On an unspecified date in Dec2020, patient experienced severe allergic reaction with symptoms that include: felt like his whole body was on fire, chest tightness, BP of 170/104, HR elevated at 110 bpm, rash all over his body including his throat, chest, and inner legs. Right side of neck was swollen and sore. Both sides are swollen, today, and his neck was stiff to turn, he feels "really weak and tired".  Patient was taken by ambulance to the emergency room.  Patient then asked if he should get the second dose of the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of severe allergic reaction with multiple symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: Swelling
Clinical narrative: Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR elevated at 110bpm; Severe allergic reaction with symptoms that include/ rash all over his body including his throat, chest, and inner legs.; Right side of neck was swollen and sore; Right side of neck was swollen and sore; his neck was stiff to turn; he feels "really weak and tired"; he feels "really weak and tired"; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19. The patient's medical history and concomitant medications were not reported. Patient is a 46y/o male certified nursing assistant (CNA).  He received his first dose of Pfizer-Biontech Covid19 vaccine, yesterday 29Dec2020. On an unspecified date in Dec2020, patient experienced severe allergic reaction with symptoms that include: felt like his whole body was on fire, chest tightness, BP of 170/104, HR elevated at 110 bpm, rash all over his body including his throat, chest, and inner legs. Right side of neck was swollen and sore. Both sides are swollen, today, and his neck was stiff to turn, he feels "really weak and tired".  Patient was taken by ambulance to the emergency room.  Patient then asked if he should get the second dose of the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of severe allergic reaction with multiple symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Nausea, Pain in extremity
Clinical narrative: 12/28 sore arm, nausea, 12/29 slight headache, fatigue  and nasal congestion, 12/31 Red pin dot rash on abdomen and large  hives  on back, headache subsided . Hydrocortisone  1% applied  to  rash and itchiness subsided within 24hr. 1/03/21 headache.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: 12/28 sore arm, nausea, 12/29 slight headache, fatigue  and nasal congestion, 12/31 Red pin dot rash on abdomen and large  hives  on back, headache subsided . Hydrocortisone  1% applied  to  rash and itchiness subsided within 24hr. 1/03/21 headache.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Hypersomnia, SARS-CoV-2 test
Clinical narrative: significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hunger, Limb discomfort, Palpitations
Clinical narrative: Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Flushing
Clinical narrative: 10 minutes post vaccination patient reported to clinic observation staff that she felt warm and flushed. Her face was red. We transported her to our on-site emergency room for evaluation.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 21Dec2020 17:30 at single dose for COVID-19 immunization. Medical history included Crohns disease, Penicillin allergy. The patient previously took nystatin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received other unspecified medications within 2 weeks of vaccination. The patient experienced general malaise 22Dec2020. On 23Dec2020, experienced fever, chills, headache, and nausea. On 24Dec2020, experienced malaise. No treatment received for the adverse events. Events outcome was recovered on Dec2020.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Malaise, Pain, SARS-CoV-2 antibody test
Clinical narrative: fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 21Dec2020 17:30 at single dose for COVID-19 immunization. Medical history included Crohns disease, Penicillin allergy. The patient previously took nystatin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received other unspecified medications within 2 weeks of vaccination. The patient experienced general malaise 22Dec2020. On 23Dec2020, experienced fever, chills, headache, and nausea. On 24Dec2020, experienced malaise. No treatment received for the adverse events. Events outcome was recovered on Dec2020.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 21Dec2020 17:30 at single dose for COVID-19 immunization. Medical history included Crohns disease, Penicillin allergy. The patient previously took nystatin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received other unspecified medications within 2 weeks of vaccination. The patient experienced general malaise 22Dec2020. On 23Dec2020, experienced fever, chills, headache, and nausea. On 24Dec2020, experienced malaise. No treatment received for the adverse events. Events outcome was recovered on Dec2020.  Information about lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Swelling
Clinical narrative: underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting her; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH5730), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunisation. There were no medical history nor concomitant medications. The consumer received the vaccine on the 28Dec2020. She doesn't have a prescribing doctor. During the night after receiving the vaccine, her body was hurting her on 28Dec2020. She started to develop side effects 4-5 hours after receiving the vaccine. The side effects started during the evening the same day she got the shot. On 29Dec2020, the side effects were worse, she had a headache, and her arm hurt a little bit more. She then realized under her armpit was swollen a little bit / underneath her armpit was a little bit swelling on 30Dec2020. She talked to someone earlier about this and they told her to call her doctor. She had a lot of headaches. Everything is hurting her. The outcome of under her armpit was swollen a little bit was not recovered, of her arm hurt a little bit more was unknown. The outcome of the other events was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Facial discomfort, Feeling abnormal, Tremor
Clinical narrative: Feeling dizzy, shakiness, and face pulsing.  States "I fell like lost control of my body." Denies nausea, shortness of breath, reash, or itching. She did have hives when she was given  a flu shot last year.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Investigation, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: tenderness/tenderness and soreness is at the injection site; soreness/body aches; muscle aches; flu like symptoms; injection site soreness; Stiff neck; This is a spontaneous report from a contactable other HCP (patient). This 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), on 29Dec2020 at single dose in the right deltoid for More protection and prevention. Medical history included blood cholesterol abnormal. The patient had the virus before. He has positive antibodies. Concomitant medication included atorvastatin, 5mg or 10mg he can not recall, Once a day, Started this about 10-15 years ago and ongoing, To control cholesterol levels. He received Covid vaccine on 29Dec2020 and was experiencing some tenderness, soreness, muscle aches, and flu like symptoms. When he says flu like symptoms, he has no fever but it is more like how a person feels when they are first starting to get the flu with the body aches and sore muscles. The tenderness and soreness is at the injection site, it was given in the right deltoid. Injection site soreness: Feels like he got punched really hard. Is not bruising. Very sensitive and tender. He has been moving his arm and getting the muscle to function. This started a couple hours after getting the shot. It was given in the right arm since he is right handed with the rationale that using his arm would help with the soreness. Achy muscles and stiff neck: Got these later on 29Dec2020. On a scale from 0-10, it would be around a 3-5. It is getting slightly better. He had this same response when he got his first flu vaccine a few years ago. The flu-like symptoms, the body aches and sore muscles, started on afternoon on 229Dec2020. The shot was administered about 10:15- 10:30am on 29Dec2020. The events are getting better, definitely not getting worse for sure. He has experienced injection site soreness and flu like symptoms: achy muscles and stiff neck, with no fever.  Weight: Between 197-198. The outcome weas recovering.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain, Weight
Clinical narrative: tenderness/tenderness and soreness is at the injection site; soreness/body aches; muscle aches; flu like symptoms; injection site soreness; Stiff neck; This is a spontaneous report from a contactable other HCP (patient). This 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), on 29Dec2020 at single dose in the right deltoid for More protection and prevention. Medical history included blood cholesterol abnormal. The patient had the virus before. He has positive antibodies. Concomitant medication included atorvastatin, 5mg or 10mg he can not recall, Once a day, Started this about 10-15 years ago and ongoing, To control cholesterol levels. He received Covid vaccine on 29Dec2020 and was experiencing some tenderness, soreness, muscle aches, and flu like symptoms. When he says flu like symptoms, he has no fever but it is more like how a person feels when they are first starting to get the flu with the body aches and sore muscles. The tenderness and soreness is at the injection site, it was given in the right deltoid. Injection site soreness: Feels like he got punched really hard. Is not bruising. Very sensitive and tender. He has been moving his arm and getting the muscle to function. This started a couple hours after getting the shot. It was given in the right arm since he is right handed with the rationale that using his arm would help with the soreness. Achy muscles and stiff neck: Got these later on 29Dec2020. On a scale from 0-10, it would be around a 3-5. It is getting slightly better. He had this same response when he got his first flu vaccine a few years ago. The flu-like symptoms, the body aches and sore muscles, started on afternoon on 229Dec2020. The shot was administered about 10:15- 10:30am on 29Dec2020. The events are getting better, definitely not getting worse for sure. He has experienced injection site soreness and flu like symptoms: achy muscles and stiff neck, with no fever.  Weight: Between 197-198. The outcome weas recovering.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Heart rate increased, Palpitations
Clinical narrative: tachycardia with mild exertion; Baseline HR elevated; dyspnea; palpitation; chest tightness; This is a spontaneous report from a contactable physician (patient). A 35-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EJ1685) via an unspecified route of administration in left arm on 29Dec2020 15:30 at single dose for COVID-19 immunization. There was no medical history, no known allergies, no allergies to medications, food, or other products. There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no any other medications the patient received within 2 weeks of vaccination. On 29Dec2020, 3 minutes following vaccine injection - dyspnea, palpitation and chest tightness; lasted 3-4 minutes. 24 hours later (30Dec2020) - dyspnea and tachycardia with mild exertion (1 flight of stairs). Baseline HR elevated. No treatment was received for the adverse events. Events outcome was recovering.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia with mild exertion; Baseline HR elevated; dyspnea; palpitation; chest tightness; This is a spontaneous report from a contactable physician (patient). A 35-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EJ1685) via an unspecified route of administration in left arm on 29Dec2020 15:30 at single dose for COVID-19 immunization. There was no medical history, no known allergies, no allergies to medications, food, or other products. There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no any other medications the patient received within 2 weeks of vaccination. On 29Dec2020, 3 minutes following vaccine injection - dyspnea, palpitation and chest tightness; lasted 3-4 minutes. 24 hours later (30Dec2020) - dyspnea and tachycardia with mild exertion (1 flight of stairs). Baseline HR elevated. No treatment was received for the adverse events. Events outcome was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Employee received COVID-19 vaccine on 12/28/20.  Reports doing well until this morning.  Woke up feeling itchy around injection site (left upper arm).  Reports area feels tender and with mild burning to touch.  Arm is sore at injection site but able to perform daily normal activities.   RN observed a red, raised, localized rash to left upper arm.  Rash extends about 10 centimeters below injection site.  Rash is localized and no other concerns at this time. RN advised to avoid touching or scratching the area.  Cold compresses and OTC cortisone cream if it gets itchy again. Instructed to monitor and report any new or worsening symptoms.  Instructed to seek immediate medical care if any hives or breathing issues develop. Patient voiced understanding and agreement with plan.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Rash erythematous, Tenderness
Clinical narrative: Employee received COVID-19 vaccine on 12/28/20.  Reports doing well until this morning.  Woke up feeling itchy around injection site (left upper arm).  Reports area feels tender and with mild burning to touch.  Arm is sore at injection site but able to perform daily normal activities.   RN observed a red, raised, localized rash to left upper arm.  Rash extends about 10 centimeters below injection site.  Rash is localized and no other concerns at this time. RN advised to avoid touching or scratching the area.  Cold compresses and OTC cortisone cream if it gets itchy again. Instructed to monitor and report any new or worsening symptoms.  Instructed to seek immediate medical care if any hives or breathing issues develop. Patient voiced understanding and agreement with plan.