chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Impaired driving ability, Tachypnoea
Clinical narrative: Light headed, mild confusion, rapid breathing difficulty driving; Light headed, mild confusion, rapid breathing difficulty driving; Light headed, mild confusion, rapid breathing difficulty driving; Light headed, mild confusion, rapid breathing difficulty driving; This is a spontaneous report from a contactable physician (patient). A 35-year-old male patient received 1st dose of bnt162b2, lot number: El0140, via an unspecified route of administration in the left arm on 19Dec2020 16:30 at a single dose for COVID-19 immunization at the hospital. There were no medical history. The patient has no known allergies. The patient has no concomitant medications reported. The patient experienced light headed, mild confusion, rapid breathing and difficulty driving on 19Dec2020, started 5-10 minutes after injection that lasted approximately an hour. Outcome of the events was recovered in Dec2020; no treatment was given for the events. The events was reported as non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Blood pressure increased, Headache, Restlessness
Clinical narrative: blood pressure was super elevated, in the 190/110 range; It was getting close to stroke level; woke up and felt restlessness and agitation; Headache; felt really restless and anxious; felt really restless and anxious; was not able to sleep/ could not go back to sleep; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730, expiration date: Mar2021 intramuscularly in left deltoid from 17Dec2020 at single dose for COVID-19 immunization. Patient medical history included seasonal allergy. Concomitant medication included mometasone furoate (FLONASE) via nasal from 2018 (about 2 years ago) and ongoing at 1 spray each nostril, 1x/day for seasonal allergy. The patient previously received flu shot, on Oct2020 (2 months ago) for immunization. Patient was a firefighter and reported that he received the vaccination in the afternoon of 17Dec2020. On that afternoon, he was on duty and felt really restless and anxious and was not able to sleep. He did not sleep at all that night. He maybe got like an hour or 2 on Friday after his shift. Friday night he had the same kind of deal and it continued on into Saturday. He did crash and burn (pending clarification) on Saturday night. On Sunday, he got up and felt normal again. A few hours later on Sunday, it started up again and then it went away. He said that after dinner Sunday evening it started up again, but he was able to get some sleep. He said that Yesterday, 21Dec2020, he was fine. He took off yesterday. This morning on 22Dec2020 at 0200 he woke up and felt restlessness and agitation and he could not go back to sleep. He said that he had a headache and his blood pressure was super elevated, in the 190/110 range on 22Dec2020. It was getting close to stroke level. He said that he thought about going to the ER, but did not experience any stroke or cardiac symptom's, although his blood pressure is still high, but not as high as it was. He has not gotten any sleep since then. He said that he has an appointment to see his physician this afternoon at 1300 22Dec2020. It was reported that all events require physician office visit. Got his flu shot like 2 months ago and nothing like this happened. He said that he heard with the second round there are supposed to me more symptoms like flu like symptoms with the Covid vaccine like fever, muscle aches. Outcome of the events was reported as unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: blood pressure was super elevated, in the 190/110 range; It was getting close to stroke level; woke up and felt restlessness and agitation; Headache; felt really restless and anxious; felt really restless and anxious; was not able to sleep/ could not go back to sleep; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730, expiration date: Mar2021 intramuscularly in left deltoid from 17Dec2020 at single dose for COVID-19 immunization. Patient medical history included seasonal allergy. Concomitant medication included mometasone furoate (FLONASE) via nasal from 2018 (about 2 years ago) and ongoing at 1 spray each nostril, 1x/day for seasonal allergy. The patient previously received flu shot, on Oct2020 (2 months ago) for immunization. Patient was a firefighter and reported that he received the vaccination in the afternoon of 17Dec2020. On that afternoon, he was on duty and felt really restless and anxious and was not able to sleep. He did not sleep at all that night. He maybe got like an hour or 2 on Friday after his shift. Friday night he had the same kind of deal and it continued on into Saturday. He did crash and burn (pending clarification) on Saturday night. On Sunday, he got up and felt normal again. A few hours later on Sunday, it started up again and then it went away. He said that after dinner Sunday evening it started up again, but he was able to get some sleep. He said that Yesterday, 21Dec2020, he was fine. He took off yesterday. This morning on 22Dec2020 at 0200 he woke up and felt restlessness and agitation and he could not go back to sleep. He said that he had a headache and his blood pressure was super elevated, in the 190/110 range on 22Dec2020. It was getting close to stroke level. He said that he thought about going to the ER, but did not experience any stroke or cardiac symptom's, although his blood pressure is still high, but not as high as it was. He has not gotten any sleep since then. He said that he has an appointment to see his physician this afternoon at 1300 22Dec2020. It was reported that all events require physician office visit. Got his flu shot like 2 months ago and nothing like this happened. He said that he heard with the second round there are supposed to me more symptoms like flu like symptoms with the Covid vaccine like fever, muscle aches. Outcome of the events was reported as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: chills; fever; did not feel good; pain at injection site; This is spontaneous report from a contactable nurse (patient). A female patient (Age: 56; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 15:00 single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, did not feel good, pain at injection site, all in Dec2020, chills on an unspecified date. The patient was worried she had gotten COVID again after her first dose of COVID vaccine. Would like to know if fever was one of the reported side effects. Received vaccine at 3:00 pm, fever. Took paracetamol (TYLENOL) this morning because temperature was 101. This afternoon she did not feel good, laid down, did not check her temperature. Checked again at 103.9 on second time. Also reported that she had 'pain at injection site and chills. No nausea.' Second dose scheduled for January. Caller was worried she might infect her husband, who was a health risk and diabetic because she was feeling feverish. Wondering if she could sleep in same room as her husband or if she will infect him. The outcome of events was unknown. The events were reported as non-serious.   Information on lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Psoriasis, Rash
Clinical narrative: rash at edge of her face, edge of eyebrow all the way down to her cheek area; Psoriasis; itch at base of her neck/she had an itch at the base of her neck palm size on both sides; This is a spontaneous report from a contactable nurse. A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had a COVID-19 vaccine on Saturday morning and on Sunday (20Dec2020), she had an itch at the base of her neck palm size on both sides. Stated that the rash was on edge of her face, edge of eyebrow all way down to her cheek area. The patient took Benadryl but stated that it still bothered her. She was not sure if it was from the injection or not. Also stated that she did have psoriasis and had treatment for it. Stated that she was okay. She wanted to know if the rash was from the COVID vaccine. Stated that it was her first dose and if she had any other issues than she will call back. Outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Feeling abnormal, Flushing, Hypersensitivity
Clinical narrative: having an allergic reaction to the first dose; severe dry mouth; flushing in face/ felt flushed on neck and both of her arms; felt a little foggy; face felt tingly; numbness sensation in entire face; Slight swelling on the back of her throat; very tired; This is spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age (Age: 51, Units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Vaccine received the 14Dec2020. She experienced, 10 minutes after her shot, 'severe dry mouth, flushing in face, was talking extra fast'. Thought she was fine. Waited the proper amount of observation time. 'felt a little foggy'. Drove home. While driving her 'face felt tingly, numbness sensation in entire face, felt flushed on neck and both of her arms. More noticeable on right side and more mild on left side. Slight swelling on the back of her throat. Was taken in for monitoring, vitals were normal. Became very tired. Was given diphenhydramine hydrochloride (BENADRYL), and within 20-30 mins was totally fine. Did not have trouble breathing'. Caller wanted to hear from us on whether or not she should get the second dose of the COVID vaccine after having an allergic reaction to the first dose. The patient underwent lab tests and procedures which included laboratory test: vitals were normal on 14Dec2020. The outcome of events was resolved on 14Dec2020. The events were reported as non-serious.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test, Paraesthesia, Pharyngeal swelling, Speech disorder
Clinical narrative: having an allergic reaction to the first dose; severe dry mouth; flushing in face/ felt flushed on neck and both of her arms; felt a little foggy; face felt tingly; numbness sensation in entire face; Slight swelling on the back of her throat; very tired; This is spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age (Age: 51, Units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Vaccine received the 14Dec2020. She experienced, 10 minutes after her shot, 'severe dry mouth, flushing in face, was talking extra fast'. Thought she was fine. Waited the proper amount of observation time. 'felt a little foggy'. Drove home. While driving her 'face felt tingly, numbness sensation in entire face, felt flushed on neck and both of her arms. More noticeable on right side and more mild on left side. Slight swelling on the back of her throat. Was taken in for monitoring, vitals were normal. Became very tired. Was given diphenhydramine hydrochloride (BENADRYL), and within 20-30 mins was totally fine. Did not have trouble breathing'. Caller wanted to hear from us on whether or not she should get the second dose of the COVID vaccine after having an allergic reaction to the first dose. The patient underwent lab tests and procedures which included laboratory test: vitals were normal on 14Dec2020. The outcome of events was resolved on 14Dec2020. The events were reported as non-serious.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tachycardia
Clinical narrative: Tachycardia; This is a spontaneous report from a contactable nurse. A 22-year-old female patient received first dose bnt162b2 (BNT162B2 also reported as COVID-19 Vaccine by Pfizer, lot EL0140, expiry date: 31Mar2021, NDC:59267-1000-2), intramuscularly in the right deltoid on 21Dec2020 09:25 at 0.3 mL singe, for Covid-19 immunisation in a hospital. The patient's medical history was not reported.  Concomitant medication included influenza vaccine inact split 3v (FLUARIX, Lot number: 3E32Z) given last 10Dec2020. The patient experienced tachycardia on 21Dec2020 09:26. The outcome of event was recovered on 21Dec2020.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: Diarrhea; nauseated; fever over 101; body aches; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot Number: EL0140, Expire Date: 31Mar2021, via intramuscular route of administration at the right deltoid, from 18Dec2020 14:26 at 0.3 mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 18Dec2020 and then two days later, within 48 hours (20Dec2020), she had fever over 101 (unit not reported), body aches, and GI symptoms. For the GI symptoms, she further stated being nauseated and having diarrhea. She stated she was still nauseated yesterday. The outcome of fever, body aches and diarrhea was recovered on 21Dec2020 whereas she recovered from being nauseated on 22Dec2020. The events did not required visit to ER or physician.  Follow-up attempts are completed. The information on the batch/lot number was obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Eye pain, Eye pruritus, Eye swelling, Eyelid rash
Clinical narrative: discomfort in the throat; face and eyes became swollen and itchy; face and eyes became swollen and itchy; face and eyes became swollen and itchy; face and eyes became swollen and itchy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Neck started to feel itchy.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscular in left arm on 21Dec2020 07:45 AM at a single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient has no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. On 21Dec2020 08:00 AM, the patient experienced a discomfort in the throat, then face and eyes became swollen and itchy. Face and eyes felt hot and was painful to touch as well as rashy. Next morning, face and eyes remain swollen but not painful to touch. Neck started to feel itchy. The events were reported as non-serious. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of  the events which included BENADRYL. The outcome of the events at the time of last observation was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Oropharyngeal discomfort, Pruritus, Rash, Swelling face
Clinical narrative: discomfort in the throat; face and eyes became swollen and itchy; face and eyes became swollen and itchy; face and eyes became swollen and itchy; face and eyes became swollen and itchy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Neck started to feel itchy.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscular in left arm on 21Dec2020 07:45 AM at a single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient has no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. On 21Dec2020 08:00 AM, the patient experienced a discomfort in the throat, then face and eyes became swollen and itchy. Face and eyes felt hot and was painful to touch as well as rashy. Next morning, face and eyes remain swollen but not painful to touch. Neck started to feel itchy. The events were reported as non-serious. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of  the events which included BENADRYL. The outcome of the events at the time of last observation was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: discomfort in the throat; face and eyes became swollen and itchy; face and eyes became swollen and itchy; face and eyes became swollen and itchy; face and eyes became swollen and itchy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Neck started to feel itchy.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscular in left arm on 21Dec2020 07:45 AM at a single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient has no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. On 21Dec2020 08:00 AM, the patient experienced a discomfort in the throat, then face and eyes became swollen and itchy. Face and eyes felt hot and was painful to touch as well as rashy. Next morning, face and eyes remain swollen but not painful to touch. Neck started to feel itchy. The events were reported as non-serious. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of  the events which included BENADRYL. The outcome of the events at the time of last observation was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Foreign body sensation in eyes, Visual impairment
Clinical narrative: Left eye visual disturbance; Feeling of film debris and or feeling of lag in eye movement; This is a spontaneous report from a contactable nurse (patient) and a contactable other health professional.  A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 19Dec2020 at 9:15 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included escitalopram oxalate (LEXAPRO) at 10 mg daily. On 22Dec2020 at 13:00, the patient experienced left eye visual disturbance, feeling of film debris and/or feeling of lag in eye movement. The patient outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body ache; low grade fever; This follow-up case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 26Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable other hcp (patient). A 36-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: J1685), via an unspecified route of administration in the left arm on 22Dec2020 13:15 at a single dose for COVID-19 immunization at the hospital. The patient has no medical history. The patient was not diagnosed with COVID-19 prior vaccination and has not been tested for COVID-19 post vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020, the patient had body ache and low grade fever that began 2 - 3 days after vaccination. Outcome of the events was not recovered. The events were assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain, potentially diarrhea (may be related to antibiotics); Injection site pain, potentially diarrhea (may be related to antibiotics); This is a spontaneous report from a contactable Physician.  A 35-years-old female patient received first dose BNT162B2( lot number EJ1685) via an unspecified route of administration at Arm Left on 22Dec2020 15:30 at the 35 years old at single dose for COVID-19 immunization. The medical history included Migraines, COVID-19 not ongoing and Allergies to medications, food, or other products. The concomitant medication was amoxicillin, clavulanic acid(AUGMENTINE). On 23Dec2020 06:00 the patient experienced Injection site pain, potentially diarrhea (may be related to antibiotics). There was no treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: fatigue; runny nose; headache; I have a sore throat; fever/mild fever; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (batch/lot number and expiration date not provided), via an unspecified route of administration, on 16Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had  fever on the day she got the vaccine on 16Dec2020. The patient no longer had fever. The patient worked with high risk patient, since this morning on 23Dec2020 the patient had a sore throat. The patient wondered should she be worried because it's a covid symptoms. It's been a week she got the vaccine. It's mentioned fatigue, headache, runny nose and mild fever as some of some of the symptoms the reporter experienced. The outcome of the event" fever/mild fever" was recovered and of the other events was unknown.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Chills, Decreased appetite
Clinical narrative: Chills and sweats; Chills and sweats; No appetite, just feeling sick in general; No appetite, just feeling sick in general; Her pain has radiated to the wrist, pelvis, knees, ankles, and back; Her pain has radiated to the wrist, pelvis, knees, ankles, and back; Her pain has radiated to the wrist, pelvis, knees, ankles, and back; Joints and bones pain; Joints and bones pain; Pain in the opposite arm also, like if she also received vaccine on that arm; Her arm is swollen; pain in her right arm and pain in her clavicle; pain in her right arm and pain in her clavicle; This is a spontaneous report from a contactable nurse reporting for herself. A 55-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-Biontech), via an unspecified route of administration in the deltoid right, on 21Dec2020 at 04:30 PM, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced chills and sweats on 21Dec2020 with outcome of recovering, no appetite, just feeling sick in general on 21Dec2020 with outcome of recovering, her pain has radiated to the wrist, pelvis, knees, ankles, and back on 21Dec2020 with outcome of recovering, joints and bones pain on 21Dec2020 with outcome of unknown, pain in the opposite arm also, like if she also received vaccine on that arm on 21Dec2020 with outcome of not recovered, her arm is swollen on 21Dec2020 with outcome of unknown, pain in her right arm and pain in her clavicle on 21Dec2020 with outcome of not recovered. The patient reported that she had pain in her right arm and pain in her clavicle. She also had pain in the opposite arm, as if she had gotten it administered there. The pain radiated to the wrist, pelvis, and ankles. She developed chills and sweats. She has no appetite and in general is feeling sick. Her arm is quite swollen. Her pain has radiated to the wrist, pelvis, knees, ankles, and back. It is very painful. The pain is in her joints and bones. Pain in the right arm was constant. She can feel it all the time. Pain in her left arm was intermittent. If she moves it she can feel soreness. Therapeutic measures were taken as a result of the events and included treatment with 1000 mg of Tylenol and 250 mg of ibuprofen and a cold shower. The events were considered non serious. Relatedness of drug to reaction/event, source of assessment primary source reporter: pain in right arm, related (Global Introspection method); pain in clavicle, related (Global Introspection method); pain in left arm, related (Global Introspection method); her pain has radiated to the wrist, pelvis, knees, ankles, and back, related (Global Introspection method); chills and sweats, related (Global Introspection method); no appetite and in general feeling sick, related (Global Introspection method).  The information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Pain, Pain in extremity, Pelvic pain
Clinical narrative: Chills and sweats; Chills and sweats; No appetite, just feeling sick in general; No appetite, just feeling sick in general; Her pain has radiated to the wrist, pelvis, knees, ankles, and back; Her pain has radiated to the wrist, pelvis, knees, ankles, and back; Her pain has radiated to the wrist, pelvis, knees, ankles, and back; Joints and bones pain; Joints and bones pain; Pain in the opposite arm also, like if she also received vaccine on that arm; Her arm is swollen; pain in her right arm and pain in her clavicle; pain in her right arm and pain in her clavicle; This is a spontaneous report from a contactable nurse reporting for herself. A 55-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-Biontech), via an unspecified route of administration in the deltoid right, on 21Dec2020 at 04:30 PM, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced chills and sweats on 21Dec2020 with outcome of recovering, no appetite, just feeling sick in general on 21Dec2020 with outcome of recovering, her pain has radiated to the wrist, pelvis, knees, ankles, and back on 21Dec2020 with outcome of recovering, joints and bones pain on 21Dec2020 with outcome of unknown, pain in the opposite arm also, like if she also received vaccine on that arm on 21Dec2020 with outcome of not recovered, her arm is swollen on 21Dec2020 with outcome of unknown, pain in her right arm and pain in her clavicle on 21Dec2020 with outcome of not recovered. The patient reported that she had pain in her right arm and pain in her clavicle. She also had pain in the opposite arm, as if she had gotten it administered there. The pain radiated to the wrist, pelvis, and ankles. She developed chills and sweats. She has no appetite and in general is feeling sick. Her arm is quite swollen. Her pain has radiated to the wrist, pelvis, knees, ankles, and back. It is very painful. The pain is in her joints and bones. Pain in the right arm was constant. She can feel it all the time. Pain in her left arm was intermittent. If she moves it she can feel soreness. Therapeutic measures were taken as a result of the events and included treatment with 1000 mg of Tylenol and 250 mg of ibuprofen and a cold shower. The events were considered non serious. Relatedness of drug to reaction/event, source of assessment primary source reporter: pain in right arm, related (Global Introspection method); pain in clavicle, related (Global Introspection method); pain in left arm, related (Global Introspection method); her pain has radiated to the wrist, pelvis, knees, ankles, and back, related (Global Introspection method); chills and sweats, related (Global Introspection method); no appetite and in general feeling sick, related (Global Introspection method).  The information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Radicular pain
Clinical narrative: Chills and sweats; Chills and sweats; No appetite, just feeling sick in general; No appetite, just feeling sick in general; Her pain has radiated to the wrist, pelvis, knees, ankles, and back; Her pain has radiated to the wrist, pelvis, knees, ankles, and back; Her pain has radiated to the wrist, pelvis, knees, ankles, and back; Joints and bones pain; Joints and bones pain; Pain in the opposite arm also, like if she also received vaccine on that arm; Her arm is swollen; pain in her right arm and pain in her clavicle; pain in her right arm and pain in her clavicle; This is a spontaneous report from a contactable nurse reporting for herself. A 55-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-Biontech), via an unspecified route of administration in the deltoid right, on 21Dec2020 at 04:30 PM, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced chills and sweats on 21Dec2020 with outcome of recovering, no appetite, just feeling sick in general on 21Dec2020 with outcome of recovering, her pain has radiated to the wrist, pelvis, knees, ankles, and back on 21Dec2020 with outcome of recovering, joints and bones pain on 21Dec2020 with outcome of unknown, pain in the opposite arm also, like if she also received vaccine on that arm on 21Dec2020 with outcome of not recovered, her arm is swollen on 21Dec2020 with outcome of unknown, pain in her right arm and pain in her clavicle on 21Dec2020 with outcome of not recovered. The patient reported that she had pain in her right arm and pain in her clavicle. She also had pain in the opposite arm, as if she had gotten it administered there. The pain radiated to the wrist, pelvis, and ankles. She developed chills and sweats. She has no appetite and in general is feeling sick. Her arm is quite swollen. Her pain has radiated to the wrist, pelvis, knees, ankles, and back. It is very painful. The pain is in her joints and bones. Pain in the right arm was constant. She can feel it all the time. Pain in her left arm was intermittent. If she moves it she can feel soreness. Therapeutic measures were taken as a result of the events and included treatment with 1000 mg of Tylenol and 250 mg of ibuprofen and a cold shower. The events were considered non serious. Relatedness of drug to reaction/event, source of assessment primary source reporter: pain in right arm, related (Global Introspection method); pain in clavicle, related (Global Introspection method); pain in left arm, related (Global Introspection method); her pain has radiated to the wrist, pelvis, knees, ankles, and back, related (Global Introspection method); chills and sweats, related (Global Introspection method); no appetite and in general feeling sick, related (Global Introspection method).  The information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: Severe soreness in arm where shot was administered.; Severe chills; mild body aches for 24 hours after shot was administered; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration (left arm) on 21Dec2020 16:30 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included multivitamin (unspecified) daily and thyroid medication (25 mcg). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 (20:00), the patient experienced severe soreness in arm where shot was administered, severe chills, and mild body aches for 24 hours after shot was administered. There was no treatment received for the adverse event. The outcome of events was recovered on an unspecified date in Dec2020. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  No follow-up attempts are possible; information about lot/batch number has been obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Ocular discomfort, Oropharyngeal pain, Pruritus, Throat tightness
Clinical narrative: Itchy face that lasted 2 mins; tightness in the throat lasted about 2 minutes; complete facial numbness; pressure behind right eye.; sore throat possibly swollen lymph nodes; sore throat possibly swollen lymph nodes; This is a spontaneous report from a contactable other health professional (patient). A 35-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), intramuscularly on 22Dec2020 13:00 at single dose on left arm for COVID-19 immunization in hospital. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient known allergy included hydrocodone. The patient experienced itchy face that lasted 2 mins followed by tightness in the throat lasted about 2 minutes, 10 minutes of no other reactions then complete facial numbness and pressure behind right eye, slight pressure still and sore throat possibly swollen lymph nodes. Adverse event started from 22Dec2020 13:30. No treatment received for the adverse events. The outcome of events itchy face and tightness in the throat was recovered on 22Dec2020, of the other events was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age (reported as 62 without unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter requested information on the administration of the second dose of the COVID-19 vaccine to a patient. The patient received vaccine first dose 16Dec2020; she was diagnosed with COVID-19 on 18Dec2020; started taking the medication "Bamlanivimab" on 21Dec2020. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that reported "diagnosis with COVID-19" is related to BNT162B2 vaccine.  Event developed 2 days after vaccination.  The event is most likely intercurrent medical condition.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: lower back pain /mild pain/excruciating LBP; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 08:00 at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had very unusual lower back pain that started the day after she received the vaccine and persisted over 5 days. The patient received the vaccine the beginning of her 12 hours shift. The following day on 19Dec2020 7:00 AM she woke up with excruciating LBP. Initially she attributed it to some garden work done the day before her shift and assumed it would resolve in 24 hours. 5 days later she still had mild pain, which was a first for she to have it persist this long. She had no other symptoms. She had never been tested for Covid. She wore N95 and face shield with every ER patient encounter and N95 in work area. She had no history of back problems or injury. She was only reporting this as the timing of, severity of, and duration of this muscle pain she was experiencing is perplexing and she was wondering if it has any relation to the vaccine. She thought perhaps her unusual pain symptoms were vaccine unrelated, but she had a degree of apprehension about the second dose of the vaccine. The patient received treatment Tylenol, Motrin, Robaxin for all events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no any other medications that the patient received within 2 weeks of vaccination. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: was tested positive in the rapid test; This is a spontaneous report from contactable physicians. A patient of unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), an unspecified route of administration on an unspecified date at single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was tested positive in the rapid test on an unspecified date with outcome of unknown. The physician appreciate knowing that the COVID-19 vaccine could not create false positives. The physician asked if the vaccine cause the positive result? The physician didn't think it was likely.  The information on the batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: but it was like a tingling sensation that won't go away on her whole left arm down to her fingers; it was like a tingling sensation that won't go away on her whole left arm down to her fingers; This is a spontaneous report from a contactable consumer(patient). A 36-year-old female patient received BNT162B2 via Intramuscular at Arm Left on 22Dec2020 18:00 at the 36-year-old at single dose for Preventative. The medical history included known allergies to Penicillin. There were no concomitant medications. The patient received her Covid19 vaccine last night 6pm. She was fine for the 15min they had her wait. About 30 minutes after on 22Dec2020 18:30 she left the facility her arm became not numb, but it was like a tingling sensation that won't go away on her whole left arm down to her fingers. She is asking what she should do. There was no treatment received. The outcome of the events was not recovered.  Information on batch/Lot number has been requested
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheaded and dizzy; This is a spontaneous report from a contactable other HCP (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 17Dec2020 03:15 pm at single dose for COVID-19 immunization. Vaccine location was left arm and it was the first dose. None medical history. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced lightheaded and dizzy at 17Dec2020 12:00 pm with outcome of recovered with sequelae. The adverse event (AE) resulted in emergency room/department or urgent care. The event was reported as non-serious. The action taken in response to the event for bnt162b2 was not applicable.  Information on lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site pain, Pain in extremity, Pregnancy test positive
Clinical narrative: Caller received the COVID vaccine on the 18Dec and on the 20th she found out she was pregnant; Caller received the COVID vaccine on the 18Dec and on the 20th she found out she was pregnant; Caller received the COVID vaccine on the 18Dec and on the 20th she found out she was pregnant; Mild arm pain on left side; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female pregnant patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 16:24 at single dose, injected in left arm for covid-19 immunization. Additional vaccines administered on same date of the Pfizer suspect reported as none. Her dad had high blood pressure. Number of previous pregnancies was 1. Previous pregnancy was a chemical pregnancy that she found out on 29Jun2020. She had a miscarriage on 01Jul2020. At that time, her doctor told her it was a chemical pregnancy. The patient's other medical history reported as none. Concomitant medications included prenatals(unspecified). The patient received the covid vaccine on the 18Dec2020, and on the 20Dec2020 she found out she was pregnant. She first got pregnancy test on 20Dec2020, and retested at home on 21Dec2020. The second dose was due to be given on 08Jan2021, but received paperwork to register with Vsafe. She registered but was not pregnant at the time she registered. She had been giving text messages that she had been doing well. It did not talk about if you were pregnant or not after the first time. She had been taking prenatals for a year. Pregnant time reported as 20Dec2020 at 9:30-10 pm. First day of last menstrual period was 19Nov2020. Estimated date of Conception: Seemed like she ovulated on 15th and 16th of the month, so it would be after that. She was in her first trimester. The patient had arm pain an hour or two after injection. It was mild, then went a little higher and then she woke up with no pain. No emergency room or physician's office required. She had pain at the injection site for a few hours, like 6-7 hours, which was mild. She had had worse injection pain besides that such as the Flu Vaccine. They gave a pain that would stay for a day or 2. She would have to take ibuprofen or acetaminophen, but she did not require that with this one. It did not hamper her daily work. She did not have a lot or expiration for the previous flu vaccines that caused arm pain. Prior vaccinations (within 4 weeks) reported as none. Flu vaccine was before November. AE following prior vaccinations(Flu vaccine) was arm pain. The outcome of the event "Mild arm pain on left side" was recovering.   Information on the Lot/Batch number has been requested.   Follow-up (23Dec2020): New information received from a contactable consumer included patient's details(age, height, weight, last menstrual period), medical history, lab data, dosage regimen details of suspect vaccine, concomitant drug details, new event(Mild arm pain on left side).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, SARS-CoV-2 test negative
Clinical narrative: Mild swelling and soreness at injection site; Mild swelling and soreness at injection site; This is a spontaneous report from a contactable other hcp (patient). A 45-year-old female patient received bnt162b2 (Lot EJ1685), intramuscularly at arm left, first dose on 21Dec2020 16:00, at single dose for COVID-19 immunization. Medical history included diabetes, hypertension, fibromyalgia, morbid obesity and obstructive sleep apnea from an unknown date. Not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced mild swelling and soreness at injection site on 21Dec2020 21:00. The events were reported as non-serious. No treatment received. No covid prior vaccination. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination included nasal swab on 21Dec2020. Covid test result is negative. The outcome of the event was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Palpitations
Clinical narrative: D-dimer was positive; Racing heart rate/Rapid heart rate; palpitations; This is a spontaneous report from a non-contactable other health professional. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration on 23Dec2020 on right deltoid muscle at single dose for COVID-19 immunization. Medical history included episode of chest pain 6 weeks before unspecified date and was seen in ER. The patient's denied any history of previous adverse reactions to vaccines. The patient's concomitant medications were not reported. During her 15 minutes waiting period after the injection on 23Dec2020, the patient began to experience racing heart rate. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Patient presented with rapid heart rate and palpitations. Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing. Lab test included D-dimer was positive and CT negative. No FU since. The outcome of  the events was unknown.  No follow-up attempts are possible. No further information is expected.