chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache; shivers; coldness; body aches; mouth hurts; feel very weak; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported for self that the female patient of unknown age received bnt162b2 (BNT162B2, reported as PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. She had a COVID vaccine shot on Friday, on 18Dec2020, now she is experiencing a headache. She would like to know if headache is normal or if she should go to a doctor. Upon callback, consumer states she received the Covid19 vaccine on Friday 18Dec2020, and is experiencing "shivers, coldness, body aches, headache, mouth hurts, I feel very weak". Consumer wants to know if these things are normal, and if she needs the second dose. She wants to "make sure she's not dying". "Can I use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine?" Response: The interim ACIP guidelines note that, " Antipyretic or analgesic medications (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time.& quot; If you are a patient, you should discuss this with your healthcare provider. The outcome of the events was unknown.   Information about Batch/Lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Arm is getting redder today and sore. Was not red or sore yesterday after the injection.; Arm is getting redder today and sore. Was not red or sore yesterday after the injection.; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 59-year-old female patient received first dose of bnt162b2 (BNT162B2), via unspecified route of administration on Left arm on 20Dec2020 07:45 AM at single dose for covid-19 immunisation. She is not pregnant at the time of vaccination. Medical history included known allergies to medications, food, or other products: PCN, cedar, mold and Hashimotos disease. Concomitant medications included other medications the patient received within 2 weeks of vaccination:ibuprofen (ADVIL [IBUPROFEN]), Levothyroxine and ergocalciferol (VIT D). Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Arm is getting redder today and sore. Was not red or sore yesterday after the injection from 20Dec2020 07:45 AM. The outcome of the event was not recovered. No treatment received. No Covid prior vaccination.  Covid tested post vaccination. Covid test type post vaccination was Nasal Swab on 15Dec2020 with result of Negative. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Vaccine Facility information available.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Pain, Vertigo
Clinical narrative: I was achy and tired; I was achy and tired; I was really, severely dizzy, like vertigo.  My head was swimming; I was really, severely dizzy, like vertigo.  My head was swimming; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 56-year-old female patient received bnt162b2 (BNT162B2, reported as Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EJ1685, Expiry Date of COVID Vaccine: Mar2021), via unspecified route of administration on 18Dec2020 12:30 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) Injections. She is a respiratory therapist. She states she got the vaccine on 12:30 PM on Friday. She states that Friday night by 09:30 pm was really bad. Her head was swimming. She said by Saturday she was achy, tired. Also, on Friday night she was severely dizzy and felt like she has vertigo. She is better now." Consumer stated, "It was just a shot." Th outcome of the events was recovering. Treatment was received and consumer stated, "The only thing I took was 800 mg Ibuprofen Friday evening." Consumer further added, "I was, just like in chart second vaccination I guess I am okay to take it. I talked to my doctor." Consumer stated "I got the covid vaccine on Friday and it was a bad night.  I was really, severely dizzy, like vertigo.  My head was swimming.  I got the shot at 12:30 that day, but the symptoms didn't start until 9:30 that night.  On Saturday I was achy and tired. But I'm better now."  Consumer questioned if dizziness was a reported side effect.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hyperhidrosis, Impaired work ability, Myalgia, Nausea
Clinical narrative: felt more like a burning especially in my neck; Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea; Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea; Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea; muscle pain that started in my neck, shoulder and then moved on to both legs; felt weak and had to go home; pain in my neck; leg pain; arm pain; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 50-year-old female patient received first dose of bnt162b2 (BNT162B2, reported as PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via Intramuscular on left arm on 18Dec2020 03:15 PM at single dose for covid-19 immunisation. She is not Pregnant at the time of vaccination. Medical history included Known allergies to medications, food, or other products: Dust mites, nickel and recent iron deficiency anemia, esophageal ulceration, reactive airway disease. Concomitant medications included other medications the patient received within 2 weeks of vaccination included Omeprazole 40 mg BID (Twice a day), colecalciferol (VITAMIN D [COLECALCIFEROL]) and Albuterol. Facility type vaccine was Hospital. No other vaccine in four weeks. No other vaccine in two weeks. The patient experienced "Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea and muscle pain that started in my neck, shoulder and then moved on to both legs. I felt weak and had to go home. The muscle pain was not like exercise pain - it felt more like a burning especially in my neck. The pain in my neck got better after Tylenol , the leg pain continued until 10 pm. The nausea was severe until 7:30 and was gone by 10 pm. I had to leave work 2 hours early because of side effects. The arm pain continued for two days, locally, minor and was gone on day three (21Dec2020)". The event started from 18Dec2020 03:30 PM. The outcome of the events was recovered. No treatment received. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: felt more like a burning especially in my neck; Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea; Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea; Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea; muscle pain that started in my neck, shoulder and then moved on to both legs; felt weak and had to go home; pain in my neck; leg pain; arm pain; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 50-year-old female patient received first dose of bnt162b2 (BNT162B2, reported as PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via Intramuscular on left arm on 18Dec2020 03:15 PM at single dose for covid-19 immunisation. She is not Pregnant at the time of vaccination. Medical history included Known allergies to medications, food, or other products: Dust mites, nickel and recent iron deficiency anemia, esophageal ulceration, reactive airway disease. Concomitant medications included other medications the patient received within 2 weeks of vaccination included Omeprazole 40 mg BID (Twice a day), colecalciferol (VITAMIN D [COLECALCIFEROL]) and Albuterol. Facility type vaccine was Hospital. No other vaccine in four weeks. No other vaccine in two weeks. The patient experienced "Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea and muscle pain that started in my neck, shoulder and then moved on to both legs. I felt weak and had to go home. The muscle pain was not like exercise pain - it felt more like a burning especially in my neck. The pain in my neck got better after Tylenol , the leg pain continued until 10 pm. The nausea was severe until 7:30 and was gone by 10 pm. I had to leave work 2 hours early because of side effects. The arm pain continued for two days, locally, minor and was gone on day three (21Dec2020)". The event started from 18Dec2020 03:30 PM. The outcome of the events was recovered. No treatment received. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypoaesthesia
Clinical narrative: left arm started to feel numb first, and then she started to feel it in her face/numbness on the side of her face; worried; This is spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient was having a side effect after taking the COVID vaccine today (21Dec2020). The patient experienced numbness on the side of her face on 21Dec2020. The patient added that she had to wait for 15 minutes and didn't have anything. The patient when driving on the way home, she started to feel numbness on her face. The patient clarified within 20 minutes of receiving the vaccine her left arm started to feel numb first, and then she started to feel it in her face. The patient has been trying to exercise it and move it because she was worried it would become weak. The patient was unsure what to do or if this is expected. The patient, while providing contact information she stated she was really worried (21Dec2020), and she can't finish the report at this time. The full report details were unable to be obtained. The outcome of the events was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: moderate myalgia; This is a spontaneous report from a non-contactable consumer.  A 30-year-old female patient (daughter of a friend) received bnt162b2 ((Pfizer-BioNTech COVID-19 mRNA vaccine) lot number and expiration date were not reported, via an unspecified route of administration on 17Dec2020 at a single dose for COVID vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced moderate myalgia following her COVID vaccination last Thursday on 17Dec2020 with outcome of recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; I have fever 100.3; Injection site is swelling; injection site have redness; feeling unwell; This is a spontaneous report from a contactable Nurse (patient). The patient received first dose of bnt162b2 (BNT162B2, lot number: EH9899, Expiry Date: Mar2021), unknown on 19Dec2020 18:00 at single dose for covid-19 immunisation. Medical history was reported as Patient History: No. There were no concomitant medications. Nurse stated, "I have received the vaccine, the Pfizer COVID vaccine yesterday at 06:00 PM. I have side effects is injection site pain, tiredness, headache, muscle pain, chills and I have fever 100.3 (I got the fever after 24 hours of receiving the vaccine) and injection site is swelling, injection site have redness and feeling unwell. I would like to know how long it takes to, the side effects is going to be gone." The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Injection site swelling, Malaise, Myalgia, Pyrexia
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; I have fever 100.3; Injection site is swelling; injection site have redness; feeling unwell; This is a spontaneous report from a contactable Nurse (patient). The patient received first dose of bnt162b2 (BNT162B2, lot number: EH9899, Expiry Date: Mar2021), unknown on 19Dec2020 18:00 at single dose for covid-19 immunisation. Medical history was reported as Patient History: No. There were no concomitant medications. Nurse stated, "I have received the vaccine, the Pfizer COVID vaccine yesterday at 06:00 PM. I have side effects is injection site pain, tiredness, headache, muscle pain, chills and I have fever 100.3 (I got the fever after 24 hours of receiving the vaccine) and injection site is swelling, injection site have redness and feeling unwell. I would like to know how long it takes to, the side effects is going to be gone." The outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Antipsychotic drug level, Anxiety, Asthenia, Blood thyroid stimulating hormone normal, Chest pain
Clinical narrative: Dizzy; I felt really weak; Shortness of breath in getting up the stairs; The shortness of breath freaks me out, I think that's where the anxiety comes in; I think the midsternal chest pain was my anxiety but like a little bit; started feeling very like flu; Headache; Weakness; Fatigue; Muscle ache; I also have like really swollen lymph nodes, my lymph nodes feels like draining right now; The shortness of breath must have pain and issue for me; This is a spontaneous report from a contactable nurse (patient). A 32-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 19-DEC-2020 07:30 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included buspirone hydrochloride (BUSPAR), omeprazole (OMEPRAZOLE), lithium (LITHIUM), doxycycline (DOXYCYCLINE) for infection right now in her toe. The lithium cause 'sinus' reflux asthma. Nurse reported an adverse effect, was kind of confuse if it is related or not. She felt good for first 15 minutes and when she was about to leave. she was not afraid of shot. she felt dizzy and then she had to go upstairs and she felt really weak and Shortness of breath getting up the stairs, to get to her car. The shortness of breath freaks her out, she think that's where the anxiety comes in. she started driving home and she had bad shortness of breath. she think the midsternal chest pain was her anxiety but like a little bit. she am not sure. In '12' hours later she went to work she started feeling very like flu, she started flu like with headache, weakness, fatigue, muscle ache. she was working in ER and it is hard to work and then 20Dec2020 she was still feeling bad but little bit better than first day and shortness of breath that was still there like all day the day before. she also had like really swollen lymph nodes, her lymph nodes feels like draining right now. Nurse stated she was taking Omeprazole. That was wired because she have 'sinus' (Further not clarified, hence not captured in tab) reflux asthma, so the shortness of breath must have pain and issue for her but Omeprazole have stopped it, so before taking the vaccine she thought she was completely fine but then after taking the vaccine, it was like she have the issue again like it was controlled before the vaccine. Result of lab test: TSH was 8. So it was elevated but that was because of lithium and then she reduced the dose so it should be better now. So every result was normal." Results of tests and procedures for investigation of the patient: Test: CBC, CMP, Lithium level, TSH: Thyroid panel unknown result.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Full blood count, Headache
Clinical narrative: Dizzy; I felt really weak; Shortness of breath in getting up the stairs; The shortness of breath freaks me out, I think that's where the anxiety comes in; I think the midsternal chest pain was my anxiety but like a little bit; started feeling very like flu; Headache; Weakness; Fatigue; Muscle ache; I also have like really swollen lymph nodes, my lymph nodes feels like draining right now; The shortness of breath must have pain and issue for me; This is a spontaneous report from a contactable nurse (patient). A 32-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 19-DEC-2020 07:30 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included buspirone hydrochloride (BUSPAR), omeprazole (OMEPRAZOLE), lithium (LITHIUM), doxycycline (DOXYCYCLINE) for infection right now in her toe. The lithium cause 'sinus' reflux asthma. Nurse reported an adverse effect, was kind of confuse if it is related or not. She felt good for first 15 minutes and when she was about to leave. she was not afraid of shot. she felt dizzy and then she had to go upstairs and she felt really weak and Shortness of breath getting up the stairs, to get to her car. The shortness of breath freaks her out, she think that's where the anxiety comes in. she started driving home and she had bad shortness of breath. she think the midsternal chest pain was her anxiety but like a little bit. she am not sure. In '12' hours later she went to work she started feeling very like flu, she started flu like with headache, weakness, fatigue, muscle ache. she was working in ER and it is hard to work and then 20Dec2020 she was still feeling bad but little bit better than first day and shortness of breath that was still there like all day the day before. she also had like really swollen lymph nodes, her lymph nodes feels like draining right now. Nurse stated she was taking Omeprazole. That was wired because she have 'sinus' (Further not clarified, hence not captured in tab) reflux asthma, so the shortness of breath must have pain and issue for her but Omeprazole have stopped it, so before taking the vaccine she thought she was completely fine but then after taking the vaccine, it was like she have the issue again like it was controlled before the vaccine. Result of lab test: TSH was 8. So it was elevated but that was because of lithium and then she reduced the dose so it should be better now. So every result was normal." Results of tests and procedures for investigation of the patient: Test: CBC, CMP, Lithium level, TSH: Thyroid panel unknown result.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Metabolic function test, Myalgia, Thyroid function test
Clinical narrative: Dizzy; I felt really weak; Shortness of breath in getting up the stairs; The shortness of breath freaks me out, I think that's where the anxiety comes in; I think the midsternal chest pain was my anxiety but like a little bit; started feeling very like flu; Headache; Weakness; Fatigue; Muscle ache; I also have like really swollen lymph nodes, my lymph nodes feels like draining right now; The shortness of breath must have pain and issue for me; This is a spontaneous report from a contactable nurse (patient). A 32-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 19-DEC-2020 07:30 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included buspirone hydrochloride (BUSPAR), omeprazole (OMEPRAZOLE), lithium (LITHIUM), doxycycline (DOXYCYCLINE) for infection right now in her toe. The lithium cause 'sinus' reflux asthma. Nurse reported an adverse effect, was kind of confuse if it is related or not. She felt good for first 15 minutes and when she was about to leave. she was not afraid of shot. she felt dizzy and then she had to go upstairs and she felt really weak and Shortness of breath getting up the stairs, to get to her car. The shortness of breath freaks her out, she think that's where the anxiety comes in. she started driving home and she had bad shortness of breath. she think the midsternal chest pain was her anxiety but like a little bit. she am not sure. In '12' hours later she went to work she started feeling very like flu, she started flu like with headache, weakness, fatigue, muscle ache. she was working in ER and it is hard to work and then 20Dec2020 she was still feeling bad but little bit better than first day and shortness of breath that was still there like all day the day before. she also had like really swollen lymph nodes, her lymph nodes feels like draining right now. Nurse stated she was taking Omeprazole. That was wired because she have 'sinus' (Further not clarified, hence not captured in tab) reflux asthma, so the shortness of breath must have pain and issue for her but Omeprazole have stopped it, so before taking the vaccine she thought she was completely fine but then after taking the vaccine, it was like she have the issue again like it was controlled before the vaccine. Result of lab test: TSH was 8. So it was elevated but that was because of lithium and then she reduced the dose so it should be better now. So every result was normal." Results of tests and procedures for investigation of the patient: Test: CBC, CMP, Lithium level, TSH: Thyroid panel unknown result.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hypoaesthesia
Clinical narrative: generalized weakness; headache; right sides numbness/bilateral hand numbness/bilateral face numbness; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) via an unspecified route of administration at the right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. The patient medical history was none. The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medication included influenza vaccine inact split 3v (FLULAVAL, lot number 542MY, expiry date unknown) on 20Nov2020 for immunization. On 18Dec2020 at 16:00 (day 1), the patient experienced headache and right sides numbness. On day 2 (19Dec2020), patient has headache. On day 3 (20Dec2020), the patient has overall improvement. On day 4 (21Dec2020), the patient experienced generalized weakness, at 1300 bilateral hand numbness, at 1540 bilateral face numbness that has persisted into the afternoon (pm). The outcome of the events headache, right sides numbness/bilateral hand numbness/bilateral face numbness and generalized weakness was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Respiratory tract congestion
Clinical narrative: Headache; Chills; Body ache and little bit congested; Body ache and little bit congested; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included high blood pressure, seizure disorder. Concomitant medication included metoprolol, aripiprazole (ABILIFY). The patient experienced headache, chills, body ache and little bit congested on an unspecified date with outcome of unknown. No treatment was received for events.  Information about Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold
Clinical narrative: a little bit of chill; like a slight bit of dizziness; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Batch/lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a little bit of chill and like a slight bit of dizziness on Dec2020 with outcome of unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: really uncomfortable, my stomach is alarming; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (COVID Vaccine, manufacturer not clarified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included hypertension, diabetes, atrial fibrillation. The patient had some concomitant medications. When probed for any concomitant, patient stated, that was her other concern. She was seeing there was an issue with if you won't blood thinner (further not clarified). Patient stated, she got her own injection (COVID Vaccine) on Friday and It was not been major but she had been to the bathroom since Friday and she was change her diet or anything. This was really uncomfortable, her stomach was alarming. Patient asked if that was normal. Outcome of the event was not reported.   Pfizer is a marketing authorization holder of COVID Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID Vaccine has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasal congestion, Pain, SARS-CoV-2 test positive
Clinical narrative: fatigue, nasal congestion and body aches/tested positive with infection; fatigue, nasal congestion and body aches/tested positive with infection; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. On 15Dec2020, the patient reported possible personal exposure (close contact / dinner with friend who tested positive on 18Dec2020, both unmasked) and received Covid vaccine on 16Dec2020. The patient reported fatigue on 17Dec2020, nasal congestion and body aches on 18Dec2020. He tested positive with infection control MD and had monoclonal Ab administered same day (18Dec2020). He wanted to know, what this means for his scheduled second vaccine and if needs to wait 90 days from positive Covid. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Arm was a little sore; a little dizziness; This is a spontaneous report from a non-contactable consumer (sister). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from Dec2020, at an unknown single dose for an unspecified immunization. The patient's medical history and concomitant medications were not reported. The patient works as an RN in (Place name), received the Pfizer vaccines (COVID-19 vaccine) on Saturday; she stated that her arm was a little sore and experienced a little dizziness "but otherwise just fine". Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Headache, Pain in extremity
Clinical narrative: I have good and bad side effects, first of all I have trouble, pain in my knees and today I relieved from much pain in knees,; Pain in the arm; Headache; Diarrhea; started with a feel and now it was more, it was a pain, it was like a crack in her abdominal; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 08:15 at single dose for COVID-19 immunization. The relevant medical history included thyroid disease and arthritis (have problem with her knees and they said it arthritis). Concomitant medications included vitamin c, vitamin d3 and vitamin e, all from an unspecified date for thyroid disease. The patient stated that first moment it was okay, not feeling much just the pain in the arm on 17Dec2020 and in the next day she had good and bad side effects, first of all she had trouble, pain in her knees on 18Dec2020 and at the time of the report she relieved much from pain in knees, they came back but that was okay. She had a little headache, not much on 17Dec2020. But at the time of the report like an hour prior to the report she started with diarrhea in Dec2020. Diarrhea was getting worse, it started with a feel and now it was more, it was a pain, it was like a crack in her abdominal, she had gone to the bathroom few minutes prior to the report and almost she felt like she had to go again. The patient did not ask the dose and stated that they were supposed to give her a one dose, it was her first dose, her second dose coming on 07Jan. The outcome of the event pain in the arm was unknown, for event arthralgia was recovering, while the other events were not recovered.  Information about Lot/Batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth, Rash, Rash pruritic
Clinical narrative: Hives around the injection site; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old male patient received the 1st dose of bnt162b2, Pfizer vaccine, lot number: EK5730, expiry date: Mar2021, via an unspecified route of administration in the right arm (deltoid) on 20Dec2020 11:10 at a single dose for COVID-19 immunization. Medical history included hypertension and diabetes mellitus. Concomitant medications included metformin since diabetic, aspirin [acetylsalicylic acid] on 20Dec2020, and ongoing zinc. The patient experienced hives around the injection site on 21Dec2020 05:30. The event was described as follows: after getting the vaccine, he woke up with hives around the injection site. It is itchy, crater-ish like. If you touch it is tough and it feels like one was bit by ants. This on the arm and head. It is bigger on the head. It is like huge bumps. He has been calling his HCP all morning, but has not heard anything back from the doctor. He is calling to see if there were any recommendations, ointments, or anything he can take. He mentioned he took Benadryl this morning for it. He went on to further explain when he woke up 5:30 am this morning he had a bunch of bumps that were itchy, like ants or mosquitoes biting. They were pretty big. He has one on his collar bone. It is stiff and hard. The bumps are spreading towards the back of his back. He also has it on his left shoulder as well. He provided the hives as the same to worse. He added on his arm near the injection site is a lot worse compared to his forearm. Near the injection site it is also warm to touch. He stated this was typical symptom from what he read. He received the vaccine at 11:10 am. The patient is scheduled to get the second dose on 10Jan2021. The event did not require patient to visit the Emergency Room and the Physician Office. The reporter stated he has been trying to contact his physician to determine if his events are severe enough to go to the ER. He was informed that his doctor has been booked all day. He may have to go to the night clinic if does not get better. Outcome of the event was not recovered.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives around the injection site; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old male patient received the 1st dose of bnt162b2, Pfizer vaccine, lot number: EK5730, expiry date: Mar2021, via an unspecified route of administration in the right arm (deltoid) on 20Dec2020 11:10 at a single dose for COVID-19 immunization. Medical history included hypertension and diabetes mellitus. Concomitant medications included metformin since diabetic, aspirin [acetylsalicylic acid] on 20Dec2020, and ongoing zinc. The patient experienced hives around the injection site on 21Dec2020 05:30. The event was described as follows: after getting the vaccine, he woke up with hives around the injection site. It is itchy, crater-ish like. If you touch it is tough and it feels like one was bit by ants. This on the arm and head. It is bigger on the head. It is like huge bumps. He has been calling his HCP all morning, but has not heard anything back from the doctor. He is calling to see if there were any recommendations, ointments, or anything he can take. He mentioned he took Benadryl this morning for it. He went on to further explain when he woke up 5:30 am this morning he had a bunch of bumps that were itchy, like ants or mosquitoes biting. They were pretty big. He has one on his collar bone. It is stiff and hard. The bumps are spreading towards the back of his back. He also has it on his left shoulder as well. He provided the hives as the same to worse. He added on his arm near the injection site is a lot worse compared to his forearm. Near the injection site it is also warm to touch. He stated this was typical symptom from what he read. He received the vaccine at 11:10 am. The patient is scheduled to get the second dose on 10Jan2021. The event did not require patient to visit the Emergency Room and the Physician Office. The reporter stated he has been trying to contact his physician to determine if his events are severe enough to go to the ER. He was informed that his doctor has been booked all day. He may have to go to the night clinic if does not get better. Outcome of the event was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: urticaria to bilateral upper extremity (BUE); This is a spontaneous report from a contactable nurse (patient).  A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 19Dec2020 21:00 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included diabetes mellitus (DM), hypertension (HTN), depression, obesity, hyperlipidaemia (HLD), migraines, and degenerative disk disease (IDD).  The patient also had allergies with sulfa, oyesters, and adhesives. Concomitant medication included insulin aspart (NOVOLOG), bupropion hydrochloride (WELLBUTRIN), metformin (METFORMIN), sumatriptan (SUMATRIPTAN), and losartan potassium (LOSAR) for unknown dates and indications. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 19Dec2020 17:00, the patient experienced urticaria to bilateral upper extremity (BUE). The patient did not received any treatment for the event. The patient was recovering from the event.  Information on the Lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness in left upper arm; This is a spontaneous report from a non-contactable consumer. A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 20Dec2020 at a single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced soreness in left upper arm starting several hours after administration on 20Dec2020. Soreness was worst the next morning. No treatment was received for the adverse event. However, the outcome of the event was recovering. The event was considered non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hypoaesthesia oral
Clinical narrative: lightheadedness for 2 hours after vaccine; Flushing and tongue numbness within 2-3 minutes of vaccine administration; Flushing and tongue numbness within 2-3 minutes of vaccine administration; This is a spontaneous report from a contactable Physician (patient)  A 42-year-old female patient received,at hospital, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on arm left on 17Dec2020 (reported as at 01:15 PM)  at a single dose for COVID-19 immunization .Medical history prior history of allergies requiring allergy shots, GERD , GERD and Sulfa and environmental/food allergies , food allergy .Concomitant medication included ibuprofen and cetirizine hydrochloride (ZYRTEC ). No Covid prior vaccination and no covid test vaccination provided . On17Dec2020 at 01:15 PM , the patient experienced Flushing and tongue numbness within 2-3 minutes of vaccine administration and lightheadedness for 2 hours after vaccine.All events were reported as non-serious. Patient received treatment with Benadryl 25 mg PO (per oral).The outcome of the events was recovered in Dec2020. Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site vesicles, Pain in extremity
Clinical narrative: a few blisters near the injection site; Arm soreness; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a few blisters near the injection site in addition to arm soreness on 20Dec2020. Outcome of events was unknown.   information about lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyslexia, Fatigue, Pain, Pain in extremity
Clinical narrative: Dizziness; Fatigue; got the injection his left arm was a little sore/Severe left arm pain, soreness, throbbing; intermittent kind of dyslexia; This is a spontaneous report from a contactable consumer (respiratory therapist - patient himself).  A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EK5730) via an unspecified route of administration on the left arm on 17Dec2020 at SINGLE DOSE for COVID-19 immunization (also reported as vaccination).  Ongoing medical history included type 2 diabetes mellitus since Dec2003, renal disorder (reported as kidney prevention) and blood cholesterol abnormal (cholesterol was not high, but because of Type II Diabetes his doctor wanted to keep it at bay). Ongoing concomitant medications included metformin (METFORMIN) since Jan2004 for type II Diabetes, lisinopril (LISINOPRIL) since May2020 for kidney prevention and atorvastatin (ATORVASTATIN) since May2020 for cholesterol. On 17Dec2020, the patient had first dose administered of BNT162B2. When he got the injection, his left arm was a little sore (like if he leaned against his left arm or rubbed it he would notice the soreness). About mid-morning on 20Dec2020, his left arm just started throbbing like he had just blocked a lacrosse ball shot, severe left arm pain, and soreness. He also had onset of dizziness and fatigue as well on 20Dec2020. He went on, did a heating pad and ibuprofen and all that stuff and all that went on. He found it odd because these events did not start until around like 3 days after the injection was administered though the paperwork showed that these kind of events are expected in the first couple of days after product administered. On 21Dec2020 when he woke up around 11:30am, the throbbing went away, he was not as dizzy as before but still super fatigued and tired (then further stated that maybe a little bit better because he does not have that constant pain constantly draining him). The patient also mentioned that he wondered if there was an intermittent kind of dyslexia that he has because he will transpose words and just last week learned how to spell received without having to tell himself 'i before e except after c'. He also mentioned that he was tested like 4 times for COVID-19 and was negative every time in 2020. The outcome of the event of dyslexia was unknown while recovering for the remaining events.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Dizziness; Fatigue; got the injection his left arm was a little sore/Severe left arm pain, soreness, throbbing; intermittent kind of dyslexia; This is a spontaneous report from a contactable consumer (respiratory therapist - patient himself).  A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EK5730) via an unspecified route of administration on the left arm on 17Dec2020 at SINGLE DOSE for COVID-19 immunization (also reported as vaccination).  Ongoing medical history included type 2 diabetes mellitus since Dec2003, renal disorder (reported as kidney prevention) and blood cholesterol abnormal (cholesterol was not high, but because of Type II Diabetes his doctor wanted to keep it at bay). Ongoing concomitant medications included metformin (METFORMIN) since Jan2004 for type II Diabetes, lisinopril (LISINOPRIL) since May2020 for kidney prevention and atorvastatin (ATORVASTATIN) since May2020 for cholesterol. On 17Dec2020, the patient had first dose administered of BNT162B2. When he got the injection, his left arm was a little sore (like if he leaned against his left arm or rubbed it he would notice the soreness). About mid-morning on 20Dec2020, his left arm just started throbbing like he had just blocked a lacrosse ball shot, severe left arm pain, and soreness. He also had onset of dizziness and fatigue as well on 20Dec2020. He went on, did a heating pad and ibuprofen and all that stuff and all that went on. He found it odd because these events did not start until around like 3 days after the injection was administered though the paperwork showed that these kind of events are expected in the first couple of days after product administered. On 21Dec2020 when he woke up around 11:30am, the throbbing went away, he was not as dizzy as before but still super fatigued and tired (then further stated that maybe a little bit better because he does not have that constant pain constantly draining him). The patient also mentioned that he wondered if there was an intermittent kind of dyslexia that he has because he will transpose words and just last week learned how to spell received without having to tell himself 'i before e except after c'. He also mentioned that he was tested like 4 times for COVID-19 and was negative every time in 2020. The outcome of the event of dyslexia was unknown while recovering for the remaining events.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Tiredness throughout the day; slight lightheadedness; slight headache; This is a spontaneous report from a contactable pharmacist (reporting for himself). A 38-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), intramuscular on 21Dec2020 09:30 on the left arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Dec2020, the patient experienced tiredness throughout the day, slight lightheadedness and slight headache.  There was no treatment that was received for the events. The events were considered non-serious. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.   Information about Batch/Lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm more than any other vaccine in the past; This is a spontaneous report from a contactable Other Health Professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, via an unspecified route of administration in the left arm, first dose on 19Dec2020 14:15 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. She had not had other vaccines within four weeks prior to vaccine  and she had no other medications in 2 weeks. Adverse event reported was soreness in the arm more than any other vaccine in the past. The onset was on 20Dec2020 with outcome of recovered in Dec2020. She took an over the counter ADVIL. She did not have covid prior vaccination nor had she tested post vaccination. The event was reported as non-serious.