chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Seizure, Vomiting
Clinical narrative: The initial case was missing the following minimum criteria: no adverse effect (unspecified). Upon receipt of follow-up information on 27Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from the contactable consumers (including patient's wife) and physician. A 69-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in Feb2012 (Batch/Lot Number: EN6198) as DOSE 1, SINGLE, and on 03Mar2021 17:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE both given via an unspecified route of administration for COVID-19 and cefalexin (KEFLEX), via an unspecified route of administration from 10Mar2021 (Batch/Lot number was not reported) to 10Mar2021, at unspecified dose and for an unspecified indication. Medical history and concomitant medications were not reported. The patient had pneumonia vaccine in Feb2012 and he ended up in hospital because he had a reaction (unspecified) from it. On 03Mar2021 17:45, the patient had the 2nd dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) for COVID 19 (as reported- pending clarification). It was also mentioned that the patient had COVID vaccines, the first was 10Feb2021 and the second was on 03Mar2021 at 6pm (AER 2021311937). It was reported that on 05Mar2021 the patient had a small cut patient procedure done to remove lymph node under left arm (noted on unknown date). On 10Mar2021, the surgeon put the patient on cefalexin. Half hour after taking cefalexin, the patient started seizing, then vomiting uncontrollably. The patient was rushed to hospital by ambulance/emergency room and was admitted on 10Mar2021. The patient had numerous labs including chest X-ray, chest CT scan, brain MRI, and lumbar puncture in 2021 with unknown results. The patient was then discharged on 13Mar2021. Outcome of the events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: her blood pressure today is so high; This is a spontaneous report from a contactable consumer (patient) reporting herself.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that, she was scheduled for the second shot today (22Mar2021). However, her blood pressure was so high that she felt it was not safe to drive. She was wondering, if she could reschedule her second dose of the vaccine for tomorrow (unspecified date) even though it was past the 21-day interval. The patient underwent lab tests and procedures which included blood pressure measurement: high on 22Mar2021. The outcome of the event high blood pressure was unknown.  No follow-up attempts are needed. Information about lot/Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nervousness, Pain
Clinical narrative: my left hand went numb a little beyond my wrist and then my left foot started feeling numb too and my fingers are still numb and the tops of my toes feel numb.; toes also sting a little bit at times; nervous about my side effect; This is a spontaneous report from a contactable consumer (patient) via Pfizer Medical Information department.  A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 21Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On 21Mar2021, about 30 minutes after receiving the vaccine, which they gave it to her in her left arm, her left hand went numb a little beyond her wrist and that lasted about 5 hours and then her left foot started feeling numb too. On 22Mar2021 (this morning) the tops of her fingers were still numb, and the tops of her toes feel numb. The tops of her toes also sting a little bit at times (start date: Mar2021). She was working from home on 2Mar2021 (today) and when she used her left hand the numbness seemed to get worse. She stated that she should rather talk to someone about her medical situation first and then she can come back to Pfizer, but she really needed to speak to someone because she was little nervous about her side effect (start date: Mar2021). Events assessed as non-serious by reporter. The clinical outcome of 'my left hand went numb a little beyond my wrist and then my left foot started feeling numb too and my fingers are still numb, and the tops of my toes feel numb' was not recovered and for rest all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: messing with her heart/ heart trouble; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), via an unspecified route of administration, on 17Mar2021, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, patient has had trouble with Pfizer's COVID-19 vaccine. Patient received the first dose on Wednesday 17Mar2021, but it was messing with her heart, patient asked that, do people with heart trouble get the vaccine. Patient was called and told she had a close episode and whether patient got a defibrillator to shock patient's heart back if it stopped. Patient was having no problems before she got the shot. Patient was going to the doctor right now. Patient got the Pfizer shot the first shot and was wondering that didn't know if a person that has heart trouble (Further clarification was unknown) probably should not get that right. Because patient's heart doctor just called to patient and patient got to go in (incomplete sentence), some type of emergency thing (clarification unknown), patient just wanted to know if the Pfizer shot related to that or you just don't know. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Heart rate, Heart rate increased
Clinical narrative: elevated Heart rate; he received a mishandled dose yesterday, an Expire batch of covid 19 vaccine; This is a spontaneous report from a contactable consumer. This (Age: 33, Unit: Unknown) male consumer (Patient) reported that:  A male patient of age 33 (Unit: not reported) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on a day prior to this report (stated as yesterday) as DOSE NUMBER UN-KNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A day prior to this report (stated as yesterday), the patient experienced elevated heart rate, he received a mishandled dose yesterday, an expire batch of covid 19 vaccine. Reporter said he got a call from the pharmacy today stating he received a "spoiled vaccine" and the Pharmacist wanted to get him a moderna vaccine today. Reporter further stated "I wasn't comfortable with mixing the two" and have a "elevated Heart rate for a few minutes yesterday". It was stated that the pharmacy said they would give another Pfizer dose tomorrow and asked for information about re-vaccination after an invalid/bad dose. Reporter was made aware if he has received Pfizer, he needed to continue with Pfizer for series. The patient underwent lab tests and procedures which included heart rate: elevated on an unspecified date. The outcome of events was unknown.  No follow-up attempts were possible; Information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Pulse abnormal
Clinical narrative: Had bad reaction affecting heart and pulse; Had bad reaction affecting heart and pulse; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had bad reaction affecting heart and pulse. The patient wanted to come back on 25Mar2021 for second shot of Covid but now is questioning getting second shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Back pain, Diarrhoea, Dyspnoea, Pain in extremity
Clinical narrative: shortness of breath with exercise; sore arm; back pain; occasional diarrhea; anemic; This is a spontaneous report from a contactable other hcp. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 62 years), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced shortness of breath with exercise but much improved, back pain, occasional diarrhea, "anaemic but feeling ok", sore arm after covid vaccine last month. The clinical outcome of the event shortness of breath was recovering and remaining all other events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Moaning, Pain
Clinical narrative: groaning; terrible pain; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. This consumer reported for an unspecified age of female patient that received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient at hair salon was experiencing terrible pain after receiving Pfizer COVID vaccine. Unclear If it was his employee or clientf but said she was groaning because she was in such pain. Patient described it as pregnancy contractions. Outcome of the events moaning and terrible pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: since Friday morning has had an elevated heart rate; This is a spontaneous report from a non-contactable consumer reported for an adult female patient (lady friend). An unspecified age adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Lot number was not reported) via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history included breast cancer survivor from an unknown date and unknown if ongoing he is a breast cancer survivor, has numerous allergies and perhaps also an autoimmune disease, numerous allergies from an unknown date and unknown if ongoing he is a breast cancer survivor, has numerous allergies and perhaps also an autoimmune disease, autoimmune disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced since Friday morning has had an elevated heart rate. The patient underwent lab tests and procedures which included heart rate resulted as elevated heart rate on an unknown date Mar2021 since Friday morning has had an elevated heart rate. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: After dose 1 had intense facial numbness on left side of face (consistent with original case Bells Palsy), numbness around my mouth and also on the right side of my face; After dose 1 had intense facial numbness on left side of face (consistent with original case Bells Palsy), numbness around my mouth and also on the right side of my face; This is a spontaneous report from a non-contactable consumer, the patient. This case is for vaccine first dose. A 66-years-old non-pregnant female elderly patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection,Batch/Lot number was not reported)via an unspecified route of administration, administered in arm left on 27Feb2021 at 14:30 (at the age of 66-years-old) as Dose 1,Single for COVID-19 immunization. Facility type vaccine was a pharmacy or drug Store. Medical history included ongoing bell's palsy (had a previous episode of bell's palsy years ago). Concomitant medications included valaciclovir hydrochloride (VALACYCLOVIR) and dihydroergocristine, lomifylline (ANTIVERT) both taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccine in four weeks. There were no known allergies. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. It was reported that the patient had a previous episode of bell's palsy years ago, still had periodic facial numbness without facial drooping. After dose 1 patient had intense facial numbness on left side of face (consistent with original case Bells Palsy) and numbness around her mouth and also on the right side of my face. Subsided in 2 days. The events did not result in emergency room/ physician office visit. The patient did not receive treatment for the events. The outcome of the events was recovering.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pruritus, Vaccination site pruritus
Clinical narrative: I just have a little bit of itching at the injection site/lip started to feel itchy; I just have a little bit of itching at the injection site/lip started to feel itchy; Numbness of tongue; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7534), intramuscularly, administered in arm left on 18Mar2021 (45-years-old at the time of vaccination) as single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). On 18Mar2021, right away after the shot may be two minutes, patient started feeling and said to the nurse that her tongue has got numb and she told her it's her nerve, until she sat in the chair and waited for 20 minutes and then she told that her tongue was still numb but they told her that it's nerves again, she was free to go and now they were here after 90 minutes after her shot and still her tongue was numb so she didn't feel like that normal. She also stated her top lip started to feel itchy. Her breathing was fine, she never had a problem with the breathing it's just the tongue thing that won't go away, she just had a little bit of itching at the injection site and still have a little bit of itching it's not anything crazy, it's not a big deal. She stated that she really have a weak immune system, Like she was allergic to everything and went to anaphylactic reactions twice. She was now getting some allergy shot once a week. She was not even sure what allergy shots was being honest, she just knows that when they did the 144 shots whatever in back, she was having all 144 things. Last week was her first time after the rush therapy and she is suppose to go tomorrow to get my injection, Tomorrow will be 19Mar, She just want to know if her tongue is going to stop being numb. Consumer stated, Its 08Apr2021 for Second date of vaccine. When probed for the route of administration of the vaccine, the consumer stated, It was an IM. When probed for the anatomical site of administration of the vaccine the consumer stated, It was my left arm. Event outcome was not resolved for all.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Herpes zoster, Insomnia, Pain
Clinical narrative: She has not slept since she got shingles; it is too painful for her to turn from side to side.; she has a rash on her back that was painful; Shingles; her skin was sensitive; headache; fever; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (Pfizer Covid vaccine, Solution for injection, Batch/lot number: EN6200, Expiration date: Unknown), via an intramuscular route in the upper right arm on 03Mar2021 at 13:30 (age at vaccination: 70-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer Covid vaccine, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an intramuscular route in the right arm on 10Feb2021 at 13:30 (age at vaccination: 70-year-old), as a single dose for covid-19 immunization. She did not take any prescription medication and was healthy before the second dose of her Covid vaccine. On 03Mar2021, patient experienced fever which started on the same evening of receiving the second dose of the covid vaccine. Her fever resolved, and it stayed resolved. But then she had a fever of 100 like two days ago. She writes in a diary every day. She noticed headache either the day she received the second dose of the Covid vaccine 03Mar2021, or the next day 04Mar2021. She thinks that she only had a headache on 03Mar2021 and 04Mar2021. She did not worry about having a headache, because people told her that she can expect that. She wrote down in her diary on 04Mar2021, that she has a headache, and her skin was sensitive. She believes that she noticed the beginning of a rash on 05Mar2021. On 05Mar2021, she wrote down that she has a rash on her back that was painful, and she thinks it could be shingles. On 06Mar2021, she knew she had shingles and went to the urgent care on 06Mar2021, because she was in so much pain. She believes that the Covid vaccine was what caused her shingles. This has been going on for 2 weeks. She has not slept since she got shingles, it was too painful for her to turn from side to side. Her skin was so sensitive, and it hurts so bad that she wants to cry every day. Her doctor from home prescribed her a nerve pain killer that people took for shingles, but she doesn't think it has helped at all. She was also on an anti-viral drug. Her fever may be related to the drug she is having to take for her shingles. She had a fever but today she does not. The patient underwent lab test and procedure which included body temperature of 100. The clinical outcome of headache was resolved, shingles has gotten worse; and fever, skin was sensitive, rash on her back, she has not slept since she got shingles, it was too painful for her to turn from side to side was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Sensitive skin
Clinical narrative: She has not slept since she got shingles; it is too painful for her to turn from side to side.; she has a rash on her back that was painful; Shingles; her skin was sensitive; headache; fever; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (Pfizer Covid vaccine, Solution for injection, Batch/lot number: EN6200, Expiration date: Unknown), via an intramuscular route in the upper right arm on 03Mar2021 at 13:30 (age at vaccination: 70-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer Covid vaccine, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an intramuscular route in the right arm on 10Feb2021 at 13:30 (age at vaccination: 70-year-old), as a single dose for covid-19 immunization. She did not take any prescription medication and was healthy before the second dose of her Covid vaccine. On 03Mar2021, patient experienced fever which started on the same evening of receiving the second dose of the covid vaccine. Her fever resolved, and it stayed resolved. But then she had a fever of 100 like two days ago. She writes in a diary every day. She noticed headache either the day she received the second dose of the Covid vaccine 03Mar2021, or the next day 04Mar2021. She thinks that she only had a headache on 03Mar2021 and 04Mar2021. She did not worry about having a headache, because people told her that she can expect that. She wrote down in her diary on 04Mar2021, that she has a headache, and her skin was sensitive. She believes that she noticed the beginning of a rash on 05Mar2021. On 05Mar2021, she wrote down that she has a rash on her back that was painful, and she thinks it could be shingles. On 06Mar2021, she knew she had shingles and went to the urgent care on 06Mar2021, because she was in so much pain. She believes that the Covid vaccine was what caused her shingles. This has been going on for 2 weeks. She has not slept since she got shingles, it was too painful for her to turn from side to side. Her skin was so sensitive, and it hurts so bad that she wants to cry every day. Her doctor from home prescribed her a nerve pain killer that people took for shingles, but she doesn't think it has helped at all. She was also on an anti-viral drug. Her fever may be related to the drug she is having to take for her shingles. She had a fever but today she does not. The patient underwent lab test and procedure which included body temperature of 100. The clinical outcome of headache was resolved, shingles has gotten worse; and fever, skin was sensitive, rash on her back, she has not slept since she got shingles, it was too painful for her to turn from side to side was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Hypoaesthesia, Swelling face
Clinical narrative: left side of her face felt swollen and numb; left side face swollen; shoulder pain, like a muscle ache at the site of the injection; shoulder pain, like a muscle ache at the site of the injection; headache; funny feeling in her face; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6207 and expiry date was unknown), via an unspecified route of administration, administered in Left arm on 19Mar2021 at 15:30 as dose 1, single (at the age of 44-years-old), for covid-19 immunization. Medical history included ongoing chronic migraine (had chronic migraines for 25 years) and ongoing bipolar disorder (had a diagnosis of Bipolar for 25 years) and Vitamin D low. There was no family history. Concomitant medications included lamotrigine (LAMICTAL ODT) taken for bipolar, oxcarbazepine (TRILEPTAL) taken for chronic migraine and topiramate (TOPAMAX) taken for migraine or bipolar, all 3 were ongoing since unknown dates over 10 years and another concomitant medication ergocalciferol (VIT D) taken for vitamin d low over two months. There were no prior vaccinations (within 4 weeks). There were no additional vaccines administered on same date of the Pfizer suspect. It was stated that the patient got the first dose of the Pfizer vaccine on 19Mar2021 (Friday) at 15:30 in the left arm and reported that she sat for the 15 minutes and right away she got shoulder pain, like a muscle ache at the site of the injection, headache; and on her drive home her left side of her face felt swollen and numb and the sensation went away but it came back. The patient had funny feeling in her face on 19Mar2021. At the time of reporting everything was gone except a slight funny feeling in her face. She was asking should she get the next dose of the vaccine. The patient was not visited to emergency room and physician office for the events. Relevant tests were none. The outcome for the events left side of her face felt swollen and numb was recovered in Mar2021; events of shoulder pain, like a muscle ache at the site of the injection, headache was recovered on 21Mar2021 and event of funny feeling in her face was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left side of her face felt swollen and numb; left side face swollen; shoulder pain, like a muscle ache at the site of the injection; shoulder pain, like a muscle ache at the site of the injection; headache; funny feeling in her face; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6207 and expiry date was unknown), via an unspecified route of administration, administered in Left arm on 19Mar2021 at 15:30 as dose 1, single (at the age of 44-years-old), for covid-19 immunization. Medical history included ongoing chronic migraine (had chronic migraines for 25 years) and ongoing bipolar disorder (had a diagnosis of Bipolar for 25 years) and Vitamin D low. There was no family history. Concomitant medications included lamotrigine (LAMICTAL ODT) taken for bipolar, oxcarbazepine (TRILEPTAL) taken for chronic migraine and topiramate (TOPAMAX) taken for migraine or bipolar, all 3 were ongoing since unknown dates over 10 years and another concomitant medication ergocalciferol (VIT D) taken for vitamin d low over two months. There were no prior vaccinations (within 4 weeks). There were no additional vaccines administered on same date of the Pfizer suspect. It was stated that the patient got the first dose of the Pfizer vaccine on 19Mar2021 (Friday) at 15:30 in the left arm and reported that she sat for the 15 minutes and right away she got shoulder pain, like a muscle ache at the site of the injection, headache; and on her drive home her left side of her face felt swollen and numb and the sensation went away but it came back. The patient had funny feeling in her face on 19Mar2021. At the time of reporting everything was gone except a slight funny feeling in her face. She was asking should she get the next dose of the vaccine. The patient was not visited to emergency room and physician office for the events. Relevant tests were none. The outcome for the events left side of her face felt swollen and numb was recovered in Mar2021; events of shoulder pain, like a muscle ache at the site of the injection, headache was recovered on 21Mar2021 and event of funny feeling in her face was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Erythema, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: cheeks and tongue have bothgone numb; cheeks are both red; Within one minute of receiving the injection, left arm went slightly numb from shoulder to fingertips; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 23Mar2021 at 10:30 (at the age of 31-years-old) as dose1, single for Covid-19 immunization. The patient's medical history included bipolar disorder and obesity with a body mass index of 47. Concomitant medications included aripiprazole (ARIPIPRAZOLE), lamotrigine (LAMOTRIGINE) and clonazepam (CLONAZEPAM); all were from an unspecified date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient was not tested for Covid-19. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 23Mar2021 at 10:30, within one minute of receiving the injection, the patient's left arm experienced slightly numb from shoulder to fingertips. On the same day, after one hour and fifteen minutes, at 11:45, the cheeks and tongue of the patient gone numb, and cheeks were both red. It was reported that it was a similar feeling to novocain wearing off after a dental procedure. The patient was feeling ok other than the numbness at the time of the report and was reported that the patient never had a reaction to any medications or vaccines prior to this. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care visit. Patient lab test included BMI: 47 on an unspecified date. Therapeutic measure and treatments were not taken in response to the events. The clinical outcome of the events was not resolved at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Cardiac discomfort, Cardiac fibrillation, Cardiac flutter, Diarrhoea
Clinical narrative: sometimes feeling of loosing consciousness; pressure on heart; flutter in chest; heart fibrillation; strong tachycardia; fatigue; drop in blood pressure; restlessness; not able to concentrate; vertigo; pressure in head; Diarrhoea; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 02:30 (at the age of 48 year) as dose 1, single for COVID-19 immunisation at Other. Medical history included Chronic kidney disease (one kidney let's say dysfunctional), Chronic bowel inflammation (Crohn's disease). Concomitant medication(s) included magnesium sulfate (MAGNESIUM SULFATE), acetylsalicylic acid (ACYLPYRIN), cetirizine hydrochloride (ZIRTEC). Patient had known allergies that was not to drugs but have combined crossed immunologic reactions (grass and food) which cause anaphylactic state. The covid vaccine however have not caused this reaction. 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. On 16Mar2021, on the day of vaccination patient experienced restlessness, not able to concentrate, vertigo, fatigue in the evening and during night of the same day as vaccination day, strong tachycardia (heart fibrillation), probably radical drop in blood pressure, pressure in head, slowed perception. Heart fibrillations are so strong, that they were well noticeable (strong confused flutter in chest and feeling that patient will be faint), On 17Mar2021, the next day after vaccination continuing strong tachycardia (heart fibrillation), pressure on heart, sometimes feeling of loosing consciousness, strong vertigo, pressure in head, not able to concentrate, added diarrhoea. Third day after vaccination everything stated above, still ongoing diarrhoea, vertigo, restlessness, not able to concentrate. Tachycardia was calming down but it was still not fine, still very low blood pressure. Diarrhoea was milder, but still was present. Patient did not receive treatment for the adverse event. The outcome of Unconsciousness, fatigue and Head pressure was unknown, for Drop in blood pressure, Restlessness, Concentration impaired, Vertigo, was not recovered, for Tachycardia, Cardiac flutter, Diarrhoea, Cardiac fibrillation, Heart pressure sensation of was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Head discomfort, Presyncope, Restlessness
Clinical narrative: sometimes feeling of loosing consciousness; pressure on heart; flutter in chest; heart fibrillation; strong tachycardia; fatigue; drop in blood pressure; restlessness; not able to concentrate; vertigo; pressure in head; Diarrhoea; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 02:30 (at the age of 48 year) as dose 1, single for COVID-19 immunisation at Other. Medical history included Chronic kidney disease (one kidney let's say dysfunctional), Chronic bowel inflammation (Crohn's disease). Concomitant medication(s) included magnesium sulfate (MAGNESIUM SULFATE), acetylsalicylic acid (ACYLPYRIN), cetirizine hydrochloride (ZIRTEC). Patient had known allergies that was not to drugs but have combined crossed immunologic reactions (grass and food) which cause anaphylactic state. The covid vaccine however have not caused this reaction. 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. On 16Mar2021, on the day of vaccination patient experienced restlessness, not able to concentrate, vertigo, fatigue in the evening and during night of the same day as vaccination day, strong tachycardia (heart fibrillation), probably radical drop in blood pressure, pressure in head, slowed perception. Heart fibrillations are so strong, that they were well noticeable (strong confused flutter in chest and feeling that patient will be faint), On 17Mar2021, the next day after vaccination continuing strong tachycardia (heart fibrillation), pressure on heart, sometimes feeling of loosing consciousness, strong vertigo, pressure in head, not able to concentrate, added diarrhoea. Third day after vaccination everything stated above, still ongoing diarrhoea, vertigo, restlessness, not able to concentrate. Tachycardia was calming down but it was still not fine, still very low blood pressure. Diarrhoea was milder, but still was present. Patient did not receive treatment for the adverse event. The outcome of Unconsciousness, fatigue and Head pressure was unknown, for Drop in blood pressure, Restlessness, Concentration impaired, Vertigo, was not recovered, for Tachycardia, Cardiac flutter, Diarrhoea, Cardiac fibrillation, Heart pressure sensation of was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vertigo
Clinical narrative: sometimes feeling of loosing consciousness; pressure on heart; flutter in chest; heart fibrillation; strong tachycardia; fatigue; drop in blood pressure; restlessness; not able to concentrate; vertigo; pressure in head; Diarrhoea; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 02:30 (at the age of 48 year) as dose 1, single for COVID-19 immunisation at Other. Medical history included Chronic kidney disease (one kidney let's say dysfunctional), Chronic bowel inflammation (Crohn's disease). Concomitant medication(s) included magnesium sulfate (MAGNESIUM SULFATE), acetylsalicylic acid (ACYLPYRIN), cetirizine hydrochloride (ZIRTEC). Patient had known allergies that was not to drugs but have combined crossed immunologic reactions (grass and food) which cause anaphylactic state. The covid vaccine however have not caused this reaction. 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. On 16Mar2021, on the day of vaccination patient experienced restlessness, not able to concentrate, vertigo, fatigue in the evening and during night of the same day as vaccination day, strong tachycardia (heart fibrillation), probably radical drop in blood pressure, pressure in head, slowed perception. Heart fibrillations are so strong, that they were well noticeable (strong confused flutter in chest and feeling that patient will be faint), On 17Mar2021, the next day after vaccination continuing strong tachycardia (heart fibrillation), pressure on heart, sometimes feeling of loosing consciousness, strong vertigo, pressure in head, not able to concentrate, added diarrhoea. Third day after vaccination everything stated above, still ongoing diarrhoea, vertigo, restlessness, not able to concentrate. Tachycardia was calming down but it was still not fine, still very low blood pressure. Diarrhoea was milder, but still was present. Patient did not receive treatment for the adverse event. The outcome of Unconsciousness, fatigue and Head pressure was unknown, for Drop in blood pressure, Restlessness, Concentration impaired, Vertigo, was not recovered, for Tachycardia, Cardiac flutter, Diarrhoea, Cardiac fibrillation, Heart pressure sensation of was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: My arm feels like numb like when your arm falls asleep when somebody lays on it; I have that on my entire arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was unknown), via an unspecified route of administration on an unspecified date in 2021 as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. As per verbatim, consumer stated, I got my first Covid shot on Thursday (on an unspecified date in 2021). On an unknown date in 2021, the patient's arm feels like numb like when your arm falls asleep when somebody lays on it, that feeling and patient have that on entire arm and wanted to known is that normal. The patient wanted to know, if the normal side effects can be told to them or not. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Headache, Myalgia
Clinical narrative: Terrible headache; Vomiting; Diarrhea; Muscle aches; Weakness; Queasy stomach; Loss of appetite; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 68-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via unspecified route of administration in arm (reported as shoulder) on 11Mar2021 (at the age of 68-years-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Vaccination facility type was reported as Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Patient medical history included Hypothyroidism due to total thyroidectomy. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 25Feb2021 15:45 as dose 1, single for COVID-19 immunization and experienced constant runny nose similar to a bad head cold for two days. The concomitant medications include thyroid (ARMOUR THYROID). The patient experienced terrible headache, vomiting, diarrhea, muscle aches, weakness for 48 hours and queasy stomach, loss of appetite for 3+ days later on an unspecified date in Mar2021. The outcome of events was resolved on an unspecified date in Mar2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Terrible headache; Vomiting; Diarrhea; Muscle aches; Weakness; Queasy stomach; Loss of appetite; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 68-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via unspecified route of administration in arm (reported as shoulder) on 11Mar2021 (at the age of 68-years-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Vaccination facility type was reported as Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Patient medical history included Hypothyroidism due to total thyroidectomy. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 25Feb2021 15:45 as dose 1, single for COVID-19 immunization and experienced constant runny nose similar to a bad head cold for two days. The concomitant medications include thyroid (ARMOUR THYROID). The patient experienced terrible headache, vomiting, diarrhea, muscle aches, weakness for 48 hours and queasy stomach, loss of appetite for 3+ days later on an unspecified date in Mar2021. The outcome of events was resolved on an unspecified date in Mar2021.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Heart rate, Heart rate irregular
Clinical narrative: irregular heart beat; over the weekend, worst on Monday; This is a spontaneous report from a contactable consumer or other non health professional (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206), dose 1 via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, it was stated that patient had an irregular heart beat since and someday towards another, first two days it was all day all night, Wednesday and Thursday. Patient was better on Friday, better over the weekend, worst on Monday. The patient called doctor they said fetch fluids, give it a couple of days. The patient underwent lab tests and procedures on an unspecified date in Mar2021 which included heart rate: irregular. The outcome of event irregular heart beat was not recovered and for condition worsened was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for 5days; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:00 AM (at the age of 51-year-old) as dose 2, single for covid-19 immunisation. Medical history included surgery from an unknown date and unknown if ongoing. Other medical history was reported as no. Patient did not have allergies to medications, food, or other products. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 26Feb2021 12:00 AM (at the age of 51-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Tylenol, had surgery. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced diarrhea for 5days on 19Mar2021 02:00. The adverse event resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of diarrhea for 5days, patient reported doctors said just for it to go away. The outcome of event diarrhoea was not recovered.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injury associated with device, Pain in extremity, Wrong technique in product usage process
Clinical narrative: she is not sure she really got vaccinated. Nurse student administered the shot felt that there was little resistance in the syringe and the administration was too fast as like there was nothing; she is not sure she really got vaccinated. Nurse student administered the shot felt that there was little resistance in the syringe and the administration was too fast as like there was nothing; She felt the needle stick but nothing else; she felt slightly sore in her arm; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), dose 2 via an unspecified route of administration on 23Mar2021 (at the age of 65-year-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), via an unspecified route of administration on 02Mar2021 (at the age of 65-years-old) dose 1, single for covid-19 immunization. On 23Mar2021, the patient experienced felt slightly sore in her arm, she was not sure she really got vaccinated. She says that the Nurse student that administered the shot felt that there was little resistance in the syringe and the administration was too fast as like there was nothing. She did not know if she really administered her the vaccine, she did not know if there was something in the vial. She felt the needle stick but nothing else. The student nurse did not think she got any medicine in it and she was too afraid to get another shot. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.