chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt hot; felt achy; Chills; generalized myalgias; high fever/her highest recorded temperature was 102.5; Deltoid soreness; This is a spontaneous report from a contactable Other HCP. This other hcp (patient) reported for herself that the 32-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Covid-19 Vaccine manufacturer: Pfizer BioNTech), intramuscular into her left deltoid on 17Dec2020 07:30 at single dose for covid-19 immunisation (Prophylaxis). Medical history included  Hypothyroidism, mood and sleep. Concomitant medications included Levothyroxine at 100mcg daily by mouth ongoing for Hypothyroidism started taking at 19 years old, escitalopram oxalate (LEXAPRO) at 10mg once a day by mouth from Dec2020 started it about 2 weeks ago ongoing for mood, zolpidem tartrate (AMBIEN) at 10mg as needed by mouth for sleep and was not taking this at the time. The patient experienced Deltoid soreness from 17Dec2020 to 18Dec2020, Chills from 20Dec2020 to 21Dec2020, generalized myalgias from 20Dec2020 to 21Dec2020, high fever from 20Dec2020 to 21Dec2020. The outcome of the events was recovered. Her vaccination cared is at her house. She received the product at the hospital she works at. The causality of the events Deltoid soreness, Chills, generalized myalgias and high fever was related. Caller is a nurse practitioner that reported that she wanted to report a possible side effect for herself with the Covid-19 vaccine. She said that she herself got vaccinated on Thursday 17Dec2020. She was doing fine except for the deltoid soreness that showed up about 12 hours after receiving the vaccine and lasted for about 12 hours and then it went away.  On Sunday, she had sudden onset of chills, generalized myalgias, and a high fever. Caller said that her highest recorded temperature was 102.5. Her symptoms started at  about 1430 and she said she had no other symptoms aside from what she reported. She said that her chills went away after about 3 hours and then she felt hot, and then she just felt achy and had the generalized myalgias. All were subsided by 0900 this morning. She said that she also had a low grade fever of 99.8 this morning, but it was all gone by 0900. Caller said that she is a emergency room employee and was given the vaccine at the hospital and they was no prescribing physician. Caller said that she has never had a reaction like this to a vaccine before. Vaccination Facility Type was hospital. Vaccine Administered at Military Facility was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) was require a visit to ER or physician office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was None.  Information on the lot/ batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle and joint pain,Chills and Fever-102.9 day after; Headache, muscle and joint pain,Chills and Fever-102.9 day after; Headache, muscle and joint pain,Chills and Fever-102.9 day after; Headache, muscle and joint pain,Chills and Fever-102.9 day after; Headache, muscle and joint pain,Chills and Fever-102.9 day after; This is a spontaneous report from a contactable Nurse (patient). A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscular on arm left on 18Dec2020 12:45 at single dose for COVID-19 immunization. Medical history included osteoarthritis. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included Atorvastatin, Ibuprofen, sambucus nigra (ELDERBERRY), Krill Oil, One A Day VitaCraves Women's, ergocalciferol (VITAMIN D), ascorbic acid (VITAMIN C). On 19Dec2020 08:00, the patient experienced headache, muscle and joint pain, chills and Fever-102.9 day after, gradually went down over night. No treatment received for the adverse event. There was no Covid prior vaccination, received COVID tested post vaccination via nasal swab on 20Dec2020 with result of negative. Events outcome was recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Headache, muscle and joint pain,Chills and Fever-102.9 day after; Headache, muscle and joint pain,Chills and Fever-102.9 day after; Headache, muscle and joint pain,Chills and Fever-102.9 day after; Headache, muscle and joint pain,Chills and Fever-102.9 day after; Headache, muscle and joint pain,Chills and Fever-102.9 day after; This is a spontaneous report from a contactable Nurse (patient). A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscular on arm left on 18Dec2020 12:45 at single dose for COVID-19 immunization. Medical history included osteoarthritis. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included Atorvastatin, Ibuprofen, sambucus nigra (ELDERBERRY), Krill Oil, One A Day VitaCraves Women's, ergocalciferol (VITAMIN D), ascorbic acid (VITAMIN C). On 19Dec2020 08:00, the patient experienced headache, muscle and joint pain, chills and Fever-102.9 day after, gradually went down over night. No treatment received for the adverse event. There was no Covid prior vaccination, received COVID tested post vaccination via nasal swab on 20Dec2020 with result of negative. Events outcome was recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested (nasal swab done) on Sunday; received positive test result; Patient had COVID, did not know she had COVID and got the vaccine; This is a spontaneous report from a Pfizer-sponsored program via a contactable pharmacist (patient). This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EH9899) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient had COVID, did not know she had COVID and got the vaccine. Patient received vaccine on Saturday, tested (nasal swab done) on Sunday. Patient received positive test result on 21Dec2020. Outcome of the event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain
Clinical narrative: Having a lot of bone pain in the arm that I got the injection at; Having a lot of bone pain in the arm that I got the injection at; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose in the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated it was the COVID-19 Vaccine. Patient was having a lot of bone pain in the arm that patient got the injection at. It was not 'muscle' (not clarified). The outcome of events having a lot of bone pain in the arm that patient got the injection at was unknown.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: bleeding coming from the injection site after the needle was removed his arm; This is a spontaneous report from a contactable other HCP (anesthesiologist) reported for himself. This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose on the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated after receiving COVID vaccine on an unspecified date (reported as "today") he noticed bleeding coming from the injection site after the needle was removed his arm. Patient said he had the vaccine he took the needle out he bleed a little bit he said he was afraid he was injected wrong possible into a vein nothing was swollen nothing was bruised red. Patient stated he was unsure if the vaccine was administered intravenously or intramuscularly. Outcome of the event was unknown. The report was assessed as non-serious.  Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: patient received BNT162B2 vaccine that had been through a temperature excursion; patient received BNT162B2 vaccine that had been through a temperature excursion; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for ninety patients. This is one of ninety reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  In Dec2020, the patient received BNT162B2 vaccine that had been through a temperature excursion. This was further elaborated as the patient received the vaccine that had been exposed to -50 degrees Celsius for about 20 minutes before being transferred to the refrigerator and then administered within 5 days. The clinical outcome of patient received BNT162B2 vaccine that had been through a temperature excursion was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020502898 same reporter reporting similar events in different patients with the same vaccine
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: severe headache with nausea; severe headache with nausea; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. Medical history included pulmonary sarcoidosis, thyroid, mild depression. Concomitant medication included famotidine, ibuprofen (DUEXIS). Nurse called in to report side effects, she got her shot on 17Dec2020 and she had a severe headache with nausea about 45 minutes after getting the shot. When probed if still experiencing the event, nurse stated, about 15 minutes it was gone on 17Dec2020.  She just took Ibuprofen (MOTRIN) for treatment. Outcome of severe headache with nausea was recovered on 17Dec2020.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events,headache with nausea, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise
Clinical narrative: Headache; malaise; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ek5730), intramuscular on the right arm on 19Dec2020 16:15 at a single dose for covid-19 immunization. The patient's medical history included reflux and anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT), spironolactone, loratadine (CLARITIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), vitamin d3, and famotidine (PEPCID). 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 headache, malaise, and diarrhea on Dec2020 (reported as 18Dec2020 19:00, pending clarification). No treatment was received for the adverse events. Outcome of the events was recovered on Dec2020.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Myalgia, Pain
Clinical narrative: He has a temperature of 100.1 but a lot of muscles aches and pain; He has a temperature of 100.1 but a lot of muscles aches and pain; He has a temperature of 100.1 but a lot of muscles aches and pain; This is a spontaneous report from a non-contactable Nurse. This Nurse reported for a male patient (Son) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at 08:20 at single dose for covid-19 immunisation. Medical history was not provided Concomitant medications included Lisinopril for a little hypertensive. He received a shot (COVID Vaccine) yesterday (19Dec2020 at 08:20), today he called on for work, and he says that he has a temperature of 100.1 but a lot of muscles aches and pain. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eyelid irritation, Fatigue, Headache, Injection site pain
Clinical narrative: Tiredness; Pain injection site; Headache; muscle pain; Joint pain; Nausea; just isn't feeling good; feels like face and around eyes are swollen; feels like face and around eyes are swollen; This is a spontaneous report from a contactable consumer reported for self. This 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 in her right arm at single dose for required to at work. None medical history and concomitant medications. She is at work right now. She doesn't have a prescribing doctor. She works at the ER, and they were provided to employees. There is pain at the injection site, which she expected. She has had tiredness, headache, muscle, and joint pain. No chills.  She has had nausea. She just wasn't feeling good. She feels like her face is swollen. Like around her eye lids is swollen, but she asked her kids, and they said it doesn't look swollen. She can feel it, but not see it. She got the vaccine on 17Dec2020. She started having all the side effects on the 18Dec2020. They have just persisted. She took something for nausea. She took Ibuprofen for pain, Headache, muscle pain, Joint pain. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Swelling face
Clinical narrative: Tiredness; Pain injection site; Headache; muscle pain; Joint pain; Nausea; just isn't feeling good; feels like face and around eyes are swollen; feels like face and around eyes are swollen; This is a spontaneous report from a contactable consumer reported for self. This 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 in her right arm at single dose for required to at work. None medical history and concomitant medications. She is at work right now. She doesn't have a prescribing doctor. She works at the ER, and they were provided to employees. There is pain at the injection site, which she expected. She has had tiredness, headache, muscle, and joint pain. No chills.  She has had nausea. She just wasn't feeling good. She feels like her face is swollen. Like around her eye lids is swollen, but she asked her kids, and they said it doesn't look swollen. She can feel it, but not see it. She got the vaccine on 17Dec2020. She started having all the side effects on the 18Dec2020. They have just persisted. She took something for nausea. She took Ibuprofen for pain, Headache, muscle pain, Joint pain. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: She does have a significant muscle ache and joint ache; She does have a significant muscle ache and joint ache; This is a spontaneous report from a contactable physician (Patient's husband). A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at single dose (Lot # EH9899) for covid-19 immunisation. Medical history, concomitant medications or past drug history were not provided. She has received the first injection of the Covid 19 Vaccination, she received it 24 hours ago (19Dec2020) and she doesn't have a fever but she does have a significant muscle ache and joint ache. So the question if it is okay for the patient to take anti-inflammatory medication like non-steroidal. Outcome of the event was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Cough, Fatigue, Malaise
Clinical narrative: tested positive for Corona Virus/ symptomatic and has been sick; tested positive for Corona Virus/ symptomatic and has been sick; This is a spontaneous report from a Pfizer-sponsored program by a contactable other HCP reported for self. This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 18Dec2020 10:45 am on left arm at single dose (Lot # EK5730) for routine vaccination. No additional vaccines received on the same date. Vaccination facility type was hospital. None medical history, concomitant medications or past drug history. She has a patient on the line who got the COVID vaccine on Friday (18Dec2020 10:45), and on Sunday (20Dec2020) she tested positive for the Corona Virus. The main reason she called is to figure out what to do about the booster. There is not really enough data to determine this at this point. There was no prescriber.  She just received it at the hospital.  She is symptomatic and has been sick on 18Dec2020 all weekend.  Saturday (19Dec2020) is when she began to have more significant symptoms and on Sunday (20Dec2020) as well.  Today, she is better, but still symptomatic. She became symptomatic on Friday night 18Dec2020, and experienced loss of smell, extreme fatigue, mild cough, nasal congestion.  She states all were related to COVID.  This all started around 7:30 pm. Relevant test included Positive for Corona Virus on Sunday, 20Dec2020. Relevant test included Positive for COVID test (Corona Virus) on Sunday, 20Dec2020. Outcome of the events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: tested positive for Corona Virus/ symptomatic and has been sick; tested positive for Corona Virus/ symptomatic and has been sick; This is a spontaneous report from a Pfizer-sponsored program by a contactable other HCP reported for self. This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 18Dec2020 10:45 am on left arm at single dose (Lot # EK5730) for routine vaccination. No additional vaccines received on the same date. Vaccination facility type was hospital. None medical history, concomitant medications or past drug history. She has a patient on the line who got the COVID vaccine on Friday (18Dec2020 10:45), and on Sunday (20Dec2020) she tested positive for the Corona Virus. The main reason she called is to figure out what to do about the booster. There is not really enough data to determine this at this point. There was no prescriber.  She just received it at the hospital.  She is symptomatic and has been sick on 18Dec2020 all weekend.  Saturday (19Dec2020) is when she began to have more significant symptoms and on Sunday (20Dec2020) as well.  Today, she is better, but still symptomatic. She became symptomatic on Friday night 18Dec2020, and experienced loss of smell, extreme fatigue, mild cough, nasal congestion.  She states all were related to COVID.  This all started around 7:30 pm. Relevant test included Positive for Corona Virus on Sunday, 20Dec2020. Relevant test included Positive for COVID test (Corona Virus) on Sunday, 20Dec2020. Outcome of the events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: arm tingled; a little pain around the injection site; This is a spontaneous report from a contactable consumer. This female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 20Dec2020 at 4:00 pm at single dose for COVID-19 immunisation in her left arm. The medical history and concomitant medications were not reported. At 4:00 pm a nurse placed the vaccine in her left arm. When she placed the medication the patient felt a zing and a burning sensation with a tingle down her arm. She didn't say anything, she thought maybe the medication was just a thicker consistency like Betamethasone, which can sometimes burn when injected in the muscle. The patient's arm tingled for about 3 to 5 minutes and then it stopped. The patient felt the medication go in and felt burning and tingling. It's 6pm and the patient feel fine, just a little pain around the injection site. The skin surrounding the injection site was normal in color and cool to the touch. No visible swelling. She personally think she placed the vaccine a little too high and hit a nerve. The outcome of the events was recovered on 20Dec2020 6pm.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: Muscle ache; Fatigue; Headache; feels Achy; This is a spontaneous report from a contactable Physician. A female patient started to receive started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 at single dose for covid-19 immunisation. This is unknown to her, but she would imagine the second dose is around 07Jan2021.  Medical history, concomitant medications or past drug history were not provided. The patient was experiencing that she was referring to is muscle aches, fatigue, and headache. She doesn't feel sickly but feels achy. It is unknown if the patient ever test positive for Covid, or had antibodies prior to the vaccine. Outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oral contusion, Paraesthesia oral, Tongue pruritus
Clinical narrative: entire tongue began to itch; entientire tongue began to itch, tingle; A small bruise-like spot appeared on the tip of her tongue; This is a spontaneous report from a contactable Nurse reported for self. This 65-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 19Dec2020 14:30 on Arm left at single dose (Lot # EKS730) for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: hospital. Medical history included Gastrooesophageal reflux disease. Concomitant medications included omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included Allergies to medications, food, or other products: Bactrim, Ceftin. On 20Dec20200 8:30 AM, 18 hours after receiving the vaccine her entire tongue began to itch, tingle. No swelling noted. A small bruise-like spot appeared on the tip of her tongue. 5 hours later the itching stopped (20Dec2020 13:30) and the bruise-like spot began to fade. The spot was completely gone the next morning. There was no trauma to the tongue at any point that would account for the spot. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received for the events. Outcome of the event tongue itching was recovered on 20Dec2020 13:30. Outcome of the event a small bruise-like spot appeared on the tip of her tongue was recovered on 21Dec2020. Outcome of the event tingling tongue was recovered in Dec2020. Events assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: developed a slight cough; This is a spontaneous report from a contactable nurse reported for herself. This 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient received the COVID Vaccine on 19Dec2020. The following day she developed a slight cough on 20Dec2020, and she felt completely fine otherwise. Outcome of the event was recovered.   Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: feeling ok not perfect; This is spontaneous report from a contactable nurse reporting for herself. This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient got the Pfizer Covid-19 vaccine on 21Dec2020 and wanted to know if she was contagious. She stated she knew it's not a live vaccine and it's an MRNA vaccine. Her pharmacist told that she was not contagious, but she just wanted to make sure. The patient was feeling ok not perfect. The patient did not state any side effects. Outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Feeling cold, Tremor
Clinical narrative: heaviness in the chest; trembling of the mouth like teeth went on chatter like it is real cold; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) for COVID-19 immunization. Medical history included blood pressure abnormal. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and acetylsalicylic acid (ASPIRIN 81) as blood pressure pills. The patient was informing the side effect that she had when she had got the vaccine (Unspecified vaccine). The patient experienced heaviness in the chest and also trembling of the mouth like teeth went on chatter like it was really cold on 17Dec2020. When probed for the lot number, EJ1685 with Pfizer was reported. The patient worked at the hospital. It was just happened between the first 4 hours after receiving. It was not still experiencing. No treatment received for the problem because they left like within the first 4 hours and after that the patient didn't feel anything. Outcome of both events was recovered in Dec2020.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Administration site pain, Chills, Pyrexia
Clinical narrative: Some chills, temperature; Some chills, temperature; Soreness in the administration site; This is a spontaneous report from a contactable nurse reported for himself. This 51-year old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. On 21Dec2020, the patient experienced some chills, temperature, and soreness in the administration site. The patient was vaccinated at 51 years old. The patient wanted to know if he should isolate himself again, and if he will get Covid again after receiving the vaccine. Outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Oedema peripheral
Clinical narrative: left deltoid hurt a lot for a while; got left actual swelling like in his armpit; This is a spontaneous report from a contactable consumer (patient). This 49-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left deltoid on 18Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient received the COVID vaccine Friday morning as part of work. The patient had a lot of, kind of significant actual swelling in the (incomplete sentence). The patient was too much concerned about this, but it was out of the ordinary enough that the patient felt it was worth reporting. So the patient got the vaccine in his left deltoid and the left deltoid hurt a lot for a while but currently the patient got left actual swelling like in his armpit it's, where the lymph nodes were, the patient got a very significant swelling. The patient stated he was experiencing it on 20Dec2020. So his age was 49 years. The patient was assuming it was a normal immune response, but he never had it with the flu vaccine or anything, so the patient wanted to report it. It's a COVID-19 Vaccine. No treatment was received for events. Outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Limb discomfort
Clinical narrative: sore and heaviness on the injection site; heaviness on the injection site; This is a spontaneous report from a contactable Nurse (patient) via Pfizer sales representative. This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient posted on Social Media that she was injected with COVID 19 vaccine. As per her comment, after 8 hours she experienced sore and heaviness on the injection site. Outcome of the events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: mild COVID symptoms; front line nurse and received it because of that; This is a spontaneous report from a contactable nurse. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for treating COVID patients. Medical history included COVID. Concomitant medications were unknown. The patient had COVID previously, received the vaccine, and was currently experiencing mild COVID symptoms. The patient received vaccine from the hospital, so there was no prescriber. Patient was a front line nurse and received it because of that. Outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. This patient of unspecified age and gender received first dose of BNT162B2, from an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient experienced fatigue the day after the first dose. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain
Clinical narrative: body aches; pregnant patient received BNT162B2 for COVID Prevention; pregnant patient received BNT162B2 for COVID Prevention; pregnant patient received BNT162B2 for COVID Prevention; This is a spontaneous report from a contactable physician (patient). This 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899), intramuscularly on 19Dec2020 at single dose in right upper arm for COVID Prevention. Medical history was none.  Concomitant drug included unspecify drugs. The patient got the vaccine on 19Dec2020, and then that evening she had body aches. She stated that she took 1000mg of Tylenol by mouth because she was really achy, but she was fine by the next day. She was pregnant. Patient last menstrual period date was 08Sep2020. She does take another medication but she does not think it was associated with the body aches she experienced. The outcome of Body aches was recovered on 20Dec2020, of other events were unknown.  Primary Source Reporter assessed Body aches related by Method of assessment.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Asthenia, Cough, Dizziness, Fatigue
Clinical narrative: Weakness; Lightheadedness; fast heart beat/heart rate is 101; coughing a little bit; panic attack; he was not acting well and his blood pressure was 158/98; he feels silly then has nervousness; he feels silly then has nervousness; feeling tired; not feeling well; This is a spontaneous report from a Contactable consumer (patient). This 52-years-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) (lot number: AK5730), on 20Dec2020 at single dose on left arm for COVID-19 immunisation. Medical history included Blood pressure high. The patient's concomitant medications were not reported. He had one injection given in his left arm around 08:30 or 08:40 in the morning on 20Dec2020, before 9 o clock. He says that they let him rest for 15 minutes after his injection, and it is a delayed reaction that just started this morning and he tried to go to work and had to go home. The patient got the vaccine on yesterday morning then tried to come to work on this morning but he was feeling weak and having light headedness, and his heart beat is so fast. He did go home to try to relax. He said he experienced a panic attack at some other times where his heart beat fast and he was quite light headed at some other times gone from rest and get up to walk or try to do something, and that's why he had gone home after he reported to work earlier. He says just now also trying to have something to do he is feeling it. He says that he took Tylenol and some cough syrup for feeling lightheaded and weak. He clarifies that he took Tylenol yesterday and then after he took vaccine and this morning the nurse gave him Tylenol also. He says he told them he was not feeling well, he felt silly and weak. They told him to go home because he told them he was not acting well and his blood pressure was 158/98. He has been doing Lisinopril 20mg for his high blood pressure, and he has been on it for a long time. He says that the label says discard after 01Oct2021. He says he takes 20mg once a day by mouth, and he keeps refilling it every 30 days. The patient took the cough syrup because he was coughing a little bit. He says that the EXP date on the Tylenol he took that he has at home is Mar2022. He provides EA013 as LOT and dose strength as 500mg. He says he took this last night and this morning at the facility they gave him the 500mg dose too. He says that he took vitals with his nurse, and his heart rate is 101. The patient asks what can he do since he is worried about reading side effects of vaccine so now he is feeling fine, then some other times it comes like first time this morning at work he feels silly then has nervousness or something and a panic attack, so they let him go home. He says he got home, and was feeling fine again. He says he tries to go to the bathroom, or tries to do something in his garage, and feels light headed and is feeling tired. He says he would like to know if that is normal, should he take anything. Lab data on 21Dec2020 included Blood pressure was 158/98, Heart rate was 101. The outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: rigors; This is a spontaneous report from contactable physician via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient had rigors that subsided in 12 hours after receiving the Pfizer-BioNTech COVID vaccine. The outcome was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Injection site pain, Pain, Periorbital discomfort
Clinical narrative: she has almost a sinus headache; the injection site was very, very sore; Chills/She couldn't get warm; cold; body aches; This is a spontaneous report from a contactable consumer (patient). This 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730) on 19Dec2020 15:15 at single dose on Left Arm for COVID-19 immunisation. Medical history included She had COVID on 10Nov2020. There were no concomitant medications. The patient received the COVID vaccine on 19Dec2020, the first dose. She didn't have much side effects or feel symptoms except the next morning on 20Dec2020, the injection site was very, very sore. As the day progressed, she had chills.  No fever, but chills. She couldn't get warm. This morning when she woke up she has almost a sinus headache on 21Dec2020. It's not really a headache, but around her eyes.  "Injection site was very, very sore" didn't really start until yesterday after lunch. She has not had chills this morning, just body aches.  She feels like she is about to get a cold. She had COVID on 10Nov2020.  She wasn't as cold this morning like she was when she went to bed last night.  She thinks the chills stopped some time in the night.  When she went to get in the shower this morning she felt the headache.  She still has the sensation around the eyes. She took some Tylenol about 11AM on 19Dec2020.  The outcome of the injection site was very, very sore was recovering, of other events were unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: she has almost a sinus headache; the injection site was very, very sore; Chills/She couldn't get warm; cold; body aches; This is a spontaneous report from a contactable consumer (patient). This 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730) on 19Dec2020 15:15 at single dose on Left Arm for COVID-19 immunisation. Medical history included She had COVID on 10Nov2020. There were no concomitant medications. The patient received the COVID vaccine on 19Dec2020, the first dose. She didn't have much side effects or feel symptoms except the next morning on 20Dec2020, the injection site was very, very sore. As the day progressed, she had chills.  No fever, but chills. She couldn't get warm. This morning when she woke up she has almost a sinus headache on 21Dec2020. It's not really a headache, but around her eyes.  "Injection site was very, very sore" didn't really start until yesterday after lunch. She has not had chills this morning, just body aches.  She feels like she is about to get a cold. She had COVID on 10Nov2020.  She wasn't as cold this morning like she was when she went to bed last night.  She thinks the chills stopped some time in the night.  When she went to get in the shower this morning she felt the headache.  She still has the sensation around the eyes. She took some Tylenol about 11AM on 19Dec2020.  The outcome of the injection site was very, very sore was recovering, of other events were unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pyrexia, Tachycardia
Clinical narrative: tachycardiac; Low grade like a 99.8; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 17Dec2020 at single dose at the left deltoid for immunization. Medical history included tachycardia heart condition (had an underline heart condition that was a tachycardia heart condition). There were no concomitant medications.  Patient got Pfizer vaccine on 17Dec2020. Patient really had not had any side effects except had a low grade like a 99.8 yesterday (in Dec2020). Which was probably just the vaccine patient was assuming probably just the vaccine had to do like kid when they get in then they get a little fever. On 19Dec2020, though however patient had tachycardia. Like right now patient was in 130 and blood pressure didn't read when went to stand. And patient had drink plenty fluids all day on 18Dec2020. Patient previously did have an underline heart condition that was a tachycardia heart condition. Patient had not had any issues with heart for about. Because the last time had it was about 2 years ago. Patient had a cardiac condition that caused her to be tachy-cardiac. But it was usually only when she was pregnant. But patient was not pregnant and it had been about 2 years since last episode of this. And the only this that changed was this on 17Dec2020. So, this was the first time patient had had anything that changed after getting that vaccine. Patient did not take any medication. She used to be on a beta blocked but she was recently taken off of that (She don't know 3 months ago). Outcome of events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling down entire left side of body, from face to foot.; Numbness and tingling of left side of face.; Had headache temporarily (resolved). Mostly on right side behind eye; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 48-year-old female patient received fist dose of bnt162b2 (BNT162B2, Batch/lot number: EK5730), via unknown route of administration in left arm on 21Dec2020 07:45 PM at single dose for covid-19 immunisation. She is not pregnant at the time of vaccination. Medical history included History of breast cancer. Past drug event included Known Allergies to medications, food, or other products: Codeine. Concomitant medications included tamoxifen. Facility type vaccine Hospital. No other vaccine in four weeks. Other medications the patient received within 2 weeks of vaccination included Tamoxifen, multi-vitamins, hair, skin and nails. The patient experienced Tingling down entire left side of body, from face to foot. Numbness and tingling of left side of face. Feel like I got Novocain shot in face. Had headache temporarily (resolved). Mostly on right side behind eye from 21Dec2020 08:00 PM. Outcome of the events was not recovered.  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. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Vaccine Facility information available. Location of injection information is available for all vaccines received on the same date.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Gait disturbance, Impaired work ability
Clinical narrative: I have had an excruciating back and hip pain; I have had an excruciating back and hip pain; I can barely walk around; This is a spontaneous report from a contactable consumer. This consumer (Respiratory therapist) reported that the 64-year-old male patient received bnt162b2 (BNT162B2, Pfizer BioNTech Covid 19 Vaccine), via unknown route of administration on 16Dec2020 at single dose for covid-19 immunisation ("It helps so that I won't get Covid."). Medical history included Blood pressure. Consumer stated, "I need it to report that I have had an excruciating back and hip pain. This is the fifth day and I still have pain but its slightly better but I don't think I am going to work today or tomorrow. I can barely walk around." Consumer stated, "It was given to me by a nurse at hospital." Consumer stated, "I take a high blood pressure medicine." Consumer stated, "I didn't take any Lab work." Treatment was received and consumer stated, "Yes I tried Ibuprofen." The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: arm pain; fatigue; severe nausea; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. This Physician (patient) reported that the patient of unknown age and gender received bnt162b2 (BNT162B2, reported as Pfizer-BioNTech COVID vaccine), via unspecified route of administration on arm on unknown date at single dose for covid-19 immunisation. Medical history was none. Concomitant medications were unknown. Physician reported arm pain, fatigue and severe nausea after receiving the Pfizer-BioNTech COVID vaccine. Patient is a HCP with no prior medical history. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling cold, Headache, Oral 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.