chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headaches; Nausea; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 45 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 09Apr2021 10:30 (Lot number: ER8734) at the age of 45 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, Lot Number: ER6199, Anatomical location: Right arm, Administration time: 10:30), administration date: 19Mar2021, when the patient was 45 years old, for covid-19 immunization, reaction: "some headaches". The following information was reported: HEADACHE (non-serious) with onset 09Apr2021, outcome "recovered" (09Apr2021), described as "Headaches"; NAUSEA (non-serious) with onset 09Apr2021, outcome "recovering", described as "Nausea". Therapeutic measures were not taken as a result of headache and nausea.  Additional information: The patient reported between one 22 hours she started receiving headaches and nausea, the headache went away and the nausea has been consistent for about eight hours so far. With the first dose that she received on 19Mar2021, she didn't receive the nausea side effect although she did have some headaches probably within that first week. The patient had not received any other vaccine within 4 weeks or any other medications within 2 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products and was not diagnosed with other illness, medical history and chronic health conditions.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021402734 same reporter/patient, different vaccine dose with partial same AE
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, SARS-CoV-2 test, Trigger finger
Clinical narrative: I started having poping/lock on my fingers. Similar to trigger finger.; A robotic movement when i tried to make a fist 1 day after the 1st sh it almost went away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2021 (Lot number: EL9269) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression." (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: TRIGGER FINGER (non-serious) with onset 04Feb2021 11:00, outcome "not recovered", described as "I started having poping/lock on my fingers. Similar to trigger finger."; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 04Feb2021 11:00, outcome "not recovered", described as "A robotic movement when i tried to make a fist 1 day after the 1st sh it almost went away.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of trigger finger, musculoskeletal stiffness.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other List of any other medications the patient received within 2 weeks of vaccination. She received the treatment of Pregabalin, etoricoxib for AE. Patient did not have any Allergies to medications, food, or other products. She was not diagnosed with Covid Prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Pain
Clinical narrative: Headache first 3 days after dose 2; Upset stomach; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovering", described as "Headache first 3 days after dose 2"; ABDOMINAL DISCOMFORT (non-serious) with onset Apr2021, outcome "recovering", described as "Upset stomach"; PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "body aches". It was unknown if therapeutic measures were taken as a result of headache, abdominal discomfort, pain.  Additional information: Other vaccine in four weeks was unknown, treatment received for AE was unknown, COVID prior vaccination unknown, COVID tested post vaccination unknown. Clinical course: Headache first 3 days after dose 2 Upset stomach and body aches as well.  Follow up (09Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The Updated information include: Upon Query awareness date of events response by reporter was 07Apr and Report on 08Apr.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Blood Glucose numbers went up with morning fasting numbers in the 200's/blood glucose numbers went up again with morning fasting numbers in the high 200's - low 300's; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: ER8730) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Blood Glucose numbers went up with morning fasting numbers in the 200's/blood glucose numbers went up again with morning fasting numbers in the high 200's - low 300's". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood glucose increased.  Additional information: After the first Pfizer Covid vaccine her Blood Glucose numbers went up with morning fasting numbers in the 200's and then her numbers stayed up for the rest of the day. After about 10 days, they went back to normal. Then, when I went for her second vaccine, her blood glucose numbers went up again with morning fasting numbers in the high 200's - low 300's. Then, they would go back down to the low 200's. She have never seen numbers like this before! Today, is 2 weeks after her second vaccine and her numbers are still high. She work with a diabetic counselor so she know how to eat. She was hoping her numbers come back down as after her first vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: swelling under his underarms, guessing that it was his lymph nodes; swelling under his underarms, He raised both arms to compare and the right arm is much bigger.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 13:40 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 60 years as dose 2, 0.3 ml, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Time given: 13:40, Lot Number: EN6208, Expiration date: 30 JUN 2021), administration date: 15Mar2021, when the patient was 60 years old, for Covid-19 Immunisation, reaction(s): "No adverse event". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Apr2021, outcome "not recovered", described as "swelling under his underarms, guessing that it was his lymph nodes"; SWELLING (non-serious) with onset 06Apr2021, outcome "not recovered", described as "swelling under his underarms, He raised both arms to compare and the right arm is much bigger.".  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. It was reported that patient was swelling under his underarms, so reporter was guessing that it was his lymph nodes. It was under the one arm that he got the vaccine. Reporter stated that patient noticed the swelling on 06Apr2021, but on 07Apr2021, the patient called the reporter down to show her the increased swelling. He raised both arms to compare and the right arm was much bigger. Reporter said that it has worsened from 06Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Laboratory test, Lymphadenopathy
Clinical narrative: right sided subclavicular lymphadenopathy with large lymph node noted right side of subclavicular notch.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2021 (Lot number: EL3429) at the age of 62 years as dose 2, single and administered in arm right, administration date 21Dec2020 (Lot number: EJ1683) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Recurrent Herpes Meningitis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 29Dec2021, outcome "not recovered", described as "right sided subclavicular lymphadenopathy with large lymph node noted right side of subclavicular notch.". The event "right sided subclavicular lymphadenopathy with large lymph node noted right side of subclavicular notch." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Adverse event resulted into doctor or other healthcare professional office/clinic visit. The patient received treatment of chest x-ray, ct scan, lab work and pain medication. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine and no other medications the patient received within 2 weeks of vaccination. The treatment received for the adverse event as pain medication. The patient was not diagnosed with Covid-19, prior to vaccination and since the vaccination the patient has not tested for Covid-19 No allergies to medications, food and other products.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Fatigue, Myalgia, Vaccination complication
Clinical narrative: her back bone is so pain; pain in her bones and muscles; she doesn't have energy to complete a report, she is so tired; pain in her bones and muscles; she has got strong reactions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "her back bone is so pain"; BONE PAIN (non-serious), MYALGIA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "pain in her bones and muscles"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "she doesn't have energy to complete a report, she is so tired"; VACCINATION COMPLICATION (non-serious) with onset Apr2021, outcome "unknown", described as "she has got strong reactions".  Additional information: Patient said she got the first shot of Pfizer COVID-19 vaccine last Friday so today had been 5 days. She said she had got strong reactions. She said her backbone was so pain, she had pain in her bones and muscles, and she was so tired. She said she wanted to make sure it was ok for her appointment for second shot which was 23Apr2021. She said she was afraid because someone tell her that the second shot was stronger for side effects, and with her back pain she could not move to get off the bed, she had to move to side and hold by arms to get up. She said why, most people did not feel that this strong. She said she did not have energy to complete a report, she was so tired, she wanted to talk to someone to help her, it could be dangerous.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Hypersomnia, Loss of personal independence in daily activities, Nausea
Clinical narrative: Extreme fatigue / exhausted; Sleeping 20 hours a day; Can't focus when I am awake; Can't functioning; Nauseous; My mouth tastes like blood; Throat is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 15:00 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Extreme fatigue / exhausted"; HYPERSOMNIA (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Sleeping 20 hours a day"; DISTURBANCE IN ATTENTION (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Can't focus when I am awake"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Can't functioning"; NAUSEA (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Nauseous"; TASTE DISORDER (non-serious) with onset 26Mar2021, outcome "not recovered", described as "My mouth tastes like blood"; OROPHARYNGEAL PAIN (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Throat is sore". Therapeutic measures were not taken as a result of fatigue, hypersomnia, disturbance in attention, loss of personal independence in daily activities, nausea, taste disorder, oropharyngeal pain.  Additional Information: It was reported that patient did not receive any other medications received 2 weeks of vaccination and any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, had not tested for COVID-19. There were no known allergies. The patient had been experiencing extreme fatigue since she got the shot, sleeping 20 hours a day and still felt exhausted. She stated that "I am about to lose my job because of you, I cant focus when I am awake because I am exhausted, I cant do my job, I can't functioning, I haven't even been awake long enough to buy food since the 27th. I have pretty much been laying here trying to get as much work done as possible before I fall asleep again. I am nauseous. My mouth tastes like blood. My throat is sore. I would rather be dead. It's been more than 2 weeks. This was only my first shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Taste disorder
Clinical narrative: Extreme fatigue / exhausted; Sleeping 20 hours a day; Can't focus when I am awake; Can't functioning; Nauseous; My mouth tastes like blood; Throat is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 15:00 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Extreme fatigue / exhausted"; HYPERSOMNIA (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Sleeping 20 hours a day"; DISTURBANCE IN ATTENTION (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Can't focus when I am awake"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Can't functioning"; NAUSEA (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Nauseous"; TASTE DISORDER (non-serious) with onset 26Mar2021, outcome "not recovered", described as "My mouth tastes like blood"; OROPHARYNGEAL PAIN (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Throat is sore". Therapeutic measures were not taken as a result of fatigue, hypersomnia, disturbance in attention, loss of personal independence in daily activities, nausea, taste disorder, oropharyngeal pain.  Additional Information: It was reported that patient did not receive any other medications received 2 weeks of vaccination and any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, had not tested for COVID-19. There were no known allergies. The patient had been experiencing extreme fatigue since she got the shot, sleeping 20 hours a day and still felt exhausted. She stated that "I am about to lose my job because of you, I cant focus when I am awake because I am exhausted, I cant do my job, I can't functioning, I haven't even been awake long enough to buy food since the 27th. I have pretty much been laying here trying to get as much work done as possible before I fall asleep again. I am nauseous. My mouth tastes like blood. My throat is sore. I would rather be dead. It's been more than 2 weeks. This was only my first shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: My arm was really sore; The person that gave me the first shot she pinched my arm you know to put the shot in and my muscle were really sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia; "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "High cholesterol" (ongoing), notes: Verbatim: High cholesterol. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "My arm was really sore"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "The person that gave me the first shot she pinched my arm you know to put the shot in and my muscle were really sore". Therapeutic measures were taken as a result of pain in extremity, vaccination site pain.  Additional Information: Patient stated, she just wanted to report some side effects that she having from the first one except for her arm was really sore for 2 or 3 days and she think its because the person that gave her the first shot she pinched her arm to put the shot in and her muscle were really sore. She has her regular medications that she takes, take medication for the blood pressure so that keeps it under control. Treatment: Consumer stated, she just used some Advil, its a pain relief. Consumer added, "No, is there anything she can do about she feels or not. Is it just going to pass or what.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Feeling really tired all day and as the day went on it got worse; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8732) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia; "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high.; "High cholesterol" (ongoing), notes: Verbatim: High cholesterol. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot Number-EN6205, Expiry Date-Unknown), administration date: 10Mar2021, for Covid-19 immunization, reaction(s): "my arm was really sore", "the person that gave me the first shot she pinched my arm you know to put the shot in and my muscle were really sore". The following information was reported: FATIGUE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Feeling really tired all day and as the day went on it got worse"; PAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "Body aches". Therapeutic measures were taken as a result of pain.  Additional information: She took medication for the blood pressure so that keeps it under control. The patient just wanted to report some side effects that she was having from the Pfizer this was the second injection that she had it did not have any side effects from the first one except for her arm was really sore for 2 or 3 days but this time her arm does not get sore at all and she thought it was because the person that gave her the first shot she pinched her arm, to put the shot in and her muscle were really sore, anyway this time she was feeling okay after she got the shot but yesterday, she got it on Wednesday and so the next day she was just feeling really tired all day and as the day went on it got worse and she had body aches and then today when she woke up she felt okay but the day was going on she was feeling really tired. When paraphrased the above concern, consumer stated, "Yeah more tired". She took regular medications that she takes. She used some Advil, it was a pain relief. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain in left shoulder where received vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 07Mar2021 (Lot number: EN6199) at the age of 74 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Heart attack", start date: Mar2020 (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "dual hearing aid" (unspecified if ongoing); "Hearing disability" (unspecified if ongoing); "allergy to iodine" (unspecified if ongoing), notes: allergy to the iodine in shellfish, makes his skin swell and itch; "anaphylactic reaction " (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement (ongoing). The following information was reported: MYALGIA (non-serious) with onset 07Mar2021, outcome "recovered" (07Mar2021), described as "Muscle pain in left shoulder where received vaccine".  Additional information: The patient took a bunch of heart medications. Clinical course: Patient had muscle pain in his left shoulder where he received the first dose Pfizer COVID-19 Vaccine. The muscle pain in the left shoulder lasted for two hours and that went away.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: moderate nausea that lasted for like 2 days; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) at the age of 27 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "recovered", described as "moderate nausea that lasted for like 2 days".  Additional information: The patient experienced the event a day after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain at injection site; fatigue; Slight swelling at injection site - dose 1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 15:15 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies to medications, food, or other products: yes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ROSUVASTATIN; IBUPROFEN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain at injection site"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Slight swelling at injection site - dose 1". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, vaccination site swelling.  Additional information: Facility where the most recent COVID-19 vaccine was administered: withheld. The patient receive no any other vaccines within 4 weeks prior to the COVID vaccine. The patient not diagnosed with COVID-19 Prior to vaccination. The patient not tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia oral, Pain in extremity, Tremor
Clinical narrative: quivering of his lower lip; numbness of his lower lip; slightly sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 22Feb2021 16:00 (Lot number: ENG198) at the age of 73 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Polio" (not ongoing), notes: victim of Polio in the 1950s. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Feb2021, outcome "recovered" (2021), described as "slightly sore arm"; TREMOR (non-serious) with onset 10Mar2021, outcome "recovering", described as "quivering of his lower lip"; HYPOAESTHESIA ORAL (non-serious) with onset 10Mar2021, outcome "recovering", described as "numbness of his lower lip". The events "slightly sore arm", "quivering of his lower lip" and "numbness of his lower lip" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, tremor, hypoaesthesia oral. Additional information: The patient received the 2nd dose of BNT162B2 (Lot number: EP7534) on 16Mar2021. The patient saw his physician on 05Apr2021 and had some bloodwork to make sure it was not post-polio syndrome.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Body aches".  Additional information: The patient had no known allergies. The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm was sore; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 43-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 11Mar2021 15:00 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: sulfa drugs; "Liver transplant" (unspecified if ongoing), notes: Recent liver transplant recipient. Concomitant medication(s) included: CYCLOSPORINE; MYCOPHENOLIC ACID; DESCOVY; TIVICAY. Past drug history included: Sustiva, reaction(s): "Allergy", notes: known allergies: Sustiva; Viramune, reaction(s): "Allergy", notes: known allergies: Viraumune. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Left arm was sore". Therapeutic measures were not taken as a result of vaccination site pain. Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404535 same drug/reporter/patient, different dose
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; slight headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 16Mar2021 12:00 (Lot number: EP7534) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "sore arm"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "slight headache". Therapeutic measures were not taken as a result of pain in extremity, headache.  Additional Information: The patient had no known allergies to medications, food or other products. The patient received antihistamines (unspecified) within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On unknown date (2021), the patient experienced sore arm and slight headache after the 1st shot. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404776 Same patient and drug, different dose and events
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Constant temple headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 54 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 31Mar2021 01:45 (Lot number: ER8734) at the age of 54 years as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication included: XARELTO. Past drug history included: Diclofenac, reaction: "drug allergy", notes: Known allergies: Diclofenac. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021 09:00, outcome "not recovered", described as "Constant temple headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient had other unspecified concomitant medications since an unknown date and for unknown indications. On 01Apr2021 at 09:00, next day of the vaccination, the patient experienced constant temple headache for 10 days and had taken tylenol as a therapeutic measure for the event, but it had not worked. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: extremely runny nose; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2021 (unspecified if ongoing), notes: symptoms: runny nose. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "extremely runny nose".  Additional information: The patient was experiencing extremely runny nose which was the same symptoms that she experienced when she got COVID-19 in Jan2021. The patient couldn't tell if it's allergies or COVID infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Additional Information: The patient wanted to cancel appointment on 07Apr2021 because of the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Feeling drunk, SARS-CoV-2 test
Clinical narrative: Felt light headed or dizzy almost felt like I was drunk; Felt light headed or dizzy almost felt like I was drunk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 16:00 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Product: COVID 19, Brand: Pfizer, Administration time: 04:00 PM, Vaccine location: Left arm,), administration date: 15Mar2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), FEELING DRUNK (non-serious) all with onset 09Apr2021 10:00, outcome "recovered" (Apr2021) and all described as "Felt light headed or dizzy almost felt like I was drunk". The event "felt light headed or dizzy almost felt like i was drunk" and "felt light headed or dizzy almost felt like i was drunk" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, feeling drunk. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. The patient was not diagnosed with COVID prior vaccination. Had to be taken by ambulance to emergency room. Blood work was done iv was given meclizine 25mg x2. All tests came back negative of anything being wrong.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Affective disorder, Diarrhoea, Food poisoning, Illness, Vomiting
Clinical narrative: Throwing up; Diarrhea; Upset; being sick; food poisoning; Was told she can get the shot up to 17 days after the 1st shot and hers will be 18 days with the next dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number :1), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Throwing up"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; AFFECTIVE DISORDER (non-serious), outcome "unknown", described as "Upset"; ILLNESS (non-serious), outcome "unknown", described as "being sick"; FOOD POISONING (non-serious), outcome "unknown", described as "food poisoning"; WRONG SCHEDULE (non-serious), outcome "unknown", described as "Was told she can get the shot up to 17 days after the 1st shot and hers will be 18 days with the next dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Caller stated she got her 2nd shot Friday morning from Pfizer and she got sick with throwing up and diarrhea yesterday, she thought she got food poisoning and she was going to get tested for Covid today. She was pretty sure it was not Covid, she didn't had a fever. Caller apologizing for being upset stated she was not 100% today after being sick yesterday. Caller clarified it was the Pfizer Covid shot.
Sex: F
Vaccine: COVID19
Symptoms: Wrong schedule
Clinical narrative: Throwing up; Diarrhea; Upset; being sick; food poisoning; Was told she can get the shot up to 17 days after the 1st shot and hers will be 18 days with the next dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number :1), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Throwing up"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; AFFECTIVE DISORDER (non-serious), outcome "unknown", described as "Upset"; ILLNESS (non-serious), outcome "unknown", described as "being sick"; FOOD POISONING (non-serious), outcome "unknown", described as "food poisoning"; WRONG SCHEDULE (non-serious), outcome "unknown", described as "Was told she can get the shot up to 17 days after the 1st shot and hers will be 18 days with the next dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Caller stated she got her 2nd shot Friday morning from Pfizer and she got sick with throwing up and diarrhea yesterday, she thought she got food poisoning and she was going to get tested for Covid today. She was pretty sure it was not Covid, she didn't had a fever. Caller apologizing for being upset stated she was not 100% today after being sick yesterday. Caller clarified it was the Pfizer Covid shot.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, Somnolence
Clinical narrative: felt overwhelmed with sleepiness; tired; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 13:15 (Lot number: ER8727) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer Survivor" (unspecified if ongoing); "Autoimmune Inflammatory Disorder" (unspecified if ongoing). Concomitant medications included: ESTER C [ASCORBIC ACID]; D3; B12 [MECOBALAMIN]. The following information was reported: SOMNOLENCE (non-serious) with onset 25Mar2021 12:30, outcome "recovered" (2021), described as "felt overwhelmed with sleepiness"; FATIGUE (non-serious) with onset 25Mar2021 12:30, outcome "recovered", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence, fatigue.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination including multivitamins. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Four days after vaccination, weather got warmer 68-70 degrees and suddenly patient felt overwhelmed with sleepiness. The patient fell asleep while stopped at a red light on her lunch break. She believed that the change to warm weather triggered this reaction. She felt extremely tired and slept for 2-3 days.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: nauseous; headache; dizzy; vomited on and off/was throwing up bile by 6 am; could not lay down or close my eyes; felt horrible; could not lay down or close my eyes without it getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 18:00 (Lot number: ew0153) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: avocados and apples" (unspecified if ongoing), notes: Known allergies= Avocados and Apples. Concomitant medication(s) included: ADDERALL. Vaccination history included: Bnt162b2 (Dose: 1, Lot no: En6206, Time: 04:00 PM, Anatomical location: Left arm), when the patient was 32 years old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 08Apr2021 04:00, outcome "not recovered", described as "nauseous"; HEADACHE (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "headache"; DIZZINESS (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "dizzy"; VOMITING (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "vomited on and off/was throwing up bile by 6 am"; SLEEP DISORDER (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "could not lay down or close my eyes"; FEELING ABNORMAL (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "felt horrible"; CONDITION AGGRAVATED (non-serious) with onset 08Apr2021 04:00, outcome "recovering", described as "could not lay down or close my eyes without it getting worse". The event "nauseous" was evaluated at the physician office visit and emergency room visit. The events "headache", "dizzy", "vomited on and off/was throwing up bile by 6 am", "could not lay down or close my eyes", "felt horrible" and "could not lay down or close my eyes without it getting worse" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea, headache, dizziness, vomiting, sleep disorder, feeling abnormal, condition aggravated.  Additional Information: Patient did not taken other vaccine in four weeks. Patient taken other medication in two weeks. Patient taken treatment with Ondansetron. No COVID test was done on post vaccination.   No follow-up attempts are possible. No further information is expected.