chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: She do have a caller (reporter) on the line, her husband (consumer) had received his first dose shot (Pfizer, Covid Vaccine) today but he does have headache, she wants to know if he was able to take Aspirin for that. He had the first vaccine and got headache. She (reporter) was unconformable to provide her information. Yes, she just want to know if that's ok to take any tablet of Aspirin. Can he take Advil, Ibuprofen. She didn't know if any of those were ok to take with vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up after taking first dose of the COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (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: VOMITING (non-serious), outcome "unknown", described as "Throwing up after taking first dose of the COVID vaccine".  Additional information: Reporter wants to check if throwing up is normal after taking first dose of the COVID vaccine because her sister is experiencing that side effect or adverse reaction. The patient was vomiting and she can't keep any fluid down; she can't retain any liquid like she can't hold any water down:  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: One of her grandchildren also got the vaccine and mentioned that she got "hit by a mad truck" but was okay in a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "One of her grandchildren also got the vaccine and mentioned that she got "hit by a mad truck" but was okay in a few days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Muscle spasms, SARS-CoV-2 antibody test
Clinical narrative: cramping; digestive issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 09:00 (Lot number: Ew0179) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELATONIN. Vaccination history included: Bnt162b2 (dose 1, single, lot number Ew0164, Expiry date: unknown, administration time: 08:15 AM, vaccine location: Left arm, Adverse event start date 21Apr2021, Adverse event start time 09:30 PM), administration date: 21Apr2021, when the patient was 38 years old, for COVID-19 immunisation, reaction(s): "Felt progressively weaker", "Terrible headache", "Trouble breathing", "Disturbing dreams", "Neck pain", "Shoulder pain", "Intermittent cramps", "Spotting".  The following information was reported: MUSCLE SPASMS (non-serious) with onset May2021, outcome "recovering", described as "cramping"; GASTROINTESTINAL DISORDER (non-serious) with onset May2021, outcome "recovering", described as "digestive issues". The events "cramping" and "digestive issues" 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 muscle spasms, gastrointestinal disorder.  Additional information: It was reported that the patient did not receive any other vaccine in four weeks. Other medications in two weeks includes multi vitamins, melatonin, Blissfield fe 1/20. The patient did not had COVID prior to vaccination. After the second dose the patient had many of the listed side effects as well as cramping and digestive issues extending at least 3 days after the vaccine. Multivitamin cannot be characterized by the proprietary medicinal product name or by the active substances and, as per EMEA guidelines, has not been coded in the concomitant medication but only captured in the narrative section. Reportedly the patient did not receive the treatment for the adverse event. The patient underwent lab test and procedure on 05May2021 which includes COVID-19 resulted negative.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Neck pain, Pain in extremity
Clinical narrative: Light headed; Nausea; fatigue; Sore left arm and neck for 2 days; Sore left arm and neck for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 11:00 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fatty liver" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; MELOXICAM; OMEGA 369 [BORAGO OFFICINALIS OIL;FISH OIL;OLEA EUROPAEA OIL]. Past drug history included: Tramadol, reaction(s): "Known allergies". Vaccination history included: Bnt162b2 (Dose 1, Light headed within minutes), for Covid-19 immunization, reaction(s): "Light headed"; Bnt162b2 (Dose 1, Nausea and fatigue for 2 1/2 days), for Covid-19 immunization, reaction(s): "fatigue", "Nausea"; Bnt162b2 (Dose 1, Slightly sore arm.), for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: DIZZINESS (non-serious) with onset 06May2021 13:00, outcome "not recovered", described as "Light headed"; NAUSEA (non-serious) with onset 06May2021 13:00, outcome "recovered" (May2021), described as "Nausea"; FATIGUE (non-serious) with onset 06May2021 13:00, outcome "recovered" (May2021), described as "fatigue"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06May2021 13:00, outcome "recovered" (May2021) and all described as "Sore left arm and neck for 2 days". Therapeutic measures were not taken as a result of dizziness, nausea, fatigue, neck pain, pain in extremity.  Additional information: Patient did not receive any other vaccine in four weeks. Other medications in two weeks were Tamsulosin, meloxicam, Multi vitamin, omega 369, c. Light-headed continuously since 5/6. Slight nausea and fatigue for 1 day. Sore left arm and neck for 2 days. It was reported as AE resulted in none of the above. If COVID prior vaccination and if COVID tested post vaccination was reported as No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 12:00 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional information: No other vaccine in four weeks and no other medications in two weeks. No known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Reported that, after first dose, patient had a little tinnitus after a week but went away. Did not know this was a side effect of Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a 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 right, administration date 14Apr2021 16:45 (Lot number: EW0164) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Fatigue". The event "fatigue" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of fatigue.  Additional information: Medical history included many (unspecified). The patient received unspecified medication within two weeks of vaccination. The patient did not have a history of allergies to medications, food, or other products. 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 vaccination. The event resulted in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: Her arm hurts so badly that she can't raise it more than a 90 degree angle from her side; Her arm hurts so badly that she can't raise it more than a 90 degree angle from her side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (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: PAIN IN EXTREMITY (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) all with onset May2021, outcome "unknown" and all described as "Her arm hurts so badly that she can't raise it more than a 90 degree angle from her side".  Additional Information: My daughter, (withheld), age 15, got her first COVID dose yesterday after school. Today her arm hurts so badly that she can't raise it more than a 90 degree angle from her side. She was able to attend school today, it seems to be tolerable if she doesn't move it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13May2021 (Lot number: ER2613) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Date of first Vaccination: 22Apr2021., Dose 1, Lot No : EW0172), administration date: 22Apr2021, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Lightheadedness".  Additional information: Consumer was asked to probe further questions: Consumer stated, No I have go to work I have just calling to tell that I was not sure how long these symptoms should last. Comment: As consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Diarrhoea, Eye pain
Clinical narrative: Getting a pain in my left eye and between my leg  and  my stomach; getting sharp pain every 3 minutes since  I had my shot; Getting a pain in my left eye and between my leg  and  my stomach; getting sharp pain every 3 minutes since  I had my shot; Getting a pain in my left eye and between my leg  and  my stomach; getting sharp pain every 3 minutes since  I had my shot; Abdominal pain; Chills; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: ABDOMINAL PAIN UPPER (non-serious), EYE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Getting a pain in my left eye and between my leg  and  my stomach; getting sharp pain every 3 minutes since  I had my shot"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "Abdominal pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  Additional information: consumer stated that, "I am getting a pain in my left eye and between my leg and my stomach, I am getting sharp pain every 3 minutes since  I had my shot, yesterday I had my shot."  Further consumer stated, "I had the COVID shot yesterday the first one, by Pfizer. And I am having abdominal pain like every 3 minute. I am not sure if I have to go to the hospital. And I am having chills and diarrhea." Consumer was informed about the role of Pfizer Medical Information and offered the number. Consumer was provided with the number of Pfizer Medical Information and was requested to select option 3, timings as 8 am to 8 pm Monday to Fridays and 9 am to 3 pm on Saturday and Sunday as per (EST).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Getting a pain in my left eye and between my leg  and  my stomach; getting sharp pain every 3 minutes since  I had my shot; Getting a pain in my left eye and between my leg  and  my stomach; getting sharp pain every 3 minutes since  I had my shot; Getting a pain in my left eye and between my leg  and  my stomach; getting sharp pain every 3 minutes since  I had my shot; Abdominal pain; Chills; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: ABDOMINAL PAIN UPPER (non-serious), EYE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Getting a pain in my left eye and between my leg  and  my stomach; getting sharp pain every 3 minutes since  I had my shot"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "Abdominal pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  Additional information: consumer stated that, "I am getting a pain in my left eye and between my leg and my stomach, I am getting sharp pain every 3 minutes since  I had my shot, yesterday I had my shot."  Further consumer stated, "I had the COVID shot yesterday the first one, by Pfizer. And I am having abdominal pain like every 3 minute. I am not sure if I have to go to the hospital. And I am having chills and diarrhea." Consumer was informed about the role of Pfizer Medical Information and offered the number. Consumer was provided with the number of Pfizer Medical Information and was requested to select option 3, timings as 8 am to 8 pm Monday to Fridays and 9 am to 3 pm on Saturday and Sunday as per (EST).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Nausea, Vomiting
Clinical narrative: He really wasn't feeling well; Nausea; Getting dizzy when turning from one side to the other in bed; Vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 16May2021 (Lot number: EW0182) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 17May2021, outcome "unknown", described as "Getting dizzy when turning from one side to the other in bed"; VOMITING (non-serious) with onset 17May2021, outcome "unknown", described as "Vomited"; MALAISE (non-serious), outcome "unknown", described as "He really wasn't feeling well"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional information included: Caller reported that when he woke up on 17May2021, he was getting dizzy when he turned from one side to the other. Caller reported that he vomited twice the morning of 17May2021.Caller wants to know if these symptoms are common Caller is mostly concerned about the dizziness since he has a history of Vertigo. Caller states he will be going to the Emergency Room.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: Why am I having an allergic reaction to the vaccine?; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Why am I having an allergic reaction to the vaccine?".  Additional information: Why am I having an allergic reaction to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity, Protein total decreased
Clinical narrative: his Spike Protein blood test had results of 16.7 U per mL (which is considered low).; Sore Arm after second dose of the Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EN6201) at the age of 71 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 (1st Dose, Lot Number: EZ9765.), administration date: 02Feb2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: PROTEIN TOTAL DECREASED (non-serious) with onset 12May2021, outcome "unknown", described as "his Spike Protein blood test had results of 16.7 U per mL (which is considered low)."; PAIN IN EXTREMITY (non-serious) with onset 23Feb2021, outcome "recovered" (24Feb2021), described as "Sore Arm after second dose of the Covid Vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concerned about administration of his vaccines: Patient stated that with the first dose of the vaccine it was administered so fast he could not believe they had time to push the vaccine into his arm. Stated he had no soreness from it or anything. With his second dose of the vaccine, he said the person who gave it was mixing things and seemed a little confused. Stated he had a sore arm for a day after that one. Patient wondered if they were administered properly and if not is that why his immunity to Covid was low. Prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect, AE(s) following prior vaccinations, patient's medical history (including any illness at time of vaccination), family medical history relevant to AE(s) reported as none at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Memory impairment
Clinical narrative: became forgetful; can't walk; extreme dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12May2021 14:45 (Lot number: EW0173, Expiration Date: 31Jul2021) at the age of 38 years as dose 2, single and administered in arm right, administration date 2021 (Lot number: ER8729, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (ongoing), notes: Verbatim: Epilepsy. Concomitant medication(s) included: LAMOTRIGINE taken for epilepsy (ongoing). The following information was reported: DIZZINESS (non-serious) with onset 13May2021, outcome "not recovered", described as "extreme dizziness"; MEMORY IMPAIRMENT (non-serious) with onset 17May2021, outcome "not recovered", described as "became forgetful"; GAIT DISTURBANCE (non-serious) with onset 17May2021, outcome "not recovered", described as "can't walk".  Additional information-Caller reports that after her second dose of the Covid vaccine she had felt extreme dizziness and it's to the point she can't walk and keeps forgetting things.  She wants to know if this was all normal. States the dizziness or bad equilibrium had not been everyday. States she got the second dose on 12May2021 and the day after was when the dizziness started, the 13th. It was not that bad at first the first 2 days and it would not happen everyday, but every few days. It would be some kind of dizziness. Started having a hard time with walking today and since this morning it has become worse and forgetting things has been really bad today and getting worse. States she didn't get any other shots the same day and no problems with vaccines in past. She doesn't get vaccines, not since she was younger. Provides first dose of Covid vaccine was given exactly 2 weeks before the second one at the same time. She did start a new medicine for epilepsy and they are building up on the dose.  Vaccination Facility Type was School/Student Health Clinic. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as None. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was None  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: menstrual cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. Relevant medical history included: "pre-existing down syndrome" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; IBUPROFEN. The following information was reported: DYSMENORRHOEA (non-serious), outcome "unknown", described as "menstrual cramps". Therapeutic measures were taken as a result of dysmenorrhoea.  Additional Information: Caller, consumer is scheduled to take the 2nd dose of the Pfizer Covid-19 vaccine today at (3:45pm) with her daughter (patient). Daughter has a condition of down syndrome and currently has menstrual cramps. To relieve that, consumer gave her daughter 2 (pcs.) of Acetaminophen 500 mg today at 10:00 am and 1 (pc.) Ibuprofen 200 mg at 10:30 am. However, upon checking the fact sheet she read that these medicines (Acetaminophen and Ibuprofen) should not be given before getting the Covid-19 vaccine. She wanted to know if she needs to reschedule the 2nd dose for her daughter because there might be an interaction with the vaccine or will it be fine to proceed. The 1st dose was given 26Apr (21days schedule).  Created Manual AE Form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Arm began to hurt in injection site over 2 weeks after 1st dose.; Cannot move my arm.; Left side frozen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 08:30 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known_allergies penicillin" (unspecified if ongoing), notes: known_allergies penicillin. The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 12May2021, outcome "unknown", described as "Left side frozen"; VACCINATION SITE PAIN (non-serious) with onset 16May2021 06:00, outcome "not recovered", described as "Arm began to hurt in injection site over 2 weeks after 1st dose."; LIMB DISCOMFORT (non-serious) with onset 16May2021 06:00, outcome "not recovered", described as "Cannot move my arm.". Therapeutic measures were not taken as a result of musculoskeletal stiffness.  Additional information: Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment drug received for the adverse events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: I have got poison ivy on both my arms and it is painful and it is blistering; It is possible that she might miss the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (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: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "I have got poison ivy on both my arms and it is painful and it is blistering; It is possible that she might miss the second dose".  Additional information: Caller reports pulling weeds on Saturday. On Sunday she broke out and became inflamed between her wrist and elbow. Caller voiced she must have touched some poison. Caller has appointment scheduled for Wednesday 19May2021 for her second Pfizer Covid 19 Vaccine. Caller asking if she will be able to receive her vaccine. Caller asking if she cannot receive the Pfizer Covid 19 Vaccine, what amount of timing will she have to receive the second vaccine. Reaction/event as reported by primary source was i have got poison ivy on both my arms and it is painful and it is blistering; It is possible that she might miss the second dose. Additional Context: Call was transferred from Pfizer by (Name)(CEP ID: Withheld) Transferring agent stated, I have a caller here. She received the first dose of the vaccine on 28Apr2021 and she is supposed to get the second dose on 19May2021 however the past weekend she got in contact with the poison ivy and right now she has blister on both arm. It is possible that she might miss the second dose. Consumer stated, I am book this Wednesday to get my second shot. I want to know if I miss it what happens. I have got poison ivy on both my arms and it is painful and it is blistering and as soon as I got off the phone, I have an appointment to go down to the drug store and he going to see if he can help me. So, I just want to know if I can still get my second Pfizer shot on Wednesday. (Vaccine name not clarified, hence suspect captured as Unspecified Vaccine and is this a Pfizer product tab Checked-Yes). Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number. Consumer further sated, can you give me any information or do I have to call this number. Consumer was informed that Pfizer medical information is the concerned department for all queries and advised to call on the number provided. Limited information was available over the call as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown. QR Comment: AE filed conservatively.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Seasonal allergy
Clinical narrative: seasonal allergies; runny nose (originally thought to be due to allergies but was excessive by 16May); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 15:30 (Lot number: ew0169) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALEVE; NAPROXEN; ZYRTEC ALLERGY.  The following information was reported: RHINORRHOEA (non-serious) with onset 14May2021, outcome "recovered", described as "runny nose (originally thought to be due to allergies but was excessive by 16May)"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "seasonal allergies ". Therapeutic measures were taken as a result of rhinorrhoea.  Additional information: The patient did not receive any other vaccines within four. Prior to the vaccination, the patient was not diagnosed with COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no Known allergies. The patient had runny nose on 14May2021 but as she has seasonal allergies did not attribute to anything beyond seasonal allergies which are occurring right now. Late in the day 16May2021, runny nose was excessive beyond seasonal allergies so deemed this should be reported. She did not need medical attention (Doctor's visit).   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Paraesthesia oral, Tremor
Clinical narrative: tremors; tingling in her tongue; sugar levels have been very low; 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 04May2021 (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: Bnt162b2 (Dose number=1), for COVID-19 immunisation. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "tremors"; PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "tingling in her tongue"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "sugar levels have been very low". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient received the second dose of Pfizer's COVID-19 vaccine on 04May, last week she began to feel tremors in her body, tingling in her tongue and her "sugar" levels have been very low, it's the first time anything like this has happened to her. She wants to know if this could be related to the vaccine. The patient declined to be transferred to the safety unit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: experienced great pain in her neck and head; experienced great pain in her neck and head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN taken for hypertension.  The following information was reported: NECK PAIN (non-serious), HEADACHE (non-serious) all with onset 14May2021, outcome "recovered" (May2021) and all described as "experienced great pain in her neck and head".  Additional information: It was reported that, Caller mentioned that she received her 1st dose of the vaccine on 14May2021 and experienced great pain in her neck and head but was over that now. She was asking when she could take her hypertension medications again, if she could take it normally or at another time. She was taking Olmesartan 40 mg and a Combination pill with 37 mg of medication and a water pill. She does not know the name of the pill with 2 medicines in it. She does not have the other dosage for the pill with 2 medicines in it. She'd have to look through her paperwork to get that information. She was reading the Olmesartan from a pharmacy bottle and the print is difficult to see. This report was not related to a study or program. It was reported that patient received other products. She declines to file safety report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: On May 14th experienced body aches, chills, and exhaustion; On May 14th experienced body aches, chills, and exhaustion; On May 14th experienced body aches, chills, and exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 13May2021 (Lot number: EW0183) 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 1), for COVID-19 immunization. The following information was reported: PAIN (non-serious), CHILLS (non-serious), FATIGUE (non-serious) all with onset 14May2021, outcome "unknown" and all described as "On May 14th experienced body aches, chills, and exhaustion".  Additional information:Event took place after use of product.  No follow-up attempts are possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: Caller states last night her daughter developed a sore throat that is lasting into today; Caller states her daughter had a sore arm which was to be expected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2), administration date 15May2021 (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: PAIN IN EXTREMITY (non-serious) with onset 15May2021, outcome "unknown", described as "Caller states her daughter had a sore arm which was to be expected"; OROPHARYNGEAL PAIN (non-serious) with onset 16May2021, outcome "not recovered", described as "Caller states last night her daughter developed a sore throat that is lasting into today". Therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: Patient took Advil for sore throat.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Joint injury, Pruritus
Clinical narrative: monitoring period he noticed a sensation in his right elbow like "someone smeared it with icy hot".  He states it feels like its hot and then it gets cold.; monitoring period he noticed a sensation in his right elbow like "someone smeared it with icy hot".  He states it feels like its hot and then it gets cold.; had itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14May2021 (Lot number: EW0170) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYMBICORT "ASTRAZENECA"; FLONASE ALLERGY RELIEF; OMEPRAZOL E taken for acidosis; LISINOPRIL HYDROCHLORTHIAZID taken for blood pressure measurement. The following information was reported: FEELING OF BODY TEMPERATURE CHANGE (non-serious), JOINT INJURY (non-serious) all with onset 14May2021, outcome "recovering" and all described as "monitoring period he noticed a sensation in his right elbow like "someone smeared it with icy hot". He states it feels like its hot and then it gets cold."; PRURITUS (non-serious) with onset May2021, outcome "recovered" (May2021), described as "had itching".  Additional Information: Patient had no medical history. After receiving the shot, within the 30 minutes the caller noticed that his right elbow, the arm that he had the injection, feels like it was smeared with icy hot. He stated it felt like it was hot and then it gets cold. The caller had itching as well in that spot but it only lasted for an hour and then it went away. The icy hot feeling has been there since the 14May2021 and its not as bad as when it first happened.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram
Clinical narrative: Bilateral enlarged axillary lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EL9262) as dose 1, single and administered in arm right (Lot number: EN6200) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHROID. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Feb2021, outcome "not recovered", described as "Bilateral enlarged axillary lymph nodes". The event "bilateral enlarged axillary lymph nodes" was 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 lymphadenopathy.  Additional information: The patient did not receive any vaccination prior to covid and did not tested for covid post vaccination. No allergies. The patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Feeling abnormal, Limb discomfort, Vitreous floaters
Clinical narrative: Floaters in left eye; Edgy and Agitated; edgy; Discomfort in Arm; Brain Fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN6207) at the age of 65 years as 2nd dose,single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood Pressure, diagnosed about 10 years ago. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; HCTZ taken for blood pressure measurement. Vaccination history included: Bnt162b2 (First Dose of the Covid Vaccine: Given on 16 Feb 2021; Lot Number: EN6200.), administration date: 16Feb2021, when the patient was 65 years old, for COVID-19 IMMUNIZATION, reaction(s): "sore arm". The following information was reported: LIMB DISCOMFORT (non-serious) with onset May2021, outcome "not recovered", described as "Discomfort in Arm"; FEELING ABNORMAL (non-serious) with onset May2021, outcome "not recovered", described as "Brain Fog"; VITREOUS FLOATERS (non-serious) with onset 13May2021, outcome "not recovered", described as "Floaters in left eye"; AGITATION (non-serious) with onset May2021, outcome "not recovered", described as "Edgy and Agitated"; FEELING ABNORMAL (non-serious) with onset May2021, outcome "not recovered", described as "edgy". Additional information: States right after the vaccine he had slight soreness in the left arm. Says it lasted maybe a day if that after the first dose of the vaccine. after the second dose of the vaccine he felt edgy and agitated that evening. States he felt that way for a couple hours and then he was fine. The patient was stated lately he has been having unusual symptoms and wonders if they are connected to the vaccine. He was stated that about a week ago he noticed discomfort in his left arm where the vaccine was given, no redness or anything like that. He was said that he had been doing yard work the day he noticed it so he did not think much of it. Thursday morning he woke up and had floaters in his left eye. He went online to see the danger possibly associated with floaters in the eye and it said to call the eye doctor. He went to the eye doctor and they told him they could see the floaters but no other issues; the floaters may possibly go away on their own. Stated he has also been somewhat edgy and agitated; like he felt the night after his second dose of the vaccine. Patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Ear pain, Ear swelling
Clinical narrative: ear congestion; ear pain and felt like water was in her ear; She felt like her ear was quite swollen in the ear on the same side she got the shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2) (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: EAR CONGESTION (non-serious), outcome "recovered", described as "ear congestion"; EAR PAIN (non-serious), outcome "recovered", described as "ear pain and felt like water was in her ear"; EAR SWELLING (non-serious), outcome "recovered", described as "She felt like her ear was quite swollen in the ear on the same side she got the shot.".  Additional Information: The reporter stated that her daughter got her first dose of the vaccine and had ear congestion, ear pain and felt like water was in her ear. She felt like her ear was quite swollen in the ear on the same side she got the shot. She stated that had gone away and she was scheduled for the second dose of the vaccine on Thursday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pain
Clinical narrative: felt a little soreness; slight headache over the past hour; developed pretty bad congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 17May2021 09:00 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bronchitis" (unspecified if ongoing), notes: since usually he gets bronchitis every year, but he has not had it this year. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 17May2021, outcome "unknown", described as "felt a little soreness"; HEADACHE (non-serious) with onset 17May2021, outcome "not recovered", described as "slight headache over the past hour"; NASAL CONGESTION (non-serious) with onset 17May2021, outcome "unknown", described as "developed pretty bad congestion".  Additional Information: Patient would like to know if it was safe to take Mucinex after the covid vaccine. Patient got his 1st dose of Pfizer this morning about 9:00. Patient says he felt a little soreness and a slight headache over the past hour, patient developed pretty bad congestion. Investigation assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.