chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling drunk, Pain, Vertigo, Visual impairment
Clinical narrative: he moves quick he really gets dizzy, like getting out of bed or laying down and trying to get up / more of when he moves, when he is in motion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 09:00 (Lot number: EN6208) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes type 2" (ongoing), notes: diagnosed 8 years ago. There were no concomitant medications. The following information was reported: DIZZINESS POSTURAL (non-serious) with onset 24Mar2021, outcome "not recovered", described as "he moves quick he really gets dizzy, like getting out of bed or laying down and trying to get up / more of when he moves, when he is in motion".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that since the past two days patient has been really dizzy and yesterday morning the room was spinning around. The event happens when he moved quickly he really gets dizzy, like getting out of bed or laying down and trying to get up, he can tell it was happening. He got dizzy more of when he moved, when he was in motion. Event was persisting, that he got better and then it started again.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness postural
Clinical narrative: he moves quick he really gets dizzy, like getting out of bed or laying down and trying to get up / more of when he moves, when he is in motion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 09:00 (Lot number: EN6208) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes type 2" (ongoing), notes: diagnosed 8 years ago. There were no concomitant medications. The following information was reported: DIZZINESS POSTURAL (non-serious) with onset 24Mar2021, outcome "not recovered", described as "he moves quick he really gets dizzy, like getting out of bed or laying down and trying to get up / more of when he moves, when he is in motion".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that since the past two days patient has been really dizzy and yesterday morning the room was spinning around. The event happens when he moved quickly he really gets dizzy, like getting out of bed or laying down and trying to get up, he can tell it was happening. He got dizzy more of when he moved, when he was in motion. Event was persisting, that he got better and then it started again.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: insomnia; This is a spontaneous report received from a non-contactable reporter (consumer) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: INSOMNIA (non-serious), outcome "unknown", described as "insomnia".   Additional information: The patient wanted to know if a side effect of the Pfizer BioNTech Covid vaccine was insomnia. He is not sure when it started, may have started around the time of the first vaccine.  He can go to bed at 11pm or midnight and then wake up at 3am-4am and toss and turn for a few hours. He said his doctor knows nothing on the topic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Since receiving her first dose she has been experiencing elevated blood glucose levels; 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 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: LANTUS. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Since receiving her first dose she has been experiencing elevated blood glucose levels". The event "since receiving her first dose she has been experiencing elevated blood glucose levels" 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 blood glucose increased.  Additional information: Patient, (age: 35, Unit: Unknown), with Type 2 diabetes, received first dose of Pfizer BioNTech Covid Vaccine on 24Mar2021. Since receiving her first dose, she has been experiencing elevated blood glucose levels.  Her blood sugar was usually in the 110s, but two hours after receiving the vaccine her blood sugar was 290.  She usually tests 2-4 times per day, and since then she has only had one reading in the "green zone."  They have now been in the 200s all they way up to the 300s.  She spoke with her doctor and they adjusted her LANTUS dose for a few days but she was still having high readings.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm after the first 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 male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "infection of the chin" (unspecified if ongoing), notes: has been on an antibiotic prescribed by his HCP off and on for the past two months. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm after the first dose".  Additional Information: The patient was prescribed with an antibiotic by his HCP and has been on an antibiotic off and on for the past two months for an infection of the chin and was asking if he can take the antibiotics after dose 2. The patient received the second dose of the BNT162B2 on 26Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She explained she had a "sore arm" after the first dose; 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 74 -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. Past drug history included: Tylenol for back pains; Cortisone for back pain; Tylenol for not feeling well. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She explained she had a "sore arm" after the first dose". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: removed the event "Circumstance or information capable of leading to medication error".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Dizziness, Nausea, Pain in extremity
Clinical narrative: sore arm; nausea; diarrhea; woosy; Patient felt as though she had COVID all over again/ felt like she went through the same COVID experience in three days after the vaccine; 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 58 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Mar2021 17:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020, stop date: Nov2020, notes: for about 14 days in Nov2020. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "mild headache"; CHILLS (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "chills/ shivering"; NAUSEA (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "nausea"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "hot, freezing"; DIARRHOEA (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "diarrhea"; PYREXIA (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "fever"; MALAISE (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "sick"; DIZZINESS (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "woosy"; SUSPECTED COVID-19 (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "Patient felt as though she had COVID all over again/ felt like she went through the same COVID experience in three days after the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Clinical course: First dose of the Pfizer COVID vaccine on 22Mar2021 around 5 PM. Patient reported that starting on 24Mar2021 at around 3 PM Wednesday and 25Mar2021 Thursday, she experienced a sore arm, mild headache, chills, nausea, hot, freezing, shivering, couldn't function and diarrhea all day. Patient felt as though she had COVID all over again. Had COVID for about 14 days in Nov2020, and felt like she went through the same experience in three days after the vaccine. Also had a fever, headache, couldn't function and felt like she hit a wall, sick and woosy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: sore arm; nausea; diarrhea; woosy; Patient felt as though she had COVID all over again/ felt like she went through the same COVID experience in three days after the vaccine; 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 58 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Mar2021 17:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020, stop date: Nov2020, notes: for about 14 days in Nov2020. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "mild headache"; CHILLS (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "chills/ shivering"; NAUSEA (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "nausea"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "hot, freezing"; DIARRHOEA (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "diarrhea"; PYREXIA (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "fever"; MALAISE (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "sick"; DIZZINESS (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "woosy"; SUSPECTED COVID-19 (non-serious) with onset 24Mar2021 15:00, outcome "unknown", described as "Patient felt as though she had COVID all over again/ felt like she went through the same COVID experience in three days after the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Clinical course: First dose of the Pfizer COVID vaccine on 22Mar2021 around 5 PM. Patient reported that starting on 24Mar2021 at around 3 PM Wednesday and 25Mar2021 Thursday, she experienced a sore arm, mild headache, chills, nausea, hot, freezing, shivering, couldn't function and diarrhea all day. Patient felt as though she had COVID all over again. Had COVID for about 14 days in Nov2020, and felt like she went through the same experience in three days after the vaccine. Also had a fever, headache, couldn't function and felt like she hit a wall, sick and woosy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Started getting rising numbers of [his] glucose / glucose levels around "130, 140, and 150"; 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 75 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 04Mar2021, outcome "unknown", described as "Started getting rising numbers of [his] glucose / glucose levels around "130, 140, and 150"". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Additional information: The patient got the first dose of the Pfizer-BioNTech COVID-19 vaccine "on the 4th, and on the 7th" he "started getting rising numbers of [his] glucose in the morning". He mentioned his glucose levels are usually between "95-105", but now they have been around "130, 140, and 150".  He explained his "old internist" mentioned to add "half a pill" when his glucose level rise, therefore instead of taking 2000 mg of Metformin/2 pills he has been taking 2500 mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product administered at inappropriate site
Clinical narrative: Headache; Anatomical site of injection: Left buttock; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in gluteus medius left, administration date 26Mar2021 11:00 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 26Mar2021 12:00, outcome "not recovered", described as "Headache"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 26Mar2021 11:00, outcome "unknown", described as "Anatomical site of injection: Left buttock". Therapeutic measures were not taken as a result of headache. Additional information: The vaccine was administered in the left buttock. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19, had no other vaccine in four weeks, no covid prior vaccination and has not been tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A 69-year-old male patient received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included leg pain (unspecified if ongoing). Concomitant medication included Mobic. The patient experienced fatigue (little tired the first day only), with outcome of recovered. Additional information: Patient stated he has a chronic problem for 20 years: his leg hurting. Reportedly, patient has taken Mobic for years, but discontinued it two days before receiving the first vaccine dose. Patient asked when he can resume his medication. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza, Lymphadenopathy, Malaise
Clinical narrative: lots of muscle soreness in her legs and arms, not feeling good at all; not feeling good at all; lymphnodes swelling on one side of her throat.; she is really tired; headache / head hurts really bad; nausea; feels like a touch of the flu; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergic to seafood" (unspecified if ongoing); "allergic to iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "she is allergic to benadryl".  The following information was reported: MYALGIA (non-serious) with onset 26Mar2021, outcome "unknown", described as "lots of muscle soreness in her legs and arms, not feeling good at all"; MALAISE (non-serious) with onset 26Mar2021, outcome "unknown", described as "not feeling good at all"; LYMPHADENOPATHY (non-serious) with onset 26Mar2021, outcome "unknown", described as "lymphnodes swelling on one side of her throat."; FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "she is really tired"; HEADACHE (non-serious) with onset 26Mar2021, outcome "unknown", described as "headache / head hurts really bad"; NAUSEA (non-serious) with onset 26Mar2021, outcome "unknown", described as "nausea"; INFLUENZA (non-serious) with onset 26Mar2021, outcome "unknown", described as "feels like a touch of the flu". Therapeutic measures were taken as a result of myalgia, malaise, lymphadenopathy, fatigue, headache, nausea, influenza.  Additional information: The patient took two Tylenol but no ibuprofen. The patient wanted to know if this was normal or what she needed to do.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: lots of muscle soreness in her legs and arms, not feeling good at all; not feeling good at all; lymphnodes swelling on one side of her throat.; she is really tired; headache / head hurts really bad; nausea; feels like a touch of the flu; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergic to seafood" (unspecified if ongoing); "allergic to iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "she is allergic to benadryl".  The following information was reported: MYALGIA (non-serious) with onset 26Mar2021, outcome "unknown", described as "lots of muscle soreness in her legs and arms, not feeling good at all"; MALAISE (non-serious) with onset 26Mar2021, outcome "unknown", described as "not feeling good at all"; LYMPHADENOPATHY (non-serious) with onset 26Mar2021, outcome "unknown", described as "lymphnodes swelling on one side of her throat."; FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "she is really tired"; HEADACHE (non-serious) with onset 26Mar2021, outcome "unknown", described as "headache / head hurts really bad"; NAUSEA (non-serious) with onset 26Mar2021, outcome "unknown", described as "nausea"; INFLUENZA (non-serious) with onset 26Mar2021, outcome "unknown", described as "feels like a touch of the flu". Therapeutic measures were taken as a result of myalgia, malaise, lymphadenopathy, fatigue, headache, nausea, influenza.  Additional information: The patient took two Tylenol but no ibuprofen. The patient wanted to know if this was normal or what she needed to do.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: when I received my first Pfizer vaccine I just had a little bit of a sore arm and that was it.; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing), notes: Had COVID-19 over thanksgiving last year (2020), with no hospitalization. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "when I received my first Pfizer vaccine I just had a little bit of a sore arm and that was it.".  Additional information: The patient went to urologist (past this week -  at the time of reporting) and the nurse in the office was shocked that she had her first Pfizer vaccine dose and told her that she should not get the second dose. The nurse said because she had already had the COVID-19 virus and had antibodies already and getting vaccinated could give her a heart attack. The patient was asking if it was true.   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: Axillary pain, Pain, Swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 28-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6204), at the age of 28, in right arm, on Mar 18, 2021, at 16:00, single dose, for COVID-19 immunisation. Medical history included arthritis (unspecified if ongoing). The patient's concomitant medications not reported. Past drug history included allergy to ciprofloxacin and prednisone. The patient experienced axillary pain (pain/soreness is worse when touched/restricted movement of arm due to pain from soreness) and swelling (swollen and sore armpit); all onset Mar 24, 2021, with outcome of not recovered. No therapeutic measures taken as a result of axillary pain/pain and swelling. Additional information: The patient did not have COVID-19 prior vaccination. The patient has not tested post-vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced chills, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (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: NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Vaccination site pain
Clinical narrative: Pain at injection site lasting 2 days; Elevated temperature 99.5 overnight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 09:00 (Lot number: ER8730) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; CALCIUM; MELATONIN. Vaccination history included: Bnt162b2 (Dose 1, lot number: EN6206, administration time: 09:00, vaccine location: Left arm), administration date: 05Mar2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Mar2021 02:00, outcome "recovering", described as "Pain at injection site lasting 2 days"; BODY TEMPERATURE INCREASED (non-serious) with onset 27Mar2021 02:00, outcome "recovering", described as "Elevated temperature 99.5 overnight". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, body temperature increased.  Additional Information: Concomitant medication also included multi vitamin. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient has no allergies to medications, food, or other products. The patient age at vaccination was 61 year (as reported).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; achiness; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Mar2021 (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 1), for COVID-19 Immunisation. The following information was reported: CHILLS (non-serious) with onset 26Mar2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "achiness". Additional information: Patient denies having any symptoms except some chills and achiness the day after receiving the second dose. Patient asks if having been exposed to covid will change how the vaccine works or if the patient needs to repeat the dose. Patient has not tested positive for covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Painful lymph nodes; Fatigue; Tired low back; Severe headache; Sore arm; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:45 (Lot number: ER8730) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: sulfa causes nausea. Concomitant medication(s) included: LISINOPRIL; AMLODIPINE; VALACYCLOVIR HCL. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Painful lymph nodes"; FATIGUE (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Fatigue"; BACK PAIN (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Tired low back"; HEADACHE (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Severe headache"; PAIN IN EXTREMITY (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Sore arm"; OROPHARYNGEAL PAIN (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Sore throat". Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, back pain, headache, pain in extremity, oropharyngeal pain.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Painful lymph nodes; Fatigue; Tired low back; Severe headache; Sore arm; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:45 (Lot number: ER8730) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: sulfa causes nausea. Concomitant medication(s) included: LISINOPRIL; AMLODIPINE; VALACYCLOVIR HCL. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Painful lymph nodes"; FATIGUE (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Fatigue"; BACK PAIN (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Tired low back"; HEADACHE (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Severe headache"; PAIN IN EXTREMITY (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Sore arm"; OROPHARYNGEAL PAIN (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Sore throat". Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, back pain, headache, pain in extremity, oropharyngeal pain.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 26-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 26, in left arm, on Feb 4, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient's medical history not reported. Concomitant medication included Prozac. The patient had  pain in extremity/sore arm, fatigue and headache, onset Feb 4, 2021, at 20:00, outcome of recovering. No therapeutic measures taken as a result of pain in extremity, fatigue and headache. Additional information: The patient received dose #2 on Feb 25, 2021, at 09:30 am. Vaccine location: Left arm. The patient did not have COVID-19 prior vaccination. The patient has not tested post vaccination. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 24, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced  dizziness, vomiting and nausea, onset Mar 2021, with outcome of recovered (Mar 2021). Patient stated 6 hours later, she experienced dizziness and vomiting for one day. She experienced nausea for two days but felt better today. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: A little tired; Headache; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis (MS)" (unspecified if ongoing); "Joint pain" (unspecified if ongoing); "Hip replacement" (not ongoing). The patient took concomitant medications. Past drug history included: Amoxicillin, reaction: "She is allergic to Amoxicillin". The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "A little tired"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Headache".  Additional Information: The reported age of patient was 59 with unspecified unit. The patient received her first dose of the Pfizer BioNTech COVID-19 vaccine yesterday (26Mar2021) and reported that she was a little tired from it and her headache went away. She stated that on Wednesday 31Mar2021, she was scheduled for a dental appointment and had to take 2000mg of amoxicillin one time beforehand due to a hip replacement. She mentioned that she was allergic to amoxicillin so she had to take diphenhydramine (BENADRYL) for 3 days beforehand or else she would break out into hives but this was her only antibiotic option as all other options cause joint pain. She would like to know if it was okay to take this amoxicillin after receiving the vaccine. She also mentioned that she had multiple sclerosis and was taking medication that suppresses her immune system.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Therapeutic response unexpected
Clinical narrative: had dizziness since prior to her first vaccination and was on an antibiotic but after her vaccination she stopped her antibiotic and her dizziness went away; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Light headed" (unspecified if ongoing); "She feels the ways she does" (unspecified if ongoing), notes: Has been having some medical testing performed to investigate why she feels the ways she does.; "Dizziness" (unspecified if ongoing), notes: Prior to her first vaccination. The patient took concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "had dizziness since prior to her first vaccination and was on an antibiotic but after her vaccination she stopped her antibiotic and her dizziness went away". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient received her first vaccine dose last Sunday. But since before that she has been feeling lightheaded and has been having some medical testing performed to investigate why she feels the ways she does. She reported that after her vaccination she stopped her antibiotic, and the dizziness went away. She has had dizziness since prior to her first vaccination and was on an antibiotic but after her vaccination she stopped her antibiotic and her dizziness went away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Splotch pox-like blistery (non-painful) sore on nose; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 18:30 (Lot number: EP6955) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "celiac disease" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; WELLBUTRIN; ESCITALOPRAM. The following information was reported: BLISTER (non-serious) with onset 22Mar2021 08:00, outcome "unknown", described as "Splotch pox-like blistery (non-painful) sore on nose". Therapeutic measures were not taken as a result of blister.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The reported event was considered non-serious (not resulted in death, not life-threatening, did not cause/prolong hospitalization, not disabling/incapacitating, no congenital anomaly/birth defect).  Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Mar2021 08:45 (Lot number: Unknown) at the age of 53 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "COPD" (unspecified if ongoing); "heart disease (CABGx3 2018)" (unspecified if ongoing). The patient took concomitant medications for diabetes, COPD, and heart disease. The following information was reported: DIARRHOEA (non-serious) with onset 26Mar2021 22:30, outcome "unknown", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient has no known allergies and did not receive any other vaccines within 4 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Moderate to severe pain all around the shoulder area, and down to finger tips; Moderate to severe pain all around the shoulder area, and down to finger tips; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 13:00 (Lot number: Er2613) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies Sulfa antibiotics" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "GERD" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE; FUROSEMIDE; LAMOTRIGINE; LEVOTHYROXINE. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Mar2021, outcome "not recovered" and all described as "Moderate to severe pain all around the shoulder area, and down to finger tips". Therapeutic measures were not taken as a result of arthralgia, pain in extremity. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea for three days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 10:00 (Lot number: EN 6208) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 25Mar2021 02:30, outcome "recovered" (28Mar2021), described as "Nausea for three days". Therapeutic measures were taken as a result of nausea.  Additional information: The patient took OTC medication which had no relief. The patient recovered after 3 days. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination. The patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient has no allergies to medications, foods, or other products.   Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Tired; Arm was sore; Mild headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 43 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 04Mar2021 11:30 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: Adhesives" (unspecified if ongoing); "known allergies: sulpha drugs" (unspecified if ongoing); "idiopathic congenital growth hormone deficiency" (unspecified if ongoing). Concomitant medications included: NORDITROPIN; ALPRAZOLAM; FLUOXETINE. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Tired"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm was sore"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Mild headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pain in extremity and headache.  Additional information: On an unspecified date in Mar2021, after the first vaccination, the patient was tired and her arm was sore. The patient also had mild headache. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Paraesthesia, Paraesthesia oral
Clinical narrative: Fatigue; Tingling on lips and legs sciatica like pain in legs; Tingling on legs; Tingling on lips and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 23:45 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Fresh apples, pears, peaches, plums" (unspecified if ongoing), notes: known allergies: Fresh apples, pears, peaches, plums. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication(s) included: SINGULAIR; SYMBICORT; ALBUTEROL [SALBUTAMOL] inhaler. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: FATIGUE (non-serious) with onset 27Mar2021 08:00, outcome "not recovered", described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset 27Mar2021 08:00, outcome "not recovered", described as "Tingling on lips and legs sciatica like pain in legs"; PARAESTHESIA (non-serious) with onset 27Mar2021 08:00, outcome "not recovered", described as "Tingling on legs"; PARAESTHESIA ORAL (non-serious) with onset 27Mar2021 08:00, outcome "not recovered", described as "Tingling on lips and legs". Therapeutic measures were not taken as a result of fatigue, pain in extremity, paraesthesia, paraesthesia oral. Additional information: Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Other.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.