chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Sleep disorder, Therapeutic response unexpected
Clinical narrative: he feels completely wired; He has been getting the best sleep of his life; his appetite has been completely knocked down and he does not feel hungry day times.; he is just very very focused. His memory seems to be a little bit better/much energy; 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 male patient received bnt162b2 (BNT162B2), administration date 22Feb2022 (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) with onset Feb2022, outcome "unknown", described as "he feels completely wired"; SLEEP DISORDER (non-serious) with onset Feb2022, outcome "unknown", described as "He has been getting the best sleep of his life"; DECREASED APPETITE (non-serious) with onset Feb2022, outcome "unknown", described as "his appetite has been completely knocked down and he does not feel hungry day times."; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Feb2022, outcome "unknown", described as "he is just very very focused. His memory seems to be a little bit better/much energy".  Additional information: It was reported, the patient has been getting the best sleep of his life, his appetite has been completely knocked down and he does not feel hungry day times. He felt completely wired and he has been drinks tons of coffee and he is very focused, he was starting to feel better. Present the side effects reported such as decrease appetite, malaise, fatigue. He further described those really incredible positive side effects as including: some of the best sleep in his life; his appetite has been completely knocked down where he just doesn't crave food anymore, he is not hungry during the daytime which is awesome; he has been trying to lose a little weight, so that is great, but weird; it is awesome but he is not hungry during the day. His memory seems to be a little bit better; he is remembering stuff maybe in the past he might have forgotten about, like where he put his wallet, now he instantly remembers where he put it. He was trying to look around online to see if anyone has found any cases of this, but he hasn't been able to find anything. The Covid-19 Vaccine has given him so much energy, he is more alert, 100% much more energetic than before. He wanted to call in and give that feedback because this is incredible. He also wondered if this is something he should be concerned about.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: I was tired to even talk.; my heart beat fast; shortness of breath; This is a spontaneous report received from a non-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) (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: FATIGUE (non-serious), outcome "unknown", described as "I was tired to even talk."; HEART RATE INCREASED (non-serious), outcome "unknown", described as "my heart beat fast"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath".   Additional information: Reporter stated that she contacted the ER twice, but then it went away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Tenderness
Clinical narrative: Developed swelling, soreness, and tenderness in the left arm pit area.; Developed swelling, soreness, and tenderness in the left arm pit area.; Developed swelling, soreness, and tenderness in the left arm pit area.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Lot number: FD7218) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose: 1, Lot No: ER8733, Location: Arm Left), administration date: 24Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot No: EW0164, Location: Arm Left), administration date: 14Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious), TENDERNESS (non-serious) all with onset 30Dec2021, outcome "not recovered" and all described as "Developed swelling, soreness, and tenderness in the left arm pit area.". The event "developed swelling, soreness, and tenderness in the left arm pit area.", "developed swelling, soreness, and tenderness in the left arm pit area." and "developed swelling, soreness, and tenderness in the left arm pit area." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of axillary pain, swelling, tenderness. Additional Information: Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Pruritus
Clinical narrative: Within 20 minutes after receiving the first dose of Pfizer vaccine until today, I feel itchiness on my face, my ears, my neck, my whole body and my eyes.; Within 20 minutes after receiving the first dose of Pfizer vaccine until today, I feel itchiness on my face, my ears, my neck, my whole body and my eyes.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2022 15:45 (Lot number: FJ6369) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing); "If COVID prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. The following information was reported: EYE PRURITUS (non-serious), PRURITUS (non-serious) all with onset 03Feb2022 16:00, outcome "not recovered" and all described as "Within 20 minutes after receiving the first dose of Pfizer vaccine until today, I feel itchiness on my face, my ears, my neck, my whole body and my eyes.". Therapeutic measures were not taken as a result of eye pruritus, pruritus.  Additional information: No other vaccine received by the patient in four weeks. Patient has not been tested Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: the first booster I got sick for two days but I got better quick very quickly; This is a spontaneous report received from a non-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 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 18Jan2021, for COVID-19 immunization, reaction(s): "Sickness", "Blood pressure high", "shaking and trembling"; Bnt162b2 (Dose: 02), for COVID-19 immunization, reaction(s): "I didn't feel good". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "the first booster I got sick for two days but I got better quick very quickly".  Additional Information:Consumer stated, "Well but the safety report you know the first dose that I had the Pfizer I got really sick and I called the reaction line and I couldn't report because I thought ,I really thought that it might be the last time in my life I thought, my blood pressure went sky high. I didn't suffer with high blood pressure but my blood pressure went so high and I was shaking and trembling and it went on for about, well until about three days before the second dose and so  I went to the heart hospital and heart hospital they checked my heart out and I talked to several doctors they still said its best to get the vaccine(Further not clarified) and when I called Pfizer they said as long your heart rate isn't up you can get the booster and my heart rate was never up only my blood pressure(Further not clarified) and I was having tremors and I was having oh it was terrible, terrible and I felt terrible(Incomplete sentence)"Consumer stated, "No I don't wanna file a safety report but anyway the second dose was better I only had it was like one day over certain I  felt I didn't feel good and then I went to sleep and I felt better the next morning and then the third the first booster I got sick for two days but I got better quick very quickly  but the second booster I don't know what its gonna do but anyway the medical department are they the ones that can tell me what is in them?(Appropriate response was provided to the consumer over the call).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: slight pain on the first night at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2022 13:00 (Lot number: FL3198) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Uterine fibroids" (unspecified if ongoing); "had a hysterectomy and blood transfusions in 2010", start date: 2010 (unspecified if ongoing); "had a hysterectomy and blood transfusions in 2010", start date: 2010 (unspecified if ongoing); "viral meningitis" (unspecified if ongoing), notes: Had viral meningitis at age 5 and 11; "suffer from migraines" (unspecified if ongoing); "Sinusitis" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN A [RETINOL]; VITAMIN E [TOCOPHEROL]; CALCIUM; ZINC; MUCINEX. Past drug history included: Jazmin contraceptive, start date: 2008, reaction(s): "blood clot episode on leg", notes: Took Jazmin contraceptive pill in 2008 for about a month but had to stop after a blood clot episode on leg; Prednisone, reaction(s): "Allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "not recovered", described as "slight pain on the first night at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient was not pregnant at the time of vaccination. The other medications the patient received within 2 weeks of vaccination included vitamins A, E, B+, calcium, zinc and Mucinex. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. After first dose, the patient had almost nothing, slight pain on the first night at injection site. The device date was reported as 25Feb2022. The case was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Thyroid disorder
Clinical narrative: Thyroid problems and hair loss after receiving the booster vaccination; Thyroid problems and hair loss after receiving the booster vaccination; 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 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), THYROID DISORDER (non-serious), outcome "unknown" and all described as "Thyroid problems and hair loss after receiving the booster vaccination".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Lyme disease, Lymph node pain, Snapping hip syndrome
Clinical narrative: burning lymph nodes and burning down the legs; burning lymph nodes and burning down the legs; her hipped popped four times; 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), administration date 11Apr2021 (Lot number: EP7533, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "osteoporosis" (unspecified if ongoing), notes: But I have my best friend and her, sister they have osteoporosis they take medication for that. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization.  The following information was reported: LYMPH NODE PAIN (non-serious), BURNING SENSATION (non-serious), outcome "recovered" and all described as "burning lymph nodes and burning down the legs"; SNAPPING HIP SYNDROME (non-serious) with onset 30Apr2021, outcome "unknown", described as "her hipped popped four times". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of snapping hip syndrome.  Additional Information: It was reported that Caller was a patient. Pfizer covid 19 vaccine, purple cap formulation confirmed. Caller would like to know which "medication", or ingredient(s), in the vaccine caused the reactions she experienced in her body. Caller reported having additional symptoms after the second dose of the vaccine including: vomiting, tired muscles, her hipped popped four times, and her legs kicked at night; these symptoms lasted four months. Her symptoms began on 30Apr2021. Bengay and Tylenol used as treatment during that time. She was tested for Lyme's disease as well which came back negative. Caller reported that she had reactions after the Pfizer covid 19 vaccine (number of doses not discussed) including burning lymph nodes and burning down the legs for seven weeks and did not experience any reaction after the Moderna vaccine. I had the second shot; I had the sore arm and vomiting was Unspecified. I had the second shot on April 1st and on the second day I had the sore arm and vomiting and my legs were so tight and my joint hurt and it lasts for four months. I had a problem for 4 months with my joints and my muscles. My legs were so tight, my left hip was popping and I couldn't move my left leg back very well. So, I went to my doctor and she test me for Lyme disease and I didn't have Lyme disease but I was bit by tick so that's why she said well I rule that out. She didn't think it was a Lyme disease thing. medication for that and their lymph nodes when they have the second Pfizer shot their lymph nodes were burning under their arm pits and at the back of their legs for seven weeks and then it went away.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: FH8028) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing). Concomitant medication(s) included: PRISTIQ taken for affective disorder (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date/Time: 16Feb2021, Site and Route of Injection: , Anatomical Site of Injection: Rt deltoid, Batch/Lot Number: EN6200), administration date: 16Feb2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "Vaccination site pain"; Bnt162b2 (Dose: 2nd , Date/Time: 09Mar2021, Site and Route of Injection: , Anatomical Site of Injection: Lt deltoid, Batch/Lot Number: EN6204), administration date: 09Mar2021, when the patient was 69 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Dec2021, outcome "recovering", described as "pain at injection site". Therapeutic measures were taken as a result of vaccination site pain.  Additional Information: The patient provide information to you regarding the reported adverse event(s) with the use of the product. The Pfizer product had a causal effect to the adverse event. Vaccination Facility Type: Unknown, list any other vaccinations within four weeks prior to the first administration date of the sus-pect. Relevant Tests were one. Specific Relevant Test for Thromboembolic events with Thrombocy-topenia were none Autopsy Information: N/A. On 09Dec2021, 6 days after her booster shot we had an office visit, where she Complained of pain at injection site that improved with Skelaxin.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: Brain-spasms/Brain-zapps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "low-self esteem" (unspecified if ongoing), notes: mental condition called low-self esteem. The patient's concomitant medications were not reported. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "Brain-spasms/Brain-zapps".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Had very sore arm". Clinical course stated by patient was "16 hours after 1st dose, had very severe sore arm. About 18 hours after 2nd dose, felt extreme dizziness, severe headache, confusion, and body aches. I started feeling better about 12 hours later and all those symptoms completely went away by the time I woke up the next morning. About 18 hours after getting the booster, my arm was very sore and started feeling the same way I did after the 2nd shot. I was dizzy, headache, body aches, I took 600mg ibuprofen and within 4 hours I felt completely normal. About 2 months after getting the booster, the arms got all 3 shots in (right) the muscle thirst when I felt weights. It was never hurt before getting these shots. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Pain, Pain in extremity
Clinical narrative: my arm was very sore; dizzy; headache; body aches; the arm I got all 3 shots in (right), the muscle hurts when I lift weights; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Anatomical location: Right arm -the arms got all 3 shots in (right)), for COVID-19 Immunization, reaction(s): "Had very sore arm"; Bnt162b2 (Second dose, Anatomical location: Right arm -the arms got all 3 shots in (right)), for COVID-19 Immunization, reaction(s): "confusion", "Felt extreme dizziness", "Severe headache", "Body aches". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "my arm was very sore"; DIZZINESS (non-serious), outcome "recovered", described as "dizzy"; HEADACHE (non-serious), outcome "recovered", described as "headache"; PAIN (non-serious), outcome "recovered", described as "body aches"; MYALGIA (non-serious), outcome "unknown", described as "the arm I got all 3 shots in (right), the muscle hurts when I lift weights". Therapeutic measures were taken as a result of pain in extremity, dizziness, headache, pain.  Additional information: She reported 16 hours after 1st dose, she had very severe sore arm. About 18 hours after 2nd dose, felt extreme dizziness, severe headache, confusion and body aches. She started feeling better about 12 hours later and all those symptoms completely went away by the time she woke up the next morning. About 18 hours after getting the booster, her arm was very sore and started feeling the same way she did after the 2nd shot. She was dizzy, headache, body aches, She took 600mg ibuprofen and within 4 hours she felt completely normal. About 2 months after getting the booster, the arms got all 3 shots in (right) the muscle thirst when she felt weights. It was never hurt before getting these shots.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Enzyme level test, Hepatic enzyme increased, Platelet count, Platelet count decreased
Clinical narrative: Low blood platelets count; Liver enzyme number increase; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: EW0175) at the age of 58 years as dose 2, single and administered in arm left, administration date 07Apr2021 (Lot number: ER8729) as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild asthma" (unspecified if ongoing), notes: mild asthma; "heart rhythm issue" (unspecified if ongoing), notes: heart rhythm issue; "Known allergies: some antibiotics" (unspecified if ongoing), notes: Known allergies: some antibiotics; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: some sea food" (unspecified if ongoing), notes: Known allergies: some sea food. There were no concomitant medications. The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "Low blood platelets count"; HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "Liver enzyme number increase". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of platelet count decreased, hepatic enzyme increased.  Additional information: Low blood platelets count and liver enzyme number increase after first two Phizer mRNA shots in Apr2021 which never happened in her all blood test reports before. Patient reported to CDC site through V-safe. After 3rd vaccine shot on 04Jan2022, patient encountered COVID Toe like symptom (purple toes on left foot). Pictures taken to be showed to her primary doctor for seeking medical treatment/advice.The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Electrocardiogram, Free thyroxine index
Clinical narrative: TSH/ abnormal; free thyroxine/ abnormal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 19Jun2021 (Lot number: EW0181) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stomach pain", start date: Mar2011 (unspecified if ongoing), notes: Pertinent details: Appendectomy; "Flu like symptoms with negative test", start date: 03Jan2022, stop date: 10Jan2022, notes: Pertinent details: Did multiple COVID tests, they were all negative; "high blood pressure" (unspecified if ongoing). Family history included: "hypokalemia" (unspecified if ongoing), notes: Biological Father- passed away at 58 due to hypokalemia; "multinodular goiter" (unspecified if ongoing), notes: Biological mother- had multinodular goiter- thyroid surgically removed- high blood pressure- chronic kidney disease; "thyroid surgically removed" (unspecified if ongoing), notes: thyroid surgically removed; "chronic kidney disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of administration: Intramuscular, Batch/lot number: PEW0178), administration date: 29May2021, when the patient was 37 years old, for COVID-19 immunization.  The following information was reported: BLOOD THYROID STIMULATING HORMONE DECREASED (non-serious) with onset 02Feb2022, outcome "unknown", described as "TSH/ abnormal"; THYROXINE ABNORMAL (non-serious) with onset 02Feb2022, outcome "unknown", described as "free thyroxine/ abnormal". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Laboratory test, Thyroxine abnormal
Clinical narrative: TSH/ abnormal; free thyroxine/ abnormal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 19Jun2021 (Lot number: EW0181) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stomach pain", start date: Mar2011 (unspecified if ongoing), notes: Pertinent details: Appendectomy; "Flu like symptoms with negative test", start date: 03Jan2022, stop date: 10Jan2022, notes: Pertinent details: Did multiple COVID tests, they were all negative; "high blood pressure" (unspecified if ongoing). Family history included: "hypokalemia" (unspecified if ongoing), notes: Biological Father- passed away at 58 due to hypokalemia; "multinodular goiter" (unspecified if ongoing), notes: Biological mother- had multinodular goiter- thyroid surgically removed- high blood pressure- chronic kidney disease; "thyroid surgically removed" (unspecified if ongoing), notes: thyroid surgically removed; "chronic kidney disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of administration: Intramuscular, Batch/lot number: PEW0178), administration date: 29May2021, when the patient was 37 years old, for COVID-19 immunization.  The following information was reported: BLOOD THYROID STIMULATING HORMONE DECREASED (non-serious) with onset 02Feb2022, outcome "unknown", described as "TSH/ abnormal"; THYROXINE ABNORMAL (non-serious) with onset 02Feb2022, outcome "unknown", described as "free thyroxine/ abnormal". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Chills, Dizziness, Flushing, Headache
Clinical narrative: Face flushing; temperature, adverse body sensations; rapid heart rate; headache; dizzy; chills; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Lot number: FM0698) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "wasps" (unspecified if ongoing), notes: known allergies: wasps; "adhesives" (unspecified if ongoing), notes: known allergies: adhesives. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, single, Batch/Lot No: FC3184), for Covid-19 Immunization; Bnt162b2 (Dose 1, single, Batch/Lot No: FA7484), for Covid-19 Immunization. The following information was reported: FLUSHING (non-serious) with onset 24Feb2022, outcome "recovering", described as "Face flushing"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 24Feb2022, outcome "recovering", described as "temperature, adverse body sensations"; HEART RATE INCREASED (non-serious) with onset 24Feb2022, outcome "recovering", described as "rapid heart rate"; HEADACHE (non-serious) with onset 24Feb2022, outcome "recovering", described as "headache"; DIZZINESS (non-serious) with onset 24Feb2022, outcome "recovering", described as "dizzy"; CHILLS (non-serious) with onset 24Feb2022, outcome "recovering", described as "chills". The events "face flushing", "temperature, adverse body sensations", "rapid heart rate", "headache", "dizzy" and "chills" 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 flushing, body temperature abnormal, heart rate increased, headache, dizziness, chills.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, if unknown if the patient had been tested for COVID-19. The patient experienced Face flushing, temperature, adverse body sensations, rapid heart rate, headache, dizzy, chills.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Face flushing; temperature, adverse body sensations; rapid heart rate; headache; dizzy; chills; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Lot number: FM0698) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "wasps" (unspecified if ongoing), notes: known allergies: wasps; "adhesives" (unspecified if ongoing), notes: known allergies: adhesives. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, single, Batch/Lot No: FC3184), for Covid-19 Immunization; Bnt162b2 (Dose 1, single, Batch/Lot No: FA7484), for Covid-19 Immunization. The following information was reported: FLUSHING (non-serious) with onset 24Feb2022, outcome "recovering", described as "Face flushing"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 24Feb2022, outcome "recovering", described as "temperature, adverse body sensations"; HEART RATE INCREASED (non-serious) with onset 24Feb2022, outcome "recovering", described as "rapid heart rate"; HEADACHE (non-serious) with onset 24Feb2022, outcome "recovering", described as "headache"; DIZZINESS (non-serious) with onset 24Feb2022, outcome "recovering", described as "dizzy"; CHILLS (non-serious) with onset 24Feb2022, outcome "recovering", described as "chills". The events "face flushing", "temperature, adverse body sensations", "rapid heart rate", "headache", "dizzy" and "chills" 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 flushing, body temperature abnormal, heart rate increased, headache, dizziness, chills.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, if unknown if the patient had been tested for COVID-19. The patient experienced Face flushing, temperature, adverse body sensations, rapid heart rate, headache, dizzy, chills.   No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: He has blood in his urine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2022 (Lot number: FL8094) at the age of 11 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BLOOD URINE PRESENT (non-serious) with onset 27Feb2022, outcome "unknown", described as "He has blood in his urine". Therapeutic measures were not taken as a result of blood urine present.  Additional information included:  The reporter was wondering if that was a side effect from the COVID shot, or don't know if he need to go to the hospital. The patient had no prior Vaccination and no lab test (within 2 weeks).  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Headache
Clinical narrative: Severe headache; Fever; Chills; Weakness; Muscle pain; Joint pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 (Lot number: EW0178) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC. Past drug history included: Bactrim, reaction(s): "Known allergies: bactrim", notes: Known allergies: bactrim. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8736, Location of injection: Arm Left), administration date: 30Apr2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Severe headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Severe headache; Fever; Chills; Weakness; Muscle pain; Joint pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 (Lot number: EW0178) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC. Past drug history included: Bactrim, reaction(s): "Known allergies: bactrim", notes: Known allergies: bactrim. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8736, Location of injection: Arm Left), administration date: 30Apr2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Severe headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Eczema
Clinical narrative: covered in spots all over my body and now they are still there and are spots that look like eczema spot in different areas all over my body; When I take a shower they all come all prevalent and then will still be there but not as noticeable some of the spots but others are small or larger dry patches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 12:00 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "allergies to mold" (unspecified if ongoing); "allergies to birch trees" (unspecified if ongoing), notes: allergies to birch trees. Concomitant medication(s) included: DULERA; LETROZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 28Mar2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 07Mar2021, when the patient was 59 years old, for COVID-19 Immunization.  The following information was reported: ECZEMA (non-serious) with onset 09Jan2022 09:00, outcome "not recovered", described as "covered in spots all over my body and now they are still there and are spots that look like eczema spot in different areas all over my body"; DRY SKIN (non-serious) with onset 09Jan2022 09:00, outcome "not recovered", described as "When I take a shower they all come all prevalent and then will still be there but not as noticeable some of the spots but others are small or larger dry patches". Therapeutic measures were not taken as a result of eczema, dry skin.  Additional information: No covid prior vaccination and post vaccination. No other vaccine in four weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chillblains, Erythema, Insomnia, Muscle spasms, Pain
Clinical narrative: 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 (Lot number: FF2593) at the age of 61 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Major depression" (unspecified if ongoing), notes: Verbatim: Clinical depression. Concomitant medication(s) included: MARPLAN [LEVONORGESTREL] taken for major depression. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunization, reaction(s): "Slight headache"; Bnt162b2 (dose 2), for COVID-19 Immunization, reaction(s): "Slight headache". The following information was reported: MUSCLE SPASMS (non-serious) with onset Nov2021, outcome "not recovered", described as "severe cramping in my thigh"; CHILLBLAINS (non-serious) with onset Nov2021, outcome "not recovered", described as "chilblains"; ERYTHEMA (non-serious) with onset Nov2021, outcome "not recovered", described as "they were red"; INSOMNIA (non-serious), PAIN (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I could not really sleep, it hurts so bad". The events "severe cramping in my thigh", "chilblains" and "they were red" were evaluated at the physician office visit. Additional information: Reporter stated that "I actually had two, the one was relatively minor just like from the, I had a booster shot and that was the one that was causing me the issues but the other two (Pfizer COVID-19 Vaccine) I just had a slight headache which was nothing compares to my report but the booster shot I had November 5th and that night I had a severe cramping in my thigh. I do not wanna exactly say it was a cramp but it was like I could not really sleep, it hurts so bad, I had to keep turning different ways and it just kept hurting but the biggest thing that it happened from that same booster shot was not until couple weeks after and I got the chilblains." "I saw a Podiatrist because I had the chilblains developed on my feet, on my toes and he is the one that let me know what they were, because I just thought I was having sore feet from exercising (Further not clarified) and but they were red and they were really tough, they were like numb and causing me a lot of, they were not numb (Further not clarified) they were causing me pain but so, Its chilblains and when I saw him the next time he confirmed that, he said there are all about the same but they are not (Further not clarified)." No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Having severe running nose; Sniffling; Sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer.). The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "Having severe running nose"; RHINORRHOEA (non-serious), outcome "unknown", described as "Sniffling"; SNEEZING (non-serious), outcome "unknown", described as "Sneezing".  Additional information: Reason for no lot number: of COVID Vaccine: Complainant hung up abruptly/transfer incomplete. Reporter queried stating this sinus related stuff or severe reaction. Limited information was available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: tiredness; Fever; chills; headache; body ache; light headed; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 23Feb2022 (Lot number: FL3197) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: other medical history: Diabetes; "fatty liver disease" (unspecified if ongoing), notes: other medical history: fatty liver disease. Concomitant medication(s) included: METFORMIN; CELECOXIB; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 01Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11Mar2021, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "tiredness"; PYREXIA (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "body ache"; DIZZINESS (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "light headed"; DIZZINESS (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "dizziness". The events "tiredness", "fever", "chills", "headache", "body ache", "light headed" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of fatigue, pyrexia, chills, headache, pain, dizziness, dizziness. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Treatment received for the adverse event was Tylenol. No follow-up attempts are possible. No further information is expected.