chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 42 year-old male patient received bnt162b2 (BNT162B2), administration date 26Aug2021 16:00 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Cipro, reaction(s): "known allergies: Cipro". The following information was reported: RASH (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Generalize rash"; MYALGIA (non-serious) with onset 27Aug2021, outcome "not recovered", described as "muscle aches"; CHILLS (non-serious) with onset 27Aug2021, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 27Aug2021, outcome "not recovered", described as "headache". Therapeutic measures were taken as a result of rash, myalgia, chills, headache. Additional information: No, other vaccine in four weeks, No, other medications in two weeks. Ibuprofen and Benadryl were used for AE treatment. No, Covid prior vaccination. No, Covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Aug2021 11:30 (Lot number: 5234) at the age of 12 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Product=COVID 19, lot number=5234, lot unknown=False, administration date=04Aug2021, administration time=08:30 AM, dose number=1, vaccine location=Right arm), administration date: 04Aug2021, when the patient was 12 years old, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious) with onset 28Aug2021, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 28Aug2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 28Aug2021, outcome "recovering", described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 28Aug2021, outcome "recovering", described as "sore arm". Therapeutic measures were not taken as a result of pain, chills, pyrexia, pain in extremity. Additional information: The patient did not have Covid prior vaccination. The patient did not test for Covid tested post vaccination. The patient did not have other medical history. The patient did not receive, other vaccine in four weeks. The patient did not receive, other medications in two weeks. No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Apr2021 (Lot number: EW0150) at the age of 46 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; HCTZ. Vaccination history included: Bnt162b2 (I received my 1st COVID vaccine), administration date: 18Mar2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "itching is worse at my injection sites". The following information was reported: FEELING ABNORMAL (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Brain fogginess"; PRURITUS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "itchy skin/itching is worse at my injection sites (right and left deltoids)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, pruritus. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: throat sore; low grade fever; extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 14:15 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMINS C; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; ELDERBERRY [SAMBUCUS NIGRA]; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]. Past drug history included: Succynlcholine, reaction(s): "Allergy to Succynlcholine", notes: Past drug event: Succynlcholine; Mivacron, reaction(s): "Allergy to Mivacron", notes: Past drug event: Mivacron; Codeine, reaction(s): "Allergy to Codeine", notes: Past drug event: codeine; Hydrocodone, reaction(s): "Allergy to Hydrocodone", notes: Past drug event: Hydrocodone. Vaccination history included: Bnt162b2 (Dose 1, administration time=03:15 PM,, vaccine location=Left arm), administration date: 13Aug2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 29Aug2021 04:00, outcome "not recovered", described as "throat sore"; PYREXIA (non-serious) with onset 28Aug2021 04:00, outcome "not recovered", described as "low grade fever"; FATIGUE (non-serious) with onset 28Aug2021 04:00, outcome "not recovered", described as "extremely tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain, pyrexia, fatigue.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Vitamins C, D, B12, Zinc, elderberry multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 after the vaccination. Known Allergies: Succynlcholine, mivacron and codeine/hydrocodone  The follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pyrexia, Vaccination site pain
Clinical narrative: flu symptoms for a week after the first vaccine; sore arm on the injection arm; Arm felt feverish; This is a spontaneous report received from a contactable consumer (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported) via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after the first shot she had flu symptoms for a week, a sore arm on the injection arm and her arm felt feverish on an unspecified date in 2021. She was actually calling in to ask for a replacement card because she lost her vaccine card. She got the first one at the vaccination site. The patient also received her second shot. Her doses were either Apr2021 and May2021 or May2021 and Jun2021. It was the end of Apr or the Middle of May2021 and the second one was probably in Jun2021. She doesn't want to report it because she feels like it is normal. Her and daughter in law had the same side effects. She felt like she had the flu for 5-7 days. She doesn't really care to report it. She just rolls with the flow. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (27Aug2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that: no new information added. Follow-up attempts completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test, Pain assessment
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: EN9581) at the age of 77 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu shot (When he takes the flu shot, he is sick all winter), reaction(s): "Sick". The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 2021, outcome "recovering" and all described as "From both elbows to up his shoulders and 4 inches across his back, has had a dull pain". Relevant laboratory tests and procedures are available in the appropriate section.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face, Visual impairment
Clinical narrative: My face is swollen and that has affected my left eye vision; My face is swollen and that has affected my left eye vision; 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 1, single for covid-19 immunisation. Relevant medical history included: "Wilson's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "My face is swollen and that has affected my left eye vision".  Additional information: Consumer stated, She said I can report compensation for my injury. I reported everything to the vaccine I received (first dose). I gave my personal information, the Doctor's information. The shot (vaccine) and anything like that and I have the Wilson's disease (further not clarified) side effect and my face is swollen, that has affected my left eye vision because I have point transplantation (further not clarified), so I want to report to receive my compensation for this injury. Vaccine name: Pfizer, Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Aug2021 16:30 (Lot number: FD8448) at the age of 12 years as dose 1, single for Covid-19 immunization. Relevant medical history included: "Cancer" (unspecified if ongoing); "UTI" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOL; SULFAMETHOXAZOLE AND TRIMETHOPRIM; KOSELUGO; VIT. D [COLECALCIFEROL]. The following information was reported: DYSPNOEA (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "Difficulty breathing"; INJECTION SITE PAIN (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "pain at injection site"; FATIGUE (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "fatigue pain at the injection site/tiredness"; HEADACHE (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "joint pain"; FEELING ABNORMAL (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "feeling bad"; PAIN IN EXTREMITY (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "arm pain". Therapeutic measures were not taken as a result of dyspnoea, injection site pain, fatigue, headache, myalgia, arthralgia, feeling abnormal, pain in extremity. Additional information: The patient did not receive any other vaccine in four weeks prior to the COVID vaccine. The patient was neither diagnosed with Covid-19 prior vaccination, nor been tested for Covid-19 post vaccination. No known allergies. No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site 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 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Aug2021 16:30 (Lot number: FD8448) at the age of 12 years as dose 1, single for Covid-19 immunization. Relevant medical history included: "Cancer" (unspecified if ongoing); "UTI" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOL; SULFAMETHOXAZOLE AND TRIMETHOPRIM; KOSELUGO; VIT. D [COLECALCIFEROL]. The following information was reported: DYSPNOEA (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "Difficulty breathing"; INJECTION SITE PAIN (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "pain at injection site"; FATIGUE (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "fatigue pain at the injection site/tiredness"; HEADACHE (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "joint pain"; FEELING ABNORMAL (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "feeling bad"; PAIN IN EXTREMITY (non-serious) with onset 27Aug2021 06:15, outcome "recovering", described as "arm pain". Therapeutic measures were not taken as a result of dyspnoea, injection site pain, fatigue, headache, myalgia, arthralgia, feeling abnormal, pain in extremity. Additional information: The patient did not receive any other vaccine in four weeks prior to the COVID vaccine. The patient was neither diagnosed with Covid-19 prior vaccination, nor been tested for Covid-19 post vaccination. No known allergies. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Eye irritation, Feeling abnormal, Headache
Clinical narrative: Sever stabbing pains in both legs , feet and back/moderate pain in hands; Sever stabbing pains in both legs , feet and back; Numbness in fingers with the inability to form a tight closed fist; Massive headache; Severe brain fog; Think the words but cannot /will not come out of my mouth properly; Forgetting things , misplace things; Burning eyes; Hot flashes; Severe weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Aug2021 (Lot number: Fc3187) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: migraine; "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Sever stabbing pains in both legs , feet and back/moderate pain in hands"; BACK PAIN (non-serious), outcome "not recovered", described as "Sever stabbing pains in both legs , feet and back"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in fingers with the inability to form a tight closed fist"; HEADACHE (non-serious), outcome "not recovered", described as "Massive headache"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Severe brain fog"; SPEECH DISORDER (non-serious), outcome "not recovered", described as "Think the words but cannot /will not come out of my mouth properly"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "Forgetting things , misplace things"; EYE IRRITATION (non-serious), outcome "not recovered", described as "Burning eyes"; HOT FLUSH (non-serious), outcome "not recovered", described as "Hot flashes"; ASTHENIA (non-serious), outcome "not recovered", described as "Severe weakness". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pain in extremity, back pain, hypoaesthesia, headache, feeling abnormal, speech disorder, memory impairment, eye irritation, hot flush, asthenia.  Additional information: Patient didn't received any other vaccine within 4 weeks prior to the COVID vaccine. Patient received other medication within 2 weeks of vaccination. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypoaesthesia, Memory impairment, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sever stabbing pains in both legs , feet and back/moderate pain in hands; Sever stabbing pains in both legs , feet and back; Numbness in fingers with the inability to form a tight closed fist; Massive headache; Severe brain fog; Think the words but cannot /will not come out of my mouth properly; Forgetting things , misplace things; Burning eyes; Hot flashes; Severe weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Aug2021 (Lot number: Fc3187) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: migraine; "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Sever stabbing pains in both legs , feet and back/moderate pain in hands"; BACK PAIN (non-serious), outcome "not recovered", described as "Sever stabbing pains in both legs , feet and back"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in fingers with the inability to form a tight closed fist"; HEADACHE (non-serious), outcome "not recovered", described as "Massive headache"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Severe brain fog"; SPEECH DISORDER (non-serious), outcome "not recovered", described as "Think the words but cannot /will not come out of my mouth properly"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "Forgetting things , misplace things"; EYE IRRITATION (non-serious), outcome "not recovered", described as "Burning eyes"; HOT FLUSH (non-serious), outcome "not recovered", described as "Hot flashes"; ASTHENIA (non-serious), outcome "not recovered", described as "Severe weakness". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pain in extremity, back pain, hypoaesthesia, headache, feeling abnormal, speech disorder, memory impairment, eye irritation, hot flush, asthenia.  Additional information: Patient didn't received any other vaccine within 4 weeks prior to the COVID vaccine. Patient received other medication within 2 weeks of vaccination. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Sever stabbing pains in both legs , feet and back/moderate pain in hands; Sever stabbing pains in both legs , feet and back; Numbness in fingers with the inability to form a tight closed fist; Massive headache; Severe brain fog; Think the words but cannot /will not come out of my mouth properly; Forgetting things , misplace things; Burning eyes; Hot flashes; Severe weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Aug2021 (Lot number: Fc3187) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: migraine; "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Sever stabbing pains in both legs , feet and back/moderate pain in hands"; BACK PAIN (non-serious), outcome "not recovered", described as "Sever stabbing pains in both legs , feet and back"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in fingers with the inability to form a tight closed fist"; HEADACHE (non-serious), outcome "not recovered", described as "Massive headache"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Severe brain fog"; SPEECH DISORDER (non-serious), outcome "not recovered", described as "Think the words but cannot /will not come out of my mouth properly"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "Forgetting things , misplace things"; EYE IRRITATION (non-serious), outcome "not recovered", described as "Burning eyes"; HOT FLUSH (non-serious), outcome "not recovered", described as "Hot flashes"; ASTHENIA (non-serious), outcome "not recovered", described as "Severe weakness". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pain in extremity, back pain, hypoaesthesia, headache, feeling abnormal, speech disorder, memory impairment, eye irritation, hot flush, asthenia.  Additional information: Patient didn't received any other vaccine within 4 weeks prior to the COVID vaccine. Patient received other medication within 2 weeks of vaccination. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 24-year-old female patient (not pregnant) received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Aug 19, 2021, at the age of 24, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), for COVID-19 immunization. The patient experienced palpitations/heart started racing, and chest pain/chest was in pain, onset Aug 20, 2021, with outcome of unknown. Heart started racing and chest was in pain were evaluated at a physician office visit. Additional Information: The patient stated "24 hours after the 2nd dose, my heart started racing and chest was in pain. This continued for the next week." The event did not require hospitalization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. This follow-up submitted to notify the batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain in extremity
Clinical narrative: Sore arm for a day and half; Headache the entire day after the shot; Shortness of breath on and off for 2 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Aug2021 16:45 (Lot number: Fl3180) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Aug2021, outcome "recovered" (Aug2021), described as "Sore arm for a day and half"; HEADACHE (non-serious) with onset 16Aug2021, outcome "recovered" (Aug2021), described as "Headache the entire day after the shot"; DYSPNOEA (non-serious) with onset 16Aug2021, outcome "recovering", described as "Shortness of breath on and off for 2 weeks". Therapeutic measures were not taken as a result of pain in extremity, headache, dyspnoea.  Additional information: 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, was the patient was not diagnosed with COVID-19 and since the vaccination, has the patient not tested for COVID-19. The patient did not received any treatment for the adverse events.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Rash papular, Rash pruritic
Clinical narrative: rash all over my body; itchy bumps looks like a rash all over my body, you know mostly on my breast, chest, on my thighs, on my wrist and in my back, stomach; itchy bumps looks like a rash all over my body, you know mostly on my breast, chest, on my thighs, on my wrist and in my back, stomach; Saturday was yesterday the first day I just felt tired and fatigue yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: EW0173) at the age of 26 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing), notes: Verbatim: Depression; "Anxiety" (unspecified if ongoing), notes: Verbatim: Anxiety; "Chronic pain" (unspecified if ongoing), notes: Verbatim: Chronic pain; "insulin resistance from PCOS, Polycystic ovary Syndrome" (ongoing); "insulin resistance from PCOS, Polycystic ovary Syndrome" (ongoing). Concomitant medication(s) included: CYMBALTA taken for depression; BUSPAR; WELLBUTRIN taken for depression; GABAPENTIN; TRAMADOL taken for pain; METFORMIN taken for insulin resistance, polycystic ovaries. The following information was reported: RASH (non-serious) with onset 29Aug2021, outcome "unknown", described as "rash all over my body"; RASH PRURITIC (non-serious), RASH PAPULAR (non-serious) all with onset 29Aug2021, outcome "unknown" and all described as "itchy bumps looks like a rash all over my body, you know mostly on my breast, chest, on my thighs, on my wrist and in my back, stomach"; FATIGUE (non-serious) with onset 28Aug2021, outcome "unknown", described as "Saturday was yesterday the first day I just felt tired and fatigue yesterday". Therapeutic measures were taken as a result of rash, rash pruritic, rash papular.  Additional information: It was stated, " calling because two days ago, on Friday she had her first Vaccine, Pfizer BioNTech. This morning which was she guess about two days later she woke up and what she was describe may be rash, itchy rash all over her body. This morning she woke up with itchy bump looks like a rash all over her body and you know mostly on her breast, chest, on her thighs, on her wrist and in her back, stomach. So, she just want to report the symptoms because this was the number that she got." Stated, the first day she just felt tired and fatigue yesterday. And but today she decided to report because she woke up this morning, early in the morning itching everywhere on her body then when she finally woke up and she looked at her skin she see bump rashes everywhere." Treatment: Stated, she took some Benadryl, it was an-antihistamine." It was stated, she had the reaction with the rash on her body from the first dose. So, her second dose was scheduled in three weeks from now.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Incorrect route of product administration, Nausea, Retching
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67 year-old male patient received bnt162b2 (BNT162B2), administration date 21Aug2021 (Lot number: EWO196) at the age of 67 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: Verbatim: Glaucoma. Concomitant medication(s) included: LITHIUM; VOLTAREN [DICLOFENAC] taken for glaucoma. Vaccination history included: Flu vaccine (4-5 years ago I took the vaccination for the flu and I got sick), for flu, reaction(s): "Sick". The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Aug2021, outcome "unknown", described as "Consumer stated, "That was in my left shoulder"; DYSPNOEA (non-serious) with onset 26Aug2021, outcome "unknown", described as "Little short of breath"; RETCHING (non-serious) with onset 26Aug2021, outcome "unknown", described as "Dry heaves"; NAUSEA (non-serious) with onset 26Aug2021, outcome "unknown", described as "Nauseous". Therapeutic measures were not taken as a result of incorrect route of product administration, dyspnoea, retching, nausea. Additional information: vaccination facility was mentioned as clinic. Prior vaccinations (within 4 weeks) was none. Reporter stated, "I took the vaccine of Pfizer, the first shot on 21Aug and yesterday, the last couple of days I had like the dry heaves and what and when I exercise which I never had a problem exercising before and when I exercise I am little short of breath." Reporter confirmed the name of the product as Pfizer COVID vaccine. Reporter stated, "Two days ago, I felt nauseous and then dry heaves about 3 times and then last night I did again." Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 16:30 (Lot number: ER8732) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: URTICARIA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "Hives".  Additional information: Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the next day of vaccination the patient woke up with hives and it lasted a day or so.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Inappropriate schedule of product administration, Inflammation, Lymphadenopathy, Pain
Clinical narrative: the first dose was on 03May2021 and the second, let me see, the second dose was on, that was on 20May2021; Arm swelled; Inflamed lymph nodes; Inflamed arm; I never had hematuria before, micro-hematuria and I am saying that this is the result of the Covid reaction to the Vaccine; tingling to my hand to my fingers and pain; tingling to my hand to my fingers and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 (Lot number: EW0177) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (It looks like the first dose was on 03May2021 , Lot number: EW0173, Anatomical Site of administration: Consumer stated, It was on the left arm), administration date: 03May2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "pain". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20May2021, outcome "unknown", described as "the first dose was on 03May2021 and the second, let me see, the second dose was on, that was on 20May2021"; PERIPHERAL SWELLING (non-serious) with onset May2021, outcome "recovering", described as "Arm swelled"; LYMPHADENOPATHY (non-serious) with onset May2021, outcome "recovering", described as "Inflamed lymph nodes"; INFLAMMATION (non-serious) with onset May2021, outcome "recovering", described as "Inflamed arm"; HAEMATURIA (non-serious) with onset May2021, outcome "recovering", described as "I never had hematuria before, micro-hematuria and I am saying that this is the result of the Covid reaction to the Vaccine"; PARAESTHESIA (non-serious), PAIN (non-serious) all with onset May2021, outcome "recovering" and all described as "tingling to my hand to my fingers and pain". The events "arm swelled", "inflamed lymph nodes", "inflamed arm", "i never had hematuria before, micro-hematuria and i am saying that this is the result of the covid reaction to the vaccine", "tingling to my hand to my fingers and pain" and "tingling to my hand to my fingers and pain" 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 peripheral swelling, lymphadenopathy, inflammation, haematuria, paraesthesia, pain.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Urine analysis
Clinical narrative: the first dose was on 03May2021 and the second, let me see, the second dose was on, that was on 20May2021; Arm swelled; Inflamed lymph nodes; Inflamed arm; I never had hematuria before, micro-hematuria and I am saying that this is the result of the Covid reaction to the Vaccine; tingling to my hand to my fingers and pain; tingling to my hand to my fingers and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 (Lot number: EW0177) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (It looks like the first dose was on 03May2021 , Lot number: EW0173, Anatomical Site of administration: Consumer stated, It was on the left arm), administration date: 03May2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "pain". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20May2021, outcome "unknown", described as "the first dose was on 03May2021 and the second, let me see, the second dose was on, that was on 20May2021"; PERIPHERAL SWELLING (non-serious) with onset May2021, outcome "recovering", described as "Arm swelled"; LYMPHADENOPATHY (non-serious) with onset May2021, outcome "recovering", described as "Inflamed lymph nodes"; INFLAMMATION (non-serious) with onset May2021, outcome "recovering", described as "Inflamed arm"; HAEMATURIA (non-serious) with onset May2021, outcome "recovering", described as "I never had hematuria before, micro-hematuria and I am saying that this is the result of the Covid reaction to the Vaccine"; PARAESTHESIA (non-serious), PAIN (non-serious) all with onset May2021, outcome "recovering" and all described as "tingling to my hand to my fingers and pain". The events "arm swelled", "inflamed lymph nodes", "inflamed arm", "i never had hematuria before, micro-hematuria and i am saying that this is the result of the covid reaction to the vaccine", "tingling to my hand to my fingers and pain" and "tingling to my hand to my fingers and pain" 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 peripheral swelling, lymphadenopathy, inflammation, haematuria, paraesthesia, pain.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Peripheral swelling, Product preparation error, Pyrexia
Clinical narrative: One of our vaccinator did not dilute the product and gave all 6 doses; One of our vaccinator did not dilute the product and gave all 6 doses; swollen deltoid region; low grade fever for 24 hours only; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A 12 year-old patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Batch/Lot number: unknown) at the age of 12 years as dose number unknown, 0.3ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 30Aug2021, outcome "unknown" and all described as "One of our vaccinator did not dilute the product and gave all 6 doses"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "recovered" (2021), described as "swollen deltoid region"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "low grade fever for 24 hours only".  Additional information: Health care professional reported that one of their vaccinator did not dilute the product and gave all 6 doses and gave 0.3 mL dose of undiluted vaccine. Health care professional consider the Pfizer product had a causal effect to the adverse events. The patient did not receive any vaccinations 4 weeks prior to BNT162B2. The patient did not perform any relevant tests. The patient had swollen deltoid region low grade fever for 24 hours only. No other adverse events signs were noted.  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: Asthma, Dyspnoea, Insomnia
Clinical narrative: She has a history of asthma, which has gotten worse since receiving the second dose of the vaccine; harder time breathing all the time since after the second dose/ has more difficulty breathing but it progressively got worsen; she cannot sleep / She could sleep fine and then would lose some sleep. Last night she only slept one hour and would have to sit up to breathe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 18:00 (Lot number: FC3183) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: diagnosed about 25 years ago; "allergic to penicillin" (unspecified if ongoing), notes: diagnosed about 25 years ago. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EW0181, Anatomical Location:Left upper arm, Time: 18:00), administration date: 28Jul2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: ASTHMA (non-serious) with onset Aug2021, outcome "not recovered", described as "She has a history of asthma, which has gotten worse since receiving the second dose of the vaccine"; DYSPNOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "harder time breathing all the time since after the second dose/ has more difficulty breathing but it progressively got worsen"; INSOMNIA (non-serious) with onset Aug2021, outcome "not recovered", described as "she cannot sleep / She could sleep fine and then would lose some sleep. Last night she only slept one hour and would have to sit up to breathe".  Additional Information: Patient had not always had big issues with asthma, and it is not frequent, it very rare for her to have difficulty breathing. Vaccination facility type was pharmacy and was not administered at facility. There were no additional vaccines administered on same date of the Pfizer Suspect. There was no emergency room visit. It was reported that patient had only first dose prior to vaccinations within 4 weeks. There was no AE following prior vaccinations and also none relevant tests reported. She went to doctor to get refill of her albuterol inhaler. Concomitant Albuterol does not really help her as much. She was wondering how long the symptoms will last, if it will go away. She did not use it frequently and it was an expired prescription. She was initially prescribed it about 25 years ago.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Malaise
Clinical narrative: feeling "under the weather".; cough; a general sick feeling all over his body; 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 21 year-old male patient received bnt162b2 (BNT162B2), administration date 25Aug2021 (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: FEELING ABNORMAL (non-serious) with onset 29Aug2021, outcome "unknown", described as "feeling "under the weather"."; COUGH (non-serious) with onset 29Aug2021, outcome "unknown", described as "cough"; MALAISE (non-serious) with onset 29Aug2021, outcome "unknown", described as "a general sick feeling all over his body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: she has a rash all over her chest and kind of on her back; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 10:15 (Lot number: EW0183) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot: EW0164., Anatomical location: left arm), administration date: 25Jun2021, when the patient was 36 years old, for COVID-19 immunization, reaction(s): "It is explained that there was some splotchiness between the first and second shot", "She thought it was dry skin". The following information was reported: RASH (non-serious) with onset 30Aug2021, outcome "not recovered", described as "she has a rash all over her chest and kind of on her back"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Aug2021 10:15, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Therapeutic measures were not taken as a result of rash.  Additional information: It was reported that Caller received her 2nd dose of the Pfizer covid vaccine/Comirnaty on 27Aug2021 and developed a rash on her chest and back. Reporter asking, Why did I get a rash? I'm a little worried. My 2nd shot was on Friday 3 days ago. Upon Follow-up Caller, reporting on the Pfizer Covid vaccine, the shot second given on 27Aug2021. The caller states today she has a rash all over her chest and kind of on her back. She would like to know why this happened. Primary Healthcare: Caller does not know how to spell the doctors name, captured as it sounded. No phone or email known. First dose was on 25Jun2021, given early in the day but the exact time is unknown, in the left arm, Lot: EW0164. NDC and Expiry unknown. Second dose was on 27Aug2021 at around 10:15am in the left arm, Lot: EW0183. NDC and Expiry unknown. Caller remarks she will call the primary doctor. It is explained that there was some splotchiness between the first and second shot but today noticed it was worse and red. She clarifies the splotchiness went away after the first dose; it started a few days after getting the first dose and last a few days then went away. She thought it was dry skin. Now after the second dose, she notices it is worse than after the first dose. It doesn't itch but is red and there. She is not allergic to anything.   No follow-up attempts are possible. No further information is expected.