chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: After the 2nd covid vaccine, within a week I developed vertigo/after receiving the 3rd shot same thing occurred.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Oct2021 (Lot number: FE3590) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfa, reaction(s): "Allergy", notes: Known Allergies: Sulfa. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140), administration date: 19Dec2020, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL1283, Location of injection: Arm Left), administration date: 08Jan2021, when the patient was 36 years old, for COVID-19 Immunization, reaction(s): "After the 2nd covid vaccine, within a week I developed vertigo.". The following information was reported: VERTIGO (non-serious) with onset 07Oct2021, outcome "not recovered", described as "After the 2nd covid vaccine, within a week I developed vertigo/after receiving the 3rd shot same thing occurred.". Therapeutic measures were not taken as a result of vertigo.  Additional information: After the second covid vaccine, within a week patient developed vertigo. She had no prior history of such. Now again, after receiving the third shot same thing occurred. This time however it came on within a day of receiving the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: I developed vertigo.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2021 (Lot number: EL1283) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: Sulfa" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140), administration date: 19Dec2020, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: VERTIGO (non-serious) with onset Jan2021, outcome "recovered" (2021), described as "I developed vertigo.". Therapeutic measures were not taken as a result of vertigo.  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.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menopause
Clinical narrative: Female friends describing missed periods/menopause symptoms.; Female friends describing missed periods/menopause symptoms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENOPAUSE (non-serious), AMENORRHOEA (non-serious), outcome "unknown" and all described as "Female friends describing missed periods/menopause symptoms."  Additional information: Description of Event: Female friends describing missed periods/menopause symptoms. Age group 40-50.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Tremor
Clinical narrative: developed shaking and frozen arm; developed shaking and frozen arm; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative.  A 15 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "developed shaking and frozen arm".  Additional Information: Unknown history but reported to be otherwise healthy teenager. Vaccination was given in the arm that is affected. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart rate was elevated to 140-160; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 23 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "heart rate was elevated to 140-160". Relevant laboratory tests and procedures are available in the appropriate section.  the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product dispensing error, Product temperature excursion issue
Clinical narrative: This is a spontaneous report received from a contactable other-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced product dispensing error, administered poor quality product, administered expired product (dose administered past the 6-hour time) and product temperature excursion issue (patient received the product after the excursion), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Lymphadenopathy, Peripheral swelling
Clinical narrative: it feels like my bones were hurting; Feels like my lymph node like it swelled up under my left arm/  my left armpit swelled up; I have is swollen lymph nodes; my arm, my left armpit swelled up; 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 54 year-old female patient received bnt162b2 (BNT162B2), administration date 09Oct2021 09:00 (Lot number: 30155BA) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; CARVEDILOL taken for hypertension. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization; Bnt162b2 (Dose:02), for Covid-19 immunization. The following information was reported: BONE PAIN (non-serious) with onset 09Oct2021, outcome "unknown", described as "it feels like my bones were hurting"; LYMPHADENOPATHY (non-serious) with onset 09Oct2021, outcome "unknown", described as "Feels like my lymph node like it swelled up under my left arm/  my left armpit swelled up; I have is swollen lymph nodes"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "my arm, my left armpit swelled up". Therapeutic measures were taken as a result of bone pain, lymphadenopathy.  Additional information: It was reported that patient receive the Pfizer booster on Saturday and it was about 9:00 clock. At Saturday patient was fine but after a while start getting it feels like bones were hurting and then it feels like lymph node like it swelled up under left arm. So is that normal for your lymph nodes to swell. Patient received treatment with Tylenol for the events. Patient arm feels like lymph node is swollen under left arm. Patients take blood pressure medicine. Patient did not receive other vaccine prior 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). Other case identifier: NVSC2021US231939_NS). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient's C-reactive protein level increased (outcome unknown). Relevant laboratory tests and procedures available in the appropriate section. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Illness
Clinical narrative: I am sick and I have a lot of symptoms. Well, I have got a lot of health problems.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Lot number: EW0158) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (its ER8727 was the 1st dose), administration date: 22Mar2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I am sick and I have a lot of symptoms. Well, I have got a lot of health problems.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness.  Additional Information: It was reported that, the patient had no medical history. Dates for I am sick and I have a lot of symptoms. Well, I have got a lot of health problems (From: Unspecified To: Unspecified). NDC number of COVID19 Vaccine: Unknown, UPC number of COVID19 Vaccine: Unknown. Consumer stated, I would like to sign up for, I have had the two Pfizer shots and that was back to on April 12 of 21 and I was wondering, I had doctors note because I am sick and I have a lot of symptoms. Well, I have got a lot of health problems. event captured as per verbatim. She had the blood test done recently. The patient was not received Treatment. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The 2nd was done on 12Apr2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "little tired".  Additional information: No reaction to Shots 1 and 2 except a little tired.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling and numbness into the right shoulder neck and head; tingling and numbness into the right shoulder neck and head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 16Feb2021 (Lot number: EN6200) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Vitamin c for allergy, notes: She took a massive dose of Vitamin C in the past because of an allergy. Vaccination history included: Bnt162b2 (Dose:1, /EXP: Unknown, LOT: EL9262, Dose: Unknown, Route: injected into right shoulder), administration date: 25Jan2021, for COVID-19 Immunization, reaction(s): "little bit of pain in the right shoulder". The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 16Feb2021, outcome "recovered" (16Feb2021) and all described as "tingling and numbness into the right shoulder neck and head".  Additional information: No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She had no relevant tests. AEs did not require a visit to Emergency Room or Physician Office.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: A little bit of pain in the right shoulder.; Tingling and numbness into the right shoulder neck and head; Tingling and numbness into the right shoulder neck and head; Tingling and numbness into the right shoulder neck and head; Tingling and numbness into the right shoulder neck and head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "A little bit of pain in the right shoulder."; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "Tingling and numbness into the right shoulder neck and head".  The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up. Additional Information: A contactable consumer reported similar events under the same suspect product for 3 patients that this is the one of 3 reports. first dose in Jan2021, second dose in  Feb2021 and experienced adverse events:  first dose ,  a little bit of pain in the right shoulder. 2nd shot had tingling and numbness into the right shoulder neck and head.  Her age was 70.5 years. She is concerned about the booster dose. Wants guidance about receiving it. She spoke to her doctor about it. She is concerned about getting a worse reaction.   Follow-up (26Nov2021): This 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.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Hypoaesthesia oral, Nerve stimulation test, Paraesthesia
Clinical narrative: Numbness on left side of face including lips/Numbness on whole left side of body-arm; Numbness on left side of face including lips; Pins and needles in feet and heals; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 34 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: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness on left side of face including lips/Numbness on whole left side of body-arm"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "Numbness on left side of face including lips"; PARAESTHESIA (non-serious), outcome "unknown", described as "Pins and needles in feet and heals". The events "numbness on left side of face including lips/numbness on whole left side of body-arm", "numbness on left side of face including lips" and "pins and needles in feet and heals" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: No prior Vaccinations (within 4 weeks). No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Mom-received Pfizer and went to hospital. Heart issues and now autoimmune issues.  No follow-up attempts are possible; lot/batch number is not available despite the follow-up attempts made. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dyspepsia
Clinical narrative: Burning sensation in chest; Experienced was heartburn, took antacid (unspecified medication) and that did not help; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: other medical condition: No. There were no concomitant medications. The following information was reported: BURNING SENSATION (non-serious), outcome "recovered" (2021), described as "Burning sensation in chest"; DYSPEPSIA (non-serious), outcome "recovered" (2021), described as "Experienced was heartburn, took antacid (unspecified medication) and that did not help". Therapeutic measures were taken as a result of burning sensation, dyspepsia.  Additional information: Patient thought it was heart burn, so he took antacid (unspecified medication) and that did not help and after several hours patient took Ibuprofen "300 mg" (further not clarified) tablets and that seems to resolve it (Treatment), so patient experience the burning sensation in chest for 24 hours at first patient thought it was heart burn but he did not respond to antacids and when he took ibuprofen it resolved, so he is recovered and it lasted for 24 hours.  Patient did not receive any other vaccines within 4 weeks prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Condition aggravated, Myalgia, Pain, SARS-CoV-2 test
Clinical narrative: Pain in left armpit followed by generalized muscle pain; Pain in left armpit followed by generalized muscle pain; Achiness of body; I have a chronic pain condition and thought I was just experiencing a flare up; 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), intramuscular, administered in arm left, administration date 07Oct2021 22:45 (Lot number: PFIZERBNTW0186) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 1992 (unspecified if ongoing); "chronic pain condition" (unspecified if ongoing); "High B.P", start date: 2017 (unspecified if ongoing); "Pre-diabetic", start date: 2010 (unspecified if ongoing); "Gall bladder", start date: 1996 (unspecified if ongoing); "Apricot" (unspecified if ongoing), notes: Apricot. Concomitant medication(s) included: QUADRIVALENT INACTIVATED INFLUENZA HA VACCINE, start date: 13Sep2021; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE] taken for fibromyalgia (ongoing) from less than 1 year; SINEQUAN taken for somnolence, start date: 13Sep2021 (ongoing); MICROZIDE [HYDROCHLOROTHIAZIDE] taken for hypertension (ongoing) from less than 1 year; WELLBUTRIN taken for weight (ongoing) from less than 1 year; BEYAZ taken for hormone therapy (ongoing) from less than 1 year; GLUCOPHAGE taken for glucose tolerance impaired (ongoing) from less than 1 year. Vaccination history included: Flu (Route: IM, Anatomical site of injection left arm), administration date: 13Sep2021, for Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN 5318, Location of injection: Arm Left), administration date: Feb2021, when the patient was 46 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN 5318, Location of injection: Arm Left), administration date: Jan2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious), MYALGIA (non-serious) all with onset 08Oct2021, outcome "recovering" and all described as "Pain in left armpit followed by generalized muscle pain"; CONDITION AGGRAVATED (non-serious) with onset Oct2021, outcome "unknown", described as "I have a chronic pain condition and thought I was just experiencing a flare up"; PAIN (non-serious) with onset 08Oct2021, outcome "recovered", described as "Achiness of body". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary pain, myalgia, pain.  Additional information: Patient was not pregnant at the time of vaccination. Patient did not have covid prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Musculoskeletal stiffness, Nausea
Clinical narrative: Bilateral neck pain; Stiffness; Nauseous; Started dry heaving; Chills/ shivering; Sweating; Pressure headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Sep2021 11:30 (Lot number: FF2587) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herniated disc" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 20Sep2021 01:30, outcome "recovering", described as "Nauseous"; RETCHING (non-serious) with onset 20Sep2021 01:30, outcome "recovering", described as "Started dry heaving"; CHILLS (non-serious) with onset 20Sep2021 01:30, outcome "recovering", described as "Chills/ shivering"; HYPERHIDROSIS (non-serious) with onset 20Sep2021 01:30, outcome "recovering", described as "Sweating"; HEADACHE (non-serious) with onset 20Sep2021 01:30, outcome "not recovered", described as "Pressure headache"; NECK PAIN (non-serious) with onset 21Sep2021 01:30, outcome "not recovered", described as "Bilateral neck pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 21Sep2021, outcome "not recovered", described as "Stiffness". The events "nauseous", "started dry heaving", "chills/ shivering", "sweating", "pressure headache", "bilateral neck pain" and "stiffness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea, retching, chills, hyperhidrosis, headache, neck pain, musculoskeletal stiffness.  Additional information: After 2 hours of getting Pfizer vaccine she got nauseous and started dry heaving, chills, sweating, shivering, pressure headache. The second day her pressure headache intensified and bilateral neck pain began. The pressure headache has not gone away nor her neck pain/ stiffness. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The treatment received for the adverse event reported as Tylenol, ibuprofen. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Retching
Clinical narrative: Bilateral neck pain; Stiffness; Nauseous; Started dry heaving; Chills/ shivering; Sweating; Pressure headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Sep2021 11:30 (Lot number: FF2587) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herniated disc" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 20Sep2021 01:30, outcome "recovering", described as "Nauseous"; RETCHING (non-serious) with onset 20Sep2021 01:30, outcome "recovering", described as "Started dry heaving"; CHILLS (non-serious) with onset 20Sep2021 01:30, outcome "recovering", described as "Chills/ shivering"; HYPERHIDROSIS (non-serious) with onset 20Sep2021 01:30, outcome "recovering", described as "Sweating"; HEADACHE (non-serious) with onset 20Sep2021 01:30, outcome "not recovered", described as "Pressure headache"; NECK PAIN (non-serious) with onset 21Sep2021 01:30, outcome "not recovered", described as "Bilateral neck pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 21Sep2021, outcome "not recovered", described as "Stiffness". The events "nauseous", "started dry heaving", "chills/ shivering", "sweating", "pressure headache", "bilateral neck pain" and "stiffness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea, retching, chills, hyperhidrosis, headache, neck pain, musculoskeletal stiffness.  Additional information: After 2 hours of getting Pfizer vaccine she got nauseous and started dry heaving, chills, sweating, shivering, pressure headache. The second day her pressure headache intensified and bilateral neck pain began. The pressure headache has not gone away nor her neck pain/ stiffness. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The treatment received for the adverse event reported as Tylenol, ibuprofen. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Severe injection sure pain; Soreness in upper body; Headache; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Oct2021 19:30 (Lot number: FE3590) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Penicillins" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: DIOVAN HCT; AMLODIPINE. Past drug history included: Levofloxicin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 26Jan2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: FE3590, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 16Feb2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Oct2021 03:00, outcome "recovering", described as "Severe injection sure pain"; PAIN (non-serious) with onset 12Oct2021 03:00, outcome "recovering", described as "Soreness in upper body"; HEADACHE (non-serious) with onset 12Oct2021 03:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 12Oct2021 03:00, outcome "recovering", described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, pain, headache, fatigue.  Additional Information: Therapeutic measures were taken as a result of events included Advil and tylonel. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: sever chills; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 09:00 (Lot number: EW0186) at the age of 44 years as dose 1, single and administered in arm left, administration date 13Oct2021 09:00 (Lot number: EW0186) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Sinuitis" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: AMLODIPINE; PROTONIX [OMEPRAZOLE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Cipro, reaction(s): "Allergy", notes: known allergies: Cipro. The following information was reported: CHILLS (non-serious) with onset 22Sep2021 01:00, outcome "recovered with sequelae", described as "sever chills"; HEADACHE (non-serious) with onset 22Sep2021 01:00, outcome "recovered with sequelae", described as "headache"; PAIN (non-serious) with onset 22Sep2021 01:00, outcome "recovered with sequelae", described as "body aches". Therapeutic measures were not taken as a result of chills, headache, pain.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Other medications in two weeks included Amlodipine, Zyrtec, Protonix. Reporter stated that, after first dose of the vaccine she came down with sever chills, headache, and body aches that lasted for 14 hours. The patient tested COVID-19 positive prior to vaccination. Cipro known allergies were reported.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Illness, Nausea
Clinical narrative: Felt tired; ill; Nausea; diarrhea; Temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 11:00 (Lot number: FE3592) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing); "Control blood pressure" (ongoing); "Anxiety" (ongoing). Concomitant medication(s) included: INFLUENZA, administration date 30Sep2021; PNEUMOCOCCAL VACCINE, administration date 30Sep2021; AMLODIPINE taken for blood pressure abnormal (ongoing); ALPRAZOLAM taken for anxiety (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ep7533, Location of injection: Arm Left, Date: 31Mar2021, Time: 11:00), administration date: 31Mar2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Date: 10Mar2021, Time (24hrs): 10:30, Batch/Lot No: Fn6207, Route of administration: Intramuscular, Location of injection: Arm Right), administration date: 10Mar2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 13Oct2021 03:00, outcome "recovered" (15Oct2021), described as "Nausea"; DIARRHOEA (non-serious) with onset 13Oct2021 03:00, outcome "recovered" (15Oct2021), described as "diarrhea"; BODY TEMPERATURE (non-serious) with onset 13Oct2021, outcome "recovered" (15Oct2021), described as "Temperature"; FATIGUE (non-serious), outcome "recovered", described as "Felt tired"; ILLNESS (non-serious), outcome "recovered", described as "ill". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, diarrhoea, body temperature.  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Woke day after booster with Diarrhea and nausea. Took temperature. Elevated temperature by 1 degree felt tired and ill for 2 days. Prior to and since the vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Vaccination site pain
Clinical narrative: soreness at the injection site (right arm); aching underneath the right arm, and near the outpart of the right breast; aching underneath the right arm, and near the outpart of the right breast; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 14:15 (Lot number: FF8841) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "elevated cholesterol" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 05Feb2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 15Jan2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Oct2021 22:00, outcome "not recovered", described as "soreness at the injection site (right arm)"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious) all with onset 12Oct2021 22:00, outcome "not recovered" and all described as "aching underneath the right arm, and near the outpart of the right breast". Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, breast pain.  Additional Information: The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient did not have COVID prior vaccination. The patient did not tested COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vascular pain
Clinical narrative: left arm numbness; bulgining painful veins on hands and feet; tingling in arms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "left arm numbness"; VASCULAR PAIN (non-serious), outcome "unknown", described as "bulgining painful veins on hands and feet"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in arms".  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: As with the first two doses I was exhausted for about three days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 12:30 (Lot number: EP7534) at the age of 54 years as dose 1, single and administered in arm left, administration date 05Apr2021 12:30 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ASTHMA" (unspecified if ongoing); "Narcolepsy" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypo thyroid" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex; "known allergies: sulfa Drug" (unspecified if ongoing), notes: known allergies: sulfa Drug; "known allergies: nitrile gloves" (unspecified if ongoing), notes: known allergies: nitrile gloves; "known allergies: Many many seasonal" (unspecified if ongoing), notes: known allergies: Many many seasonal. Concomitant medication(s) included: POTASSIUM; FENOFIBRATE; LEVOTHYROXINE; OMEPRAZOLE. Past drug history included: Prednisone, reaction(s): "known allergies: prednisone", notes: known allergies:prednisone; Ghb, reaction(s): "known allergies: ghb", notes: known allergies: ghb; Demerol, reaction(s): "known allergies: Demerol", notes: known allergies: Demerol; Morphine, reaction(s): "known allergies: morphine", notes: known allergies: morphine. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "As with the first two doses I was exhausted for about three days.". Therapeutic measures were not taken as a result of fatigue.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: three blisters at the injection site; 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 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 16:00 (Lot number: 301551BA) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seasonal Allergies" (unspecified if ongoing), notes: She has always suffered from them; "Asthamatic" (unspecified if ongoing), notes: She is Asthmatic and has not suffered from an attack in many years.  Diagnosed as a child at age 8-9. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, 1st dose given 06Feb2021 EL3247,, Injected in left arm), administration date: 06Feb2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, 2nd dose given 01Mar2021, Lot EN6200. Injected in left arm), administration date: 01Mar2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE VESICLES (non-serious) with onset 13Oct2021 07:00, outcome "not recovered", described as "three blisters at the injection site".  Additional information: it was reported that patient took it yesterday afternoon and she had three blisters at the injection site after removing the bandage. She would like to know if this had been reported. She queried about why does she had them, referring to the blisters. No prior vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No Family Medical History Relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. 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 (1st dose of covid vaccine), for COVID-19 immunization; Bnt162b2 (2nd dose of covid vaccine), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt unwell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Miosis, Visual impairment
Clinical narrative: It felt like I popped steroid pills; Had trouble reading numbers at work; My pupil is constricting; Insomnia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing); "Allergy: Cats and dogs" (unspecified if ongoing); "Allergy: Milk" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "It felt like I popped steroid pills"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "recovered" (2021), described as "Had trouble reading numbers at work"; MIOSIS (non-serious) with onset 2021, outcome "unknown", described as "My pupil is constricting"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "Insomnia".  Additional information: Patient had very, very good near sightedness, this was effected for a while and now it is better. Feels like his pupil is constricting and it just stops midway.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: She felt tired after receiving the vaccine and it was for about 3 days; I was just little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 23Sep2021 (Lot number: 30135BA) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Epilepsy" (unspecified if ongoing), notes: Verbatim: Epilepsy. Concomitant medication(s) included: FLU VACCINE VII; ALBUTEROL [SALBUTAMOL] taken for asthma.  The following information was reported: FATIGUE (non-serious) with onset 26Sep2021, outcome "recovered", described as "She felt tired after receiving the vaccine and it was for about 3 days; I was just little tired".  Additional information: The reporter stated that I have a consumer on the line that received her first dose of the Pfizer Covid-19 Vaccine a couple weeks ago and is scheduled to receive the 2nd dose this Thursday and she had mentioned to me after having the 1st dose that she felt tired after receiving the vaccine and it was for about 3 days.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chills, 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 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jul2021 (Lot number: EW0167) at the age of 42 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Chronic fatigue syndrome" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "known allergies: Percocet". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0167, Location of injection: Left Arm), when the patient was 42 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Pain in arm"; CHILLS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "chills for two days"; ALOPECIA (non-serious) with onset 25Aug2021, outcome "not recovered", described as "now hair loss". Additional information: It was reported as Pain in arm later that night chills for two days now hair loss. No other vaccine was received in four weeks. The patient not received Covid vaccination prior and post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chills, Pain in extremity
Clinical narrative: Chills; pain in arm soar for three days; significant loss of hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Aug2021 12:00 (Lot number: EWO167) at the age of 14 years as dose 2, single and (Lot number: EWO167) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sickle cell disease (SS)" (unspecified if ongoing); "asthma( mild)" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYUREA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]; FLOVENT. The following information was reported: CHILLS (non-serious) with onset 01Sep2021, outcome "recovered" (04Sep2021), described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 01Sep2021, outcome "recovered" (04Sep2021), described as "pain in arm soar for three days"; ALOPECIA (non-serious) with onset 01Sep2021, outcome "not recovered", described as "significant loss of hair". Therapeutic measures were not taken as a result of chills, pain in extremity, alopecia.  Additional information: Facility type vaccine: School or Student Health Clinic. Other vaccine in four weeks: No. Other medications in two weeks coded under concomitant medications. Covid prior vaccination and tested post vaccination: No.  No follow-up attempts are possible. No further information is expected.