chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Illness, Nausea
Clinical narrative: fatigue; sick; nausea; bruise on her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 23 year-old female patient received bnt162b2 (COMIRNATY), administration date Jan2022 (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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "fatigue"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "sick"; NAUSEA (non-serious) with onset 2022, outcome "unknown", described as "nausea"; CONTUSION (non-serious) with onset 2022, outcome "recovered", described as "bruise on her arm".  Additional information: Reporter reported that She called on behalf of her 23 years old daughter. She stated her daughter received the booster dose of the COMIRNATY vaccine in earlier Jan2022. Caller stated her daughter felt so sick and has nausea and fatigue even 3 weeks after receiving the booster dose. She mentioned her daughter also experience these type of side effects after receiving the Flu vaccine. She asked if there was any information regarding nausea and fatigue as side effects 3 weeks after receiving the booster dose. She stated her daughter also presented a bruise on her arm were she received the dose, for about a week. In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).And spoke from attached "Persons 18 Years and Older: Local reactions lasted between 1 and 2 days and systemic reactions lasted around 1 day. Swollen lymph nodes (lymphadenopathy) were also reported and generally resolved within 10 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Fatigue, Feeling abnormal
Clinical narrative: couldn't get out of bed; felt as if somebody had beaten her bad; her joints are all activated (she has Rheumatoid arthritis) and they all hurt; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Jan2022 (Lot number: O33138A) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: she has Rheumatoid arthritis. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose Unknown, had never happened before with the previous vaccines.), for COVID-19 Immunization, reaction(s): "had never happened before with the previous vaccines.". The following information was reported: BEDRIDDEN (non-serious) with onset 18Jan2022, outcome "unknown", described as "couldn't get out of bed"; FEELING ABNORMAL (non-serious) with onset 18Jan2022, outcome "unknown", described as "felt as if somebody had beaten her bad"; ARTHRALGIA (non-serious) with onset 18Jan2022, outcome "unknown", described as "her joints are all activated (she has Rheumatoid arthritis) and they all hurt"; FATIGUE (non-serious) with onset 18Jan2022, outcome "unknown", described as "tired".  Additional information: The patient was enquired that if booster was exactly the same formulation as the previous vaccines.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash macular
Clinical narrative: Itching; Burning sensation over entire body; Widely dispersed red spots on skin too; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 14:00 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "Renauds" (unspecified if ongoing), notes: Renauds; "fibromyalgia" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing), notes: Known allergy: Penacillin. Concomitant medication(s) included: ZOFRAN [ONDANSETRON]; FIORINAL CODEINA; ROBAXIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 31Mar2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 21Apr2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Itching"; BURNING SENSATION (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Burning sensation over entire body"; RASH MACULAR (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Widely dispersed red spots on skin too". Therapeutic measures were taken as a result of pruritus, burning sensation, rash macular.  Additional information: Patient did not received any other vaccine within 4weeks prior to the COVID vaccine and prior to vaccination patient not diagnosed with COVID 19 and since the vaccination patient has not been tested for COVID 19 and treatment received for the adverse event is hydroxyzine HCL 25mg.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Pruritus, Rash erythematous, Vaccination site rash
Clinical narrative: automatic itching; red rash almost instantaneously; hot flushes/flushing/flushy feeling/hot flushing feeling; immediate rash to the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 26 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FK9729, Expiration Date: 21Jun2022) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization, reaction(s): "No adverse event"; Bnt162b2 (Dose:02), for COVID-19 Immunization, reaction(s): "No adverse event".  The following information was reported: PRURITUS (non-serious), outcome "recovered", described as "automatic itching"; RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "red rash almost instantaneously"; HOT FLUSH (non-serious), outcome "recovered", described as "hot flushes/flushing/flushy feeling/hot flushing feeling"; VACCINATION SITE RASH (non-serious), outcome "recovered", described as "immediate rash to the injection site".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Dyspnoea, Loss of personal independence in daily activities, Paraesthesia oral
Clinical narrative: Unstable lightheaded/ severe Lightheadedness; Dizzy/ Woozy feeling; Little shortness of breath; Tingling sensation in my lip; Funny taste in my mouth; Cant drive the car; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 10Jan2022 (Lot number: FJ6369) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing), notes: I have an autoimmune disease. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "light headedness"; Covid-19 vaccine (Dose: 1,MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "pain"; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "light headedness", "pain". The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "Cant drive the car"; DIZZINESS (non-serious) with onset 10Jan2022, outcome "not recovered", described as "Unstable lightheaded/ severe Lightheadedness"; DIZZINESS (non-serious) with onset Jan2022, outcome "unknown", described as "Dizzy/ Woozy feeling"; DYSPNOEA (non-serious) with onset Jan2022, outcome "unknown", described as "Little shortness of breath"; PARAESTHESIA ORAL (non-serious) with onset Jan2022, outcome "unknown", described as "Tingling sensation in my lip"; DYSGEUSIA (non-serious) with onset Jan2022, outcome "unknown", described as "Funny taste in my mouth".  Additional information: The prior 2 shots patient felt some light headedness the 1st day or so, but had more pain.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Interchange of vaccine products, Off label use, Urticaria
Clinical narrative: Patient's concomitant medication included: Pfizer COVID Vaccine, Moderna COVID-19 Vaccine; Patient's concomitant medication included: Pfizer COVID Vaccine, Moderna COVID-19 Vaccine; inappropriate route of administration; Urticaria; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4506964 (Genentech).  A 76 year-old male patient received bnt162b2 (BNT162B2), oral (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PEPCID [FAMOTIDINE]; BENADRYL; ALLEGRA. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Patient's concomitant medication included: Pfizer COVID Vaccine, Moderna COVID-19 Vaccine"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "inappropriate route of administration"; URTICARIA (non-serious), outcome "recovered", described as "Urticaria". Therapeutic measures were taken as a result of urticaria.  Additional information: On unknown date, patient started therapy for Urticaria.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Fatigue, Lymphadenopathy, Pain
Clinical narrative: dizziness; fatigue; bad body aches; largely swollen lymph node; ear fullness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 20:00 (Batch/Lot number: unknown) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "thyroid issue" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing), notes: Verbatim: Known allergies: Latex, sulfa drugs, iodine dye; "sulfa allergy" (unspecified if ongoing), notes: Verbatim: Known allergies: Latex, sulfa drugs, iodine dye; "iodine dye allergy" (unspecified if ongoing), notes: Verbatim: Known allergies: Latex, sulfa drugs, iodine dye. Concomitant medication(s) included: LEVOTHYROXINE; SERTRALINE; PRAVASTATIN; ATENOLOL. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose administration time: 12:00, prev dose vaccine location: Left arm), administration date: 12Apr2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose administration time: 12:00 , prev dose vaccine location: Left arm), administration date: 03May2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 19Jan2022 12:00, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 19Jan2022 12:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 19Jan2022 12:00, outcome "recovering", described as "bad body aches"; LYMPHADENOPATHY (non-serious) with onset 19Jan2022 12:00, outcome "not recovered", described as "largely swollen lymph node"; EAR DISCOMFORT (non-serious) with onset 19Jan2022 12:00, outcome "recovering", described as "ear fullness". Therapeutic measures were not taken as a result of dizziness, fatigue, pain, lymphadenopathy, ear discomfort.  Additional information: The patient did not receive any other vaccine in four weeks. The patient had not been tested covid-19 post vaccination. The patient had not tested positive covid -19 prior vaccination. 15 hours after first dose booster for Covid 19, the patient had ear fullness, dizziness, bad body aches, largely swollen lymph node under left arm (2 days later and it was still swollen), fatigue.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; Arm was sore at site of the shot; Joint pain/joint aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200112656 (Pfizer).  A 53 year-old male patient received bnt162b2 (COMIRNATY), administered in deltoid right, administration date 18Jan2022 (Lot number: FJ6369) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number: EP6955, Expiry date: 30Jun2021, Anatomical location: right deltoid), administration date: 19Mar2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, single, Lot number: EP6955, Expiry date 30Jun2021, Anatomical location: right deltoid), administration date: 07Apr2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 19Jan2022, outcome "recovered" (Jan2022), described as "Fever"; CHILLS (non-serious) with onset 19Jan2022, outcome "recovered" (Jan2022), described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 19Jan2022, outcome "recovered" (Jan2022), described as "Arm was sore at site of the shot"; ARTHRALGIA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Joint pain/joint aches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The concomitant medication included unspecified hypertension medication. Caller clarified the typical reaction to be last evening her husband started to have a fever, the highest was 102.3, chills, joint aches, arm was sore at site of the shot. Caller confirmed all these events have resolved, but he still had joint pain; no additional details provided.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Patient received Covid booster and experienced fatigue and fever following shot; Patient received Covid booster and experienced fatigue and fever following shot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP).  A 13-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER: UNKNOWN), for Covid-19 Immunization.  The following information was reported: PYREXIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Patient received Covid booster and experienced fatigue and fever following shot".  Additional Information: Clinical course: Patient received Covid booster and experienced fatigue and fever following shot. Event did not take place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 08:00 (Lot number: Ff8839) at the age of 69 years 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 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EL9265,, prev dose lot unknown=False,, prev dose administration date=10Feb2021,, prev dose administration time=08:30 AM, prev dose dose number=2,, prev dose vaccine location=Right arm), administration date: 10Feb2021, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Obscured by other product labelling, prev dose administration date=21Jan2021,, prev dose administration time=08:45 AM, prev dose dose number=1,, prev dose vaccine location=Right arm), administration date: 21Jan2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 01Oct2021, outcome "not recovered", described as "Tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient had no COVID prior to vaccination and post vaccination patient has not been tested for COVID.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Inappropriate schedule of product administration
Clinical narrative: Jul2021 I received my first Pfizer Covid vaccine/ In August the second dose/ Today I received my Pfizer Covid booster; stomach ballooned by 5 inches/ bloating and stomach distention for 6 months/ 3 pant sizes up in a week. Still up 3 due to the bloat; 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 patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 20Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, so much worse), administration date: Aug2021, for Covid-19 immunization, reaction(s): "so much worse"; Bnt162b2 (Dose 2, 3 pant sizes up in a week. Still up 3 due to the bloat), administration date: Aug2021, for Covid-19 immunization, reaction(s): "3 pant sizes up in a week. Still up 3 due to the bloat"; Bnt162b2 (Dose 1, severe bloating), administration date: Jul2021, for Covid-19 immunization, reaction(s): "severe bloating"; Bnt162b2 (Dose 1, stomach distention), administration date: Jul2021, for Covid-19 immunization, reaction(s): "stomach distention". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Jan2022, outcome "unknown", described as "Jul2021 I received my first Pfizer Covid vaccine/ In August the second dose/ Today I received my Pfizer Covid booster"; ABDOMINAL DISTENSION (non-serious) with onset 20Jan2022, outcome "not recovered", described as "stomach ballooned by 5 inches/ bloating and stomach distention for 6 months/ 3 pant sizes up in a week. Still up 3 due to the bloat".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Incorrect dose administered
Clinical narrative: Pfizer just got my 5th dose feeling ; Pfizer just got my 5th dose feeling ; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (153987). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 5 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "Pfizer just got my 5th dose feeling".  Additional information: Patient reported ''Pfizer just got my 5th dose feeling''  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 4 days after the third dose , I have strong hives in my entire body legs, arms, belly and back. The hives didn't go way; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 14:45 (Lot number: FL3209) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Surgical menopause" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Left, MANUFACTURER UNKNOWN), administration date: 22Jan2021, when the patient was 46 years old, for Covid-19 immunization; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, MANUFACTURER UNKNOWN, After the second dose I started to have sporadically. I thought that was some allergies. I went to the doctor,, did some exames and everything is normal.), administration date: 25Feb2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "I started to have sporadically. I thought that was some allergies.". The following information was reported: URTICARIA (non-serious) with onset 18Jan2022, outcome "not recovered", described as "4 days after the third dose , I have strong hives in my entire body legs, arms, belly and back. The hives didn't go way". The event "4 days after the third dose , i have strong hives in my entire body legs, arms, belly and back. the hives didn't go way" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional information: Vaccine facility type was hospital. Other vaccine in four weeks reported as no. 4 days after the third dose, patient had strong hives in her entire body: legs, arms, belly and back. The hives didn't go way. She searched and she found person with the same hives due vaccine allergies. Ae treated with Zyrtec. Covid prior vaccination and covid tested post vaccination reported as no. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Condition aggravated, Dyspnoea, Fatigue
Clinical narrative: She had a bad reaction fever; chills; tired; She still feels tired and headache; She also experiences still shortness of breath; With each shot, she gets her symptoms are worst; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization, reaction(s): "With each shot, she gets her symptoms are worst"; Bnt162b2 (Dose number: 2), for COVID-19 immunization, reaction(s): "With each shot, she gets her symptoms are worst". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "She had a bad reaction fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "not recovered", described as "tired"; HEADACHE (non-serious), outcome "not recovered", described as "She still feels tired and headache"; DYSPNOEA (non-serious), outcome "not recovered", described as "She also experiences still shortness of breath"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "With each shot, she gets her symptoms are worst". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Phone-Out 09:17 AM, 1st attempt by phone to consumer to obtain contact information. Call answered by consumer who stated "She had a bad reaction fever, chills, and tired after her 3rd shoot. She still feels tired and headache. No doctor. She also experiences still shortness of breath for a long time and is not recovering. With each shot, she gets her symptoms are worst. She just wants to know if it will go away eventually." Medical team number was given, but stated she already call them and no information was provided. No more information to provide.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: She had a bad reaction fever; chills; tired; She still feels tired and headache; She also experiences still shortness of breath; With each shot, she gets her symptoms are worst; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization, reaction(s): "With each shot, she gets her symptoms are worst"; Bnt162b2 (Dose number: 2), for COVID-19 immunization, reaction(s): "With each shot, she gets her symptoms are worst". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "She had a bad reaction fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "not recovered", described as "tired"; HEADACHE (non-serious), outcome "not recovered", described as "She still feels tired and headache"; DYSPNOEA (non-serious), outcome "not recovered", described as "She also experiences still shortness of breath"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "With each shot, she gets her symptoms are worst". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Phone-Out 09:17 AM, 1st attempt by phone to consumer to obtain contact information. Call answered by consumer who stated "She had a bad reaction fever, chills, and tired after her 3rd shoot. She still feels tired and headache. No doctor. She also experiences still shortness of breath for a long time and is not recovering. With each shot, she gets her symptoms are worst. She just wants to know if it will go away eventually." Medical team number was given, but stated she already call them and no information was provided. No more information to provide.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Nausea, Vomiting
Clinical narrative: Vomiting; slept entire second day; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 15:00 (Lot number: FJ8762) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression", start date: 2018 (ongoing), notes: was taking 125 mg at the time of 2nd dose. Concomitant medication(s) included: ZOLOFT taken for depression, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date: 29Mar2021, Time (24hr): 09:00 AM ET, Anatomical site of Injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 29Mar2021, when the patient was 18 years old, for COVID-19 immunisation; Bnt162b2 (Dose: 2nd , Date: 19Apr2021, Time (24hr): 09:00 AM ET, Anatomical site of Injection: Left Arm, Batch/Lot number: EP6955, Route of administration: Intramuscular), administration date: 19Apr2021, when the patient was 18 years old, for COVID-19 immunisation, reaction(s): "he started not feeling well at night", "sick", "vomiting", "Nauseous". The following information was reported: NAUSEA (non-serious) with onset Dec2021, outcome "unknown", described as "nauseous"; VOMITING (non-serious) with onset 21Dec2021 06:00, outcome "recovered" (Dec2021), described as "Vomiting"; HYPERSOMNIA (non-serious) with onset Dec2021, outcome "recovered" (2021), described as "slept entire second day".  Additional information: Patient had similar reaction to that he had to his second dose where he was just nauseous. His booster dose he had a similar reaction. For the booster, (name withheld) received the booster at 03:00 PM in the afternoon and was vomiting at 06:00 AM the next morning. So about the same 15 hour window after getting the shot. Similar recovery- slept entire second day and resumed normal activities within 48 hours. Specific Relevant Test for thromboembolic events with thrombocytopenia was reported as None. Prior vaccination (within 4 weeks)was None.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Lymphadenopathy, Nausea
Clinical narrative: body ache; 101 Fever; gland swelling; headache; fatigue; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Aug2021 10:15 (Lot number: FC3183) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Time(24hr): 20:00, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EL1284), administration date: 11Jan2021, when the patient was 39 years old, for covid 19 immunization; Bnt162b2 (Dose 2, single, Time(24hr): 08:30, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EL8982), administration date: 29Jan2021, when the patient was 39 years old, for covid 19 immunization, reaction(s): "gland swelling", "headache", "body ache", "fatigue", "nausea". The following information was reported: PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "body ache"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered", described as "101 Fever"; LYMPHADENOPATHY (non-serious) with onset Aug2021, outcome "unknown", described as "gland swelling"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Aug2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset Aug2021, outcome "unknown", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Gland swelling for a further week. Also occurred following boosters with 101 fever for 24hrs onset 4hrs after injection.  Follow-Up (28Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: body ache; 101 Fever; gland swelling; headache; fatigue; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Aug2021 10:15 (Lot number: FC3183) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Time(24hr): 20:00, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EL1284), administration date: 11Jan2021, when the patient was 39 years old, for covid 19 immunization; Bnt162b2 (Dose 2, single, Time(24hr): 08:30, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EL8982), administration date: 29Jan2021, when the patient was 39 years old, for covid 19 immunization, reaction(s): "gland swelling", "headache", "body ache", "fatigue", "nausea". The following information was reported: PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "body ache"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered", described as "101 Fever"; LYMPHADENOPATHY (non-serious) with onset Aug2021, outcome "unknown", described as "gland swelling"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Aug2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset Aug2021, outcome "unknown", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Gland swelling for a further week. Also occurred following boosters with 101 fever for 24hrs onset 4hrs after injection.  Follow-Up (28Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: has a frequent headache after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "has a frequent headache after the booster dose".  Additional information: The patient had the two doses and got the third dose because there was a lot of information about the effectiveness of the vaccine after 6 months so it was suggested to get a booster dose. The caller has had the booster as well but he didn't have any side effects. The caller clarifies that his wife is having more than frequent headaches. This could be a symptom from something else but he isn't sure if the vaccine exacerbated it or something.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tinnitus
Clinical narrative: fever; aches; chills; headache; Tinnitus/ringing in my ears; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 07Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization, reaction(s): "chills", "headache", "aches", "Fever"; Bnt162b2 (Second dose), for Covid-19 immunization, reaction(s): "chills", "headache", "aches", "Fever". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "aches"; CHILLS (non-serious), outcome "recovered", described as "chills"; HEADACHE (non-serious), outcome "recovered", described as "headache"; TINNITUS (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Tinnitus/ringing in my ears".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, SARS-CoV-2 test
Clinical narrative: never have any energy; I have had a cough since my 2nd dose on 12May2021 and I always feel tired and rundown. I never have any energy, and I cough every morning and have coughing fits during the day.; feel tired and rundown; 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 male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm right, administration date 12May2021 13:30 (Lot number: EW0170) at the age of 47 years as dose 2, single and administered in arm left, administration date 27Dec2021 12:00 (Lot number: FL3197) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; ADDERALL; NEXIUM [ESOMEPRAZOLE SODIUM]; PANTOPRAZOLE SODIUM (ongoing). Past drug history included: Phenergen, reaction(s): "known allergies: Phenergen". Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=PFIZER,, Prev dose brand unknown=False,, Prev dose lot number=ER8731,, Prev dose lot unknown=False,, Prev dose administration date=21Apr2021,, Prev dose administration time=01:30 PM, Prev dose dose number=1,, Prev dose vaccine location=Left arm), administration date: 21Apr2021, when the patient was 47 years old, for Covid-19 immunization and vitamins. The following information was reported: ASTHENIA (non-serious) with onset 14May2021 10:00, outcome "not recovered", described as "never have any energy"; COUGH (non-serious) with onset 14May2021 10:00, outcome "not recovered", described as "I have had a cough since my 2nd dose on 12May2021 and I always feel tired and rundown. I never have any energy, and I cough every morning and have coughing fits during the day."; FATIGUE (non-serious) with onset 14May2021 10:00, outcome "not recovered", described as "feel tired and rundown". The events "never have any energy", "i have had a cough since my 2nd dose on 12may2021 and i always feel tired and rundown. i never have any energy, and i cough every morning and have coughing fits during the day." and "feel tired and rundown" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, cough, fatigue.   Additional information: The patient was treated with decongestants, cough med, acid reducers. The patient did not receive any other vaccine in four weeks. The patient did not diagnosed with covid-19 prior vaccination. The patient was tested for Covid-19 post vaccination. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Circumoral swelling, Lip swelling, Nasal oedema, Sinusitis
Clinical narrative: sinus infection; lip swelling/swelling was huge, up to my nostrils and round my mouth/could feel a ridge up by my nostrils; lip swelling/swelling was huge, up to my nostrils and round my mouth/could feel a ridge up by my nostrils; lip swelling/swelling was huge, up to my nostrils and round my mouth/could feel a ridge up by my nostrils; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): GL-011822-1190 (Reference Number).  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation; hyaluronic acid (RESTYLANE), from 14Jan2022 17:00 (Batch/Lot number: unknown) to 14Jan2022 17:00 at 1.2 mL (1.2 ml(received 1 ml of restylane kysse 0.75 ml in the lips and 0.25 ml around the mouth)). Relevant medical history included: "dental cleaning" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose), administration date: Dec2020, when the patient was 46 years old, for covid-19 immunization; Bnt162b2 (2nd Dose), administration date: Jan2021, when the patient was 46 years old, for covid-19 immunization. The following information was reported: LIP SWELLING (non-serious) with onset 14Jan2022 20:00, outcome "recovering", NASAL OEDEMA (non-serious), CIRCUMORAL SWELLING (non-serious) all with onset 14Jan2022 23:30, outcome "recovering" and all described as "lip swelling/swelling was huge, up to my nostrils and round my mouth/could feel a ridge up by my nostrils"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". Therapeutic measures were taken as a result of lip swelling, nasal oedema, circumoral swelling, sinusitis. Additional information: She received the injection around 5:00 PM and by 8:00PM the same night she started to experience lip swelling and by 11:30 PM the same night nurse reports the swelling was huge, up to her nostrils and round her mouth. She could feel a ridge up by her nostrils. Patient was given an injection of Kenalog and prescription for prednisone on 15Jan2022. Patient reported that Kenalog helped a lot and prednisone helped even more. Patient reported on Sunday 6Jan2022 the swelling had decreased to the normal expected swelling, she still has slight swelling. Patient had Restylane kysse about a year ago and did not experience this swelling then. Denies any other vaccines within the past year. Nurse reports she recently had a sinus infection but no other illnesses reported. Nurse reports she has had a routine dental cleaning in the past 6 months.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product storage error
Clinical narrative: severe headache; they had left the vaccine in a freezer longer than it was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient 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: Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "severe headache"; PRODUCT STORAGE ERROR (non-serious), outcome "unknown", described as "they had left the vaccine in a freezer longer than it was".  Additional information: Attempted warm transfer from (name) with 159558. Agent relays he has a caller on the line and her daughter received the booster. reporter is the patient parent said that her daughter received a third dose on Monday, from a local pharmacy and they just called them and told that they had left the vaccine in a freezer longer than and reporter said that after her daughter received the vaccine she was been dealing with a severe headache, at entire time.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: my arm was sore and swollen; my vision is really blurry; Itchy; feel like that I got the flu; Headache; my arm was sore and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 21Jan2022 (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: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 22Jan2022, outcome "unknown" and all described as "my arm was sore and swollen"; VISION BLURRED (non-serious) with onset 22Jan2022, outcome "unknown", described as "my vision is really blurry"; PRURITUS (non-serious) with onset 22Jan2022, outcome "unknown", described as "Itchy"; FEELING ABNORMAL (non-serious) with onset 22Jan2022, outcome "unknown", described as "feel like that I got the flu"; HEADACHE (non-serious) with onset 22Jan2022, outcome "unknown", described as "Headache".  Additional information: report was not related to study programme, Consumer stated that well patient do not want to give all the information, just ant to see if the patient do not know if calling to right number, patient want to know some thing about side effects because on Friday got the shot in the evening and then when patient woke up arm was sore and swollen and king of felt, feel itchy all over, it kind of feel like that got the flu and have a bad headache and vision was really blurry. so the patient know if should go to get check or wait and see if kind of stop or what. Consumer was informed about Pfizer Medical information department, As, consumer hung up the call abruptly. Further probing could not be done. Hence, limited information available over the call.  The lot number for bnt162b2 was not provided and will be requested during follow up.