chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Infusion site bruising, Infusion site pain, Pain, Pharyngeal inflammation
Clinical narrative: Dyspnoea; Fatigue; Pharyngeal Inflammation; Infusion Site Pain; Pain; Infusion Site Bruising; Chills; Asthenia; Feeling Hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; macitentan (OPSUMIT) (Batch/Lot number: unknown) for pulmonary arterial hypertension; treprostinil sodium (REMODULIN) (Batch/Lot number: unknown) for pulmonary arterial hypertension; treprostinil (TREPROSTINIL) (Batch/Lot number: unknown) for pulmonary arterial hypertension; warfarin (WARFARIN) (Batch/Lot number: unknown) for pulmonary arterial hypertension; macitentan (MACITENTAN) (Batch/Lot number: unknown) for pulmonary arterial hypertension. The patient's relevant medical history was not reported. Concomitant medication(s) included: SILDENAFIL CITRATE. The following information was reported: DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Dyspnoea"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; PHARYNGEAL INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "Pharyngeal Inflammation"; INFUSION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Infusion Site Pain"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain"; INFUSION SITE BRUISING (non-serious) with onset 2021, outcome "unknown", described as "Infusion Site Bruising"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Asthenia"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "Feeling Hot". The action taken for macitentan, treprostinil sodium, treprostinil, warfarin and macitentan was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: General body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US187443_NS (Novartis).  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 09Oct2021 (Batch/Lot number: unknown) at the age of 65 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 (First dose), for Covid-19 immunization; Bnt162b2 (Second dose), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "General body aches".  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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Vaccination site nodule, Vaccination site swelling
Clinical narrative: lymph nodes in under arm both sides swollen; Tired for 2 days; swelling left arm where shot given; Knot at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 10:00 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "obese" (unspecified if ongoing); "veinous insufficiency" (unspecified if ongoing); "known allergies: Strawberries, fresh caught fish" (unspecified if ongoing); "known allergies: straw materials" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE]; SINGULAIR. Vaccination history included: Bnt162b2 (Dose 2, Single, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 12Mar2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Single, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 19Feb2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 13Oct2021 13:00, outcome "not recovered", described as "lymph nodes in under arm both sides swollen"; FATIGUE (non-serious) with onset 13Oct2021 13:00, outcome "not recovered", described as "Tired for 2 days"; VACCINATION SITE SWELLING (non-serious) with onset 13Oct2021 13:00, outcome "not recovered", described as "swelling left arm where shot given"; VACCINATION SITE NODULE (non-serious) with onset 13Oct2021 13:00, outcome "not recovered", described as "Knot at injection site". Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, vaccination site swelling, vaccination site nodule.  Additional information: Other medications in two weeks included Claritin, albuterol , steroid inhaler, singular. No other vaccine in four weeks. Patient had no Covid prior vaccination and Covid not tested post vaccination.   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.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She became ill after the second injection; 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 2, 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. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She became ill after the second injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Within 3 hours of receiving the vaccine I began to feel severely light headed; Fatigued; Short of breath; Pressure in my chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Sep2021 (Lot number: EW0191) 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 no: 1), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Within 3 hours of receiving the vaccine I began to feel severely light headed"; FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Fatigued"; DYSPNOEA (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Short of breath"; CHEST DISCOMFORT (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Pressure in my chest". The events "within 3 hours of receiving the vaccine i began to feel severely light headed", "fatigued", "short of breath" and "pressure in my chest" were evaluated at the emergency room visit.  Additional information: Within 3 hours of receiving the vaccine patient began to feel severely light headed, fatigued, short of breath and pressure in chest. Symptoms did not resolve after 48 hours, at which time contacted primary care provider's office and was directed to immediately go to the ER for an evaluation. On 20Sep2021, After 3 hours in the ER, and many tests later, patient was diagnosed with an adverse event to a vaccine. Symptoms that warranted an ER visit slowly resolved over the next week.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise
Clinical narrative: experienced malaise and headache for 3 days as well as loose stool x1.; experienced malaise and headache for 3 days as well as loose stool x1.; experienced malaise and headache for 3 days as well as loose stool x1.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 11Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "type II well controlled diabetic" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 immunization; Bnt162b2 (Dose 2, Single), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), HEADACHE (non-serious), DIARRHOEA (non-serious) all with onset Oct2021, outcome "recovered" (Oct2021) and all described as "experienced malaise and headache for 3 days as well as loose stool x1.".  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.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Skin discolouration, Skin lesion, Urticaria
Clinical narrative: red marks on her thighs that would gradually turn black and blue; bruises or a rash on her leg; hives; red marks on her thighs that would gradually turn black and blue; red marks on her thighs that would gradually turn black and blue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (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 (1st Dose), when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: SKIN LESION (non-serious), ERYTHEMA (non-serious), SKIN DISCOLOURATION (non-serious) all with onset Oct2021, outcome "unknown" and all described as "red marks on her thighs that would gradually turn black and blue"; RASH (non-serious) with onset Oct2021, outcome "unknown", described as "bruises or a rash on her leg"; URTICARIA (non-serious) with onset Oct2021, outcome "unknown", described as "hives".  Additional information: After the second vaccine, about 3 days later or maybe 4, she started getting red marks on her thighs and thought maybe they were hives. she didn't do anything about it. Then, she noticed in the shower that they were changing colors. It would start out red and they were in all different shapes like oval, round, there was like no specific shape, Then, it would turn gradually into a black and blue colour and disappear. Then, a whole new batch of spots would appear. She states she tried to take a picture every day, but what only shows up is a red spot or a black and blue spot. she wanted to try and get it documented. She is scared. She is 62 years old and she is very nervous about what she put in her body.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I have a swollen lymph node under my arm where I got the booster shot. Is that a common reaction.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Regulatory Authority. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "I have a swollen lymph node under my arm where I got the booster shot. Is that a common reaction."  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: inflammation in her lymph nodes by her neck and armpits; 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 received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (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: LYMPHADENITIS (non-serious), outcome "unknown", described as "inflammation in her lymph nodes by her neck and armpits".  Additional information: Description of Event: After receiving 3rd Covid shot, patient reported inflammation in her lymph nodes by her neck and armpits. Patient also reported similar side effects after initial 2 shots.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  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.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Platelet count decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. 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: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "Routing bloodwork shortly after revealed platelets had crashed/ her father in withheld had same experience". Relevant laboratory tests and procedures are available in the appropriate section.- Additional information: Patient is still battling even after receiving platelet boosting meds. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Palpitations
Clinical narrative: Feel my heart is really fast; Feel the heart coming really very fast; Feel very bad; Make me not comfortable; 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) (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 (First dose, No events reported), for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Feel my heart is really fast; Feel the heart coming really very fast"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feel very bad"; DISCOMFORT (non-serious), outcome "unknown", described as "Make me not comfortable".  Additional information: I have a problem. I want to know, the third shot, I need to get it or not because after the second shot, I feel my heart is really fast and like for a 'time no feeling' (not clear), after the second shot for about 25 minutes. Then, I feel very bad then after that, then when I went down on the street I was try to fetch the, to catch 'purse' or something like that, I feel the heart coming really very fast. So, that is why now, I have a question, I need to do the third shot or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: had a flare following; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 52 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 52 years as dose number unknwon, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "had a flare following".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Vaccination site swelling
Clinical narrative: developed very swollen glands at collar bone and under arm on injection side.Strange body aches too during the first 36hrs.; developed very swollen glands at collar bone and under arm on injection side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 10:00 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Polyester allergy" (unspecified if ongoing); "Bee allergy" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Mitral-valve prolapse" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [ERGOCALCIFEROL]; ZINC; VITAMIN C [ASCORBIC ACID]; ACV. Vaccination history included: Bnt162b2 ([product=COVID 19, brand=Pfizer,, administration date=14Apr2021,, administration time=02:30 PM,, dose number =1,, vaccine location=Right arm]), administration date: 14Apr2021, when the patient was 45 years old, for COVID-19 Immunization, reaction(s): "itchy", "hive-like rash". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset May2021, outcome "not recovered", described as "developed very swollen glands at collar bone and under arm on injection side."; PAIN (non-serious) with onset May2021, outcome "not recovered", described as "Strange body aches too during the first 36hrs."; LYMPHADENOPATHY (non-serious) with onset May2021, outcome "not recovered", described as "developed very swollen glands at collar bone and under arm on injection side". Therapeutic measures were not taken as a result of vaccination site swelling, pain, lymphadenopathy.  Additional Information: Developed strange hive-like rash on injection arm top from about elbow down and top of right hand on same arm. Incredibly itchy!! Almost unbearable at times. Cortisone 10 clear salve helped eventually. After 2nd shot, have developed very swollen glands at collar bone and under arm on injection side. Freaks me out!! This started Thurs Eve after Wed 10am injection. Strange body aches too during the first 36hrs. It was No If COVID tested post vaccination.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   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: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: My arm is hurting me and I have already taken two Advil; Having bad pain in my left arm; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old patient received bnt162b2 (BNT162B2), administration date 19Oct2021 (Batch/Lot number: unknown) at the age of 35 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 (First dose), for COVID-19 immunization, reaction(s): "First two were very severe with allergies"; Bnt162b2 (Second dose), for COVID-19 immunization, reaction(s): "First two were very severe with allergies". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Oct2021, outcome "unknown", described as "My arm is hurting me and I have already taken two Advil; Having bad pain in my left arm"; DIZZINESS (non-serious) with onset 19Oct2021, outcome "unknown", described as "Dizziness". Therapeutic measures were taken as a result of pain in extremity, dizziness. Additional information: When probed if this is the first time consumer called in Pfizer Drug Safety, consumer stated, "No, Patient had  gone in already three times, this one is the less severe reaction, the first two were very severe with allergies (event captured as per verbatim) and patient had to take Benadryl (treatment) for that but this one is not severe as the first two that had." (further not clarified appropriately if consumer called in Pfizer Drug Safety earlier, hence report type captured as-initial report), no itching.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: worst flu he ever had.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (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: INFLUENZA (non-serious), outcome "unknown", described as "worst flu he ever had." Additional information: Reporter states that his friends both took Pfizer and one person had no side effects with the first or second shot and then her husband is very healthy and had no side effects on the first one, but the second one knocked him out for 3 or 4 days like the worst flu he ever had. Reporter states he had all the side effects and was in bed for a couple of days and took him out of commission. Reporter asks if this happens easily. Reporter also states he knows a few people that have taken the vaccine and had different conditions and that one person he knows was in remission for 30 years and it came back within 3 months, he had Guillain-Barre. Reporter asks if there is a chance the drug can cause autoimmune flare ups like Parkinsons or Guillain Barre. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: foggy brain; 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 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "foggy brain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The injection site started feeling sore around 11 PM; 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), administration date 19Oct2021 17:30 (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 Immunisation; Bnt162b2 (Dose:2), for COVID-19 Immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Oct2021 23:00, outcome "unknown", described as "The injection site started feeling sore around 11 PM".  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.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: nine days after the first Pfizer shot wanted to know is it really weird to have a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "nine days after the first Pfizer shot wanted to know is it really weird to have a headache".  Additional information: Stated that nine days after the first Pfizer shot wanted to know is it really weird to had a headache. Reporter details: Stated that she worked as nursing assistant. Stated that she worked in pharmaceutical and medical sales. Email address captured as provided.  Follow-up attempts completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Diarrhoea, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: vomiting; diarrhea; shaking; numb/ tingling hands and feet; numb/ tingling hands and feet; chills; aches; Other vaccine same date vaccine date 20Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 13:30 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single and administered in arm left, administration date 18Mar2021 14:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 20Oct2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 25Feb2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 20Oct2021, outcome "unknown", described as "Other vaccine same date vaccine date 20Oct2021"; VOMITING (non-serious), outcome "not recovered", described as "vomiting"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; TREMOR (non-serious), outcome "not recovered", described as "shaking"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "not recovered" and all described as "numb/ tingling hands and feet"; CHILLS (non-serious), outcome "not recovered", described as "chills"; PAIN (non-serious), outcome "not recovered", described as "aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, diarrhoea, tremor, hypoaesthesia, paraesthesia, chills, pain.  Additional information: The patient did not receive any other medications within two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (covid test name post vaccination: Bianox).  Follow-up attempts completed. No further information is expected.The lot/batch number is not available despite the follow-up attempts made.
Age: 35.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Product use issue, SARS-CoV-2 test, Tremor, Vomiting
Clinical narrative: vomiting; diarrhea; shaking; numb/ tingling hands and feet; numb/ tingling hands and feet; chills; aches; Other vaccine same date vaccine date 20Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 13:30 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single and administered in arm left, administration date 18Mar2021 14:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 20Oct2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 25Feb2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 20Oct2021, outcome "unknown", described as "Other vaccine same date vaccine date 20Oct2021"; VOMITING (non-serious), outcome "not recovered", described as "vomiting"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; TREMOR (non-serious), outcome "not recovered", described as "shaking"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "not recovered" and all described as "numb/ tingling hands and feet"; CHILLS (non-serious), outcome "not recovered", described as "chills"; PAIN (non-serious), outcome "not recovered", described as "aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, diarrhoea, tremor, hypoaesthesia, paraesthesia, chills, pain.  Additional information: The patient did not receive any other medications within two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (covid test name post vaccination: Bianox).  Follow-up attempts completed. No further information is expected.The lot/batch number is not available despite the follow-up attempts made.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Eating disorder, Vomiting
Clinical narrative: 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 35 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 15Oct2021 (Lot number: FF8841) at the age of 35 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DECREASED APPETITE (non-serious) with onset 16Oct2021, outcome "not recovered", described as "They both experienced a loss of appetite and are still experiencing it a week later"; VOMITING (non-serious) with onset 16Oct2021, outcome "not recovered", described as "He states sometimes he gets hungry and eats but then throws it up"; EATING DISORDER (non-serious) with onset 16Oct2021, outcome "not recovered", described as "Cannot eat". Additional information: Caller states he was calling about the Pfizer vaccine and states his son took the vaccine a week ago and was fine and had no adverse events but the caller and his wife also had their vaccine and both have no appetite and cannot eat. Caller asking if this was normal. Caller states his loss of appetite began on 16Oct2021 and he had the 1st dose of the Pfizer Covid vaccine on 15Oct2021 with lot FF8841 in his right arm and states his patient card has no expiry date or NDC written on it but has ZAN27 written on it. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 10:00 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single and administered in arm left, administration date 02Apr2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin when i was young. Concomitant medication(s) included: IBUPROFEN. The following information was reported: TINNITUS (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Tinnitus". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The facility where the most recent COVID-19 vaccine was administered pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Lymphadenopathy, Pain in extremity, Vaccination site pain
Clinical narrative: Left arm pit swelling and pain along with soreness at injection site.; Left arm pit swelling and pain along with soreness at injection site.; Left arm pit swelling and pain along with soreness at injection site.; dizzy; weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 09:15 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 24Oct2021 02:00, outcome "not recovered" and all described as "Left arm pit swelling and pain along with soreness at injection site."; DIZZINESS (non-serious) with onset 24Oct2021, outcome "not recovered", described as "dizzy"; ASTHENIA (non-serious) with onset 24Oct2021, outcome "not recovered", described as "weak". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity, vaccination site pain, dizziness, asthenia.  Additional information: Lot was unknown because it was downstairs in her purse and she was in her bed. Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient did not test for COVID post vaccination. No other medical history. There were no known allergies. Device Date was 24Oct2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: I have a swollen lymph node in the left armpit, which is the same arm of my booster vaccine. When I received my second dose 6 months ago, I had the same side effect. It is very large, swollen and pain; painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 11:45 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism; "high blood pressure" (unspecified if ongoing), notes: high blood pressure. The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Known Allergy: Augmentin", notes: Augmentin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Vaccine location-Left arm.Unable to locate or read the details), for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 2021, for COVID-19 Immunization, reaction(s): "swollen lymp node in the left armpit"; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 2021, for Covid 19 Immunization, reaction(s): "painful lymph nodes".The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Oct2021 07:00, outcome "recovering", described as "I have a swollen lymph node in the left armpit, which is the same arm of my booster vaccine. When I received my second dose 6 months ago, I had the same side effect. It is very large, swollen and pain"; PAIN (non-serious) with onset 23Oct2021 07:00, outcome "recovering", described as "painful". Therapeutic measures were not taken as a result of lymphadenopathy, pain.  Additional Information:Patient received other vaccine on same date as dose 3 on Left Arm (dose number 1).No other vaccines were received within 4 weeks prior to the COVID vaccine.Prior to vaccination,patient was not diagnosed with COVID-19.Since the vaccination, patient been not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling of face; 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) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious), outcome "unknown", described as "Swelling of face".  Additional information: Patient took the booster shot of Pfizer and had one of the side effects which was the swelling of face." Patient want to know that how to get rid of the swelling of face.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Apr2021 11:30 (Batch/Lot number: unknown) at the age of 59 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: FATIGUE (non-serious) with onset 25Apr2021 07:00, outcome "recovered" (28Apr2021), described as "Fatigue"; HEADACHE (non-serious) with onset 25Apr2021 05:00, outcome "recovered" (01May2021), described as "Headache". Therapeutic measures were not taken as a result of fatigue, headache.  Additional information: Vaccination Facility Type: Pharmacy or drug store 2nd. Public Health Clinic/Administration Facility 1st. Vaccine Administered at Facility? No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Laboratory test, Nausea, Vaccination site pain
Clinical narrative: soreness at vaccination site; 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 78 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 08:30 (Lot number: EL9269) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MGUS Monoclonal paraproteinemia", start date: 2014 (ongoing), notes: MGUS Monoclonal paraproteinemia, Onset Date: 2014, Stop Date: Ongoing; "Barrett's esophagus", start date: 1995 (ongoing), notes: Illness/AE: Barrett's esophagus, Onset Date: 1995, Stop Date: Ongoing; "Degenerative spondylolisthesis", start date: 2010 (ongoing), notes: Degenerative spondylolisthesis, Onset Date: 2010, Stop Date: Ongoing; "Atrial fibrillation", start date: 30Dec2020 (ongoing), notes: Illness/AE: Atrial fibrillation, Onset Date: 30Dec2020, Stop Date: Ongoing; "GERD" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Headache" (unspecified if ongoing); "Bodyache" (unspecified if ongoing); "Multiple Gamopathy of Unknown significance", start date: 2015 (ongoing); "Hyperlipidemia" (ongoing); "Acid Reflux" (ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease, barrett's oesophagus, start date: 1995 (ongoing); ATORVASTATIN taken for blood cholesterol, start date: 1995 (ongoing); ELIQUIS taken for atrial fibrillation, start date: 2020 (ongoing); TYLENOL taken for headache, pain, start date: 06Oct2021, stop date: 14Oct2021; PRILOSEC [OMEPRAZOLE] taken for gastrooesophageal reflux disease, start date: 2020 (ongoing); LIPITOR taken for hyperlipidaemia, start date: 2020 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, PFIZER/BIONTECH COVID-19 VACCINE DETAILS:, Date: 19Feb2021 at 09:00, Left Arm, Intramuscular, Batch/Lot number: EL9262), administration date: 19Feb2021, when the patient was 77 years old, for COVID-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Mar2021, outcome "recovered" (13Mar2021), described as "soreness at vaccination site"; HEADACHE (non-serious) with onset 10Mar2021, outcome "recovered" (13Mar2021), described as "headache"; FATIGUE (non-serious) with onset 10Mar2021, outcome "recovered" (13Mar2021), described as "Fatigue"; NAUSEA (non-serious) with onset 10Mar2021, outcome "recovered" (13Mar2021), described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; 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 parent.  A 41 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 41 years 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: HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Additional information: This report was related to a study or programme.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: 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) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Substantial hair loss". Additional Information: Since receiving the first dose of vaccine patient have noticed SUBSTANIAL hair loss, did not have this problem before the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: Soreness at the injection site for approx 30 hours; insomnia (still ongoing); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 12:00 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "reactive airway disease" (unspecified if ongoing); "apraxia" (unspecified if ongoing); "ehlers-danlos syndrome" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; PROBIOTICS.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Oct2021 12:15, outcome "not recovered", described as "Soreness at the injection site for approx 30 hours"; INSOMNIA (non-serious) with onset 23Oct2021 12:15, outcome "not recovered", described as "insomnia (still ongoing)". Therapeutic measures were not taken as a result of vaccination site pain, insomnia.  Additional information: The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. There were no known allergies. Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks were reported as Clartin, multivitamin, iron supplement, probiotics.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.