chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: arm and shoulder soreness; sore shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (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: PAIN IN EXTREMITY (non-serious) with onset 21Apr2021, outcome "recovered" (23Apr2021), described as "arm and shoulder soreness"; ARTHRALGIA (non-serious) with onset 21Apr2021, outcome "recovered" (23Apr2021), described as "sore shoulder".  Additional information: Reporter states the arm and shoulder soreness was just like the other 2 times, it last for 2 days.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101807341 same patient/drug, different AE and dose.;US-PFIZER INC-202101804704 same patient/drug, different AE and dose.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza, Pain in extremity
Clinical narrative: Arm and Shoulder Soreness; sore shoulder/Arm and Shoulder Soreness; Knocked him out the day after, it felt like a bad case of the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 18May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1. Event date: From: 21Apr2021 To: 23Apr2021), administration date: 21Apr2021, for Covid-19 immunization, reaction(s): "Arm and Shoulder Soreness", "Arm and Shoulder Soreness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19May2021, outcome "recovered" (22May2021), described as "Arm and Shoulder Soreness"; ARTHRALGIA (non-serious) with onset 19May2021, outcome "recovered" (22May2021), described as "sore shoulder/Arm and Shoulder Soreness"; INFLUENZA (non-serious) with onset 19May2021, outcome "recovered" (22May2021), described as "Knocked him out the day after, it felt like a bad case of the flu".  Additional Information: Caller stated Knocked him out the day after, it felt like a bad case of the flu and lasted that day and the next day he felt 50% better and the next day 80-90% better and then he was fine. Caller stated that he is over 50 Years Old.   Follow-up are completed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101807340 same patient/drug, different AE and dose.;US-PFIZER INC-202101804704 same patient/drug, different AE and dose.
Age: 66.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: sore arm; felt a little weak; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 66 years as dose number unknown, single for covid-19 immunisation; influenza vaccine (FLU) (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; ASTHENIA (non-serious), outcome "unknown", described as "felt a little weak"; FATIGUE (non-serious), outcome "unknown", described as "tired". Additional information: Caller reporting adverse reaction with the COVID19 Vaccine. While providing information for herself caller states her husband got the vaccine and he got the flu shot two weeks ago and had no reaction. He got a sore arm. Everyone in the family had a sore arm. Caller states that her husband didn't have a problem with the vaccines, he was just tired. They both were dead dog tired for 24 hours. They had sore arm, but the more they moved the arm around the better it felt. Her husband when he got flu shot he felt a little weak. He was doing work outside and had to come in and sit down. That passed. He got the flu shot at (name). Caller doesn't have her husband's vaccine card to provide NDC, lot, and expiry for the COVID vaccines. He has his card and is in (place)on a fishing trip. Caller clarified that her husband had Pfizer COVID vaccine and he got it a week before she did. It was a night mare to get appointments. COVID vaccines was a Pfizer product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Follow-up (03Feb2022): 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: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: She just had extremely tired; Sore arm; Patient inadvertently received her third dose last 17Dec2021.; 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 parent.  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Dec2021 (Lot number: FK5618) at the age of 7 years as dose 3 (booster) single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, LOT# for 1st dose FK5127., Anatomical location: right arm), administration date: 19Nov2021, for Covid-19 immunization; Bnt162b2 (DOSE 2, LOT# for 2nd dose FL0007, Anatomical location: Left arm), administration date: 15Dec2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Patient inadvertently received her third dose last 17Dec2021."; FATIGUE (non-serious), outcome "unknown", described as "She just had extremely tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Therapeutic measures were not taken as a result of inappropriate schedule of product administration, fatigue, pain in extremity. Additional information: The reporter asked for her daughter (Patient) who received the pediatric Pfizer-BioNTech COVID-19 Vaccine second dose then third dose right away. She mentioned that, Patient took her first dose at the local elementary school on 19Nov2021. Patient's second dose was supposed to be given by 10Dec2021 but there was a storm so it was cancelled. Caller mentioned that, Patient's second dose was administered 15Dec2021.The clinic had another vaccination program, and the Patient inadvertently received her third dose last 17Dec2021. It was only found out after the Patient cried that she already got the 2nd dose. Caller confirmed all 3 doses are the pediatric dose, and asked if there was any information for this? Caller mentioned they moved from (city) to (City) in October, and was unsure if insurance would still cover the expenses of the HCP. Asked for financial assistance information. The caller asked about information about who took the 2nd dose of the covid-19 vaccine and got the 3rd dose after 2 days. The patient was not having Other Products, no Patient History. Investigation Assessment: Unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache; Fatigue; pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 09:45 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 12Apr2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Mar2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 08Dec2021 07:00, outcome "recovered" (Dec2021), described as "Headache"; FATIGUE (non-serious) with onset 08Dec2021 07:00, outcome "recovered" (Dec2021), described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 08Dec2021 07:00, outcome "recovered" (Dec2021), described as "pain at injection site". Therapeutic measures were taken as a result of headache, fatigue, vaccination site pain.  Additional information- It was reported that Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. Patient did not receive any other vaccine in four weeks. Patient did not suffer from  covid prior  to vaccination and not covid tested post vaccination. It was also reported that patient did not suffer from any allergy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Fever; Chills/Teeth chattering; my hands and arms were shaking; headache; tremendously fatigue; Incredible cold feeling; 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 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization, reaction(s): "I had no reaction". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills/Teeth chattering"; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "my hands and arms were shaking"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tremendously fatigue"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "Incredible cold feeling". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever; Chills/Teeth chattering; my hands and arms were shaking; headache; tremendously fatigue; Incredible cold feeling; 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 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization, reaction(s): "I had no reaction". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills/Teeth chattering"; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "my hands and arms were shaking"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tremendously fatigue"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "Incredible cold feeling". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration, Laboratory test
Clinical narrative: the first vaccine, the Pfizer vaccine but that was in September/Dates for COVID-19 Vaccine: (Start: 7 Dec 2021); I have experienced 98 percent of hair loss since receiving the second dose of the COVID Vaccine/ I noticed just sections of my hair falling out; 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), administration date 07Dec2021 (Lot number: FJ8757) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Alopecia areata", start date: 2015 (not ongoing); "auto immune disease", start date: 2015 (not ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: Sep2021, when the patient was 53 years old, for Covid-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset Dec2021, outcome "unknown", described as "I have experienced 98 percent of hair loss since receiving the second dose of the COVID Vaccine/ I noticed just sections of my hair falling out"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "the first vaccine, the Pfizer vaccine but that was in September/Dates for COVID-19 Vaccine: (Start: 7 Dec 2021)". The event "i have experienced 98 percent of hair loss since receiving the second dose of the covid vaccine/ i noticed just sections of my hair falling out" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: laboratory test: (2021) unknown results. Therapeutic measures were not taken as a result of alopecia.  Additional information included: Consumer further stated, "Because I read in some studies that show that people (Further not clarified) who have had alopecia in the past after receiving the vaccine have experienced hair loss so I would have to said patient one of those people. The patient experienced auto immune disease by way of Alopecia areata but all of the hair regrew and I have not had any signs of any auto immune disease since then.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 12:30 (Lot number: EW0175) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (ongoing), notes: Inhaler is treatment; "menstrual" (ongoing); "allergies" (ongoing); "Headache" (ongoing). Family history included: "high blood pressure" (ongoing), notes: Medicine controls. Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal (ongoing); ADVIL 12 HOUR taken for headache, menstrual disorder (ongoing); TYLENOL taken for headache (ongoing); BENADRYL taken for hypersensitivity (ongoing); ALBUTEROL [SALBUTAMOL] taken for hypersensitivity (ongoing); QVAR taken for asthma (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Apr2021, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of vaccination site pain.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Mobility decreased, Pain
Clinical narrative: Second dose at first could not walk; Now she cannot sit down, basically stand or sit all day long; Stabbing pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 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: GAIT INABILITY (non-serious), outcome "unknown", described as "Second dose at first could not walk"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Now she cannot sit down, basically stand or sit all day long"; PAIN (non-serious), outcome "unknown", described as "Stabbing pains". The events "second dose at first could not walk", "now she cannot sit down, basically stand or sit all day long" and "stabbing pains" were evaluated at the physician office visit.  Additional information: First patient was could not walk and now she cannot sit down and she has to stand or lay down all day long. She went to her family doctor and was told there was nothing she can do. Then she sent to gynecologist and he said there is nothing he can do for her. This occurred after her second dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Illness, Limb discomfort, Magnetic resonance imaging
Clinical narrative: massive headache on the right side of her head; body /muscle aches; body /muscle aches; When she gets up it is hard to walk; her muscle seems to be twitching; has been sick since with these symptoms; she can't lift up her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 (Lot number: FE3592) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Lyme" (ongoing), notes: She has had this for years. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 22Sep2021, outcome "recovering", described as "massive headache on the right side of her head"; PAIN (non-serious) with onset 22Sep2021, outcome "recovering", MYALGIA (non-serious) with onset 22Sep2021, outcome "not recovered" and all described as "body /muscle aches"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "When she gets up it is hard to walk"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "her muscle seems to be twitching"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "has been sick since with these symptoms"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "she can't lift up her arm". The events "massive headache on the right side of her head", "body /muscle aches", "body /muscle aches", "when she gets up it is hard to walk", "her muscle seems to be twitching", "has been sick since with these symptoms" and "she can't lift up her arm" 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 headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had the vaccine and then the next day she had these symptoms and really they have not gone away. The headache has gotten a little better but the muscle aches seem to get worse. She feels like the body aches have gotten better and her muscles are just hurting real bad and she doesn't know why. She has had the body aches for over a month and they have gotten a little better but the muscles and just different parts of her body, like different muscles, ache. It has been different things that have been happening since she got the shot. She had MRI this month in Dec2021 because her headache had not gone away. Her provider thought that she was having a migraine so she was given Imitrex which just intensified her headaches so that didn't work.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Myalgia, Pain
Clinical narrative: massive headache on the right side of her head; body /muscle aches; body /muscle aches; When she gets up it is hard to walk; her muscle seems to be twitching; has been sick since with these symptoms; she can't lift up her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 (Lot number: FE3592) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Lyme" (ongoing), notes: She has had this for years. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 22Sep2021, outcome "recovering", described as "massive headache on the right side of her head"; PAIN (non-serious) with onset 22Sep2021, outcome "recovering", MYALGIA (non-serious) with onset 22Sep2021, outcome "not recovered" and all described as "body /muscle aches"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "When she gets up it is hard to walk"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "her muscle seems to be twitching"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "has been sick since with these symptoms"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "she can't lift up her arm". The events "massive headache on the right side of her head", "body /muscle aches", "body /muscle aches", "when she gets up it is hard to walk", "her muscle seems to be twitching", "has been sick since with these symptoms" and "she can't lift up her arm" 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 headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had the vaccine and then the next day she had these symptoms and really they have not gone away. The headache has gotten a little better but the muscle aches seem to get worse. She feels like the body aches have gotten better and her muscles are just hurting real bad and she doesn't know why. She has had the body aches for over a month and they have gotten a little better but the muscles and just different parts of her body, like different muscles, ache. It has been different things that have been happening since she got the shot. She had MRI this month in Dec2021 because her headache had not gone away. Her provider thought that she was having a migraine so she was given Imitrex which just intensified her headaches so that didn't work.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: she had swollen lymph nodes on left side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: EW0162) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Lyme Disease" (unspecified if ongoing); "Allergy: other cleaning products" (unspecified if ongoing), notes: allergy to Nickel and Ethylenediamine Dihydrochloride and other cleaning products. Concomitant medication(s) included: DOXYCYCLINE taken for lyme disease, hypersensitivity. Past drug history included: Nickel, reaction(s): "Allergy: Nickel", notes: allergy to Nickel and Ethylenediamine Dihydrochloride and other cleaning products.; Ethylenediamine dihydrochloride, reaction(s): "Allergy: Ethylenediamine Dihydrochloride", notes: allergy to Nickel and Ethylenediamine Dihydrochloride and other cleaning products. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16Apr2021, outcome "recovered" (2021), described as "she had swollen lymph nodes on left side".  Additional information: Patient was taking this for what they thought was Chronic Lyme Disease but now they think it was from her allergy to Nickel and Ethylenediamine Dihydrochloride. Patient states it is in a lot of cleaning equipment and they are cleaning things better to be Covid safe. Patient received her 1st dose of the Pfizer vaccine in April. After the 1st dose she had swollen lymph nodes, for a couple weeks and went away. Patient clarifies that originally, her only reactions to the vaccines were swollen lymph nodes under her arm on the side that she had the injection on,  which she saw was common. Event started on the day of the vaccine and lasted for a week or two after the vaccine. Patient asks any links between the Pfizer vaccine and breast cancer and asks is there any antibody testing being done.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: Enlarged heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL (ongoing). Vaccination history included: Bnt162b2 (1st dose), administration date: 13Mar2021, for COVID-19 immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 14Oct2021, outcome "unknown", described as "Enlarged heart".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: I am having a symptom that my lymph node underneath my underarm area, it's swollen; it hurt to touch and even when I am raising my arm; 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 17Dec2021 (Lot number: 330308D) 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "I am having a symptom that my lymph node underneath my underarm area, it's swollen"; LYMPH NODE PAIN (non-serious), outcome "unknown", described as "it hurt to touch and even when I am raising my arm".  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Diarrhoea, Fatigue, Loss of personal independence in daily activities, Reflux gastritis
Clinical narrative: diarrhea; Lost weight; Compromised, exhausted; Unable to keep her level of activity up; old reflux; she was pretty 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 71 year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL9264) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Patient history: High cholesterol; "thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). Vaccination history included: Bnt162b2 (First dose, LOT: EL3247), administration date: 20Jan2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "diarrhea"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Lost weight"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Compromised, exhausted"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Unable to keep her level of activity up"; REFLUX GASTRITIS (non-serious) with onset 2021, outcome "unknown", described as "old reflux"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "she was pretty tired.". The event "diarrhea" was 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 diarrhoea, fatigue, fatigue.  Additional information: Diarrhea started a week to 10 days after getting the second vaccine. She got that vaccine 10Feb2021 and had the diarrhea for about 90 days. Patient Details: Height: 5 ft, 5 and a half.    No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: diarrhea; Lost weight; Compromised, exhausted; Unable to keep her level of activity up; old reflux; she was pretty 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 71 year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL9264) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Patient history: High cholesterol; "thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). Vaccination history included: Bnt162b2 (First dose, LOT: EL3247), administration date: 20Jan2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "diarrhea"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Lost weight"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Compromised, exhausted"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Unable to keep her level of activity up"; REFLUX GASTRITIS (non-serious) with onset 2021, outcome "unknown", described as "old reflux"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "she was pretty tired.". The event "diarrhea" was 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 diarrhoea, fatigue, fatigue.  Additional information: Diarrhea started a week to 10 days after getting the second vaccine. She got that vaccine 10Feb2021 and had the diarrhea for about 90 days. Patient Details: Height: 5 ft, 5 and a half.    No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Noise in both ears, which worsened after his second dose of Pfizer Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 (Lot number: EL9267, Expiration Date: 31May2021) at the age of 67 years as dose 1, single and administered in arm left, administration date 15Mar2021 (Lot number: EN6207, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset Feb2021, outcome "not recovered", described as "Noise in both ears, which worsened after his second dose of Pfizer Covid-19 Vaccine". Therapeutic measures were taken as a result of tinnitus.  Additional information: No Prior vaccinations within 4 weeks. This reporter is the patient who experienced the noise in both ears that he had onset of after his first dose of Pfizer Covid-19 Vaccine, and that worsened after his second dose of Pfizer Covid-19 Vaccine. Patient have noise; this noise, it don't disappear, the noise become more strong; it don't disappear, noise in both ears, it was hope like all this 8 months. Event Noise in both ears was described as, Initial onset date about 3-4 days after first dose of Pfizer Covid-19 Vaccine which would have been around 26Feb2021-27Feb2021. Time of onset unknown. The noise in both ears started and would come and go. After he was administered the second dose of Pfizer Covid-19 Vaccine the noise in both ears became more strong. Sometimes he cannot sleep because of the noise in both ears. He started using sleeping pills because the noise in both ears is very strong. After that his wife tried to help him, had him start taking Valerian Root and Zinc Citrate 50 to help with the noise in both ears-but Valerian Root and Zinc Citrate 50 do not really help the noise in both ears (Valerian Root (Described as natural) and Zinc Citrate 50). The noise in both ears is all the time now. The noise in both ears drives him crazy and sometimes he cannot focus because of it. He talked to his doctor like 3-4 months ago about this event and doctor told him they really can't do anything about this event, they just have to wait; but he is going to talk to his doctor again. He verified he has not had any emergency room visit or hospitalization relative to this event. He asked for personal medical advisement regarding this event; for medication recommendations for treatment of this event; for information on if a ear doctor would be able to help him; and if there was information on how long this event could last; and if he should or should not get a booster dose of Pfizer Covid-19 Vaccine relative to this event.  Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Vomiting
Clinical narrative: vomiting; not feeling well; chills; body aches/body hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Dec2021 (Lot number: FK5618) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 19Dec2021, outcome "unknown", described as "body aches/body hurting"; VOMITING (non-serious) with onset 20Dec2021, outcome "recovered" (20Dec2021), described as "vomiting"; MALAISE (non-serious) with onset 19Dec2021, outcome "unknown", described as "not feeling well"; CHILLS (non-serious) with onset 19Dec2021, outcome "recovering", described as "chills". Therapeutic measures were taken as a result of pain, vomiting, malaise, chills.  Additional Information:chills got better after some medicine (Tylenol.) and was given Mucinex Cold and Flu 266mg from a cap with measurement then vomiting stopped after the medicine, patient only vomited a little.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Decreased appetite, Gait disturbance, Inappropriate schedule of product administration
Clinical narrative: could not walk; very weak; no appetite; On 01Mar2021, patient received 1st dose/On 18Apr2021, patient received 2nd dose COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4195685-00 (RA).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf[citrate free] for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of Administration: Intramuscular), administration date: 12Mar2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Felt like Humira was not working", "Feel hot", "Feeling sick", "Inflammation was getting bad", "Injection site hurt", "drug ineffective". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Apr2021, outcome "unknown", described as "On 01Mar2021, patient received 1st dose/On 18Apr2021, patient received 2nd dose COVID-19 Vaccine"; GAIT DISTURBANCE (non-serious) with onset Nov2021, outcome "not recovered", described as "could not walk"; ASTHENIA (non-serious) with onset Nov2021, outcome "not recovered", described as "very weak"; DECREASED APPETITE (non-serious) with onset Nov2021, outcome "not recovered", described as "no appetite". The action taken for adalimumab was unknown.  Additional information: The patient received booster dose on 12Dec2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Incorrect dose administered, Product administration error
Clinical narrative: The patient had severe anxiety so mentally she was obviously freaking out but physically she was fine; When administering the vaccination, the needle came of the syringe so the patient did not get the entire dose; When administering the vaccination, the needle came of the syringe so the patient did not get the entire dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. Other Case identifier(s): US-PFIZER INC-202101835380 (Pfizer).  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 20Dec2021 (Lot number: FJ8757, Expiration Date: Feb2022) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codein, reaction(s): "Allergic to codein", notes: Allergic to codein. Vaccination history included: Covid-19 (DOSE 1; MANUFACTUERER UNKNOWN), when the patient was 44 years old, for Covid-19 immunization; Covid-19 (DOSE 2; MANUFACTUERER UNKNOWN), when the patient was 44 years old, for Covid-19 immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 20Dec2021, outcome "unknown" and all described as "When administering the vaccination, the needle came of the syringe so the patient did not get the entire dose"; ANXIETY (non-serious) with onset 20Dec2021 20:30, outcome "unknown", described as "The patient had severe anxiety so mentally she was obviously freaking out but physically she was fine".  Additional information: The patient did not receive any other medication prior to COVID-19 vaccine. Pharmacist reported that the patient probably received only half or less than half of the vaccine due to the needle that had came lose while she was given the vaccine. Some went in her arm and some didn't. The injury was the same as with a normal vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet disorder
Clinical narrative: platelets dropped to 5,000.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from License Party. Other Case identifier(s): NVSC2021US288090 (Novartis).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLATELET DISORDER (non-serious), outcome "unknown", described as "platelets dropped to 5,000.". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Illness
Clinical narrative: Chills; Stomach ache; Gagging; Fever; Dizzy; Tired; I just feel sick; unwell, I am not feeling great; 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) (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, single), for COVID-19 immunization; Bnt162b2 (DOSE 2, single), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach ache"; RETCHING (non-serious), outcome "unknown", described as "Gagging"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; ILLNESS (non-serious), outcome "unknown", described as "I just feel sick"; MALAISE (non-serious), outcome "unknown", described as "unwell, I am not feeling great".  Additional information: Consumer stated, "I had my booster today, this afternoon and it was about 2:30 in the afternoon and I was doing fine all afternoon and this evening I laid down, I started getting chills and I stared getting the side effects and I covered up and got me a cup of tea and I did not vomit but I was gagging around and now I got slight fever and I got a stomach ache and what else. Anyway, kind of dizzy, tired and I was just wondering how long will it last?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Retching
Clinical narrative: Chills; Stomach ache; Gagging; Fever; Dizzy; Tired; I just feel sick; unwell, I am not feeling great; 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) (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, single), for COVID-19 immunization; Bnt162b2 (DOSE 2, single), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach ache"; RETCHING (non-serious), outcome "unknown", described as "Gagging"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; ILLNESS (non-serious), outcome "unknown", described as "I just feel sick"; MALAISE (non-serious), outcome "unknown", described as "unwell, I am not feeling great".  Additional information: Consumer stated, "I had my booster today, this afternoon and it was about 2:30 in the afternoon and I was doing fine all afternoon and this evening I laid down, I started getting chills and I stared getting the side effects and I covered up and got me a cup of tea and I did not vomit but I was gagging around and now I got slight fever and I got a stomach ache and what else. Anyway, kind of dizzy, tired and I was just wondering how long will it last?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.