chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Overdose
Clinical narrative: stomach ache; stomach feels funny; They were suppose to received 10mcg each and the 7 y/o and 11 y/o received 20 mcg each; 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), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 1, 20 mcg single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious) with onset 09Nov2021, outcome "unknown", described as "They were suppose to received 10mcg each and the 7 y/o and 11 y/o received 20 mcg each"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach ache"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "stomach feels funny".  Additional information:Caller states her 2 daughters received the Pfizer BTC Vaccine, (5-11y/o formula, orange cap), on Tuesday 09Nov2021. They were suppose to received 10mcg each and the 7 y/o and 11 y/o received 20 mcg each. The caller states the pharmacy called and informed her of this error and told her to return on 30Nov2021 for their 2nd vaccine doses. The caller states "they both have received the same amount as both doses would've been , I am not giving them anymore of the vaccine." "The only reason I had them get vaccinated is because we are going out of town, I never want them to get vaccinated.one daughter 7 y/o has stomach ache, stomach feels funny.Is there a problem with receiving too much of this vaccine.Question: Do you know if and how I can take legal action.Response: Referred the caller to the FDA and their HCP.I called the VAERS to report and they told me to call the CDC , who told me to call the FDA and Pfizer. I feel like I am being transferred all over the place."Question: Will their vaccine cards be ok to travel, if it looks like they only had one dose each. what should I do.Reason for no lot number: of Covid vaccine: Caller unwilling to complete the report.Expiry Date of Covid vaccine: Not provided.Other products: Not Provided.Patient History: Not Provided.Investigation Assessment: Not provided. Stated that she called VAERS and filed a report for both of them.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Also has pains in her head, also last a short time, "it's a sharp pain, comes and goes quickly."; she c/o pain legs/pain legs and arms bilaterally; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Nov2021 10:30 (Batch/Lot number: unknown) at the age of 11 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: PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "not recovered", described as "she c/o pain legs/pain legs and arms bilaterally"; HEADACHE (non-serious) with onset 12Nov2021, outcome "not recovered", described as "Also has pains in her head, also last a short time, "it's a sharp pain, comes and goes quickly."". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: The reporter's 11y/o daughter received her 1st dose of the Pfizer BTC vaccine, (5-11y/o formula, orange cap). Since yesterday, one day after vaccine dose, she c/o pain legs and arms bilaterally. Doesn't last long, 5 sec and gone, Also has pains in her head, also last a short time, it's a sharp pain, comes and goes quickly.  Follow-up (12Nov2021): This is a follow-up spontaneous report received from a contactable consumer (patient's dad). This consumer reported for a 11-year-old female patient (reporter's daughter) that: The reporter's daughter is 11 years old and received the Pfizer COVID vaccine 2 days ago. Today she is at school, and he called her to see how school was going. She said she keep getting pains in her legs and arms on both sides. The pains in her legs are more on the right side. He was driving when he was talking to her so she didn't specify where the pain in her head is. She said they don't last long. He tried to lead her with questions. She said the pain has come and gone over the last two days. He called the pediatrician, and the nurse said she wasn't worried about it. He was a paramedic for 15 years. He doesn't know her weight. She is super healthy. She didn't tell him about them yesterday. So he doesn't know all of the information. He wouldn't say she was improving because he doesn't think she would have said anything. He has the vaccine card in his other vehicle  Follow-up (16Dec2021): 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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nasal congestion, Rhinorrhoea
Clinical narrative: Muscle aches; injection site soreness; runny nose/congestion; runny nose/congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 26 years as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (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. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "Muscle aches"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness"; RHINORRHOEA (non-serious), NASAL CONGESTION (non-serious), outcome "unknown" and all described as "runny nose/congestion". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: he had arm pain; underarm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), intramuscular (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), outcome "unknown", described as "he had arm pain"; AXILLARY PAIN (non-serious), outcome "unknown", described as "underarm pain". It was unknown if therapeutic measures were taken as a result of pain in extremity, axillary pain.  Additional information: After the vaccine, the child said he had arm pain, including underarm pain. This occurred for a few days after the vaccination. Patient had not covid prior vaccination. Patient had not covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: strong abdominal pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child female patient received bnt162b2 (BNT162B2), administration date Nov2021 (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: ABDOMINAL PAIN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "strong abdominal pains". Additional Information: Patient had received her first does the Pfizer COVID-19 vaccine three days prior. She reported this to VAERS as a possible adverse event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Allergic Reaction on arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 10:30 (Batch/Lot number: unknown) at the age of 7 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: VACCINATION SITE REACTION (non-serious) with onset 11Nov2021 10:30, outcome "recovering", described as "Allergic Reaction on arm". Therapeutic measures were not taken as a result of vaccination site reaction.  Additional information: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Patient had known allergies: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thyroid function test
Clinical narrative: maybe her arm hurt a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 64 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, Vaccine Lot Number: EWO186, left upper arm), administration date: 22Sep2021, when the patient was 64 years old, for Covid-19 immunization, reaction(s): "experienced something really strange", "state her hair started coming out". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "maybe her arm hurt a little bit". The event "maybe her arm hurt a little bit" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated the first dose of her Pfizer COVID Vaccine was administered on 22Sep2021 and her patient card has the lot number of EW and she does not know if it was a zero or V and then 186 written for the lot; states the 2nd dose was administered on 13Oct2021 and the patient card does not state the lot or have it written on it. After that, reporter stated that, she had a correction for the Pfizer COVID Vaccine 1st dose lot number and it was the letter O so the lot is EWO186. Vaccine Administered at Vaccination Facility Type:  health clinic. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect and no Prior Vaccinations (within 4 weeks), AE(s) following prior vaccinations, Patients Medical History (including any illness at time of vaccination) and no Family Medical History Relevant to AE(s).  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-202101573822 same reporter/patient/product, different dose/event.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Immediately started my period within two hours of injection and still bleeding now, two weeks since shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 13:30 (Batch/Lot number: unknown) at the age of 46 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: MENSTRUATION IRREGULAR (non-serious) with onset 26Oct2021 15:45, outcome "not recovered", described as "Immediately started my period within two hours of injection and still bleeding now, two weeks since shot.". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: Pregnancy at time of Vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. if treatment ae:  No. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No. Device Date : 12Nov2021.  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: Dizziness, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Dose 1: 17Mar2021 / Dose:2 07May2021; light headedness/dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07May2021 11:45 (Lot number: ER8737) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "DVT left leg", start date: 2006 (unspecified if ongoing), notes: Other medical history: DVT left leg 2006; "Fibroids/recom surgery uterus" (unspecified if ongoing), notes: Uterine fibroids removal reconstruction. There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Known allergies", notes: Known allergies: Naproxen. Vaccination history included: Bnt162b2 (Dose number: 1, Prev dose lot number= EN6204, Prev dose lot unknown=false, Prev dose administration date=17Mar2021, Prev dose administration time=10:30 AM, Prev dose dose number=1, Prev dose vaccine location=Right arm), administration date: 17Mar2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07May2021 11:30, described as "Dose 1: 17Mar2021 / Dose:2 07May2021"; DIZZINESS (non-serious) with onset 07May2021 11:30, described as "light headedness/dizziness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was not pregnant at the time of vaccination. Other vaccine in four weeks was reported as no. Other medications in two weeks were reported as none.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: except she felt a bit under the weather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "except she felt a bit under the weather".  Follow-up attempts completed. No further information is expected. The lot/batch number is not available despite the follow-up attempts made.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fall, SARS-CoV-2 test
Clinical narrative: The same happened on 02Nov2021. I fell to the floor and couldn not get up for approx 10 minutes.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Apr2021 10:45 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing); "Known allergies: sulpha" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM; SERTRALINE; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose Lot unknown reason: Not available/provided to reporter at the time of report completion, Pev dose lot unknown True, Prev dose administration date: 06Apr2021, Prev dose administration time: 12:00 PM, Prev dose vaccine location: Right arm, Prev dose dose number: 1), administration date: 06Apr2021, when the patient was 71 years old, for COVID-19 Immunization, reaction(s): "Thinking I was having a stroke", "I collapsed to the floor and could not get up for 10 minutes.", "I had no response from my legs or arms or hands". The following information was reported: FALL (non-serious) with onset 02Nov2021, outcome "recovering", described as "The same happened on 02Nov2021. I fell to the floor and couldn not get up for approx 10 minutes.". The event "the same happened on 02nov2021. i fell to the floor and couldn not get up for approx 10 minutes." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fall.  Additional info: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient had 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.  Follow-up (17Dec2021): 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: Feeling abnormal
Clinical narrative: she felt bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: 051F21A) as dose number unknown, 0.3ml, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "she felt bad". Therapeutic measures were taken as a result of feeling abnormal.  Additional information: Consumer also mentioned a lady, said she felt bad after getting the Pfizer vaccine. Treatment was given as Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Fever; chills; intermittent mild to moderate headache; mild raised rash on upper back / Rash spread to spides / rash was found to have spread to full torso, arms and upper legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 16:00 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VENLAFAXINE HCL; VYVANSE; WELLBUTRIN. 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, Vaccine Administration Time: 12:00 PM), administration date: 20Apr2021, when the patient was 40 years old, 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, Vaccine Administration Time: 12:00 PM), administration date: 30Mar2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 16Nov2021 08:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 16Nov2021 08:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 16Nov2021 08:00, outcome "not recovered", described as "intermittent mild to moderate headache"; RASH (non-serious) with onset 16Nov2021 08:00, outcome "not recovered", described as "mild raised rash on upper back / Rash spread to spides / rash was found to have spread to full torso, arms and upper legs". The events "fever", "chills", "intermittent mild to moderate headache" and "mild raised rash on upper back / rash spread to spides / rash was found to have spread to full torso, arms and upper legs" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, headache, rash.  Additional information: Known allergies: No. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:Yes   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in his limbs; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A male 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: HYPOAESTHESIA (non-serious), outcome "recovered with sequelae", described as "Numbness in his limbs". The event "numbness in his limbs" was evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoaesthesia. Additional information: Reporter stated that the patient had received his first dose of the Pfizer vaccine and call back three days later and reported numbness in his limbs so, he went to his primary care and received gabapentin but still having some lasting effect. So, his primary care called and wanted some guidance on when he should receive his second dose. The lot number of COVID-19 Vaccine was not received as the reporter hung up the call abruptly.  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, Malaise
Clinical narrative: I feel horrible and it''s already been 3 days and I don''t know if I am having like an adverse reaction to it; I don''t feel any better; 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 Nov2021 (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: FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "not recovered", described as "I feel horrible and it''s already been 3 days and I don''t know if I am having like an adverse reaction to it"; MALAISE (non-serious) with onset Nov2021, outcome "not recovered", described as "I don''t feel any better".  Additional information: It was reported that caller took the Pfizer shot on Wednesday night at a local pharmacy and I feel horrible and it's already been 3 days and I don't know if I am having like an adverse reaction to it or what I should do. But I don't feel any better." Patient provided the mailing address. The lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts completed. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Experienced pain that she voiced seems like muscle pain from her shoulder to her elbow; Experienced pain that she voiced seems like muscle pain from her shoulder to her elbow; 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 92 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 92 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "left mastectomy", start date: 1994 (unspecified if ongoing), notes: left mastectomy with lymph node removal. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose1, Dosage text: injected in right arm), administration date: Feb2021, when the patient was 91 years old, for COVID-19 immunization.The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "Experienced pain that she voiced seems like muscle pain from her shoulder to her elbow". The event "experienced pain that she voiced seems like muscle pain from her shoulder to her elbow" and "experienced pain that she voiced seems like muscle pain from her shoulder to her elbow" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, myalgia.  Additional information: She recieved the second Pfizer Covid 19 Vaccine on 16March2021. Since the vaccine in March she has experienced pain that she voiced seems like muscle pain from her shoulder to her elbow. That is the arm she recieved the vaccine in due to left mastectomy with lymph node removal. Caller asking if they symptoms are normal and how long it may last. AE Treatment: Caller says she did not treat it, it was not out of the ordinary, the part about it was the fact that it seemed to have affected muscle, and she just has it sometimes, she has severe pain in it sometimes like needles sticking in it. She says the other people she talks to about it have the same type symptoms. Caller provides no further details about the other people who had symptoms. Caller says she doesn't take shots in that arm, her left arm, so she thought since it has been so long since she had her mastectomy that it might be all right to take the shot in that arm but they tell her since they removed lymph nodes that was reason she shouldn't take shots in that arm because it didn't have anything to fight infection, so she just does what they tell her to do.  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 follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: I am feeling like I got hit by a truck; I just feel really tired; 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 27Nov2021 (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: FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "I am feeling like I got hit by a truck"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "I just feel really tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis, Skin exfoliation
Clinical narrative: Psoriasis; The skin in and around my ears began in flacking & pealing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Mar2021 15:00 (Lot number: EN6208) at the age of 65 years as dose 2, single, intramuscular, administered in arm right, administration date 27Feb2021 15:00 (Lot number: EN6198) as dose 1, single and intramuscular, administration date 21Oct2021 (Lot number: FH8027) as dose 3, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PSORIASIS (non-serious) with onset 2021, outcome "unknown", described as "Psoriasis"; SKIN EXFOLIATION (non-serious) with onset 2021, outcome "unknown", described as "The skin in and around my ears began in flacking & pealing". Therapeutic measures were taken as a result of skin exfoliation. No follow-up attempts are possible. No further information is expected.  Follow-up (21Dec2021): This is a spontaneous follow-up report received from a same contactable consumer. This Consumer (patient) reported in response to Non-HCP letter sent which included that:  Updated Information: Primary Reporters/patient phone number, middle initial added, age, vaccination facility added.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm soreness and swelling; arm soreness and swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "headache" (unspecified if ongoing), notes: Her 12 year old daughter is small. She had headaches that predated the vaccination. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Oct2021, outcome "unknown" and all described as "arm soreness and swelling".  Additional information: Description of complaint: It was reported that, she has four children and they all are vaccinated. The other 3 are fine. Her 12 year old daughter was small. She had headaches that predated the vaccination. They were enough to ask the pediatrician about the, but they were not disabling. She received her first vaccine 04Oct2021. She had arm soreness and swelling. Caller had picked her daughter up from school three days in September and had to pick her up three days in October. She got her second vaccine 04Nov2021 and has not been back to school since. The headaches are increasing in intensity and frequency. She has seen peds neurology. Caller's oldest daughter works for Pfizer and caller's husband is a doctor and worked at #. The pediatric neurologist put patient on Beta Blockers and it doesn't help. It doesn't respond to anything. She was not sure if it was related but after the second vaccine they have gotten so severe. They are increasing in severity and not going down. She was a child prior to this and a year ago she had never been sick. She had never been on an antibiotic. She will be getting an MRI and going to headache clinic.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: had a sore arm; undiluted dose administered; undiluted dose administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 10 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 02Dec2021 15:35 (Lot number: FK5127, Expiration Date: 28Feb2022) at the age of 10 years as dose 1 (tris), 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 02Dec2021 and all described as "undiluted dose administered".   Additional information: No other vaccines administered on same date with the Pfizer vaccine considered as suspect nor hadn't had any other vaccines in the last 4 weeks. The patient received his first Pediatric Covid 19 Vaccine and was administered undiluted. The reporting pharmacist explained she made sure the patient stuck around for the 15 minutes to monitor him especially since it was his first dose. The patient didn't have any reaction and was not feeling unwell when he left and seemed fine.  Up on RA (20Dec2021) Updated information include: Classification removed, RA Coding updated, 'New event" (had a sore arm)  Additional information: Reporter inadvertenty administered an undiluted 0.2 ml dose of the pediatric (5-11 %) Pfizer Covid vaccine. Preparation and administered. I opened a vial of both the adult and the pediatric Pfizer vaccine at the same time. I diluted the adult vial, then was called away from preparing the pediatric vial, then was called away from preparing the pediatric vial, and forgot to finish dilution. since the cap was of, later that day I had diluted it but I did not. Reporter was in communication with patients father on 02Dec and 03Dec. He said (Patient name) had a sore arm, but no other adverse effects and did not require medical treatment.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Headache, Pain in extremity, Vomiting
Clinical narrative: Vomiting; Diarrhea; Loss of appetite; Headache; Sored arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 10:45 (Lot number: FL0007) at the age of 6 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: VOMITING (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Vomiting"; HEADACHE (non-serious) with onset 30Nov2021 15:30, outcome "not recovered", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 30Nov2021 15:30, outcome "not recovered", described as "Sored arm"; DECREASED APPETITE (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Loss of appetite"; DIARRHOEA (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Diarrhea". Therapeutic measures were not taken as a result of vomiting, headache, pain in extremity, decreased appetite, diarrhoea.  Additional information: No other vaccines was reported in four weeks. On Tuesday 30Nov2021 her daughter started with a and, same thing plus. Today early in the morning she started with and. No covid prior vaccination. Patient was not tested for covid post vaccination. No known allergies reported.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: Sweats; Lethargy; Lack of appetite; Foggy headed; Insomnia; Chills; Body aches/severe body aches (similar to flu); Migraine like headache; Fever of 100.2F; Nausea; Swollen lymph nodes on right armpit; Sore injection site (injection site was right arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Mar2021 (Lot number: ER8732) at the age of 32 years as dose 1, single and administered in arm right, administration date 17Apr2021 (Lot number: ER8735) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypogammaglobulinemia" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "restless leg" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "common variable immune deficiency" (unspecified if ongoing); "chronic fatigue syndrome" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; ROPINIROLE; GAMUNEX C; TRIPHALA; VIT D; OM3GAFORT CHOLESTEROL. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: HYPERHIDROSIS (non-serious) with onset 2021, outcome "not recovered", described as "Sweats"; LETHARGY (non-serious) with onset 2021, outcome "not recovered", described as "Lethargy"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "Lack of appetite"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "Foggy headed"; INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "Insomnia"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Body aches/severe body aches (similar to flu)"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Migraine like headache"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "Fever of 100.2F"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nausea"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "Swollen lymph nodes on right armpit"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Sore injection site (injection site was right arm)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Lethargy, Lymphadenopathy, Nausea
Clinical narrative: Sweats; Lethargy; Lack of appetite; Foggy headed; Insomnia; Chills; Body aches/severe body aches (similar to flu); Migraine like headache; Fever of 100.2F; Nausea; Swollen lymph nodes on right armpit; Sore injection site (injection site was right arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Mar2021 (Lot number: ER8732) at the age of 32 years as dose 1, single and administered in arm right, administration date 17Apr2021 (Lot number: ER8735) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypogammaglobulinemia" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "restless leg" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "common variable immune deficiency" (unspecified if ongoing); "chronic fatigue syndrome" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; ROPINIROLE; GAMUNEX C; TRIPHALA; VIT D; OM3GAFORT CHOLESTEROL. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: HYPERHIDROSIS (non-serious) with onset 2021, outcome "not recovered", described as "Sweats"; LETHARGY (non-serious) with onset 2021, outcome "not recovered", described as "Lethargy"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "Lack of appetite"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "Foggy headed"; INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "Insomnia"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Body aches/severe body aches (similar to flu)"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Migraine like headache"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "Fever of 100.2F"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nausea"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "Swollen lymph nodes on right armpit"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Sore injection site (injection site was right arm)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Sweats; Lethargy; Lack of appetite; Foggy headed; Insomnia; Chills; Body aches/severe body aches (similar to flu); Migraine like headache; Fever of 100.2F; Nausea; Swollen lymph nodes on right armpit; Sore injection site (injection site was right arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Mar2021 (Lot number: ER8732) at the age of 32 years as dose 1, single and administered in arm right, administration date 17Apr2021 (Lot number: ER8735) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypogammaglobulinemia" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "restless leg" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "common variable immune deficiency" (unspecified if ongoing); "chronic fatigue syndrome" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; ROPINIROLE; GAMUNEX C; TRIPHALA; VIT D; OM3GAFORT CHOLESTEROL. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: HYPERHIDROSIS (non-serious) with onset 2021, outcome "not recovered", described as "Sweats"; LETHARGY (non-serious) with onset 2021, outcome "not recovered", described as "Lethargy"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "Lack of appetite"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "Foggy headed"; INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "Insomnia"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Body aches/severe body aches (similar to flu)"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Migraine like headache"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "Fever of 100.2F"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nausea"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "Swollen lymph nodes on right armpit"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Sore injection site (injection site was right arm)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: chills; fever; headaches; aches and pains; flu like symptoms; very bad tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 35 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills"; PYREXIA (non-serious), outcome "recovered", described as "fever"; HEADACHE (non-serious), outcome "recovered", described as "headaches"; PAIN (non-serious), outcome "recovered", described as "aches and pains"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms"; FATIGUE (non-serious), outcome "recovered", described as "very bad tiredness".  Additional information: Reporter stated that, patient received first two doses of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) and afterwards experienced moderately to severe reactions close to 3 days with the first dose and for the second vaccine, the symptoms were the same, but patient had them for 4 days, which was longer than he expected.  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.