chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: after receiving my vaccines I've become fatigued again; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jan2021 09:00 (Lot number: EK9231) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Probably had chronic fatigue" (unspecified if ongoing), notes: verbatim: Probably had chronic fatigue but undiagnosed. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "after receiving my vaccines I've become fatigued again".  Additional information: Facility where the most recent COVID-19 vaccine was administered: Hospital. 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. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No known allergies: No allergies. Device Date : 04Aug2021  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling from the tips of my toes and it slowly went up into my head and now it is at the top of my head; My face is kind of like numbish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Aug2021 16:00 (Lot number: EW0198) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Kidney Disease" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; NORVASC; TRULICITY. The following information was reported: PARAESTHESIA (non-serious) with onset 03Aug2021 19:00, outcome "not recovered", described as "tingling from the tips of my toes and it slowly went up into my head and now it is at the top of my head"; HYPOAESTHESIA (non-serious) with onset 03Aug2021 19:00, outcome "unknown", described as "My face is kind of like numbish". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia.  Additional information: Patient not received prior vaccinations (within 4 weeks). Consumer stated she had not gone to the doctor yet. There was no investigation assessment performed.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain in the arm/sore arm; The pain was in the Injection site in Left arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 11:30 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Aug2021, outcome "recovered" (05Aug2021), described as "Pain in the arm/sore arm"; VACCINATION SITE PAIN (non-serious) with onset 05Aug2021, outcome "recovered" (05Aug2021), described as "The pain was in the Injection site in Left arm.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Pain in extremity
Clinical narrative: pain in the arm from last night and today/a lot of pain in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 04Aug2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Aug2021, outcome "not recovered", described as "pain in the arm from last night and today/a lot of pain in his arm". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: The patient reported that, he received it yesterday (04Aug2021) and he was having a lot of pain in his arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dysarthria, Hypoaesthesia, Panic attack, Paraesthesia
Clinical narrative: Had slurred speech; Cannot put thoughts into words; Tingling in her arms and legs/ tingling in her left arm that she got the vaccine; Her foot went numb; Had fast, heavy breathing; Almost like a panic attack; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 04Aug2021 (Lot number: FC3180, Expiration Date: Sep2021) at the age of 52 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Thyroid condition" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing). The following information was reported: PARAESTHESIA (non-serious) with onset 04Aug2021, outcome "not recovered", described as "Tingling in her arms and legs/ tingling in her left arm that she got the vaccine"; HYPOAESTHESIA (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "Her foot went numb"; RESPIRATION ABNORMAL (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "Had fast, heavy breathing"; PANIC ATTACK (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "Almost like a panic attack"; DYSARTHRIA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Had slurred speech"; APHASIA (non-serious) with onset 05Aug2021, outcome "unknown", described as "Cannot put thoughts into words". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia, respiration abnormal, panic attack, dysarthria, aphasia. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal
Clinical narrative: Had slurred speech; Cannot put thoughts into words; Tingling in her arms and legs/ tingling in her left arm that she got the vaccine; Her foot went numb; Had fast, heavy breathing; Almost like a panic attack; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 04Aug2021 (Lot number: FC3180, Expiration Date: Sep2021) at the age of 52 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Thyroid condition" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing). The following information was reported: PARAESTHESIA (non-serious) with onset 04Aug2021, outcome "not recovered", described as "Tingling in her arms and legs/ tingling in her left arm that she got the vaccine"; HYPOAESTHESIA (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "Her foot went numb"; RESPIRATION ABNORMAL (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "Had fast, heavy breathing"; PANIC ATTACK (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "Almost like a panic attack"; DYSARTHRIA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Had slurred speech"; APHASIA (non-serious) with onset 05Aug2021, outcome "unknown", described as "Cannot put thoughts into words". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia, respiration abnormal, panic attack, dysarthria, aphasia. No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Limb mass, Pain in extremity
Clinical narrative: very large lump under his arm and it is painful to put it down; it is painful to put it down/arm sore; whole right arm pit hurts; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reporting for a 16-year-old male patient.  A 16-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 14:30 (Lot number: FA7485) at the age of 16 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LIMB MASS (non-serious) with onset 05Aug2021, outcome "not recovered", described as "very large lump under his arm and it is painful to put it down"; PAIN IN EXTREMITY (non-serious) with onset 05Aug2021, outcome "not recovered", described as "it is painful to put it down/arm sore"; AXILLARY PAIN (non-serious) with onset 05Aug2021, outcome "not recovered", described as "whole right arm pit hurts". Therapeutic measures were taken as a result of limb mass, pain in extremity, axillary pain.  Additional information: Mother calling on behalf of her 16-year-old son.He received his first dose of the Pfizer Covid-19 Vaccine on 03Aug2021.He exp very large lump under his arm and it was painful to put it down.Caller was asking was that a usual side effect reported. Caller stated she was calling regarding the Pfizer vaccine, provided the number FA7485 as stated on the card. Was calling regarding her son who got the first vaccine. Clarified that she was referring to the Pfizer Covid vaccine. She knew that everybody has different side effects. Her whole family already got it. He hadn't gotten it yet. He has a really large lump under his arm put and it hurts him to put his arm down. She wanted to know if this was a usual side effect from the vaccine. Has a really large lump under his arm put and it hurts him to put his arm down: This morning, he noticed and states that it had been sore but, this morning, he noticed there was a lump there. His whole arm pit hurts. Clarified that it is the right arm, and it started this morning. It still feels the same. Treatment: He did take Ibuprofen. They wanted him to get protected from getting Covid, since they all had it and he hadn't had it. He has been practicing for football. Between 1:00 and 3:00 pm, then states that she believes it was between 1:30pm and 2:30 pm. The patient was not in emergency room for the reported events. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Nasopharyngitis, Nausea
Clinical narrative: Headache; Nausea; Have the stuffy nose now, kind of like a head cold; Have the stuffy nose now, kind of like a head cold; 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 02Aug2021 (Lot number: EW0168, Expiration Date: 23Aug2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 02Aug2021, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset 02Aug2021, outcome "unknown", described as "Nausea"; NASAL CONGESTION (non-serious), NASOPHARYNGITIS (non-serious) all with onset 02Aug2021, outcome "unknown" and all described as "Have the stuffy nose now, kind of like a head cold". No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Loss of personal independence in daily activities, Mental fatigue
Clinical narrative: a hard time following technical more complex conversations; mentally exhausted; some cognitive issues; 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 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jul2021 17:00 (Lot number: FA7484) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "A. FIB/ A. Flutter", start date: Apr2021 (unspecified if ongoing), notes: a. fib/a flutter and had an ablation in APR 2021, which was very successful; "COVID-19" (unspecified if ongoing), notes: last year, he did have COVID infection and describes that he had  moderate covid effects and it was fine up until just this last week, he felt pretty fine. The patient's concomitant medications were not reported. The following information was reported: COGNITIVE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "some cognitive issues"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 02Aug2021, outcome "not recovered", described as "a hard time following technical more complex conversations"; MENTAL FATIGUE (non-serious) with onset 02Aug2021, outcome "not recovered", described as "mentally exhausted". The events "some cognitive issues", "a hard time following technical more complex conversations" and "mentally exhausted" were evaluated at the physician office visit.  Additional information: After taking the first dose of vaccine the patient has noticed some cognitive issues. States with his job he does heavy data analysis and methodologies. since having the covid dose, he notices he had several experiences in which he had a hard time following technical more complex conversations before getting mentally exhausted. He was unable to follow certain patterns that he normally does every day. He was in good health with no risk factors. He thought there may be a causal effect with the Covid vaccines that he's had. He states basically it's more of a cognitive issue. He states the injection was good, everything was fine. He still works in the tech industry and the only way he can really describe it is he has to focus so hard that he gets completely exhausted. He states that's the biggest issue he's having. When he's dealing with data and data analysis its like he can't keep track of where it's going, he can't keep track of the conversation, that's what he's dealing with right now.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: A mild case of dizziness occurred 2 days after the first vaccination date.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jun2021 15:00 (Lot number: EW0217) 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: DIZZINESS (non-serious) with onset 23Jun2021, outcome "recovered" (24Jun2021), described as "A mild case of dizziness occurred 2 days after the first vaccination date.". The event "a mild case of dizziness occurred 2 days after the first vaccination date." was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness.  Additional Information: It was unknown whether the patient was diagnosed with COVID-19. The patient was been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (Lot number: EL9263) at the age of 82 years as dose 1, single and administration date 01Mar2021 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing), notes: pulmonary dfficulites after breast cancer chemo therapy. The patient's concomitant medications were not reported. Vaccination history included: Flu shots. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Slight soreness".  Additional information: I had no in effects after vaccination. A slight, very slight soreness same as one experience with other vaccinations such as flu shots etc.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: real heavy chest tightening, its not hurt me to breathe anything but my chest is really tight; 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 18Aug2021 (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: CHEST DISCOMFORT (non-serious) with onset 18Aug2021, outcome "unknown", described as "real heavy chest tightening, its not hurt me to breathe anything but my chest is really tight".  Additional information: Concern: consumer stated, "I just wanted to know if anybody reported about chest tightening with the Covid shot because I am experiencing that. I got my first COVID shot today." Further consumer stated, "A real heavy chest tightening like its not hurt me to breathe anything but my chest is really tight." Further probing could not be done as consumer hung up the call abruptly. Limited information was available over the call. Phone out at 8:06 AM, 2nd attempt by phone to Consumer to obtain contact information. Call answered by consumer who provided mailing address (withheld).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Pain in extremity, Weight
Clinical narrative: She was fine with the first injection, she just had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "underactive thyroid" (unspecified if ongoing), notes: Verbatim: underactive thyroid. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing).  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "She was fine with the first injection, she just had a sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The report is cross referenced to report ID: # Caller states that she is calling regarding the Pfizer Covid 19 vaccination. While reporting her own symptoms, caller mentioned daughter who had the shot and was sick for 2 days. This was with the second vaccination, she had the Pfizer. She was fine with the first injection, she just had a sore arm. Time the Vaccination Was Given was about 6:30 at night.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over my body; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported that:  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itching all over my body".  Additional information: Patient took the Pfizer shot on Friday and patient woke up this morning and had got a lot of itching all over my body.  Follow-up attempts completed. No further information is expected.  Follow-up (08Nov2021): 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: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dysacusis
Clinical narrative: Feel like a little bit of tightness on my chest when I eat, when I swallow and when I move around a little; I don't know why I can hear an echo, I don't know why; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Feel like a little bit of tightness on my chest when I eat, when I swallow and when I move around a little"; DYSACUSIS (non-serious), outcome "unknown", described as "I don't know why I can hear an echo, I don't know why".  Additional information: Consumer stated, I have a concern, I am not sure if I should actually go and get checked out or if its just a reaction of the vaccine, so I feel like a little bit of tightness on my chest when I eat, when I swallow and when I move around a little.  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, Feeling hot, Swelling
Clinical narrative: armpit on the left arm is really swollen; I cannot take the temperature of it but it is warm, it is really warm compared to the rest of the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left (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: SWELLING (non-serious), outcome "unknown", described as "armpit on the left arm is really swollen"; FEELING HOT (non-serious), outcome "unknown", described as "I cannot take the temperature of it, but it is warm, it is really warm compared to the rest of the body". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The report was not related to a study or programme. Reason for no lot number of Covid-19 Vaccine: Other: Consumer stated he don't know what that is. Consumer was concerned about the vaccine side effects. When probed for the concern: Consumer stated, the vaccine was taken under left arm and that was on Friday afternoon, now the armpit on the left arm is really swollen, obviously I cannot take the temperature of it, but it is warm, it is warm compared to the rest of the body, is that normal? Consumer was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday. 10:11 AM, 2nd attempt by phone to consumer to obtain follow-up information contained on consumer questionnaire. Phone answered by consumer who did not want to provide mailing address, but agree to provide e-mail address instead QR Comment: Reporter type was not available over the call as the consumer denied answering further questions, hence reporter type captured as consumer or non-healthcare professional by default.  Follow-up attempts completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Investigation, Laboratory test, Rash, Urticaria
Clinical narrative: chronic hives; rash; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 39 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 03Mar2021 (Lot number: EN6205) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zyrtec, notes: zyrtec; Cimetidine; Benadryl; Prednisone; Xolair. Vaccination history included: Bnt162b2 (First dose, anatomical site: arm, Route: IM, Batch/lot no: EL9262), administration date: 10Feb2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Mar2021, outcome "not recovered", described as "chronic hives"; RASH (non-serious) with onset Mar2021, outcome "not recovered", described as "rash". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, rash.  Additional Information: Lab Test: Consumer stated, That was a good question, believe so, she is seeing a functional medicine specialist as well and know that she is been doing some blood work, so the last blood work that did on her was, reporter believe it was sometime in summers but she is having a lot of blood work done by another facility as well. Yeah, for the last lab work had from like July but reporter know that she is being seeing another specialist as well who have been doing quite a bit of blood work which was after that but I don't know if it was within 2 to 3 weeks. Treatment: Consumer stated, Yes, so she since the reaction she has been taking two antihistamines, she was started on Xolair, and then she is been on Prednisone and most recently Hydroxychloroquine. The patient was not hospitalized or admitted to an intensive care unit. No any organ involvement: (dermatological/mucosal). Generalized urticarial: Yes. The event required the initiation of new medication or other treatment or procedure. Patients outcome following the potential anaphylactic reaction: Not Recovered (not anaphylactic). The following laboratory tests or diagnostic studies performed in Hematology. The patient did not had a history of any previous allergies to specific products or any conditions indicative of an allergy.Patient has tried multiple medications prior to the event being reported including Zyrtec, cimetidine, Benadryl, prednisone, Xolair. The patient did not received any recent vaccines for any other conditions and for SARS-CoV-2 other than Pfizer-BioNTech COVID-19 Vaccine prior to or around the time the event being reported.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Joint swelling, Muscle spasms, Myalgia
Clinical narrative: Right elbow is swollen for no reason; Muscle pain/it went into right hip and it was burning and extremely painful/went to the right thigh doing the same thing; Muscle pain/it went into right hip and it was burning and extremely painful/went to the right thigh doing the same thing; Had like a Charlie horse and shooting pains down into shin; Had like a Charlie horse and shooting pains down into shin; Had really painful joint pains in both hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious), BURNING SENSATION (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Muscle pain/it went into right hip and it was burning and extremely painful/went to the right thigh doing the same thing"; MUSCLE SPASMS (non-serious), PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Had like a Charlie horse and shooting pains down into shin"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Had really painful joint pains in both hands"; JOINT SWELLING (non-serious) with onset Sep2021, outcome "not recovered", described as "Right elbow is swollen for no reason".  Additional information: The reason for no lot number of Covid vaccine was because complainant does not have the product with them at the time of call. The side effects of the patient didn't last as long and no cramping. Reporter seriousness for it's almost like they are getting the same side effects and now it's attaching their joints; and they thought that was weird. Reporter called his brother to talked to him and his brother got the Moderna and got flu like symptoms and he was fine and his brother told him that withheld (his sister-in-law/patient) had the same effects and they thought that was weird, but hers didn't last long. Patient received the second dose on either the 6 or 7Apr2021. It was unknown if other vaccines given the same day or problems with vaccines in past.   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: Pain
Clinical narrative: Right elbow is swollen for no reason; Muscle pain/it went into right hip and it was burning and extremely painful/went to the right thigh doing the same thing; Muscle pain/it went into right hip and it was burning and extremely painful/went to the right thigh doing the same thing; Had like a Charlie horse and shooting pains down into shin; Had like a Charlie horse and shooting pains down into shin; Had really painful joint pains in both hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious), BURNING SENSATION (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Muscle pain/it went into right hip and it was burning and extremely painful/went to the right thigh doing the same thing"; MUSCLE SPASMS (non-serious), PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Had like a Charlie horse and shooting pains down into shin"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Had really painful joint pains in both hands"; JOINT SWELLING (non-serious) with onset Sep2021, outcome "not recovered", described as "Right elbow is swollen for no reason".  Additional information: The reason for no lot number of Covid vaccine was because complainant does not have the product with them at the time of call. The side effects of the patient didn't last as long and no cramping. Reporter seriousness for it's almost like they are getting the same side effects and now it's attaching their joints; and they thought that was weird. Reporter called his brother to talked to him and his brother got the Moderna and got flu like symptoms and he was fine and his brother told him that withheld (his sister-in-law/patient) had the same effects and they thought that was weird, but hers didn't last long. Patient received the second dose on either the 6 or 7Apr2021. It was unknown if other vaccines given the same day or problems with vaccines in past.   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: Body temperature, Headache, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: The 3rd vaccine caused her heart rate to go to "99" with a little fever; The 3rd vaccine caused her heart rate to go to "99" with a little fever; she had a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 24Sep2021 (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single unknown manufacture), for COVID-19 IMMUNISATION; Covid-19 vaccine (dose 2, single unknown manufacture), for COVID-19 IMMUNISATION. The following information was reported: HEART RATE INCREASED (non-serious), PYREXIA (non-serious), outcome "recovered" and all described as "The 3rd vaccine caused her heart rate to go to "99" with a little fever"; HEADACHE (non-serious), outcome "unknown", described as "she had a headache". Relevant laboratory tests and procedures are available in the appropriate section. Additional information The patient received the 3rd dose of the Pfizer COVID Vaccine on Friday night, 24Sep2021. She is calling today to know if she can use Valtrex, another antiviral after receiving the antiviral vaccine on Friday or would it impede the vaccine in any way. she does not think it will interact, but before she took it, she wanted to make sure there was no caution she should take before taking another antiviral. She wanted to know if it is okay to take anti-viral medications after getting the third dose of the COVID vaccine. she did not file an Adverse Event but notes that she was fine after dose 1 and 2 and states they didn't bother me. She did not have anything side effect wise after the first two COVID vaccines. She had side effects after getting the COVID booster. The 3rd vaccine caused her heart rate to go to 99 with a little fever, all of which have resolved by now she says. She just got the booster Friday night 24Sep2021.Saturday she was warm, and she had a headache. Then Saturday evening to Sunday, her heart rate was 99. Her temperature was 99. something. Her fever came down. Her pulse is back to 62. She states I guess everyone has a different reaction, nothing major. She just wanted to question if she could use Valtrex or would it have an impact on the vaccine. She really just wants to find out if she can take the medication. She was a pharmaceutical rep for 15 years which was almost 20 years ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Extrasystoles, Heart rate increased
Clinical narrative: his heart is skipping a beat; having hard time to breath; his heart rate is little bit high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administration date 27Sep2021 04:00 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Meningococcal vaccine (No, may be a month ago, it's been over a month. It was like, for cancer, for pelvic cancer. I don't know what they call for his age, right before they go to the middle school. They have the meningitis one and they offered that one for like pubic cancer or pelvic cancer."), administration date: Aug2021, for Pelvic cancer. The following information was reported: EXTRASYSTOLES (non-serious) with onset 27Sep2021, outcome "unknown", described as "his heart is skipping a beat"; DYSPNOEA (non-serious) with onset 27Sep2021, outcome "unknown", described as "having hard time to breath"; HEART RATE INCREASED (non-serious) with onset 27Sep2021, outcome "unknown", described as "his heart rate is little bit high". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of extrasystoles, dyspnoea, heart rate increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: Muscle pains; led and joint pain; led and joint pain; sore throat; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 17:45 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Latex" (unspecified if ongoing), notes: known allergies: Latex. Concomitant medication(s) included: PRO-AIR; DULERA; VIT D [COLECALCIFEROL]. The following information was reported: MYALGIA (non-serious) with onset 24Sep2021 19:30, outcome "not recovered", described as "Muscle pains"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 24Sep2021 19:30, outcome "not recovered" and all described as "led and joint pain"; OROPHARYNGEAL PAIN (non-serious) with onset 24Sep2021 19:30, outcome "not recovered", described as "sore throat". The events "muscle pains", "led and joint pain", "led and joint pain" and "sore throat" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of myalgia, pain in extremity, arthralgia, oropharyngeal pain.  Additional information: Patient 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.What treatment received for the adverse event: Continue taking your meds.Prior to vaccination, was the patient diagnosed with COVID-19: No.Since the vaccination, has the patient been tested for COVID-19: No.Reason why batch/lot is Unknown: Wasn't written on my card.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia, Sluggishness
Clinical narrative: fever at 100.9 degrees Fahrenheit/around 20 minutes ago from time of call temperature was 101.8 degrees Fahrenheit/100.8 degrees Fahrenheit earlier today; wife zoned out, wasn't concentrating; sluggish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. This consumer (patient's husband) reported for a female patient (reporter's wife).  A 73-year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 11:30 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, tolerated the first Covid 19 vaccine very easy), administration date: Jan2021, for COVID-19 Immunization, reaction(s): "tolerated"; Bnt162b2 (Dose: 2, He reports after the second Covid 19 vaccine he and his wife were both down for the afternoon), administration date: Feb2021, for COVID-19 Immunization, reaction(s): "down for the afternoon". The following information was reported: FEELING ABNORMAL (non-serious) with onset 28Sep2021, outcome "unknown", described as "wife zoned out, wasn't concentrating"; PYREXIA (non-serious) with onset 29Sep2021 10:00, outcome "unknown", described as "fever at 100.9 degrees Fahrenheit/around 20 minutes ago from time of call temperature was 101.8 degrees Fahrenheit/100.8 degrees Fahrenheit earlier today/45 minutes ago from time of this call that her fever was 101.8 degrees Fahrenheit"; SLUGGISHNESS (non-serious) with onset Sep2021, outcome "unknown", described as "sluggish". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter and his wife received the booster dose of the Pfizer Covid-19 vaccine on 28Sep2021 around 11:30 AM after the booster dose his wife became quiet and distant. Several hours later at dinnertime, the wife zoned out, wasn't concentrating, went to bed to sleep it off. This morning around 10 AM, the wife had a fever at 100.9 degrees Fahrenheit, and around 20 minutes ago from time of call her temperature was 101.8 degrees Fahrenheit. Reporter stated that she was still in bed and has only taken a few sips of water. Stated that her temperature earlier today was 100.8 degrees Fahrenheit and around 45 minutes ago from time of this call that her fever was 101.8 degrees Fahrenheit. The wife was very sluggish, will not get out of bed, won't take a sip of water, and did not take her morning medications. Reporter was asking if his wife can take aspirin to bring her fever down? Reported seriousness as unspecified for all the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Nasal congestion
Clinical narrative: cough; flu like; stuffiness and runny nose; nasal congestion; itching; headache; feverish; Tired; Rash; This is a spontaneous report received from a contactable health care professional for a 45 year-old female consumer (patient)   A 45 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Aug2021 (Lot number: FP8448) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Antomical site of Injection: Left Arm, Route: Intramuscular, Batch/Lot number: FA7485), administration date: 10Aug2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "Skin Rash", "Itching", "cough", "nasal congestion". The following information was reported: COUGH (non-serious), outcome "recovered", described as "cough"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like"; RHINORRHOEA (non-serious), outcome "recovered", described as "stuffiness and runny nose"; NASAL CONGESTION (non-serious), outcome "recovered", described as "nasal congestion"; PRURITUS (non-serious), outcome "recovered", described as "itching"; HEADACHE (non-serious), outcome "recovered", described as "headache"; PYREXIA (non-serious), outcome "recovered", described as "feverish"; FATIGUE (non-serious), outcome "recovered", described as "Tired"; RASH (non-serious), outcome "recovered", described as "Rash". Therapeutic measures were taken as a result of cough, nasal congestion, rash.  Additional information: the patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. Patient did not require medical intervention. Patient was not seen in the Emergency Department. The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit.  Follow up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: cough; flu like; stuffiness and runny nose; nasal congestion; itching; headache; feverish; Tired; Rash; This is a spontaneous report received from a contactable health care professional for a 45 year-old female consumer (patient)   A 45 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Aug2021 (Lot number: FP8448) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Antomical site of Injection: Left Arm, Route: Intramuscular, Batch/Lot number: FA7485), administration date: 10Aug2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "Skin Rash", "Itching", "cough", "nasal congestion". The following information was reported: COUGH (non-serious), outcome "recovered", described as "cough"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like"; RHINORRHOEA (non-serious), outcome "recovered", described as "stuffiness and runny nose"; NASAL CONGESTION (non-serious), outcome "recovered", described as "nasal congestion"; PRURITUS (non-serious), outcome "recovered", described as "itching"; HEADACHE (non-serious), outcome "recovered", described as "headache"; PYREXIA (non-serious), outcome "recovered", described as "feverish"; FATIGUE (non-serious), outcome "recovered", described as "Tired"; RASH (non-serious), outcome "recovered", described as "Rash". Therapeutic measures were taken as a result of cough, nasal congestion, rash.  Additional information: the patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. Patient did not require medical intervention. Patient was not seen in the Emergency Department. The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit.  Follow up attempts are completed. No further information is expected.