chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity, Peripheral coldness, SARS-CoV-2 test
Clinical narrative: arm was a little sore; very cold- her hands and feet were very cold; shaking very, very bad; Tired; kind of felt that her energy was zapped; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Mar2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 68 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 Mar2021, outcome "recovered" (Mar2021), described as "arm was a little sore"; PERIPHERAL COLDNESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "very cold- her hands and feet were very cold"; TREMOR (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "shaking very, very bad"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Tired"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "kind of felt that her energy was zapped". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: It was reported that, the patient received the first vaccine last Friday, stating tomorrow will mark 2 weeks. Everything went fine, she felt fine after getting the vaccine. She may have gotten it between 1-1:30 in the afternoon. Her arm was a little sore later in the evening. She took a Tylenol just to help maybe through the night in case it started to get a little worse. Caller explains at 2am, she woke up and she was very cold. Her felt her hands and they were very cold, her feet were very cold. She proceeded to go to the restroom and she just started shaking very, very bad. She has never shook like that. She was like a person that has Parkinson's. She would say the shaking lasted about 20 minutes, and she didn't know how long the shaking would last. She clarifies she believes the shaking lasted 20 minutes, 30 minutes at the most. But then, it seemed that it started calming down. She never had the shaking after that. She became a little tired and had a little bit of a cold feeling for about a day or two. She typically has a spunky type of personality and she kind of felt that her energy was zapped. Other than that, she states she didn't have any other experiences. She did have COVID. She was diagnosed with it 03Feb2021 When probed for the outcome of the events she experienced, she believes she recovered completely from them all after 2-3 days.  Caller confirms she received the vaccine Friday, 12Mar2021. She makes the comment "it seems like ages ago since I had it".  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: arm was a little sore; very cold- her hands and feet were very cold; shaking very, very bad; Tired; kind of felt that her energy was zapped; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Mar2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 68 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 Mar2021, outcome "recovered" (Mar2021), described as "arm was a little sore"; PERIPHERAL COLDNESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "very cold- her hands and feet were very cold"; TREMOR (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "shaking very, very bad"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Tired"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "kind of felt that her energy was zapped". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: It was reported that, the patient received the first vaccine last Friday, stating tomorrow will mark 2 weeks. Everything went fine, she felt fine after getting the vaccine. She may have gotten it between 1-1:30 in the afternoon. Her arm was a little sore later in the evening. She took a Tylenol just to help maybe through the night in case it started to get a little worse. Caller explains at 2am, she woke up and she was very cold. Her felt her hands and they were very cold, her feet were very cold. She proceeded to go to the restroom and she just started shaking very, very bad. She has never shook like that. She was like a person that has Parkinson's. She would say the shaking lasted about 20 minutes, and she didn't know how long the shaking would last. She clarifies she believes the shaking lasted 20 minutes, 30 minutes at the most. But then, it seemed that it started calming down. She never had the shaking after that. She became a little tired and had a little bit of a cold feeling for about a day or two. She typically has a spunky type of personality and she kind of felt that her energy was zapped. Other than that, she states she didn't have any other experiences. She did have COVID. She was diagnosed with it 03Feb2021 When probed for the outcome of the events she experienced, she believes she recovered completely from them all after 2-3 days.  Caller confirms she received the vaccine Friday, 12Mar2021. She makes the comment "it seems like ages ago since I had it".  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Neck pain, Pain, Pain in extremity
Clinical narrative: pain in my arm, going towards my neck and arm; pain in my arm, going towards my neck and arm; pain in my arm, going towards my neck and arm; chills; feel very cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 16:30 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), NECK PAIN (non-serious) all with onset 16Mar2021, outcome "not recovered" and all described as "pain in my arm, going towards my neck and arm"; CHILLS (non-serious) with onset 16Mar2021, outcome "not recovered", described as "chills"; FEELING COLD (non-serious) with onset 16Mar2021, outcome "not recovered", described as "feel very cold". Therapeutic measures were not taken as a result of pain in extremity, pain, neck pain, chills, feeling cold.  Additional information: It was reported that may be an hour or two later after vaccination, the patient started to have these symptoms. It was further reported that that the pain is going to her neck, and to the middle of her arm.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 11:00 (Lot number: EP6955) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021 18:00, outcome "recovering", described as "Sore left arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; minor soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 10Mar2021 at 18:00 (at the age of 63-year-old) as dose 1, single for covid-19 immunization. Patient's medical history was not reported. Concomitant medication included ONE A DAY (reported as 1 a day vitamin) from an unspecified date and unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient experienced 3 days of minor soreness at injection site, peaked on day after injection. On 11Mar2021, the patient experienced fatigue. The patient did not take any treatment for the adverse events. The clinical outcome of the events minor soreness at injection site and fatigue was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter (patient) information, suspect information, concomitant information, event information and narrative were amended.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: Slept a lot; not really felt good since; having trouble thinking; dizzy; Headache; felt hazy/feltcrappy/felt strange/feeling yucky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6205) at the age of 73 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: THINKING ABNORMAL (non-serious) with onset 11Mar2021, outcome "not recovered", described as "having trouble thinking"; DIZZINESS (non-serious) with onset 11Mar2021, outcome "recovering", described as "dizzy"; HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "Headache"; FEELING ABNORMAL (non-serious) with onset 11Mar2021, outcome "recovering", described as "felt hazy/feltcrappy/felt strange/feeling yucky"; HYPERSOMNIA (non-serious), outcome "not recovered", described as "Slept a lot"; MALAISE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "not really felt good since". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of thinking abnormal, dizziness, headache, feeling abnormal, hypersomnia, malaise. Additional information: On 11Mar2021, the patient got the first shot of the vaccine after which the patient got dizzy and has not really felt good since. The patient was having trouble thinking and felt hazy. The patient experienced headache and slept a lot and felt worse when waking up. The patient stated starting to feel better but did not know if this was a side effect or not. The patient had a headache for 2 days. It was reported that they gave the shot and the patient had to go up to the second floor and on the way up to the second floor, the patient started getting dizzy and felt strange, but the patient was not sure. The patient did not know why and sat down for 15 minutes and felt a little dizzy. But it just kind of continued a little bit and then the patient just started feeling crappy when the patient got home. The patient reported feeling yucky. The patient did not receive treatment for the events. The second dose was scheduled for 01Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Malaise, Thinking abnormal
Clinical narrative: Slept a lot; not really felt good since; having trouble thinking; dizzy; Headache; felt hazy/feltcrappy/felt strange/feeling yucky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6205) at the age of 73 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: THINKING ABNORMAL (non-serious) with onset 11Mar2021, outcome "not recovered", described as "having trouble thinking"; DIZZINESS (non-serious) with onset 11Mar2021, outcome "recovering", described as "dizzy"; HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "Headache"; FEELING ABNORMAL (non-serious) with onset 11Mar2021, outcome "recovering", described as "felt hazy/feltcrappy/felt strange/feeling yucky"; HYPERSOMNIA (non-serious), outcome "not recovered", described as "Slept a lot"; MALAISE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "not really felt good since". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of thinking abnormal, dizziness, headache, feeling abnormal, hypersomnia, malaise. Additional information: On 11Mar2021, the patient got the first shot of the vaccine after which the patient got dizzy and has not really felt good since. The patient was having trouble thinking and felt hazy. The patient experienced headache and slept a lot and felt worse when waking up. The patient stated starting to feel better but did not know if this was a side effect or not. The patient had a headache for 2 days. It was reported that they gave the shot and the patient had to go up to the second floor and on the way up to the second floor, the patient started getting dizzy and felt strange, but the patient was not sure. The patient did not know why and sat down for 15 minutes and felt a little dizzy. But it just kind of continued a little bit and then the patient just started feeling crappy when the patient got home. The patient reported feeling yucky. The patient did not receive treatment for the events. The second dose was scheduled for 01Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: VERTIGO (non-serious), outcome "unknown", described as "Vertigo".  Additional Context: Consumer was experiencing side effects from the covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: right thigh area in the muscle feels throbbing and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "recovered" (2021), described as "right thigh area in the muscle feels throbbing and pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hangover
Clinical narrative: feeling like she had a mild hangover; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number=1), for COVID-19 immunisation. The following information was reported: HANGOVER (non-serious), outcome "unknown", described as "feeling like she had a mild hangover".  Additional information: The patient was generally in good health, very excited to have received this vaccine and event took place after use of product (2nd COVID shot).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Musculoskeletal discomfort, Musculoskeletal stiffness, Procedural pain
Clinical narrative: lower back was completely frozen solid and has been very uncomfortable/ hard to straighten up/ tightens up when moving; lower back was completely frozen solid and has been very uncomfortable/ hard to straighten up/ tightens up when moving; back pain on the area where the patient had back surgery 47 years ago; a little flu like; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 11Mar2021 (Lot number: EN6206) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Back surgery", start date: 1974, stop date: 1974, notes: 47 years ago; "could not straighten up the back (only for a single time)" (not ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EN6201)), administration date: 10Feb2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "arm was sore". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 12Mar2021, outcome "unknown", described as "a little flu like"; MUSCULOSKELETAL STIFFNESS (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 13Mar2021, outcome "recovering" and all described as "lower back was completely frozen solid and has been very uncomfortable/ hard to straighten up/ tightens up when moving"; PROCEDURAL PAIN (non-serious) with onset 13Mar2021, outcome "recovering", described as "back pain on the area where the patient had back surgery 47 years ago". Therapeutic measures were taken as a result of influenza like illness, musculoskeletal stiffness, musculoskeletal discomfort, procedural pain. Additional information: Treatment included paracetamol (TYLENOL) 500 mg cut in half (250 mg) along with a half of methocarbamol (muscle relaxant) which seemed to help. The patient was also concomitantly taking unspecified "heart drugs" for an unspecified indications.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Vomiting
Clinical narrative: Vomiting; Disorientation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Mar2021 (Lot number: ER2613) at the age of 69 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: VOMITING (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "Vomiting"; DISORIENTATION (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "Disorientation". Additional information: The vomiting started in the evening and it resolved about 4 hours after he got the vaccine. The patient noticed the disorientation almost immediately and said that it was like 4 hours of just disorientation. AEs did not require a visit to the emergency room or physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache
Clinical narrative: stomach cramps; Headache; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C PLUS [ASCORBIC ACID]; ZINC; TYLENOL; ANTIHISTAMINE. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Mar2021, outcome "unknown", described as "stomach cramps"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Tiredness".  Additional information: The patient got first shot on Monday 08Mar2021. He found out later that he may have done things wrong that may have messed up the vaccine effectiveness. He cannot reach anyone to ask about the vaccine. Patient stated that the CDC has a warning about taking Tylenol and he took it before getting the vaccine. He took an antihistamine as well. He is asking if him taking Tylenol and antihistamine affected the vaccine. He takes a lot of vitamin c and zinc. Asking if vitamins are contraindicated. Three days after the vaccine he had stomach cramps. He cannot tell if it had anything to do with the vaccine. He has headaches and tiredness, reports he has had these before and have been limited but have been more severe after the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Breast pain, Insomnia, Pain
Clinical narrative: her right breast and right side has been bothering her/breast began to hurt; her right breast and right side has been bothering her/breast began to hurt; She states she can't sleep with it, can't do nothing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 26Feb2021 08:10 (Batch/Lot number: unknown) at the age of 85 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: has had this condition for years; "Diabetic" (unspecified if ongoing), notes: diagnosed about 20 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (First dose, Lot: Unknown, Expiry date: Unknown , Route: Intramuscular injection , Anatomical location: Left arm), administration date: 04Feb2021, for COVID-19 immunisation. The following information was reported: BREAST PAIN (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "her right breast and right side has been bothering her/breast began to hurt"; INSOMNIA (non-serious) with onset Mar2021, outcome "unknown", described as "She states she can't sleep with it, can't do nothing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no prior vaccinations (within 4 weeks). Clinical course: She received the second vaccine on 26Feb2021, but she mostly had been having problems this week. Her right breast and right side had been bothering her. She broke out all under arm only on the right side. She did not know where it came from. Her breast has been bothering her ever since she had the shot. She clarified her breast began to hurt and she cannot wear a bra anymore. Both times, she had worn a sports bra and the other kind of bra, she had not been able to keep them on. She stated she cannot sleep with it, cannot do nothing. She thought the pain goes away and comes back. Sometimes, it hurts real bad. The events did not result to emergency room or physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I had a headache for a couple of days and than it went away; 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 16 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered", described as "I had a headache for a couple of days and than it went away".  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-2021304214 Same reporter/same drug, different patient/ event(split)
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: stiff neck; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day 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: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiff neck"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  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-2021301279 Same reporter/drug/event, different patient.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Lymphadenopathy, Vaccination site pain
Clinical narrative: The shot was on the other side and it was a lymph thing.; Soreness in left armpit; Tiredness; Left arm soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 09:55 (Lot number: EN6208) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for arthritis. The following information was reported: FATIGUE (non-serious) with onset 17Mar2021 12:00, outcome "recovering", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 16Mar2021 10:15, outcome "not recovered", described as "Left arm soreness at injection site"; AXILLARY PAIN (non-serious) with onset 18Mar2021 04:00, outcome "not recovered", described as "Soreness in left armpit"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "The shot was on the other side and it was a lymph thing.".  Additional information: They did the shot way up in the arm just below the shoulder. She heard about blood clots and it worried her.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: My daughter feels to long since the shot and is not related; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "My daughter feels to long since the shot and is not related".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Unable to sleep within the next 10 days: 1-2 hrs. per night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 13:30 (Lot number: EN6202) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: JANUVIA; METFORMIN; GLIMEPIRIDE; ATORVASTATIN. The following information was reported: INSOMNIA (non-serious) with onset 03Mar2021, outcome "recovered", described as "Unable to sleep within the next 10 days: 1-2 hrs. per night". Therapeutic measures were not taken as a result of insomnia.  Additional information: Patient was not sleeping at all for 10 days, sleeping only maybe an hour at night. Sleepless symptoms were suddenly dropped after that. Caller received the vaccination- clarified Covid vaccine on 02Mar2021 and he was supposed to have his second one on 30Mar2021. Caller reports he developed an adverse effect- he was not sleeping at all for 10 days, sleeping only maybe an hour at night. Caller reports this adverse event has suddenly disappeared and he is okay now. Caller states that he needs to know any suggestions on what to do; if he should get the second vaccination; he was also concerned about how he would feel after the second vaccination. He was concerned that this adverse event would come back and if there was any way for him to sleep at least a little bit. other medications in two weeks: ram  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Musculoskeletal stiffness
Clinical narrative: pain in lower part of bottom and leg was stiff numb and heavy; pain in lower part of bottom and leg was stiff numb and heavy; pain in lower part of bottom and leg was stiff numb and heavy/radiated down to the leg like she could not move her leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 88 year-old female patient received bnt162b2 (BNT162B2), administration date 13Feb2021 (Batch/Lot number: unknown) at the age of 88 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: LIMB DISCOMFORT (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "pain in lower part of bottom and leg was stiff numb and heavy"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "pain in lower part of bottom and leg was stiff numb and heavy/radiated down to the leg like she could not move her leg". Additional Information: Weight: Caller is not sure her mother's weight, she believes that it is 135 or 136 pounds.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: tiredness; woke up dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Mar2021 09:00 (Batch/Lot number: unknown) at the age of 85 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: DIZZINESS (non-serious) with onset 18Mar2021, outcome "unknown", described as "woke up dizzy"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Insomnia, Nausea
Clinical narrative: Chills; shaking; Nausea; Vomiting/threw up twice; mind was racing; severe headache/dull pain in the back of his head; couldn't sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 09:00 (Lot number: EN6198) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "aorta valve transplant" (unspecified if ongoing), notes: 3 years ago, everything seems to be fine. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1 Received 17Feb2021, lot EN6201), administration date: 17Feb2021, when the patient was 78 years old, for COVID-19 immunisation, reaction(s): "mild flu like symptoms". The following information was reported: CHILLS (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Chills"; TREMOR (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "shaking"; NAUSEA (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Nausea"; VOMITING (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Vomiting/threw up twice"; FEELING ABNORMAL (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "mind was racing"; HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (15Mar2021), described as "severe headache/dull pain in the back of his head"; INSOMNIA (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "couldn't sleep".  Additional information:  The caller walks every day, about 1.5 hours which was close to 4 miles. After the second shot at 5:00 pm or so, the caller ate a big supper, then a chill came over him that was so strong he was actually shaking, he put a heating pad on his chest. The caller couldn't sleep, he threw up twice, was nauseous, had a severe headache, this was Thursday evening. Friday the caller woke up and felt fairly good. Then at 2:00 pm the caller had another attack- chills, not as hard as the day before it was milder, he wasn't nauseous, he seemed to come through it. Saturday evening the caller still had this mild headache in the back of his head, he had it until Sunday. The caller feels fine now but maybe if they told him to take it easy after the second shot this wouldn't have happened. The symptoms were more than severe, the caller almost called someone to take him to the Emergency room. The caller still had the dull pain in the back of his head but it went away now. The caller did not know if it was because he was so active after the second shot? Then it hit him like unbelievable. The caller will be 79 in a month and he was not used to having that kind of reaction.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Chills; shaking; Nausea; Vomiting/threw up twice; mind was racing; severe headache/dull pain in the back of his head; couldn't sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 09:00 (Lot number: EN6198) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "aorta valve transplant" (unspecified if ongoing), notes: 3 years ago, everything seems to be fine. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1 Received 17Feb2021, lot EN6201), administration date: 17Feb2021, when the patient was 78 years old, for COVID-19 immunisation, reaction(s): "mild flu like symptoms". The following information was reported: CHILLS (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Chills"; TREMOR (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "shaking"; NAUSEA (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Nausea"; VOMITING (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Vomiting/threw up twice"; FEELING ABNORMAL (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "mind was racing"; HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (15Mar2021), described as "severe headache/dull pain in the back of his head"; INSOMNIA (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "couldn't sleep".  Additional information:  The caller walks every day, about 1.5 hours which was close to 4 miles. After the second shot at 5:00 pm or so, the caller ate a big supper, then a chill came over him that was so strong he was actually shaking, he put a heating pad on his chest. The caller couldn't sleep, he threw up twice, was nauseous, had a severe headache, this was Thursday evening. Friday the caller woke up and felt fairly good. Then at 2:00 pm the caller had another attack- chills, not as hard as the day before it was milder, he wasn't nauseous, he seemed to come through it. Saturday evening the caller still had this mild headache in the back of his head, he had it until Sunday. The caller feels fine now but maybe if they told him to take it easy after the second shot this wouldn't have happened. The symptoms were more than severe, the caller almost called someone to take him to the Emergency room. The caller still had the dull pain in the back of his head but it went away now. The caller did not know if it was because he was so active after the second shot? Then it hit him like unbelievable. The caller will be 79 in a month and he was not used to having that kind of reaction.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: backache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "backache". Therapeutic measures were taken as a result of back pain.  Additional info: The reporter wanted to know if it is okay to take Advil, though it is not for the vaccine but for his backache, after the vaccine. The patient took 2 Advil after the first dose. Reporter also wanted to know if he can take his diabetic medications and Muconase after the dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: slept for almost 24 hours straight; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in left arm, administration date 15Feb2021 15:00 (Lot number: EN6201) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "traumatic brain injury which causes a lot of fatigue" (unspecified if ongoing); "Heart conditions" (unspecified if ongoing); "taking ritalin to be able to function" (ongoing). Concomitant medication(s) included: RITALIN taken for loss of personal independence in daily activities, start date: 1995 (ongoing). Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EL9262) at 09:45 AM, intramuscularly in left arm), administration date: 25Jan2021, when the patient was 78 years old, for COVID-19 immunisation. The following information was reported: HYPERSOMNIA (non-serious) with onset 15Feb2021, outcome "recovered" (17Feb2021), described as "slept for almost 24 hours straight".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: having aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: had covid two months ago. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 15Mar2021, outcome "unknown", described as "having aches and pains".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (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: FATIGUE (non-serious), outcome "unknown", described as "felt tired".  Additional information: The patient received the second dose of BNT162B2 on 04Mar2021.   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-2021304462 Same reporter, drug, and events; different patient
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: had a mild flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 (Lot number: EN6201) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "aorta valve transplant", start date: 2018 (unspecified if ongoing), notes: 3 years ago, everything seems to be fine. There were no concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "had a mild flu like symptoms". Therapeutic measures were taken as a result of influenza like illness.  Additional Information: Because of the event, the patient rested that day.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable consumer from medical information team.  A 55-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. 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 "Sore arm".  Additional Information: The patient also had a sore arm after the first dose of the vaccine.   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) : PFIZER INC-2021304566 Same reporter, product, and event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: moderate pain in the left deltoid where he received the immunization / tender to the touch; limits his ability to raise his arm without pain / where he received the immunization; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left (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: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "moderate pain in the left deltoid where he received the immunization / tender to the touch"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "not recovered", described as "limits his ability to raise his arm without pain / where he received the immunization".  Additional information: It was reported that the patient was healthy and received his first dose of vaccine two weeks ago (from the time of the report). The patient continues to experience the events. It was reported that his left deltoid was not red or swollen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia
Clinical narrative: My mother can't stand for a long time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and follow-up spontaneous report from Pfizer-sponsored program Support CEP 159558.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (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: DYSSTASIA (non-serious) with onset 2021, outcome "unknown", described as "My mother can't stand for a long time".  Additional Information: Reporter stated that "My mother (patient) and my sister got their first dose on 27Feb2021 and they are scheduled for their second dose on 23March2021. My sister is currently in the hospital and has pneumonia in her right lung. My mother can't stand for a long time so do I need to reschedule her appointment"   No follow-up attempts are needed; information about lot/batch number cannot be obtained.