chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She has trouble with her hands./ It flared up her hands. / You don't know the pain I am in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 86 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), outcome "unknown", described as "She has trouble with her hands./ It flared up her hands. / You don't know the pain I am in".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Echocardiogram, Palpitations
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 48 year-old male patient received bnt162b2 (COMIRNATY), administration date Jun2021 (Batch/Lot number: unknown) at the age of 47 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Acid reflux (esophageal)" (unspecified if ongoing); "had mild palpitations for years" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious), outcome "not recovered", ANXIETY (non-serious) with onset Jan2022, outcome "not recovered" and all described as "we all are now experiencing heart palpitations and anxiety". The event "we all are now experiencing heart palpitations and anxiety" and "we all are now experiencing heart palpitations and anxiety" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Confirms that this was the Pfizer Covid vaccine, Comirnaty, states that was the one he wanted. Patient received it in Jun2021, he thinks, he had 1st and 2nd dose but has not had any boosters. His brother and several friends have gotten the Covid shot and we all are now experiencing heart palpitations and anxiety. If this was something aware of please let us know what is the solution. He spent a lot of money trying to figure how to stop this and have not been able to work. Reason for no lot number: of Comirnaty: Complainant does not have the product with them at the time of call. The report not related to a study or programme. Reporter states he has had mild palpitations for years but after this shot it increased. States it is ongoing and has worsened but kind of leveled out. Reporter saw psychiatrist today and they prescribed him Prozac. When querying for product, patient states he hasn't picked it up yet, he was just prescribed it today. He hasn't been working so the anxiety comes and goes, its worse if he was not sitting around and doing nothing. Reporter does not have his vaccination card available. States it must be at home. Lot and Expiry unknown. Confirms that this was the Pfizer Covid vaccine, Comirnaty, states that is the one he wanted. He received it in Jun2021, he thinks, he had 1st and 2nd dose but has not had any boosters. Reporter adds that he had a death in the family and his symptoms got a little worse after that. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200458434 same reporter/drug/AE, different patient; US-PFIZER INC-202200463155 Pfizer.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: It appears my tinnitus has increased substantially after receiving the Covid vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "It appears my tinnitus has increased substantially after receiving the Covid vaccine.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Got the booster shot 6 days ago; started having headache for 3 days non stop and sometime its throbbing; the headache is not going away; Got the booster shot 6 days ago; started having headache for 3 days non stop and sometime its throbbing; the headache is not going away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 23 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), PAIN (non-serious) all with onset Mar2022, outcome "not recovered" and all described as "Got the booster shot 6 days ago; started having headache for 3 days non stop and sometime its throbbing; the headache is not going away". The event "got the booster shot 6 days ago; started having headache for 3 days non stop and sometime its throbbing; the headache is not going away" and "got the booster shot 6 days ago; started having headache for 3 days non stop and sometime its throbbing; the headache is not going away" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of headache, pain.  Additional information: The patient go got first dose and second dose and got the booster shot 6 days ago and she men-tioned that her son was started having headache for 3 days nonstop and sometime its throbbing. She just wants to confirm if it was normal, or he need to get medical attention. On paraphrasing the concern: Reporter stated that he was experiencing. He has the Pfizer booster shot, last Wednesday so, 6 days ago. So, he was having normal side effect before (further not clarified) but, last 3 days he has nonstop headache and even reporter gave him 3 Advil the pain does not go away (further clarifications unknown). Sometimes it's always there but then throbbing happen. The pa-tient took him to the urgent care. They checked provision all that stuff he said, he was ok, but the headache was not going away. It's been 3 days. Reporter wanted to  know if that was normal, or anybody reported that to you guys.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: I got a very bad taste in my mouth and everything kind of smelled bad; really bad sense of smell and taste; Also, food smells and tastes differently; I got a very bad taste in my mouth and everything kind of smelled bad; really bad sense of smell and taste; Also, food smells and tastes differently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2022 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: TASTE DISORDER (non-serious) with onset Feb2022, outcome "not recovered", PAROSMIA (non-serious) with onset Feb2022, outcome "unknown" and all described as "I got a very bad taste in my mouth and everything kind of smelled bad; really bad sense of smell and taste; Also, food smells and tastes differently". Therapeutic measures were not taken as a result of taste disorder, parosmia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Dizziness, Fatigue, Illness
Clinical narrative: Knocked me down worse; Knocked me down worse; very sick; fatigued; Chilled; Achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 10:00 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number:1 (11:45 am), Lot number:EL32A8,, Anatomical location:Right arm), administration date: 28Jan2021, when the patient was 77 years old, for COVID-19 immunization; Bnt162b2 (Dose number:2 (11:50 am), Dose anatomical location: Arm), administration date: 18Feb2021, when the patient was 77 years old, for covid- 19 immunization. The following information was reported: DIZZINESS (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "Knocked me down worse"; ILLNESS (non-serious), outcome "unknown", described as "very sick"; FATIGUE (non-serious), outcome "unknown", described as "fatigued"; CHILLS (non-serious), outcome "unknown", described as "Chilled"; PAIN (non-serious), outcome "unknown", described as "Achy".  Additional information:   Patient and her husband contracted COVID 19 in Nov2020. They had it for 5 weeks. At one point they checked into the Emergency Room at local (Hospital withheld) because they were not well, and wanted to make sure that they didn't have pneumonia. Her husband was coughing a lot, and she was having difficulty breathing - along with the other COVID 19 symptoms such as extreme fatigue.  The hospital ran us through their protocols for COVID 19, and determined that their lungs were clear. they each were given were given 5 steroid tablets, and sent home to recuperate. Fortunately they have good neighbours who checked on them, and brought them groceries.  The day after first COVID shot, they both started with chills and fever, then fatigue. They felt as though they had Covid all over again. The symptoms lasted about 24 hours. After the second shot, she  was knocked down, got up, and laid back down, and was down for the day. S.he just felt tired, and awful for the entire day.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Knocked me down worse; Knocked me down worse; very sick; fatigued; Chilled; Achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 10:00 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number:1 (11:45 am), Lot number:EL32A8,, Anatomical location:Right arm), administration date: 28Jan2021, when the patient was 77 years old, for COVID-19 immunization; Bnt162b2 (Dose number:2 (11:50 am), Dose anatomical location: Arm), administration date: 18Feb2021, when the patient was 77 years old, for covid- 19 immunization. The following information was reported: DIZZINESS (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "Knocked me down worse"; ILLNESS (non-serious), outcome "unknown", described as "very sick"; FATIGUE (non-serious), outcome "unknown", described as "fatigued"; CHILLS (non-serious), outcome "unknown", described as "Chilled"; PAIN (non-serious), outcome "unknown", described as "Achy".  Additional information:   Patient and her husband contracted COVID 19 in Nov2020. They had it for 5 weeks. At one point they checked into the Emergency Room at local (Hospital withheld) because they were not well, and wanted to make sure that they didn't have pneumonia. Her husband was coughing a lot, and she was having difficulty breathing - along with the other COVID 19 symptoms such as extreme fatigue.  The hospital ran us through their protocols for COVID 19, and determined that their lungs were clear. they each were given were given 5 steroid tablets, and sent home to recuperate. Fortunately they have good neighbours who checked on them, and brought them groceries.  The day after first COVID shot, they both started with chills and fever, then fatigue. They felt as though they had Covid all over again. The symptoms lasted about 24 hours. After the second shot, she  was knocked down, got up, and laid back down, and was down for the day. S.he just felt tired, and awful for the entire day.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: tired and cold; tired and cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 81 year-old male patient received bnt162b2 (BNT162B2), administration date 11Nov2021 10:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "We contracted Covid 19", start date: Nov2020, stop date: Dec2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Time (24hr): 11:45 AM, Anatomical site of the injection: Right arm, Batch/lot number: EL32A8), administration date: 28Jan2021, for COVID-19 immunization, reaction(s): "Chills", "fever", "fatigue"; Bnt162b2 (Dose 2, Time (24hr): 11:50 AM, Anatomical site of the injection: Arm), administration date: 18Feb2021, for COVID-19 immunization, reaction(s): "Little tired". The following information was reported: NASOPHARYNGITIS (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "tired and cold".  Additional information: Patient contracted Covid 19 in Nov2020. Had it for 5 weeks. At one point, they checked into the Emergency Room at their local (Hospital withheld) because they were not well, and wanted to make sure that they didn't have pneumonia. He was coughing a lot, along with the other Covid 19 symptoms such as extreme fatigue. The hospital ran them through their protocols for Covid 19, and determined that their lungs were clear. The patient was given 5 steroid tablets and sent home to recuperate. Fortunately they have good neighbors who checked on them, and brought them groceries. The patient didn't feel as bad as his wife did after booster, he was tired and cold, but his reaction lasted for about one day.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Parosmia, Taste disorder
Clinical narrative: I got a very bad taste in my mouth and everything kind of smelled bad; really bad sense of smell and taste; Also, food smells and tastes differently; I got a very bad taste in my mouth and everything kind of smelled bad; really bad sense of smell and taste; Also, food smells and tastes differently; when I got my 2nd dose it became more intense/it has only gotten worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administration date 22Feb2022 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1), administration date: 02Feb2022, when the patient was 29 years old, for COVID-19 immunization, reaction(s): "I got a very bad taste in my mouth and everything kind of smelled bad", "I got a very bad taste in my mouth and everything kind of smelled bad". The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset Feb2022, outcome "not recovered" and all described as "I got a very bad taste in my mouth and everything kind of smelled bad; really bad sense of smell and taste; Also, food smells and tastes differently"; CONDITION AGGRAVATED (non-serious) with onset Feb2022, outcome "not recovered", described as "when I got my 2nd dose it became more intense/it has only gotten worse". Therapeutic measures were not taken as a result of taste disorder, parosmia, condition aggravated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph node swelling under left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Apr2021 11:00 (Lot number: EW0153) at the age of 37 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: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph node swelling under left armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Anatomical Site of injection: Left upper arm. Within 3-5 days of injection, lymph node swelling under left armpit occurred and lasted 3-5 days after each of the 3 injections. No other events occurred, no medical treatment was sought.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph node swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200461453 (Pfizer).  A 37 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Jan2022 11:00 (Lot number: FJ1614) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date / Time: , Date: 10Apr2021, Time: 11:00, Site and Route of injection , Anatomical Site of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: EW0153), administration date: 10Apr2021, for Covid-19 immunization, reaction(s): "lymph node swelling under left armpit"; Bnt162b2 (Dose: 2nd, Date / Time: , Date: 01May2021, Time: 11:00, Site and Route of injection: , Anatomical Site of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: ER8736), administration date: 01May2021, for Covid-19 immunization, reaction(s): "lymph node swelling under left armpit". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph node swelling". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Within 3-4 days of injection, lymph node swelling under left armpit occurred and lasted 3-4 days after each of the 3 injections. No other events occurred, no medical treatment was sought.  Follow-up (25Mar2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Memory impairment, Pyrexia
Clinical narrative: Caller also mentioned that both of him and his wife experienced this/his mind seemed to be forgetful; his wife experienced this/2 days fever; weakness and tiredness for 2-3 months; weakness and tiredness for 2-3 months; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization.  The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Caller also mentioned that both of him and his wife experienced this/his mind seemed to be forgetful"; PYREXIA (non-serious), outcome "unknown", described as "his wife experienced this/2 days fever"; FATIGUE (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "weakness and tiredness for 2-3 months".  Additional information: Caller also stated that he had "2 days fever" and "weakness and tiredness for 2-3 months. Caller also mentioned that he "all couple times and his mind seemed to be forgetful".Caller also mentioned that both of him and his wife experienced this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypertonia
Clinical narrative: she experienced "Hypertonic" in the neck area right after taking the shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes Type 1" (ongoing), notes: Diabetes Type 1. There were no concomitant medications. The following information was reported: HYPERTONIA (non-serious) with onset Jan2021, outcome "unknown", described as "she experienced "Hypertonic" in the neck area right after taking the shot".  Additional information: The patient was administered a first dose of the Pfizer Covid-19 vaccine purple cap formulation on Jan2022 and states that she experienced "Hypertonic" in the neck area right after taking the shot. Caller was asking if the patient should take a second dose of the Pfizer Covid 19 vaccine amidst the adverse reaction that happened.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Blood test, Pain, Vaccination site swelling
Clinical narrative: Caller clarified that with the first shot of the Covid -19 vaccine her stomach swelled up; Severe Body Pain; Swelling at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Oral allergy syndrome" (unspecified if ongoing), notes: Note: Oral allergy syndrome; "Allergy to birch trees" (unspecified if ongoing), notes: Note: Allergy to birch trees.; "Food allergy" (unspecified if ongoing), notes: Note: Certain food makes her throat itch. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "Caller clarified that with the first shot of the Covid -19 vaccine her stomach swelled up"; PAIN (non-serious), outcome "unknown", described as "Severe Body Pain"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Swelling at injection site". The events "caller clarified that with the first shot of the covid -19 vaccine her stomach swelled up", "severe body pain" and "swelling at injection site" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal distension.  Additional Information: Caller was a consumer that was calling for her daughter about the Pfizer Covid-19 Vaccine and said that her daughter was unable to talk at the moment. Caller was calling about the Covid-19 and was calling to find out about adverse reactions. She said that her daughter seems to be having one. Caller clarified that with the first shot of the Covid -19 vaccine her stomach swelled up. She said that her daughter said that she had severe body pain and swelling at the injection site.  Caller said that her daughter was having blood work done. Caller requested to have her daughter call and complete the report. Caller declined to complete the rest of the report and wants her daughter to call to report her symptoms. Her daughter has been on Benadryl, Zyrtec, and Claritin and may have had a another medication and is still really suffering from this.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200463196 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Blood test, Peripheral swelling
Clinical narrative: With the second dose her daughter's arm and stomach swelled up; With the second dose her daughter's arm and stomach swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "oral allergy syndrome" (unspecified if ongoing); "allergy to birch trees" (unspecified if ongoing); "certain foods make her throat itch" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Mar2021, for COVID-19 immunization, reaction(s): "stomach swelled up"; Bnt162b2 (1st dose, severe body pain and swelling at the injection site), administration date: Mar2021, for COVID-19 immunization, reaction(s): "Swelling at injection site", "Severe Body Pain". The following information was reported: PERIPHERAL SWELLING (non-serious), ABDOMINAL DISTENSION (non-serious), outcome "unknown" and all described as "With the second dose her daughter's arm and stomach swelled up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, abdominal distension.  Additional information: This report was not related to a study or programme. Patient had been on Benadryl, Zyrtec, and Claritin and may have had a another and was still really suffering from this.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200463196 similar report from same reporter
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Magnetic resonance imaging, Myalgia, Pain
Clinical narrative: body, joint, shoulders and arms pains; body, joint, shoulders and arms pains; muscle aches; body, joint, shoulders and arms pains; body, joint, shoulders and arms pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), administration date: 2021, for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), administration date: 2021, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "body, joint, shoulders and arms pains"; MYALGIA (non-serious) with onset Nov2021, outcome "not recovered", described as "muscle aches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that early Nov2021, after booster dose, it felt like something attacked his joints and muscle groups, after the booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: body, joint, shoulders and arms pains; body, joint, shoulders and arms pains; muscle aches; body, joint, shoulders and arms pains; body, joint, shoulders and arms pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), administration date: 2021, for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), administration date: 2021, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "body, joint, shoulders and arms pains"; MYALGIA (non-serious) with onset Nov2021, outcome "not recovered", described as "muscle aches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that early Nov2021, after booster dose, it felt like something attacked his joints and muscle groups, after the booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: muscle weakness; arm soreness; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "muscle weakness"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm soreness".  Additional information: Patient received her first and second dose of the Pfizer Covid-19 vaccine adult dose in Mar2021 or Apr2021, and booster dose in 10Jan2022. Since that time she have been experiencing arm soreness and muscle weakness.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Ketoacidosis, Pollakiuria, Type 1 diabetes mellitus, Vitiligo
Clinical narrative: frequent urination; ketoacidosis; diagnosed as a late onset type one diabetic; vitiligo spread one month after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 17:30 (Lot number: ER8731) at the age of 41 years as dose 2, single for covid-19 immunisation. Facility type vaccine: Pharmacy or Drug Store. Relevant medical history included: "Vitiligo was dormant for 15 years prior to vaccine" (not ongoing). No Known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Vaccination history included: Bnt162b2 (1st dose, lot number= EP6955), administration date: 02Apr2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "vitiligo". No covid prior vaccination. No covid tested post vaccination.  The following information was reported: POLLAKIURIA (hospitalization, disability, life threatening) with onset May2021, outcome "not recovered", described as "frequent urination"; KETOACIDOSIS (hospitalization, disability, life threatening) with onset May2021, outcome "not recovered", described as "ketoacidosis"; TYPE 1 DIABETES MELLITUS (hospitalization, disability, life threatening) with onset May2021, outcome "not recovered", described as "diagnosed as a late onset type one diabetic"; VITILIGO (hospitalization, disability, life threatening) with onset May2021, outcome "not recovered", described as "vitiligo spread one month after the first dose". The patient was hospitalized for pollakiuria, ketoacidosis, type 1 diabetes mellitus, vitiligo (hospitalization duration: 3 day(s)). The events "frequent urination", "ketoacidosis", "diagnosed as a late onset type one diabetic" and "vitiligo spread one month after the first dose" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pollakiuria, ketoacidosis, type 1 diabetes mellitus, vitiligo. Treatment for DKA and lifelong insulin injections.  The patient reported that he started to have frequent urination and vitiligo spread one month after the first dose. After months of the frequent urination he was admitted into the ICU with ketoacidosis. He was know diagnosed as a late onset type one diabetic, triggered by the vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: Swollen lymph nodes around the breast area which always come and go; Redness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 46 years 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: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "Swollen lymph nodes around the breast area which always come and go"; ERYTHEMA (non-serious), outcome "not recovered", described as "Redness".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Palpitations
Clinical narrative: Heart palpitations/pounding heart; shortness of breath; Chest pain on right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Jan2022 13:15 (Batch/Lot number: unknown) at the age of 21 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: PALPITATIONS (non-serious) with onset 28Jan2022 01:00, outcome "not recovered", described as "Heart palpitations/pounding heart"; DYSPNOEA (non-serious) with onset 28Jan2022 01:00, outcome "not recovered", described as "shortness of breath"; CHEST PAIN (non-serious) with onset 28Jan2022 01:00, outcome "not recovered", described as "Chest pain on right side". Therapeutic measures were not taken as a result of palpitations, dyspnoea, chest pain.  Additional information: Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. No other medications in two weeks. AE does not result in physician office visit or emergency room visit. No COVID prior vaccination. No COVID tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy on left Axilla; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Complex regional pain syndrome" (ongoing), notes: Complex regional pain syndrome on the right arm. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "lymphadenopathy on left Axilla". The event "lymphadenopathy on left axilla" was evaluated at the physician office visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: Caller was an LPN calling on behalf of her own side effect after receiving the second dose of Pfizer BioNtech vaccine. First dose was administered Aug202 and second dose of vaccine was given some time after. After the second dose of Pfizer BioNtech Covid vaccine she developed lymphadenopathy on left axilla that has not yet subsided and was still ongoing even after 6 months. It was about 2-3 centimetre, and it was pretty large however it does not cause any pain or discomfort. She was due for her booster dose, and she would like to know if she could receive the booster with an ongoing lymphadenopathy and if there was any information on how long she needs to wait before this subsides. She had read somewhere that some cases, had an ongoing lymphadenopathy for up to 43 weeks post vaccination. She stated that after visiting the oncologist, the oncologist opted that she should have a biopsy on the lymph node and to delay receiving the booster dose for another 3-4 months and she would like to know if there was any information regarding getting the booster dose at any time aside from the recommended 6 months interval and what would be the level of immunity or antibody level. She also stated that the oncologist advised her not to get the booster dose on the left arm however she was suffering from complex regional pain syndrome on the right arm. She would like to know if he could receive the vaccine in other sites aside from her arms, though she was worried if she injects on her leg it would affect her groin lymph node. She would like to know what her antibody level would be if she delays receiving the booster dose for 3-4 months, she would like to know if she would still be being protected. She would like to know if the Covid vaccines come in prefilled syringes. She would like to know what were the blood tests that she could do to determine her antibody level of protection as there was no data regarding her case about receiving the Pfizer BioNtech Booster dose at a longer interval. She would like to know if there was any information at all regarding administration of vaccine to someone with underlying complex regional pain syndrome.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: skin redness/ itching; skin redness/ itching; chronic (6 months) body rash/ itching/hives all over the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Aug2021 13:15 (Lot number: FC3182) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C. Vaccination history included: Bnt162b2 (Dose 1, lot number=FA6780, administration time=11:00 AM, vaccine location=Left arm), administration date: 25Jul2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 22Sep2021, outcome "not recovered" and all described as "skin redness/ itching"; URTICARIA (non-serious) with onset 22Sep2021, outcome "not recovered", described as "chronic (6 months) body rash/ itching/hives all over the body". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of erythema, pruritus, urticaria.  Additional information: The patient body after a month from the date of the 2nd dose (15Aug2021) Pfizer covid-19 vaccine and consistently re-occurring every after 24 hours (up to this date) after taking Zyrtec antihistamine medicine. Patient has no history of allergies, very healthy individual. Patient haven't seen a doctor, or receive treatment, only taking antihistamine Zyrtec. Patient experienced symptoms of Covid-19 a week before 2nd dose (15Aug2021) and did recover.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hypersensitivity, Malaise, SARS-CoV-2 test negative, Suspected COVID-19
Clinical narrative: skin redness/ itching; skin redness/ itching; chronic (6 months) body rash/ itching/hives all over the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Aug2021 13:15 (Lot number: FC3182) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C. Vaccination history included: Bnt162b2 (Dose 1, lot number=FA6780, administration time=11:00 AM, vaccine location=Left arm), administration date: 25Jul2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 22Sep2021, outcome "not recovered" and all described as "skin redness/ itching"; URTICARIA (non-serious) with onset 22Sep2021, outcome "not recovered", described as "chronic (6 months) body rash/ itching/hives all over the body". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of erythema, pruritus, urticaria.  Additional information: The patient body after a month from the date of the 2nd dose (15Aug2021) Pfizer covid-19 vaccine and consistently re-occurring every after 24 hours (up to this date) after taking Zyrtec antihistamine medicine. Patient has no history of allergies, very healthy individual. Patient haven't seen a doctor, or receive treatment, only taking antihistamine Zyrtec. Patient experienced symptoms of Covid-19 a week before 2nd dose (15Aug2021) and did recover.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss- Covid vaccine/Bald spot in back of head right now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: 301458A) at the age of 84 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing), notes: Hypothyroidism, controlled for years. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT: EL9262), administration date: 12Feb2021, when the patient was 83 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, LOT: EL9269), administration date: 23Mar2021, when the patient was 83 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Hair loss- Covid vaccine/Bald spot in back of head right now". Therapeutic measures were taken as a result of alopecia.  Additional information: The patient had some hair loss and was suspecting it was from the vaccine. After booster shot in 22Oct2021 noticed her hair falling out in Dec2021, had not had Covid so the only thing she can suspect was hair. The patient was treating hair loss with ketoconazole shampoo, used it twice a week for two months, had not slowing down the hair loss. Product information was unknown, covered with pharmacy label. bald spot in back of head right now, every time she combs 3-4 strands come out.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neoplasm malignant
Clinical narrative: lymphadenopathy; got cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Jul2021 (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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant) with onset Jul2021, outcome "unknown", described as "got cancer"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymphadenopathy". Clinical course: Caller mentioned that after the second dose of Pfizer Covid 19 Vaccine she got cancer and she also mentioned that she ''currently'' had lymphadenopathy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 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: CHEST PAIN (non-serious), outcome "unknown", described as "chest pain".  Additional information: Patient stated that he experienced chest pain after taking the vaccine and he wanted to know if it's normal to experience chest pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.