chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Very very low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PYREXIA (non-serious), outcome "unknown", described as "Very very low grade fever". Additional Information: The patient has not received any other vaccine within 4 weeks prior to COVID 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) : US-PFIZER INC-202101465991 Same patient and drug, different events separated in time;US-PFIZER INC-202101465729 Same patient and drug, different events separated in time
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Headache, Off label use, Product use issue
Clinical narrative: Anxious; shortness of breath; soreness at the ejection site; headache; other vaccine same date product= Pfizer Flu shot; other vaccine same date product= Pfizer Flu shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 11:30 (Lot number: FF8839) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 27Oct2021 (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Nsaids, reaction(s): "Known allergies: NSAIDS", notes: Allergies: NSAIDS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 08Feb2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 20Jan2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 27Oct2021, outcome "unknown" and all described as "other vaccine same date product= Pfizer Flu shot"; ANXIETY (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "Anxious"; DYSPNOEA (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "shortness of breath"; VACCINATION SITE PAIN (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "soreness at the ejection site"; HEADACHE (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of anxiety, dyspnoea, vaccination site pain, headache.  Additional information: Facility type vaccine was Workplace clinic, facility country was reported. Other vaccine was received in four weeks. Other vaccine 4weeks product include Pfizer Flu Vaccine with vaccination date 27Oct2021, lot number Unknown, dose number 1 in left arm. No other medications were taken in two weeks. Adverse events began roughly 1-2 hours following injection. Symptoms worsened the next morning. adverse event start date: 27Oct2021 & time was 01:00 PM. Patient not recovered. No treatment received. No covid prior vaccination. No covid tested post vaccination. I am the patient and the symptoms/awareness date was 27Oct2021. Patient reported the symptoms/awareness date as 27Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Anxious; shortness of breath; soreness at the ejection site; headache; other vaccine same date product= Pfizer Flu shot; other vaccine same date product= Pfizer Flu shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 11:30 (Lot number: FF8839) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 27Oct2021 (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Nsaids, reaction(s): "Known allergies: NSAIDS", notes: Allergies: NSAIDS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 08Feb2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 20Jan2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 27Oct2021, outcome "unknown" and all described as "other vaccine same date product= Pfizer Flu shot"; ANXIETY (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "Anxious"; DYSPNOEA (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "shortness of breath"; VACCINATION SITE PAIN (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "soreness at the ejection site"; HEADACHE (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of anxiety, dyspnoea, vaccination site pain, headache.  Additional information: Facility type vaccine was Workplace clinic, facility country was reported. Other vaccine was received in four weeks. Other vaccine 4weeks product include Pfizer Flu Vaccine with vaccination date 27Oct2021, lot number Unknown, dose number 1 in left arm. No other medications were taken in two weeks. Adverse events began roughly 1-2 hours following injection. Symptoms worsened the next morning. adverse event start date: 27Oct2021 & time was 01:00 PM. Patient not recovered. No treatment received. No covid prior vaccination. No covid tested post vaccination. I am the patient and the symptoms/awareness date was 27Oct2021. Patient reported the symptoms/awareness date as 27Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Expired product administered, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Tiredness; Slight fever of 37.8 C; Expiry Date of Pfizer covid 19 vaccine: 28Feb2021; 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 (COMIRNATY), administered in arm left, administration date 27Oct2021 (Lot number: FH8028, Expiration Date: 28Feb2021) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot EM9810, The caller clarifies and confirms that she did not have any side effects with the first two doses of the Pfizer Covid 19 vaccine.), administration date: 06Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine"; Bnt162b2 (2nd dose, lot EN6200, The caller clarifies and confirms that she did not have any side effects with the first two doses of the Pfizer Covid 19 vaccine.), administration date: 28Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: HEADACHE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 28Oct2021, outcome "recovering", described as "Tiredness"; PYREXIA (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Slight fever of 37.8 C"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 27Oct2021, outcome "unknown", described as "Expiry Date of Pfizer covid 19 vaccine: 28Feb2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration
Clinical narrative: Dose: 1, Date: 15Oct2021; Dose: 2, Date: 15Oct2021; Joint pain...elbows mostly knees & hips Still aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 08:45 (Lot number: Ew0178) as dose 1, single and administered in arm right, administration date 15Oct2021 08:45 (Lot number: Ff2590) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines have lessened greatly" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "Dose: 1, Date: 15Oct2021; Dose: 2, Date: 15Oct2021"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Joint pain...elbows mostly knees & hips Still aches". Therapeutic measures were not taken as a result of arthralgia.  Additional information: The most recent COVID-19 vaccine was administered at Workplace clinic facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received vitamins and ibuprofen medications within 2 weeks of vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe progressive Tinnitus in the left ear only; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2020 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 19Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Severe progressive Tinnitus in the left ear only". The event "severe progressive tinnitus in the left ear only" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Hospital. Hospitalization Prolonged: No. Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The adverse event result in any of the following: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had received COVID 19 vaccine, brand=Pfizer, dose 3 (booster), single in left arm on 25Oct2021 for Covid-19 immunization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Contusion, Fatigue, Off label use
Clinical narrative: Pain, swelling and bruising of left breast; swelling and bruising of left breast; swelling and bruising of left breast; body aches; fatigue; I was nursing/I continued to nurse throughout the adverse event; I was nursing/I continued to nurse throughout the adverse event; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF8841) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 37 years old, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264), administration date: 11Feb2021, when the patient was 37 years old, for Covid-19 Immunisation. The following information was reported: BREAST PAIN (non-serious) with onset 09Oct2021, outcome "unknown", described as "Pain, swelling and bruising of left breast"; BREAST SWELLING (non-serious), CONTUSION (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "swelling and bruising of left breast"; PAIN (non-serious) with onset 09Oct2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 09Oct2021, outcome "unknown", described as "fatigue"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 08Oct2021, outcome "unknown" and all described as "I was nursing/I continued to nurse throughout the adverse event". Therapeutic measures were not taken as a result of breast pain, breast swelling, contusion, pain, fatigue, off label use, product use issue  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications were received the patient within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101484960 mother case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product use issue
Clinical narrative: Pain, swelling and bruising of left breast; swelling and bruising of left breast; swelling and bruising of left breast; body aches; fatigue; I was nursing/I continued to nurse throughout the adverse event; I was nursing/I continued to nurse throughout the adverse event; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF8841) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 37 years old, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264), administration date: 11Feb2021, when the patient was 37 years old, for Covid-19 Immunisation. The following information was reported: BREAST PAIN (non-serious) with onset 09Oct2021, outcome "unknown", described as "Pain, swelling and bruising of left breast"; BREAST SWELLING (non-serious), CONTUSION (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "swelling and bruising of left breast"; PAIN (non-serious) with onset 09Oct2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 09Oct2021, outcome "unknown", described as "fatigue"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 08Oct2021, outcome "unknown" and all described as "I was nursing/I continued to nurse throughout the adverse event". Therapeutic measures were not taken as a result of breast pain, breast swelling, contusion, pain, fatigue, off label use, product use issue  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications were received the patient within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101484960 mother case
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Overdose, Product administered to patient of inappropriate age
Clinical narrative: However, this morning he woke up feeling bad again; Her son is 6 years old and was provided a higher dose than recommended, and received a 30mcg dose.; was provided a higher dose than recommended, and received a 30mcg dose.; Her son is 6 years old and was provided a higher dose than recommended, and received a 30mcg dose.; Got adult vaccine; headache; low grade fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 31Oct2021 11:30 (Lot number: 30135BA) at the age of 6 years as dose 1, 30 ug single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 31Oct2021 11:30, outcome "unknown" and all described as "Her son is 6 years old and was provided a higher dose than recommended, and received a 30mcg dose."; OVERDOSE (non-serious) with onset 31Oct2021 11:30, outcome "unknown", described as "was provided a higher dose than recommended, and received a 30mcg dose."; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 31Oct2021 11:30, outcome "unknown", described as "Got adult vaccine"; HEADACHE (non-serious) with onset 31Oct2021, outcome "unknown", described as "headache"; PYREXIA (non-serious) with onset 31Oct2021, outcome "unknown", described as "low grade fever"; FEELING ABNORMAL (non-serious) with onset 01Nov2021, outcome "unknown", described as "However, this morning he woke up feeling bad again". The patient underwent the following laboratory tests and procedures: body temperature: (31Oct2021) 99-100; (01Nov2021) unknown results. Therapeutic measures were taken as a result of headache, pyrexia.  Additional information: Reporter had her 6 year old with her who got the vaccine. She mentioned her son is experiencing side effects already. He has a headache and running a low grade fever. Headache- Started yesterday, a few hours after the shot. When it first started the headache came and went; it went away at first yesterday. However, this morning he woke up feeling bad again. The headache had come back. He had taken Tylenol. The headache comes and goes with Tylenol. Low grade fever- has had since yesterday. It comes and goes with the Tylenol as well. It has been between 99-100. This morning the fever was back again too.   Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: However, this morning he woke up feeling bad again; Her son is 6 years old and was provided a higher dose than recommended, and received a 30mcg dose.; was provided a higher dose than recommended, and received a 30mcg dose.; Her son is 6 years old and was provided a higher dose than recommended, and received a 30mcg dose.; Got adult vaccine; headache; low grade fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 31Oct2021 11:30 (Lot number: 30135BA) at the age of 6 years as dose 1, 30 ug single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 31Oct2021 11:30, outcome "unknown" and all described as "Her son is 6 years old and was provided a higher dose than recommended, and received a 30mcg dose."; OVERDOSE (non-serious) with onset 31Oct2021 11:30, outcome "unknown", described as "was provided a higher dose than recommended, and received a 30mcg dose."; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 31Oct2021 11:30, outcome "unknown", described as "Got adult vaccine"; HEADACHE (non-serious) with onset 31Oct2021, outcome "unknown", described as "headache"; PYREXIA (non-serious) with onset 31Oct2021, outcome "unknown", described as "low grade fever"; FEELING ABNORMAL (non-serious) with onset 01Nov2021, outcome "unknown", described as "However, this morning he woke up feeling bad again". The patient underwent the following laboratory tests and procedures: body temperature: (31Oct2021) 99-100; (01Nov2021) unknown results. Therapeutic measures were taken as a result of headache, pyrexia.  Additional information: Reporter had her 6 year old with her who got the vaccine. She mentioned her son is experiencing side effects already. He has a headache and running a low grade fever. Headache- Started yesterday, a few hours after the shot. When it first started the headache came and went; it went away at first yesterday. However, this morning he woke up feeling bad again. The headache had come back. He had taken Tylenol. The headache comes and goes with Tylenol. Low grade fever- has had since yesterday. It comes and goes with the Tylenol as well. It has been between 99-100. This morning the fever was back again too.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Malaise, Nausea, Pain in extremity
Clinical narrative: redness at the injection site today; Lump under injection arm; lymph nodes under her arm are quit swollen/lymph nodes were only swollen under the arm she received the injection in; nausea; did not feel well; arm and shoulder were quit sore; arm and shoulder were quit sore; fever; 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 female patient received bnt162b2 (BNT162B2), administration date 28Oct2021 (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 (DOSE 1, SINGLE), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "No Adverse effect"; Bnt162b2 (DOSE 2, SINGLE), administration date: 25Mar2021, for COVID-19 immunization, reaction(s): "No Adverse effect". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 29Oct2021, outcome "not recovered", described as "lymph nodes under her arm are quit swollen"; PYREXIA (non-serious) with onset 28Oct2021, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 29Oct2021, outcome "unknown", described as "nausea"; MALAISE (non-serious) with onset 29Oct2021, outcome "unknown", described as "did not feel well"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 29Oct2021, outcome "unknown" and all described as "arm and shoulder were quit sore"; INJECTION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness at the injection site today"; MASS (non-serious), outcome "unknown", described as "Lump under injection arm". The patient underwent the following laboratory tests and procedures: body temperature: (29Oct2021) tapered off during the day, notes: Fever.  Additional information: Thursday, the patient had the booster dose. Same day, she developed fever. The patient did not feel well. Had nausea. Had fever all day Friday.  On Saturday in the morning, she had a fever, but it tapered off but she did notice her arm and shoulder were quit sore. She also noticed the lymph nodes under her arm were quit swollen and were still swollen as speak. Caller also reported redness next to the injection site that she just noticed today and had not noticed previously. Lump under her arm is just under the injection site arm. Noticed redness at the injection site today that she has not noticed previously.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site mass
Clinical narrative: redness at the injection site today; Lump under injection arm; lymph nodes under her arm are quit swollen/lymph nodes were only swollen under the arm she received the injection in; nausea; did not feel well; arm and shoulder were quit sore; arm and shoulder were quit sore; fever; 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 female patient received bnt162b2 (BNT162B2), administration date 28Oct2021 (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 (DOSE 1, SINGLE), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "No Adverse effect"; Bnt162b2 (DOSE 2, SINGLE), administration date: 25Mar2021, for COVID-19 immunization, reaction(s): "No Adverse effect". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 29Oct2021, outcome "not recovered", described as "lymph nodes under her arm are quit swollen"; PYREXIA (non-serious) with onset 28Oct2021, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 29Oct2021, outcome "unknown", described as "nausea"; MALAISE (non-serious) with onset 29Oct2021, outcome "unknown", described as "did not feel well"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 29Oct2021, outcome "unknown" and all described as "arm and shoulder were quit sore"; INJECTION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness at the injection site today"; MASS (non-serious), outcome "unknown", described as "Lump under injection arm". The patient underwent the following laboratory tests and procedures: body temperature: (29Oct2021) tapered off during the day, notes: Fever.  Additional information: Thursday, the patient had the booster dose. Same day, she developed fever. The patient did not feel well. Had nausea. Had fever all day Friday.  On Saturday in the morning, she had a fever, but it tapered off but she did notice her arm and shoulder were quit sore. She also noticed the lymph nodes under her arm were quit swollen and were still swollen as speak. Caller also reported redness next to the injection site that she just noticed today and had not noticed previously. Lump under her arm is just under the injection site arm. Noticed redness at the injection site today that she has not noticed previously.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lip swelling, Pharyngeal swelling, Swollen tongue
Clinical narrative: My throat was swollen; my tongue was swollen; my lips are swollen; I had the first one but it was more than 4 weeks, so it was on 08/23/2021, that was when I had the first one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 17:00 (Lot number: FF2590) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Anatomical Location: Left Arm), administration date: 23Aug2021, for COVID-19 immunization. The following information was reported: PHARYNGEAL SWELLING (non-serious), outcome "unknown", described as "My throat was swollen"; SWOLLEN TONGUE (non-serious), outcome "not recovered", described as "my tongue was swollen"; LIP SWELLING (non-serious), outcome "not recovered", described as "my lips are swollen"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Oct2021, outcome "unknown", described as "I had the first one but it was more than 4 weeks, so it was on 08/23/2021, that was when I had the first one". The events "my throat was swollen", "my tongue was swollen" and "my lips are swollen" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pharyngeal swelling, swollen tongue, lip swelling.  Additional information: My throat was swollen, my tongue was swollen and my lips are swollen, my tongue and my lips are still swollen and I know it's from the shot Patient stated she wants to report some side effects that she having but I do not know if it's the side effects but I went down on the 12th of October to get my second COVID shot at about 5 o'clock in the afternoon. And I woke up the next morning my throat was swollen, my tongue was swollen and my lips are swollen. My tongue and my lips are still swollen and I know it's from the shot. I don't know what to do. No other medical condition. Concomitant medications are for my heart. Treatment: Patient stated, she went to Urgent care, they didn't know what to do, they gave my antibiotic (Unspecified medication). It didn't do any good, I am still having the side effects on my lips and my tongue.  Follow-Up (08Nov2021): .No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Feeling hot, Mouth haemorrhage, Off label use, Pain assessment, Pain in extremity
Clinical narrative: Some blood taste in mouth; Left underarm 1-10 sore at a 9; hot/warm and a bit swollen morning, noon and night one day following vaccination.; hot/warm and a bit swollen morning, noon and night one day following vaccination.; Bleeding gums; Off Label Use; Flu, other vaccine same date vaccine date = 02Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 17:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 02Nov2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Kidney stones" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: D3. Vaccination history included: Bnt162b2 (Dose Number: 2, brand=Pfizer EN6204, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 08Mar2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Right), administration date: 15Feb2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 02Nov2021, outcome "unknown", described as "Off Label Use"; PRODUCT USE ISSUE (non-serious) with onset 02Nov2021, outcome "unknown", described as "Flu, other vaccine same date vaccine date = 02Nov2021"; PAIN IN EXTREMITY (non-serious) with onset 03Nov2021 16:00, outcome "recovering", described as "Left underarm 1-10 sore at a 9"; FEELING HOT (non-serious), SWELLING (non-serious) all with onset 03Nov2021 16:00, outcome "recovering" and all described as "hot/warm and a bit swollen morning, noon and night one day following vaccination."; MOUTH HAEMORRHAGE (non-serious) with onset 03Nov2021 16:00, outcome "recovering", described as "Bleeding gums"; TASTE DISORDER (non-serious) with onset 04Nov2021, outcome "recovering", described as "Some blood taste in mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity. Therapeutic measures were not taken as a result of feeling hot, swelling, mouth haemorrhage, taste disorder.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Product use issue, Swelling, Taste disorder
Clinical narrative: Some blood taste in mouth; Left underarm 1-10 sore at a 9; hot/warm and a bit swollen morning, noon and night one day following vaccination.; hot/warm and a bit swollen morning, noon and night one day following vaccination.; Bleeding gums; Off Label Use; Flu, other vaccine same date vaccine date = 02Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 17:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 02Nov2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Kidney stones" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: D3. Vaccination history included: Bnt162b2 (Dose Number: 2, brand=Pfizer EN6204, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 08Mar2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Right), administration date: 15Feb2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 02Nov2021, outcome "unknown", described as "Off Label Use"; PRODUCT USE ISSUE (non-serious) with onset 02Nov2021, outcome "unknown", described as "Flu, other vaccine same date vaccine date = 02Nov2021"; PAIN IN EXTREMITY (non-serious) with onset 03Nov2021 16:00, outcome "recovering", described as "Left underarm 1-10 sore at a 9"; FEELING HOT (non-serious), SWELLING (non-serious) all with onset 03Nov2021 16:00, outcome "recovering" and all described as "hot/warm and a bit swollen morning, noon and night one day following vaccination."; MOUTH HAEMORRHAGE (non-serious) with onset 03Nov2021 16:00, outcome "recovering", described as "Bleeding gums"; TASTE DISORDER (non-serious) with onset 04Nov2021, outcome "recovering", described as "Some blood taste in mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity. Therapeutic measures were not taken as a result of feeling hot, swelling, mouth haemorrhage, taste disorder.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Worsening of menstrual cycle intensity and length; Worsening of menstrual cycle intensity and length; Worsening of menstrual cycle intensity and length; worsening of asthma symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EN6207) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Exercise induced asthma" (unspecified if ongoing); "ventricular bigeminy" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. Past drug history included: Diflucan, reaction(s): "Drug allergy". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 22Mar2021, outcome "not recovered" and all described as "Worsening of menstrual cycle intensity and length"; ASTHMA (non-serious) with onset 22Mar2021, outcome "not recovered", described as "worsening of asthma symptoms". The events "worsening of menstrual cycle intensity and length", "worsening of menstrual cycle intensity and length", "worsening of menstrual cycle intensity and length" and "worsening of asthma symptoms" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstrual disorder, condition aggravated. Therapeutic measures were taken as a result of asthma.  Additional Information: Worsening of menstrual cycle intensity and length, worsening of asthma symptoms resulting in more frequent use of albuterol inhaler that was otherwise rarely needed. Patient haven't been on other vaccine in four weeks. Patient hasn't been tested Covid prior vaccination. Patient hasn't been tested Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Inappropriate schedule of product administration, Menstruation irregular, Pain in extremity, Pyrexia
Clinical narrative: fever; sore arm; Periods have stopped; developed irregular spotting; prev dose administration date=26Jun2021, prev dose dose number=2,; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jun2021 (Lot number: FA9091) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot_number=EX0904,, administrator route=Intramuscular,, DOSE 1, SINGLE, anatomical location=Left arm), administration date: 06Apr2021, when the patient was 40 years old, for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; AMENORRHOEA (non-serious), outcome "unknown", described as "Periods have stopped"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "developed irregular spotting"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "prev dose administration date=26Jun2021, prev dose dose number=2,". The events "fever", "sore arm", "periods have stopped" and "prev dose administration date=26jun2021, prev dose dose number=2," were evaluated at the physician office visit. Therapeutic measures were taken as a result of pyrexia. It was unknown if therapeutic measures were taken as a result of pain in extremity, amenorrhoea, menstruation irregular, inappropriate schedule of product administration.  Additional information: The patient had no to very mild immediate side effects: sore arm, fever (controlled by Tylenol in 2 hours) after second dose. The patient noticed that since 2nd dose and especially after booster she found a connection in affecting her menstrual cycle. Periods have stopped and developed irregular spotting. The patient did not have covid prior vaccination. The patient did not test covid post vaccination. There were no known allergies and there was no other medical history.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Premenstrual dysphoric disorder
Clinical narrative: Has caused severe p.m.d.d.; depression symptoms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Apr2021 09:30 (Lot number: Ew0177) at the age of 42 years as dose 1,single and administered in arm right, administration date 17May2021 09:30 (Lot number: Er8736) 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: PREMENSTRUAL DYSPHORIC DISORDER (non-serious) with onset 30Apr2021 11:00, outcome "not recovered", described as "Has caused severe p.m.d.d."; DEPRESSION (non-serious) with onset 30Apr2021 11:00, outcome "not recovered", described as "depression symptoms". Therapeutic measures were not taken as a result of premenstrual dysphoric disorder, depression.  Additional information: The patient had no other vaccine in four weeks nor other medication in two weeks. The patient did not have covid prior to vaccination or was tested post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Bronchitis, Dysgeusia, Nasopharyngitis, Pain
Clinical narrative: Left arm hurt at injection site for a few days; Metal taste in mouth for a couple of weeks; pains; felt kind of like he had a cold; asthma was real bad; Aches; Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 13:00 (Lot number: ER8727) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Asthma" (unspecified if ongoing), notes: Verbatim: Asthma, 11-12 years ago; "Verbatim: HIV positive", start date: 24Jan2001 (unspecified if ongoing), notes: Verbatim: HIV positive; "Verbatim: COPD" (unspecified if ongoing), notes: Verbatim: COPD. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 31Mar2021, outcome "recovering", described as "Aches"; BRONCHITIS (non-serious) with onset 31Mar2021, outcome "recovering", described as "Bronchitis"; VACCINATION SITE PAIN (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "Left arm hurt at injection site for a few days"; DYSGEUSIA (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "Metal taste in mouth for a couple of weeks"; PAIN (non-serious) with onset 31Mar2021, outcome "recovering", described as "pains"; NASOPHARYNGITIS (non-serious) with onset 31Mar2021, outcome "recovering", described as "felt kind of like he had a cold"; ASTHMA (non-serious) with onset 31Mar2021, outcome "recovering", described as "asthma was real bad". The events "bronchitis" and "asthma was real bad" were evaluated at the physician office visit. Therapeutic measures were taken as a result of bronchitis, asthma.  Additional details: Emergency Room? Yes Throwing up. 10Nov2021 went to (name). Placed IV and gave medication. One was to keep him from throwing up. He was more half asleep than he was awake. Treated and released. Physician Office?No. If the patient was hospitalized, how many days was the hospital stay? No. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination)? None or Unknown Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. COPD 4-5 years ago. Family Medical History Relevant to AE(s): Family is diabetic. Relevant Tests: Pancreas levels 600-700.  No follow-up attempts are possible. No further information is expected.