chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Mobility decreased, Skin swelling
Clinical narrative: she's having trouble with her stomach/ It's on her right lower quadrant/ started maybe 2 weeks ago/It's like pain/ It's not going away/ It's not a constant pain; puffier, blocking me up/She's not real distended though; She can't go to the bathroom either; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (she's having trouble with her stomach/ It's on her right lower quadrant/ started maybe 2 weeks ago/It's like pain/ It's not going away/ It's not a constant pain), SKIN SWELLING (puffier, blocking me up/She's not real distended though) and MOBILITY DECREASED (She can't go to the bathroom either) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022D21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN LOWER (she's having trouble with her stomach/ It's on her right lower quadrant/ started maybe 2 weeks ago/It's like pain/ It's not going away/ It's not a constant pain), SKIN SWELLING (puffier, blocking me up/She's not real distended though) and MOBILITY DECREASED (She can't go to the bathroom either). At the time of the report, ABDOMINAL PAIN LOWER (she's having trouble with her stomach/ It's on her right lower quadrant/ started maybe 2 weeks ago/It's like pain/ It's not going away/ It's not a constant pain) had not resolved and SKIN SWELLING (puffier, blocking me up/She's not real distended though) and MOBILITY DECREASED (She can't go to the bathroom either) outcome was unknown.            Patient height was reported as 60 inches. Patient had no allergies and no COVID-19 diagnosis reported.  No concomitant medications were provided. No other vaccine was given to patient within 1 month prior to Moderna COVID-19 vaccine.  Then she was having trouble with her stomach. It was on her right lower quadrant. Reportedly, it started might be 2 weeks ago from the time of reporting.  She was thinking of taking some medicine.   This case was linked to MOD-2022-513824 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary mass, Pain in extremity
Clinical narrative: she's having trouble with her stomach/ It's on her right lower quadrant/ started maybe 2 weeks ago/It's like pain/ It's not going away/ It's not a constant pain; puffier, blocking me up/She's not real distended though; She can't go to the bathroom either; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (she's having trouble with her stomach/ It's on her right lower quadrant/ started maybe 2 weeks ago/It's like pain/ It's not going away/ It's not a constant pain), SKIN SWELLING (puffier, blocking me up/She's not real distended though) and MOBILITY DECREASED (She can't go to the bathroom either) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022D21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN LOWER (she's having trouble with her stomach/ It's on her right lower quadrant/ started maybe 2 weeks ago/It's like pain/ It's not going away/ It's not a constant pain), SKIN SWELLING (puffier, blocking me up/She's not real distended though) and MOBILITY DECREASED (She can't go to the bathroom either). At the time of the report, ABDOMINAL PAIN LOWER (she's having trouble with her stomach/ It's on her right lower quadrant/ started maybe 2 weeks ago/It's like pain/ It's not going away/ It's not a constant pain) had not resolved and SKIN SWELLING (puffier, blocking me up/She's not real distended though) and MOBILITY DECREASED (She can't go to the bathroom either) outcome was unknown.            Patient height was reported as 60 inches. Patient had no allergies and no COVID-19 diagnosis reported.  No concomitant medications were provided. No other vaccine was given to patient within 1 month prior to Moderna COVID-19 vaccine.  Then she was having trouble with her stomach. It was on her right lower quadrant. Reportedly, it started might be 2 weeks ago from the time of reporting.  She was thinking of taking some medicine.   This case was linked to MOD-2022-513824 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: immunocompromised patient received a 3rd dose of 0.25ml instead of a 0.5ml dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (immunocompromised patient received a 3rd dose of 0.25ml instead of a 0.5ml dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (immunocompromised patient received a 3rd dose of 0.25ml instead of a 0.5ml dose). At the time of the report, UNDERDOSE (immunocompromised patient received a 3rd dose of 0.25ml instead of a 0.5ml dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2022: Follow up document contain no new information.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: The first dose received on 29-Aug-2021 and second dose received on 16-Sep-2021; The patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose received on 29-Aug-2021 and second dose received on 16-Sep-2021) and EXPIRED PRODUCT ADMINISTERED (The patient received expired vaccine) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose received on 29-Aug-2021 and second dose received on 16-Sep-2021) and EXPIRED PRODUCT ADMINISTERED (The patient received expired vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose received on 29-Aug-2021 and second dose received on 16-Sep-2021) and EXPIRED PRODUCT ADMINISTERED (The patient received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported   This case was linked to MOD-2022-510159 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: lymph nodes around my groin area start swelling up; It is kind of gets hard but it is hurt and it is point down now/I kind of lost function of my 'sored'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes around my groin area start swelling up"; PAIN (non-serious), outcome "unknown", described as "It is kind of gets hard but it is hurt and it is point down now/I kind of lost function of my 'sored'".  Additional information: It was stated, the 2 weeks after patient got the second vaccine shot. It was the lymph nodes around patient groin area start swelling up and patient kind of lost function of patient 'sored' (Further clarification unknown hence not captured). It was kind of gets hard but it was hurt and it was point down now."  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety with the vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: ANXIETY (non-serious), outcome "unknown", described as "anxiety with the vaccine".  Additional information: Reporter stated that the agent mentioned that the caller reported "anxiety with the vaccine" which is a "total misinformation" and slandering as caller did not report any side effect for herself from the vaccine as she did not have any maybe with other patients.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Immunisation reaction, Rash
Clinical narrative: Had a strong reaction to trumenba possible rash; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  An adolescent patient received meningococcal group b rlp2086 (TRUMENBA), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "Had a strong reaction to trumenba possible rash". Additional information: Adolescent patient (16 or 17 Individual). Vaccine given earlier this year. Possibly given menactra at the same time.Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Mobility decreased, Nausea, Tremor
Clinical narrative: unsteadiness in walking; nausea; extraordinary fatigue; mobility is dramatically reduced; hands tremble; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (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: GAIT DISTURBANCE (non-serious), outcome "recovered", described as "unsteadiness in walking"; NAUSEA (non-serious), outcome "recovered", described as "nausea"; FATIGUE (non-serious), outcome "recovered", described as "extraordinary fatigue"; MOBILITY DECREASED (non-serious), outcome "recovered", described as "mobility is dramatically reduced"; TREMOR (non-serious), outcome "recovered", described as "hands tremble".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Very painful and swollen chest/under arm lymphnode - left side; Very painful and swollen chest/under arm lymphnode - left side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via COVAES. The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 12:00 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma allergies neuropathy; "Neuropathy" (unspecified if ongoing), notes: Asthma allergies neuropathy; "Allergy" (unspecified if ongoing), notes: Allergy with unspecified drug. Concomitant medication(s) included: RELPAX; ALLEGRA D. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 23Feb2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details Location of injection: Arm Left Vaccine Administration Time: 02:00 PM), administration date: 16Mar2021, when the patient was 53 years old, for COVID-19 Immunization.  The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 14Nov2021 04:00, outcome "not recovered" and all described as "Very painful and swollen chest/under arm lymphnode - left side". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included: Relpax, Allegra d as needed. No hospitalization prolonged. 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.  .  Follow-up attempts completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Diffuse alopecia
Clinical narrative: Telogen Effluvium; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Sep2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 18Aug2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: DIFFUSE ALOPECIA (non-serious) with onset Nov2021, outcome "recovering", described as "Telogen Effluvium". The event "telogen effluvium" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of diffuse alopecia.  Additional information: The patient was not diagnosed with COVID-19 Prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was just sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "arm was just sore".  Additional information: The first arm of the patient was just sore until second shot on 21jun2021 with in 2 weeks later the patient arm would experience hike an electric shot and still soreness was unable to move arm, the patient left arm was semi-paralyzed for about 10-20 seconds a couple times while driving still experiencing same symptoms presently.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Aggression, Fatigue
Clinical narrative: profoundly challenging; debilitating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AGGRESSION (non-serious), outcome "not recovered", described as "profoundly challenging"; FATIGUE (non-serious), outcome "not recovered", described as "debilitating".  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101599532 Different patients, Same reporter, vaccine, event.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a very bad headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 16Nov2021 10:00 (Batch/Lot number: unknown) at the age of 59 years 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 (prev dose product:COVID 19,, prev dose brand:Pfizer,, prev dose brand unknown:False,, prev dose lot unknown:False,, prev dose lot unknown reason:Not available/provided to reporter at the time of Report Completion,, prev dose number:2), for Covid-19 immunization; Bnt162b2 (prev dose product:COVID 19,, prev dose brand:Pfizer,, prev dose brand unknown:False,, prev dose lot unknown:False,, prev dose lot unknown reason:Not available/provided to reporter at the time of Report Completion, prev dose number:1), for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 16Nov2021 14:00, outcome "recovering", described as "had a very bad headache". Therapeutic measures were not taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nightmare
Clinical narrative: swollen lymph node under left collar bone 2 days after now on day 4 and larger; Also bad nightmares after each vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 16:15 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High BP" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN [LOSARTAN POTASSIUM]; TIROSINT. Vaccination history included: Covid19 vaccine (Dose number: 1, product=COVID 19, Brand name unknown=COVID19 Vaccine,, Administration time=12:00 PM, Vaccine location=Left arm, adverse event: Also bad nightmares after each vaccine), administration date: 01Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "bad nightmares"; Bnt162b2 (Dose Number: 2, Product=COVID 19,, Brand=Pfizer,, Administration time=12:00 PM, Vaccine location=Left arm,, adverse event: Also bad nightmares after each vaccine), administration date: 01Mar2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "bad nightmares". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16Nov2021, outcome "not recovered", described as "swollen lymph node under left collar bone 2 days after now on day 4 and larger"; NIGHTMARE (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Also bad nightmares after each vaccine". Therapeutic measures were not taken as a result of lymphadenopathy, nightmare.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. facility type vaccine: Pharmacy or Drug Store.  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-202101616528 same patient/drug, different AE and dose.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nightmare
Clinical narrative: Also bad nightmares after each vaccine; swollen lymph node under left collar 2 days after now on day 4 andlarger; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 12:00 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single and administered in arm left, administration date 01Feb2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High BP" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN; TIROSINT. The following information was reported: NIGHTMARE (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Also bad nightmares after each vaccine"; LYMPHADENOPATHY (non-serious) with onset 16Nov2021, outcome "not recovered", described as "swollen lymph node under left collar 2 days after now on day 4 andlarger". Therapeutic measures were not taken as a result of nightmare, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No known allergies.  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-202101616389 same patient/drug, different AE and dose.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Acute tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date Nov2021 (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), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Nov2021, outcome "unknown", described as "Acute tinnitus". The event "acute tinnitus" was evaluated at the emergency room visit.  Additional information: Reporter stated, patient has acute tinnitus. Regarding treatment she don't know, but patient went to the emergency room. She really don't know anatomical site of vaccine administration, vaccination Facility details. This was her second dose. Vaccination date for first and second shot of COVID-19 vaccine: Reporter stated, she don't know, she think the second dose was this week but she don't know the date." She don't know a lot of information, she just heard about her condition.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: if the pain continues and gets worse, does she report that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "she has A-fib for years" (unspecified if ongoing), notes: she has A-fib for years. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "if the pain continues and gets worse, does she report that".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Premature menarche, Vomiting
Clinical narrative: Start of first menses; abdominal cramping; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 19:15 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Vaccine Administration Time: 07:00 PM), administration date: 07Oct2021, when the patient was 12 years old, for COVID-19 Immunisation. The following information was reported: PREMATURE MENARCHE (non-serious) with onset 06Nov2021 08:00, outcome "recovered", described as "Start of first menses"; ABDOMINAL PAIN (non-serious) with onset 06Nov2021 08:00, outcome "recovered", described as "abdominal cramping"; NAUSEA (non-serious) with onset 06Nov2021 08:00, outcome "recovered", described as "nausea"; VOMITING (non-serious) with onset 06Nov2021 08:00, outcome "recovered", described as "vomiting". The events "start of first menses", "abdominal cramping", "nausea" and "vomiting" were evaluated at the physician office visit. Therapeutic measures were taken as a result of premature menarche, abdominal pain, nausea, vomiting.  Additional information: Start of first menses, abdominal cramping, nausea, vomiting that was not treatable with anti-emetics. Lasting 3 days post shot. Prior to vaccination,the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. No known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Limb discomfort
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "could not lift or rotate her arm."; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "could not lift or rotate her arm". Additional information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Caller wanted to know if she has the correct information about getting a refund for her husband who is taking Latanaprost. The eye drops never worked, no solution came out of the bottle, relayed information from withheld and she did have the correct info. As we were talking she said when she got her 1st dose of the Pfizer Covax vaccine she could not lift or rotate her arm. It still has not gone away. When she went to get her 2nd dose the HCP told her she was the 5th person to complain about this. He told her the first dose was given in the wrong part of her arm. She is now waiting to have surgery on her arm. She said she is an RN and this has affected her job as well.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101619553
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, SARS-CoV-2 test
Clinical narrative: Second vaccine: late period; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18Sep2021 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 2021, when the patient was 31 years old, for COVID-19 immunization, reaction(s): "First vaccine :Heavy period with clots"; Bnt162b2, administration date: 2021, when the patient was 31 years old, for Covid-19 Immunization, reaction(s): "First vaccine :Heavy period with clots". The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 10Oct2021, outcome "not recovered", described as "Second vaccine: late period". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation delayed. Additional information: The patient was administered the most recent COVID-19 vaccine at the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 18Nov2021 No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Tremor
Clinical narrative: extreme feeling of cold; body shakes; full body shivers; 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 male patient received bnt162b2 (BNT162B2), administration date 24Apr2021 12:00 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sulfa meds" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Vaccine Administration Time: 12:00 PM), administration date: 03Apr2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: FEELING COLD (non-serious) with onset 25Apr2021, outcome "unknown", described as "extreme feeling of cold"; TREMOR (non-serious) with onset 25Apr2021, outcome "unknown", described as "body shakes"; CHILLS (non-serious) with onset 25Apr2021, outcome "unknown", described as "full body shivers". Therapeutic measures were not taken as a result of feeling cold, tremor, chills.  Additional information: After his second shot he had extreme feeling of cold and body shakes similar to rigors. He had this one other time coming out of anesthesia. It was 15-20 minutes of intense cold and violent, large, full body shivers. The patient did not receive any treatment. He was still going to get his booster. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19. Prior to vaccination  nor the patient has not been tested for COVID-19, Since the vaccination.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: After first dose, severe flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "After first dose, severe flu like symptoms". It was unknown if therapeutic measures were taken as a result of influenza like illness.  Additional information: The patient's age group included Adult (18-64 years). Facility type vaccine included hospital.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dry eye, Dysgeusia, Eye pain, Fatigue
Clinical narrative: less appetite; eye pain; changes in taste a little bit; discomfort in his eyes/dry eyes; discomfort in his eyes/dry eyes; has an inconsistent bad taste in his mouth and describes as tasting like gasoline.; slept for 11 hours; really tired; have some sensory issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 9 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: DECREASED APPETITE (non-serious) with onset Nov2021, outcome "unknown", described as "less appetite"; EYE PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "eye pain"; TASTE DISORDER (non-serious) with onset Nov2021, outcome "unknown", described as "changes in taste a little bit"; OCULAR DISCOMFORT (non-serious), DRY EYE (non-serious) all with onset Nov2021, outcome "unknown" and all described as "discomfort in his eyes/dry eyes"; DYSGEUSIA (non-serious) with onset Nov2021, outcome "unknown", described as "has an inconsistent bad taste in his mouth and describes as tasting like gasoline."; HYPERSOMNIA (non-serious) with onset Nov2021, outcome "unknown", described as "slept for 11 hours"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "really tired"; SENSORY DISTURBANCE (non-serious) with onset Nov2021, outcome "unknown", described as "have some sensory issues".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Ocular discomfort, Sensory disturbance, Taste disorder
Clinical narrative: less appetite; eye pain; changes in taste a little bit; discomfort in his eyes/dry eyes; discomfort in his eyes/dry eyes; has an inconsistent bad taste in his mouth and describes as tasting like gasoline.; slept for 11 hours; really tired; have some sensory issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 9 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: DECREASED APPETITE (non-serious) with onset Nov2021, outcome "unknown", described as "less appetite"; EYE PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "eye pain"; TASTE DISORDER (non-serious) with onset Nov2021, outcome "unknown", described as "changes in taste a little bit"; OCULAR DISCOMFORT (non-serious), DRY EYE (non-serious) all with onset Nov2021, outcome "unknown" and all described as "discomfort in his eyes/dry eyes"; DYSGEUSIA (non-serious) with onset Nov2021, outcome "unknown", described as "has an inconsistent bad taste in his mouth and describes as tasting like gasoline."; HYPERSOMNIA (non-serious) with onset Nov2021, outcome "unknown", described as "slept for 11 hours"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "really tired"; SENSORY DISTURBANCE (non-serious) with onset Nov2021, outcome "unknown", described as "have some sensory issues".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he only had a "sore arm"; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 25-year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "he only had a "sore arm"".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: still having problems in his lower back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (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: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "still having problems in his lower back".  Additional Information: Caller stated that "I was in there last week" and the therapist shared with caller "one gentleman was still having problems in his lower back" and this particular gentleman got the "shot about the same time as I did" and that the "others recouped.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (22Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache that is increasing in intensity and in frequency; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (COMIRNATY), administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 04Oct2021, when the patient was 12 years old, for COVID-19 immunization, reaction(s): "arm soreness and swelling", "arm soreness and swelling". The following information was reported: HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "Headache that is increasing in intensity and in frequency". The event "headache that is increasing in intensity and in frequency" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional information: Reporter stated that her daughter had a headache which predated with the vaccine that was not disabling at that time and her daughter was not back to school since the second dose due to the headache that was increasing in intensity and in frequency. It was much severe. She had seen peds neurology. The pediatric neurologist put patient on Beta blockers and it doesn't help. It doesn't respond to anything. She was a child prior to this and a year ago she had never been sick. She had never been on an antibiotic. They would joke that her immune system was something they wanted to clone. Her immune system is far greater than others. She would be getting an MRI and going to headache clinic.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: 1st Dose- 03Sep2021 and 2nd Dose-20Sep2021; Foggy Headed; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 20Sep2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "RHEUMATOID ARTHRITIS" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; VITAMIN C [ASCORBIC ACID]; TYLENOL ARTHRITIS; IBUPROFEN; TIZANIDINE HCL; LORATADIN; OMEPRAZOLE; LIOTHYRONINE SODIUM; LEVOTHYROXINE; METHOTREXATE; VITAMIN D3. Past drug history included: Morphine sulfate, reaction(s): "ALLERGIES: MORPHINE SULFATE". Vaccination history included: Bnt162b2 (Dose 1), administration date: 03Sep2021, when the patient was 46 years old, for Covid-19 Immunization, reaction(s): "Foggy headed". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Sep2021, outcome "unknown", described as "1st Dose- 03Sep2021 and 2nd Dose-20Sep2021"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Foggy Headed".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: feel "lower back of head pain" which is "more intense at night"; back of her head and lower back hurts; back of the head a bit numb; tingling all over her body/ tingling on her left leg; lower back of head pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 57 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 22Nov2021, outcome "unknown", described as "back of the head a bit numb"; PARAESTHESIA (non-serious) with onset 22Nov2021, outcome "unknown", described as "tingling all over her body/ tingling on her left leg"; HEADACHE (non-serious) with onset 22Nov2021, outcome "not recovered", described as "lower back of head pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "feel "lower back of head pain" which is "more intense at night""; BACK PAIN (non-serious), outcome "unknown", described as "back of her head and lower back hurts".  Additional information: Reporter reported that her 57 year old mother received second dose of Pfizer vaccine 22Nov21, within 15 minutes experienced "back of the head a bit numb" "tingling all over her body", the next day "tingling on her left leg". Continues to feel "lower back of head pain" which is "more intense at night". Reporter states "before the vaccine she never felt that". Reporter wants to know of any similar reported AEs. Reporter was calling about the Pfizer covid adult dose. Her mother had some side effects after the second dose that she is worried about since it has been a week and still has the side effects. (Pharmacy name) said its normal. The back of her head, lower back hurts especially at night. Asking if this is normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; 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 male patient received bnt162b2 (BNT162B2), administration date 13May2021 (Lot number: EW0173) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 22Apr2021, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 24Jun2021, outcome "unknown", described as "shingles". The event "shingles" was evaluated at the physician office visit.  Additional Information: Caller wants to report to be a side effect of the Covid 19 vaccine, got the first two shots, about 2 weeks after second shot he developed shingles, recently got the booster and got shingles again. Both cases were mild. States between the second Covid vaccine and the booster Covid vaccine, he got a shingles vaccine, was supposed to protect any future occurrence. Caller was wanting to report this and curious to see if this has been reported after the vaccines.  No follow-up attempts are possible. No further information is expected.