chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Have gotten covid (likely tested positive); Have gotten covid (likely tested positive); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Have gotten covid (likely tested positive)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive. Reason why batch/lot is unknown: not available/provided to reporter at the time of report completion.Reported Event: Posted on social media as of two days ago that they have gotten covid (likely tested positive). I strongly believe they are at least fully vaccinated though I do not know with what vaccine. Age 23 or 24 years old, withheld female. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Intense headaches for 1 month after second shot that have still continued semi-consistently in the 9 months after vaccination; Seems to have re-ignited the post concussion syndrome, diagnosed with after a head injury 4 years ago / Headaches are in similar spot; Seems to have re-ignited the post concussion syndrome, diagnosed with after a head injury 4 years ago / Headaches are in similar spot; Lingering brain fog; Confusion; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 34-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 at 12:00 (Lot number: ER8732) at the age of 34 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Post concussion syndrome" (unspecified if ongoing), notes: "Post concussion syndrome" was diagnosed after a head injury 4 years ago and "Head injury" (unspecified if ongoing), notes: "Post concussion syndrome" was diagnosed after a head injury 4 years ago. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6203; Anatomical site: Left arm; Administration time: 12:00; Route of administration: Unspecified), administration date: 03Mar2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 25Mar2021 at 14:00, outcome "not recovered", described as "Intense headaches for 1 month after second shot that have still continued semi-consistently in the 9 months after vaccination"; POST CONCUSSION SYNDROME (non-serious) with onset 25Mar2021 at 14:00, outcome "not recovered" and DISEASE RECURRENCE (non-serious) with onset 25Mar2021 at 14:00, outcome "not recovered", both described as "Seems to have re-ignited the post concussion syndrome, diagnosed with after a head injury 4 years ago / Headaches are in similar spot"; FEELING ABNORMAL (non-serious) with onset 25Mar2021 at 14:00, outcome "not recovered", described as "Lingering brain fog"; CONFUSIONAL STATE (non-serious) with onset 25Mar2021 at 14:00, outcome "not recovered", described as "Confusion". The events "Intense headaches for 1 month after second shot that have still continued semi-consistently in the 9 months after vaccination", "Seems to have re-ignited the post concussion syndrome, diagnosed with after a head injury 4 years ago / Headaches are in similar spot", "Lingering brain fog" and "Confusion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, post concussion syndrome, disease recurrence, feeling abnormal and confusional state.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and the results were unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Nasal congestion, Pain, Pain in extremity
Clinical narrative: Overall body soreness particularly in the right arm; Soreness particularly in the right arm; Tiredness; Stuffy nose; Dose received:3/ Dose number = 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 26-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 05Jan2022 at 11:00 (Lot number: FL3197) at the age of 26 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3247, Route of Administration: Intramuscular), administration date: 11Feb2021, when the patient was 26 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3247, Administration time: 10:30, Route of Administration: Intramuscular), administration date: 05Mar2021, when the patient was 26 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 11:00, outcome "unknown", described as "Dose received:3/ Dose number = 3"; PAIN (non-serious) with onset 06Jan2022, outcome "unknown", described as "Overall body soreness particularly in the right arm"; PAIN IN EXTREMITY (non-serious) with onset 06Jan2022, outcome "unknown", described as "Soreness particularly in the right arm"; FATIGUE (non-serious) with onset 06Jan2022, outcome "unknown", described as "Tiredness"; NASAL CONGESTION (non-serious) with onset 06Jan2022, outcome "unknown", described as "Stuffy nose". Therapeutic measures were not taken as a result of pain, pain in extremity, fatigue and nasal congestion.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, SARS-CoV-2 test, Temperature regulation disorder, Vaccination site erythema
Clinical narrative: Muscle cramps in left hand/fingers / muscle cramps in both thighs/legs; Temperature regulation; Random chills; Red & raised bump at injection site; Red & raised bump at injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jul2021 at 18:00 (Lot number: EW1077) at the age of 35 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing), notes: General Anxiety Disorder and "Dysthymia" (unspecified if ongoing). Concomitant medication included: DESVENLAFAXINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0183; Anatomical Location: Right arm; Administration Time: 18:00; Route of Administration: Unspecified), administration date: 04Jun2021, when the patient was 35 years old, for COVID-19 immunisation.  The following information was reported: MUSCLE SPASMS (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", described as "Muscle cramps in left hand/fingers / muscle cramps in both thighs/legs"; TEMPERATURE REGULATION DISORDER (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", described as "Temperature regulation"; CHILLS (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", described as "Random chills"; VACCINATION SITE ERYTHEMA (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", and all described as "Red & raised bump at injection site", VACCINATION SITE SWELLING (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", and all described as "Red & raised bump at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, temperature regulation disorder, chills, vaccination site erythema and vaccination site swelling.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and the result was negative (for all the 6 tests). The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Muscle cramps in left hand/fingers / muscle cramps in both thighs/legs; Temperature regulation; Random chills; Red & raised bump at injection site; Red & raised bump at injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jul2021 at 18:00 (Lot number: EW1077) at the age of 35 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing), notes: General Anxiety Disorder and "Dysthymia" (unspecified if ongoing). Concomitant medication included: DESVENLAFAXINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0183; Anatomical Location: Right arm; Administration Time: 18:00; Route of Administration: Unspecified), administration date: 04Jun2021, when the patient was 35 years old, for COVID-19 immunisation.  The following information was reported: MUSCLE SPASMS (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", described as "Muscle cramps in left hand/fingers / muscle cramps in both thighs/legs"; TEMPERATURE REGULATION DISORDER (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", described as "Temperature regulation"; CHILLS (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", described as "Random chills"; VACCINATION SITE ERYTHEMA (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", and all described as "Red & raised bump at injection site", VACCINATION SITE SWELLING (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", and all described as "Red & raised bump at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, temperature regulation disorder, chills, vaccination site erythema and vaccination site swelling.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and the result was negative (for all the 6 tests). The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Aug2021 (Lot number: EW0196) at the age of 43 years as dose 2, single and administration date 27Jul2021 (Lot number: EW0196) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 31Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 31Dec2021, outcome "recovering" and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab.  Clinical information: The patient was not receiving any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paresis, Muscular weakness, SARS-CoV-2 test
Clinical narrative: Progressive symmetrical facial and upper extremity muscle weakness that worsened over the course of two weeks and has persisted with fluctuation since; Progressive symmetrical facial and upper extremity muscle weakness that worsened over the course of two weeks and has persisted with fluctuation since; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Dec2020 at 18:00 (Lot number: EK9231) at the age of 36 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Mild intermittent asthma and "Penicillin allergy" (unspecified if ongoing), notes: known allergies: penicillin. There were no concomitant medications. The following information was reported: FACIAL PARESIS (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 29Dec2020 at 12:00, outcome "not recovered",  both described as "Progressive symmetrical facial and upper extremity muscle weakness that worsened over the course of two weeks and has persisted with fluctuation since". The event "Progressive symmetrical facial and upper extremity muscle weakness that worsened over the course of two weeks and has persisted with fluctuation since" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of facial paresis and muscular weakness.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. At the time of this report the patient still had symmetrical facial and upper extremity muscle weakness. Since the vaccination, the patient had been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Immunisation, Swelling
Clinical narrative: Primary immunisation: covid-19 vaccine - unknown manufacturer; Booster: BNT162b2; Has been down all week; Armpit is swelling; This is a spontaneous report from 2 contactable reporters, consumer (reporter) and consumer (Pfizer employee).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Jan2022 (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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot number: Unknown, Route of administration: unspecified) for COVID-19 immunisation and Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, SINGLE, Lot number: Unknown, Route of administration: unspecified) for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Jan2022, outcome "unknown", described as "Primary immunisation: covid-19 vaccine - unknown manufacturer; Booster: BNT162b2"; DEPRESSED MOOD (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Has been down all week"; SWELLING (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Armpit is swelling".   Additional Information: It was reported that his old high-school friend indicated that his wife, "had been down all week and now her armpit was swelling" after getting the booster on Monday 03Jan2022 (in an email) and that was all the information the reporter had.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasal congestion, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; light congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (005570). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2) (Lot number: BNT162B2) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "tested positive for Covid"; NASAL CONGESTION (non-serious), outcome "unknown", described as "light congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: tested positive for Covid illness between doses; negative, notes: had a negative covid test.  Additional Information: Caller was consumer who called on behalf of her son (11 y/o male) who received the pediatric formulation of the Pfizer-Biontech Covid19 vaccine, then tested positive for Covid illness between doses.  She stated he has since quarantined for 10 days, had a negative covid test, and only light congestion as a symptom, and has returned to school.  Caller would like to know when she can take him for a second dose.She was getting conflicting recommendations from her pediatrician who was telling her to rely on natural immunity and wait 2 months before receiving another dose, and her pharmacist stated to get the dose now. As the company who makes the product what were our recommendations.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Immunisation, Joint swelling
Clinical narrative: Left ankle swelled up with great deal of sensitivity, but no underlying injury. It went away suddenly after two days.; Left ankle swelled up with great deal of sensitivity, but no underlying injury. It went away suddenly after two days.; dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 51-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Dec2021 at 15:00 (Lot number: 33030BD)at the age of 51 year(s) 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 2, SINGLE; Lot number: EW0177; Route of administration: Unspecified; Anatomical site: Left arm; Administration time: 12:00), administration date: 17May2021, when the patient was 51 year(s) old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0171; Route of administration: Unspecified; Anatomical site: Left arm; Administration time: 11:30), administration date: 26Apr2021, when the patient was 51 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021 at 15:00, outcome "unknown", described as "dose number=3"; JOINT SWELLING (non-serious), HYPERAESTHESIA (non-serious) all with onset 27Dec2021 at 22:00, outcome "recovered" (29Dec2021), and all described as "Left ankle swelled up with great deal of sensitivity, but no underlying injury. It went away suddenly after two days". Therapeutic measures were not taken as a result of joint swelling and hyperaesthesia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID; Breakthrough COVID; booster dose; 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 02Dec2021 13:45 (Lot number: FF8839) at the age of 42 years as dose 3 (booster), single, administered in arm right, administration date 25Mar2021 13:15 (Lot number: El3248) as dose 2, single and administered in arm right, administration date 03Mar2021 13:15 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU.  The following information was reported: IMMUNISATION (medically significant) with onset 02Dec2021 13:45, outcome "unknown", described as "booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovering" and all described as "Breakthrough COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19 Clinical course: The patient did not receive any other medication within two weeks of vaccination and the patient had no COVID-19 prior to vaccination. The patient had no known allergies.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity, Vaccination site pain
Clinical narrative: just lightly feels like my glands are swollen under my left arm; booster; the arm was sore; it was really sore and stiff; soreness in the injection area; 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), intramuscular, administered in arm left, administration date 05Jan2022 (Lot number: FE3594, Expiration Date: Feb2022) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 05Jan2022, outcome "recovered" (Jan2022), described as "the arm was sore"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 05Jan2022, outcome "unknown", described as "it was really sore and stiff"; VACCINATION SITE PAIN (non-serious) with onset 05Jan2022, outcome "unknown", described as "soreness in the injection area"; LYMPHADENOPATHY (non-serious) with onset 06Jan2022, outcome "unknown", described as "just lightly feels like my glands are swollen under my left arm".  Additional information: Reporter seriousness for The arm was sore but that went away so, last night it was really sore and stiff so, I had soreness in the injection area which was the left arm, just lightly feels like my glands are swollen under my left arm was Unspecified.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Pyrexia
Clinical narrative: Continuous fever of 102 degree; Dose received: 3; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration date 06Jan2022 at 17:00 (Lot number: unknown) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1; MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, Anatomical Location: Left arm, Administration time: 12:00), administration date: 29Mar2021, when the patient was 37 years old, for COVID-19 immunisation and Covid-19 vaccine manufacture unknown (DOSE 2; MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, Anatomical Location: Left arm, Administration time: 11:00), administration date: 19Apr2021, when the patient was 37 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 06Jan2022 at 17:00, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 07Jan2022 at 12:00, outcome "not recovered", described as "Continuous fever of 102 degree". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not got fever for the last two doses. Therapeutic measures taken as a result of the continuous fever of 102 degree included treatment with just Tylenol.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Dose number: 3; Pain in arm after injection; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).   An adolescent patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER 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: Covid 19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Covid 19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose number: 3"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm after injection". It was unknown whether therapeutic measures were taken as a result of the event pain in extremity.  Additional information: It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 PCR test positive on 07Jan2022; Covid-19 PCR test positive on 07Jan2022; dose received 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 (Lot number: EW0186) at the age of 64 years as dose 3 (booster), single, administered in arm left, administration date 08Feb2021 (Lot number: EN5318) as dose 2, single and administered in arm left, administration date 29Jan2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing), notes: Known allergies: No. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jan2022, outcome "not recovered" and all described as "Covid-19 PCR test positive on 07Jan2022"; IMMUNISATION (medically significant) with onset 07Jan2022, outcome "unknown", described as "dose received 3". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: It was unknown if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200028871 same patient, different vaccine dose/AE
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Glossodynia, Paraesthesia oral, Pyrexia
Clinical narrative: Spicy tingling sensation at the tip of the tongue to taste; Spicy tingling sensation at the tip of the tongue to taste; Fever; Cough; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 at 17:00 (Lot number: PH8030) at the age of 39 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Chronic cough" (unspecified if ongoing), notes: As a child. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FJ1611; Anatomical location: left arm; Administration time: 17:00; Route of administration: unspecified), administration date: 01Dec2021, when the patient was 39 years old, for COVID-19 immunisation.  The following information was reported: PARAESTHESIA ORAL (non-serious), GLOSSODYNIA (non-serious) all with onset 24Dec2021 at 16:00, outcome "recovering", and all described as "Spicy tingling sensation at the tip of the tongue to taste"; PYREXIA (non-serious) with onset 24Dec2021 at 16:00, outcome "recovering", described as "Fever"; COUGH (non-serious) with onset 24Dec2021 at 16:00, outcome "recovering", described as "Cough". Therapeutic measures were taken as a result of paraesthesia oral, glossodynia, pyrexia and cough. Additional information: The patient had no allergies that he knows of. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included lots of green tea and NyQuil for PARAESTHESIA ORAL, GLOSSODYNIA, PYREXIA and COUGH. Since the vaccination, the patient had not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Immunisation, Myalgia
Clinical narrative: Fever; Muscle and joint aches; Muscle and joint aches; Pain; Tiredness; Some diarrhea; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 06Jan2022 at 10:30 (Lot number: unknown) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medications included: HYDROCHLOROTHIAZIDE; METOPROLOL ER and AMLODIPINE. Past drug history included: Toradol, reaction: "Drug allergy", notes: Known allergies: Torodol. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 16Apr2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 11May2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 06Jan2022 at 10:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious), all with onset 06Jan2022 at 21:00, outcome "recovering", and all described as "Muscle and joint aches"; PAIN (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Pain"; FATIGUE (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Tiredness"; DIARRHOEA (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Some diarrhea". Therapeutic measures were not taken as a result of pyrexia, myalgia, arthralgia, pain, fatigue and diarrhoea.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Muscle and joint aches; Muscle and joint aches; Pain; Tiredness; Some diarrhea; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 06Jan2022 at 10:30 (Lot number: unknown) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medications included: HYDROCHLOROTHIAZIDE; METOPROLOL ER and AMLODIPINE. Past drug history included: Toradol, reaction: "Drug allergy", notes: Known allergies: Torodol. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 16Apr2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 11May2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 06Jan2022 at 10:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious), all with onset 06Jan2022 at 21:00, outcome "recovering", and all described as "Muscle and joint aches"; PAIN (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Pain"; FATIGUE (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Tiredness"; DIARRHOEA (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Some diarrhea". Therapeutic measures were not taken as a result of pyrexia, myalgia, arthralgia, pain, fatigue and diarrhoea.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Syncope
Clinical narrative: fainted; patient received a vaccine that was from the purple cap formula for the COVID-19 vaccine (approved for 12-years and older); This is a spontaneous report received from a contactable consumer from Medical information team. The reporter is the parent.  A 6 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: FH8030) 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: SYNCOPE (medically significant), outcome "unknown", described as "fainted"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "patient received a vaccine that was from the purple cap formula for the COVID-19 vaccine (approved for 12-years and older)". Additional information: The patient fainted at the pharmacy after the injection The patient had her 2nd dose. When the patient received her 2nd dose the pharmacy staff looked at the first dose lot number and told that this was an adult dose, not the 5-11 orange cap formula.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: Itchy hives; Rash down both forearms and top and bottom of left foot; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in right arm, administration date 05Jan2022 (Lot number: unknown) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (unspecified if ongoing), notes: Ehlers danlose syndrome; "Fibromyalgia" (unspecified if ongoing); "Migraine" (unspecified if ongoing), notes: Migraines; "Chronic headaches" (unspecified if ongoing), notes: Chronic daily headache and "Penicillin allergy" (unspecified if ongoing), notes: known allergies; Penicillin. Concomitant medications were not reported. Past drug history included: Amoxicillin, reactions: "Drug allergy"; Erythromycin, reactions: "Drug allergy"; Darvon, reactions: "Drug allergy" and Lyrica, reactions: "Drug allergy".  The following information was reported: URTICARIA (non-serious) with onset 05Jan2022 at 20:00, outcome "not recovered", described as "Itchy hives"; RASH (non-serious) with onset 05Jan2022 at 20:00, outcome "not recovered", described as "Rash down both forearms and top and bottom of left foot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria and rash.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The injection site is swelling; The injection site is swelling, redness; Arm pain; No fever other than at the injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 04Jan2022 at 12:15 (Lot number: 330258D) at the age of 57 years as dose 1, single for COVID-19 immunisation. The patient did not have any relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 05Jan2022 at 13:00, outcome "unknown", described as "The injection site is swelling"; VACCINATION SITE ERYTHEMA (non-serious) with onset 05Jan2022 at 13:00, outcome "unknown", described as "The injection site is swelling, redness"; PAIN IN EXTREMITY (non-serious) with onset 05Jan2022 at 13:00, outcome "unknown", described as "Arm pain"; VACCINATION SITE WARMTH (non-serious) with onset 05Jan2022 at 13:00, outcome "unknown", described as "No fever other than at the injection site". It was unknown whether therapeutic measures were taken as a result of events.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Paraesthesia
Clinical narrative: Dose received: 3; Approximately 3 hours after receiving the injection, I experienced paresthesia in my left arm as a tingling feeling in my fingertips and hand, which makes using a keyboard difficult as I cannot feel the keys; This is a spontaneous report from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Lot number: FD0809) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraine with aura" (unspecified if ongoing); "Acne" (unspecified if ongoing); "Hypoglycemia" (unspecified if ongoing) and "Fruit allergy" (unspecified if ongoing), notes: Known allergies: Strawberries. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0162; Anatomical location: left arm; Route of administration: unspecified), administration date: 14Apr2021, when the patient was 33 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0172; Anatomical location: left arm; Route of administration: unspecified), administration date: 05May2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022, outcome "unknown", described as "Dose received: 3"; PARAESTHESIA (non-serious) with onset 07Jan2022, outcome "unknown", described as "Approximately 3 hours after receiving the injection, I experienced paresthesia in my left arm as a tingling feeling in my fingertips and hand, which makes using a keyboard difficult as I cannot feel the keys". Therapeutic measures were not taken as a result of paraesthesia.Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: Booster; I became positive from another person who had three shots from Pfizer; I became positive from another person who had three shots from Pfizer; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I became positive from another person who had three shots from Pfizer". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101873713 same reporter/drug/AE, different patient;US-PFIZER INC-202101870449 same reporter/drug/AE, different patient
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: For 2.5 days had body aches and chills, all worst in first night; For 2.5 days had body aches and chills, all worst in first night; Some chest pain; Very swollen lymph node in armpit; Very swollen lymph node in armpit painful; Primary immunisation: BNT162b2; Booster: COMIRNATY; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 35-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 05Jan2022 at 09:00 (Lot number: FL3197) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EK8734; Route of administration: unspecified; Anatomical site: Left arm; Administration time: 09:00), administration date: 02Apr2021, when the patient was 34 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8737; Route of administration: unspecified; Anatomical site: Left arm; Administration time: 09:00), administration date: 23Apr2021, when the patient was 35 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 09:00, outcome "unknown", described as "Primary immunisation: BNT162b2; Booster: COMIRNATY"; PAIN (non-serious), CHILLS (non-serious) all with onset 05Jan2022 at 21:00, outcome "recovered" (18Jan2022), and all described as "For 2.5 days had body aches and chills, all worst in first night"; CHEST PAIN (non-serious) with onset 05Jan2022 at 21:00, outcome "recovered" (an unknown date in Jan2022), described as "Some chest pain"; LYMPHADENOPATHY (non-serious) with onset 05Jan2022 at 21:00, outcome "recovered" (an unknown date in Jan2022), described as "Very swollen lymph node in armpit"; LYMPH NODE PAIN (non-serious) with onset 05Jan2022 at 21:00, outcome "recovered" (an unknown date in Jan2022), described as "Very swollen lymph node in armpit painful". Therapeutic measures were not taken as a result of pain, chills, chest pain, lymphadenopathy and lymph node pain.  Additional Information: Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.