chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Booster; My underarm was hurting; the armpit on my right arm, the arm that I had the Pfizer shot is very swollen, so the lymph nodes are very swollen and it hurts there is pain there; My underarm was hurting; the armpit on my right arm, the arm that I had the Pfizer shot is very swollen, so the lymph nodes are very swollen and it hurts there is pain there; Lymph nodes are very swollen; 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), administered in arm right, administration date 18Nov2021 15:30 (Lot number: EW0171) 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 (Second dose), for COVID-19 immunization; Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 15:30, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "My underarm was hurting; the armpit on my right arm, the arm that I had the Pfizer shot is very swollen, so the lymph nodes are very swollen and it hurts there is pain there"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "not recovered", described as "Lymph nodes are very swollen". Additional Information: The patient noticed on night of the vaccination as underarm was hurting but late last night I actually realized that the underarm like the armpit on my right arm, the arm that I had the Pfizer shot was very swollen, so the lymph nodes are very swollen and it hurts there is pain there, I read that lymph node do get swollen that it is a possibility, It is still swollen this morning, is that anything that I need to be concerned about? I mean I know that it is a possible side effect is there anything I need to do further with that?"  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Began to have hives after 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 22Apr2021 00:30 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Pulmonary sequestration" (unspecified if ongoing); "Ovarian cysts" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA; JUNEL FE 1/20; VITAMIN D2. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 31Mar2021, when the patient was 28 years old, for COVID-19 immunisation. The following information was reported: URTICARIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Began to have hives after 2nd dose". Therapeutic measures were taken as a result of urticaria.  Additional information: This report was received via COVAES. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's concomitant medications ALLEGRA; JUNEL FE 1/20; VITAMIN D2 were taken for an unspecified indication, start and stop dates were not reported. The event hives got better after taking Allegra daily. The patient also received PNEUMOCOCCAL 13 VALENT VACCINE administered in left arm on 29Oct2021 as dose 1 for an unspecified indication. The patient received the 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 18Nov2021 at 17:30 (Batch/Lot number: F51611) for COVID-19 immunisation and experienced hives again, on arm, face, chest, a little itchy but not serious.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: Inappropriate schedule of vaccine administered; tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 15Nov2021 15:15 (Lot number: FH8028) at the age of 34 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162B2 (first dose, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 21Sep2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s): "brain fog", "Disorientation", "Headache", "ear fullness", "sensitivity to noise", "tinnitus in both ears and head occurred".  The following information was reported: TINNITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "tinnitus"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Nov2021 15:15, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The event "tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: After second dose of vaccination has increased tinnitus volume slightly. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Daily multivitamin was received within 2 weeks of vaccination. The patient had no known allergies. Prior to vaccination, the patient did not have COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Intermenstrual bleeding
Clinical narrative: Breakthrough menstrual bleeding post COVID booster; Breakthrough menstrual bleeding post COVID booster; This is a spontaneous report received from a contactable consumer who is also a Pfizer colleague. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown" and all described as "Breakthrough menstrual bleeding post COVID booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Urticaria
Clinical narrative: I am breaking out with hives all over my body; Tightness of the chest; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Nov2021 (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: URTICARIA (non-serious) with onset Nov2021, outcome "unknown", described as "I am breaking out with hives all over my body"; CHEST DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "Tightness of the chest".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Immunisation, Malaise, Pain
Clinical narrative: I had malaise like bone crushing pain for 36 hours after my booster; Pain, unnecessary pain; I had malaise like bone crushing pain for 36 hours after my booster; Pain, unnecessary pain; I had malaise like bone crushing pain for 36 hours after my booster; Pain, unnecessary pain; I had malaise like bone crushing pain for 36 hours after my booster; Pain, unnecessary pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: 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), MALAISE (non-serious), BONE PAIN (non-serious), PAIN (non-serious), outcome "unknown" and all described as "I had malaise like bone crushing pain for 36 hours after my booster; Pain, unnecessary pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus ringing of the ears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (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 immunisation. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus ringing of the ears".  Additional information: The patient got tinnitus ringing of the ears ever since, which was reported like every time it is "quiet", it's up to her ears like crazy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Immunisation, Meralgia paraesthetica, Musculoskeletal discomfort
Clinical narrative: got booster shot; bone crushing pain; knee meralgia; knee meralgia, it was really uncomfortable; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation; Bnt162b2 (dose 2, single), administration date: Mar2021, for COVID-19 immunisation, reaction(s): "tinnitus ringing of the ears". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "got booster shot"; BONE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "bone crushing pain"; MERALGIA PARAESTHETICA (non-serious) with onset 2021, outcome "recovered" (2021), described as "knee meralgia"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "knee meralgia, it was really uncomfortable".  Additional information: It was reported that bone crushing pain and patient's knee meralgia was really uncomfortable was experienced for 36 hours. The patient reported that the third one (booster dose) was so "ridiculous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Immunisation
Clinical narrative: Booster; Allergic reaction; 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 dose3 (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), for COVID-19 Immunisation; Covid-19 vaccine (Dose 2), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction".  Additional information: Consumer stated, "I think I am having 'non-severe' allergic reaction (Further clarification unknown) to the Pfizer booster shot." Consumer stated, "What can you do if I am having an allergic reaction which I think I am, what I need to do that's all you need to tell me." When paraphrased the above concern, consumer stated, "What I am going to do is, I am going to call where I live at, I am going to a call a hospital because I need to know what to do and you know I barely get you, I know you do not know what I can do at this present time, I need to talk to someone to tell me right away. I might have to call a hospital or something." In response to further probing, consumer stated, "No, I don't think I can do it right now. I don't think so, I can't quite understand you I cannot answer clearly. I am just going to call a hospital." QR comment: Reporter type was not available over the call as the consumer was unwilling to answer further questions; hence reporter type was captured as consumer or non-healthcare professional by default.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Illness, Insomnia, Nausea
Clinical narrative: Was up all night; Throwing up; Chills; Nauseous; His whole body hurts; Diarrhea; He is afraid of is getting the second shot because he was sick for a couple of days; Both arms are hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 17Nov2021 19:30 (Lot number: FF2593) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INSOMNIA (non-serious) with onset 17Nov2021, outcome "recovering", described as "Was up all night"; VOMITING (non-serious) with onset 17Nov2021, outcome "recovering", described as "Throwing up"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovering", described as "Chills"; NAUSEA (non-serious) with onset 17Nov2021, outcome "recovering", described as "Nauseous"; PAIN (non-serious) with onset 17Nov2021, outcome "recovering", described as "His whole body hurts"; DIARRHOEA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Diarrhea"; ILLNESS (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "He is afraid of is getting the second shot because he was sick for a couple of days"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Both arms are hurting". Therapeutic measures were taken as a result of insomnia, vomiting, chills, nausea, pain, diarrhoea, illness, pain in extremity.  Additional information: The patient was afraid of getting the second shot because he was sick for a couple of days. He had the COVID-19 Shot and called because he was up all night, throwing up, he got the chills and nauseous, his whole body hurts and diarrhea and they told him to call back after, if things started to get better, it took him couple of days to come around and also he wanted to know if that was a normal reaction, the throwing up. The patient's diarrhea didn't improve. The second shot was due on 08Dec2021. The patient did not have any other medical condition. The patient had no prior vaccinations with in 4 weeks. The patient was slowly gets better, the diarrhea but his both arms were hurting. He was given Motrin, 600 mg. Time of vaccination was like 19:30 pm.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Was up all night; Throwing up; Chills; Nauseous; His whole body hurts; Diarrhea; He is afraid of is getting the second shot because he was sick for a couple of days; Both arms are hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 17Nov2021 19:30 (Lot number: FF2593) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INSOMNIA (non-serious) with onset 17Nov2021, outcome "recovering", described as "Was up all night"; VOMITING (non-serious) with onset 17Nov2021, outcome "recovering", described as "Throwing up"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovering", described as "Chills"; NAUSEA (non-serious) with onset 17Nov2021, outcome "recovering", described as "Nauseous"; PAIN (non-serious) with onset 17Nov2021, outcome "recovering", described as "His whole body hurts"; DIARRHOEA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Diarrhea"; ILLNESS (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "He is afraid of is getting the second shot because he was sick for a couple of days"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Both arms are hurting". Therapeutic measures were taken as a result of insomnia, vomiting, chills, nausea, pain, diarrhoea, illness, pain in extremity.  Additional information: The patient was afraid of getting the second shot because he was sick for a couple of days. He had the COVID-19 Shot and called because he was up all night, throwing up, he got the chills and nauseous, his whole body hurts and diarrhea and they told him to call back after, if things started to get better, it took him couple of days to come around and also he wanted to know if that was a normal reaction, the throwing up. The patient's diarrhea didn't improve. The second shot was due on 08Dec2021. The patient did not have any other medical condition. The patient had no prior vaccinations with in 4 weeks. The patient was slowly gets better, the diarrhea but his both arms were hurting. He was given Motrin, 600 mg. Time of vaccination was like 19:30 pm.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Immunisation, Nausea, Pain in extremity
Clinical narrative: Sore arm that is hot to the touch.; Sore arm that is hot to the touch.; Fever and chills with slight nausea about 12 hours after dose.; Fever and chills with slight nausea about 12 hours after dose.; Fever and chills with slight nausea about 12 hours after dose.; dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 11:30 (Lot number: FH827) at the age of 39 years as dose 3 (booster),single for covid-19 immunisation. Relevant medical history included: "Sepsis" (unspecified if ongoing), notes: With intravenous treatment in 2017. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6200), administration date: 18Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200), administration date: 23Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 11:30, outcome "not recovered", described as "dose 3"; PYREXIA (non-serious), CHILLS (non-serious), NAUSEA (non-serious) all with onset 27Nov2021 23:30, outcome "not recovered" and all described as "Fever and chills with slight nausea about 12 hours after dose."; PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious) all with onset 29Nov2021, outcome "not recovered" and all described as "Sore arm that is hot to the touch.". Therapeutic measures were not taken as a result of immunisation, pyrexia, chills, nausea, pain in extremity, feeling hot. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 29Nov2021.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore arm that is hot to the touch.; Sore arm that is hot to the touch.; Fever and chills with slight nausea about 12 hours after dose.; Fever and chills with slight nausea about 12 hours after dose.; Fever and chills with slight nausea about 12 hours after dose.; dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 11:30 (Lot number: FH827) at the age of 39 years as dose 3 (booster),single for covid-19 immunisation. Relevant medical history included: "Sepsis" (unspecified if ongoing), notes: With intravenous treatment in 2017. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6200), administration date: 18Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200), administration date: 23Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 11:30, outcome "not recovered", described as "dose 3"; PYREXIA (non-serious), CHILLS (non-serious), NAUSEA (non-serious) all with onset 27Nov2021 23:30, outcome "not recovered" and all described as "Fever and chills with slight nausea about 12 hours after dose."; PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious) all with onset 29Nov2021, outcome "not recovered" and all described as "Sore arm that is hot to the touch.". Therapeutic measures were not taken as a result of immunisation, pyrexia, chills, nausea, pain in extremity, feeling hot. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 29Nov2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pruritus, Rash, Urticaria
Clinical narrative: Persistent hives all over body; Itching; Systemic rash; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 12Nov2021 12:00 (Lot number: 30155ba) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0153, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 21Apr2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: er8727, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 02Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 15Nov2021 08:00, outcome "not recovered", described as "Persistent hives all over body"; PRURITUS (non-serious) with onset 15Nov2021 08:00, outcome "not recovered", described as "Itching"; RASH (non-serious) with onset 15Nov2021 08:00, outcome "not recovered", described as "Systemic rash"; IMMUNISATION (non-serious) with onset 12Nov2021 12:00, outcome "unknown", described as "Booster". Therapeutic measures were not taken as a result of urticaria, pruritus, rash.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not received other medications in two weeks. Patient did not have Covid prior vaccination. Patient did not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain, Pyrexia
Clinical narrative: feverish; chills and aches upon waking at 7am, got progressively worse.; chills and aches upon waking at 7am, got progressively worse.; Dose Number:3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 13:00 (Lot number: FJ1620) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: Lactose intolerant" (unspecified if ongoing); "Known allergies:Gluten sensitivity" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Left), administration date: 07Mar2021, when the patient was 45 years old, for COVID-19 Immunization, reaction(s): "no ADRs"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 45 years old, for COVID-19 Immunization, reaction(s): "no ADRs". The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 13:00, outcome "unknown", described as "Dose Number:3"; PYREXIA (non-serious) with onset 29Nov2021 07:00, outcome "recovering", described as "feverish"; PAIN (non-serious), CHILLS (non-serious) all with onset 29Nov2021 07:00, outcome "not recovered" and all described as "chills and aches upon waking at 7am, got progressively worse.". Therapeutic measures were not taken as a result of pyrexia, pain, chills.  Additional information:Adverse event, product problem or Error: Adverse events checked. Describe event, problem or product use error: No lab test performed. Suspect product name: BNT162B2, Manufacturer: Pfizer. Date of use: From 28Nov2021 13:00 to 28Nov2021 13:00.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority sponsored program (159558). The reporter is the patient. A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: FH8028) at the age of 36 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "anxiety" (ongoing), notes: medical Anxiety. Concomitant medication(s) included: RISPERDAL taken for anxiety (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, Lot: EL9261, Expiry: Unknown), administration date: 27Jan2021, when the patient was 35 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, Lot: EN5318, Expiry: Unknown), administration date: 17Feb2021, when the patient was 35 years old, for Covid-19 immunization; Tetanus, administration date: May2021. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "booster dose"; FATIGUE (non-serious) with onset 24Nov2021, outcome "unknown", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "unknown", described as "swollen lymph nodes"; NIGHT SWEATS (non-serious) with onset 23Nov2021, outcome "unknown", described as "night sweats"; ABDOMINAL DISCOMFORT (non-serious) with onset 24Nov2021, outcome "unknown", described as "stomach is queasy and unsettled"; PYREXIA (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "fever"; PAIN (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "body aches"; DIZZINESS (non-serious) with onset 24Nov2021, outcome "unknown", described as "dizziness"; FEELING COLD (non-serious) with onset 25Nov2021, outcome "unknown", described as "very cold at times"; NERVOUSNESS (non-serious) with onset 25Nov2021, outcome "unknown", described as "shaky"; CHILLS (non-serious) with onset 25Nov2021, outcome "unknown", described as "shivers"; DECREASED APPETITE (non-serious) with onset 24Nov2021, outcome "unknown", described as "lack of appetite"; NAUSEA (non-serious) with onset 30Nov2021, outcome "unknown", described as "pretty nauseous". The event "swollen lymph nodes" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: pyrexia: (22Nov2021) 99.7 degrees. Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Immunisation, Lymphadenopathy, Nausea, Nervousness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority sponsored program (159558). The reporter is the patient. A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: FH8028) at the age of 36 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "anxiety" (ongoing), notes: medical Anxiety. Concomitant medication(s) included: RISPERDAL taken for anxiety (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, Lot: EL9261, Expiry: Unknown), administration date: 27Jan2021, when the patient was 35 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, Lot: EN5318, Expiry: Unknown), administration date: 17Feb2021, when the patient was 35 years old, for Covid-19 immunization; Tetanus, administration date: May2021. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "booster dose"; FATIGUE (non-serious) with onset 24Nov2021, outcome "unknown", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "unknown", described as "swollen lymph nodes"; NIGHT SWEATS (non-serious) with onset 23Nov2021, outcome "unknown", described as "night sweats"; ABDOMINAL DISCOMFORT (non-serious) with onset 24Nov2021, outcome "unknown", described as "stomach is queasy and unsettled"; PYREXIA (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "fever"; PAIN (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "body aches"; DIZZINESS (non-serious) with onset 24Nov2021, outcome "unknown", described as "dizziness"; FEELING COLD (non-serious) with onset 25Nov2021, outcome "unknown", described as "very cold at times"; NERVOUSNESS (non-serious) with onset 25Nov2021, outcome "unknown", described as "shaky"; CHILLS (non-serious) with onset 25Nov2021, outcome "unknown", described as "shivers"; DECREASED APPETITE (non-serious) with onset 24Nov2021, outcome "unknown", described as "lack of appetite"; NAUSEA (non-serious) with onset 30Nov2021, outcome "unknown", described as "pretty nauseous". The event "swollen lymph nodes" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: pyrexia: (22Nov2021) 99.7 degrees. Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority sponsored program (159558). The reporter is the patient. A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: FH8028) at the age of 36 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "anxiety" (ongoing), notes: medical Anxiety. Concomitant medication(s) included: RISPERDAL taken for anxiety (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, Lot: EL9261, Expiry: Unknown), administration date: 27Jan2021, when the patient was 35 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, Lot: EN5318, Expiry: Unknown), administration date: 17Feb2021, when the patient was 35 years old, for Covid-19 immunization; Tetanus, administration date: May2021. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "booster dose"; FATIGUE (non-serious) with onset 24Nov2021, outcome "unknown", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "unknown", described as "swollen lymph nodes"; NIGHT SWEATS (non-serious) with onset 23Nov2021, outcome "unknown", described as "night sweats"; ABDOMINAL DISCOMFORT (non-serious) with onset 24Nov2021, outcome "unknown", described as "stomach is queasy and unsettled"; PYREXIA (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "fever"; PAIN (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "body aches"; DIZZINESS (non-serious) with onset 24Nov2021, outcome "unknown", described as "dizziness"; FEELING COLD (non-serious) with onset 25Nov2021, outcome "unknown", described as "very cold at times"; NERVOUSNESS (non-serious) with onset 25Nov2021, outcome "unknown", described as "shaky"; CHILLS (non-serious) with onset 25Nov2021, outcome "unknown", described as "shivers"; DECREASED APPETITE (non-serious) with onset 24Nov2021, outcome "unknown", described as "lack of appetite"; NAUSEA (non-serious) with onset 30Nov2021, outcome "unknown", described as "pretty nauseous". The event "swollen lymph nodes" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: pyrexia: (22Nov2021) 99.7 degrees. Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pyrexia
Clinical narrative: dose_number=3; Fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 29Nov2021 (Lot number: FF8839) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "dose_number=3"; PYREXIA (non-serious) with onset 29Nov2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 29Nov2021, outcome "unknown", described as "chills". Therapeutic measures were not taken as a result of immunisation, pyrexia, chills.  Additional information: The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Dyspepsia, Headache, Hyperhidrosis
Clinical narrative: Bad sweats; Pounding headache; Cramps in the left side of his stomach; Nausea; Heart burn; Dizzy; Doesn't feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, lot number unknown, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset 01Dec2021, outcome "unknown", described as "Bad sweats"; HEADACHE (non-serious) with onset 01Dec2021, outcome "unknown", described as "Pounding headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 01Dec2021, outcome "unknown", described as "Cramps in the left side of his stomach"; NAUSEA (non-serious) with onset 01Dec2021, outcome "unknown", described as "Nausea"; DYSPEPSIA (non-serious) with onset 01Dec2021, outcome "unknown", described as "Heart burn"; DIZZINESS (non-serious) with onset 01Dec2021, outcome "unknown", described as "Dizzy"; MALAISE (non-serious) with onset 01Dec2021, outcome "unknown", described as "Doesn't feel well". Additional information: Patient reporting on the second Covid vaccination he had about an hour and a half ago.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: Bad sweats; Pounding headache; Cramps in the left side of his stomach; Nausea; Heart burn; Dizzy; Doesn't feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, lot number unknown, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset 01Dec2021, outcome "unknown", described as "Bad sweats"; HEADACHE (non-serious) with onset 01Dec2021, outcome "unknown", described as "Pounding headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 01Dec2021, outcome "unknown", described as "Cramps in the left side of his stomach"; NAUSEA (non-serious) with onset 01Dec2021, outcome "unknown", described as "Nausea"; DYSPEPSIA (non-serious) with onset 01Dec2021, outcome "unknown", described as "Heart burn"; DIZZINESS (non-serious) with onset 01Dec2021, outcome "unknown", described as "Dizzy"; MALAISE (non-serious) with onset 01Dec2021, outcome "unknown", described as "Doesn't feel well". Additional information: Patient reporting on the second Covid vaccination he had about an hour and a half ago.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chest pain, Pain in extremity
Clinical narrative: Arm pain; Chest pain when the patient breathes; Stomach hurts; Back hurts; This is a spontaneous report received from a contactable consumer.  An 8 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 8 years as first single dose for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: amoxicillin, reaction(s): "allergy: amoxicillin".  The following information was reported: Pain in extremity (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Arm pain"; Chest pain (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Chest pain when the patient breathes"; Abdominal pain upper  (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Stomach hurts"; Back pain (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Back hurts". It was unknown if therapeutic measures were taken as a result of pain in extremity, chest pain, abdominal pain upper, back pain.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Antineutrophil cytoplasmic antibody, B-lymphocyte count, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: One patient noted suicidal ideation after the BNT162b2 mRNA vaccine.; The initial case was missing the following minimum criteria: [unidentifiable patient]. Upon receipt of follow-up information on 07Dec2021, this case now contains all required information to be considered valid. This is a literature report.  The primary aim of this study was to assess the impact of vaccine timing, immunological status, demographics, and concomitant treatments on vaccine immunogenicity in autoimmune rheumatic disease (AIRD) patients treated with RTX (rituximab). Secondary aims were to implement an educational intervention to physicians and patients and assess its effect on timing of COVID-19 vaccination in relation to RTX infusions. Authors performed a prospective single center study to optimize SARSCoV-2 vaccination timing and to assess vaccine immunogenicity in AIRD patients who received RTX at a health care hospital. Authors first educated faculty on the rationale for timing SARS-CoV-2 vaccines 24 weeks post-RTX. Authors measured timing of vaccine administration through telephone survey of patients. Authors then analyzed vaccine immunogenicity in relation to vaccine timing and other clinical and immunologic parameters. Patients were contacted by telephone from March through August of 2021. Study participants were surveyed on recent vaccine administration, and in those who had not yet received a vaccination, whether or not they were intending to obtain a COVID-19 vaccine. Vaccine administration was not part of the study. A patient (no qualifiers provided) received bnt162b2 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "AIRD" (ongoing). Concomitant medication included: RITUXIMAB taken for AIRD. One patient noted suicidal ideation after the BNT162b2 mRNA vaccine. The patient underwent the following laboratory tests and procedures: antineutrophil cytoplasmic antibody: unknown results; blood immunoglobulin G (normal high range 700): unknown results; serum IgM (normal high range 40): unknown results; absolute CD19: unknown results; CD20: unknown results; antinucleocapsid antibody: unknown results; serum IgG antibody levels against SARS-CoV-2: unknown results; SARS-CoV-2 PCR: unknown results. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event suicidal ideation with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Suicidal ideation
Clinical narrative: One patient noted suicidal ideation after the BNT162b2 mRNA vaccine.; The initial case was missing the following minimum criteria: [unidentifiable patient]. Upon receipt of follow-up information on 07Dec2021, this case now contains all required information to be considered valid. This is a literature report.  The primary aim of this study was to assess the impact of vaccine timing, immunological status, demographics, and concomitant treatments on vaccine immunogenicity in autoimmune rheumatic disease (AIRD) patients treated with RTX (rituximab). Secondary aims were to implement an educational intervention to physicians and patients and assess its effect on timing of COVID-19 vaccination in relation to RTX infusions. Authors performed a prospective single center study to optimize SARSCoV-2 vaccination timing and to assess vaccine immunogenicity in AIRD patients who received RTX at a health care hospital. Authors first educated faculty on the rationale for timing SARS-CoV-2 vaccines 24 weeks post-RTX. Authors measured timing of vaccine administration through telephone survey of patients. Authors then analyzed vaccine immunogenicity in relation to vaccine timing and other clinical and immunologic parameters. Patients were contacted by telephone from March through August of 2021. Study participants were surveyed on recent vaccine administration, and in those who had not yet received a vaccination, whether or not they were intending to obtain a COVID-19 vaccine. Vaccine administration was not part of the study. A patient (no qualifiers provided) received bnt162b2 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "AIRD" (ongoing). Concomitant medication included: RITUXIMAB taken for AIRD. One patient noted suicidal ideation after the BNT162b2 mRNA vaccine. The patient underwent the following laboratory tests and procedures: antineutrophil cytoplasmic antibody: unknown results; blood immunoglobulin G (normal high range 700): unknown results; serum IgM (normal high range 40): unknown results; absolute CD19: unknown results; CD20: unknown results; antinucleocapsid antibody: unknown results; serum IgG antibody levels against SARS-CoV-2: unknown results; SARS-CoV-2 PCR: unknown results. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event suicidal ideation with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.