chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Immunisation, Mouth haemorrhage
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (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 (DOSE1, MANUFACTURER, UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Booster"; EPISTAXIS (non-serious) with onset 13Nov2021, outcome "unknown", described as "blood running from her mouth and nose"; MOUTH HAEMORRHAGE (non-serious) with onset 13Nov2021, outcome "recovered" (13Nov2021), described as "blood running from her mouth".  Additional Information: Originating AE Request: REQ-607510.Patient Age is unknown years.Reporter Subtype is Patient. No of attachment is 1. PQC Details:  Product: COMIRNATY Question: Was not able to collect demographic information from Caller before call disconnected.Unable to callback Caller due to no callback number being provided.Caller stated before the call disconnected that she had the booster dose of the purple cap Pfizer Covid-19 vaccine on 11Nov2021 and on 13Nov2021 she started having complaints blood running from her mouth and nose for 5 hours where for 2.5 hours of the 5 hours the blood was streaming out really bad then the pools started to congeal in her sink and were 3-5 inches across in length per Caller.Caller reported that she had complaints of a nosebleed that lasted for another 3-4 minutes on 19Nov2021 and another bad nose bleed 01Dec2021.Caller stated that she believes she called Pfizer MI a few weeks to ask if there was information about the above complaints on 13Nov2021 and was told there was no information available.Caller stated that she is calling again to see if there is any information at this time about the above complaints.Call disconnected while Caller while describing the events on 13Nov2021 and 19Nov2021.  DSU:e-transmitting AE due to call disconnecting and no callback number was provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Parosmia, Skin odour abnormal
Clinical narrative: Random smells not associated with environment / Typically a funky smell like body odor; smelly feet; Administration date: 26Nov2021; dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 14:45 (Lot number: FM8030) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ehlers Danlos Syn" (unspecified if ongoing); "depression" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: PTSD; "GAD" (unspecified if ongoing), notes: GAD. Concomitant medication(s) included: PROZAC; GABAPENTIN; TRAZODONE. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09Apr2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 12Mar2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 14:45, outcome "unknown", described as "Administration date: 26Nov2021; dose number: 3"; PAROSMIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Random smells not associated with environment / Typically a funky smell like body odor"; SKIN ODOUR ABNORMAL (non-serious) with onset 27Nov2021, outcome "not recovered", described as "smelly feet". Therapeutic measures were not taken as a result of parosmia, skin odour abnormal.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Did not reported any allergies. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received Prozac, gabapentin and trazodone within 2 weeks of vaccination. It was reported that Random smells not associated with environment for several seconds to several minutes (30 min or longer) at each event. At least 100 instances of strange scent experiences in a day. Typically a funky smell like body odor, smelly feet. Seriousness was no.Seriousness criteria-Results in death,Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect was  reported as no.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Immunisation, Lymphadenopathy, Pain in extremity
Clinical narrative: Tiredness; Pain at injection site; Low grade fever; Pain in upper arm; Swollen left arm pit lymph nodes; Tenderness in left side of neck; Dose 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 13:00 (Lot number: FE3592) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "adult ADD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; ALEVE; LORATADINE. Past drug history included: Ephedrine, reaction(s): "known allergies: ephedrine", notes: known allergies: ephedrine/ pseudoephedrine; Pseudoephedrine, reaction(s): "known allergies: pseudoephedrine", notes: known allergies: ephedrine/ pseudoephedrine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9267, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 24Feb2021, when the patient was 68 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 03Feb2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 13:00, outcome "unknown", described as "Dose 3"; FATIGUE (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Pain at injection site"; PYREXIA (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Low grade fever"; PAIN IN EXTREMITY (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Pain in upper arm"; LYMPHADENOPATHY (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Swollen left arm pit lymph nodes"; TENDERNESS (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Tenderness in left side of neck". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, vaccination site pain, pyrexia, pain in extremity, lymphadenopathy, tenderness.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment included:Naproxen, rest, warm packs applied to pain sites. concomitant therapy included multivitamin.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness, Vaccination site pain
Clinical narrative: Tiredness; Pain at injection site; Low grade fever; Pain in upper arm; Swollen left arm pit lymph nodes; Tenderness in left side of neck; Dose 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 13:00 (Lot number: FE3592) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "adult ADD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; ALEVE; LORATADINE. Past drug history included: Ephedrine, reaction(s): "known allergies: ephedrine", notes: known allergies: ephedrine/ pseudoephedrine; Pseudoephedrine, reaction(s): "known allergies: pseudoephedrine", notes: known allergies: ephedrine/ pseudoephedrine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9267, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 24Feb2021, when the patient was 68 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 03Feb2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 13:00, outcome "unknown", described as "Dose 3"; FATIGUE (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Pain at injection site"; PYREXIA (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Low grade fever"; PAIN IN EXTREMITY (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Pain in upper arm"; LYMPHADENOPATHY (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Swollen left arm pit lymph nodes"; TENDERNESS (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Tenderness in left side of neck". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, vaccination site pain, pyrexia, pain in extremity, lymphadenopathy, tenderness.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment included:Naproxen, rest, warm packs applied to pain sites. concomitant therapy included multivitamin.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Malaise, Wheezing
Clinical narrative: booster shot; wheezy to her stomach; really dizzy; not feeling well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (134184). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (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; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster shot"; WHEEZING (non-serious) with onset 2021, outcome "unknown", described as "wheezy to her stomach"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "really dizzy"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "not feeling well". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity
Clinical narrative: COVID booster; Sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; MANUFACTUERER UNKNOWN), for Covid-19 immunization, reaction(s): "no ADRs". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: Event took place after use of product. Name of product: COVID booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Palpitations, Sinus tachycardia
Clinical narrative: sinus tachycardia; Palpitation; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 16:45 (Lot number: fs1620) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfite antibiotics, reaction(s): "Allergy", notes: known allergies: sulfite antibiotics. Vaccination history included: Bnt162b2 (Dose Number: 2 Batch/Lot No: ew0161., Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 15Apr2021, when the patient was 40 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: er8730, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 25Mar2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 16:45, outcome "unknown", described as "booster"; SINUS TACHYCARDIA (non-serious) with onset 01Dec2021 12:00, outcome "recovered" (Dec2021), described as "sinus tachycardia"; PALPITATIONS (non-serious) with onset 01Dec2021 12:00, outcome "recovered" (Dec2021), described as "Palpitation". The events "sinus tachycardia" and "palpitation" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of sinus tachycardia, palpitations.  Additional information: No hospitalization Prolonged. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since the vaccination. Device Date: 02Dec2021  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pustule, Urticaria
Clinical narrative: hives, they have just kept getting worse, mainly on her arms, her head; some pustules in certain spots; the Pfizer Covid booster she had on Monday morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 (Lot number: FD6809) at the age of 75 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, Expire date-2Jun2021, Anatomical location -unknown, Lot Number-EN6203), administration date: 02Mar2021, when the patient was 75 years old, for Covid-19 immunization; Bnt162b2 (Dose-2, Expire date-unknown, Anatomical location -left arm, Lot Number-EN6208), administration date: 23Mar2021, when the patient was 75 years old, for Covid-19 immunization; Influenza vaccine (Yes, Caller states she had the influenza vaccine three weeks before the booster on 29Nov2021.), administration date: Nov2021, when the patient was 75 years old, for immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "the Pfizer Covid booster she had on Monday morning"; URTICARIA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "hives, they have just kept getting worse, mainly on her arms, her head"; PUSTULE (non-serious) with onset 01Dec2021, outcome "not recovered", described as "some pustules in certain spots". Therapeutic measures were taken as a result of urticaria, pustule.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Immunisation, Paraesthesia oral
Clinical narrative: 5 days after shot developed numb/tingling in lip. It has persisted for a week. I have HSV-1 but no cold sores present, just lip tingling for a week now.; 5 days after shot developed numb/tingling in lip. It has persisted for a week. I have HSV-1 but no cold sores present, just lip tingling for a week now.; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 19:45 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no just HSV-1" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; CELEXA [CELECOXIB]. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 09Apr2021, when the patient was 27 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Mar2021, when the patient was 27 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 19:45, outcome "unknown", described as "booster"; HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 26Nov2021 06:00, outcome "not recovered" and all described as "5 days after shot developed numb/tingling in lip. It has persisted for a week. I have HSV-1 but no cold sores present, just lip tingling for a week now.". The event "5 days after shot developed numb/tingling in lip. it has persisted for a week. i have hsv-1 but no cold sores present, just lip tingling for a week now." and "5 days after shot developed numb/tingling in lip. it has persisted for a week. i have hsv-1 but no cold sores present, just lip tingling for a week now." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of hypoesthesia oral, paraesthesia oral.  Additional information: This case assessed as non-serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Tinnitus
Clinical narrative: Tinnitus, ringing- buzzing sound in left ear.; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Nov2021 (Lot number: Fm8028) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: El3249, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: Jan2021, when the patient was 54 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ek9231, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: Jan2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "booster"; TINNITUS (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Tinnitus, ringing- buzzing sound in left ear.". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Vaccination time was 11:45 AM. Patient had no allergies. Reported Event: Tinnitus, ringing- buzzing sound in left ear. It's not going away. Noted symptom began approx 1 week after booster shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was 02Dec2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Nausea, Tremor, Vomiting
Clinical narrative: Shakiness; Acute headache; nausea; Vomiting; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Nov2021 13:00 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pernicious anaemia" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 09Apr2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Mar2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 13:00, outcome "unknown", described as "Booster"; TREMOR (non-serious) with onset 29Nov2021 09:00, outcome "recovering", described as "Shakiness"; HEADACHE (non-serious) with onset 29Nov2021 09:00, outcome "recovering", described as "Acute headache"; NAUSEA (non-serious) with onset 29Nov2021 09:00, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 29Nov2021 09:00, outcome "recovering", described as "Vomiting". Therapeutic measures were not taken as a result of tremor, headache, nausea, vomiting.  Additional Information: No other vaccine in four weeks administered. Adverse event:  Acute headache nausea vomiting shakiness beginning about 30 hours post vaccination and lingering 4 more days at present. Patient did not have Covid prior to vaccination and not test performed. No Known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Immunisation, Nausea, Night sweats
Clinical narrative: booster; body aches; severe night sweats; nausea; High fever of 104 degrees, lower fever of around 102 degrees for 5 days; severe fatigue; . This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Nov2021 18:00 (Lot number: FJ8762) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8729, Vaccine Administration Time: 15:00 PM), administration date: 17Apr2021, when the patient was 18 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Vaccine Administration Time: 15:00 PM), administration date: 08May2021, when the patient was 18 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 18:00, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 24Nov2021, outcome "recovering", described as "body aches"; NIGHT SWEATS (non-serious) with onset 24Nov2021, outcome "recovering", described as "severe night sweats"; NAUSEA (non-serious) with onset 24Nov2021, outcome "recovering", described as "nausea"; PYREXIA (non-serious) with onset 24Nov2021, outcome "recovered" (29Nov2021), described as "High fever of 104 degrees, lower fever of around 102 degrees for 5 days"; FATIGUE (non-serious) with onset 24Nov2021, outcome "recovering", described as "severe fatigue". The events "body aches", "severe night sweats", "nausea", "high fever of 104 degrees, lower fever of around 102 degrees for 5 days" and "severe fatigue" 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 pain, night sweats, nausea, pyrexia, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: booster; body aches; severe night sweats; nausea; High fever of 104 degrees, lower fever of around 102 degrees for 5 days; severe fatigue; . This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Nov2021 18:00 (Lot number: FJ8762) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8729, Vaccine Administration Time: 15:00 PM), administration date: 17Apr2021, when the patient was 18 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Vaccine Administration Time: 15:00 PM), administration date: 08May2021, when the patient was 18 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 18:00, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 24Nov2021, outcome "recovering", described as "body aches"; NIGHT SWEATS (non-serious) with onset 24Nov2021, outcome "recovering", described as "severe night sweats"; NAUSEA (non-serious) with onset 24Nov2021, outcome "recovering", described as "nausea"; PYREXIA (non-serious) with onset 24Nov2021, outcome "recovered" (29Nov2021), described as "High fever of 104 degrees, lower fever of around 102 degrees for 5 days"; FATIGUE (non-serious) with onset 24Nov2021, outcome "recovering", described as "severe fatigue". The events "body aches", "severe night sweats", "nausea", "high fever of 104 degrees, lower fever of around 102 degrees for 5 days" and "severe fatigue" 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 pain, night sweats, nausea, pyrexia, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Ear pain, Headache, Immunisation
Clinical narrative: Earache; she had fever; chills; persistent headache; received her 3rd dose of BNT162b2; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 (Lot number: FF8841, Expiration Date: Mar2022) at the age of 60 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, Left arm, Intramuscular, EL3247), administration date: 17Feb2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Left arm), administration date: 10Mar2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "received her 3rd dose of BNT162b2"; PYREXIA (non-serious) with onset 02Dec2021 02:30, outcome "unknown", described as "she had fever"; CHILLS (non-serious) with onset 02Dec2021 02:30, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 02Dec2021, outcome "unknown", described as "persistent headache"; EAR PAIN (non-serious) with onset 03Dec2021, outcome "unknown", described as "Earache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, headache.  Additional information: Patient had taken Tylenol twice for relief of symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Earache; she had fever; chills; persistent headache; received her 3rd dose of BNT162b2; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 (Lot number: FF8841, Expiration Date: Mar2022) at the age of 60 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, Left arm, Intramuscular, EL3247), administration date: 17Feb2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Left arm), administration date: 10Mar2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "received her 3rd dose of BNT162b2"; PYREXIA (non-serious) with onset 02Dec2021 02:30, outcome "unknown", described as "she had fever"; CHILLS (non-serious) with onset 02Dec2021 02:30, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 02Dec2021, outcome "unknown", described as "persistent headache"; EAR PAIN (non-serious) with onset 03Dec2021, outcome "unknown", described as "Earache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, headache.  Additional information: Patient had taken Tylenol twice for relief of symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation, Pain in extremity, Peripheral swelling
Clinical narrative: pain in both calves; Shortness of breath; swelling of hands and calves; booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.   A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 09:30 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; ANNOVERA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion , Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 26Feb2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 05Feb2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021, outcome "not recovered", described as "pain in both calves"; DYSPNOEA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Shortness of breath"; PERIPHERAL SWELLING (non-serious) with onset 19Nov2021, outcome "not recovered", described as "swelling of hands and calves". The events "pain in both calves", "shortness of breath" and "swelling of hands and calves" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of pain in extremity, dyspnoea, peripheral swelling.   Additional Information: It was reported that patient received dose 3, No other vaccine in four weeks, No covid prior vaccination, No covid tested post vaccination. It was reported that patient known allergies was not reported.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Pain
Clinical narrative: COVID Booster; Headache; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Second Dose, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID Booster"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "body aches".  Additional information: Name of Product was COVID booster. Event took place after use of product. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Myalgia
Clinical narrative: Booster; Mild fever; Pain at injection site; Tiredness; Headache; Overall muscle aches; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 09:45 (Lot number: FH8027) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose Product: COVID 19, Prev dose Brand: Pfizer, Prev dose Lot number: EL3247, Prev dose Administrator route: Intramuscular, Prev dose Vaccine location: Left arm, Prev dose Dose number: 2), administration date: 19Feb2021, when the patient was 30 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose Product: COVID 19, Prev dose Brand: Pfizer, Prev dose Lot number: EL3247, Prev dose Administrator route: Intramuscular, Prev dose Vaccine location: Left arm, Prev dose Dose number: 1), administration date: 29Jan2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Booster"; PYREXIA (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Mild fever"; VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Pain at injection site"; FATIGUE (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Headache"; MYALGIA (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Overall muscle aches"; CHILLS (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Chills". Therapeutic measures were taken as a result of immunisation, pyrexia, vaccination site pain, fatigue, headache, myalgia, chills.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Treatment with Tylenol (OTC) received for the adverse event.Prior to vaccination, was 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Booster; Mild fever; Pain at injection site; Tiredness; Headache; Overall muscle aches; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 09:45 (Lot number: FH8027) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose Product: COVID 19, Prev dose Brand: Pfizer, Prev dose Lot number: EL3247, Prev dose Administrator route: Intramuscular, Prev dose Vaccine location: Left arm, Prev dose Dose number: 2), administration date: 19Feb2021, when the patient was 30 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose Product: COVID 19, Prev dose Brand: Pfizer, Prev dose Lot number: EL3247, Prev dose Administrator route: Intramuscular, Prev dose Vaccine location: Left arm, Prev dose Dose number: 1), administration date: 29Jan2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Booster"; PYREXIA (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Mild fever"; VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Pain at injection site"; FATIGUE (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Headache"; MYALGIA (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Overall muscle aches"; CHILLS (non-serious) with onset 01Dec2021 20:00, outcome "recovering", described as "Chills". Therapeutic measures were taken as a result of immunisation, pyrexia, vaccination site pain, fatigue, headache, myalgia, chills.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Treatment with Tylenol (OTC) received for the adverse event.Prior to vaccination, was 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.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Fall, Immunisation, Nausea
Clinical narrative: Booster; pain in my arm and the armhole; pain in my arm and the armhole; feel nauseous; dizzy; fallen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient, Other Case identifier(s) 106960.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported IMMUNISATION (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), outcome not recovered; NAUSEA (non-serious), outcome not recovered; DIZZINESS (non-serious), outcome not recovered; FALL (non-serious), outcome not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Booster; pain in my arm and the armhole; pain in my arm and the armhole; feel nauseous; dizzy; fallen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient, Other Case identifier(s) 106960.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported IMMUNISATION (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), outcome not recovered; NAUSEA (non-serious), outcome not recovered; DIZZINESS (non-serious), outcome not recovered; FALL (non-serious), outcome not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye pain, Fatigue, Headache, Immunisation
Clinical narrative: Fever of 100.8 day after vaccination; Dose number:3; Extreme fatigue; Headache; Eye ache; Right arm (entire side of body) very sore; Right arm (entire side of body) very sore; Local inflammation at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 16:30 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Prediabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Monistat, reaction(s): "Drug allergy", notes: Known allergies: Monistat. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown Route of administration: unspecified Administration time: 04:45 Anatomical site: right arm), administration date: 18Jan2021, when the patient was 61 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown Route of administration: unspecified Administration time:16:00 Anatomical site: left arm), administration date: 03Feb2021, when the patient was 61 years old, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 16:30, outcome "unknown", described as "Dose number:3"; FATIGUE (non-serious) with onset Dec2021, outcome "recovering", described as "Extreme fatigue"; PYREXIA (non-serious) with onset 02Dec2021, outcome "recovering", described as "Fever of 100.8 day after vaccination"; HEADACHE (non-serious) with onset Dec2021, outcome "recovering", described as "Headache"; EYE PAIN (non-serious) with onset Dec2021, outcome "recovering", described as "Eye ache"; PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset Dec2021, outcome "recovering" and all described as "Right arm (entire side of body) very sore"; VACCINATION SITE INFLAMMATION (non-serious) with onset Dec2021, outcome "recovering", described as "Local inflammation at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, headache, eye pain, pain in extremity, pain, vaccination site inflammation.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 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 events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events onset date was also reported as 30Nov2021 at 20:00   The lot number for bnt162b2 was not provided and will be requested during follow up.