chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness on the left side of the face; Numbness on the left side of the face; This is a spontaneous report from a contactable reporter (pharmacist).   A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 26Nov2021 (Lot number: FJ8762) at the age of 53 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) and HYPOAESTHESIA (non-serious) both with onset 26Nov2021, outcome "not recovered", and described as "Tingling and numbness on the left side of the face". Therapeutic measures were not taken as a result of paraesthesia and hypoaesthesia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Under arm swollen with node; Under arm swollen with node and a little painful; The patient received dose 1 and 2 of Moderna and dose 3 of BNT162b2; Dose received : 3; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 29Nov2021 at 19:00 (Lot number: unknown) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Scleroderma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 05May2021, when the patient was 42 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 05Apr2021, when the patient was 42 years old, for COVID-19 immunisation.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Nov2021 at 19:00, outcome "unknown", described as "The patient received dose 1 and 2 of Moderna and dose 3 of BNT162b2"; IMMUNISATION (non-serious) with onset 29Nov2021 at 19:00, outcome "unknown", described as "Dose received : 3"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Under arm swollen with node"; AXILLARY PAIN (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Under arm swollen with node and a little painful". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy and axillary pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Immunisation, Pain, Pyrexia
Clinical narrative: Joint pain; Aches; Mild fever; Fatigue; Dose received: 3 / dose number = 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 02Dec2021 at 13:45 (Lot number: FJ1620) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Migraines and "Acid Reflux (osophageal)" (unspecified if ongoing), notes: Reflux. Concomitant medications included: FAMOTIDINE and VITAMIN D. Past drug history included: Ciprofloxacin, reactions: "Drug allergy", notes: Known allergy: Ciprofloxacin and Bactrim, reactions: "Drug allergy", notes: Known allergy: Bactrim. Vaccination history included: bnt162b2 (BNT162B2), DOSE 2, SINGLE; Lot number: EP6955; Anatomical location: Left arm; Vaccine Administration Time: 11:00, administration date: 12Apr2021, when the patient was 37 years old, for COVID-19 immunisation; and bnt162b2 (BNT162B2), DOSE 1, SINGLE Lot number: EP6955; Anatomical location: Left arm; Vaccine Administration Time: 10:45, administration date: 22Mar2021, when the patient was 37 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 13:45, outcome "unknown", described as "Dose received: 3 / dose number = 3"; ARTHRALGIA (non-serious), described as "Joint pain"; PAIN (non-serious), described as "aches"; PYREXIA (non-serious), described as "mild fever"; FATIGUE (non-serious), described as "fatigue"; all with onset 02Dec2021 at 22:00, outcome "recovering", Therapeutic measures were not taken as a result of arthralgia, pain, pyrexia and fatigue.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. It was reported that symptoms were most severe 12 hours after vaccination. Symptoms mostly resolved 30 hours post dose. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea; Vomiting; Sore arm; This is a spontaneous report from a contactable reporter(Consumer or other non HCP).  A 5-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 03Dec2021 at 16:15 (Lot number: FK5127) at the age of 5 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: FK5127, Route of administration: Intramuscular; Anatomical site: Left arm; Administration time: 16:00), administration date: 11Nov2021, when the patient was 5 years old, for COVID-19 immunisation.  The following information was reported: NAUSEA (non-serious) with onset 04Dec2021 at 04:30, outcome "recovering", described as "Nausea"; VOMITING (non-serious) with onset 04Dec2021 at 04:30, outcome "recovering", described as "Vomiting"; PAIN IN EXTREMITY (non-serious) with onset 04Dec2021 at 04:30, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of nausea, vomiting and pain in extremity.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Palpitations, Tremor
Clinical narrative: Brain fog; Dizziness; Palpitations; Hand tremors; This is a spontaneous report from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 42 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical site: unspecified; Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Brain fog"; DIZZINESS (non-serious), outcome "not recovered", described as "Dizziness"; PALPITATIONS (non-serious), outcome "not recovered", described as "Palpitations"; TREMOR (non-serious), outcome "not recovered", described as "Hand tremors". The events "Brain fog", "Dizziness", "Palpitations" and "Hand tremors" were evaluated at the physician office visit.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Brainfog, dizziness starting 4 days after second dose. Also palpitations, hand tremors. Brainfog and dizziness persistent for 6 weeks now. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Immunisation, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Lymphadenopathy in Left Axillary Region, It started as an uncomfortable feeling and turned in painful in 2 hours.; Axillary and Pectoral region is painful to touch.; Astenia and Fever accompanied; Astenia and Fever accompanied; Lymphadenopathy in Left Axillary Region, It started as an uncomfortable feeling and turned in painful in 2 hours.; Dose number= 3; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 at 17:15 (Lot number: FJ8757) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0169, Anatomical location: Arm Left, Route of administration: Unspecified) administration date: 21Apr2021, when the patient was 27 years old and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0183, Anatomical location: Arm Left, Route of administration: Unspecified) administration date: 12May2021, when the patient was 27 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 17:15, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious), TENDERNESS (non-serious), ASTHENIA (non-serious), PYREXIA (non-serious), LYMPH NODE PAIN (non-serious) all with onset 03Dec2021 at 16:00, outcome "unknown" and all described as "Lymphadenopathy in Left Axillary Region, It started as an uncomfortable feeling and turned in painful in 2 hours". Therapeutic measures were not taken as a result of lymphadenopathy, tenderness, asthenia, pyrexia and lymph node pain.  Additional Information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Lymphadenopathy in Left Axillary Region, It started as an uncomfortable feeling and turned in painful in 2 hours.; Axillary and Pectoral region is painful to touch.; Astenia and Fever accompanied; Astenia and Fever accompanied; Lymphadenopathy in Left Axillary Region, It started as an uncomfortable feeling and turned in painful in 2 hours.; Dose number= 3; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 at 17:15 (Lot number: FJ8757) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0169, Anatomical location: Arm Left, Route of administration: Unspecified) administration date: 21Apr2021, when the patient was 27 years old and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0183, Anatomical location: Arm Left, Route of administration: Unspecified) administration date: 12May2021, when the patient was 27 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 17:15, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious), TENDERNESS (non-serious), ASTHENIA (non-serious), PYREXIA (non-serious), LYMPH NODE PAIN (non-serious) all with onset 03Dec2021 at 16:00, outcome "unknown" and all described as "Lymphadenopathy in Left Axillary Region, It started as an uncomfortable feeling and turned in painful in 2 hours". Therapeutic measures were not taken as a result of lymphadenopathy, tenderness, asthenia, pyrexia and lymph node pain.  Additional Information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Fatigue; Chills; Fever; Severe sweating; Vomiting; Diarrhea; severe Headache; joint paint and unbearable pain in my hips felt like someone was pulling each leg in an opposite direction with no relief whether sitting, standing or laying down and pain reduces does not work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 10:45 (Lot number: FJ1620) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Partial thyroid removal" (unspecified if ongoing); "allergy to pineapple, kiwi" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Biaxcin, reaction(s): "Biaxcin allergy"; Z-pack, reaction(s): "Z-Pack allergy". Vaccination history included: Bnt162b2 (Dose 1, single, lot number:Fh8030, expiry date not reported, at left arm, at 10:30), administration date: 11Nov2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "Fatigue", "Chills", "Fever". The following information was reported: FATIGUE (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Fever"; HYPERHIDROSIS (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Severe sweating"; VOMITING (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Vomiting"; DIARRHOEA (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Diarrhea"; HEADACHE (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "severe Headache"; ARTHRALGIA (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "joint paint and unbearable pain in my hips felt like someone was pulling each leg in an opposite direction with no relief whether sitting, standing or laying down and pain reduces does not work". Therapeutic measures were not taken as a result of fatigue, chills, pyrexia, hyperhidrosis, vomiting, diarrhoea, headache, arthralgia.  Additional Information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Fatigue; Chills; Fever; Severe sweating; Vomiting; Diarrhea; severe Headache; joint paint and unbearable pain in my hips felt like someone was pulling each leg in an opposite direction with no relief whether sitting, standing or laying down and pain reduces does not work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 10:45 (Lot number: FJ1620) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Partial thyroid removal" (unspecified if ongoing); "allergy to pineapple, kiwi" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Biaxcin, reaction(s): "Biaxcin allergy"; Z-pack, reaction(s): "Z-Pack allergy". Vaccination history included: Bnt162b2 (Dose 1, single, lot number:Fh8030, expiry date not reported, at left arm, at 10:30), administration date: 11Nov2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "Fatigue", "Chills", "Fever". The following information was reported: FATIGUE (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Fever"; HYPERHIDROSIS (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Severe sweating"; VOMITING (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Vomiting"; DIARRHOEA (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Diarrhea"; HEADACHE (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "severe Headache"; ARTHRALGIA (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "joint paint and unbearable pain in my hips felt like someone was pulling each leg in an opposite direction with no relief whether sitting, standing or laying down and pain reduces does not work". Therapeutic measures were not taken as a result of fatigue, chills, pyrexia, hyperhidrosis, vomiting, diarrhoea, headache, arthralgia.  Additional Information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes under injection arm.; Severe pain for three days; The patient received the third dose/booster dose of BNT162b2; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 01Dec2021 at 18:00 (Lot number: unknown) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish; "Allergy to nuts" (unspecified if ongoing), notes: Known allergies: Nuts and "Peanut allergy" (unspecified if ongoing), notes: Known allergies: Peanut. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Administration time: 15:00), administration date: 05Apr2021, when the patient was 28 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Administration time: 15:00), administration date: 15Mar2021, when the patient was 28 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 18:00, outcome "unknown", described as "The patient received the third dose/booster dose of BNT162b2"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021 at 23:00, outcome "recovering", described as "Swollen lymph nodes under injection arm"; PAIN (non-serious) with onset 01Dec2021 at 23:00, outcome "recovering", described as "Severe pain for three days". Therapeutic measures were not taken as a result of lymphadenopathy and pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata, SARS-CoV-2 test
Clinical narrative: Alopecia barbae; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 28-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 24Mar2021 at 08:00 (Lot number: EP6955) at the age of 28 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Pyloric stenosis" (unspecified if ongoing), notes: Infantile pyloric stenosis and "Pyloroplasty" (unspecified if ongoing), notes: Resolved infantile pyloric stenosis through surgery after birth. Concomitant medication included: RIFAMPIN, stop date: an unknown date in Mar2021.  The following information was reported: ALOPECIA AREATA (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Alopecia barbae". The event "Alopecia barbae " was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata.  Additional Information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. It was reported that the patient had stopped taking RIFAMPIN about 10 days prior. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment included steroid injection and topical steroid for alopecia areata. The patient also received bnt162b2 (BNT162B2), administered in right arm, administration date 13Apr2021 at 08:00 (Lot number: EW0153) at the age of 28 years as dose 2, single for COVID-19 immunisation.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, Rhinorrhoea, Sneezing
Clinical narrative: After 48 hours excessive sneezing and runny nose lasting 1 day.; After 48 hours excessive sneezing and runny nose lasting 1 day.; After 24 hours swollen and painful lymph nodes in left armpit lasting 5 days.; After 24 hours swollen and painful lymph nodes in left armpit lasting 5 days.; Dose received: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 27Nov2021 (Lot number: FH8030) at the age of 64 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included MULTIVITAMINS (unspecified). Past drug history included: Macrobid, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6203, Anatomical site: left arm), administration date: 19Apr2021, when the patient was 63 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0170, Anatomical site: left arm), administration date: 10May2021, when the patient was 63 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) both with onset 29Nov2021, outcome "recovered" (03Dec2021), and both described as "After 24 hours swollen and painful lymph nodes in left armpit lasting 5 days"; SNEEZING (non-serious), RHINORRHOEA (non-serious) both with onset 29Nov2021, outcome "recovered" (30Nov2021), and both described as "After 48 hours excessive sneezing and runny nose lasting 1 day". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, sneezing and rhinorrhoea.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Illness, Product preparation issue, Underdose
Clinical narrative: The vaccines they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls; The vaccines they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls; dying in bed; sick as a dog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Lot number: EW0162) at the age of 60 years as dose 1, single and administration date 07May2021 (Lot number: EW0171) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: UNDERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 2021, outcome "unknown" and all described as "The vaccines they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "dying in bed"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick as a dog".  Additional information: It was reported that the patient completed the primary series of the Pfizer Covid vaccine in May. The caller just received a letter from her vaccination provider stating that the vaccines they received were overdiluted, using 2.0 ml diluent instead of 1.8 ml. The letter stated that the patient needs to be revaccinated. The caller was asking for any available information regarding how to proceed. According to the letter that the caller received, between 01Apr2021 and November everyone had to have another vaccine because of this event. Both of the vaccines the caller received were diluted.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Immunisation, Pain
Clinical narrative: Sore arm at injection site; Tender and swollen right arm pit; Fatigue; Chills; Body aches; tender and swollen right armpit; Dose number:3; This is a spontaneous report from a non-contactable reporter (consumer). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in the right arm, administration date 03Dec2021 (Lot number: unknown) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications included birth control (unspecified). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical site: Right Arm, Route of administration: Unspecified), administration date: 16Apr2021, when the patient was 36 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Anatomical site: Right Arm, Route of administration: Unspecified), administration date: 07May2021, when the patient was 36 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose number:3"; VACCINATION SITE PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "Sore arm at injection site"; AXILLARY PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "Tender and swollen right arm pit"; FATIGUE (non-serious) with onset 04Dec2021, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 04Dec2021, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "Body aches"; SWELLING (non-serious) with onset 04Dec2021, outcome "recovering", described as "tender and swollen right armpit". Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, fatigue, chills, pain and swelling. Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: Sore arm at injection site; Tender and swollen right arm pit; Fatigue; Chills; Body aches; tender and swollen right armpit; Dose number:3; This is a spontaneous report from a non-contactable reporter (consumer). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in the right arm, administration date 03Dec2021 (Lot number: unknown) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications included birth control (unspecified). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical site: Right Arm, Route of administration: Unspecified), administration date: 16Apr2021, when the patient was 36 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Anatomical site: Right Arm, Route of administration: Unspecified), administration date: 07May2021, when the patient was 36 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose number:3"; VACCINATION SITE PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "Sore arm at injection site"; AXILLARY PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "Tender and swollen right arm pit"; FATIGUE (non-serious) with onset 04Dec2021, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 04Dec2021, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "Body aches"; SWELLING (non-serious) with onset 04Dec2021, outcome "recovering", described as "tender and swollen right armpit". Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, fatigue, chills, pain and swelling. Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Before the vaccine, I had a very regular menstrual cycle, every 28 days. I ceased having my period after my second dose of the vaccine. I'm now nearly 8 months since my first Pfizer covid-19 vaccine and still not having my period.; This is a spontaneous report from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 23Apr2021 (Lot number: EW0161) at the age of 47 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Drug allergy", notes: Known allergies: amoxicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8732, Anatomical location: Left arm), administration date: 26Mar2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: AMENORRHOEA (non-serious) with onset an unknown date in May2021, outcome "not recovered", described as "Before the vaccine, I had a very regular menstrual cycle, every 28 days. I ceased having my period after my second dose of the vaccine. I'm now nearly 8 months since my first Pfizer covid-19 vaccine and still not having my period". Therapeutic measures were not taken as a result of amenorrhoea.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Dose received: 3 / dose number = 3/ 37 year old female received Pfizer-BioNTech booster; Painful arm at injection site (Injection site pain).; This is a spontaneous report received from a non-contactable reporter (pharmacist). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 04Dec2021 at 09:15 (Lot number: FJ1620) at the age of 37 years, as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (BNT162B2) DOSE 1, SINGLE; Lot number: EL6247; Anatomical location: Left arm, administration date 08Mar2021, when the patient was 36 years old, for COVID-19 immunisation; bnt162b2 (BNT162B2), DOSE 2, SINGLE; Lot number: EL6247; Anatomical location: Left arm, administration date 29Mar2021, when the patient was 36 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021 at 09:15, outcome "unknown", described as "described as "Dose received: 3 / dose number = 3/ 37 year old female received Pfizer-BioNTech booster''; VACCINATION SITE PAIN (non-serious) with onset 04Dec2021, outcome "resolved" (05Dec2021), described as "painful arm at injection site (Injection site pain).'' Pain lasted for 24 hours. Therapeutic measures were not taken for the event injection site pain.   Additional Information. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Myalgia, Pyrexia
Clinical narrative: Dose received 3/dose number = 3; Mild fever; Chills; Myalgias; This is a spontaneous report from a non-contactable reporter (pharmacist).  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered intramuscularly in the left arm, administration date 03Dec2021 (Lot number: unknown) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Route of administration: Unspecified), administration date: an unknown date in Feb2021, when the patient was 44 years old and Bnt162b2 (DOSE 2, SINGLE;  Lot Number: Unknown; Route of administration: Unspecified), administration date: an unknown date in Feb2021, when the patient was 44 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose received 3/dose number = 3"; PYREXIA (non-serious) with onset 03Dec2021, outcome "recovering", described as "Mild fever"; CHILLS (non-serious) with onset 03Dec2021, outcome "recovering", described as "Chills"; MYALGIA (non-serious) with onset 03Dec2021, outcome "recovering", described as "Myalgias". Therapeutic measures were not taken as a result of pyrexia, chills and myalgia.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. It was reported that patient developed the events 12 hours after Pfizer-BioNTech vaccine. The next day, developed fever and chills again. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: High fever for five days; Headaches; Nausea; Chills; Lightheaded; Sore body; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 at 00:00 (Lot number: unknown) at the age of 17 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Diagnosed depression and anxiety and "Anxiety" (unspecified if ongoing), notes: Diagnosed depression and anxiety. Concomitant medication(s) included: FLUOXETINE and unspecified birth control medication. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown Anatomical site: left arm; Administration time: 00:00), administration date: 25Apr2021, when the patient was 17 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (21May2021 at 00:00), described as "High fever for five days"; HEADACHE (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Headaches"; NAUSEA (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Nausea"; CHILLS (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Chills"; DIZZINESS (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Lightheaded"; PAIN (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Sore body". The events "High fever for five days", "Headaches", "Nausea", "Chills", "Lightheaded" and "Sore body" were evaluated at the physician office visit. It was unknown whether any therapeutic measures were taken as a result of the events pyrexia, headache, nausea, chills, dizziness and pain.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The fever was very hard to get rid of. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever for five days; Headaches; Nausea; Chills; Lightheaded; Sore body; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 at 00:00 (Lot number: unknown) at the age of 17 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Diagnosed depression and anxiety and "Anxiety" (unspecified if ongoing), notes: Diagnosed depression and anxiety. Concomitant medication(s) included: FLUOXETINE and unspecified birth control medication. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown Anatomical site: left arm; Administration time: 00:00), administration date: 25Apr2021, when the patient was 17 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (21May2021 at 00:00), described as "High fever for five days"; HEADACHE (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Headaches"; NAUSEA (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Nausea"; CHILLS (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Chills"; DIZZINESS (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Lightheaded"; PAIN (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Sore body". The events "High fever for five days", "Headaches", "Nausea", "Chills", "Lightheaded" and "Sore body" were evaluated at the physician office visit. It was unknown whether any therapeutic measures were taken as a result of the events pyrexia, headache, nausea, chills, dizziness and pain.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The fever was very hard to get rid of. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Urticaria
Clinical narrative: Hives starting on upper body that appeared ~36-48 hours after vaccination and slowly spreading; Dose number=3; This is a spontaneous report from a contactable reporter (pharmacist).   A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Dec2021 (Lot number: FH8027) at the age of 70 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number : EN6200, Route of Administration : Intramuscular, Anatomical Location : Right arm), administration date: 20Feb2021, when the patient was 69 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number : EN6202, Route of Administration : Intramuscular, Anatomical Location : Right arm), administration date: 13Mar2021, when the patient was 69 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Dose number:3"; URTICARIA (non-serious) with onset 02Dec2021 at 22:00, outcome "unknown", described as "Hives starting on upper body that appeared approximately 36-48 hours after vaccination and slowly spreading". Therapeutic measures were not taken as a result of urticaria was unknown.  Additional Information: The patient had no known drug allergies (NKDA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The events resulted in emergency room/department or urgent care.