chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Softness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA156051) via an unspecified route of administration in the left arm on 11Mar2021 at 13:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included desvenlafaxine/succinate monohydrate (PRISTIQ) 25 mg, ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE) and paracetamol (TYLENOL); all for unknown indication from unknown date and unknown if ongoing. The patient previously received acetylsalicylic acid (ASPIRIN) and ibuprofen (MOTRIN), for an unknown indication on an unknown date and experienced drug allergy. On an unknown date in Mar2021, the patient experienced softness at injection site, lasting about 48 hours after vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event softness at injection site recovered on 13Mar2021, after the duration of 48 hours.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a noncontactable nurse (patient). A 51-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at the age of 51, via an unspecified route of administration, in the left arm, on Mar 8, 2021, at 12:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On Mar 9, 2021, patient experienced arm pain and round area of swelling at injection site. No therapeutic measures taken as a result of the reported events. Since the vaccination, patient has not tested for COVID-19. The outcome of arm pain and round area of swelling at injection site: recovering (at the time of this report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swollen arm at site of vaccination; This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 13Mar2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 20:00, the patient experienced swollen arm at site of vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen arm at site of vaccination was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Product administered at inappropriate site
Clinical narrative: Pain and soreness in left underarm; Vaccine was administered in the left leg; This is a spontaneous report from a contactable consumer, the patient.  A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left leg on 05Mar2021 at 11:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer diagnosis (right breast), lumpectomy in Mar2020 and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication included tamoxifen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 07Mar2021 at 11:45, 48 hours after the vaccination (also reported on 08Mar2021 at 16:00), the patient began to experience pain and soreness in left underarm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain and soreness in left underarm was recovered on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Allodynia, Facial pain, Fatigue, Headache, Hyperaesthesia
Clinical narrative: Nasal congestion; Burning hyperesthesia over the back; facial pain, seemingly over paranasal sinuses-e.g. pain over cheekbones/maxillary sinuses.; Fatigue; Headache; developed allodynia; This is a spontaneous report from a non-contactable physician, the patient. A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 08Mar2021 at 09:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient had no known allergies to medications, food, or other products. 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 vaccination. Concomitant medications included silodosin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. On 08Mar2021, approximately 45 minutes post vaccination, the patient developed headache that extended to facial pain, seemingly over paranasal sinuses-example, pain over cheekbones or maxillary sinuses. As day went on, the patient developed nasal congestion, fatigue, and later that evening developed allodynia manifesting as burning hyperesthesias over the back. The patient was fully recovered by next day. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache that extended to facial pain, seemingly over paranasal sinuses-example, pain over cheekbones or maxillary sinuses, nasal congestion, fatigue, and allodynia manifesting as burning hyperesthesias over the back was resolved on 09Mar2021. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Nasal congestion; Burning hyperesthesia over the back; facial pain, seemingly over paranasal sinuses-e.g. pain over cheekbones/maxillary sinuses.; Fatigue; Headache; developed allodynia; This is a spontaneous report from a non-contactable physician, the patient. A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 08Mar2021 at 09:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient had no known allergies to medications, food, or other products. 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 vaccination. Concomitant medications included silodosin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. On 08Mar2021, approximately 45 minutes post vaccination, the patient developed headache that extended to facial pain, seemingly over paranasal sinuses-example, pain over cheekbones or maxillary sinuses. As day went on, the patient developed nasal congestion, fatigue, and later that evening developed allodynia manifesting as burning hyperesthesias over the back. The patient was fully recovered by next day. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache that extended to facial pain, seemingly over paranasal sinuses-example, pain over cheekbones or maxillary sinuses, nasal congestion, fatigue, and allodynia manifesting as burning hyperesthesias over the back was resolved on 09Mar2021. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the left underarm, maybe soreness in lymphnode; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Mar2021 at 18:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy (sulfa allergy) and fruit (avocado) allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took pertussis vaccine (MANUFACTURER UNKNOWN) on an unknown date and experienced vaccine allergy. On 10Mar2021 at 09:00, the patient experienced soreness in the left underarm, maybe soreness in the lymph node. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness in the left underarm may be soreness in the lymph node was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 32-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 32, via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. On an unknown date, patient had diarrhea. The outcome of diarrhea: unknown (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 35-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 35, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 8, 2021, patient experienced sore arm, fatigue, headache, body ache and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of sore arm, fatigue, headache, body ache and chills: resolving (at the time of the report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: I woke up Monday morning with vertigo. I was dizzy and nauseated when I moved my head a certain way. This has continued and is current problem; I woke up Monday morning with vertigo. I was dizzy and nauseated when I moved my head a certain way. This has continued and is current problem; I woke up Monday morning with vertigo. I was dizzy and nauseated when I moved my head a certain way. This has continued and is current problem; This is a spontaneous report from a contactable nurse, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 04Mar2021 at 09:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included reactive airways disease. The patient had no known allergies to food, medications, or other products. 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 vaccination. Concomitant medications included montelukast sodium (SINGULAIR) and pantoprazole (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the arm left on 11Feb2021 at 10:00 as a single dose for COVID-19 immunisation. On 08Mar2021 at 05:15, the patient experienced vertigo, dizzy and nauseated. The patient woke up Monday morning with vertigo. She was dizzy and nauseated when she moved her head a certain way. This has continued and was current problem(as reported). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with meclizine (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, dizzy and nauseated was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site induration, Vaccination site swelling
Clinical narrative: Very hard, swollen arm at injection site around 1 week after injection.; Moderate pain in arm pit, by lymph node; Very hard, swollen arm at injection site around 1 week after injection.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included "simultaneously experiencing bad poison oak rash" and the patient had sensitivity to bananas. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and unspecified collagen supplement; both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021, the patient experienced very hard, swollen arm at injection site and moderate pain in arm pit, by lymph node. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very hard, swollen arm at injection site and moderate pain in arm pit, by lymph node was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: My left arm has weakness and has pain when I fully extend my arm up. This started about 5 days after injection and is ongoing.; My left arm has weakness and has pain when I fully extend my arm up.  This started about 5 days after injection and is ongoing.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 24Feb2021 at 18:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies to medication, food or other products. 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 vaccination. The patient did not receive any other medications within two weeks of vaccination. On 01Mar2021, 5 days after vaccination, the patient experienced left arm weakness and pain when she fully extend her arm up. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm has weakness and has pain when fully extend arm up. This started about 5 days after injection and is ongoing was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling; Numbness,; Pins and needles in hands, arms, and legs. Also had random needle-like stabbing over different parts of my body.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 vaccination. Concomitant medications were not reported. The patient previously took ciprofloxacin lactate (CIPRO) and sulfamethoxazole; trimethoprim (BACTRIM) for unknown indications on an unknown date and experienced drug allergy. On an unknown date in Mar2021, 5 hours after vaccination, the patient experienced tingling, numbness, pins and needles in hands, arms and legs. The patient also had random needle like stabbing over different parts of her body. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with hydroxyzine hydrochloride (ATARAX). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling, numbness, pins and needles in hands, arms and legs and random needle like stabbing over different parts of body was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Eye pain, Fatigue, Lymphadenopathy
Clinical narrative: Chills; Severe body ache; Eye pain; Sore armpit; Malaise; Fatigue; Swollen lymph nodes; This is a spontaneous report from a contactable pharmacist, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via intramuscular route of administration in the right arm on 15Jan2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an intramuscular route of administration in the right arm on 05Feb2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraine, Epstein-Barr virus test, irritable bowel syndrome (IBS-C), hyperlipidemia, carpal tunnel syndrome and gluten intolerance (gluten containing food). The patient previously received nitrofurantoin (MACROBID) on an unspecified date for an unknown indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine with in 4 weeks prior to vaccination. Concomitant medications included verapamil hydrochloride (VERAPAMIL), ropinirole (MANUFACTURER UNKNOWN), levocetirizine dihydrochloride (XYZAL), rosuvastatin calcium (CRESTOR), erenumab (AIMOVIG), vitamin d (MANUFACTURER UNKNOWN) and linaclotide (LINZESS) and VIRACID; all from unknown date for unknown indication unknown if ongoing. On 20Jan2021 at 08:00 the patient experienced chills, sore armpit, severe body ache, eye pain, malaise, fatigue, swollen lymph nodes  which last over 1month. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as result of events. On 23Feb2021, the patient underwent lab test included SAR-CoV-2 test and the result was Ab combo of 0.09. The clinical outcome of the events chills, sore armpit, severe body ache, eye pain, malaise, fatigue, swollen lymph node and sore armpit was recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, SARS-CoV-2 test
Clinical narrative: Chills; Severe body ache; Eye pain; Sore armpit; Malaise; Fatigue; Swollen lymph nodes; This is a spontaneous report from a contactable pharmacist, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via intramuscular route of administration in the right arm on 15Jan2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an intramuscular route of administration in the right arm on 05Feb2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraine, Epstein-Barr virus test, irritable bowel syndrome (IBS-C), hyperlipidemia, carpal tunnel syndrome and gluten intolerance (gluten containing food). The patient previously received nitrofurantoin (MACROBID) on an unspecified date for an unknown indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine with in 4 weeks prior to vaccination. Concomitant medications included verapamil hydrochloride (VERAPAMIL), ropinirole (MANUFACTURER UNKNOWN), levocetirizine dihydrochloride (XYZAL), rosuvastatin calcium (CRESTOR), erenumab (AIMOVIG), vitamin d (MANUFACTURER UNKNOWN) and linaclotide (LINZESS) and VIRACID; all from unknown date for unknown indication unknown if ongoing. On 20Jan2021 at 08:00 the patient experienced chills, sore armpit, severe body ache, eye pain, malaise, fatigue, swollen lymph nodes  which last over 1month. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as result of events. On 23Feb2021, the patient underwent lab test included SAR-CoV-2 test and the result was Ab combo of 0.09. The clinical outcome of the events chills, sore armpit, severe body ache, eye pain, malaise, fatigue, swollen lymph node and sore armpit was recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Lymphadenopathy, Pain
Clinical narrative: Body aches; Tired; Mild headache; Mild swollen lymph nodes under armpit and collar bone on side of injection; Dose 1 administered on 21Feb2021 and dose 2 administered on 05Mar2021; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and 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 vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 21Feb2021 at 16:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 06Mar2021, the patient experienced body aches, tired, mild headache and mild swollen lymph nodes under armpit and collar bone on side of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, tired, mild headache and mild swollen lymph nodes under armpit and collar bone on side of injection was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy for three days.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Feb2021 at 09:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, atrial fibrillation and penicillin allergy. 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. Concomitant medications included anastrozole (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS), rosuvastatin calcium (CRESTOR) and montelukast sodium (SINGULAIR); all for unspecified indication from unknown date and unknown if ongoing. On 23Feb2021 at 09:30, the patient experienced dizziness for three days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy was resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Axillary lymphadenopathy on same side as injection (Left shoulder) beginning day after vaccination; This is a spontaneous report from a contactable healthcare professional, the patient.  A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 03Mar2021 at 18:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 23:00, day after vaccination, the patient experienced axillary lymphadenopathy on same side as injection (left shoulder). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event axillary lymphadenopathy on same side as injection (left shoulder) was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Nausea, Vomiting
Clinical narrative: Severe nausea; Vomiting; Muscle fatigue; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Mar2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, house dust mite allergy and formaldehyde allergy. 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 vaccination. Concomitant medications included unspecified vitamins (unspecified). On 10Mar2021, 5 days after injection, the patient experienced severe nausea, vomiting and muscle fatigue. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not  been tested for COVID-19. The clinical outcome of the events severe nausea, vomiting and muscle fatigue was not recovered at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 51-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EL3247), at the age of 51, via an unspecified route of administration, in the left arm, on Mar 11, 2021, at 11:00, single dose, for COVID-19 immunisation. Medical history included known allergies to oysters. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified medication within two weeks of vaccination. On Mar 11, 2021, at 18:00, patient experienced soreness at the injection site and fatigue. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the reported events. The outcome of soreness at the injection site and fatigue recovered on an unknown date in Mar 2021. No follow-up attempts needed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Listless
Clinical narrative: Sleeplessness; Listless; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL4249) via an unspecified route of administration in the right arm on 01Feb2021 at 08:30 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications within two weeks of vaccination. On 04Feb2021 at 14:15, the patient experienced sleeplessness and listless. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. On an unknown date, the patient underwent nasal swab and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event sleeplessness and listless was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Retching, SARS-CoV-2 test
Clinical narrative: Significant stomach pain as if there were hands inside my stomach squezzing it as one would do to a wet rag to remove water; Significant dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 07Mar2021 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included graves disease and hypertension, both on an unknown date. 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 vaccination. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and fexofenadine hydrochloride (ALLEGRA), all on an unknown date for unknown indication and unknown if ongoing. The patient previously received amlodipine besilate (NORVASC) and experienced drug allergy on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 14Feb2021 at 18:30 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. On 08Mar2021 at 10:30, the patient experienced significant dry heaves for about 4 hours, day after second dose injection. On 11Mar2021, days 4 through day 6 after second dose injection, the patient experienced significant stomach pain as if there were hands inside her stomach squeezing it as one would do to a wet rag to remove water. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent nasal swab and the result was found to be negative. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event significant dry heaves was recovered on 08Mar2021. The clinical outcome of the event significant stomach pain as if there were hands inside her stomach squeezing it as one would do to a wet rag to remove water was recovered on 13Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Very Dizzy unable to function; This is a spontaneous report from a contactable other healthcare professional, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the right arm on 11Mar2021 at 14:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, diabetes, endometrial cancer, allergy to tree nuts (walnut) and COVID-19. 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 vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and triamterene/hydrochlorothiazide (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown dates and unknown if ongoing. On 14Mar2021 at 00:30, the patient experienced very dizzy and was unable to function. The events did not result in doctor or other health care professional office or clinic visit and emergency room or department or urgent care. It was unknown whether therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Nausea, Paraesthesia, Respiration abnormal
Clinical narrative: Strange breathing; Elevated heart rate; Tingling sensations in arm; Slight headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E/3302) via an unspecified route of administration in the arm on 11Mar2021 at 15:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy (banana). Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks of receiving the COVID-19 vaccine. The patient did not receive any other medications within two weeks of receiving the COVID-19 vaccine. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 11Mar2021 at 17:00, the patient experienced strange breathing, elevated heart rate, tingling sensations in arm that was administered the vaccine, slight headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events strange breathing, elevated heart rate, tingling sensations in arm that was administered the vaccine, slight headache and nausea was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears since 2nd injection; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 13Mar2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV (human immunodeficiency virus) infection. The patient had no known allergies to medications, food or other products. 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 vaccination. Concomitant medications included HIV medication (unspecified) from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 18Feb2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 14Mar2021 at 08:00, the patient experienced ringing in ears since 2nd injection. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears since 2nd injection was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme left arm pain; This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Mar2021, at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient did not have  any known allergies. It was unknown if the patient received any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021, at 09:30, the patient experienced extreme left arm pain. It was reported that the patient nearly went to emergency room secondary to the extent of pain. The event did not result in a visit to the doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme left arm pain was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Hypersomnia, Nausea, Tension headache
Clinical narrative: Vise-like headache; Nausea; Severe fatigue; Cough; was so fatigued that I slept most of the time except to use the bathroom or to drink fluids.; This is a spontaneous report from a contactable consumer, the patient. An 81-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 02Mar2021 at 09:00 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 09Feb2021, as a single dose for COVID-19 immunisation. On 12Mar2021 at 03:00, on the 10th day after receiving the second shot, the patient woke up with a vise-like headache, nausea, severe fatigue, and cough. The patient was so fatigued that she slept most of the time except to use the bathroom or to drink fluids. The patient had to make herself get out of bed. These symptoms persisted for 24 hours and then disappeared as fast as they came. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vise-like headache, nausea, severe fatigue and cough was recovered on 13Mar2021 at 03:00.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle ache on arm; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfr28ef7934) via an unspecified route of administration in the right arm on 14Mar2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. 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 vaccination. Concomitant medications were not reported. On 14Mar2021 at 17:00, the patient experienced muscle ache on arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle ache on arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.