chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Flushing, Pain in extremity, Paraesthesia
Clinical narrative: diffuse arthralgias; pain in the plantar fascia; flushed w/o fever; pins & needles sensation diffusely (face, arms, legs),; fatigue; This is a spontaneous report from a contactable physician. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, Graves' disease, seasonal allergy, migraine, cerebral aneurysm and the patient was allergic to sulfa drugs and IV dye. Concomitant medications included thiamazole (METHIMAZOLE), taken chronically for thyroid disorder from an unknown date. The patient previously took melatonin and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en7534) via an unspecified route of administration in the left arm on 11Mar2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced diffuse arthralgias, pain in the plantar fascia, flushed without fever, pins and needles sensation diffusely in face, arms, legs and fatigue. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), benadryl, baby Acetyl Salicylic Acid (ASA), tylenol and prednisone one daily. The patient reported that there was no relief with NSAIDS. The clinical outcome of the events diffuse arthralgias, pain in the plantar fascia, flushed without fever, pins and needles sensation diffusely in face, arms, legs and fatigue were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site pain
Clinical narrative: 2 inch diameter red welt at injection site,; Red welt at injection site, painful and extremely itchy; Red welt at injection site, painful and extremely itchy; This is a spontaneous report from a contactable consumer, the patient. A 66-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 left arm on 07Apr2021 at 11:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included GERD (Gastroesophageal reflux disease), anemia and caffeine allergy. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), esomeprazole magnesium (NEXIUM), cyanocobalamin (B12), iron (MANUFACTURER UNKNOWN) and aluminium hydroxide gel, dried, magnesium carbonate (PEPCID) all for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 as a single dose for COVID-19 immunisation.  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 patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 08Apr2021 at 06:00, next day after vaccination the patient experienced 2-inch diameter red welt at injection site, painful and extremely itchy. Four days in no change in size, pain or itchy. 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. The clinical outcome of the events 2-inch diameter red welt at injection site, painful and extremely itchy was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Swollen Lymph Node in injection arm; horrible headache; muscle aches; fever; chills; nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 07Apr2021 at 12:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and migraine. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks prior to vaccination included sertraline (MANUFACTURER UNKNOWN), bromelains, calcium carbonate, camellia sinensis leaf, glucosamine hydrochloride, zingiber officinale root (REPLENEX) (reported as Replenx), Pre/Probiotic and ibuprofen (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 17Mar2021 at 12:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 07:00 the patient experienced swollen lymph node in injection arm, horrible headache, muscle aches, fever, chills, nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department. No therapeutic measures were taken as a result of the events. The clinical outcome of the events swollen lymph node in injection arm, horrible headache, muscle aches, fever, chills, nausea was not resolved 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: Pyrexia
Clinical narrative: Swollen Lymph Node in injection arm; horrible headache; muscle aches; fever; chills; nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 07Apr2021 at 12:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and migraine. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks prior to vaccination included sertraline (MANUFACTURER UNKNOWN), bromelains, calcium carbonate, camellia sinensis leaf, glucosamine hydrochloride, zingiber officinale root (REPLENEX) (reported as Replenx), Pre/Probiotic and ibuprofen (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 17Mar2021 at 12:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 07:00 the patient experienced swollen lymph node in injection arm, horrible headache, muscle aches, fever, chills, nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department. No therapeutic measures were taken as a result of the events. The clinical outcome of the events swollen lymph node in injection arm, horrible headache, muscle aches, fever, chills, nausea was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Loss of consciousness
Clinical narrative: blacked out; hypotension episode; light headed; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0158), via an unspecified route of administration in the left arm on 10Apr2021 at 12:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included "fibro", anxiety, post-traumatic stress disorder (PTSD), depression. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications included gabapentin, duloxetine hydrochloride (CYMBALTA), amitriptyline hydrochloride (AMITRIPTYLLIN), esomeprazole. The patient previously took metronidazole and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 10:00, the patient experienced what she believed to be a hypotension episode and blacked out. The patient was still lightheaded but felt OK otherwise. She would follow up with the doctor if it continued. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was not resolved.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Intense Tinnitus; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 09Apr2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 01:00, the patient experienced intense tinnitus. 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. The clinical outcome of the event intense tinnitus was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea
Clinical narrative: severe bloating; severe diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) in the left arm on an unknown date in Mar2021 at 10:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic dermatology issues. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), clobetasol (MANUFACTURER UNKNOWN) and cetrimide; lidocaine hydrochloride; triamcinolone acetonide (TRI), all from an unknown date for unspecified indication. The patient previously took Bacitracin and experienced allergy. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 at 16:00 (after two weeks of vaccination), the patient experienced severe bloating and severe diarrhea. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe bloating and diarrhea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pharyngeal mass
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP7533), at the age of 30, via an unspecified route of administration, left arm, on Apr 8, 2021, at 15:00, single dose, for COVID-19 immunisation. The patient has no medical history. The patient has no allergies to medications, food or other products. The patient received medications (unspecified) within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Apr 8, 2021, at 15:30 (30 minutes after the vaccine), patient experienced numb lips and tongue. At 15:45 (45 minutes after the vaccine), patient still had numb lips and tongue. She also experienced numb palate and a lump in the throat. At 16:00 (60 minutes after vaccine), patient still had all the reported events and also experienced numbness in bilateral 4th and 5th fingers. The events resulted in emergency room/department visit or urgent care. Therapeutic measures taken as a result of adverse events included treatment with prednisone and Ativan (lorazepam). The clinical outcome of numb lips, tongue and palate, lump in throat and numbness in bilateral 4th and 5th fingers: recovering (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lymph node pain, Nausea, Vaccination site pain
Clinical narrative: lymph node pain; severe pain in arm that vaccine was given in; dizziness; nausea; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 08Apr2021 at 10:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 07:00, day after vaccination, the patient experienced dizziness, nausea and fatigue and on 10Apr2021, from second day to the time of report the patient experienced lymph node pain and severe pain in arm to which vaccine was administered. The events did not result in doctor or other healthcare professional office/clinic visit.  Therapeutic measures were not taken as the result of adverse events. The clinical outcome of the events dizziness, nausea and fatigue, lymph node pain and severe pain in arm were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Shortly after injection of first dose, I experienced a "vaccine-like" or "metal like" taste in my mouth; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the arm left on 10Apr2021 at 13:15(at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history were reported as no. Concomitant medications included ascorbic acid (VITAMIN C), tocopheryl acetate (VITAMIN E) and colecalciferol (VITAMIN D3) all taken for unknown indication from unknown date. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to COVID-19 vaccine. On 10Apr2021 at 13:15 shortly after injection of first dose, the patient experienced a "vaccine-like" or "metal like" taste in her mouth. It was reported that the event lasted very long maybe less than two hours and she did not really look at the clock. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event "vaccine-like" or "metal like" taste in mouth was resolved on 10Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache, Pain, Pyrexia
Clinical narrative: Vomiting; general body pain; chills; fever; headache; abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 10Apr2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroparesis. The patient did not receive any medication within two weeks of vaccination. The patient did not have allergies to medications, food, or other products. . The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number :Unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 01:00 the patient experienced vomiting, body pain, chills, fever, headache and abdominal pain. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vomiting, body pain, chills, fever, headache and abdominal pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; general body pain; chills; fever; headache; abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 10Apr2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroparesis. The patient did not receive any medication within two weeks of vaccination. The patient did not have allergies to medications, food, or other products. . The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number :Unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 01:00 the patient experienced vomiting, body pain, chills, fever, headache and abdominal pain. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vomiting, body pain, chills, fever, headache and abdominal pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Lethargy, Myalgia, Sensitive skin
Clinical narrative: Large hard lump; Hot; Very sensitive; Red; Lethargic; Tired; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 58-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 09Apr2021 at 11:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had no known allergies to medications, food or other products. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient did not receive any other vaccine 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. On 10Apr2021 at 03:30, the patient experienced large hard lump, red, hot and very sensitive, lethargic, tired, muscle pain. 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. The clinical outcomes of large hard lump, red, hot and very sensitive, lethargic, tired, and muscle pain were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Skin warm
Clinical narrative: Large hard lump; Hot; Very sensitive; Red; Lethargic; Tired; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 58-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 09Apr2021 at 11:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had no known allergies to medications, food or other products. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient did not receive any other vaccine 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. On 10Apr2021 at 03:30, the patient experienced large hard lump, red, hot and very sensitive, lethargic, tired, muscle pain. 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. The clinical outcomes of large hard lump, red, hot and very sensitive, lethargic, tired, and muscle pain were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Peripheral swelling
Clinical narrative: Pain; Swelling, and tingling in bilateral hands and half way up forearms.; Tingling in bilateralhands and half way up forearms.; This is a spontaneous report received from a contactable nurse (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 25-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, opioid type dependence and anxiety from an unspecified date. The patient did not have allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), naloxone hydrochloride, buprenorphine hydrochloride (SUBOXONE) and vitamin nos (DAILY WOMENS VITAMIN) from unknown dates taken for unknown indications. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Apr2021 at 09:00, the patient experienced pain, swelling, and tingling in bilateral hands and half way up forearms. Therapeutic measures were taken as a result of pain, swelling, and tingling in bilateral hands and half way up forearms and included treatment with rest, ice, compress and elevate. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events pain, swelling, and tingling in bilateral hands and half way up forearms were recovered with sequelae on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Violent vomiting; diarrhea; fever; nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included celiac disease. Concomitant medications included levothyroxine sodium (SYNTHROID) 100mcg, metoprolol (MANUFACTURER UNKNOWN) 50mg and vitamin d nos (VITAMIN D); all for unspecified indication from unknown date. The patient previously took azithromycin (MANUFACTURER UNKNOWN) for unspecified indication on unknown date and experienced drug allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 23Feb2021 at 11:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 18:00, the patient experienced violent vomiting, diarrhea, fever and nausea for four days. 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 event.  The clinical outcome of the event violent vomiting, diarrhea, fever and nausea for four days was recovered on 22Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Flushing, Headache, Mast cell activation syndrome, Rash macular
Clinical narrative: moderate vertigo; chest tightness; slight wheezing; forehead tightness; mild facial swelling; had flushing on my lower arms with small unraised red spots; had flushing on my lower arms with small unraised red spots; suspected mast cell activation syndrome; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) dose 1 via an unspecified route of administration, administered in the left arm on 10Apr2021 at 08:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included Basedow's disease from an unknown date and unknown if ongoing , anaphylactic reaction from an unknown date and unknown if ongoing , mast cell activation syndrome from an unknown date and unknown if ongoing , penicillin allergy from an unknown date and unknown if ongoing , sulfanomide allergy from an unknown date and unknown if ongoing , beans and legumes allergy from an unknown date and unknown if ongoing , and pollen allergy from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOXYL) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Apr2021, at 08:45 AM, the patient experienced suspected mast cell activation syndrome (medically significant), and flushing on my lower arms with small unraised red spots (rash macular and flushing). At 9:15 am, the patient experienced forehead tightness, mild facial swelling. At 20:15 (8:15pm), the patient experienced chest tightness, and slight wheezing. On 11Apr2021, at 08:45 AM, the patient developed moderate vertigo. The patient stated, "about 15 min after the injection I had flushing on my lower arms with small unraised red spots.  About an hour after I experienced forehead tightness and mild facial swelling.  I pre treated with Benadryl and Pepcid due to suspected Mast Cell Activation Syndrome.  I have had 4 previous anaphylaxis reactions to foods and this didn't feel the same.  I took more Benadryl about an hour and a half after the injection, and the tightness and forearm symptoms dissipated.  12 hours after the injection I developed chest tightness and slight wheezing.  I took Zyrtec and Pepcid with minimal improvement.  24 hours after injection I developed moderate vertigo". The patient was recovering from the events, forehead tightness and flushing on my lower arms with small unraised red spots, but had not recovered from the other events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vertigo, Wheezing
Clinical narrative: moderate vertigo; chest tightness; slight wheezing; forehead tightness; mild facial swelling; had flushing on my lower arms with small unraised red spots; had flushing on my lower arms with small unraised red spots; suspected mast cell activation syndrome; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) dose 1 via an unspecified route of administration, administered in the left arm on 10Apr2021 at 08:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included Basedow's disease from an unknown date and unknown if ongoing , anaphylactic reaction from an unknown date and unknown if ongoing , mast cell activation syndrome from an unknown date and unknown if ongoing , penicillin allergy from an unknown date and unknown if ongoing , sulfanomide allergy from an unknown date and unknown if ongoing , beans and legumes allergy from an unknown date and unknown if ongoing , and pollen allergy from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOXYL) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Apr2021, at 08:45 AM, the patient experienced suspected mast cell activation syndrome (medically significant), and flushing on my lower arms with small unraised red spots (rash macular and flushing). At 9:15 am, the patient experienced forehead tightness, mild facial swelling. At 20:15 (8:15pm), the patient experienced chest tightness, and slight wheezing. On 11Apr2021, at 08:45 AM, the patient developed moderate vertigo. The patient stated, "about 15 min after the injection I had flushing on my lower arms with small unraised red spots.  About an hour after I experienced forehead tightness and mild facial swelling.  I pre treated with Benadryl and Pepcid due to suspected Mast Cell Activation Syndrome.  I have had 4 previous anaphylaxis reactions to foods and this didn't feel the same.  I took more Benadryl about an hour and a half after the injection, and the tightness and forearm symptoms dissipated.  12 hours after the injection I developed chest tightness and slight wheezing.  I took Zyrtec and Pepcid with minimal improvement.  24 hours after injection I developed moderate vertigo". The patient was recovering from the events, forehead tightness and flushing on my lower arms with small unraised red spots, but had not recovered from the other events.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Headache; Nausea; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 39-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 left arm on 10Apr2021 at 13:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included thyroid disorder. The patient did not have any allergies to medications, food or other products. Concomitant medications were not reported. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 23:45, the patient experienced headache, nausea and tiredness. 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. The clinical outcome of the events headache, nausea and tiredness were not resolved at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Soreness in same arm as injection; Stiffness in same arm as injection; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 10Apr2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received unspecified medications within 2 weeks of the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 20Apr2021 at 16:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. 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 patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021 at 23:00, the patient experienced soreness and stiffness in same arm as injection. 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. The clinical outcome of the event soreness and stiffness in same arm as injection was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Pyrexia
Clinical narrative: Extremely tired; Mild fever; Unable to lift arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 60-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 right arm on 09Apr2021 at 12:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included heart disorder. The patient had no Allergies to medications, food, or other products. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 12:30, the patient experienced unable to lift arm, extremely tired and mild fever. 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. The clinical outcome of the events unable to lift arm, extremely tired and mild fever was resolving at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained.  No further information is expected
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Breast pain, Confusional state, Diarrhoea
Clinical narrative: Severe soreness in breasts on day three; Severe soreness in breasts on day three (constant discomfort throughout day); Exhausted day 2 and 3; Stomach pain day 2; Diarrhea day 2; Back pain day 1, 2, 3; Foggy mental status day 1; Sore arm day 1 and two; Shaking immediately after vaccination; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 09Apr2021 at 08:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included degenerative disk disease in low back (back pain unrelated to DDD), meat allergy and seafood allergy. Concomitant medications included sertraline hydrochloride (ZOLOFT), lorazepam (MANUFACTURER UNKNOWN), and lisdexamfetamine mesilate (VYVANSE), all for an unknown indication from an unknown start date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 07:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation and also experienced drug allergy to cefalexin (KEFLEX). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021, the patient experienced shaking immediately after vaccination and also experienced foggy mental status day 1, sore arm day 1 and two and back pain day 1, 2, 3. On 10Apr2021, the patient experienced stomach pain day 2, diarrhea day 2 and exhausted day 2 and 3.  On 11Apr2021, the patient experienced severe soreness in breasts on day three (constant discomfort throughout day). No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the event severe soreness in breasts on day three (constant discomfort throughout day), back pain, foggy mental status, exhausted, stomach pain, diarrhea, shaking immediately after vaccination and sore arm were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Pain in extremity, Tremor
Clinical narrative: Severe soreness in breasts on day three; Severe soreness in breasts on day three (constant discomfort throughout day); Exhausted day 2 and 3; Stomach pain day 2; Diarrhea day 2; Back pain day 1, 2, 3; Foggy mental status day 1; Sore arm day 1 and two; Shaking immediately after vaccination; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 09Apr2021 at 08:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included degenerative disk disease in low back (back pain unrelated to DDD), meat allergy and seafood allergy. Concomitant medications included sertraline hydrochloride (ZOLOFT), lorazepam (MANUFACTURER UNKNOWN), and lisdexamfetamine mesilate (VYVANSE), all for an unknown indication from an unknown start date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 07:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation and also experienced drug allergy to cefalexin (KEFLEX). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021, the patient experienced shaking immediately after vaccination and also experienced foggy mental status day 1, sore arm day 1 and two and back pain day 1, 2, 3. On 10Apr2021, the patient experienced stomach pain day 2, diarrhea day 2 and exhausted day 2 and 3.  On 11Apr2021, the patient experienced severe soreness in breasts on day three (constant discomfort throughout day). No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the event severe soreness in breasts on day three (constant discomfort throughout day), back pain, foggy mental status, exhausted, stomach pain, diarrhea, shaking immediately after vaccination and sore arm were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: Since last night nauseous; Since last night bad headache which I never have; Since last night light fever; Flu like feeling; Shooting pains everywhere have arthritis; Clammy; Tingling in head all on & off last 5 days; Last five days extreme tiredness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E128733) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and Barrett's esophagus. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), omeprazole and clindamycin (MANUFACTURER UNKNOWN) all started from an unknown date, for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 07:45 as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) which caused allergy. 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 patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that, from last five days, 06Apr2021 at 12:00, the patient experienced extreme tiredness, clammy, flu like feeling, shooting pains everywhere have arthritis, tingling in head all on and off last 5 days. Since last night, on 10Apr2021, the patient felt nauseous, bad headache (which she never had) and slight fever. The patient had been taking TYLENOL every 6 hours as therapeutic measures for the reported events and reported to first time having to take something but not helping. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events flu like feeling, shooting pains everywhere, clammy, tingling in head, extreme tiredness, nauseous, bad headache and slight fever was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia
Clinical narrative: Since last night nauseous; Since last night bad headache which I never have; Since last night light fever; Flu like feeling; Shooting pains everywhere have arthritis; Clammy; Tingling in head all on & off last 5 days; Last five days extreme tiredness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E128733) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and Barrett's esophagus. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), omeprazole and clindamycin (MANUFACTURER UNKNOWN) all started from an unknown date, for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 07:45 as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) which caused allergy. 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 patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that, from last five days, 06Apr2021 at 12:00, the patient experienced extreme tiredness, clammy, flu like feeling, shooting pains everywhere have arthritis, tingling in head all on and off last 5 days. Since last night, on 10Apr2021, the patient felt nauseous, bad headache (which she never had) and slight fever. The patient had been taking TYLENOL every 6 hours as therapeutic measures for the reported events and reported to first time having to take something but not helping. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events flu like feeling, shooting pains everywhere, clammy, tingling in head, extreme tiredness, nauseous, bad headache and slight fever was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.