chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Migraine with aura; Burning pain along her right side; prolonged nosebleed; bruise developed under right eye; mouth ulcer; Joint pain; Stiffness; Stomach pain; headache; arm soreness; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patients medical history included Bechet's disease. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 since having the vaccine. The patient experienced normal headache and arm soreness after 48 hours of vaccination and severe fatigue on 22Mar2021 and prolonged nosebleed, a bruise developed under her right eye, mouth ulcer, joint pain, stiffness, and stomach pain on 23Mar2021 and had another nose bleed on 24Mar2021 and migraine with aura and unusual burning pain along her right side on 25Mar2021. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, arm soreness, fatigue, nosebleed, bruising, mouth ulcer, joint pain, stiffness, stomach pain, migraine with aura and burning pain was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: Sore throat; shortness of breath after walking short distance in home; Headache; Tiredness/ fatigued; Chills; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. An 84-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 05Mar2021 at 11:45 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and had abatacept (ORENCIA) infusion monthly. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alendronate sodium (FOSAMAX) and levothyroxine sodium (SYNTHROID) for unknown indications from unknown dates. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Mar2021, the patient experienced headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 23Mar2021 which included nasal swab and the test result was negative. The patient did not receive any treatment for the events headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home. The clinical outcomes of the events headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat; shortness of breath after walking short distance in home; Headache; Tiredness/ fatigued; Chills; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. An 84-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 05Mar2021 at 11:45 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and had abatacept (ORENCIA) infusion monthly. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alendronate sodium (FOSAMAX) and levothyroxine sodium (SYNTHROID) for unknown indications from unknown dates. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Mar2021, the patient experienced headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 23Mar2021 which included nasal swab and the test result was negative. The patient did not receive any treatment for the events headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home. The clinical outcomes of the events headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Eye irritation, Nasal congestion, Ocular hyperaemia, Pyrexia
Clinical narrative: Have a scratchy voice; I experience the swelling of my eyes; They became bloodshot; Felt incredibly irritated; Have a scratchy voice; They burned along the lash line.; I had an incredibly stuffy and runny nose; Runny nose; I now feel like feverish; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration, administered in right arm on 26Mar2021 at 16:45 (at the age of 22 years) as dose 1, single for covid-19 immunization. Medical history included irritable bowel syndrome, acid reflux. The patient's concomitant medications were not reported. The patient previously took witch hazel and experienced allergy. Patient had no other vaccine in four weeks. The patient did not test COVID-19 positive prior to vaccination. On 27Mar2021, at 02:30, the patient experienced the swelling of her eyes. They became bloodshot and felt incredibly irritated and they burned along the lash line. it hurt to close her eyes and she had an incredibly stuffy and runny nose then she felt like feverish and had a scratchy voice and her eyes were still swollen. The patient received for the events scratchy voice, ocular hyperemia, swelling of eyelid, eye irritation, and rhinorrhea with Benadryl and flush her eyes and did a compare. The patient was not tested for COVID-19 since the vaccination. The outcome the events was unknown.  Information about Lot and batch number requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Swelling of eyelid, Throat irritation
Clinical narrative: Have a scratchy voice; I experience the swelling of my eyes; They became bloodshot; Felt incredibly irritated; Have a scratchy voice; They burned along the lash line.; I had an incredibly stuffy and runny nose; Runny nose; I now feel like feverish; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration, administered in right arm on 26Mar2021 at 16:45 (at the age of 22 years) as dose 1, single for covid-19 immunization. Medical history included irritable bowel syndrome, acid reflux. The patient's concomitant medications were not reported. The patient previously took witch hazel and experienced allergy. Patient had no other vaccine in four weeks. The patient did not test COVID-19 positive prior to vaccination. On 27Mar2021, at 02:30, the patient experienced the swelling of her eyes. They became bloodshot and felt incredibly irritated and they burned along the lash line. it hurt to close her eyes and she had an incredibly stuffy and runny nose then she felt like feverish and had a scratchy voice and her eyes were still swollen. The patient received for the events scratchy voice, ocular hyperemia, swelling of eyelid, eye irritation, and rhinorrhea with Benadryl and flush her eyes and did a compare. The patient was not tested for COVID-19 since the vaccination. The outcome the events was unknown.  Information about Lot and batch number requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: face was covered with hives; body now has hives all over; Head started to itch; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: Er8730), via unspecified route of administration in the left arm on 27Mar2021 at 08:15 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy from unknown date. Patient received magnesium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), both for unspecified indication from unknown dates within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 12:15, 4 hours after the vaccination, the patient experienced head start to itch and within next 15 minutes, patients face was covered with hives and in next hour had hives all over body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures taken as a result of hives and itching that included treatment with Benadryl. The clinical outcome of the event of hives and itching was resolving, at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Vaccination site pain
Clinical narrative: I have a huge, painful warm mass inmy left axilla; tenderness topalpation of injection site; This is a spontaneous report from a contactable health care professional, the patient. A 38-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730,) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The medical history included endometriosis and anxiety and had allergies to IVP (intravenous pyelogram) dye. The concomitant medications received within two weeks of vaccination included loratadine (CLARITIN), guaifenesin (MUCINEX), norgestimate and ethinyl estradiol (ESTRELLA), venlafaxine (EFFEXOR), and alprazolam (Xanax) all for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202 via unspecified route of administration in the left arm on 24Feb2021 (at the age 38-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced axillary mass which was a huge, painful and warm mass in the left axilla which appeared less than 12 hours after injection and it was also visible and also there was tenderness to palpation of the injection site (vaccination site tenderness). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of axillary mass and vaccination site tenderness was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pyrexia, Rash pruritic
Clinical narrative: Fever; body aches; Joint pain; Headache; severe itching with rash; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old 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 24Mar2021 at 13:15 (at the age of 72-year-old) as single dose for COVID-19 immunisation. Medical history included obesity, copes and arthritis. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), meloxicam (MANUFACTURER UNKNOWN), metoprolol tartrate (LOPRESSOR), vitamin c and vitamin d (MANUFACTURER UNKNOWN), all for unknown indications. The patient had a history of allergy to penicillin, codeine and latex. Since the vaccination, the patient had not been tested for COVID-19. 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. On 25Mar2021, at 04:00, the patient experienced fever, body aches, joint pain, headache which were lasted for about 2 days. On an unknown date in 2021, day 8 after the vaccination, the patient had experienced severe itching with rash over her entire body. Therapeutic measures taken as a result of adverse events included Benadryl antihistamine. Adverse events 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 events fever, body aches, joint pain and headache was resolved in Mar2021 whereas the outcome of severe itching with rash was unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in jaw
Clinical narrative: Extremely severe & debilitating pain in sides of head & jaw.; Extremely severe & debilitating pain in sides of head & jaw.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8730, Pfizer NTEC), via an unspecified route of administration in left arm on 25Mar2021 at 07:30 (at the age of 62-years-old) as dose 2, single for Covid-19 immunization. The patient medical history included arthritis, rib injury from Aug2020 and dental emergency. The patient had no known allergies. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6202) via an unspecified route of administration in left arm on 04Mar2021 at 12:15 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated that, on 25Mar2021 at 22:00 the patient had experienced extremely severe & debilitating pain in sides of head & jaw. Felt like in a vise. Worst pain she had ever experienced in her life, exponentially more pain than labor contractions, dental emergency, & rib fracture. If there had been a way to quickly end my life, she was afraid she would have done it to make the pain stop - that was how severe it was & desperate she was. Had some hydrocodone pain medication leftover from a rib injury last August & after 4 hours of agony & ice packs on head & jaw with no relief she craved and took it. Each minute felt like an hour. Worried hydrocodone will interfere with immune response but had no choice. Had to take one every 6 hours to keep pain at tolerable level and she only had 5 left. Terrified of possibility of boosters. She would not do Pfizer again & do not know if she could switch to J&J after this. The patient did not receive treatment for the adverse events. The clinical outcome for the events was recovering.; Sender's Comments: Based on plausible temporality the causal role of the BNT162B2 vaccine cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Right side neck swelling pressure in lower head and shoulder; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via an unspecified route of administration in the right arm on 24Mar2021 at 09:15 as a single dose (at the age of 59-years-old) for COVID-19 immunisation. The patient had a history of allergies (unspecified) to medications, food and other products. Medical history included type 2 diabetic mellitus, high blood pressure and NASH (Non-alcoholic steatohepatitis). The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the right arm on 03Mar2021 at 15:30 (at the age of 59-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. On 27Mar2021 at 4:00, after 3 days of vaccination the patient had experienced right side neck swelling pressure in lower head and shoulder. The patient did not receive treatment for the reported event. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event right side neck swelling pressure in lower head and shoulder was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Pain, Swelling
Clinical narrative: Right side neck swelling pressure in lower head and shoulder; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via an unspecified route of administration in the right arm on 24Mar2021 at 09:15 as a single dose (at the age of 59-years-old) for COVID-19 immunisation. The patient had a history of allergies (unspecified) to medications, food and other products. Medical history included type 2 diabetic mellitus, high blood pressure and NASH (Non-alcoholic steatohepatitis). The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the right arm on 03Mar2021 at 15:30 (at the age of 59-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. On 27Mar2021 at 4:00, after 3 days of vaccination the patient had experienced right side neck swelling pressure in lower head and shoulder. The patient did not receive treatment for the reported event. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event right side neck swelling pressure in lower head and shoulder was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mass, Muscular weakness, Musculoskeletal discomfort, Speech disorder
Clinical narrative: Right side neck swelling pressure in lower head and shoulder; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via an unspecified route of administration in the right arm on 24Mar2021 at 09:15 as a single dose (at the age of 59-years-old) for COVID-19 immunisation. The patient had a history of allergies (unspecified) to medications, food and other products. Medical history included type 2 diabetic mellitus, high blood pressure and NASH (Non-alcoholic steatohepatitis). The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the right arm on 03Mar2021 at 15:30 (at the age of 59-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. On 27Mar2021 at 4:00, after 3 days of vaccination the patient had experienced right side neck swelling pressure in lower head and shoulder. The patient did not receive treatment for the reported event. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event right side neck swelling pressure in lower head and shoulder was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe joint ache; This is spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an unspecified route of administration in the left arm on 01Mar2021 at 09:30 (at the age of 53-year-old) as a single dose as a single dose for COVID-19 immunisation. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 at 17:00, the patient experienced severe joint ache. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. No therapeutic treatment was taken for the reported events. The clinical outcome of the event severe joint ache was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymphnode in underarm on left arm; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 26Mar2021 at 09:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included the patient was diagnosed with COVID-19 prior to the vaccination. The patient had no known allergies to food, medications or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since vaccination, the patient had not been tested for COVID-19. Concomitant medications received within two weeks of vaccination included birth control- IDU MIRENA. On 27Mar2021 at 12:00, the patient experienced swollen lymph node in underarm on left arm. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of lymphadenopathy axillary was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Redness at injection site; Itchiness at injection site; Heat at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 31-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 16Mar2021 at 15:00 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC); both taken for unknown indication on an unknown date and ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) taken for birth control on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced redness, itchiness and heat at injection site 10 days post vaccination. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events vaccination site itchiness, vaccination site redness and vaccination site warmth were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Neck pain
Clinical narrative: swollen nodes in armpit that same evening.; Sore neck glands 2days after shot; Swollen Lymph Nodes on right side of body.; Unusual Right knee pain next morning/day after shot; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in the right arm on 24Mar2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN); all for unspecified indications, from unspecified start dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm on 03Mar2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 03:00, the patient experienced swollen lymph nodes on right side of body and unusual right knee pain next morning/day after shot, and gone by following day morning. On 26Mar2021, patient had sore neck glands followed by swollen nodes in armpit that same evening. Day 3 after receiving the vaccine, nodes were still swollen. All issues are on right side of body. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of right knee was recovered on 26Mar2021 and sore neck glands, swollen nodes in armpit, and swollen lymph nodes was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Formication, Pruritus, Rash erythematous, SARS-CoV-2 test
Clinical narrative: Itching.; Random red rash appears  on numerous  parts of the body; feel headcrawling; This is a spontaneous report from contactable healthcare professional. A 28-year-old male patient received the second dose BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3249) via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE: Lot number: EL0140) via an unspecified route of administration in the left arm on 23Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 12Jan2021 the patient experienced itching, red rash and crawling sensation. The patient had itching, a random red rash appeared on numerous parts of the body one month after receiving the second dose of the vaccine. The patient also felt head crawling. The event resulted in a doctor or other healthcare professional office/clinic visit. On an unknown date, post-vaccination, the patient underwent a COVID-19 virus test (nasal swab test) and resulted negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itching, red rash and crawling sensation were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lethargy, Muscle spasms, Pain
Clinical narrative: Left arm became painful throughout length; Became very lethargic; Trapezius muscle on left side spasmed; General body aches; chills; Fever (101.0 F); This is a spontaneous report from a contactable other healthcare professional, the patient. A 31-year-old non- pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration in left arm on 27Mar2021 at 09:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar Type 2. The patient was received acetaminophen (MANUFACTURER UNKNOWN) for an unknown indication and other unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205), via an unspecified route of administration in left arm on 06Mar2021 at 09:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 13:00 (4 hours after vaccination), the patient experienced left arm became painful throughout length and became very lethargic, trapezius muscle on left side spasmed when attempts were made to get up from a nap by pushing off with left arm. Slowly developed general body aches, chills, fever (101.0 F) that was refractory to acetaminophen. No treatment was received for any events. 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 events pain in left arm, lethargy, general body pain, chills, fever (also reported as ongoing for last 14 hours) and muscle spasm was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Left arm became painful throughout length; Became very lethargic; Trapezius muscle on left side spasmed; General body aches; chills; Fever (101.0 F); This is a spontaneous report from a contactable other healthcare professional, the patient. A 31-year-old non- pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration in left arm on 27Mar2021 at 09:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar Type 2. The patient was received acetaminophen (MANUFACTURER UNKNOWN) for an unknown indication and other unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205), via an unspecified route of administration in left arm on 06Mar2021 at 09:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 13:00 (4 hours after vaccination), the patient experienced left arm became painful throughout length and became very lethargic, trapezius muscle on left side spasmed when attempts were made to get up from a nap by pushing off with left arm. Slowly developed general body aches, chills, fever (101.0 F) that was refractory to acetaminophen. No treatment was received for any events. 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 events pain in left arm, lethargy, general body pain, chills, fever (also reported as ongoing for last 14 hours) and muscle spasm was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 26March2021 at 14:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included birth control (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN): all from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and sulfa meds on an unknown date for unspecified indication and experienced a sulfonamide allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27March2021 at 03:00, the patient experienced muscle aches and chills as expected and her lymph node in her armpit of the arm injected to harden and the area to swell to a visible level. It was still very tender and swollen. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event muscle aches, chills, swollen lymph node and lymph node tenderness was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Left arm was sore for several days, then began getting pain and stiffness in left elbow.; Left arm was sore for several days, then began getting pain and stiffness in left elbow.; This is a spontaneous report from a contactable consumer, the patient. A 62-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 10Mar2021 (at the age of 62-years-old) at 11:45 as a single dose for COVID-19 immunisation. Medical history included low thyroid, sleep apnea, arthritis in knees and ankle, osteoporosis. Birdshot retinopathy was once suspected but if the patient had it was in remission. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), and vit d (MANUFACTURER UNKNOWN) all for unknown indications from unknown dates. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 10Mar2021 at 13:00, after vaccination, the patient experienced left arm was sore for several days, then began getting pain and stiffness in left elbow (pain in elbow). This has remained. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The clinical outcomes of pain in arm and pain in elbow were not resolved at this time of report.  No follow-up attempts are possible; information about lot number cannot be obtained
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure abnormal, Blood pressure measurement, Cold sweat, Diarrhoea
Clinical narrative: Blood pressure 151/120; Started getting very clammy then my left arm and leg was kicking on their own; Started getting very clammy then my left arm and leg was kicking on their own; Then two nights later had very bad stomach cramping; Diarrhea all night; This is a spontaneous report from a contactable consumer or other non Healthcare professional (patient, reported for self). A 53-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER2613 31Jul2021), via an unspecified route of administration, administered in Arm Right at the age of 53-year-old on 25Mar2021 12:00 as dose 1, single for COVID-19 immunization. Medical history included multiple myeloma-stem cell transplant. Concomitant medication(s) (List of other medications the patient received within 2 weeks of vaccination) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were 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. On 25Mar2021 12:00 the patient Started getting very clammy then her left arm and leg was kicking on their own. Blood pressure was 151/120 (units not reported). Then two nights later had very bad stomach cramping and diarrhea all night (medically significant). Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure measurement: 151/120 on 25Mar2021 Blood pressure 151/120. The patient received treatment with Benadryl. The clinical outcome of the events was reported as recovering.  Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: Blood pressure 151/120; Started getting very clammy then my left arm and leg was kicking on their own; Started getting very clammy then my left arm and leg was kicking on their own; Then two nights later had very bad stomach cramping; Diarrhea all night; This is a spontaneous report from a contactable consumer or other non Healthcare professional (patient, reported for self). A 53-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER2613 31Jul2021), via an unspecified route of administration, administered in Arm Right at the age of 53-year-old on 25Mar2021 12:00 as dose 1, single for COVID-19 immunization. Medical history included multiple myeloma-stem cell transplant. Concomitant medication(s) (List of other medications the patient received within 2 weeks of vaccination) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were 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. On 25Mar2021 12:00 the patient Started getting very clammy then her left arm and leg was kicking on their own. Blood pressure was 151/120 (units not reported). Then two nights later had very bad stomach cramping and diarrhea all night (medically significant). Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure measurement: 151/120 on 25Mar2021 Blood pressure 151/120. The patient received treatment with Benadryl. The clinical outcome of the events was reported as recovering.  Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Nausea
Clinical narrative: Extreme nausea; Diarrhea; Complete loss of appetite; This is a spontaneous report from a contactable nurse, the patient. A 44-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 right arm on 25Mar2021 at 15:30 (44-year-old at the time of vaccination) as a single dose for COVID-19 immunisation. Medical history included PCOS (polycystic ovarian syndrome), hashimotos disease and GERD (Gastro-oesophageal reflux disease). Concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), levothyroxine (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY), levocetirizine dihydrochloride (XYZAL) all started since an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in right arm on 04Mar2021 at 15:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced extreme nausea, diarrhoea and complete loss of appetite. The patient did not receive any treatment for the 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 extreme nausea, diarrhoea, and complete loss of appetite was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash all Over body; This is a spontaneous report from a contactable patient. A 63-year-old non pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history of the patient included breast cancer, psoriasis and rosacea. The patient was allergic to Senna laxatives. The patient previously 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 16Mar2021 13:30 as a single dose for COVID-19 immunisation. Concomitant medications include Anastrazole (MANUFACTURER UNKNOWN) and Synthroid (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021, 3 days after the first dose of vaccination, the patient experienced itchy rash all over body, thought it was hives. Rash continued and second shot was received. Rash became worse on an unknown date, and 2 weeks after second rash and with 6 days course of steroids, rash was still present and worse as steroids tapered. The adverse event led to doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken for the adverse events and it included treatment with Zyrtec and steroids from an unknown date. The clinical outcome of the event itchy rash all over body and rash became worse was not resolved at the time of reporting.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Breast pain, Lymphorrhoea
Clinical narrative: Lymph nodes to left breast producing yellow leakage; Lymph nodes to left breast producing yellow leakage; severe pain in left breast; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 24Mar2021 11:15 as dose 2, single for COVID-19 immunization. Medical history included High blood pressure, brain tumor and allergies: latex. Concomitant medication included estradiol (ESTROGEN) and blood pressure medication. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization. On 27Mar2021 06:00 the patient woke up with severe pain in left breast and experienced lymph nodes to left breast producing yellow leakage. The events resulted to a doctor or other healthcare professional office/clinic visit. It was unknown whether treatment was received. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.